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The Department of Health and Human Services (HHS), the Public Health Service (PHS), 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) on May 4-5, 2000. The proceedings were held at the Holiday Inn Select in Decatur, Georgia. The following individuals were present to contribute to the discussion.
BSC Members
Dr. James Melius, ChairAgenda Item: ATSDR will present its behavioral and social science activities.
Action Item: The Executive Secretary will distribute to the BSC a revised list that fully describes the backgrounds of ATSDR's behavioral and social science staff members.
ATSDR Updates. Dr. Henry Falk, the ATSDR Assistant Administrator, explained that several approaches are used to address issues at sites due to differences in chemical exposures, community structures and public concerns. In addition to conducting studies, the Agency evaluates EPA data, convenes a public forum for discussion, and implements other community activities. The success of these initiatives varies among sites. The following areas are priority sites for ATSDR.Recent Sites of High Public Interest
ATSDR Changes Funding Allocation to Meet Demands. As EPA's cleanup activities shift over time, the Agency's responses will change as well. For example, ATSDR previously focused on reviewing EPA environmental data, but the Agency currently conducts more health-related and community-based initiatives. Another change is that ATSDR now conducts less elaborate public health assessments (PHAs). Instead of a detailed and systematic review of a site, the Agency provides health consultations, technical assistance and exposure investigations. These activities are designed to more timely answer site-specific questions related to cleanups, community concerns or exposure pathways. PHAs are still beneficial in summarizing findings at a site, but ATSDR sees a need to target activities and be more responsive to the public. Under the Community Involvement Branch (CIB), the Agency is also conducting more community outreach and site-specific health education. ATSDR is confident that a pediatric environmental health specialty unit will be established in all ten regions. The facilities will offer opportunities for referral, consultation and diagnoses of children who potentially have environmental problems.
ATSDR Responses to Requests from Congress. The number of briefings the Agency has made to Congressional members and staff is impressive and has dramatically increased since FY96. The rise in the requests for information at the Congressional level is due to increasing interest in ATSDR's site activities.
Increase in Public Requests for ATSDR Information. The public views ATSDR as an expert and resource for assistance. Since FY95, usage of the web site and toll-free number has sharply risen and the Agency's overall visibility has dramatically increased.
One of ATSDR's goals is to emphasize its valuable role in addressing toxic substance issues outside of Superfund hazardous waste sites. For example, in response to the problem with mercury preservatives in vaccines, ATSDR's scientists and the mercury toxicological profile were extremely helpful to other organizations involved in the initiative. To strengthen the Agency's visibility and credibility in the scientific community, the BSC recommended that ATSDR increase its external publications to showcase the outstanding data which have been collected. The Board pointed out that literature searches do not produce ATSDR studies; internal documents are not viewed as peer reviewed publications.
Action Item: Dr. Falk will present ATSDR's highest priority areas at future Board meetings and highlight exposure characterizations, chemicals and other active issues at these sites. This information will allow Board members to provide more targeted guidance and inform their respective constituents about ATSDR's ongoing activities.
Update on the Progress of ATSDR's Research Agenda. Dr. Melissa McDiarmid, the RAS Chair, reported that since the last BSC meeting, the criteria for priorities were incorporated into the draft research agenda. On November 31, 1999, the document was submitted to Dr. Jeffrey Koplan, the ATSDR Administrator and Centers for Disease Control and Prevention (CDC) Director. Based on the criteria that were established, the Agency's research projects will:Another significant development was the second external partners' workshop that was held in January 2000. Participants provided valuable input and a summary of suggestions are presented under each focus area of the research agenda.
Internal activities were also held to better understand the Agency's direction and research priorities. Over six brown-bag sessions, staff members reviewed the comments from the second external workshop. Separate focus group sessions were held for Senior Executive Management (SEM), branch and section chiefs, and scientific staff members. At a subsequent retreat, five workgroups identified 27 projects as a starting point for the research agenda. This activity is still under development. At the retreat, ATSDR merged special populations with the tribes and communities focus areas because both areas address vulnerable populations and contain similar research concerns. The Agency does not intend to diminish the significance of either category; the merger was done for the logistical purposes for the retreat.
An action plan was created to continue the development of the research agenda. Draft 1 was prepared after the workgroups synthesized the internal and external input. The document is being reviewed by RAS and the SEM Forum. After the review, Draft 1 will be revised; Draft 2 will be released for public comment through the ATSDR web site, and a Federal Register notice. The document will also be directly disseminated to BSC members and SCs, individuals who participated in the workshops and those who were unable to attend, the National Association of City and County Health Officials, state health departments, People of Color and Disenfranchised Communities, and other organizations on the ATSDR master stakeholder list. Following the public comment period, the Agency will convene additional internal and external meetings. Draft 2 will be refined by the workgroups; Draft 3 will be reviewed by RAS and the SEM Forum. At the November 2000 BSC meeting, Draft 4 will be presented to the Board for review and approval.
Discussion. The Board deliberated on ATSDR's research agenda as follows. The Agency provided its reasons for combining special populations with tribes and communities, but the BSC was still concerned that the individual projects would receive less attention under one category. ATSDR can play an important dual role in any research agenda by translating basic science into practice and bringing community-based projects to the attention of the research community. ATSDR should thoroughly review the research agendas of other agencies to eliminate repetition.
ATSDR clarified why it is developing a research agenda when its mission primarily relates to services. The Agency is challenged with delivering services that constantly evolve due to uncertainties in exposures, populations and health effects. Consequently, the research effort is essential to improve ATSDR's products and services. ATSDR broadly solicited input from other federal agencies and external partners to avoid duplicating research activities. Additional meetings with other agencies will be held before the research agenda is finalized. ATSDR will continue to collaborate with its partners during the implementation phase as well. One of the most successful interagency activities was ATSDR's involvement with the childhood cancer study. The National Cancer Institute (NCI) took the lead in operating the childhood cancer registry, but ATSDR played a primary role in explaining the types of environmental data that should be collected. ATSDR hopes to become involved with similar partnerships in the future.
Agenda Item: For the research agenda, ATSDR will present a review, the implementation plan, and any related interagency activities.
Action Item: To ensure that ATSDR's research agenda accurately reflects community and tribal concerns, the Executive Secretary will distribute the draft document for discussion at the July 2000 CTS meeting.
Panel Discussion of Other Research Agendas. Dr. Richard Sattin represented CDC; Dr. Hal Zenick represented EPA; and Dr. Bryan Hardin represented the National Institute of Occupational Safety and Health (NIOSH). The agencies' research agendas are outlined below.CDC. The agency's Prevention Research Initiative was established in FY99 in response to three needs. First, the change in life expectancy in the United States was primarily due to public health interventions and medical care. However, only 1% of the $1 trillion investment in the U.S. health care budget was allocated to population-based prevention research. Second, CDC's program announcements supported extramural activities, but only a small portion of funds was allocated to prevention research. The majority of dollars was spent on programs. Third, the former CDC Director saw a need for the Academic Health Centers and Prevention Research (AHCPR) to obtain more faculty who could conduct community-based research and apply findings. CDC developed the 21st Century Research Fund in FY99 which proposed to increase the National Institutes of Health (NIH) budget to $1.2 billion, the AHCPR budget to $25 million, and the CDC budget to $25 million. Although the increases were below the proposed amounts, the Prevention Research Initiative was incorporated as a line item into the Congressional budget.
The Office of Prevention Research (OPR) was established to advance the public's health through prevention research, as well as to promote, support, and facilitate the conduct of prevention research, particularly extramural research and the transfer to public health practice. Despite the formation of OPR, defining "prevention research" was a constant struggle for the agency because very few CDC centers, institutes and offices (CIOs) had developed research agendas. This gap did not allow CDC to create cross-cutting initiatives so that environmental health-related issues could be broadly addressed in communities, i.e., linking underlying chronic health problems with environmental exposures in susceptible populations. Because no model existed, CDC went to the Excellence in Science Committee to request the development of research agendas. The group develops science policies and coordinates various research activities throughout all CDC CIOs. Another difficulty was that roles in implementing research priorities had not been clearly defined, particularly between CDC and NIH.
To address these challenges, OPR defined its functions as (1) providing a central focus for the extramural research community; (2) promoting extramural research programs supported by CDC; (3) promoting and facilitating the development, implementation and evaluation of the research agenda with an external peer review process; and (4) monitoring the progress and success of extramural research. The prevention research framework is structured under four areas: gather information to develop interventions, test the interventions to obtain successful community models, identify and disseminate best practices, and provide infrastructure support for prevention research. CDC saw a need to enhance the research process and provided up to three years of funding for projects. An external peer review component was incorporated to ensure that funded activities meet the objectives of the program. CDC currently has a number of activities under development. For example, the agency is exploring the future role of CDC scientists and considering standardized cycles for the submission and review of applications. CDC is also developing a pilot project that will allow applications to be electronically submitted and reviewed.
Under the Prevention Research Initiative, CDC spent $12.5 million of the $14.8 million to support 52 extramural research grants in FY99. The agency will provide incremental funding in subsequent years so that investigators do not become discouraged and the momentum of the research projects will continue. Flat-line funding of $500,000 will be allocated in year 2; no new monies have yet been received for FY 2001. Some budget cycles will end during this period and the overall budget will increase to the previous level of funding. CDC realizes that the budget process needs improvement. In FY99, the agency focused on several research areas: prevention and urban research, injury prevention and public health statistics through Centers of Excellence; health communications; prevention in managed care settings; public health genetics; intervention effectiveness in occupational health; and new vaccines, i.e., varicella and herpes simplex. The criteria used to select the research areas were based on whether external input was solicited, if the project was new, whether the activity was important to public health, and if an external peer review component was included.
In the current year, funds were provided to individual CIOs. The project officer manages the grant, but is required to provide periodic progress reports to OPR. Approximately 65% of monies were awarded to schools of public health; other grant recipients included local health departments and schools of medicine, nursing and engineering. CDC also places a heavy emphasis on grant reviewers. Individuals are selected based on expertise in applied public health research. Engineers who review the biomechanics portion of the applications serve on review panels as well. However, CDC makes strong efforts to ensure that both groups have a basic understanding of the application beyond their field of expertise. The agency plans to incorporate this approach into all CDC study groups.
EPA. The EPA divisions that are the driving force for the Office of Research and Development (ORD) research agenda have specific mandates and are required to produce strong science to support regulatory decisions. The needs of the ten EPA regions are also factored into a fairly systematic planning process. ORD is divided into five laboratories and centers that focus on risk assessment and risk management. The three national laboratories are responsible for EPA's intramural research framework and have both health and ecology mandates. The two national centers are responsible for EPA's $100 million extramural grant program and have both environmental and health mandates. The peer review component that has been incorporated evaluates projects for both science and relevance. ORD has made strong efforts to develop the program so that science is conducted for a purpose.
All EPA divisions operate under ten strategic goals: clean air; clean and safe water; safe food; pollution prevention and risk reduction in communities, homes, workplaces, and ecosystems; improved waste management, restoration of contaminated waste sites, and emergency response; reduction of global and cross-border environmental risks; expansions of Americans' Right To Know About Their Environment; sound science, improved understanding of environmental risk and greater innovation to address environmental problems; a credible deterrent to pollution and greater compliance with the law; and effective management. ORD plays a role in eight of the ten strategic goals. In addition to conducting research to support these goals, ORD also has a core research program that addresses near-term and problem-driven issues and develops basic methodologies and models for broad application. The majority of PHS agencies have no core research program to address problems on a long-term basis.
In the late 1990s, ORD developed a strategic plan with input from a diverse group of stakeholders, including internal and external scientists, EPA's programs and regions, and industry. The stakeholders identified a number of research topics that were consistent with ORD's mission, such as particulate matter in air, integrated ecosystem protection and endocrine disruptors. Risk-based criteria were then established in the areas of human health and the ecosystem, risk management, and risk assessment methods and models. To avoid duplicating efforts, ongoing activities in other parts of the government were examined and EPA's strategy documents were disseminated to other agencies for review and comment. The research areas were rated on whether additional data were needed in epidemiology, toxicology or exposure. The agenda that was developed allowed the laboratories and centers to create an implementation plan or request for proposals (RFPs).
Over the past six years, ORD has continued to focus on several emphasis areas, i.e., ecological and human health risk assessment, particulate matter, drinking water, global changes, endocrine disruptors, pollution prevention and new technologies, safe food, and children's health. One of the most innovative products under development is an easy and affordable mechanism for communities to monitor air and water quality. The agency is also designing strategies to change individual behavior to reduce air pollution and improve environmental quality.
The core research program is primarily conducted under the ecological and human health risk assessment programs. One of ORD's current difficulties is in merging these two activities. Another challenge is the planning process because Congress requires federal agencies to concurrently consider three budget cycles. A stakeholder's request for ORD funding may be accommodated by linking onto an ongoing activity, but more complex projects may not be awarded for two years since budgets must be submitted to Congress two fiscal years in advance. Many federal agencies are now advocating for a two-year budget process to reduce planning efforts.
The systematic planning process includes scientist-to-scientist meetings, progress reviews, regional planning meetings, strategic reviews, recommendations by research coordination teams, cross-goal prioritization, proposals by the ORD Executive Council, research by the Coordination Council Review, final decisions, and budget submission. Although the planning process is conducted on an annual basis, ORD is responding to the Government Performance and Results Act by developing long-term multi-year plans for the implementation process. This critical approach will allow the laboratories and centers to review goals and performance measures for any year; inform stakeholders about upcoming budget cuts; ensure projects have agency-wide endorsement; and allocate resources to support environmental issues that may arise in the future.
In addition to stakeholder input, EPA also solicits feedback from communities and tribes. The agency's National Environmental Justice Advisory Committee (NEJAC) will adopt a different strategy for its May 2000 meeting. A panel of agency representatives will discuss a more holistic approach to address health disparities in communities. This integrated process may lead to a stronger funding base as well. In addition to NEJAC meetings, EPA also seeks community input through public stakeholder meetings and outreach efforts from regional program officers.
Due to mandates, opportunities are limited for EPA and other agencies to obtain community input on a broader basis. However, ATSDR is the community practice leader in the country. A collaborative effort could be structured which would utilize the strengths and integrate the missions of each respective agency. For example, ATSDR could identify data gaps from a site-specific perspective and then inform other agencies about these findings for application in the research arena. This dynamic approach is a critical need because agencies currently develop collaborative efforts after an issue arises. This method has proven to be ineffective due to different agendas, roles and mandates among agencies.
NIOSH. In 1995, the agency engaged in an effort to launch the National Occupational Research Agenda (NORA). The plan was to develop 15-25 top priorities to improve worker safety and health in the U.S. and guide research into the next decade. NIOSH established several criteria to select the research areas: seriousness of the hazard; number of workers exposed to or magnitude of the risk; potential for risk reduction; expected trend in importance of the subject; need for research; and sufficiency of existing research. Because NIOSH's budget and internal resources were insufficient to address all of these areas, input was solicited from other federal agencies, academia, health professionals, industry and labor.
NIOSH established the Corporate Liaison, Worker Liaison, and Outreach Committees to obtain external feedback; internal advice was solicited from the agency's Board of Scientific Counselors, Mine Health Research Advisory Committee, and National Advisory Committee on Occupational Safety and Health. In addition to the external and internal committees, meetings were convened with expert workgroups and communities. The NORA planning process was also published in the Federal Register.
NORA was completed using a highly iterative process. An internal planning workgroup developed an initial list of priority topics. A public meeting was held on November 30, 1995 and an agency-wide meeting was convened shortly thereafter. Information was gathered from four workgroups. NIOSH synthesized NORA and then released the draft document for public review and comment. The document was revised, finalized and unveiled on April 28, 1996. NORA was developed to provide a framework to guide occupational safety and health research at the national level. Approximately 500 organizations and individuals outside of NIOSH provided input into the research agenda. The final product resulted in 21 priorities under three categories: disease and injury, work environment and the workforce, and research tools and approaches.
The process to implement NORA required an even stronger effort than the planning phase. A broad-based network of public and private partners was established. The twenty partnership teams have 120 NIOSH staff members and 150 external partners; the Federal Liaison Committee has more than forty federal partners; and the NORA Liaison Committee has 22 partners from industry, labor, academia, professional societies and government. Additionally, the Quality Assurance Committee is responsible for ensuring that all projects submitted to NORA are consistent with one of the 21 priority areas of the research agenda. Although NORA was unveiled in 1996, the committees continue to hold meetings, produce white papers, organize activities under each priority area, and provide guidance to NIOSH. The success of NORA is evaluated by a number of mechanisms: the amount of funding allocated to research projects; partnership products, such as co-sponsored extramural research, NORA team products, conferences and workshops; and recognition of NORA through scientific literature, NORA citations and web site hits.
One of NORA's 21 priority areas focuses on special populations among workers, i.e., racial and ethnic minority groups, women, young workers and older workers. Exposures to these groups will not be monitored because surveillance is not a NORA priority area. However, surveillance research methods is one of the 21 priority areas. For example, a research project could be supported by NORA if an investigator proposed to develop a new technique or data source to conduct surveillance, particularly among special populations. NIOSH also conducts cancer etiology studies in worker populations to determine an excess risk and cause of the disease. Cluster studies are extremely difficult to implement with scientific rigor. These types of investigations rarely provide a definitive scientific conclusion.
In terms of NIOSH's investment in NORA priority areas, $15.4 million was allocated in FY96, $28.1 million in FY97, and $46.9 million in FY98. The budget includes grants, intramural research and cooperative agreements. NIOSH has also been monitoring investments by other federal agencies. In FY96, NIOSH invested $165 million in occupational safety and health research, while other agencies invested $39 million for similar activities. In FY98, NIOSH increased its investment to $187 million; support from other agencies in occupational safety and health research decreased from $37 million to $31 million. However, the investment to NORA activities by other federal agencies increased from $15 million to $23 million during FY96-FY98.
To obtain external funds, NIOSH uses study sections modeled after the NIH system. Of the $5 million Congressional earmark to implement NORA, NIOSH allocated 75% to extramural programs. In FY98 and FY99, NIOSH spent $8 million and $9 million, respectively, on projects conducted under targeted RFAs. These activities were performed in partnership with NIH institutes; EPA joined the collaborative effort in FY 2000. In actual dollars, NIOSH's budget has grown from $80 million in 1980 to $200 million in 1999. In terms of inflation-adjusted dollars, however, the agency's current purchasing power has decreased since 1980. The success rate of NORA grants increased 20% in FY99. NIOSH attributes much of the growth in the overall budget to NORA.
Discussion. The Board deliberated on the agencies' research agendas as follows. CDC should consider a different approach in the Prevention Research Initiative. Instead of incorporating a community component into an established activity, the agency should solicit community input up-front and then develop the project to more effectively address health issues at a site.
EPA listed its first strategic goal as clean air, but the agency described no process which will inform community and tribal members about chemicals emitted into the air along U.S. borders. The American public suffers adverse health effects from releases at these sites, but no action can be taken since the emissions occur in another country. The government has historically gathered site-specific data to make public health determinations, but no agency has linked these findings with treatment. Residents at Superfund sites continue to be frustrated with the fact that EPA does not set aside funding for ATSDR to provide health care to impacted communities.
Citizens have testified to Congress that ATSDR and EPA activities should be supported, but Congress believes sites are being cleaned and issues are being appropriately addressed. Agencies are losing strong constituencies because opportunities for communities to provide input are limited and untimely. For example, EPA stated that the FY 2002 budget for federal agencies is almost complete. Agencies must make a concerted effort to seek feedback from the public early in the process of developing and implementing research projects.
While ATSDR is developing its research agenda, careful attention should be paid to study populations. Agencies constantly develop new cohorts without taking advantage of existing subjects. Due to the expense of implementing a research agenda, agencies should also use existing data so that epidemiologic studies are conducted in a more cost-effective manner. In terms of interagency collaborative efforts, ATSDR should explore opportunities in NIH. Pages 12-15 of the November 1999 BSC meeting minutes contain a summary of NIEHS research priorities and areas of emphasis. EPA and NIEHS jointly developed proposals for mixtures studies. Additionally, a workshop on biomarkers of exposure, effect and susceptibility was established to develop a partnership between EPA and NIEHS researchers. One of the strongest epidemiologic recommendations that was made during the workshop was to develop a mechanism to utilize existing cohorts and create prospective studies. ATSDR should make strong efforts to be included in the EPA/NIEHS partnership since the activities are consistent with the Agency's mission and area of expertise.
The panel followed up with some comments based on the Board's discussion. EPA recently received a request from Region 10 to provide resources to complete the Columbia River assessment. The agency confirmed that funds will be allocated to finalize the evaluation. EPA realizes that encouraging Canada, Mexico and other border countries to address environmental health issues is a complex issue. The agency admits that it has been only marginally successful in this regard. The North American Cooperation Environmental Commission will host a meeting next week in Toronto to discuss children's health. The meeting will be the first legitimate attempt to facilitate a discussion on trilateral issues. If the meeting is a success, EPA will consider partnering with this group on U.S./Canada environmental health issues. As an interim measure, EPA's Tribal Operations Council is attempting to establish a Tribal Science Council to determine science and research needs and set priorities. In terms of using existing populations, a multi-agency task force has been established to determine the feasibility of developing a longitudinal birth cohort. The HHS Secretary has endorsed this activity; ATSDR's Office of Children's Health is involved with the initiative along with CDC, EPA and NIEHS.
ATSDR also clarified a few issues raised during the discussion. Over the past few years, consideration has been given to securing funds for EPA to support ATSDR in conducting treatment and clinical activities in communities. Historically, Congress has not been in favor of ATSDR becoming involved in the health care and clinical treatment arenas. This issue will have to be addressed by Congress and not EPA. In terms of site-specific issues, ATSDR has made strong efforts to explain to Congressional staff members that health concerns remain in a community even after clean-up activities have been completed. During future briefings, the Agency will continue to raise this issue.
In an effort to coordinate activities, ATSDR works with the Research Director's Forum in which representatives from a variety of agencies meet on a regular basis to discuss their respective research agendas and science issues. Unlike EPA, ATSDR does not have an office and budget specifically established for research. However, several models that may be applied to ATSDR's research agenda were noted, particularly NIOSH's Federal Liaison Committee. ATSDR thanked the panel for providing the Board with information to begin to focus on implementing the research agenda.
Action Items: (1) The Executive Secretary will make copies of the panel's overheads for distribution to the BSC and SCs. (2) Dr. Zenick will provide the status of the Columbia River assessment to the Executive Secretary to be shared with the Board and SCs. (3) Since ATSDR has developed a collaborative relationship with the International Joint Commission, Dr. Falk will contact the group to determine if assistance can be provided to EPA in addressing U.S./Canada environmental health issues.
Panel Discussion of Issues Related to Storing Samples. Ms. Elaine Gunter represented the National Center for Environmental Health (NCEH); Ms. Barbara Kilbourne represented CDC; and Dr. Wendy Kaye represented ATSDR.NCEH. ATSDR should consider specimen banking due to the following reasons. First, study sites may include unique populations or exposures. Second, specimens can be used by other investigators to explore different hypotheses after the original study purpose has been completed. Third, new technologies or biomarkers will emerge in the future. Although biological samples are the primary focus, other matrices can be stored as well, such as residual serum, urine, hair, whole blood, white blood cells and extracted DNA. In order to bank specimens, ATSDR must consider the available sample volume, storage temperature, analyte stability and related data.
In planning a study or using samples from a previous investigation, ATSDR must be mindful of the fact that storage temperatures affect specimen stability. At -20C, serum is not totally frozen. Enzymatic processes are still occurring until the temperature is less than -40C. For long-term stability, vapor-phase liquid nitrogen storage is the best method. Some analytes are extremely stable and require no preservatives, including trace metals in urine, serum and whole blood; pesticides, PCBs, dioxins and furans in serum; non-persistent pesticides in urine; phthalates and polycyclic aromatic hydrocarbons (PAHs); extracted DNA; and proteins and antibodies. Conversely, vitamins such as C and RBC folate are not stable without original preservatives or processing. White blood cells require prompt isolation and cryopreservation. Additionally, freeze-thaw affects many enzymes.
Due to the different characteristics of specimens, ATSDR should designate reserves. While designing a study, the Agency should collaborate with laboratorians to ensure that extra specimens can be properly collected, processed, shipped and stored. The designated reserve should be incorporated into the Institutional Review Board (IRB). For maximum study efficiency, a nested case/control design should be used so that only the subjects needed to answer research questions will be used. Saving related data will provide maximum specimen usefulness to future researchers, particularly critical demographic data, i.e., age, sex, race/ ethnicity and geographic location. Other information that describes the original purpose or outcome of the study should be maintained as well. However, data under litigation may not be linked. ATSDR's collections should be stored in the CDC/ATSDR Specimen Packaging and Information Repository (CASPIR). The facility is located in Lawrenceville, Georgia and serves as the repository for all ATSDR and CDC CIOs. After a study has been completed, donating samples to CASPIR is easy. Several valuable collections that are stored at CASPIR have been of tremendous benefit to previous studies, such as Legionnaire's Disease, Hantavirus, dried blood spots, AIDS and the National Health And Nutrition Examination Surveys (NHANES). The cost of storing samples in CASPIR is approximately 14¢ per vial per year.
CDC. In collecting and storing biological materials, CDC's most notable problem lies in specimen management due to reluctance by scientists to discard samples, variable quality of stored materials, different methods of cataloging records, and a turnover of collection custodians. To address this problem, CDC involves all parties in active specimen management; provides uniform and high-quality storage under documented conditions; develops standardized and searchable methods to track specimens; ensures the continuity of custodians; and allows investigators to maintain control. CDC has also created the Archival Specimen Tracking and Retrieval Operation (ASTRO) to track the entire history of samples and epidemiologic data. However, laboratory results are not maintained under ASTRO.
Another action CDC has taken to improve specimen management is the development of unique specimen identifiers so that each vial will have a different number. The tracking system will be implemented throughout CDC regardless of whether the specimen is located on or off the CASPIR site. To efficiently locate stored specimens, the description of the study must be clearly defined, i.e., the study's date, location, population and purpose.
CDC's 1,558 freezers currently hold approximately 38 million specimens; CASPIR alone has the capacity to store 8.5 million samples. The facility is operated by contractors. One of the primary goals of CASPIR is to provide a centralized repository for invaluable and well-characterized collections. Strong efforts are made not to utilize the facility as a warehouse. CDC is most challenged in universally applying a unique identifier to each specimen. The agency is also aiming to integrate collection data with other information systems, facilitate both internal and external collaborations, and increase overall efficiency throughout CDC. To achieve these goals, the agency has created the CASPIR Policy Board for the operation of the facility. Representatives from all CIOs serve on the Board. The most critical policy the board developed was guidance for human subjects review to enter specimens into and withdraw samples from the bank.
Specimens submitted to CASPIR must adhere to following criteria. The scientific custodian is responsible for providing copies of consent forms for the overall study. A notation must be made if no consent was obtained. Specimens collected from non-research protocols that will be used for future research projects must have a consent form. Requests for linked specimens which are beyond the purpose of the original study require approval by the CDC IRB. Samples withdrawn from CASPIR must adhere to the following criteria. (???)
The scientific custodian must approve the request for withdrawal. Non-research specimens are not subject to IRB review, but the IRB may request that the study be examined by the Scientific Review Panel. The panel is a group of scientifically qualified individuals selected by a CIO to make decisions on admission to or release of collections from CASPIR. The panel meets on an ad hoc basis and considers the following areas to address requests for samples: the possibility of obtaining consent from the original study participants; the existence of medical interventions that may require the reporting of laboratory results; the existence of limited specimens from each individual in the collection; and whether the proposed study is the best use of the specimen.
IRB approval is required for all specimens linked with identifiers that will be withdrawn and used for genetic testing. For anonymous specimens or unlinked collections, genetic testing must undergo examination by the Human Subjects Review Office. To eliminate some of the confusion between "anonymous" and "linked," CDC has clearly defined these terms. Anonymous means that no person on the planet can learn the identity of the individual from whom the original sample was taken. Linked means that the name, social security number or other data are connected to the specimen and the identity of the person from whom the specimen was collected could be learned.
ATSDR. Storing specimens for future testing is unquestionably of benefit to ATSDR, but two critical decisions must be made during the planning process: whether the specimens will be linked or anonymously stored and if storage is optional for the study. Both of these issues will affect how the consent form is written and the type of consent that will need to be obtained. Optional storage means that an individual can participate in a study without agreeing to storing specimens for future testing. This option must be explicitly stated to the subject. In addition to the consent form for the overall study, a separate consent statement for storage must be signed as well. Non-optional storage means that future testing is an integral part of a study. An individual who is unwilling to allow the storage of specimens for future testing cannot participate in the study.
Consent forms must explain how the specimens will be used. If future plans are unclear, new consent forms will have to be obtained at the time of testing. Consent forms must also specifically state whether future plans will include genetic or HIV testing. To assist in the decision-making process, subjects should also be informed about tests which will be excluded from the study, the process to remove specimens from storage, and the type of test results that will be shared with the participant. For anonymous specimens, subjects must be explicitly told about plans to store leftover specimens.
Participants must also be told that removing samples from storage and receiving test results are not permitted with anonymous specimens. To ensure confidentiality, the Privacy Act prohibits parties other than the participants from receiving test results as well. However, the investigator can decide to share test results with the participant if the individual's health is determined to be at risk. Extreme caution should be taken in writing consent forms because IRBs will not allow specimens to be used for any purpose that is not expressly stated on the form. CDC and ATSDR are usually more strict in enforcing IRB regulations than universities. CDC is not storing specimens from communities or organizations and ATSDR is not storing leftover specimens for future testing. However, the Board suggested that IRB issues be resolved in order to use banked samples to address future research questions and potentially identify previous trends. The panel noted that ATSDR investigators can use CDC's stored samples to determine if a collection meets demographic or geographic needs and can be tested to identify exposure levels.
Agenda Item: ATSDR will present scientific issues and its programs related to biomarkers and biological monitoring.
Overview of Cultural Sensitivity Training on Native American Issues. Ms. Leslie Campbell, the Acting Tribal Coordinator of the Office of Tribal Affairs (OTA), explained that three concepts which impact ATSDR's policies and public health programs must be understood to effectively work with tribal governments. First, sovereignty entitles tribes to the right of self-government and distinguishes tribal members from other ethnic minorities. Second, federally recognized tribes have a special government-to-government relationship with the federal government. Third, federal trust responsibility directs all federal agencies to consult with and consider the interests of tribes when engaged in activities that may affect the population. This special relationship between the federal government and the 550 federally recognized tribes is a result of Indian treaties, statutes, executive orders and historical relations. The protection of the sovereignty of each tribal government is included in the trust responsibility.The Supreme Court decision of Worcester v. Georgia in 1832 gave Indian tribes sovereign treaty-making power, but defined an Indian nation as a domestic dependent nation under the dominion of the United States. Guardianship began to evolve into a trust relationship that emphasized tribal rights and corresponding government obligations to protect tribal resources. From 1817 through 1977, the political climate of interacting with tribes dramatically changed. In 1975, Congress passed the Indian Self-Determination and Education Assistance Act, which gave all tribes the opportunity to assume control over government programs and services formerly provided by the Bureau of Indian Affairs.
In working on tribal sites or developing tribal environmental health programs, ATSDR must understand and honor the rights of sovereign nations while following Agency tribal policies. ATSDR is making strong efforts to integrate public health science with tribal policy in four areas: (1) technical staffing in OTA and internal collaborations with other staff; (2) training courses for Agency staff in government-to-government relations; (3) development and dissemination of pertinent ATSDR tribal policy; and (4) cooperative agreements with Tribal Colleges and Universities to build infrastructure and environmental health expertise. The Agency is currently involved in approximately forty Superfund sites, excluding Alaska, that are near reservations. Two recent case studies illustrate the ATSDR/ tribal coordination.
Drinking water contaminated by an unplanned release left 1,000 individuals in the St. Regis Mohawk tribe without water. HHS and the tribe requested that ATSDR assist in this matter in a government-to-government relationship. ATSDR collaborated with the tribe, tribal council, health agency, environmental department and EPA to quickly identify the problem, develop a technical consultation and make recommendations. This issue has now been resolved in most of the homes in the tribe. To address cancer concerns of Alaska Natives, DoD, the Core of Engineers (COE) and the Alaska Native Health Board (ANHB) requested ATSDR's assistance. The regional health concerns related to whether the increased incidence of cancer was caused by the 500-800 formerly used defense sites throughout Alaska or other environmental assaults. Since this complex and technical issue needed to be addressed through an interagency effort, ATSDR developed a work group with COE, ANHB, EPA and state agencies. A pilot project was created to identify problems in the communities; research is being conducted on the food chain and subsistence lifestyles.
The pilot project was first tested in the Savoonga and Gambel villages. ATSDR met directly with the village governments and residents to explain its role in the activity. In a health consultation, ATSDR and the villages collectively defined the needs and concerns of the community. Communication continued throughout the duration of the activity. The findings from the health consultation will be released shortly. ATSDR has taken many steps to work more effectively with tribal governments, particularly the creation of OTA. However, the Agency is requesting that the BSC provide guidance to further improve the following areas: methods to more fully integrate public health science into tribal policy; the sufficiency of current mechanisms; and recommendations to strengthen ongoing activities. The Board commended ATSDR in its strategies to enhance relationships with tribes, but a suggestion was made to direct the questions to tribal members and health professionals instead of the BSC. ATSDR responded that in collaboration with IHS, a national tribal forum on environmental health is currently being developed. Input is being directly solicited from tribal members to determine current needs and how agencies can best address these issues.
Lessons Learned fron Division of Health Studies. Dr. Jeffrey Lybarger, Director of DHS, presented some perspectives on activities related to the development of ATSDR's research agenda. The mission of DHS is to evaluate the relationship between exposures to hazardous substances and adverse human health effects. The goal is achieved through the Human Health Studies Program (HHSP), which covers four focus areas of investigation and seven priority health conditions (PHCs): cancer, birth defects and reproductive disorders, immune function disorders, kidney dysfunction, liver dysfunction, lung and respiratory diseases, and neurobehavorial disorders. To identify an approach for conducting research and to learn more about PHCs, the focus areas of research were built on a body of knowledge. The occurrence of PHCs among persons living near hazardous waste sites was determined; associations between PHCs and exposure were evaluated; sensitive methods to locate persons with adverse health effects were identified; and clinical regimens that may be useful for persons with adverse health effects were assessed.DHS employed several approaches to implement the program. RFPs were annually released for states, universities and other partners to conduct research on selected PHCs, such as birth defects, respiratory diseases and immune function disorders. Site reviews were conducted to provide opportunities in identifying study ideas, such as neurobehavioral studies of lead-exposed persons in the Bunker Hill community. Descriptive databases were developed to identify analytic opportunities, such as -cell changes among persons living near waste sites. Hypotheses for selected follow-up studies were generated in descriptive studies, such as the investigation on speech and hearing effects in children in the TCE subregistry. DHS traditionally uses biomarkers of exposure and effect whenever possible in conducting analytic studies. In the future, DHS hopes to add susceptible populations as a component of the PHC research to determine increased sensitivity and identify the presence or absence of disease due to hazardous substances.
One of the most notable limitations in the HHSP related to irregular resources. Only $2 million was allocated in the most successful year of the program. In 1997, 1998 and 2000, ATSDR received no funding to support RFPs for PHC research. This situation is most likely because ATSDR's priorities are changing to health promotion, medical monitoring, site-specific studies and other activities. To make the research agenda a critical initiative throughout ATSDR, a strong statement will have to be made by the Agency's supporters and a specific portion of the budget will have to be allocated to PHCs. Another limitation is related to the time to develop a protocol and obtain clearances. This goal is extremely difficult to meet since budgets must be developed in advance. The required approach does not lead to conclusions that can be incorporated to provide a body of knowledge. Coordinating strategies from a variety of partners, i.e., EPA, other federal agencies and particularly state health departments, is extremely difficult. Additionally, the PHC categories are still broad and need to be more focused.
Despite the limitations, a number of benefits have resulted from the HHSP. ATSDR has built a body of evidence for outcomes that are based on knowledge rather than methods. ATSDR has also provided assistance in prioritizing requests that were outside the scope of the research agenda. The activities fulfilled an Agency need by addressing public health concerns related to Superfund. The internal benefits include ATSDR's access to a broad spectrum of disciplines and new methodologies; early identification of priority situations and the capacity to respond; development of a cadre of talented staff; and ability to interact with other government agencies and outside experts.
In developing the research agenda, DHS is proposing the following recommendations to ATSDR based on the lessons learned. An area of research with specific needs and goals for the Superfund program should be identified. The scope should be focused and specific. ATSDR's commitment in achieving its research goals is essential and should continue. A coordinated program throughout the Agency is critical and should be developed. A formal periodic evaluation component should be incorporated. ATSDR must commit resources to the research agenda. A mechanism should be created to address the conflict between necessary knowledge and priority activities that will guarantee resources at any given time.
Discussion. The Board deliberated on the DHS activities as follows. ATSDR is to be commended for using biomarkers of exposure and effect because these approaches are validated and well-documented. However, to address complex mixtures, assess exposure and identify health problems in communities, ATSDR should develop innovative strategies to use biomarkers. In terms of collaborative efforts, the Agency should consider adding large managed care organizations to its list of partners. Unlike other federal agencies, ATSDR does not release RFPs to private universities. In addition to not utilizing the expertise of these investigators, this practice will alienate potential ATSDR supporters. DHS agreed that strong efforts need to be made in refining biomarkers of exposure and effect. In response to new partners, the Agency confirmed that it has always advocated for releasing RFPs to private institutions under Superfund reauthorization.
Division of Toxicology (DT) Applied Research Program (ARP). Dr. Christopher DeRosa, Director of DT, presented an overview of ATSDR's ARP. Dr. Mildred Williams-Johnson presented the Environmental Health and Toxicology Research Program (EHTRP); Ms. Yee-Wan Stevens presented the Voluntary Research Program (VRP); and Dr. Heraline Hicks presented the Great Lakes Human Health Effects Research Program (Great Lakes).
Overview. The BSC is to be commended for providing DT with such excellent guidance over the past nine years of the ARP. The Board's advice has been of great benefit in establishing the scope and direction of the program and evaluating outputs from the research. ARP is an integrated toxicology program that is Congressionally mandated under Superfund legislation. Under ARP, substances that are typically encountered at hazardous waste sites are placed on the National Priorities List (NPL). In cooperation with EPA, DT analyzes the 275 substances based on frequency and toxicity. The NPL then triggers the development of toxicological profiles. These data represent peer and publicly reviewed evaluations of literature in the areas of exposure, toxicology and epidemiology. The profiles inform the deliberative process that accompanies each ATSDR program, including emergency response, PHCs and health advisories.
ARP improves and strengthens the information base for public health practice. For exposure, the program provides tools to better identify media-specific levels of contamination; characterizes pathways which may expose vulnerable communities; and defines body burdens resulting from completed exposure pathways. For toxicity, ARP develops tools to better identify target organs, biomarkers and mode of toxic actions. ARP has addressed chemical mixtures in collaboration with EPA and NIEHS. The HazDat database was used to identify representative mixtures which were then provided to NIEHS for testing of estrogenecity and dioxin-like effects. DT also developed criteria based on a weight of evidence and accurately predicted the direction of interaction. This model is currently being used to develop rules that can be applied internationally in Germany, Norway, Canada, The Netherlands and other countries. The method has already been adopted by EPA in revised draft risk assessment guidelines for chemical mixtures.
Environmental Health and Toxicology Research Program. The program was initiated over eight years ago to fill research needs for evaluating the relationship between toxic substances and adverse health effects. The program was originally designed to enhance research capabilities of investigators at the Association of Minority Health Professions Schools (AMHPS). EHTRP was the first ATSDR program to use Superfund dollars to address this Congressional mandate. The program was also ATSDR's first relationship with a non-state organization. Consistent with the mission of AMHPS, EHTRP serves the health needs of poor or minority communities. Demographics show that these populations are largely impacted by hazardous waste sites and other toxic chemicals in the environment. In its numerous evaluations of EHTRP, the BSC endorsed the program, attested to its high quality and "concurred that the rate of publications documented the success of the program."
EHTRP has proven to be a critical element for filling ATSDR's research needs. To date, 37 papers have been published under the program and four manuscripts are currently under review. The publications have addressed fourteen research needs that are reflected in updates to the toxicological profiles. Ongoing activities will address an additional twelve research needs. In 1998, Meeting Environmental Health Challenges Through Research, Education and Service was published to promote the program and describe research activities and findings during the first five years of the cooperative agreement. The publication also discussed the impact the research will have on ATSDR's ability to fulfill its mission to evaluate the human health consequence of exposure to toxic substances in the environment. The booklet was widely distributed to Congress, Congressional staff members, state and local officials, as well as the scientific community.
EHTRP integrates well with ATSDR's research agenda. For exposure assessment, Xavier University is examining environmental media levels for manganese. The substance is found in over 603 NPL sites and has been defined as a contaminant of concern in more than 378 PHAs. Although manganese is an essential element, inhalation at high levels is known to be a neurotoxic hazard. Substantial data now indicate that manganese may also be toxic from oral exposure. Research on this compound is critical since manganese is widely available as a gasoline additive. Wide distribution of manganese in the environment may result in a public health concern.
For evaluation and surveillance of health effects, Tuskegee University is studying the reproductive and developmental effects of chlordane, which is a persistent and organic chemical. Since chlordane is infrequently used in the United States, EPA has not mandated that research be conducted under the Toxic Substances Control Act. As a result, the Tuskegee project is the only mechanism to gather critical data on chlordane, which has been listed as a potential endocrine disruptor. The project will also determine whether low level exposure of the compound over a long period can be associated with reproductive hazards and developmental effects in the developing fetus.
For community and tribal issues and susceptible populations, Morehouse School of Medicine is conducting a longitudinal study to examine the effect of lead exposure from the maternal/ infant relationship in utero through early childhood. The investigators have utilized innovative methods to actively involve the community in the study, such as educating residents on the toxicity and hazards of lead exposure; establishing community liaisons; developing collaborations with state and local health officials; visiting homes in a specially designed van; maintaining contact with study participants; and providing transportation for subjects to participate in follow-up activities. These creative strategies have resulted in a high recruitment rate. The 80% retention rate is particularly impressive for a longitudinal study conducted in a poor and minority community.
For health promotion and intervention, Charles Drew University is analyzing the effect of lead body burden on blood pressure during pregnancy. As a component of the recruitment effort, study participants and family members are educated about lead hazards and toxicity. Because the institution serves a large Spanish speaking population, the majority of staff members are bilingual and extensively interact with the community. Educational materials are developed in both Spanish and English. The university provides transportation to study participants.
For the evaluation of chemical mixtures, Meharry Medical College is analyzing the effects of ingested and inhaled PAHs. Collectively, PAHs are ranked #9 on the NPL and are defined as contaminants of concern in more than 148 sites. The literature shows that PAHs are a significant carcinogenic agent, but there is limited information about other possible health effects. Meharry has gathered new information which demonstrates that the ingestion of PAHs is associated with neurological effects. Preliminary data indicate that inhaled PAHs may be linked to reproductive effects. This new evidence will assist scientists in evaluating potential public health concerns in communities with possible exposure to PAHs.
In the future, efforts will be made to use the research capabilities at AMHPS institutions to address children's health, women's health and endocrine disruptors. In 2002, a symposium will be convened to evaluate findings from the second five-year cycle of the cooperative agreement, assess the impact of the conclusions on ATSDR's public health mission, and plan future directions of the program. The Agency has greatly benefitted from its collaboration with AMHPS. EHTRP appeals to and is respected by academic scientists. The investigators expanded activities under the program and secured more than $4 million in research funds from sources other than ATSDR to answer environmental health questions. The program attracts both experienced and young research scientists. EHTRP has stimulated entry into the environmental health arena by undergraduate and graduate students. The program continues to serve as the primary mechanism for filling research needs that ATSDR has identified for priority hazardous substances.
Voluntary Research Program. In 1992, ATSDR published its procedures for conducting voluntary research. The program was designed as an open and public process. Public meetings were held with EPA, NIEHS, environmental groups and industry. ATSDR placed strong emphasis on external peer review of the program as well. To implement the program, the Agency signed five Memoranda of Understanding (MOU) with industry groups: 1 with General Electric Company, 1 with Chemical Manufacturers Association, and 3 with Halogenated Solvents Industry Alliance, Inc. The findings from this research have been shared with the scientific community; press releases about the studies are issued as well. The conclusions have been used to update ATSDR's toxicological profiles and are currently addressing twelve research needs. Since industry groups conduct the VRP studies, DT verifies the scientific adequacy of all protocols and results to ensure extremely high standards of accountability and technical credibility. In negotiations with EPA, DT received assurances that the private sector companies would not be penalized by the findings.
VRP integrates well with ATSDR's research agenda. For evaluation and surveillance of health effects, the program fills critical toxicologic data gaps and uses state-of-the-art computational toxicology tools. For community and tribal issues and susceptible populations, the studies address relevant health effects for the developing fetus, children, adults of reproductive age, the elderly, and immunologically compromised individuals. In the future, strong efforts will be made to attract more partners to the program. VRP will also support the proposed study on verification of neurodevelopmental test methods. Collaborations will be expanded to address research needs for volatile organic chemicals and other compounds. VRP has produced measurable results, particularly strong and effective partnerships with the private sector. ATSDR has been able to augment its mandated research programs in conjunction with NIEHS. Additionally, the Agency saved $5 million in research costs due to the VRP partnerships.
Great Lakes Research Program. The Congressionally mandated research program is in the eighth year and was designed to characterize short- and long-term adverse health effects due to exposure among populations in the Great Lakes Region. Research activities are conducted by state health departments and academic institutions. A cohort of approximately 14,000 persons was established for the study. The program has determined exposure pathways and body burden levels in vulnerable or susceptible populations; identified sensitive human health endpoints; addressed fourteen substance-specific research data needs; and maintained collaborative relationships with partners. In an external evaluation, the BSC attested to the program's high quality and "concurred that the program has had substantial impact on the increase in scientific knowledge about pathways of exposure and human health outcomes related to toxicants."
Great Lakes integrates well with ATSDR's research agenda by addressing data gaps identified in all five focus areas. For exposure assessment, sociodemographic data were collected to evaluate exposure potential; an exposure matrix was developed to assess total exposure; multi-media contaminant levels were assessed; biomarkers of exposure, effect and susceptibility were determined; and a database of body burden levels was established by age, sex, ethnicity and locality. For the evaluation and surveillance of health effects, human health studies were initiated to evaluate adverse health outcomes; a longitudinal cohort of adults was established; and a unique cohort of neonates and young children was developed. The neonates are now 3-5 years of age and are still being followed. The three-year data have been released, but DT is interested in following the children past pre-school age to examine the issue of trans-generational impacts.
For community and tribal issues and susceptible populations, elevated exposures and intrinsic physiologic sensitivity were identified in the Great Lakes communities based on personal behavior, nutritional status and other factors. The populations include subsistence anglers, Native Americans, African Americans, Asian Americans, pregnant women, the developing fetus, young children, adults of reproductive age, the elderly, and the urban poor. Of the ten Great Lakes research grants, two focus on Native Americans, one targets African Americans, and seven focus on the remaining susceptible populations identified in the program.
Continued examination of sociodemographic and sociobehavioral data in these populations will assist ATSDR in establishing and determining the causes for health disparities. The communities as well as the Mohawk, Red Cliff and Chippawa tribes actively participated in health fairs and other activities at the very beginning of the Great Lakes studies. Residents and tribal members helped to design questionnaires, develop survey instruments and set priorities. An environmental specialist was placed on one reservation.
For health promotion and intervention strategies, fish advisories were developed in partnership with EPA and the State of Michigan. With assistance from DHEP, two million fish advisories were widely disseminated throughout the state to licensed anglers, state and local health departments, forty tribal nations, pediatricians, and obstetricians/gynecologists. A variety of effective risk communication strategies were implemented, including community and tribal newsletters and community health education classes.
For the evaluation of chemical mixtures, the body burden of chemical profiles was determined and additive or synergistic effects of Great Lakes contaminants were investigated. Over the course of the program, body burdens were reduced to background levels in the Great Lakes cohort. In the future, Great Lakes will continue to extensively coordinate and collaborate with local, state, federal, national and international partners. The program will target more research activities to children's health, endocrine disruptors, mixtures, surveillance and biomarkers.
Great Lakes will also use cohorts that were established for the study to monitor body burdens and health outcomes. New health promotion and risk communication tools will be developed and evaluated. ATSDR has learned several lessons from Great Lakes. First, coordination and collaboration enhance research outcomes. Second, targeted and continued funding focuses and expands research. Third, solid science influences policy. Although the research is being conducted in the Great Lakes states, conclusions from the study can be applied to other Superfund sites in the United States as well as to international countries.
Discussion. The Board deliberated on DT's activities as follows. DT should consider adding persons with chronic disorders, such as liver, lung and kidney diseases, to the Great Lakes cohort. These susceptible populations can attract partners with a wealth of resources. EPA informed the BSC that it is currently determining the feasibility of assembling an agency-wide workgroup to address subsistence reliance in other regions of the country. To avoid overlapping activities, EPA raised the possibility of using the Great Lakes data to address subsistence reliance in a multi-agency effort. DT confirmed that the data can indeed be applied to other areas in the United States where populations rely on fish as part of a subsistence diet, such as the Chesapeake and Gulf regions.
Great Lakes was modeled as a disease prevention program and includes all the traditional components: surveillance, evaluation, control and interdiction strategies, development of infrastructure at the local level, and risk communication. The value of Great Lakes is that the program can be replicated without sacrificing a population's reliance on important nutritional aspects of the diet so long as key messages are emphasized, i.e., the types of fish to eat, safe bodies of water to catch fish, and how to decrease PCB exposure by properly preparing fish. Because the Great Lakes budget has been reduced by 55% over the past three years, DT wholeheartedly agreed that a multi-agency effort to address subsistence reliance should be aggressively pursued.
Action Item: Dr. Hicks will provide Ms. Moses with a copy of the Great Lakes materials that were disseminated to the Native American tribes.
Public Comment Period. No attendees responded to the Chair's request to make a public comment.There being no further discussion, Dr. Melius recessed the BSC meeting at 5:20 p.m. on May 4, 2000.
C/TS Report and Recommendations. Dr. Melius reconvened the BSC meeting at 8:35 a.m. on May 5, 2000 and yielded the floor to the first presenter. Dr. Jeffrey Roseman, Chair of the CTS, highlighted the outcomes from the Subcommittee's May 2-3, 2000 meeting. Because federal facilities have long been an issue with communities, the CTS invited DoD and DOE representatives to the meeting to answer questions. The discussion was structured in four areas.
In studies funded by DOE and DoD, the CTS was also concerned about agencies not gathering offsite data unless a plume was documented to have traveled into the surrounding community. This approach does not take into account the fact that volatile organic chemicals travel beyond the fence line and expose residents to a variety of contaminants. As a result, studies funded by DOE and DoD do not truly meet the needs of impacted citizens near federal facilities. DOE and DoD should provide communities with an accurate account of chemicals being used onsite.
The DoD and DOE representatives admitted their inability to answer many of the questions raised by the CTS. Consequently, the CTS directed the federal facilities recommendations to ATSDR rather than DoD and DOE since its charge is to provide guidance to the BSC from a community perspective.
After the panel discussion with the DoD and DOE representatives, the CTS turned to outstanding issues within ATSDR. A set of general recommendations was made to address these items.
Discussion. The Board deliberated on the CTS report as follows. Conducting activities on federal facilities is indeed difficult due to secrecy, contractors and other issues. Despite these challenges, however, communities should have access to data gathered in worker studies. With respect to the federal facility recommendations, ATSDR should first address the issue of funding because DoD and DOE maintain control over expenditures even when dollars are transferred to other federal agencies. This type of funding stream limits ATSDR's ability to implement certain initiatives in communities.
To ease the process of obtaining data from DoD and DOE, key individuals outside of the federal government should take steps to obtain Q clearances. This model was implemented at the Rocky Flats site and allowed non-government persons to review documents that were previously classified. Since DoD and DOE do not consistently evaluate the health effects of federal facility workers, data should be gathered on whether the workforce inside the facility was at an increased risk of illness. This information should be easy for the departments to obtain and would also help to address issues raised by communities near federal sites.
As ATSDR develops its research agenda, efforts should be made to answer the community's questions by mechanisms other than cause and effect studies, such as surveillance, selected monitoring, registry data or other descriptive activities. These initiatives could be implemented in conjunction with state health departments and other organizations. The feasibility of developing a repository or database at the national level to maintain all information collected by federal agencies should be explored. Communities would then be able to access data for a particular site or cluster without having to submit FOIA requests.
ATSDR clarified that it has always requested funding considerably above the amount received from DoD and particularly DOE. This process has historically been unsatisfactory since the Agency has no input into the budget. For example, even with the new funding mechanism that will begin in FY 2001, DOE made arbitrary decisions as opposed to referring to the recommendations made by the HHS agencies during the planning process over the past year. As a result, ATSDR continues to struggle with funding issues. Despite this dilemma, however, the HHS agencies make strong efforts to obtain community input into studies funded by DoD and DOE, such as distributing plans of future projects to the public, convening community meetings, obtaining guidance from advisory committees, and developing an annual work plan based on needs expressed by communities and tribes. ATSDR agreed that the possibility of developing a standardized method to definitively determine a community's health status should be explored.
The Board requested that ATSDR convey the CTS federal facility recommendations to DoD and DOE. The departments should also be informed that the funding mechanism is unsatisfactory and has severely limited ATSDR's scientific credibility to evaluate sites and respond to community concerns.
The Chair entertained a motion for the BSC to adopt the recommendations and for ATSDR to convey the concerns to DoD and DOE. The CTS federal facility recommendations were unanimously approved by the Board and forwarded to ATSDR for consideration. For the CTS general recommendations, ATSDR assured the BSC that the outstanding items would be addressed and a status report would be made at the next meeting. After a motion was entertained by the Chair, the CTS general recommendations were approved by the Board and forwarded to ATSDR for consideration.
The BSC, SCs and ATSDR representatives applauded Dr. Roseman for his excellent leadership of and strong advocacy for the CTS. Dr. Melius officially named Dr. William Au as the new CTS Chair.
Action Item: Dr. David Bennett of EPA will provide Dr. Au with the report on the cleanup of the nuclear weapons complex. The document includes a web page with links to research groups and stakeholder organizations.
Budget Initiatives and Future Directions. Dr. Falk explained that the bulk of the Agency's funding is from the EPA Superfund budget. DoD, DOE and other federal facilities allocate a smaller portion to ATSDR's budget, but HHS provides no funding to the Agency. Of the total $1.4 billion Superfund budget, only $70 million was set aside for ATSDR in FY 2000. This figure represents a reduction from $76 million in FY99. The Agency is making strong efforts to at least return to the FY99 level of funding. The future of ATSDR's funding is closely linked to the future of Superfund, particularly since some Congressional members are considering decreasing support for activities at Superfund sites. The Agency has emphasized to Congress that health issues may persist long after cleanup activities have been completed at a site.ATSDR is also challenged by the fact that many sites are not listed on the NPL. As a result, the Agency must conduct activities at non-NPL sites that also have hazardous waste problems. Since the ATSDR budget is largely dependent on Superfund dollars, every attempt is being made to maintain the Agency's commitment to these activities. Existing collaborations are being enhanced with EPA headquarters and regional offices as well as with states and community groups that have cooperative agreements with ATSDR. Efforts are also being made to attract private and professional organizations that have an interest in the Agency's activities. The value of ATSDR's expertise and its unique role are being conveyed to Congress, existing partners and potential collaborators. However, the Agency realizes its vulnerability in the long-term due to a dependence on one funding stream.
For its future growth and direction, ATSDR is requesting that the Board provide guidance on strengthening support in the following areas: (1) broaden collaborations and partnerships; (2) enhance coordination with HHS, CDC and NCEH; (3) expand the relationship with EPA; (4) emphasize expertise in toxic substances; (5) focus on diseases potentially linked to hazardous substances; (6) continue its community focus; and (7) increase international presence. For global activities, the Middle East, India, South Africa, Mexico and Geneva have already expressed an interest in using the guidance values, toxicology profiles, environmental medicine case studies, and other products that have been developed by ATSDR. Also at the international level, the Agency's expertise has been solicited in building a DDT elimination component into the anti-malaria program.
For FY2002, ATSDR is proposing several cross-cutting initiatives, including community chemical bioterrorism issues; an international environmental health clearinghouse; use of the Geographic Information System for public health analyses; facilitation of environmental justice in minority and underserved communities; identification of health risks from subsistence lifestyles in Native American populations; implementation of ATSDR's multi-year applied research agenda with additional funding from EPA; a public health response plan for tremolite asbestos contamination; development of a national environmental disease registry; and a children's health program. Since the majority of these activities already exist in HHS, ATSDR has emphasized to the CDC Director that linkages and resources for the initiatives be provided to the Agency. ATSDR noted that the list of cross-cutting initiatives is an initial attempt to focus future activities. The Agency encourages the Board to suggest other items for inclusion.
Discussion. The Board deliberated on ATSDR's future directions as follows. The Agency should consider approaching NIH institutes other than NIEHS to fund studies of persons with chronic conditions, activities to close gaps in racial disparities, and an analysis of the relationship between diabetes and dioxin. The BSC expressed an interest in discussing these initiatives in more detail at a future meeting. The Board stated its commitment to play an active role in helping ATSDR to formulate the activities. However, the BSC cautioned the Agency to take immediate action if the initiatives will be included in the research agenda. The activities complement ATSDR's current programs. The Agency confirmed that individuals with underlying medical or chronic conditions have been included in susceptible populations.
Evaluation of Adverse Health Effects of Exposure to Asbestos Contamination Vermiculite. Dr. Lybarger remarked that in December 1999, ATSDR was contacted by EPA and petitioned by Senator Baucus to provide assistance in the health evaluation of the Libby, Montana site. EPA had announced its intent to conduct medical testing of most of the residents to determine human disease as a marker of exposure. The site has a history of vermiculite mining beginning in the 1920s. The process involved surface mining, transportation and staging of the ore, processing and packaging. The plant ceased operations in 1990, but the community has already been exposed due to air emissions from stacks. Significant occupational exposure occurred as well. Vermiculite is widely used in gardening products and insulation materials. The ore was known to be contaminated with an average of 3%-5% tremolite/actinolite asbestos; however, some ore and waste products were found to have up to 26% asbestos. The exfoliation process heated the ore to extremely high temperatures and tremendously increased the original size of the vermiculite.In addition to residents and workers, exposure was reported due to take-home contamination, recreational use, release into the ambient air during exfoliation, and product use. To date, illnesses have been reported among workers and family members. A tremolite fiber is very thin in size and >10-50 in length. The fiber may generate more pleural disease than previously reported for chrysotile. The earliest signs of the disease appear to be pleural changes, such as thickening or plaques, with later interstitial fibrotic changes. As a result, the pleural disease may be more severe than originally anticipated. A higher risk of mesothelioma may possibly exist than for other forms of asbestos.
A local pulmonologist provided 186 case reports of asbestos-related disease in 140 workers, 35 non-worker household contacts, and 11 residents with clear pathways of exposure. ATSDR has been unable to confirm all the case reports in this practice because the physician is reluctant to release medical records due to patient-doctor confidentiality. As a result, the Agency is currently designing a protocol with the physician and developing a case series to evaluate and document all the cases. As ATSDR identifies additional cases through screening or evaluation with other local physicians, a full case series will be developed to more accurately determine the distribution of disease in the community. The pulmonologist reported that patients have been presented with shortness of breath, chest pains, chronic cough, rales on auscultation, reduced lung function, and abnormal chest radiographs, including a diffusion of pleural thickening, pleural plaques and interstitial changes.
ATSDR took several public health actions to address both the immediate and future needs of the community. For medical testing, ATSDR identified asbestos-related health effects among persons exposed to asbestos from the vermiculite mine and made referrals for additional evaluation and treatment. ATSDR will ensure that chest x-rays are independently evaluated by three certified readers. Some community members still mistrust the local hospital due to its previous role as the provider for the vermiculite mine.
EPA was provided with information needed to identify and eliminate exposure pathways to asbestos in the community. The types of illnesses experienced by exposed persons were identified to better educate local physicians. The local medical community was provided with an estimate of the additional medical care needs the community will have over the next ten to twenty years. Assistance was provided to assess the public health hazards posed by past and current exposures to asbestos. ATSDR estimates that 3,000-5,000 individuals will be eligible to participate in the medical testing program.
For the epidemiologic investigation, ATSDR is currently developing a medical case series evaluation to document and characterize the types of asbestos-related changes among ill persons. The mortality analysis is characterizing the historic rate of mesothelioma and other lung diseases. For the community involvement component, ATSDR informed the public about its activities in the area and provided mechanisms for health education, such as media releases, meetings with the community interaction group, and a toll-free telephone number. Public involvement and participation in the medical testing program were encouraged.
ATSDR has already begun the recruitment effort by placing telephone calls to individuals who may be eligible for services. Questionnaires are then sent to potential program participants. ATSDR expects to begin medical testing on June 26, 2000. At this point, the Agency only has resources to conduct medical testing in the Libby area. In the future, however, ATSDR hopes to obtain additional funding to serve special populations and individuals who have moved from the community. To address confidentiality issues, test results will only be provided to physicians designated by program participants.
For the community and physician education component, ATSDR informed the community about risk factors for asbestos exposure and methods to reduce risks. To better assist patients, local physicians were provided with information about the diagnosis and treatment of asbestos-related illness during onsite training sessions. ATSDR also invited the physicians to an NIH-sponsored meeting next week to discuss innovative therapies that can be offered to patients.
For future activities, ATSDR has identified several public health needs that may be necessary. The response plan for Libby would include additional medical testing, continued education to health care providers and the community, further health research, the development of an ATSDR asbestos registry, and enhancement of local medical care. At the national level, ATSDR would review health statistics, conduct medical testing at 200 additional vermiculite facilities, expand the epidemiologic studies, and possibly create a mesothelioma registry. ATSDR is taking the public health concerns at Libby very seriously and investing a tremendous amount of resources in the screening effort because asbestos causes three fatal illnesses.
The Agency has a significant opportunity to document the effects, clinical course and natural history of tremolite asbestos because only a minimal amount of data have been gathered in this area. In particular, very little evidence exists on ingestion and respiratory exposure pathways from tremolite. The literature reports weak associations with renal and gastrointestinal cancers. In the long-term, ATSDR hopes that local and state health departments will manage screening activities with assistance and guidance from the Agency. The Libby investigation will provide an opportunity for ATSDR to enhance linkages with NIH and NCI. The partnership with EPA will also be strengthened since exposure routes cannot be tracked without medical data gathered by ATSDR. The Agency's expertise in community-based activities at Superfund sites will be invaluable as well.
Discussion. The Board deliberated on ATSDR's investigation at the Libby site as follows. The Agency should contact the Occupational Safety and Health Administration to assist in filling data gaps on exposure to vermiculite mine workers. The Billings, Montana health office is extremely focused and could be a valuable resource in this effort. To avoid duplicating activities, ATSDR should link with Montana's existing cancer registry instead of developing a separate mesothelioma registry. The Agency should also contact CDC to collaborate in this effort. To strengthen the database on this subject, ATSDR should review a 1980 or 1981 paper published in the Lancet that discussed abdominal lymphomas and differential diagnoses, including asbestos exposure.
ATSDR must ensure that the follow-up period of the Libby cohort is sufficient due to the long latency period of mesothelioma. The Board expressed concern that the screening activities will emphasize pulmonary effects and ignore gastrointestinal and dermal effects. Consequently, no funds will be available to address other health effects that may arise in the future. ATSDR confirmed that it has received an extensive amount of cooperation from the Montana Department of Health in developing the protocol and reviewing mortality statistics in the state.
Since less than 1,000 deaths occur from mesothelioma in the United States per year, ATSDR is considering the possibility of providing financial support for state epidemiologists to collect data to develop a mesothelioma registry. However, the Agency will consider the Board's suggestion to gather these data from cancer registries. In terms of funding, ATSDR has received supplemental dollars from EPA to immediately conduct screening activities. However, issues related to long-term support have been thoroughly considered. ATSDR's formal public health response plan, particularly long-term screening and development of a registry, was designed to address these concerns. The Agency is exploring possible mechanisms to fund long-term activities.
Public Comment Period. Ms. Judy Shoji read a statement for the record, which is appended to the minutes as Attachment 1*. Ms. Doris Bradshaw resides in Memphis, Tennessee near a DoD facility. The area is also a Superfund site that is listed on the NPL. The communities in closest proximity to the facility are exposed to any one of the 240 chemicals in the groundwater. For example, EPA recently found TCE three feet outside of the fence line. The agency reported that the offsite level of the chemical was higher than onsite. Despite the close proximity of homes and schools to the facility, DoD continues to excavate chemical warfare materials. Ms. Bradshaw requested that the BSC ask ATSDR to determine if DoD's contingency plan for this activity is safe and appropriate.There being no further discussion, Dr. Melius adjourned the BSC meeting at 12:05 p.m. on May 5, 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________________________
*Attachment 1 is available upon request. This page last updated on July 1, 2001
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