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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 November 18-19, 1999. The proceedings were held at the Sheraton-Buckhead Hotel in Atlanta, Georgia. The following individuals were present to contribute to the discussion.
BSC MembersSince being officially appointed as the ATSDR Assistant Administrator, Dr. Falk reported that he has focused on becoming familiar with the Agency's staff and projects being implemented at several Superfund sites. To date, he has (1) visited seven of the Agency's ten regional offices; (2) met with ATSDR field personnel who have direct involvement with sites; (3) met with Superfund managers and headquarters staff within the U.S. Environmental Protection Agency (EPA); and (4) met with environmental groups that have collaborative relationships with ATSDR, i.e., the Association of Occupational and Environmental Clinics (AOEC) and the American College of Occupational and Environmental Medicine. After the initial round of visits was completed, Dr. Falk hoped to visit actual community sites where projects are being conducted by the Agency. He provided updates on ATSDR's ongoing activities.
Congress has asked EPA to conduct a study that outlines anticipated Superfund funding needs for the next ten years. ATSDR has gone on record with EPA to emphasize the importance of its needs being recognized and included in the ten-year projection. ATSDR has recognized a conflict of interest because Superfund dollars allocated to the Agency are subtracted from EPA's budget request. As a result, ATSDR acknowledges the need for more direct collaboration with Congress on budget issues. In this effort, ATSDR presented its FY'2000 budget request directly to the Office of Management and Budget (OMB). This new development is significant because the Agency previously had to depend on EPA to make its case. The Agency hopes this opportunity will continue in the future. In addition to EPA, ATSDR also receives funding from other federal partners, such as the Department of Energy (DOE), the Department of Defense (DOD) and NASA. DOE contributes the largest portion of funds to ATSDR: $5 million in FY'98, $12 million in FY'99, and $8 million anticipated for FY'2000.
Discussion. Dr. Melius requested a description of the areas of most interest to Congress during ATSDR's briefings. Dr. Falk explained that many government agencies and community groups inform Congressional members and Senators about Superfund site activities. Since these reports often conflict, Congress frequently requests briefings by ATSDR in order to obtain an accurate accounting. Congress has also expressed an interest in the Agency's contribution to the Superfund process, such as evaluating data and identifying appropriate health studies that should be undertaken. ATSDR has been asked to present results of studies and PHAs as well. He clarified that the briefings are really educational sessions rather than formal Congressional testimonies.
Dr. Andrea Wargo, ATSDR's Associate Administrator in Washington, explained that ATSDR has two major types of interactions with Congress. In addition to the Agency's briefings on site-specific issues, technical assistance is also provided on matters of national interest, such as scientific evaluations on mercury and PCBs. She conveyed that Congress views ATSDR as experts with respect to the relationship of chemical exposures and health effects. Dr. Stark pointed out that ATSDR is the only federal agency which enters communities and tribes to address health issues. She saw the need for the Agency to develop constituencies who firmly believe this function is important and unique. Dr. Harris inquired if ATSDR's divisions and offices intended to collectively issue a formal response to the budget cut. Dr. Falk replied that the Agency's divisions have been preparing for the upcoming budget meeting which will be held in two weeks. During this meeting, budgets at both the division and Agency levels will be evaluated. The appropriations language for the current year requested a continuation of funding for the Toms River project and the Great Lakes initiative. The General Accounting Office (GAO) urged ATSDR to use more flexible approaches to PHAs that provide earlier responses. Consequently, the Agency will conduct more focused health consultations in the future rather than initiating a full-fledged PHA at every site. Congress has directed ATSDR to take $3 million from the $6 million cut for PHAs.
Approval of May 1999 Meeting Minutes. Dr. Melius entertained a motion to approve the May 1999 minutes. No changes were made by any of the Board members. Dr. White so moved; Dr. Harris seconded the motion. There being no further discussion, the May 1999 BSC Meeting Minutes were unanimously approved.
Review of Action Items from May 1999 Meeting. Dr. Robert Spengler, the Board's Executive Secretary, explained that the "BSC Response" and "Status" columns on the action items chart were left blank to allow Board members to clarify or edit information under the other columns. If no changes were made, items would be noted as "accepted" under the "BSC Response" column and "completed" under the "Status" column. He explained that for item 10, a list of "grand rounds" educational programs conducted by ATSDR was shared with Ms. Judy Shoji during May 1999 Board meeting. However, providing a list of physicians who have been trained through ATSDR is a more complex request. Physicians' names are generally not collected under programs conducted by state health agencies. Nevertheless, ATSDR was able to obtain the number and breakdown of providers who participated in the training programs, i.e., the number of nurses, physicians, etc. The Agency is still attempting to collect more specific information by obtaining names from CDC of providers who submitted forms for continuing medical education (CME) units in environmental medicine case studies. The agencies are still determining if and how these names can be released.Dr. Claudio mentioned that if the providers' names are able to be collected, communities with no other expertise for technical assistance grants (TAG) could access the list for assistance. Dr. Maureen Lichtveld, Director of ATSDR's Division of Health Education and Promotion (DHEP), reported that a web-based version of the environmental medicine case studies will be developed during FY'2000. Some of the key studies will be interactive as well. This feature will allow users to instantly obtain CME units over the Internet and will also provide a better mechanism to track providers who completed the course. Dr. Roseman turned to item 13, which related to specimen storage and death certificates. He emphasized that this topic should be covered by the Board soon. Dr. Spengler has already committed to scheduling this item for the May 2000 BSC meeting so the Board members and Special Consultants (SCs) can have a joint discussion. As an ACTION ITEM, Ms. Moses requested that orientation materials be sent to the new Board members who will serve on the Community/Tribal Subcommittee (C/TS or the Subcommittee) since the terms for Drs. Claudio and Roseman would expire in April 2000. She hoped that in the future, terms for BSC members on the C/TS would be staggered. Dr. Spengler anticipated that the two new Board members would be seated by the next BSC meeting. He acknowledged that the extremely important issue raised by Ms. Moses needed the Board's immediate attention. He recommended that during the C/TS presentation on the following day, a discussion be held to identify the two new BSC members who would serve on the Subcommittee.
Update on the ATSDR Research Agenda. Dr. McDiarmid reported that the Research Agenda Subcommittee (RAS) convened several conference calls in preparation of the November 3, 1999 workshop with affected communities, professional organizations, academia and other collaborators. In addition to Dr. McDiarmid as Chair, the membership includes Dr. William Au, Dr. Robin Leonard, and Dr. Alice Stark, with Special Consultants, Ms. Doris Bradshaw and Ms. Rachel Moses. Approximately forty individuals attended the first meeting; the second workshop is scheduled for January 2000. Dr. McDiarmid characterized the meeting as a success primarily because the participants provided thoughtful and valuable input in a relatively short period of time. Some of the short-term recommendations made were solid and can be implemented by ATSDR for quick results. She summarized the key recommendations made for the six topics covered during the workshop.
Discussion. Mr. Sanchez further defined "trust" under the area of special issues with tribes and communities. All federal agencies have a trust responsibility to tribes that are recognized by or have a special relationship with the government. He emphasized the need for this definition to be clearly delineated in the research agenda. Dr. Stark remarked that in addition to communities and tribes trusting agencies, the government must be able to trust stakeholders as well. Agencies must have a level of confidence that citizens are appreciative of their work, provide accurate data, and are helpful during site activities. In terms of the recommendation to "develop methods for small community studies," Dr. Leonard saw a definite potential to collaborate on issues with small groups. The research community's system of funding research must be used to establish a mechanism to support new concepts. If a new strategy has not been proven to be successful, the typical practice among researchers is to ignore the concept. She encouraged ATSDR and other agencies to foster a willingness to consider new approaches and methodologies as they are developed.
Dr. Stark added that one new approach would be for the research community to not use existing epidemiologic methods with a small cohort. Instead, a strategy should be developed that is specifically designed to address small study populations. She realized that citizens are most frustrated and angered when agencies conclude a community or tribe has an insufficient number of members to conduct a study. Because the government's relationship with Indian tribes is different than with communities, Ms. Moses requested that the cultural sensitivity training session presented to ATSDR staff be made available to the Board as well. She also asked that "cooperative agreements with Indian tribes" be added to the recommendation to "continue partnerships with tribal colleges and universities." As a participant at ATSDR's cultural sensitivity training session, Dr. Falk agreed with Ms. Moses that the differences between Indian tribes and communities need to be clearly delineated. As an ACTION ITEM, he requested that some of the pertinent material from the session be compiled and sent to each Board member for discussion at the next meeting. He added that the packet should include information on the history of the relationship between the government and tribes, as well as definitions for "trust" and "sovereignty."
Overview of ATSDR's Current Research Investigations. Under the six focus areas discussed during the Research Agenda Workshop, Dr. Spengler provided a brief synopsis of the 162 ongoing activities within the Agency. Of these projects, 95 have a toxicologic approach and 67 have an epidemiologic approach. Of the 95 toxicology-based activities, approximately 67 are conducted at no cost to ATSDR. The projects are implemented by either EPA or industry under a voluntary research effort. Dr. Spengler emphasized that due to the volume of these activities, only a cursory overview would be provided. He directed the attendees to contact ATSDR if more detailed information was requested for any of the projects.Discussion. Dr. Stark asked if ATSDR had made a decision to proceed with the cancer registry.
Dr. Jeffrey Lybarger, Director of the Agency's Division of Health Studies (DHS), explained that the leadership and development of the registry is now within the National Cancer Institute (NCI). ATSDR's role in this effort would be to provide guidance on how environmental factors could be considered in the development and utilization of the registry. The Agency plans to convene a workshop on this issue after January 2000. The areas that will be covered during the workshop include the feasibility of developing the registry, epidemiologic and statistical methods, as well as hypotheses of environmental and exposure hazards which may be considered. Dr. Collins inquired if an exposure registry exists for pesticide usage in farm workers. Dr. Sheila Newton of NIEHS replied that in collaboration with NCI, NIEHS is conducting a cultural health study of pesticide exposure to a cohort of 60,000 farm workers and their families. The study also includes a follow-up of health outcomes in children of the farm workers. Dr. Roseman asked if national data from health departments had been compiled to identify the prevalence of elevated blood lead levels.
In CDC's Lead Poisoning Prevention Program, Dr. Falk responded that web-based mapping data show age of housing and various demographic factors by zip code and county. The program does not yet contain blood lead data from screening programs, but CDC is currently in the process of including this information. Although lead is the most common chemical found at sites, maps showing the geographic distribution of the chemical have not been developed to date. Dr. Falk expressed an interest in creating a compendium of these data. An initial step was taken in this effort when the blood lead levels in children who lived adjacent to the Bunker Hill, Idaho site were compared with other sites where blood lead levels were measured. Ms. Moses requested more information on ATSDR's environmental health education and promotion activities with tribes. Dr. Lichtveld conveyed that the Agency is currently involved with five tribal nations under a specific cooperative agreement. The initiative focused on developing infrastructure during the first five years. During the current cycle, expertise is being shared among and between tribes, particularly the needs assessment that was developed. Dr. Lichtveld committed to providing Ms. Moses with more detailed information on ATSDR's projects with tribes.
Overview of the NIEHS Research Program. Before describing the research program, Dr. Newton provided a background on NIEHS. Under HHS, PHS branches out to NIH, which includes NIEHS. Although ATSDR and NIEHS are PHS agencies within HHS, ATSDR's principal funding source is EPA, while the bulk of the NIEHS budget is through HHS. In the environmental health research program, NIEHS is changing its focus from studying one chemical. The institute is now taking a multidisciplinary and interactive approach to include various elements of human and environmental health in the research agenda. These exposures include both social and environmental factors, such as industrial chemicals, physical agents, byproducts of combustion, food, nutrients and drugs. NIEHS also analyzes gene-environment interaction, as well as individual and population susceptibility caused by age, time, gender, and nutritional status. The research program is implemented under three basic aspects: communication, prevention and intervention studies, as well as good science for informed decisions at both the field and policy levels.
The National Toxicology Program (NTP) is a major factor in the NIEHS research agenda. While NIEHS has the lead role in this enterprise and provides the largest portion of the budget, CDC and the National Institute for Occupational Safety and Health (NIOSH) are federal partners. As regulatory agencies, FDA, EPA, the Occupational Safety and Health Administration (OSHA), and the Consumer Product Safety Commission (CPSC) serve in an oversight capacity for the NTP. ATSDR is a member of the NTP Executive Committee and provides input on decisions made in the program, such as the selection of chemicals for testing and policy issues. NIEHS plays a role in Superfund activities under the Superfund Basic Research Program (SBRP) and the Worker Safety Training Program. The SBRP was established in 1986 under the Superfund Amendment and Reauthorization Act (SARA) as a multidisciplinary and university-based grant. The program focuses on issues related to Superfund and hazardous substances. The various grants under the program target both health and non-health activities. SARA legislation mandates NIEHS to develop the following items in administering the SBRP: methods and technologies to detect hazardous substances in the environment; advanced techniques to identify implications on human health from hazardous substances; and methods to assess risks to human health from hazardous substances.
The goal of SBRP is to take a full public health approach in examining underlying mechanisms and to gain insight about prevention and environmental diseases. Under SBRP, NIEHS funds a variety of research areas, including fate and transport, remediation, biodegradation, ecology, epidemiology, exposure assessment, biomarkers, waste site characterization, and analytical chemistry. The 69 collaborating institutions in the program use approximately 850 scientists and 225 students to conduct 134 projects. SBRP grants are housed in the University of Washington, the University of Arizona, Colorado State University, and the University of California at both Davis and Berkeley. Due to SBRP, NIEHS anticipates that more risk assessment measures will be established; cost-effective remediation technologies will be developed; fundamental research to solve real public health, environmental and engineering problems will be provided; and graduate students will be trained in a multidisciplinary approach. NIEHS places a heavy emphasis on communication in its activities. To the scientific community, the institute communicates through its Environmental Health Perspectives journal; professional education, including research training and curriculum development; and peer reviewed publications, workshops and conferences.
To the community, NIEHS communicates by soliciting input from and providing information to citizens. In particular, an outreach and health education component is included in all Environmental Health Science Centers. The institute has also sponsored several townhall meetings in impacted communities throughout the country. ATSDR was a key partner with NIEHS in several of these meetings. One of the most significant outcomes of a previous symposium was the NIEHS request for applications (RFA) to develop an environmental justice initiative that supported community-based efforts in outreach and education. Additionally, the institute supports a science education program in grades K-12 by developing and distributing materials, awarding grants to train teachers, and creating electronic curricula for schools. Approximately 225 projects are in the NIEHS intramural program and 460 initiatives are in the extramural program.
Dr. Newton concluded by listing the NIEHS areas of emphasis for FY'2001 that have been submitted to the NIH Director: environmental etiology of Parkinson's Disease; children's environmental health in terms of both development and behavior; a study of sisters on genes, the environment and breast cancer; innovative technologies for exposure assessment; toxicologic testing of herbal dietary supplements; the Centers for Health Disparity Research and Intervention; research on diet and disease; male reproductive health and hormonally active agents; surrogate markers for toxicologic agents; oceans and human health; genomic imprinting and environmental disease susceptibility; advanced research cooperation in environmental health; the national twin registry; mouse genomics centers; oxidative stress and environmental diseases; and integrative biology in environmental health sciences.
Discussion. Dr. Claudio requested the status of the institute's human environmental genome. Overall, she hoped the NIH Council of Public Representatives would be used to assist NIEHS in applying its model of community outreach to other NIH institutes. In support of this effort, she recommended that NIEHS present its successes and failures to NIH. To the question, Dr. Newton explained that the environmental genome project will attempt to study a variety of factors among different persons. A portion of the project is included in the request for proposals (RFP) for the single nucleotide polymorphism activity. The environmental genome project will focus on both polymorphism and gene expression, including DNA repair genes and single transduction genes. To the comment, Dr. Newton acknowledged that the opportunity to replicate the NIEHS model of community outreach in other NIH institutes is greater due to the Council and recommendations from the Institute of Medicine. All NIH institutes are now required to develop strategic plans for public input.
Dr. Stark asked if biologic agents were included in any of the NIEHS projects. She also inquired if the SBRP grants were only awarded to universities. Dr. Newton replied that NIEHS has not historically included biologic and infectious agents in its activities because the National Institute of Allergy and Infectious Diseases has responsibility for these types of projects. Due to increased opportunities, however, NIEHS plans to pursue this area of research in the future in collaboration with other HHS agencies. To the second question, Dr. Newton responded that a variety of research institutions are funded under the SBRP program. Dr. Collins asked if medical schools were involved in the institute's curriculum development activities. Dr. Newton conveyed that medical schools are indeed involved in this collaborative effort with NIOSH. She added that more information could be obtained from the NIEHS web site, which outlines the structure of the curriculum development program. Ms. Bradshaw inquired about the status of the institute's involvement with the Mississippi Delta and Columbia projects. Dr. Newton admitted that activities under these projects were at a standstill due to changes in administration. However, NIEHS recently appointed a staff member to take the lead in these initiatives.
Overview of EPA Superfund Research Program. Dr. Benjamin Blaney explained that EPA is the regulatory agency which ensures Superfund sites are appropriately identified and cleaned. EPA's research program includes risk assessment, site characterization, site monitoring, remediation processes, and technology development. The agency's Office of Research and Development (ORD) was established five years ago with five different offices that address environmental effects, exposure, risk assessment, risk management and quality assurance. A large portion of ORD's $100 million grant program is allocated to human health risk assessment (HHRA) and children's health problems. Under the Government Performance Results Act (GPRA), ORD focuses on the following areas: clean and safe air, water and food; risk reduction in communities; safe waste management; global climate; public empowerment; and sound science. Although ORD conducts research in all eight areas, the majority of basic research is based on sound science to improve the understanding of environmental risks and better address environmental problems.
In the 1980s, EPA adopted the HHRA approach to determine impacts. Since that time, the complexity of HHRA has been expanded to address sensitive sub-populations, geographic areas, cumulative risk, the effectiveness of public health decisions, mechanistically-based data, tools and approaches, as well as multiple exposures, media and pathways. The goal of ORD research is to reduce the use of default assumptions in HHRA. A draft research strategy has been developed in this effort. In the HHRA, children's risks are the highest priority. ORD focuses on susceptibility, special exposures and special protection for children. The future direction of HHRA research in EPA will be a continuation of current activities, but cancer and non-cancer risk assessments will be harmonized as well. In terms of Superfund risk assessment research, ORD estimates human exposure and dose response; dose response models for mixtures; and ecological risk assessments. The Exposure Factors Handbook is used to complete these activities, particularly issues related to exposure factors, dermal exposure and bioavailability. Two major projects that will be completed in FY'2000 are the soil ingestion study in 112 children and 40 adults, as well as the development of exposure scenarios. The handbook for children will consolidate all data for this population and add three new studies: an analysis of fat intake, long-term distributions of food intake, and an estimation of soil ingestion using arsenic in urine data. An on-line version of the Exposures Factors Handbook is now available.
With respect to dermal exposure research, ORD has cooperative agreements with the University of Washington, North Carolina State University, and the University of Michigan. Studies are conducted in the areas of soil adherence to skin, dermal absorption characteristics, and chemical absorption from contaminated soil. A report and several journal articles will be released in FY'2000 summarizing the key findings from these data. In terms of site characterization and monitoring activities, the Superfund program has four basic areas of research: surface and subsurface characterization; sampling methods, designs and environmental statistics; groundwater and soil analytical methods; and site program demonstration for innovative techniques. The goal of this research is to minimize soil sampling errors, maximize the quality of 3-D contaminant profiles, and develop and evaluate screening and analytical methods to rapidly provide high-quality data.
The scope of Superfund remediation research includes groundwater, soils, sediments, and the natural attenuation of compounds. The primary objective of this activity is to develop more cost-effective techniques that will identify environmental impacts. Metals, complex mixtures and semi- and non-volatile organics are among the major problems at contaminated sites. EPA supports five Hazardous Substances Research Centers to better determine waste research needs. Future directions for ORD Superfund research will focus on ecological risk, sediments screening and characterization, risk communication, and mechanisms of bioavailability. For more information about this research,
Dr. Blaney directed the attendees to access the ORD web site or contact the various Center Directors listed in the materials that he distributed.
Discussion. Ms. Bradshaw noted that ORD's soil sampling activities do not include offsite sampling in communities. Since this issue has long been a source of frustration with residents, she asked if the agency had changed this practice. She also inquired about the level of input the community was able to provide in the research program. Dr. Blaney was unable to provide detailed responses because sampling activities fall under the Superfund Program Office. He directed Ms. Bradshaw to contact Mr. Larry Reed in this division. In the interim, however, he mentioned that the types of characterizations currently being developed can be used both on- and off-site. ORD works closely with and relies heavily upon the Superfund Program Office and EPA's ten regional offices to identify the community's needs.
Dr. Harris conveyed that ATSDR's Environmental Health and Toxicology Research Program is undertaken through a cooperative agreement with the Association of Minority Health Professions Schools. She asked whether EPA planned on developing this collaboration in the future, particularly with ORD's dermal exposure research. Dr. Blaney committed to obtaining an answer to this question. He pointed out that EPA in general and ORD specifically are taking a more community-based approach to address environmental problems. Most notably, the research laboratories are selecting particular areas to study and the Impact Program assists communities in collecting monitoring data for more effective decision-making.
Overview of NIOSH Research Program. Dr. Scott Deitchman explained that NIOSH was established to address occupational illness and injury in the United States. Current estimates show that on a daily basis, 9,000 workers sustain disabling injuries on the job, 16 workers die from work-related injuries, and 137 workers die from work-related diseases. The Occupational Safety and Health Act of 1970 was developed "to assure safe and healthful working conditions for every working man and woman." The Act created OSHA to promulgate and enforce standards, while NIOSH was established to conduct research, make recommendations and train professionals. NIOSH fulfills its charge by implementing the following activities: (1) research through surveillance, field and laboratory studies, and extramural projects; (2) health and safety recommendations from onsite health hazard evaluations by medical epidemiologists and industrial hygienists; (3) assistance to small businesses and other federal agencies; (4) information dissemination through publications, professional conferences and the Internet; and (5) education through eighteen university-based research centers to train professionals in occupational medicine, occupational health nursing, industrial hygiene and safety.
NIOSH laboratory research is conducted to evaluate potential hazards under controlled conditions; develop technology needed for field research; as well as to develop and evaluate control technology and personal protective equipment. Employers are prohibited from supplying employees with respirators for occupational use unless the equipment has been certified by NIOSH. The institute also conducts laboratory research to examine the effects of toxicants and hazards on cellular, biological, physical and mental function, such as pulmonary, cardiovascular, carcinogenic, genotoxic and reproductive effects. NIOSH's field research is performed throughout the United States and includes exposure assessments, epidemiologic studies and fatality investigations. Additionally, intervention studies are conducted to identify potential workplace hazards, determine the extent of worker exposure, and demonstrate effective approaches to prevention. Field research can result in hypothesis generation, voluntary workplace changes or recommended standards. The institute's laboratory facilities and field offices are located throughout the country.
NIOSH conceived the National Occupational Research Agenda (NORA) with a vision to collaborate and coordinate resources among other federal agencies, universities and industry. After a two-year planning process, NORA was unveiled in April 1996. The research agenda was developed with input from NIOSH scientists in addition to feedback from 500 organizations and individuals outside the institute. NORA was created in recognition of limited resources, the need to target research, and the lack of mechanisms to promote collaboration. The overarching objective of the research agenda is to provide a framework that guides occupational safety and health research at the national level. NIOSH designed NORA with 21 research topics, which have been categorized into three areas. First, disease and injuries include allergic and irritant dermatitis, asthma and chronic obstructive pulmonary disease, fertility and pregnancy abnormalities, hearing loss, infectious disease as an occupational hazard, low back disorders, musculoskeletal disorders of the upper extremities, and traumatic injuries. Second, work environment and workforce issues cover emerging technologies used in the workplace, the indoor environment, occupational health as a result of mixed exposures, organization of the workplace, and at-risk special populations.
Third, research tools and approaches encompass cancer research methods, control technology and personal protective equipment, exposure assessment methods, health services research, intervention effectiveness research, risk assessment methods, social and economic consequences of workplace illness and injury, as well as surveillance research. To implement NORA, NIOSH set a goal to increase activities and resources in 21 priority areas. Liaison committees of 23 organizations were established to provide guidance on various initiatives under the research agenda. The federal liaison committee contains representatives from other federal agencies to identify common interests and leverage resources. Moreover, a total of 130 NIOSH representatives and 160 external members serve on partnership teams for the 21 priority areas. Each team develops a specific research agenda and topics for the respective priority area. This information is then shared with the remainder of the occupational health and safety community.
To track the effectiveness of NORA, the dollar amount spent for each priority area is monitored. The funding source can be NIOSH, other federal agencies and private sector organizations. Products developed under the partnerships are examined as well, such as collaborations and responses to research solicitations. The effectiveness of NORA is also tracked by literature searches and public recognition of the research agenda. NIOSH uses bibliometrics, surveys and web site utilization to determine impact. In FY'99, NIOSH invested $62.4 million in NORA, which increased from $15.4 million in FY'96. The Institute has yielded a substantial return on its investment given the success of NORA. The research agenda has broad input and growing support from the community; stimulates research activities and resources in priority areas; has an ongoing and dynamic partnership network in occupational safety and health between public and private sectors; has an active and coordinated federal effort; and created a new culture.
In examining the ATSDR/NIOSH collaboration, both the similarities and differences between the two agencies must be addressed. Although a common interest is shared in the health effects of toxic exposures, NIOSH's target population is workers, while ATSDR serves communities. In developing a strategy for potential collaboration, topics that fulfill the respective missions of the agencies must be included. For example, toxic fumes from blasting in large surface mines have both occupational and environmental exposures. Since clouds of dust and fumes travel from blasting sites to adjacent communities, both miners and residents are exposed. Another possibility for an ATSDR/ NIOSH collaboration is a study of health effects from exposure to fugitive dust caused by mine waste and roadways. This project could cover binders and control measures as well.
A third option is occupational and community exposure to incinerator byproducts, such as fly ash, stack emissions and disposal of waste from incinerators. The residential use of pesticides could also engage the two agencies in a partnership. NIOSH has already studied the health effects of pesticide exposure in professional applications, while ATSDR has analyzed these same health effects in a residential setting. The collaboration could include identifying measures of current exposures, developing methods to estimate historical exposures, and selecting exposure assessments in homes. Dr. Deitchman was confident that opportunities for partnership already exist, but the agencies need to identify these areas.
Discussion. Dr. Roseman raised the possibility of undertaking a joint NIOSH/ATSDR study to examine the interaction between high-level exposures and sensitivities of special populations. Dr. Claudio indicated that workers who are exposed in both the workplace and communities could also be a joint investigation for the agencies to consider. This project could include a study of mixtures to determine populations that are exposed to multiple contaminants. As the ATSDR research agenda is developed, Dr. Stark encouraged the Agency to thoroughly examine NORA. She viewed NIOSH's research agenda as a solid model because the institute maintained its unique focus on workers, and did not spread resources or activities into areas for which other agencies are responsible.
Dr. Collins requested clarification on bibliometrics. Dr. Deitchman explained that bibliometrics is an evaluation tool to measure the amount of data published on NORA topics, as well as how often these publications are cited in, influenced by or included with other research and grant applications. Dr. Deitchman committed to providing Dr. Spengler with more information on bibliometrics so that the material could be distributed to the Board. Dr. White was pleased NIOSH included a mechanism to measure success other than publications. She added that the actual benefits of research to impacted communities and other target audiences are not realized when impact is solely measured by publications. Ms. Moses asked that data on the locations of the mining studies and methods to estimate emissions from the mines be provided to her at a later date. Dr. Deitchman confirmed that he would obtain this information from NIOSH's Mining Research Group Director and forward it to Dr. Spengler for dissemination.
Overview of NCEH Research Program. Dr. Rossanne Philen reported that similar to ATSDR, NCEH's research agenda is currently in the development stage. The center's opportunities for research during the next three to five years cover 27 priorities under five broad areas of interest. The research agenda was developed to reflect the breadth NCEH's internal activities, but several areas had to be covered on a broader perspective. The center avoided prioritizing projects; however, goals were set that primarily reflect current activities and not the future vision of research. The research agenda will be consistent with the existing strategic plan and the Healthy People 2010 initiative. NCEH anticipates the document will be dynamic, evolving useful to researchers. The center was established to prevent illness, disability or death caused by interactions between persons and the environment. NCEH's four divisions and one office focus on the following areas: the Division of Birth Defects, Child Development, Disability and Health; the Emergency and Environmental Health Services Division; Environmental Hazards and Health Effects Division; Division of Environmental Health Laboratory Sciences; and the Office of Genetics and Disease Prevention.
The five broad priority areas covered in the research agenda are as follows. First, "decreasing health risks from environmental exposures" will develop new and better methods to measure human exposure to toxic substances; improve estimates of health risks from environmental exposures; and determine the effectiveness of environmental programs to prevent disease. Second, "improving children's health" will determine the best methods to track birth defects and developmental disabilities; conduct multi-center studies of the causes of birth defects and developmental disabilities; develop new or better biomarkers for newborn screening; and reduce the burden of asthma in inner-city children. Third, "enhancing emergency preparedness and response" will assess geospatial technology to establish post-disaster health and medical needs; develop and evaluate the effectiveness of interventions for reducing or preventing disease in displaced populations; and develop better methods to measure exposures to chemical warfare agents.
Fourth, "preventing leading killers of diabetes, cardiovascular disease and cancer" will standardize clinical measurements of risk factors in these chronic diseases; develop new and better instruments and technologies for measuring disease biomarkers; and determine associations between genetic variants and chronic diseases. Fifth, "improving the lives of persons with disabilities" will monitor individuals with disabilities to learn the natural history and causes of secondary conditions; develop interventions to identify and decrease secondary conditions; and develop measures to determine the cost-effectiveness of intervention strategies. Dr. Philen emphasized that based on these and other activities, several opportunities exist to establish a successful ATSDR/NCEH collaboration.
Discussion. Ms. Bradshaw noted that NCEH's projects more than adequately address the community's needs. Since she had no knowledge of the center, she inquired about NCEH's efforts to interact with citizens. Dr. Philen replied that the center's involvement with communities follow the standard process. Concerned citizens notify the local health department about health impacts at the site. The state then contacts CDC to investigate the site-specific issue. If problems in an area are more complex, CDC will provide assistance in technical expertise, scientific issues and funding. For broader research areas, the agency frequently distributes RFPs for other organizations to conduct community-based activities. Dr. Melius inquired about NCEH's plans to involve communities and other independent groups in the development of the research agenda. Dr. Philen replied that efforts were made to identify outside reviewers who should provide input on the research agenda. Based on these recommendations, the document was circulated to the center's advisory committee and external reviewers. Comments from these groups are currently being incorporated into the research agenda. The revised document will be reviewed by the advisory committee shortly.
BSC Roundtable Discussion. Before opening the floor for the discussion, as an ACTION ITEM, Dr. Melius requested that the overheads from all the presenters be copied and distributed to all interested persons after the meeting. He also asked that in the future, copies of slides used for presentations be circulated during the meeting. To structure the discussion, he turned the Board's attention to two documents that were included in the packet of materials. First, Building an ATSDR Environmental Public Health Research Agenda contains a time-line of the development process. Second, the Partners and Constituents Workshop provides an overview of the relevant outcomes from the meeting. Dr. Melius reminded the Board that ATSDR's draft research agenda would not be presented for another year. At this point, the BSC should only provide input on items to be considered during the development process, rather than focus on specific areas or resource constraints. Consequently, he directed the Board to discuss fairly broad areas for inclusion in ATSDR's research agenda, such as successful models from other agencies that ATSDR could replicate and potential partnerships. During the next two meetings, the BSC would begin to narrow these broad areas into a more clearly defined research strategy.
Mr. Matheny asked if ORD's Exposure Factors Handbook was a component in the Risk Assessment Guidance reform. Dr. Blaney committed to referring Mr. Matheny to the appropriate EPA staff who could answer this question. Ms. Bradshaw noted that the level of community input is minimal in the agencies' respective research agendas. She strongly emphasized the critical need for federal agencies to interact with communities in all research programs. With respect to ATSDR, Dr. Melius agreed that community involvement is necessary in the research program. However, he reiterated that the research plan to address these areas must first be developed, such as the best methods to communicate with the public and effective strategies to address different populations. Due to the different cultures, directions, perspectives and guidelines among the agencies, Dr. White saw no coordinated effort. Because of ATSDR's small research budget, she acknowledged the need for the Agency to apply expertise from other agencies to fulfill its mission. She urged the agencies to develop a coordination effort at the highest level while maintaining a focus on respective missions and goals.
Dr. Newton mentioned that NIEHS convened a series of meetings with EPA regional staff, ATSDR representatives, and concerned community members. These comments were compiled and incorporated into the RFA for the SBRP. Dr. Falk's position was that a fair amount of coordination already exists between the agencies at different levels. However, he concurred with Dr. White that stronger attempts need to be made in this area, particularly in terms of health issues. As an initial collaborative effort on a broader agenda, he conveyed that he would be meeting with the leaders of NIEHS and the EPA Superfund Program in January 2000. Dr. DeRosa agreed with Dr. Falk about the existence of interagency collaborations. In order to address completed exposure pathways and make a case on actual documented exposures, ATSDR, EPA and NIH discussed the possibility of using both sensitive and specific biomarkers during the NIEHS regional meetings. This area will be a major priority in ATSDR's research agenda. Additionally, a committee chaired by ATSDR with representatives of NIH and EPA focuses on pesticides, toxic substances, as well as research and development. The group has been meeting biannually since 1992 to coordinate substance-specific applied research being conducted in NIEHS, ATSDR and other agencies. The outcomes from the group's meetings have been summarized in a series of reports so that other agencies are aware of these ongoing activities.
Given the federal budget cuts, Dr. Roseman pointed out that NCEH's evaluation of the cost-effectiveness of each intervention strategy in the research agenda was extremely important. He encouraged ATSDR to include this component into its research agenda. Since several of the same projects are being conducted by various agencies, Dr. Stark saw an enormous benefit in determining whether activities were complimentary or redundant. In terms of community interaction, she indicated that citizen involvement is inappropriate under certain circumstances, such as basic laboratory development. In ATSDR's research agenda, however, a greater emphasis should be placed on social science and risk communication that directly relate to community involvement. Dr. Stark did not believe these types of issues would fall under the purview of any other agency. Dr. Melius inquired if the community participation component of the SBRP had changed with the release of the new RFA.
Dr. Claudio replied that the first cycle of SBRP grants did not require community outreach, but the current round does includes public involvement. The NIH centers have positively responded to this change. Additionally, a few centers with SBRP grants have already implemented community outreach and education under the program. Dr. Claudio's position was that community involvement could influence any type of basic research, such as training students in laboratory settings or making presentations to residents. In terms of community health, Dr. Au raised the possibility of ATSDR developing human-based studies and exposure assessments using human tissues. Other agencies could be involved by addressing environmental measurements. Additionally, ATSDR could examine acquired susceptibility in persons exposed to hazardous environmental waste areas who later become more sensitive to infection, late onset of disease, passive exposure, or workplace chemical exposure due to immune suppression. Dr. Au recalled that during the Research Agenda Workshop, both NIEHS and the National Center for Toxicological Research clearly indicated an interest in collaborating with ATSDR on developing new approaches to address the issue of susceptibility.
Dr. Harris commented that effectively evaluating interagency collaborations in the research agenda will be one of the most significant challenges. She strongly urged the Agency to develop both process and outcome measures for each research agenda topic. Dr. Claudio pointed out that the EPA/NIEHS/ATSDR Centers for Children's Environmental Health should be reviewed to determine the success or failure of an interagency collaboration. As an ACTION ITEM, Dr. Falk requested that a joint meeting with ATSDR, NIEHS and EPA be convened in the future to determine how well the agencies collaborated in the children's environmental health project. Dr. Collins suggested that a few research areas be selected so the agencies could identify responsibility for each item. Dr. Newton explained that this task would not be undertaken at the agency level primarily because responsibilities would be different based on the responding agency. Instead, the activity would be conducted under an Administration initiative and only for one specific topic, such as asthma.
Dr. McDiarmid pointed out that a lack of resources will prevent activities under the different research agendas from being duplicated by multiple agencies. She commended NIOSH for realizing this fact by developing a research agenda for its target population of persons interested in occupational health. As a result, NORA will be supported by industry, affected working groups and unions, in addition to NIOSH and its funding sources. Dr. McDiarmid urged ATSDR to apply this concept and focus the research agenda to its target audience of persons interested in the health impacts of environmental exposures. Dr. Stark indicated that archiving tissue specimens could be a cross-cutting issue for the agencies' research agendas. The banked samples could provide invaluable information in the future for a variety of research activities conducted by all agencies. Since the process is extremely expensive, a strong interagency partnership must be developed for this effort. Dr. Stark recognized that budget cuts will also force agencies to restrict activities to basic clinical chemistries and interviews in addition to tissue collection.
Dr. Robin Wagner of ATSDR-DHS mentioned that another potential opportunity for collaboration in the research agenda would be the human genome project. In particular, the interaction between toxins and genes should be addressed. ATSDR is frequently asked about individual exposure possibilities and the implications for disease. Therefore, the Agency could create this type of research program to include computational, mathematical and biological components. Dr. Falk agreed that the issue of genetics should be considered because only a minimal amount of activities are currently being conducted in this area within ATSDR. If the members believe genetics is an important issue that should be included in the research agenda, he asked the Board to convey its position to the Agency. In examining the schedule for the development of ATSDR's research agenda, Dr. Melius posed two questions for the BSC to consider: (1) Are additional working groups needed? (2) How should criteria be established to set priorities? He asked the RAS to discuss and determine whether ATSDR needs to hold special workshops in the areas of behavioral science and genetics. He noted that the next Research Agenda Workshop will be held on January 19, 2000.
Dr. Spengler clarified that the second workshop would be identical to the first in terms of the agenda and the overall process. However, a different set of partners and constituents would attend so that ATSDR could obtain a variety of perspectives. He explained that draft criteria are currently being developed and will be disseminated to the RAS for review and comment during a conference call scheduled for December 1999. As an ACTION ITEM, Dr. Melius requested that the RAS report on input which was provided about the draft criteria. He asked that the update be presented to the full Board at the next BSC meeting. Dr. Leonard recalled that the BSC previously went on record with its recommendation for ATSDR to hire behavioral sciences staff. Despite federal budget cuts, evidence exists that this type of expertise is needed internally within the Agency.
Dr. William Cibulas, Research Implementation Branch Chief, Division of Toxicology, announced that a prevention specialist was recently hired for a six-month period to examine the effectiveness of fish advisories in the Great Lakes Basin. With respect to opportunities for partnerships, he turned the Board's attention to the Federal Register notice that outlines fifty priority substances, associated research agendas, and agencies collaborating with ATSDR to fill these data needs. The notice is referenced as the "Update on the Status of the Superfund Substance-Specific Applied Research Program," Federal Register (Vol. 64, No. 10, January 15, 1999). On another matter, Dr. Falk recognized that ATSDR has no mandate to conduct international activities. However, no policy prohibits the Agency from being involved on a global level. During the past few months, several issues have surfaced that should cause ATSDR to consider international activities. For example, the Pops Treaty is proposing to eliminate twelve organic substances, including DDT. This substance is necessary for malaria eradication. ATSDR's toxicological profiles and ability to assist health agencies have been helpful in this effort. He asked the Board to consider the Agency's involvement in international activities for discussion at a future meeting. Dr. Leonard added that ATSDR's role in this effort may generate new funding sources, such as the World Health Organization and the World Bank.
Public Comment Period. Dr. Lybarger announced that Dr. JeAnne Burg would be retiring from federal service within a week. He encouraged the Board members and Agency staff to send regards to Dr. Burg.
Ethics and Conflicts of Interest. Ms. Gloria Kovach, of CDC's Office of Committee Management (OCM), conveyed that issues related to ethics and conflicts of interest impact every advisory body established under the Federal Advisory Committee Act (FACA). She presented a videotape that outlined the rules and regulations which BSC members must adhere to as special government employees, including pre- and post-employment restrictions, conflicting financial interests, appearance concerns, use of inside information, and limitations on outside activities. Dr. Spengler added that once individuals are officially selected to serve on the BSC, the information is also provided in writing before members begin their terms.
There being no further discussion, Dr. Melius recessed the BSC meeting at 4:35 p.m. on November 18, 1999.
C/TS Update, Operational Guidelines and Recommendations. Dr. Melius reconvened the BSC meeting at 8:35 a.m. on November 19, 1999. He yielded the floor to the first presenter. Dr. Roseman turned the Board's attention to the October 26, 1999 version of the C/TS guidelines. He mentioned that the guidelines were being presented for the BSC to consider, approve and forward to ATSDR as a formal C/TS document. He pointed out that OCM reviewed the draft guidelines and inserted language as required by FACA. Dr. Roseman reminded the Board that he and Dr. Claudio would be rotating off the C/TS in April 2000. Consequently, he urged the BSC Chair to identify two new members soon so that these persons could attend the Subcommittee's April 2000 meeting. He highlighted the following changes to the guidelines that were not included in the version circulated to the Board:Dr. Roseman explained that the section on the Information Resource has not yet been completed because several issues were still unclear. He emphasized that Dr. Henry Cole has been extremely helpful to the C/TS and SCs by serving in this capacity. Dr. Cole synthesized activities, as well as developed and maintained the tracking system. However, some of these responsibilities are now under the purview of the DFO. Dr. Roseman intends to send a letter to Dr. Spengler requesting ATSDR's continued support of the Information Resource. The letter will also describe the role of the Information Resource to ensure that these responsibilities do not overlap with the DFO or C/TS Chair. In terms of the Agency's research agenda, the Subcommittee has not yet made any formal recommendations, but the issue of tissue sampling was extensively discussed during the C/TS meeting. Dr. Roseman was pleased about the Board's request to place this item on the agenda for a future BSC meeting. The Subcommittee's position is that tissue sampling will play a significant role in building a constituency among the research community and citizens.
With respect to Public Health Assessments (PHAs), Dr. Roseman turned the Board's attention to the document that outlined the Subcommittee's formal recommendations. Since more information was needed about PHAs, Mr. Robert Williams, Director of the Agency's Division of Health Assessment and Consultation, graciously facilitated a roundtable discussion on this issue in San Francisco. A decision was made to formalize the Subcommittee's recommendations so that changes which ATSDR has made to the PHA process over the last ten years can be identified. Dr. Roseman mentioned that the major focus of the roundtable discussion was the definition and expectations of PHAs. The scientific community and the public have extremely different perspectives about PHAs. Citizens have also expressed concern about the lack of community involvement in developing, implementing and evaluating PHAs. However, an ATSDR health assessor described a team approach to site activities which was strongly endorsed by the C/TS and SCs. The Subcommittee requests that strong efforts be made to replicate this model as an Agency-wide policy.
Another source of frustration to communities is the fact that PHAs are used by federal agencies and PRPs as evidence to support no problems exist at a site. These conclusions are presented as hard science, but the inadequacy of data and scientific uncertainties are not reflected in PHA recommendations. The PHAs also do not offer suggestions on how to obtain solid data that will answer scientific questions. The SCs raised the issue of ATSDR's reliance upon samples collected by other agencies. Communities have no confidence that the specimens are accurate, but no resources are provided for citizens to collect these types of data. EPA specifically prohibits TAGs from being used by community groups to gather new information. Dr. Roseman mentioned that another extremely important area is the issue of sensitivity to communities and tribes. As a result, a small work group of SCs will collaborate with Dr. White to develop a cultural sensitivity module. The proposal for this activity is still being developed and will be presented to the Board upon completion.
Dr. Roseman reported on some of the major topics that have been a focus of the past two Subcommittee meetings. However, these issues are still being discussed and no formal recommendations have been made on chemical mixtures, health care in communities, and activities at federal facilities. Nevertheless, the Subcommittee is formally requesting that a portion of the next BSC meeting be devoted to presentations by federal facilities representatives. The areas of most interest to the C/TS are (1) cleanup activities at federal sites where ATSDR is involved; (2) how a federal facility views its interactions with ATSDR as well as communities and tribes surrounding the site, particularly in terms of releasing information; (3) ongoing research activities being conducted by federal facilities which relate to exposures and health effects; (4) oversight mechanisms federal facilities believe to be appropriate in preparing ATSDR's reports; and (5) how conflict of interest issues are addressed in a federal facility's relationship with ATSDR. Dr. Roseman concluded by pointing out that one of the most significant accomplishments by the C/TS and SCs was the development of EPA's health TAG.
BSC Response to C/TS Update and Recommendations. Ms. Moses expressed concern with the evaluation component of the guidelines because the "continuation, modification or cessation of the C/TS" would be based on the evaluation report. As a result, the SCs would not have an opportunity to provide input into this process. Dr. White's position was that the wording should more accurately reflect recommendations made for better processes, coordination or activities. The current language implies that the C/TS will be reviewed only on its activities, rather than on a broader scope of projects undertaken by the BSC and ATSDR. In response to the comments by Ms. Moses and Dr. White, the following sentence was deleted from the guidelines: "The results of the evaluation will be reported to the ATSDR Assistant Administrator, with appropriate recommendations for continuation, modification, or cessation of the C/TS." Drs. Melius and Spengler proposed that the following language be added instead: "Following review by the C/TS and BSC, the results of the evaluation will be reported to the ATSDR Assistant Administrator. The report shall reflect accomplishments and recommendations for activities and operation of the C/TS." The Board accepted this language. Dr. Melius expressed his appreciation and admiration to the C/TS members and SCs for their hard work in developing the guidelines. He entertained a motion to approve the document. Dr. Claudio so moved; Dr. Au seconded the motion. The C/TS guidelines were unanimously approved by the Board for submission and action by ATSDR.Dr. Melius turned to the Subcommittee's PHA recommendations. He remarked that the best suggestion made by the C/TS was for ATSDR to "initiate an independent systematic evaluation to determine the extent to which PHAs have been responsive to community concerns. . .". He acknowledged that the Agency has made many changes in order to be responsive to community concerns, but he believed the recommendation should be broadened to reflect ATSDR's responsiveness to scientific concerns. He wholeheartedly agreed about the need to develop a benchmark that will continually, formally and consistently evaluate the PHA process on a much broader perspective. Although a significant amount of time, money and effort would be required for an independent evaluator to collect data directly from communities, Dr. Melius underscored that this assessment would be invaluable to ATSDR. Dr. White noted that the Agency's research agenda provides an opportunity to strengthen the PHAs and address the expectations of all constituents and stakeholders. She indicated that a tremendous gap exists in translating and implementing science into community-based practice. Dr. Claudio added that as an advisory body, the BSC should ensure its recommendations are widely implemented throughout the Agency. This progress should be also be periodically evaluated by the C/TS. Despite budget constraints and OMB requirements, Dr. Spengler was confident an evaluation mechanism could be designed for PHAs.
Dr. Falk viewed the Subcommittee's PHA document as a useful guide for the Agency in terms of identifying items that communities want to be evaluated. He admitted that ATSDR needs to improve on communicating health effects to residents. He committed to reporting the Agency's progress in this area at a future meeting. Dr. Lichtveld turned to the Subcommittee's proposal to develop a cultural sensitivity training module. She conveyed that ATSDR would welcome input by the SCs in developing appropriate questions which should be asked when health assessors enter communities and tribes. Dr. Leonard recognized the importance and significance of federal agencies being sensitive to various cultural groups, tribes and community members. However, she was concerned about the risk of overemphasizing these issues at each individual site and becoming less focused on the social science process. She proposed that a consistent and systematic approach be taken at all sites. Mr. Sanchez emphasized that communication is very much a cultural issue. With all due respect to Dr. Leonard's comments, he stressed that federal agencies must be aware of and take into consideration the differences in culture and language among communities and tribes.
Dr. Stark explained that a PHA is defined differently by the government than communities and tribes. She proposed that the name be changed to, for example, a "data review." She believed that much of the anger and frustration would be eliminated if communities and tribes did not expect ATSDR to "assess the public's health" during a data review. Dr. Melius entertained a motion to forward the PHA document to ATSDR with an emphasis on the evaluation and sensitivity recommendations. Dr. Roseman so moved; Dr. McDiarmid seconded the motion. The motion was carried.
Dr. Falk turned to the Subcommittee's request to invite representatives from federal facilities to the next BSC meeting. He conveyed that Dr. Spengler serves on an HHS advisory committee which focuses on epidemiologic research conducted at federal sites. DOE serves as a liaison member to that committee. The chair of the committee left Dr. Falk a message requesting to have a point of contact from the BSC. Dr. Falk committed to reporting the details of the reason for this request after speaking with the committee chair. Ms. Bradshaw added that communities are also interested in knowing why federal facilities serve as the lead agency in site activities. Ms. Linda Freeman of ATSDR-DHEP reported that she will serve as the Project Coordinator for the health TAGs. The Agency has met with all of EPA's regional TAG coordinators to discuss its involvement in the program. ATSDR is interested in convening an Agency-wide work group to discuss and agree upon the coordinated effort and outreach strategies that will be necessary to implement the health TAGs. Dr. Lichtveld requested that the C/TS Chair provide her with names of SCs who would be interested in working with DHEP to develop the outreach plan for the health TAGs.
In addition to the health TAGs, Dr. Melius acknowledged that the C/TS guidelines and PHA recommendations were two other solid accomplishments by the Subcommittee and SCs. He thanked the members for their diligence in these efforts. As an ACTION ITEM, he confirmed that the Board will identify the new C/TS members and SCs by the next BSC meeting. Dr. Melius will ensure that all persons listed in the guidelines are contacted and have input into the selection and nomination processes. He announced that he would be unable to stay for the remainder of the meeting.
Dr. Roseman would serve as Acting Chair in Dr. Melius' absence.
Expert Panel on ATSDR's Late Breaking Activities. Review of the Toxicological Profile for PCBs. Dr. DeRosa reported that the PCB profile is a work-in-progress and reflects the third edition to the toxicological profiles. The data collected formed the basis for the findings from the Great Lakes Research Program. The profile also allowed ATSDR to develop a technical support document for uniform fishing advisories in the Great Lakes Basin. The document was disseminated to more than one million persons throughout Michigan, including licensed fishermen, forty tribal nations, local health departments, as well as practicing pediatricians, obstetricians and gynecologists. The document played a significant role in ATSDR's presentation to the public announcing the listing of the Fox River as a Superfund site. In developing the Agency's toxicological profiles, an extensive peer review process is undertaken for both draft and final versions of the document. Internal and external reviewers include the Health Effects Review Workgroup and the Minimal Risk Level (MRL) Workgroup on which NIEHS and EPA serve.A public comment period is also provided through a Federal Register notice which announces the chemicals that are being profiled and requests additional data. The date the draft profile will be available is then announced in a subsequent Federal Register notice. The document is released to the commercial and technical press. ATSDR received extensive public comments on the PCB profile from industry, academia, private sector organizations, environmental groups and concerned citizens. In response to the comments, the Agency convened an expert panel of constituents to make the process open and transparent, as well as to provide additional input on key issues in the PCB profiles, i.e., neurotoxic endpoints, the assessment of oncogenicity, and reproductive and developmental deficits. The meeting primarily focused on reviewing the Agency's responses to public comments, identifying key literature that might be missing, identifying key ongoing research, providing an expert review of conclusions drawn in the profile, and reviewing the derivation of the MRL.ATSDR has taken steps to address uncertainties with the MRL numerator by using computational models, pharmacokinetic modeling, pharmacodynamic modeling, and benchmark doses that can be used in lieu of uncertainty factors in certain situations. The Agency developed a technical paper on this issue based on the Board's previous recommendations. The paper will be published in an upcoming issue of Toxicology and Industrial Health. ATSDR also re-examined key health guidance values that are missing for the top twelve chemicals using pharmacokinetic and pharmacodynamic modeling to determine if these tools can fill data gaps. These conclusions will be compiled in a paper and solicited for public comment.
The expert panel made the following recommendations about the PCB profile: improve the readability of the document; add additional studies identified during discussions; provide an additional review of conclusions reached from epidemiological studies; and provide a weight of evidence discussion using additional studies for the MRL. ATSDR plans to release the final PCB profile either in late spring or early winter in the year 2000. The Agency will carefully consider on a case-by-case basis whether the guidance or development of the other toxicological profiles will be altered. In addition to the PCB profile, this action will most likely be taken for lead and other chemicals with consistent health endpoints irrespective of route of exposure. With the new approach, ATSDR will develop an index for the toxicological profiles and a quick reference guide for health care providers.
Paducah Gaseous Diffusion Plant (PGDP). Before beginning the presentation, Mr. Williams thanked the C/TS and SCs for providing ATSDR with valuable recommendations about the PHA process. He reported that the PGDP is a DOE facility located in Kentucky on a former ordnance works site. The facility was used for TNT and ammunition production during World War II. The Atomic Energy Commission took over the plant in 1950. The gaseous diffusion occurs in process buildings at the plant. Approximately 38,000 cylinders of depleted uranium are stored onsite. A process vent that is 200 feet high releases emissions from the diffusion process. The unfenced border outside the plant boundary is DOE property. Although the area surrounding the site is primarily farmland, many residences are located within one-half mile north and east of the facility. The population of 200 persons is increasing due to new facilities, industry, housing projects and highways currently being developed.
Two operations at the plant were still being used up until the 1970s: UF6 manufacturing and uranium metal conversion. The current operation is a uranium enrichment process by gaseous diffusion. In 1953, reprocessed uranium contaminated with radionuclides was used from plutonium production reactors. The primary contaminants were Tc-99, Am-241, Pu-239 and Np-237. In 1988, Kentucky Radiological Health detected Tc-99 and TCE in residential wells. Consequently, DOE supplied homes north of the site with municipal water. The plant is currently privatized, but DOE is still responsible for past exposure and cleanup activities. In May 1994, EPA placed the site on the NPL for TCE and Tc-99 in the groundwater. The prevailing wind direction and the groundwater plumes extend north to northeast.
ATSDR's activities at the site include a draft PHA that was released for data validation on August 4, 1999. Several past and current pathways are being analyzed in the air, groundwater, surface water, soil, sediment, food and biota. Multiple opportunities exist for human exposure. To date, the Agency has examined more than 750,000 sampling data points and reviewed over 150 documents. The controversy at the site began with a major lawsuit that was filed by the Natural Resources Defense Council against DOE on behalf of workers at the Paducah facility. The lawsuit alleges that workers were unknowingly exposed to high-level contaminants in reprocessed uranium. Further allegations were that exposure occurred in unsuitable areas, such as cafeterias; multiple spills and releases of materials are also contentions of the lawsuit. Throughout 1999, several newspapers reported on the Paducah incident. As a result of the press coverage and lawsuit, a hearing was held with the U.S. House of Representatives and Commerce Committee. ATSDR participated on three conference calls with Congressional staff to explain its analysis of the data, whether the Agency had knowledge of the contaminants that left the fence-line boundary of the plant, and if ATSDR planned on requesting additional characterizations.
DOE's response to Congress was to initiate a two-phase site investigation conducted by independent contractors. Phase I of the investigation has now been completed. Activities that occurred at the site from 1990 to September 1999 were examined. The study pointed out several public and environmental protection issues that were not adequately addressed by DOE and its contractors. The investigation also included areas related to the health, safety and notification of workers. Phase II of the investigation began in October 1999 and will examine activities at the site prior to 1990. ATSDR's involvement in Phase II of the investigation will be to continue with the data validation; request additional information from agencies involved at PGDP; modify the draft PHA after the data have been received; and release the draft PHA for public comment. In addition to workers, health impacts have been documented for community residents from past releases from the stack. The main concerns are cancer and asthma, but accurately identifying the source of the high cancer rate in the area is difficult due to other potential sources and contributing factors. Fishing advisories have been posted for PCBs and mercury contamination has been located in ponds. ATSDR is not specifically addressing the health concerns in the worker population due to the ongoing medical surveillance.
ATSDR is aware that onsite exposure to mercury is still an ongoing problem. NIOSH is currently addressing this issue. The Agency is also not performing biomonitoring for uranium because this testing is being implemented under the worker medical surveillance program. To determine offsite contamination and exposure, ATSDR is using data collected by DOE, the Kentucky Health Department, and Kentucky Radiological Health. As part of the data validation process, ATSDR intends to continue its collaborative efforts with these agencies to develop sampling plans and further characterize the area. Some ATSDR staff obtained clearances to examine secured DOE data; however, obtaining information from Paducah was more difficult because the plant is privatized. Consequently, the Agency is attempting to gather data from all sources, including private research projects. ATSDR was able to use information from a study that analyzed chromium releases from cooling towers at Paducah, as well as a medical monitoring study on persons who drank groundwater contaminated with TCE. Dr. McDiarmid advised ATSDR to seriously consider conducting biomonitoring on residents to characterize potential health outcomes. This activity could easily be undertaken due to current knowledge about groundwater contamination, upper limits for both uranium and depleted uranium, the ability to conduct isotopic analysis, and exposed workers who also reside in surrounding communities.
Mercury in Vaccines. Dr. DeRosa announced that the toxicological profile for mercury was released in April 1999 in response to an extensive interagency dialogue with the Committee on the Environment and Natural Resources. In the public health message that was released, the agencies agreed to reinforce the value of fish advisories for mercury and other substances. ATSDR presented its perspectives on methyl mercury at the National Academy of Sciences meeting in June 1999. The mercury profile was selected by the World Health Organization as the primary source document for the updated mercury assessment. The American Academy of Pediatrics (AAP) expressed an interest in mercury in terms of childhood immunizations because thimerosal, which is 50% mercury by molecular weight, was being used in vaccines. ATSDR was asked by CDC to participate in drafting the joint PHS/AAP statement on thimerosal in vaccines that was issued on July 8, 1999. Available information on thimerosal is limited to a few acute poisoning cases, but the increase in vaccines during the first year of life prompted a review of potential health risks. Data on methyl mercury indicate the chemical is neurotoxic to infants or fetuses at sufficiently high exposures.
In addition to assisting CDC's National Immunization Program in drafting the joint statement on thimerosal in vaccines, ATSDR also (1) participated in multiple conference calls with the other collaborating agencies to clarify toxicology issues relevant to organic mercury; (2) attended the NIH workshop on thimerosal in August 1999; (3) participated in the prioritization of a national research agenda for thimerosal in August 1999; (4) presented the scientific basis for ATSDR's chronic methyl mercury health guidance values, as well as pharmacokinetic and pharmacodynamic insights for both methyl and ethyl mercury at the October 1999 meeting of the Advisory Committee on Immunization Practices (ACIP); and (5) participated in developing the Morbidity and Mortality Weekly Report article on thimerosal in the November 5, 1999 issue. Using the entire database on alkyl mercurials, ATSDR reached the following conclusions.
The current status is that the ACIP saw no recognized risk from exposure to thimerosal in vaccines. Consequently, the committee recommended that Hib, hepatitis B and DTaP vaccines containing thimerosal as a preservative can continue to be used in the routine infant schedule beginning at two months of age. Nevertheless, vaccine manufacturers, FDA and PHS agencies are now collaborating to reduce the thimerosal content of vaccines or develop new vaccines with no thimerosal. In this effort, caution must be taken to not cause unnecessary disruptions in the immunization system, particularly in developing countries. The next steps of the activity will be a continuing effort to eventually replace thimerosal-containing vaccines with thimerosal-free vaccines, as well as a study of the efficacy in lowering the amount of thimerosal as a vaccine preservative. Additionally, information on ethyl mercury will continue to be collected and evaluated as data become available. Fecal, hair and mammary excretion of ethyl mercury will be examined. The speed of breakage of the ethyl mercury bond in thimerosal will be analyzed as well. As an outgrowth of ATSDR's mercury assessment efforts, the HHS Assistant Secretary and the U.S. Surgeon General have strongly endorsed the toxicological profile for mercury, including the MRL for methyl mercury. ATSDR has been asked to write a critical review of organic mercurials for publication in Toxicology and Industrial Health.
Public Comment Period. No attendees responded to the Acting Chair's request to make a public comment. Review of Future Agenda Items, Action Items and Meeting Dates. Dr. Spengler reviewed the topics that had been proposed during the course of the meeting as future agenda items and requested as action items.Agenda Items
Action Items
Action Items for the RAS
Dr. Spengler reminded the Board members that the next BSC meeting is scheduled for May 4-5, 2000. The date for the following meeting is tentatively scheduled for November 30-December 1, 2000. There being no further discussion, Dr. Roseman adjourned the BSC meeting at 11:45 a.m. on November 19, 1999.
I hereby certify that to the best of my knowledge, the foregoing minutes of the proceedings are accurate and complete.
Dr. James Melius, Chair This page last updated on July1, 2001
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