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DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY

Board of Scientific Counselors
May 6-7, 1999
Atlanta, Georgia

Minutes of the Meeting


TABLE OF CONTENTS


The Department of Health and Human Services (HHS), the Public Health Service, 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 6-7, 1999. The proceedings were held at the Westin Peachtree Plaza Hotel in Atlanta, Georgia. The following individuals were present to contribute to the discussion.

BSC Members

Dr. James Melius, Chair
Dr. William Au
Dr. Millicent Collins
Dr. Cynthia Harris
Dr. Robin Leonard
Dr. Melissa McDiarmid
Dr. Jeffrey Roseman
Dr. Charles Sorber
Dr. Alice Stark
Dr. LuAnn White

C/TS Special Consultants

Ms. Doris Bradshaw
Mr. Marvin Crafter
Ms. Peggy Grandpre
Mr. Richard Matheny
Ms. Rachel Moses
Mr. Gilbert Sanchez

Federal Officials

Dr. Henry Falk, ATSDR Acting
Assistant Administrator
Dr. Robert Spengler,
BSC Executive Secretary
Ms. Sandee Coulberson,
C/TS Designated Federal Official

ATSDR Staff

Ms. Cynthia Allen
Mr. David Ayers
Dr. Mark Bashor
Dr. William Carter, Jr.
Dr. Gregory Christenson
Dr. William Cibulas
Mr. Larry Cseh
Dr. Christopher DeRosa
Ms. Annette Dodd
Ms. Tina Forrester
Mr. Rick Gillig
Dr. Michael Grayson
Dr. Lisa Hayes
Ms. Janet Heitgerd
Dr. Heraline Hicks
Mr. Monty Howie
Mr. Joe Hughart
Ms. Sandy Isaacs
Dr. Dennis Jones
Ms. Georgi Jones
Ms. Paula Kocker
Dr. Maureen Lichtveld
Dr. Jeffrey Lybarger
Ms. Sandra Malcom
Mr. Peter McCumiskey
Ms. Marianne Miller
Ms. Donna Orti
Mr. Jerry Pereira
Dr. Richard Rheingans
Ms. Donna Rossie
Mr. Peter Sherman
Dr. Lester Smith
Mr. John Steward
Dr. Allen Susten
Dr. Andrea Wargo
Dr. Rueben Warren
Mr. Robert Williams
Ms. Sharon Williams-Fleetwood
Dr. Mildred Williams-Johnson
Dr. Jewell Wilson
Mr. Ron Wilson
Mr. Steve Von Allmen
Ms. Marianne Yaun

Other Attendees

Dr. Roger Bernier
Ms. Burma Burch
Ms. Gloria Kovach
Ms. Judy Shoji
Dr. Mamora Shoji

Introduction and Opening Remarks. Dr. James Melius, Chair of the BSC, called the meeting to order at 9:00 a.m. on May 6, 1999. Because several individuals were new to the Board, he asked that the members formally introduce themselves. BSC member, Dr. Luz Claudio, did not attend the meeting. Dr. Robert Spengler is the ATSDR Associate Administrator for Science and the BSC Executive Secretary. Dr. Cynthia Harris is the Director and Associate Professor of the Institute of Public Health in the College of Pharmacy and Pharmaceutical Sciences at Florida A&M University. Dr. John Schelp is with the Office of the Director at the National Institute of Environmental Health Sciences (NIEHS). Dr. Robin Leonard is an occupational epidemiologist for the DuPont Corporation.

Dr. Millicent Collins is the Acting Chair of the Department of Pediatrics of the Public Benefit Corporation in Washington, D.C. She also serves on the Howard University Combined Pediatric Residency Program. Dr. Melissa McDiarmid is an occupational environmental medicine physician at the University of Maryland--Baltimore. Dr. Alice Stark is the Director of the Bureau of Environmental and Occupational Epidemiology at the New York State Department of Health. Dr. LuAnn White is with Tulane School of Public Health. Dr. Jeffrey Roseman is Professor of Epidemiology at the University of Alabama--Birmingham. He serves as Chair of the BSC's Community/Tribal Subcommittee (C/TS or the Subcommittee). Dr. Charles Sorber is President of the University of Texas--Permian Basin. Dr. William Au is Professor of Preventive Medicine and Community Health at Texas A&M University--Galveston. Dr. Henry Falk is ATSDR's Acting Assistant Administrator.

Dr. James Melius is with the Laborers' Union, which is involved with several clean-up activities. He announced that former ATSDR Assistant Administrator Dr. Barry Johnson retired on December 16, 1998. The Agency is currently searching for his successor and hopes to have the appointment filled by the fall of 1999. After Dr. Falk's four-month term expires, Dr. Maureen Lichtveld will serve for four months beginning in mid-August 1999.

ATSDR Update. Dr. Falk provided additional details about the search for the Agency's Assistant Administrator. Dr. Peter McCumiskey acted in the position first; his four-month term ended in April 1999. The search committee contains four members from the Centers for Disease Control and Prevention (CDC) and three outside members: Dr. Steve Thacker of the Epidemiology Program Office; Dr. Bryan Hardin of the National Institute of Occupational Safety and Health (NIOSH); Dr. Helene Gayle of the National Center for HIV, STD and TB Prevention (NCHSTP); and Dr. Eric Sampson of the National Center for Environmental Health (NCEH); Dr. Bailus Walker of Howard University and former BSC Chair; Dr. Ed Thompson, Mississippi State Health Office; and Dr. Jane Delgado of the National Coalition of Hispanic Health and Human Services Organization. The announcement for the position closed on May 3, 1999. The Agency is interested in reaching a resolution fairly quickly.

Budget Issues: ATSDR's budget was $74 million in FY'98; is estimated at $76 million for FY'99; and the president has proposed $64 million for FY 2000. If the $12 million decrease from 1999 to 2000 holds, some of the Agency's programs will be significantly impacted, such as health studies, cooperative agreements, research areas and the Child Health Initiative. ATSDR has tried to convey the importance of this decreased funding and is making a strong effort to replace the funds. Dr. Jeffrey Koplan, the CDC Director and ATSDR Administrator, is currently approaching key Congressional representatives and Senators for the Agency's funding committees about the budget.

ATSDR Initiatives. Five ATSDR initiatives have been advanced for FY 2001. Of those, Susceptible Populations, the Child Health Initiative, and Brownfields have been submitted to the U.S. Environmental Protection Agency (EPA) for special funding. Bioterrorism and Women's Health have been forwarded to CDC for funding. Through previous activities, ATSDR was able to identify several susceptible populations, including children, groups with socioeconomic issues, communities undergoing social injustices, and persons with underlying illnesses. The Agency's goal is to increase efforts in these populations with targeted screening, health promotion programs, and educational activities. The Child Health Initiative focuses on the three to four million children who live within one mile of a hazardous waste site. Childhood populations are of great concern to ATSDR. Consequently, the Agency has targeted such areas as asthma, childhood cancer and developmental disorders. In addition to these areas, two new components of the initiative will focus on issues related to potential exposures near schools and the training of health care professionals who serve children.

Brownfields are abandoned or under-utilized industrial commercial facilities. Many of these sites are currently being redeveloped and used for other purposes. ATSDR's position is that these sites should be thoroughly reviewed to identify potential public health problems before any modifications to the properties are made. The bioterrorism and women's health activities are being broadly undertaken at CDC. ATSDR has an opportunity to become involved with these activities by addressing those areas which are important to the Agency's mission. CDC has submitted the proposal requesting this partnership, which would be the first time the Agency received CDC funding.

CDC received more than $100 million in FY'99 for the bioterrorism activity and expects additional dollars in FY'2000. The bioterrorism initiative will study both biological and biochemical issues. NCEH is focusing on areas related to nerve gas agents and chemical weapons, while ATSDR is targeting issues pertaining to industrial chemical releases in terrorist acts. Lead is one of the primary issues in the women's health initiative because the chemical stores in the body for many years and can be passed to children. Lead in older women can affect bone modeling and remodeling, and can cause several other long-term effects, particularly in post-menopausal women. The initiative will study long-term effects of lead exposures to women from early adulthood, occupational and environmental perspectives.

CDC/ATSDR Priority Areas: Dr. Koplan has identified the priority areas as (1) strengthening the science for public health actions and ensuring its applicability to public health; (2) collaborating with health care partners for prevention; (3) promoting healthy living at every stage of life; and (4) working with partners to improve global health. These priorities are most relevant to ATSDR's epidemiologic investigations, such as the birth defects project; as well as partnerships and cooperative agreements with health organizations, states, local health departments, tribes, and research organizations.

Toxicological Profiles. Several toxicological profiles have recently been released. First, the mercury profile presented a minimal risk level (MRL) of 0.3 g/kilo/day, which is higher than earlier ATSDR versions. This level also exceeds EPA's level of 0.1. ATSDR's MRL is used at Superfund sites, but is not proposed as an alternative to the EPA regulation. A National Academy of Sciences (NAS) committee has been formed to review the different methods that have been implemented to calculate these numbers. The committee will decide whether different numbers should be used or if one government standard should be set. ATSDR will be assisting NAS in this process over the next eighteen months. The PCB and arsenic profiles are expected to generate a lot of discussion as well. The arsenic profile is currently undergoing NAS review; the PCB profile is a priority for several agencies. ATSDR will continue to collaborate with a variety of HHS departments and EPA as the toxicology profiles evolve.

Department of Energy (DOE) Funding. In FY'98, ATSDR received $5 million from DOE. The Agency anticipates receiving between $9 and $12 million in FY'99. This increase will cover site activities at Hanford, Oak Ridge, Los Alamos and Savannah River. However, uncertainty still exists about funding for the revised Hanford Medical Monitoring Program. Dr. Falk met with DOE appropriations staff on April 30, 1999 to voice the Agency's support for the program. Resolution has not been reached to date because DOE prefers that the program undergo further modifications, while ATSDR's position is to implement the program pursuant to the current proposal.

Superfund Legislation. Legislation related to Superfund is currently being considered in the 106th Congress. HR1300 by Representative Boehlert would reauthorize Superfund; however, a full-scale reauthorization is not expected in FY'99 due to political differences. Nevertheless, some bills were introduced in FY'98 that were favorable to ATSDR and may address certain portions of Superfund. HR1510 is environmental justice legislation introduced by Representative Lewis that would identify environmental high-impact areas and request ATSDR's assistance in implementing certain activities.

Recent Community Involvement Activities. A large dose-reconstruction study in Oak Ridge, Tennessee should be completed in late 1999. A community meeting was recently held so that all stakeholders in the process could begin to collectively plan what additional studies may be needed or partial health services provided. Additional sites include Grand Bois, Louisiana, which is concerned about health effects from an oilfield waste processing plant; Brick Township, New Jersey, which is concerned about autism; Alberton, Montana, which is concerned about long-term effects from chlorine releases; and Marion, Ohio, which is concerned about leukemia and lymphoma.

Dr. Falk described the main purpose of this BSC meeting as developing ATSDR's research agenda. He looked forward to the Board's input on this new activity. He hoped the research agenda would lead to a more sustained, organized and coordinated effort for the Agency's research issues. He noted that Dr. Spengler has placed this issue high on ATSDR's list of priorities.

Review of BSC's Purpose, Operation and Charter. For the new Board members, Dr. Spengler provided historical information about the Agency. ATSDR was established in 1980 by the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA). In 1986, ATSDR evolved as a fully functional public health agency under Dr. Johnson's leadership. Congress linked CDC and ATSDR by having the CDC Director also serve as the Agency's Administrator. The Assistant Administrator performs ATSDR's day-to-day functions and oversees the Agency's operations. In 1987, Dr. Johnson formed the BSC with Dr. Charles Xintaras serving as the Executive Secretary.

The purpose of the BSC is to serve as a quality assurance mechanism for ATSDR's scientific activities. The charter states that the Board should (1) provide advice and guidance on the adequacy of science and ATSDR-supported research; (2) assist in identifying emerging problems for further investigation by the Agency; (3) review the accuracy and currency of science in ATSDR's reports and products; (4) identify program areas to emphasize or de-emphasize and recommend new research programs; and (5) advise the Agency on the scientific quality, timeliness and utility of its results. These five purposes strongly support ATSDR's development of a five-year research agenda.

The BSC is structured under the Federal Advisory Committee Act (FACA) charter as defined by the HHS Secretary. These guidelines were created to ensure that community membership on committees is balanced through geography, race, ethnicity and gender. The Board's composition is a Chair and ten members who all serve four-year terms. The members represent expertise in several areas including medicine, toxicology and environmental health sciences, including epidemiology and engineering. The Board's non-voting members include two Ex Officios from EPA and NIEHS, as well as three C/TS Special Consultants. As the BSC Executive Secretary, Dr. Spengler's office is responsible for providing the Board with logistical and administrative support.

Notice of the Board's two biannual public meetings are published in the Federal Register. Detailed minutes of the proceedings are produced. The meetings have typically been held in April and November. The BSC has the ability to develop and utilize subcommittees and work groups, such as the Great Lakes Subcommittee, the C/TS and other ad hoc groups. Board members serve as special government employees and are therefore bound by federal guidelines for conflicts of interest, standards of conduct, and issues related to travel and reimbursement. Recommendations made by the C/TS are forwarded to the BSC for formal action. The Board makes recommendations to both the HHS Secretary and ATSDR Administrator.

Dr. Spengler posed two issues for the Board's consideration. First, the last page of the charter states that the Board will terminate on July 28, 1999. ATSDR is submitting documents to ensure the continuance of the BSC. He noted that changes could be made in the charter to expedite its approval. For example, he suggested that the first sentence of the third paragraph on page 2 be deleted. The removal of this statement would allow the Agency the flexibility to form subcommittees. Second, he proposed that Committee Management staff present at the next Board meeting the rules and regulations related to standards of conduct and conflicts of interest. Ms. Burma Burch of CDC is the Department Committee Management Officer.

Focusing the BSC on Issues of Science: Building a Five-Year Research Agenda. Dr. Melius explained that the remainder of the meeting would focus on ATSDR's proposed research agenda in order to begin implementing the activity. He mentioned that this new initiative is extremely appropriate for the BSC's and Subcommittee's involvement. Because this meeting would serve as the initial discussion of the research agenda, he encouraged the Board to provide comments, suggestions or revisions. Dr. Spengler added that the proposed research agenda will cover the years 2001 through 2005. He presented an overview of the initiative.

The purpose of the research agenda is to help guide, coordinate and monitor the development and implementation of a research agenda that would be appropriate for Agency-conducted or supported science activities. Several guiding principles were created in developing a strategic plan. The proposed collaborators of the research agenda include ATSDR, the BSC, experts, partners and constituents, such as community and tribal groups. ATSDR hopes that the result of this activity will be a simple, understandable and useful product. The research agenda will encourage several multi-disciplinary approaches, identify new partnerships and areas of collaboration, consider a full range of applied research, compliment the development of ongoing CDC research priorities, and ultimately result in a commitment to follow the agenda.

ATSDR has identified several benefits of the research agenda. It will (1) become an important planning and communication tool; (2) foster internal and external collaboration; (3) attract additional support and resources; (4) compliment research conducted by others; (5) result in the review of ongoing work; (6) identify cross-cutting areas for research; and (7) strengthen ties with new and existing partners. With the Board acting as partners in the development process, the Agency anticipates that areas of mutual importance will be identified, the quality of the science will be improved, and the direction and impact of programs will be addressed. ATSDR has defined roles and responsibilities for itself and the BSC. In addition to providing advice during the development phase, the Agency is proposing that the Board form a subcommittee which would take an advisory role in providing guidance and reviewing progress. If necessary, working groups could be created to support the subcommittee's activities.

ATSDR will seek advice from the BSC, experts, constituents and other partners. The Agency will also provide leadership and support to develop the applied research agenda. The existing Science Forum includes ATSDR's Assistant Directors for Science of each division, as well as office representatives. This group can be used to assist the subcommittee and the Board with planning and information resource issues. The developmental time-line of the research agenda has been divided into five phases.

The purposes of the tracking system will be to (1) guide intra- and extramural funding decisions; (2) encourage other agencies to include these priorities in their programs; (3) monitor the impact on environmental public health research; (4) update the agenda as appropriate with input from partners and constituents; and (5) review and communicate the progress of the agenda on an annual basis. ATSDR's preliminary list of partners and constituents includes other federal agencies, affected community representatives, academic institutions, professional societies, state and local health and environmental departments, American Indian and Alaska Native representatives, national and international organizations, industry, and others. Dr. Spengler posed three items for the Board's discussion of the research agenda: the overall approach, suggested modifications or enhancements, and the level of the Board's support for the proposal.

Discussion. Dr. Melius requested more information about the level of interaction that will be used in the process. He advised the Agency not to develop a final document and then present it for public review. He suggested that the subcommittee focus on specific areas and involve affected constituents early in the process. Dr. Spengler reiterated that ATSDR would engage a variety of stakeholders during the development process. Models of research agendas with a strong public involvement component would be reviewed, most notably NIOSH's National Occupational Research Agenda (NORA). This well-planned agenda used a strategic approach by creating working groups for all 21 focus areas. Dr. Spengler encouraged Board members to forward models of other research agendas to the Agency.

Dr. Melius' position was that NORA was very time consuming; however, many stakeholders had an opportunity to participate in the process. The public involvement component was of great benefit to NIOSH. Because environmental health is fragmented in terms of research, he viewed ATSDR's proposal as an opportunity to make a stronger coordinated effort in identifying roles, responsibilities and mutual research areas. Dr. Stark asked that the differences between ATSDR's current and proposed research processes be delineated. She reported that the New York State Health Department recently underwent a process to develop a research agenda. Although she supported the Agency's proposal, her experience was that this very difficult undertaking requires a great deal of objectivity and flexibility. She advised ATSDR to be prepared to encounter a great deal of disagreement from constituents. Dr. Spengler replied that the Agency has no existing agency-wide research agenda; the proposed activity is a completely new undertaking. He clarified that ATSDR divisions currently have operational plans, but the goal is to create an overarching agenda by compiling the divisions' independent plans with external input.

Dr. Leonard added that many private sector companies are developing research agendas as well. For example, CMA is convening technical implementation panels and the American Industrial Health Council has been reorganized to address these difficult scientific issues. Consequently, she anticipated that industry would be a willing partner in ATSDR's research agenda. Dr. Leonard was also in favor of the Agency's proposal. She pointed out that the Board members could assist ATSDR in the development phase by drawing on their individual experiences.

Dr. Harris asked if the issue of tracking the impact of the agenda had been discussed. She also requested the Agency's definition of "progress." Dr. Spengler responded that ATSDR clearly understands the need for evaluating, monitoring and measuring impacts of the activity. He explained that NORA, for example, measures impact by the amount of funding used by external groups for implementing activities which support research priorities. Impact is also measured by the extent to which other organizations are affected. NORA recently queried ATSDR about the level of its occupational research activities to determine the Agency's commitment in this area. He added that defining evaluation parameters is still at the beginning stage. Dr. Spengler acknowledged ATSDR's need for more information on good tracking system models.

Dr. Roseman hoped that the agenda would review the process by which research is funded. Concern has been expressed about the individuals who sit on peer review committees, the lack of community involvement, and the narrow focus of topics. Dr. Au emphasized the importance of obtaining broad-based input during the development process. He pointed out that such feedback needs to be objectively evaluated. The main principle of the review must lie in providing solid science for decision-making processes.

Dr. McDiarmid served on the deliberative panel for NORA, as well as the priority planning committee for the Occupational Safety and Health Administration. She realized that science should be primary, but research agendas are oftentimes personal or identity-driven. To avoid controversy between ATSDR and its partners, she urged that the missions of all stakeholders be clearly defined in order to smoothly guide the process. Dr. Stark returned to Dr. Falk's update on the Agency's activities, particularly lead and women's health. Because lead has been studied by federal, state and local governments, she inquired about the need for the Agency's continued involvement in this area. She posed this question with respect to ATSDR's mission, activities being conducted by other agencies, and research verus programmatic issues.

Dr. Falk replied that in the last two years, agencies with environmental health initiatives have had a fair amount of interaction, including EPA, CDC, ATSDR, and NIEHS. Defining the missions of these agencies has resulted in some positive experiences. For example, discussions about the roles and purposes of DOE, ATSDR, and NCEH have taken place at DOE sites. Moreover, developing the Year 2000 and Year 2001 guidelines has been a joint venture between NIOSH, ATSDR, and NCEH. The agencies have taken the lead on the goals and objectives that are most appropriate to their respective missions. This approach has stimulated work at certain sites.

Dr. Falk firmly believed that defining missions was easier now than in the past. He noted that lead is an interesting model to review because ATSDR and NCEH studied the area differently. He agreed with Drs. McDiarmid and Stark that general principles should be identified before specific research areas are addressed. Before technical issues and missions are defined, Dr. Leonard clarified that a clear communication process should be developed. She indicated that the developmental time-line presented by Dr. Spengler should be expanded to include more steps in each of the five phases. Although an inordinate amount of time would be spent on procedural issues, she saw a tremendous benefit with this broader system.

Building an ATSDR Environmental Public Health Research Agenda. Mr. Robert Williams, of ATSDR's Division of Health Assessment and Consultation (DHAC) reported that developing an applied research agenda will be extremely important in the Agency's site-specific activities because the research must be used to answer communities' questions. He specified that "environmental public health" will be viewed as one distinct area in the proposed activity. ATSDR defines environmental assessment as characterizing the release of contaminants into the environment for the purpose of making public health decisions. In order to analyze and determine associations between contaminants and adverse health effects, environmental public health professionals need to have knowledge of these contaminants in the environment and how they are transported. The Agency has adapted a continuum to identify this relationship, which begins with the source of contamination and ends with clinical disease.

The source of contamination, environmental transport and total human exposure all relate to completed exposure pathways and how individuals come into contact with contaminants. ATSDR has made progress over the years with a number of activities. Some of these accomplishments include software packages, such as the Analytical Contaminant Transport Analysis System; a Geographic Information System (GIS), which is a state-of-the-art program recognized by other agencies; interim protocols to study specific types of exposures; methods to be respectful of and sensitive to cultural concerns of diverse populations; and expert panels to determine specific issues such as bioavailability and dose reconstruction methods. However, the Agency still has uncertainties in the area of environmental assessment, most notably real-time monitoring to determine if collected samples accurately represent exposure to a population. Moreover, improved protocols are needed to correlate samples with contaminants in the environment. ATSDR is also interested in more rigorously applying GIS to better answer questions. Knowledge about the use and validation of models for public health practice should be strengthened as well.

With respect to exposure assessment, the Agency's goal is to obtain a better understanding of individual exposure and improve exposure measurements. ATSDR's progress in this area is evidenced by its use of biomarkers for PCBs, dioxin, arsenic and other contaminants. Criteria have also been developed for the collection of environmental or biologic samples during exposure investigations. At some sites, the Agency's biomarkers were able to identify contamination or exposure sources with certainty. These tools were particularly helpful in informing citizens about their exposure. Furthermore, exposure dose reconstruction has used existing data to estimate past exposure. ATSDR recognizes that this area needs continued research and development. Additional data for biomarkers are needed to (1) identify background levels to study exposure by region, age, sex, race or culture; (2) analyze chemical mixtures and low-dose effects; and (3) develop protocols to compare exposures across sites and use these correlations in other communities.

Toxicology. Dr. Christopher DeRosa, of ATSDR's Division of Toxicology (DT), acknowledged that toxicology has a variety of definitions. For example, the National Science Foundation defines toxicology as the science that attempts to preserve life by understanding what harms life. The Society of Toxicology interprets toxicology as a discipline that gathers information to understand how to best preserve life. Other scientists view toxicology as both science and art. The overarching goal from ATSDR's perspective is that toxicology should improve the information base for public health practice to make optimal decisions in the absence of perfect data. The Agency plans to achieve this goal using health mandates defined by Superfund. A comprehensive toxicology program will be based on critical assessment, credible science and public service. These three areas are addressed using a strong marketing plan tailored to the audiences who need this information.

In cooperation with EPA and NIEHS, ATSDR provides priority and focus to the program by listing and ranking the substances most commonly encountered at waste sites. The Agency's toxicological profiles are 250 documents that have been developed over the last twelve years, and rank substances by exposure and toxicity. Data gaps are also identified in the profiles and serve as the gateway to an applied substance-specific research program. With respect to general environmental exposure, ATSDR has been pursuing the Great Lakes Human Health Effects Research Program for the past six years. Eight cohorts of at-risk populations were identified in the Great Lakes Basin. The groups were studied to determine the potential for adverse health effects based on the consumption of contaminated fish. According to the International Joint Commission, this practice accounted for 95% of the completed exposure pathway in the populations.

This enlightening experience allowed the Agency to identify fetuses, men and women of reproductive age as at-risk groups. The effort also provided ATSDR with insight about the potential for joint toxic actions. These findings were incorporated into a mixtures research project that the Agency has been conducting with several federal and international partners. Although the toxicological profiles are quite comprehensive, 80,000 substances are in use according to the Toxic Substances Control Act Registry of Toxic Materials. To address data gaps associated with all of these chemicals, ATSDR is using computational toxicology. These tools can be used in structure activity relationships and kinetic modeling to extend the biologically plausible range of inference and extrapolation needed for the Agency's activities. For example, emergency response actions at sites require that answers be obtained in real-time.

Future directions of the program include studies of chemical mixtures and episodic exposures to chemical combinations. ATSDR has already created a trend analysis of the chemicals that are typically encountered at sites. These data have been distributed to the Agency's academic and government partners for further testing. Some of the findings are currently supporting ATSDR's narrative weight of evidence to characterize the potential for joint toxic actions. These results will be broadened to analyze mechanisms of interaction. Congress prescribed that the toxicological profiles be updated at three-year intervals. These modifications will allow the Agency to review emerging data sets and human health concerns. For example, sections on children's health and endocrine disrupters have been added to the profiles. ATSDR realizes that body burdens of chemicals in the general population are within an order of magnitude of experimentally demonstrated effect levels. Consequently, the Agency needs to study exposures in the context of incremental exposures.

Epidemiology. Dr. Jeffrey Lybarger explained that the Division of Health Studies (DHS) adopted one of the Agency-wide goals, which was to evaluate the relationship between exposure and adverse health effects. In 1992, Dr. Johnson challenged DHS to redirect its program in this area. As a result, the program was restructured to include priority health conditions. To address the goals and applied nature of the research program, DHS identified three areas. First, community concerns were typically site-specific and isolated, but did contribute to the Agency's total knowledge base. Second, decisions were needed to identify risks for persons living near hazardous waste sites and recommend follow-up activities, including health promotion, education and intervention. Third, this important work needed to be documented in relation to the Superfund program. This body of knowledge has been able to consistently and satisfactorily answer the question that residents near hazardous waste sites do indeed experience different health impacts.

In 1992, DHS reviewed DT's outstanding literature reviews to identify the most important toxic substances related to Superfund. Seven priority health conditions were used to develop a paradigm for research activities conducted by DHS. The priority areas were evaluated using four approaches. The literature base defined several isolated studies of differing health outcomes and methodologies. However, developing a coherent body of knowledge around a specific health outcome was difficult. Therefore, basic descriptive work was undertaken and applied in the field. Oftentimes, a direct analysis between exposure and adverse health effects could not be made, but a wealth of knowledge was provided in the area of analytic epidemiology.

Thus, the first approach was to use existing data to identify occurrences experienced by general populations near Superfund sites. Second, analytic studies were conducted to test hypotheses and make specific public health decisions. Third, biomedical testing was performed to standardize the Agency's methodologies and allow the combination of data sets. The development of test batteries was undertaken through a series of workshops in which experts for each of the seven priority health conditions participated. Fourth, improvements in diagnosis and treatment can assist ATSDR in identifing specific illnesses experienced by residents near hazardous waste sites and referring them to treatment. This extremely important activity may possibly allow the Agency to support more clinical-based research, such as the lead study in post-menopausal women at the Bunker Hill smelter site.

ATSDR implemented the research program through a series of grant opportunities for state-based researchers in universities and health departments. The research announcements have focused on several of the priority health conditions, including birth defects, reproductive disorders and respiratory diseases. However, no research announcements have been distributed in three years due to increased demands placed upon the Agency, as well as decreased resources. Nevertheless, ATSDR was able to disseminate a research announcement for susceptible populations in FY'99. The Agency is requesting the Board's guidance in identifying specific research areas.

The birth defects activity is the best example of ATSDR using several studies to develop a body of knowledge for a particular priority health condition. The neurobehavioral toxicity initiative is another of the Agency's accomplishments in this area. Within the next month, ATSDR will begin follow-up neurobehavioral testing of children who were exposed to methyl parathion. The Agency will also conduct neurobehavioral testing on people chronically exposed to hydrogen sulfide. Moreover, biomedical test findings from the descriptive studies will be combined. ATSDR is also following-up on a group of residents who were diagnosed with beta lymphocytosis as a result of the descriptive studies. One example of a community-driven issue that the Agency is undertaking is the New Jersey autism study.

Discussion. Dr. Melius requested more information about the interaction between ATSDR's divisions in terms of applying research programs. Dr. Lybarger responded that all of the divisions undergo a great deal of programmatic interaction. For example, DHAC supplies site assessments so that DHS can identify concerns and problems which require epidemiologic studies. Because DHAC is now conducting total exposure assessments, GIS evaluations and exposure investigations, DHS is able to better define exposed populations. The upcoming hydrogen sulfide study is a direct result of DHAC's efforts. DT's activity, which is a chemical-specific research program that defines data gaps, provides complimentary views and methodologies to build a body of knowledge for ATSDR's other research divisions. These data are then presented to the Division of Health Education and Promotion (DHEP) for implementation, intervention and health education programs. Subsequently, these activities define new needs for research areas.

Dr. Harris asked about the strategy that will be used to prioritize mixtures in the new chemical mixtures research initiative. Dr. DeRosa replied that the HazDat database will be used. The database is compiled through the public health assessment process and other site-specific activities. A trend analysis will be used to identify (1) commonly recurring chemical combinations based on a two- to five-component measurement, (2) the types of sites, and (3) the amounts of the mixtures. Interactive profiles will be developed from the trend analysis. A narrative weight of evidence will be compiled based on the Agency's expectations that the joint toxic actions of the chemicals will exceed or be less than the additive amount of EPA's guidelines for chemical mixtures. Codified criteria will be used to assess whether the data are sufficient, marginal or insufficient. In addition, a double blind test will be used to demonstrate if the narrative weight of evidence correctly predicts the direction of the chemical interaction. The double blind test was validated and published in 1999 in Environmental Health Perspectives.

In terms of specific analytic studies for the research agenda, Dr. Leonard saw an opportunity for ATSDR's divisions to interact and plan studies very early in the process. This approach will decrease the chance of a division rejecting data collected by another division. She urged the Agency to consider some type of inter-division collaboration. Dr. Stark remarked that the toxicological profiles are excellent products. She suggested that collected biological samples be stored as long as possible because they can be extremely valuable in the future. She turned to the continuum for relating environmental contamination with clinical disease presented by Mr. Williams. She recommended that the entire research component be shifted. For example, the diagram uses total human exposure to determine internal dose, biologically effective dose and early biological effect. Dr. Stark proposed that these three steps be used to identify total human exposure. Because waiting for the presence of clinical disease was not advisable, she was interested in the Agency conducting more research on adducts, enzyme level changes, biologically effective doses, and internal doses. Researching serum levels and metabolic products would also provide ATSDR with more focus. Furthermore, she emphasized the value of GIS, which provides an opportunity to use data on co-variables and confounders that could not otherwise be collected.

Ms. Bradshaw commented on the chemical mixtures research activity. She noted that affected communities and military sites have more than five chemicals. Therefore, she was interested in studies being conducted in areas other than lead or arsenic because other contaminants are seriously impacting residents. She did not recall ever reviewing any in-depth research undertaken by ATSDR which specifically targeted these public concerns. Dr. DeRosa clarified that his comments pertained to the Agency's research framework which is used to validate a narrative weight of evidence. The two- to five-component mixtures are used to address an in vitro or in vivo laboratory-type validation effort. During site activities, ATSDR attempts to characterize exposures and apply the body of knowledge across all chemicals.

Dr. White concurred with Ms. Bradshaw's observations. She believed the environmental public health component was solid; however, she recalled no mechanism to effectively apply behavioral science in public health practice. She saw no chance of ATSDR developing a successful intervention if community concerns were not incorporated into the research agenda. She pointed out that the optimal time to include these factors would be early in the development process. To inform the Board about community involvement issues with respect to the research agenda, Dr. Lichtveld mentioned that she would be presenting on behavioral and social sciences, prevention effectiveness, and the translation of science to service.

Dr. Roseman emphasized Dr. Stark's recommendation that the Agency develop a sample storage database which would be available and known to researchers. He was also in favor of death certificates being changed to reflect the length of time an individual lived at the last location. This information is extremely useful in environmental epidemiology. He turned to priority health conditions and noted that endocrine disrupters are a focus of toxicology and not epidemiology. As a result, he described additional areas for ATSDR to consider as priority health conditions: diabetes, endometriosis and dioxin, thyroid diseases, research to evaluate assumptions of MRLs, and a new epidemiologic design in which a cohort is used as its own control.

Due to the link that was made between birth defects and environmental contaminants, Dr. Harris inquired about the usefulness of statewide birth defects registries to ATSDR. She also asked if DHEP planned on conducting a folic acid education activity in communities with a high incidence of neural tube defects. Dr. Lybarger responded that the Board needs to consider the important issues of confidentiality and the availability of data if formal recommendations are made for registries, data sets, birth/death certificates and sample banking. For example, ATSDR frequently is unable to obtain death certificates even from states proposed for an Agency action. To date, ATSDR has not tried to bank samples due to difficulties related to privacy, informed consent, and government sensitivity about these issues. However, the Agency has conducted a great deal of research using cancer and birth defects registries. These data were valuable in ATSDR's cancer cluster and end-stage renal disease studies. In response to Dr. Roseman, Dr. Lybarger recalled that the Agency's first pediatric workshop on biomarkers resulted in a recommendation to evaluate endocrine disrupters, including diabetes, thyroid diseases and other isolated outcomes.

Dr. Au remarked that a better understanding of susceptible populations will strengthen ATSDR's evaluation and prevention efforts. Therefore, he recommended that the four steps in the continuum's target dose evaluation paradigm be restructured to emphasize areas of susceptibility. He wanted to ensure that the diagram reflected the different factors which contribute to an individual's uptake and metabolism of toxic chemicals.

Based on the presentations, as well as ATSDR's mission, responsibilities and experience, Dr. Melius saw the need to develop the research agenda. In terms of providing guidance, he asked the Board to consider two areas omitted from the proposal: questions and concerns of impacted community residents; and factors related to environmental health science. The BSC would then prioritize the accomplishments that should be made given the Agency's resources.

Before yielding the floor to the next presenter, Dr. Melius entertained a motion to approve the minutes of the November 5-6, 1998 Board meeting. Dr. Stark moved that the minutes be approved; the motion was seconded by Dr. Collins. There being no further discussion, the November 5-6, 1998 BSC meeting minutes were unanimously approved by the members who served at the proceedings: Drs. Collins, Leonard, Roseman, Stark and White.

Special Populations. Dr. Rueben Warren, of ATSDR's Office of Urban Affairs (OUA) was encouraged by the presentations related to applied research, which is critical to the success of the Agency. Although research is designed to answer questions and solve problems, it must also raise new and appropriate questions. Basic and applied research are both needed, but methodology is less important than where and by whom questions are raised. For applied research, questions must be raised by the public. "Community" is defined by a variety of individuals, agencies and organizations which hold common values, experiences and interests. These commonalities can be physical, geographical, social, cultural, political or economic. ATSDR is committed to serving affected communities, industry and government.

Community groups are based upon strategies, situations and outcomes. From the Agency's perspective, communities can either benefit or suffer from the production and use of toxic chemicals, hazardous wastes or byproducts which may have adverse effects on human health. Public health practice has always instituted a concern for special populations that are particularly vulnerable to matters impacting human health. Poverty and destitution are social factors that have typically been primary considerations due to the relationship between adverse health and poverty. Issues of physical, environmental, behavioral and spiritual well-being are also evolving as risk areas of concern. Public health practice must improve its methods in addressing these concerns. Beginning in the 1960s, Medicaid/Medicare, maternal/child health, and neighborhood/migrant health centers were created to target public health issues. The field has changed its focus from infectious diseases to chronic diseases, and is currently developing strategies to address environmental and occupational diseases.

For special populations, however, public health has not evolved from one era to the next. These groups and their needs must be defined before health concerns are addressed. Some populations continue to be characterized as special from a negative health perspective, i.e., disadvantaged, vulnerable, susceptible, minority and at-risk. At the highest levels of federal, state and local governments, as well as with non-government partners, attempts have been made to identify, implement, plan and evaluate policies, procedures and programs to address the health needs of special populations. Previous efforts were made to identify the problems of, but not solutions for these groups. Developing an effective strategy to resolve a population's health concerns is not possible without involving those affected individuals.

Historically, public health practice has used a phased approach. For phase 1, general strategies were targeted to the general public. For phase 2, ATSDR identified special populations, targeted research and developed interventions for groups including children, low-income residents and minority populations. Although special populations are demographically diverse, they are all disproportionately susceptible to real or potential risks of adverse health effects from toxic and hazardous chemicals at different stages of human development. These groups include racial and ethnic minority populations, tribal nations, low-income citizens, women of child-bearing age, medically compromised individuals, infants, children and the unborn.

The Institute of Medicine (IOM) published an environmental justice report in March 1999 that described minority and low-income groups as communities of concern. ATSDR is requesting that the Board consider defining special populations using the IOM designation. The Agency's position is that the term "communities of concern" will eliminate negative labels. ATSDR has made some accomplishments in targeting special populations, including the documented success by the Minority Health Program. Furthermore, environmental justice activities have focused on low-income and minority groups to ensure that these populations are involved in the planning, implementation and evaluation of policies and regulations which impact upon the environment or environmental health.

With respect to the research agenda, ATSDR is requesting the Board's assistance in the following areas: (1) a better characterization of special populations, i.e., locations, special concerns, and scientific or educational needs; (2) increased knowledge about why different chemicals affect different populations at different times; (3) more activities to determine the public health impact on children due to the close proximity of schools to toxic and hazardous waste sites; (4) a better understanding of the social and behavioral context from which public health impacts on special populations; and (5) improved mechanisms to communicate to the public science which is known and unknown, as well as ATSDR's mission and responsibilities.

Behavioral and Social Sciences; Prevention Effectiveness. Dr. Maureen Lichtveld of DHEP emphasized the notion that public health is intended for people; therefore, the research agenda must lead to more effective public health service. Public health decisions have traditionally been made with limited consideration given to behavioral and social sciences. However, research in this area is critical in influencing behavioral changes to prevent diseases. Intervention research in this science will also strengthen the focus on health outcomes. Public health practice in general and ATSDR specifically are currently struggling with defining and measuring these outcomes. The Agency is requesting the Board's assistance in efforts to resolve this challenge.

ATSDR has made accomplishments in behavioral and social sciences. Previously, the Agency educated health professionals throughout the country about the diagnosis and treatment of individuals exposed to hazardous substances. ATSDR has now expanded its mandate to include a more holistic and community-based approach which integrates the disciplines of health education, risk communication, health promotion and clinical-based research. The Agency is requesting that the Board consider five behavioral and social sciences areas to incorporate into the research agenda. The steps were developed by translating ATSDR's goal to evaluate the relationship between exposure and disease, and linking appropriate services to each area. All of the steps include environmental health education and risk communication components.

The first area is theories and principles underlying the intervention. The Agency is interested in developing effective strategies to identify and measure a population's behavioral changes. The second area is standardized measures for implementing health promotion, health education and risk communication activities. These tools could be used in schools, communities, health care facilities, religious organizations, or other sites unrelated to health care. The third area is evaluation, including cost-effectiveness. The strengths of the interventions would also be assessed from individual, community and policy perspectives. The fourth area is methods to measure the effectiveness of the strategies. The fifth area is audience analysis and segmentation to appropriately and scientifically address the needs of and influence behavioral changes in special populations.

The area of prevention effectiveness is a new undertaking for the Agency. This science is defined as the quantitative assessment of the expected impacts of public health policies, programs and practices on health outcomes. Prevention effectiveness is needed to identify interventions which produce the greatest benefit. Public health policymakers use the science to systematically structure scientific information gathered through epidemiology and other disciplines, and develop public health intervention options for appropriate decision-making. Prevention effectiveness assists communities in obtaining clear estimates of expected consequences or identifying alternative approaches. The science also provides an opportunity to quantitatively measure public health impacts for interventions.

ATSDR began the prevention effectiveness initiative in late 1997 with a minimal budget. Collaborative efforts resulted in a recently published study that focused on economic health burdens and specific outcomes of individuals exposed to several volatile organic compounds. Another study will be completed shortly which analyzed the economic health burden due to lead exposure. The target of the study is IQ decrements. Through partnerships with CDC and EPA, ATSDR has used prevention effectiveness to express morbidity and mortality related to Superfund sites. The Agency is building capacity in this science by training its staff and federal partners. One example of ATSDR's prevention effectiveness activities is the hypertension decision analysis model that was implemented at the Bunker Hill site. The model was used to determine whether a hypertension screening program will (1) benefit the community, (2) lead to treatment compliance by disease-positive participants, and (3) change health outcomes in the population. Some of the research needs in prevention effectiveness include developing consistent techniques; quantifying and evaluating environmental health outcomes; creating practical tools to estimate the effectiveness of site-specific interventions at the community level; and developing tools to improve decision-making at the program level.

Discussion. Dr. Melius thanked Discussion Panel 1 for making succinct and excellent presentations. Ms. Moses inquired about the existence of any ongoing ATSDR environmental justice programs with Indian tribes or communities. Dr. Warren replied that the President's Executive Order mandates the Agency to undertake certain activities in this area. Because only a few environmental justice initiatives have been measured, ATSDR is currently developing a strategy to address, measure and respond to concerns about this issue. No specific population has been addressed from an environmental justice perspective to date; however, the OUA responds to these concerns either by telephone or site visit.

Dr. Collins asked about the point at which OUA begins to identify a population as special. Dr. Warren responded that OUA has early input. The goal is to incorporate the area of special populations throughout the Agency because a multiple approach is needed to address these concerns. ATSDR focuses on matters that affect a special group rather than the population itself. OUA coordinates and manages, but does not actually implement, activities related to special populations.

Dr. Harris inquired about the basis for the IOM report creating the term "communities of concern." She asked for confirmation if the designation will be adopted Agency-wide. She expressed two potential and negative consequences that might occur if this blanket term is adopted: (1) some environmental justice efforts which were painstakingly made may be lost, and (2) some targeted populations may be overlooked because all communities near hazardous waste sites are communities of concern in the public health assessment process. Dr. Warren clarified that certain activities, and not a minority or low-income status, designate sites as environmental justice communities. For example, excluding residents from a public health action proposed for their community is an environmental justice concern. Agencies typically provide citizens with results of an activity, but do not include communities in the planning process. The term proposed in the IOM report was developed to identify, address and respond to these concerns. A distinction must be made between concerns related to environmental justice and science.

Dr. Leonard echoed Dr. Harris' concerns. Her position was that the language should be specific versus broad. She added that connotations such as at-risk, susceptible or vulnerable directly impact the actions taken for a specific population, and have increased the public health community's awareness about this issue. Dr. Lichtveld concurred that specificity is critical for research needs and emphases on special populations. She noted, however, that some of these issues are beyond the scope of ATSDR's mandate.

Dr. Roseman asked about the difference between the Agency's standard evaluation process and research. He also inquired about specific areas in the ATSDR/community interaction which have been unsuccessful. Dr. Lichtveld responded that the Agency has a model which will be fully implemented later in the year to determine if site-specific needs were addressed, i.e., identification of at-risk populations and implementation of appropriate public health actions. Research will be linked to the model because strategies to address public needs will be measured at baseline, six months and one year. ATSDR is beginning to reject evaluation forms as valid tools. Instead, the Agency is moving towards a method of building knowledge using a needs assessment approach. Moreover, ATSDR is considering specific action plans as part of its strategic planning effort, including a social marketing component to identify successes and failures. The Agency views the C/TS and Special Consultants as an important mechanism in improving the ATSDR/community interaction.

Dr. Warren added that the ATSDR/community interaction has also been problematic due to the Agency's decision-making on data collected by other entities, and point of site entry after other agencies. Dr. Au suggested that ATSDR and communities collectively draft concrete time-lines for strategies in the early stages of the process. He believed this approach would help to alleviate some of the community's concerns, frustrations and feelings of helplessness. Dr. Lichtveld pointed out the difficulty in ATSDR entering a site early. EPA is required to make an environmental characterization of a site and, as a result, usually enters a community first. However, the Agency has developed mechanisms for early site entry, including (1) an agreement with EPA to be involved in the environmental characterization process for public health purposes and community participation; (2) the Community Involvement Branch (CIB), which is the primary liaison between communities and ATSDR; (3) DHEP's community-driven, holistic and participatory approach to public health practice, such as a needs assessment with input from a broad range of stakeholders; and (4) assistance from OUA in creating a joint public health action plan.

Dr. Warren pointed out that agencies must accept the negative history associated with government, particularly in low-income and minority communities. Therefore, all federal partners should be aware of activities being undertaken by other agencies to avoid replication or conflict. Furthermore, agencies must understand the notion that environmental science should not be independent of public health. Dr. Stark agreed that the evaluation component proposed by Dr. Lichtveld should include real measures of effectiveness. For example, decreased fish consumption should be determined by blood sample collections and PCB levels of fish eaters instead of polling individuals about fish consumption. She inquired about ATSDR's methods to identify true community representatives, and strategies to obtain input from citizens who are less publicly visible. Dr. Lichtveld responded that the participatory approach used in the needs assessment attempts to include residents who are less outspoken. ATSDR also partners with community-based organizations, churches, schools and community health nurses. To ensure that all residents are provided an opportunity to be heard, the research agenda will solicit input beyond these community partners. The activity will be built on both individual and population levels.

Dr. Warren added that over a period of time, formal and informal community leadership will evolve and self-select. He also expressed the need for ATSDR to employ more behavioral scientists. Dr. Harris inquired about the process that will be used to define and measure "ideal reduction behavior among populations." Dr. Lichtveld replied that a baseline theory will be used to develop principles. For example, the ideal reduction behavior among fish eaters would be for the population to discontinue all fish consumption. Because this outcome will not be achieved in all groups, the Agency would attempt to invoke behavioral changes close to the ideal situation, such as different ways to prepare fish, specific parts of the fish to discard, or particular species that should not be eaten.

Translating Science into Service. Dr. Lichtveld conveyed that a challenge lies in connecting the components of science, service, public health practice and public health policy. For the Board's consideration, ATSDR is proposing a framework for the research agenda that links these four areas. Public health problem solving is generally influenced by the level of scientific technical knowledge and public values. The science of public health practice is defined in three broad areas: assessment, assurance and policy development. Competency in technical, political, managerial, programmatic and fiscal areas are needed to fulfill assurance requirements. CDC, national organizations and state health departments are collaboratively developing the National Public Health Performance Standards Program to measure necessary activities; 20% of core public health services are currently not performed by local public health agencies. These changes are a result of managed care or privatized situations.

ATSDR views the Board as an important partner in leveraging environmental health within the context of public health. To increase the science base for public health practice, the Agency was instrumental in developing the Guide to Community Preventive Services for intervention planning. ATSDR also proposes to provide useful comparative data for evaluation and strengthen the external leverage in partnership activities. The integrated framework for environmental health combines health promotion, health education, risk communication and medical intervention to support intervention, capacity building and prevention goals. ATSDR aims to compile these services in a systematic and structured framework in the research agenda. The outcome will be to create a logical flow from science to service to science.

Before this accomplishment can be made, however, the Agency must address several challenges that influence environmental health service delivery: (1) the application of population-based epidemiologic findings in community-oriented intervention strategies; (2) toxicological concordance of effects and effect levels among species; (3) the development of standardized methods and techniques to quantitatively assess knowledge gained and behavioral changes; (4) the use of quantitative outcome information to increase the impacts of public health interventions; (5) the availability of biological markers of exposure, effect and susceptibility; and (6) the use of clinical practice to identify and address community health issues, i.e., a collaborative medicine/public health paradigm.

Issues of public values and popular opinions must also be considered, including societal factors, holistic versus individual approaches, and the critical role of communities in interventions. Dr. Lichtveld posed two questions for the Board's consideration: What role should ATSDR's proposed environmental public health research agenda play in enhancing the "translation" of science into service? What areas of research in public health practice should ATSDR consider for inclusion in the research agenda?

Discussion. Dr. White commented that generally, the translation of science to service will be extremely important in the research agenda. Specifically, the Board should focus on building the public health infrastructure because environmental health is typically given a low priority in this area. She suggested that agencies such as CDC, NIEHS and EPA become involved in a coordinated effort to integrate environmental and public health research.

For public values and popular opinions, Dr. Harris strongly recommended that "cultural considerations" be a separate societal factor. This component should stand alone because it will be critical in terms of ATSDR's proactive role in addressing disproportionate exposures of subpopulations. Dr. Stark wondered if the Agency's system of registries would be a part of the infrastructure. Dr. Lichtveld did not recall that infrastructure development impacted on developing the national exposure registry. However, the registry had a tremendous amount of support as evidenced by an original participation rate of 98%. In FY'99, the ATSDR had resources to add another registry. Additionally, the Agency is convening a workshop to determine the feasibility of creating a children's environmental health registry.

Dr. Lybarger added that the national exposure registry did not provide infrastructure in the global context of a public health system, but it has been a solid tool for longitudinal evaluation of the research program. The 98% participation rate declined because cohorts decreased during follow-up activities; however, the current rate of participation is still strong. ATSDR developed the national exposure registry to (1) facilitate knowledge by following participants for longer periods of time; (2) provide a support system to supply information to communities; and (3) interact with communities. The registry has resulted in several findings that has resulted in follow-up activities and studies. Dr. Lichtveld mentioned that CDC is linking numerous surveillance systems to build a national database.

Dr. Collins requested more information about the "regulatory/legal" interaction referenced in the environmental health education and risk communication planning model. Dr. Lichtveld replied that ATSDR has tried to obtain specific language in the area of health education. The Agency's statute stipulates that information should be broadly disseminated to physicians to increase knowledge about diagnosing and treating. ATSDR can also provide physician education to states and other organizations as the Administrator deems appropriate. The Agency has interpreted the language to incorporate more community-based activities as well. ATSDR has gone on the Congressional record requesting a direct mandate to undertake community health education and provide resources to local non-profit organizations. Superfund authorizes the Agency to perform certain activities, including public health assessments, toxicological profiles, health education, epidemiological studies, registries, and health studies. ATSDR advises entities and provides public health activities, but does not have the authority to regulate.

Dr. Falk emphasized the importance of ATSDR's advisory role, which often leads to substantial regulatory impacts. He returned to the issue of infrastructure and pointed out that registries can be a critical tool in scientific activities of the research agenda. He urged the Board to consider how to use registries appropriately during the development process. Dr. White saw a valuable use for surveillance systems and registries in generating hypotheses for the research agenda. Dr. Melius inquired about items to include in the research agenda for public health practice in relation to ATSDR. From the perspective of the science of public health practice, Dr. Lichtveld replied that the Agency would be more successful in collaborating with CDC on its existing environmental health initiatives, rather than developing this area in the research agenda. From the perspectives of behavioral/social sciences and prevention effectiveness, she acknowledged ATSDR's responsibility to include and emphasize these areas in the research agenda. No existing model implements these types of activities in a structured fashion. Additionally, no system links identified data needs in the field with the research agenda.

From the perspective of susceptible populations, Dr. Lybarger asked the Board to consider access to medical care, intervention programs and behavioral science issues. Dr. Lichtveld added that ATSDR is collaboratively developing biomarker batteries focused on children. In December 1999, the Agency will hold a workshop on asthma and respiratory conditions. Ms. Bradshaw commented that ATSDR does not appear to address serious illnesses. She urged the Agency to direct more activities toward diseases which cause morbidity. Dr. Lichtveld replied that the Agency identified the areas of neurobehavioral effects, birth defects/developmental disorders, respiratory diseases, certain cancers, and diseases of the kidney, liver and immune system as priority conditions related to exposure. ATSDR is one of few agencies that continually studies disease clusters, such as the brain cancer and autism projects. The area of environmental epidemiology is an extremely difficult undertaking, but is oftentimes not the best tool to answer community's questions.

Dr. Falk provided some general comments about the discussion. NIH has conducted studies showing a reduction in harmful consequences of asthma with behavioral, residential, dietary and environmental changes. The translation of this scientific approach to a community application is critical. In terms of ATSDR, the issue is not necessarily to try and stop exposure to chemicals at sites; rather, an emphasis needs to be placed on the level of residual exposure an individual can live with or tolerate and the status of clean-up activities. Translating science must include an educational component to define the meaning of exposures for communities.

Dr. Harris requested that the individual who will have ultimate authority to approve the research agenda be identified. Due to the amount of effort and large number of organizations that will be involved during the development phase, she wanted to ensure that the decision-maker would be informed early in the process. Dr. Falk anticipated that the new ATSDR Assistant Administrator would offer a real sense of commitment and support for the research agenda. He hoped the appointment would be filled during the early stages of the development process. Although Dr. Koplan will be kept informed about the research agenda, the Agency's Assistant Administrator will make day-to-day decisions.

Establishment of a Subcommittee on ATSDR's Environmental Public Health Agenda. For the Board's role in developing the research agenda, Dr. Melius proposed the following process. A subcommittee of four BSC members and two Special Consultants was created to work with Dr. Spengler and other ATSDR staff. The subcommittee shall provide a status report at each BSC meeting. Board members can recommend themselves or other individuals to serve on work groups as these needs are identified. The C/TS and Special Consultants can be involved in the work groups as well. By general consensus, the membership of the ATSDR Research Agenda Subcommittee was created as follows: Dr. Au, Ms. Bradshaw, Dr. Leonard, Dr. McDiarmid, Ms. Moses, and Dr. Stark.

Dr. Melius pointed out that Drs. Leonard and Stark could continue to serve as consultants on the subcommittee or work groups after their terms expire in November 1999. He added that a behavioral sciences work group would have a strong need for consultants because the Agency does not have a lot of staff in this area. Dr. Leonard also saw a need to develop a work group on the science of managing and conducting public health practice and programs. Dr. Falk indicated that the Research Agenda Subcommittee should also provide updates to CDC and EPA to learn about similar activities at these agencies.

Public Comment Period. Ms. Judy Shoji of Atlanta conveyed that she has been affected by Superfund sites since birth. She read a prepared statement into the record (attached hereto as Exhibit 1). Her comments focused on the critical need to increase physician education in the area of environmental medicine. She made an official request to receive complete listings of all physicians, as well as persons who are not doctors, who have been educated by ATSDR. As outlined in her statement, she also asked the Board to reconsider Dr. Max Lum's 1989 five-year plan to reach all primary care physicians. Dr. Stark replied that the Agency provides core grants to several states to implement an integrated research and service program. She cited New York State as one of the Agency's successes in this grant activity. Consistent with ATSDR's requirements, all grantees must include a professional education component in their programs. Given the limitations on resources, Dr. Stark commended the Agency for making a bona fide effort to increase provider education.

There being no further discussion, Dr. Melius adjourned the BSC meeting at 4:35 p.m. on May 6, 1999.

C/TS Status Report and Recommendations. Dr. Melius reconvened the BSC meeting at 8:45 a.m. on May 7, 1999. For the new Board members, Dr. Roseman provided historical information about the Community/Tribal Subcommittee (C/TS). Several community groups, tribal members and ATSDR met in Houston in 1997. Citizens urged the Agency to be more responsive to community needs and concerns, and involve residents in all phases of site activities. Because of the need to continue the dialogue between ATSDR, communities and tribes, the C/TS was created and nine Special Consultants were selected in 1997. The Subcommittee's official mission statement is outlined in the Federal Register as follows:

The Subcommittee will provide the BSC and ATSDR with the views and recommendations of the community/tribal representatives on ATSDR's community involvement programs, practices and policies, as well as other relevant issues impacting communities and tribes who live near Superfund and hazardous waste sites. The Subcommittee will review ATSDR's community involvement practices, programs and policies; provide advice, findings and recommendations to the Board on these issues; and bring broad-based community and tribal involvement issues to the attention of the Board.

Dr. Roseman turned the Board's attention to the draft guidelines for the C/TS and Special Consultants that were distributed. He pointed out that some sections were incomplete, such as the roles of the BSC, Subcommittee and Facilitator Dr. Henry Cole. He also emphasized that changes in membership for the C/TS and Special Consultants were approved by ATSDR. The Subcommittee will increase to four BSC members; two additional individuals will be chosen to serve as Special Consultants. During his tenure as C/TS Chair, Dr. Roseman characterized the difficulties between communities and federal agencies in two broad areas: differences between public and scientific perspectives, and public health decision-making in the absence of science. He then read the thirteen recommendations made at the March and May 1999 C/TS meetings (attached hereto as Exhibit 2). He noted for the record that Recommendations 1 and 2 were resolved and required no action by the BSC. The Subcommittee and Special Consultants were requesting approval on Recommendations 3-13 to be submitted to ATSDR for a formal response.

Discussion. Ms. Bradshaw clarified for the record that the Subcommittee and Special Consultants only reviewed the first five pages of the last draft of the guidelines. She relayed that Mr. Sanchez would be submitting written comments to Dr. Roseman. Dr. Leonard asked if communities are concerned about being less involved with activities related to federal sites. She saw the need to explore the development of a consistent process across federal sites and private facilities. Ms. Bradshaw replied that federal sites are different than private facilities because federal sites have no oversight mechanism or requirements to adhere to regulations. Federal facilities are also able to review and edit public health assessment documents at their discretion. Ms. Bradshaw believed that a Congressional act is needed to change this process.

Dr. Leonard asked for clarification about issues related to Recommendation 8. She raised the possibility of tailoring mapping procedures used in private sites to federal facilities and tribes. Ms. Moses responded that federal agencies frequently assume state health departments effectively network with Indian tribes on health care-related issues. However, such collaborations typically do not occur. The recommendation was made to ensure that federal agencies contact Indian tribes directly through the Indian Health Service and not state health departments. She agreed that mapping activities will need to be more site-specific.

Dr. Melius entertained a motion to approve the draft guidelines with the realization that the Subcommittee would complete the document by the next meeting. He was interested in expediting the approval because the guidelines called for a fourth BSC member to serve on the C/TS. Additionally, the Agency needed to immediately begin the selection process to add two new Special Consultants and fill the vacant seat. Dr. Stark requested that the motion be tabled until she had an opportunity to read the document. Regardless of the Board's approval, however, she pointed out that ATSDR would need to review the recommendations to ensure they could legally be implemented. Ms. Moses informed the BSC that the guidelines were initiated by ATSDR and not the C/TS or Special Consultants. She emphasized that the document contained no hidden agenda. An agreement was reached that the Subcommittee and Special Consultants would operate under the guidelines.

For the new members, Dr. Melius clarified the route of communication. C/TS recommendations are presented to the Board. Upon approval, the BSC communicates the requests to ATSDR for consideration. In the opposite direction, the Agency relays its decisions to the Board. The BSC informs the Subcommittee of ATSDR's decisions. Dr. Roseman suggested that the Board develop a tracking system similar to the document used by the C/TS. As a Subcommittee member, Dr. White described the experience of listening to communities' perspectives as extremely enlightening and interesting. To facilitate dialogue between the BSC, ATSDR and communities, she proposed that time be set aside at each Board meeting for citizens to present their views.

Dr. Melius further suggested that when issues are presented to the BSC from a scientific perspective, a follow-up discussion could take place on the same topic from a community perspective. This coordinated approach would provide an opportunity for the Board, C/TS and Special Consultants to collectively develop recommendations for the Agency. Dr. Spengler turned to Recommendations 11 and 12, which related to the next Subcommittee meeting proposed for San Francisco, and the two-day public health assessment workshop. He emphasized the difficulty in ATSDR supporting these two activities due to the short time-frame to make logistical arrangements. He raised the possibility of the public health assessment workshop being combined with the next C/TS meeting as opposed to a separate workshop. Ms. Moses clarified that the recommendation to convene the workshop was made because the agenda item is too important an issue for a regular Subcommittee meeting. Public health assessments significantly impact communities and tribes throughout the country. She noted that time did not allow DHAC to complete the presentation at the May meeting.

Mr. Williams expressed DHAC's support and commitment to hold the two-day workshop. He confirmed that the division will make strong efforts to identify resources for this activity. Dr. Melius entertained a motion to approve and forward the Subcommittee's recommendations to ATSDR for consideration, which was seconded by Dr. Harris. There being no further discussion, the C/TS and Special Consultants recommendations attached to these minutes as Exhibit 2 were unanimously approved by the Board and will be submitted to ATSDR for consideration.

Dr. Melius entertained a motion to approve the Subcommittee's draft guidelines. Although the document was incomplete, he emphasized the importance of the BSC committing to this effort. He added that the Board would review the final guidelines prior to the next meeting and formally revisit this issue. Dr. Stark commented that the guidelines were well-written. As a general point of order, she asked that materials requiring a BSC vote be sent to the members prior to meetings. Dr. Stark then moved to approve the draft guidelines. The motion was seconded by Dr. Sorber. There being no further discussion, the C/TS and Special Consultants draft guidelines were unanimously approved by the Board and require finalization prior to the next BSC meeting. Upon the Board's approval of the draft document, Dr. Harris agreed to serve as the fourth BSC member on the C/TS. Dr. Melius thanked the Subcommittee and Special Consultants for their hard work in this process.

Coordinated DOE Research and Public Health Activities Plan. FY'99 Energy and Water Development Appropriations. Dr. Mark Bashor, ATSDR's Associate Administrator for Federal Programs and Director of the Office of Federal Programs, provided historical information on the Agency's activities at federal hazardous waste sites. The 1986 Superfund amendments resulted in a number of changes. First, the Agency's public health authorities were strengthened. Second, CERCLA became applicable to facilities owned or operated by any agency, department or instrumentality of the U.S. government. Prior to 1986, the Department of Defense, which operates the military, and DOE, which operates nuclear weapons complex facilities, argued for immunity against environmental legislation. Due to the Superfund amendments, the federal government could become principal responsible parties for producing pollution similar to private corporations. Lastly, federal entities would be responsible to pay for clean-up activities, removal of contaminants or ATSDR's health authorities. Superfund, which is primarily a private tax on chemical and petroleum industries, would not be used to clean up sites polluted by federal entities. Because most of the Agency's funding comes from the Superfund trust fund, appropriate agreements needed to be developed with other federal departments for transferring dollars. ATSDR first received DOE funding in 1992 to pursue public health actions at nuclear weapons complex facilities.

In the early 1990s, several Congressional bills were created to transfer all epidemiologic studies and research out of DOE. The bills directed HHS, CDC and ATSDR to undertake these activities. To avoid the bills being passed into law, the Secretary of Energy developed a Memorandum of Understanding (MOU) with the HHS Secretary to conduct epidemiologic research. HHS subsequently transferred the activity to CDC. Since the MOU was signed, ATSDR has partnered with DOE, NCEH and NIOSH in these projects. Due to the administrative burden placed on the Agency by negotiating the agreements with twelve DOE offices throughout the country, Congress developed the following language for the FY'99 Energy and Water Development Appropriations.

"The conferees agree that all funding for HHS-managed studies, either through CDC or ATSDR, shall be incorporated into a single memorandum of understanding with HHS, and that DOE and HHS will prepare a consolidated and coherent strategy which includes a public health agenda for each DOE site. The agencies are directed to report to the Committees on Appropriations on the status of the implementation of the public health agenda by December 31, 1998. The final public health agenda for each site shall be provided to the Committees no later than September 30, 1999."

The appropriations language also directed all health studies to be transferred and consolidated into DOE's Office of Environment, Safety and Health (OESH). The draft MOU was released for public comment. ATSDR is requesting that the Board provide advice and comments on the draft DOE/HHS MOU and the coordinated site plan. If possible, the Agency would like to receive comments on the MOU by June 30, 1999.

Structure of the Consolidated Plan. Dr. Peter McCumiskey, ATSDR's Deputy Assistant Administrator, explained that the oversight mechanism for the NCEH and NIOSH energy-related analytic studies was DOE's OESH, while DOE's Office of Environment Management oversaw ATSDR's public health activities. In 1997, DOE expressed concern that the collective CDC/ATSDR effort was not cohesive and contained no shared vision. In response, an Energy Oversight Committee (EOC) was formed at CDC and ATSDR to provide management structure in developing a cohesive and coherent strategy for the DOE effort. The EOC established an Energy Coordinating Committee (ECC) to create a comprehensive approach for DOE sites. Staff from the three departments who are responsible for conducting site-specific activities comprise the ECC.

To solicit input in developing the agenda for the coordinated strategy, public workshops were held at Oak Ridge, Rocky Flats and Los Alamos. Feedback was also sought from the Health Effects Subcommittees at Hanford, Idaho Engineering Environmental Laboratory, Savannah River and Fernald. The HHS Advisory Committee on Energy-Related Epidemiologic Research (ACERER) is reviewing the consolidated plan and MOU as well. Moreover, principles from NIOSH, NCEH and ATSDR held three meetings with DOE in the past year to develop the time-line for the coordinated strategy.

Public Health Activities of the Consolidated Plan for DOE Sites. Mr. Williams turned the Board's attention to the draft agenda that was distributed for FY'99 and FY'2000 public health activities at DOE sites. ATSDR has added a comprehensive public health agenda for each DOE site with input from NCEH and NIOSH. The draft agenda represents a broad range of input from ATSDR, CDC, other federal agencies, communities, tribes, workers, and state/local health departments. DOE and ATSDR have presented the document to sites with a CDC health effects subcommittee, as well as communities and tribes with no such subcommittee. For each site, the draft agenda contains a background and history; a What We Have Learned section; a description of current studies or public health activities; data gaps; proposed activities; and community involvement and tribal interactions.

The draft agenda will be revised every year to reflect the collection of new scientific data, additional comments from stakeholders, and the budget. ATSDR developed the public health agenda from the perspective of first, identifying and responding to needs, and second, budget issues. As a result, the FY'99 activities are estimated at $38 million, although $9+ million and $26 million are expected to be allocated to ATSDR and HHS, respectively. The FY'2000 activities outlined in the document represent $50 million. The Agency realizes that some identified needs will not be met. The current status of the draft agenda is that approximately 1,000 packets were mailed to stakeholders who were identified by CDC, ATSDR, DOE, communities, tribes, workers, labor unions, and other organizations.

On May 11, 1999, the document will be announced in the Federal Register for a public comment period, which will end on June 30, 1999. Comments will be tracked and responded to by the appropriate agency. The document is available on the WEB sites of ATSDR, CDC and DOE. ATSDR is requesting that the Board (1) review and comment on the draft public health agenda by June 30, 1999; (2) consider a coordinated federal strategy to integrate missions so that activities are not duplicated; and (3) ensure the input from stakeholders is sufficiently broad.

Discussion. Dr. Melius thanked Discussion Panel 2 for the wealth of information that was provided. Dr. Leonard asked if comments on the site plan and MOU should be made by the collective Board or individual BSC members. Dr. Bashor replied that the Agency would be pleased to receive comments by one or both of these methods. Since the public comment period ends on June 30, 1999, Dr. Melius recommended that BSC members comment individually because the Board's next formal meeting would be in November 1999.

Dr. McDiarmid emphasized the difficulty in providing guidance on the appropriateness of endpoints or health outcomes for the surveillance and epidemiologic studies because the contaminants known to be present at sites were not included in the public health agenda. Mr. Williams indicated that these data were probably excluded to keep the document concise. However, he did raise the possibility of adding this information into the final agenda. Because ATSDR developed a survey of principle contaminants at nuclear weapons complex facilities, Dr. Bashor confirmed that data on major toxicants are available and would strengthen the site summaries.

Dr. Collins asked that the Agency's preference for receiving responses be identified. Mr. Williams replied that written comments should be submitted to the ATSDR Chief of the Program Evaluation, Records and Information Services Branch. Comments are submitted to this central location for tracking purposes, and will eventually be disseminated to the appropriate entities for response and consideration. Dr. Harris inquired about the time-line for fully implementing the public health agenda after the document was finalized in September 1999. Dr. McCumiskey replied that budget decisions will not be made until July or August, although several activities described in the plan are currently ongoing. He reiterated the imbalance between the activities and budget, but did not foresee additional FY'99 dollars being allocated to HHS. However, he was hopeful that funding would increase in FY'2000. Dr. McCumiskey mentioned that the public health agenda does not prioritize sites.

In the event funding was not increased in FY'2000, Dr. Stark inquired about possible mechanisms to prioritize activities at sites. Mr. Williams confirmed that the public health agenda proposes to prioritize activities to best address the highest public health needs. Ms. Grandpre questioned why the majority of the studies produced no statistically significant findings at the sites. She asked about the level of community participation in these activities or whether the results were only based on scientific data. Dr. Falk responded that several studies attempted to recreate past exposures at sites and provide best estimates. For example, dose reconstruction studies tried to identify releases at facilities. The Fernald project attempted to estimate the likely risk of an individual's exposure to radon or uranium. Alternatively, several activities were formal epidemiologic studies, such as some NIOSH and NCEH projects that produced statistically significant results. At DOE sites, Dr. Falk recalled that CDC made strong efforts to locate old data, while some of the health studies were based on death certificates, newly collected information and physical examinations of residents.

In the oversight committee for the DOE coordinated plan, Ms. Bradshaw asked why community members were excluded. However, if citizen input was solicited early during the development process, she requested that these individuals be identified. Dr. McCumiskey responded that the EOC was established only for the propose of creating an internal management structure between DOE, ATSDR and CDC. For actual site activities, communities are involved through workshops or a FACA. Dr. Falk added that ACERER, which sets the research agenda for energy-related activities, has a Subcommittee on Community Affairs. He committed to providing Ms. Bradshaw with the names of community members who sit on the various committees and subcommittees.

Given the fact that a public health agenda is being proposed for each DOE site, Dr. Melius requested clarification on ATSDR's charge to the Board to "prepare a consolidated and coherent strategy." Mr. Williams replied that this format was set by Congressional staff. He confirmed that the coherent strategy would be a compilation of the different site plans. Dr. Harris inquired about the existence of an evaluation process to monitor the progress of the general plan and specific activities. Mr. Williams replied that an evaluation component has been designed for each site. The overall plan will be evaluated each year by stakeholders and other entities.

Mr. Matheny noticed that the ATSDR portion of the MOU reflects input from committees, communities and tribes. He did not see a similar discussion for the CDC section. Dr. McCumiskey clarified that CDC will use ACERER to review specific analytic research activities undertaken at DOE sites, the broad research agenda, and the adequacy of community involvement. Dr. Falk added that CDC's other oversight mechanisms are housed in NIOSH and NCEH. These centers provide scientific peer review of each study. Historically, ATSDR was not involved with ACERER because the Agency believed the CERCLA mandate should not provide the committee with the authority to make final decisions on ATSDR-related activities. With the development of the joint plan, however, Dr. Spengler now sits on ACERER as a liaison. Nevertheless, the BSC will continue to be the Agency's primary advisor.

Dr. Roseman asked if site studies would be compiled or whether standardized methods would be developed to compare sites in the public health agenda. Dr. Falk acknowledged the need for the Board to be provided with more details about the background and history of the sites and studies. He proposed that this information be presented at a future BSC meeting. Dr. Stark requested that the point of contact for questions about the documents be identified. Mr. Williams offered to direct individuals to the appropriate agency for issues related to the public health agenda. Dr. Bashor would serve as the point of contact for the MOU.

Dr. White asked that the "advice and comments" ATSDR was requesting from the Board for the coordinated site plan and draft MOU be specified. Dr. Bashor cited Dr. McDiarmid's suggestion to add the major contaminants to the site summaries as a good example of guidance from the BSC. The Board could also advise the Agency on worker health, community health, public health, research, and agenda items to present at future BSC meetings. Dr. Melius pointed out that the Board's role in this effort would be more clearly delineated after the C/TS meeting on federal sites, and the draft MOU and public health agenda were reviewed by the BSC.

Dr. Leonard was less concerned with site-specific studies at this point because she agreed with Dr. Falk that the Board needed more data in this area. She planned to focus her comments on the appropriateness of the interagency process for both the MOU and public health agenda. She also wanted to ensure that the MOU did not lose sight of some important issues the BSC previously resolved. Dr. Bashor commended Dr. Leonard for providing an excellent summary of the type of advice the Agency is requesting from the Board. He clarified that the MOU is a broad policy document which attempts to clearly define the authorities under which ATSDR operates and methods of interagency communication.

Dr. Harris requested that the Board be provided with final versions of the MOU and public health agenda before the November 1999 BSC meeting. Dr. Bashor replied that updated drafts of the documents could be distributed to the BSC before the next meeting. These versions would include comments from stakeholders. By September 30, 1999, the MOU will be submitted to HHS and DOE for formal departmental clearance, and the coordinated site plan will be released to Congress; however, Dr. Bashor did not anticipate having signed and formal documents in November. To facilitate an efficient process for responses, Dr. Melius asked Dr. Spengler to distribute to the Board a list of action items and contact information for the members.

Emerging Issues. Counter-Terrorism Activity. Mr. Joe Hughart, ATSDR's Deputy Director of the Office of Federal Programs, reported that the Agency has a formal role in the counter-terrorism activity due to Superfund's National Oil and Hazardous Substances Pollution Contingency Plan. This language authorizes ATSDR to operate an emergency response center and serve as the lead HHS agency in responding to chemical releases. CDC is the lead agency for oil releases. The Agency realizes it needs to better understand the scope and type of substances at issue. More than 90% of domestic terrorism incidents that occurred in this decade involved bombs or arson. ATSDR's Superfund mandate covers reactive and ignitable substances. The Agency's strength lies in addressing toxic substances and industrial chemicals that can be used in terrorism activities.

ATSDR's collaborative efforts with CDC include the operation of the emergency response center and defense program initiatives, such as responses to military chemical agents. The Agency is also authorized to provide technical assistance to federal, state and local agencies on emergency response, disaster preparedness and national security issues. HHS developed a departmental plan for counter-terrorism activities and charged ATSDR with three significant roles: (1) participation in a chemical/medical rapid deployment team; (2) development of a registry of victims for follow-up health studies; and (3) development of an information system on hazardous substances that could potentially be used by terrorists as agents. The Agency has taken the following steps to fulfill these roles:

With respect to counter-terrorism from a scientific perspective, ATSDR plans to present three issues at future meetings and solicit the Board's advice. The first area is chemicals produced by plants, animals and microorganisms that can be used as agents. The Agency is unsure whether these toxins should be characterized as biological or chemical agents. The second area is reactive and ignitable substances. The third area is psychological effects caused by incidents of terrorism involving hazardous substances. ATSDR will collaborate with the HHS Substance Abuse and Mental Health Administration in this initiative.

International Health Activities. Ms. Georgi Jones, Director of ATSDR's Office of Policy and External Affairs (OPEA), mentioned that OPEA is the liaison with CDC's global health office. OPEA is also responsible for coordinating and reporting ATSDR's international activities. Consistent with Dr. Koplan's priority areas, both CDC and ATSDR will be expanding their roles in the global health arena. ATSDR's international health initiatives have previously been limited by the Superfund trust fund; however, global activities should benefit the domestic agenda. The Agency has three primary global health collaborators.

The Agency has conducted training on public health assessments, toxicological databases, emergency response, and epidemiologic issues in Mexico, Portugal, Macau and Chile. Moreover, ATSDR has provided technical assistance on chemical mixtures to the Netherlands, the bombing of chemical plants to Croatia, and a Nova Scotia steel plant. Another of the Agency's priority areas is the expansion of epidemiologic studies, particularly in eastern European countries, the former Soviet Union, China and most of the developing world. Because these countries have significant and very well-documented exposures, the United States could apply these findings domestically. A neural tube defects study and a multiple sclerosis cluster investigation have been conducted near the U.S./Mexico border. ATSDR also has an ongoing study of health endpoints associated with the ingestion of arsenic in contaminated drinking water in Inner Mongolia, China. At a future meeting, the Agency plans to request that the Board comment on current global initiatives, and provide guidance on other international health activities which should be undertaken.

Discussion. Dr. Melius thanked Discussion Panel 3 for updating the Board on the Agency's emerging issues. Dr. Leonard noted that the psychological effects activity validates the need for ATSDR to increase its expertise in the area of behavioral and social science. Ms. Moses requested more information on toxins that can be produced by plants and animals, and reactive and ignitable substances. Mr. Hughart responded that plants, animals and shellfish can produce poisonous substances that are highly toxic. Some of these toxins can cause more damage than industrial chemicals on a gram per gram basis. Additionally, some of these substances are being proposed for use as terrorist agents. Fortunately, many of these toxins are ineffective in the presence of heat. The Agency is currently differentiating between substances of concern and insignificant toxins.

Mr. Hughart conveyed that ATSDR has received several requests to train law enforcement agencies in the area of reactive and ignitable substances. The Agency uses EPA's Toxic Release Inventory to identify the sources of agents in communities. ATSDR informs police departments about the locations, hazards and sources of agents, potential delivery methods, probable community targets, possible health impacts, and resources to respond to incidents. ATSDR's primary goal is to increase awareness about terrorism activities among local police departments, health departments and businesses. Many of these incidents can be prevented through strengthened security or decreased through training and preparation.

Dr. Stark asked that the lead agency for biological agents be identified. Mr. Hughart replied that CDC will take the lead in this area with its new Office of Bioterrorism. Dr. Au noted that plant and animal poisons are unstable in heat because the organisms cannot survive outside their natural environments. He raised the possibility of persistent organisms being biologically or genetically engineered. He asked if ATSDR had considered all mechanisms of transmission for these organisms, i.e., air, water, food or human contact. Mr. Hughart agreed that locating the sources of toxins and then concentrating poisons were previously difficult tasks. However, with recent advances in genetic engineering, fermentation and gene splicing, these toxins can now be produced in the laboratory. He cited Biological Warfare in the 21st Century as one of the best references on toxins.

In regard to ATSDR international health activities, Dr. Leonard pointed out that the infrastructure for reference populations and background information in the former Soviet Union is not good. She wanted to ensure that the Agency was aware of this deficiency when studies are designed for these countries. She also noted that the use of Superfund dollars for international activities might not be a critical legal issue. Dr. Leonard saw a strong justification for private companies based or operating in foreign countries to become involved in some of these issues. Ms. Jones confirmed that ATSDR's general counsel have determined no legal prohibition exists in using Superfund dollars on a global basis. As the trustee of Superfund, the Agency has made strong efforts to use the funds for the benefit of both domestic and international populations.

Dr. Collins inquired about the limitations of expanding ATSDR's global activities in Africa. Ms. Jones responded that ATSDR's international initiatives have primarily occurred in European and Latin American countries because the global partners are based in these areas. She added that the primary limitation to developing initiatives in Africa would be infrastructure. Dr. Leonard added that the Agency's primary expertise is in toxic chemicals, which is inconsistent with the public health needs in many African countries. Dr. DeRosa reported that the State Department is currently negotiating the World Trade Agreement, which will have a significant impact on environmental regulations throughout the world. Because the State Department has determined that the ATSDR Great Lakes Research Program is generalizable to other populations, Dr. Heraline Hicks is now a delegate to the negotiations in Nairobi.

Ms. Moses requested additional information about the public health assessment training that was conducted in Mexico and Chile. Mr. Williams responded that ATSDR's basic health assessment training course was modified for the needs of these countries. The five-day training course was originally designed for states and local health departments. Since many foreign countries view the United States as the leader in public health, Dr. Au described international populations as a unique opportunity to address domestic health problems. He asked if ATSDR had considered a collaborative effort with USAID. Ms. Jones responded that ATSDR's involvement with USAID is limited to the draft MOU, but CDC has an extensive partnership with the organization.

Although ATSDR has taken caution in justifying its international activities, Dr. Melius pointed out that U.S. communities are still suffering from exposure, but are constantly informed about decreases in federal resources. He also noted the problem of federal staff working in foreign countries for extended periods of time, which would cause activities at domestic sites to cease. Dr. Melius advised the Agency to place a strong emphasis on the mutual benefit of global initiatives. Mr. Hughart conveyed that the draft MOU between ATSDR and USAID clearly stipulates Superfund dollars will not be used for international activities unless U.S. communities gain a direct and significant benefit.

Public Comment Period. Dr. Mamora Shoji, of the Department of Medicine at Emory University, made several observations related to physician education and training. Based on his interpretation of the minutes from previous BSC meetings, ATSDR has attempted to conceal information from physicians. His position is that doctors at Emory appear to have limited knowledge in the areas of toxic exposures, multi-chemical sensitivity and fibromyalgia. Consequently, physicians do not know how to diagnose or treat these and similar diseases. Both doctors and medical students should be trained and better educated about these issues in order to more effectively treat patients.

The Agency has made an effort in the area of physician education and training with its role in establishing environmental clinics; however, this attempt is insufficient. Physicians should be involved in, have a clear understanding of, and know the difference between public health studies and public health assessments. To achieve this goal, the Board's membership should include more medical doctors. Furthermore, less emphasis should be placed on the issue of behavioral and social sciences of residents near Superfund sites. More activities should be focused on treating, detoxifying and measuring the health outcomes of citizens. Dr. Shoji concluded that problems related to site exposure will not be resolved without this approach.

Ms. Bradshaw made public comments as a member of the Memphis Defense Depot community and not as a C/TS Special Consultant. She announced that an article in a local newspaper recently reported the discovery of more than 5,000 vials by the Defense Logistics Agency (DLA). Although the contents were unknown, DLA discarded the vials in a chemical warfare dump near the community with no notification to the residents. Consistent with the time-frame that local pits were dug, five residents died on the same street. The community believed the timing of these deaths in relation to the digging activities were unusual occurrences. Attempts to obtain information about possible exposure from the site were unsuccessful. The residents were deeply concerned due to the discovery of dead birds in the area.

DLA announced its plan to remove dieldrin from the site without the approval of EPA or ATSDR. The clean-up procedures were well below standard because the area was dusty and the chemical exceeded EPA's regulatory level for communities by 4,000 times. DLA had no monitoring process and some workers wore no protective equipment during the clean-up. Ms. Bradshaw's complaint to EPA about the lack of oversight mechanisms at the site was not registered until almost one year later. The residents have now learned that mustard gas bombs will be dug up in the community. The site has released no emergency response plan to address uncertainties about the dangers of these bombs. Unfortunately, military sites do not adhere to the step-wise process for clean-up activities as defined by Superfund, i.e., public health assessment, risk assessment, and provision of findings to the community. Ms. Bradshaw emphasized her fear because 75% of the community has died. She commended the Agency for its strong efforts to obtain data on federal facilities.

Ms. Judy Shoji remarked that the Jet Propulsion Laboratory (JPL) in Los Angeles County is another federal site which did not conduct an initial public health assessment. When the draft document was presented to the community, however, old data related to toxic exposures were excluded. JPL publicly announced that an updated version of the public health assessment will include old information. The findings showed no likelihood of past, present or future health hazards. This conclusion was based upon an analysis of the current level of toxins in the drinking water, but EPA data show extremely high levels of chemicals in the water. Ms. Shoji strongly believed that public health assessments at federal sites are not being conducted in accordance with CERCLA regulations.

Dr. Falk encouraged Ms. Bradshaw to provide him with information about improper clean-up activities related to chemical weapons. CDC advises the Army on appropriate procedures to store or destruct chemical weapons. He committed to forwarding this information to the proper authorities. Dr. Roseman returned to Dr. Shoji's comments and asked if ATSDR had a descriptive summary of its efforts to train health professionals. Dr. McCumiskey replied that both DHAC and DHEP have branches which primarily use physicians. He added that a summary of activities in physician training for community outreach could be provided to Dr. Shoji.

Schedule of and Agenda Items for the Next BSC Meeting. Board members suggested several agenda items to be considered for future meetings.

By general consensus, the Board tentatively decided to hold the next two meetings on November 18-19, 1999 and May 4-5, 2000. Dr. Melius took the Chair's prerogative and concluded that BSC meetings shall be no less than 1½ days because the Board formally meets on a biannual basis. He reiterated Dr. Stark's request that materials requiring a formal BSC action be distributed to the members prior to meetings. He also asked that ATSDR's questions posed for the Board's consideration be clear and definitive. He encouraged the C/TS and Special Consultants to also provide topics for consideration as future BSC agenda items.

There being no further discussion, Dr. Melius adjourned the BSC meeting on May 7, 1999 at 12:22 p.m.

I hereby certify that to the best of my knowledge, the foregoing minutes of the proceedings are accurate and complete.

Dr. James Melius, Chair
Board of Scientific Counselors


This page last updated on July 1, 2001

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