ORRHES Meeting Minutes
November 16-17, 2000

November 16, 2000

The Agency for Toxic Substances and Disease Registry (ATSDR) and the Centers for Disease Control and Prevention (CDC) convened the first meeting of the Oak Ridge Reservation Health Effects Subcommittee (ORRHES) on November 16-17, 2000. The meeting, which was held at the YMCA of Oak Ridge, began at 9:00 a.m.

Members present were:
Alfred A. Brooks, Ph.D.
Donald A. Creasia, Ph.D.
Kowetha A. Davidson, Ph.D., Chair
Robert Eklund, M.D.
Edward L. Frome, Ph.D.
Karen H. Galloway
Jeffrey P. Hill
David H. Johnson
Susan A. Kaplan
Andrew J. Kuhaida, Ph.D.
Ronald H. Lands, M.D.
James F. Lewis
Lowell P. Malmquist, D.V.M.
LC Manley
Therese McNally, B.S., B.S.N.
Donna Mims Mosby
William Pardue
Barbara Sonnenburg
Charles A. Washington
Members absent were Robert Craig, Ph.D. and Karen Galloway.

All the liaisons to the Subcommittee attended:
Elmer Warren Akin, U.S. Environmental Protection Agency (EPA)
Brenda Vowell, R.N.C., Tennessee Department of Health
Chudi Nwangwa, Tennessee Department of Environmental Conservation (TDEC)

Agency staff present were:

ATSDR: Bert Cooper, Rita Ford, Jack Hanley, Sandy Isaacs, Yahya Muhammed, Theresa NeSmith, Marilyn Palmer, Jerry Pereira, Robert Williams.

CDC/National Center for Environmental Health (NCEH): Arthur Robinson

CDC/ATSDR Headquarters:
Office of General Counsel: Kenya Ford, Paula Kocher
Committee Management Office: Helen Kuykendall

Department of Energy: Timothy Joseph

Others present over the course of the meeting included:

Gordon Blaylock, Oak Ridge National Laboratory and SENES, retired
W.H. Brooks, Oak Ridge resident
Walter Coin, Oak Ridge resident
Jan Connery, Environmental Research Group (ERG)
Edwin A. Farmer, Oak Ridge resident
J.W. Fouse PACE and community representative
Larry Gipson, ORNL retiree, Scarboro resident
Ronnie Griffin, Scarboro resident
Susan Gawarecki, Local Oversight Committee
Ann Henry: RN, Employee Occupational Health Services, Memphis Medical Center
Tim Joseph, Oak Ridge Operations Office point of contact
Bill Murray, A.B. Murray Consulting, LLC
Marie Murray, recorder
Norman Mulvenon: retired physicist, Chair of the Oak Ridge Local Oversight Committee/Citizens Advisory Panel (ORRLOC -- CAP)
Arthur Nelson, Oak Ridge resident
Robert Peele, was associated with Oak Ridge Health Agreement Steering Panel (ORHASP).
J.A. Sharkir-Ali, Oak Ridge NAACP
John Steward, PACE health and safety union representative
Janice Stokes, Oak Ridge resident
Debbie West, court reporter
Steve Wiley, Y-12 environmental studies health coordinator

Opening Comments

Rear Admiral (U.S. Public Health Service) Robert Williams, Director of ATSDR's Division of Health Assessment and Consultation, welcomed everyone on behalf of ATSDR and CDC. He did so on behalf of Ms. Loretta Bush, the Subcommittee's Executive Secretary and Designated Federal Official (DFO), who was injured in an auto accident on the previous day and was therefore unable to attend. Mr. Jerry Pereira, Chief of ATSDR's Community Involvement Branch, sat in for Ms. Bush.

Mr. Williams thanked the members for their willingness to serve on this Subcommittee, which is a key component of ATSDR's outreach to the Oak Ridge community. Its purpose is to provide advice and recommendations to ATSDR and CDC, particularly in prioritizing and determining how to evaluate health issues and community concerns, and to determine the public health responsibilities suggested. He assured the members that that advice will be taken seriously and responded to. If ATSDR is unable to respond, it will invite in those who can to do so.

Subcommittee Chair Dr. Kowetha Davidson then introduced herself. She has a Ph.D. in zoology, is on staff at the Oak Ridge National Laboratory, and is a member of the Oak Ridge Associated Universities (ORAU) Institutional Review Board. She defined her role on the committee as providing technical expertise as well as to serve as a liaison to the African American community.

Dr. Davidson also thanked the members for their willingness to serve on this FACA committee, and welcomed them, agency staff and members of the public to this meeting. This meeting's focus was to be on information and process about committees formed under the Federal Advisory Committee Act (FACA) and in particular about the ORRHES. She welcomed this community's opportunity to provide ideas and recommendations in partnership to ATSDR at the front end of their work in Oak Ridge; to bring solutions and ultimately closure to questions about the laboratory. She called for sensitivity to the people of the community and their environmental concerns, and maintenance of an atmosphere of fairness and respect in dealings among the members and with the community. She commented on the diversity of the Subcommittee's member, each providing something different and important to the committee as a whole. A strong unit could be formed to deal with and resolve the issues brought before them.

As Chair, she expressed her expectations of the Subcommittee members: 1) to exert every effort to work together, letting diversity work for rather than against the Subcommittee; 2) to subordinate personal goals/interests for the good of the process, considering the entire community; 3) to remain focused on the specific issues examined while listening to other concerns of the community as well as ATSDR's missions; 4) to develop a systematic approach to the Subcommittee's work; and 5) to bring closure to environmental issues problematic to the community for many years. The Y-12, X-10, and K-25 Areas are geographic units from which environmental contaminants may have been released. This Subcommittee will be focused on what the community was or are exposed to, at what levels, whether those levels are sufficient to cause public health concerns, and on what can be done.

Dr. Davidson concluded that "this is our Subcommittee;" which has the means and opportunity to determine how the Subcommittee will function. The members should communicate with other members of the community about their environmental health concerns, because the Subcommittee can influence what goes into the ATSDR public health assessment.

Subcommittee Introductions

The Subcommittee members introduced themselves:

Alfred Brooks is a resident and land owner with a long-time interest in Oak Ridge. He belongs to many community groups, some of which address on-site environmental problems, so he had already reviewed a good deal of data.

Don Creasia is a retired X-10 worker. He is an environmental toxicologist with a specialty in inhalation.

Bob Eklund is an emergency medicine practitioner. Treating his patients with chemical poisoning led to an interest in Oak Ridge, not just of the workers but also residents living around the Oak Ridge complex.

Ed Frome is a biostatistician in the Computer Science/Mathematics Division of Oak Ridge, and has worked at the lab since 1966. He was part of the ORAU epidemiologic health effects studies of Oak Ridge workers, and still works on beryllium.

Jeff Hill is an ORNL worker, a fisherman, and a new grandfather, therefore with a renewed interest in the environment and future. He has been the labor union environmental safety and health representative for the Atomic Trades and Labor Council.

David Johnson is a member of the Knox County Minority Health Coalition and has served on numerous community committees. He is interested in all minority communities and other disenfranchised individuals.

Susan Kaplan has worked in laboratories since age 16. She is a chemical engineer and independent business owner since 1987. She joined the Local Oversight Committee in 1995 and has been Vice Chair since 1996, and Chairs their Subcommittee on Economic Transition and Workforce Issues. She is an activist who began the Institute for Technology, Social, and Policy and Awareness.

Al Kuhaida is the mayor of Oak Ridge. He had a career in environmental management, first in assessment of uranium mines, waste storage, and recently in remediation on the ORR. HE is now semi-retired and is on several environmentally-related committees. He was born on the Ohio River near the West Virginia steel mills, which produced air and water pollution. He moved to Oak Ridge as teenager and recalled when the East Fork Poplar Creek occasionally ran in colors or with an oily scum. He fished and camped on the Clinch River and later discovered the cesium contamination of fish at that time. As a teenager, a "No Trespassing" sign was a challenge; and at least once he entered an area exposed to radiation.

Ron Lands grew up in Roane County until medical school and the Army, and settled in Oak Ridge 10 years ago. He is an oncologist and hematologist at the Methodist Medical Center.

James Lewis is a retired mechanical engineer who worked for the TVA. for 27 years. He was born and raised in Knoxville. As Vice President of the NAACP, he heard numerous community complaints about Oak Ridge pollution. He hoped the Subcommittee would make a special effort to ensure that the community is informed in an understandable way about lab issues.

Peter Malmquist is a veterinarian, retired since 1999, who has lived in Roane county since 1962. He volunteers with the county commissions, church boards, and a member and Chair of the county Board of Health. He lives on the Clinch River, and he has some concern about downstream pollution.

LC Manley is a retired ORNL lab technician who has lived in Oak Ridge (Scarboro) since 1958. He hoped to bring to closure some of the negative reports about his community concerning mercury and airborne exposures. If there is no problem, the negative publicity of the recent past must be corrected.

Therese McNally grew up in Oak Ridge; her father was a Y-12 physicist. She also played everywhere as a child and agreed that the site fences were irrelevant.

Donna Mosby is a lay person and community activist with a particular interest in the issues affecting children. She was concerned about the divisions in the community over these issues, particularly in Scarboro.
Bill Pardue is a retired nuclear industry worker (not in Oak Ridge) with an expertise in facilities design and the handling of toxic materials. He has been on the Oak Ridge Site-Specific Advisory Board ( SSAB) for 5 years as well as on the Governor's Panel to Evaluate Toxic Substances in the K-25 Incinerator.

Barbara Sonnenburg lives on Watts Bar Lake, and represents Meigs County. She is a representative of the LOC Board and is on the Tennessee Air Pollution Control Board. As the representative, she had heard much testimony about health concerns. She was an elected representative on the Memphis School Board and on the City Council for 16 years. As the latter's Chair, she began a local Hazmat response team, the first in the country to bring together the first responders, representatives of the chemical industry, railroads, trucks, etc. She formed the same template on the national level.

Charles A. Washington, Sr. worked at ORNL for 27 years, and in that time worked with every element on the periodic chart. He knew of site emissions to the closest community, which was minority, and which was not informed. He was present to find out what/how much was emitted, the meteorological conditions of the time, and what effects would have resulted in Scarboro. He was President of the National Organization of Black Chemical Engineers, President of the Inventors's Forum, a member of the SSAB. He is a strong proponent of environmental justice, which addresses the economic and social effects of plant activities. He stated that lakes and streams within 100 miles of the lab were contaminated, and that "low levels matter." He hoped to put some definition to these issues in the course of the Subcommittee's work.

Of the absent members, Robert Craig is an oncologist and environmental scientist, who is a members of the East Tennessee Economic Council and Oak Ridge Chamber of Commerce for 2001. Ms. Karen Galloway is a secretary at Battelle/ORNL. She was born and raised downstream of the ORNL.

The Subcommittee liaisons also introduced themselves:

Brenda Vowell is a nurse and has worked Tennessee Department of Health for 30 years. She has lived most of her life in Anderson County, and is currently Director of Quality Management for the 15-county area surrounding Knox county. She has worked in the mercury studies and most recently participated in coordinating CDC's examinations of children in the Scarboro community.

Chudi Nwangwa is a chemist and the liaison for the Tennessee Department of Environmental Conservation. He has worked for the TDEC Oversight Office in Oak Ridge for 10 years.

Elmer W. Akin is the liaison for the EPA. His training is in toxicology and he is the Region IV Senior Risk assessor. As a regulatory agency with cleanup authority over Superfund sites, EPA conducts risk assessments but does not do health studies. They are very interested in CDC/ATSDR's health studies relevant to Superfund Sites.

Presentation on the FACA

Ms. Helen Kuykendahl, of the CDC/ATSDR Committee Management Office, outlined the history, procedures, and membership aspects of federal; advisory committees. Since 1794, when George Washington enlisted an advisory committee to investigate the Whiskey Rebellion, such committees have been used to obtain outside expertise not available within the federal government. They have addressed a wide variety of subjects, such as labor laws, government housing, vaccines, etc.; most recently, the Three Mile Island and Space Shuttle Challenger events.

The Federal Advisory Committee Act (FACA) was enacted by Public Law 92-463 in October 1992. It defines a FACA as "any committee, board, commission, council, conference, panel, task force, or other similar group, or any Subcommittee or other subgroup thereof for the purpose of obtaining advice or recommendations on issues or policies which are within the scope of his or her responsibilities." The FACA was created to prevent advisory committees from being dominated by any one viewpoint or special interest. It is the only way that consensus advice can be provided to an agency, which must respond to the advice and recommendations.

In 1997, the General Services Administration (GSA) assumed responsibility for FACA and further defined committee guidelines. Each agency is required to have a committee management officer; the agency is accountable to GSA, and GSA accountable to Congress.

Ms. Kuykendahl explained that the Oak Ridge Reservation is a Subcommittee of the Citizens Advisory Committee on Public Health Service Activities and Research at Department of Energy (DoE) sites. It is an umbrella committee consisting of the Subcommittees at the Savannah River Site, Hanford, Fernald, Idaho National Engineering and Environmental Laboratory (INEEL), and now Oak Ridge, DoE sites.

She outlined the basic FACA guidelines, which provide strict procedures in establishing and operating an advisory committee. (Further information on FACA is available at the GSA Website: www. policyworks.gov).

The committee's function is only advisory.

• The FACA And Government in the Sunshine Act require open access to committee meetings. The meetings planned are Published in the Federal Register and must be open to the public unless closed with prior permission.
• Membership must be fairly balanced in terms of the points of view represented and the functions to be performed, composed of equitable geographic, ethnic and gender representation (as long as the effectiveness of the committee is not impaired). The members are selected without discrimination based on age, sex, ethnicity, gender, sexual orientation, disability, or cultural, religious, or socioeconomic status.
• Members cannot serve continuously as a member of any single advisory committee for more than 4 years, serve on more than one committee within an agency at the same time, or serve concurrently with another person from the same organizations in the same city without a DHHS waiver.
• Each committee must have a Designated Federal Official (DFO), who is Ms. Loretta Bush for the ORRHES. She supervises the day to day operations of the committee, provides direction, control, and assistance to ensure that the committee operates as required. She ensures: that the committee fulfills its mission, calls or approves the calling of committee meetings and the final meeting agenda, that the meeting notices are published in the Federal Register 15 calendar days in advance, attends each meeting, ensures that detailed minutes are kept of each meeting, and ensures new member orientation.
• The Committee Chair, Dr. Kowetha Davidson, is responsible to preside at meetings and ensure that all rules of order are maintained (Roberts Rules of Order are suggested). She manages the committee with the DFO, ensures that public comment periods are held, and certifies the accuracy of the meeting minutes.
• DHHS policies require federal advisory committees to hold meetings with the advance approval of the DFO, who must approve the agenda. A quorum (50% + 1) must be present to vote. The advice given by the committee must be within the scope of its charter (for the ORRHES, these are public health activities at the Oak Ridge Reservation).
• Members are compensated at $250/day of Subcommittee meetings, but not for time spent in preparing for meetings. The members' roles involve them as private citizens engaged as temporary special government employees. They represent only their personal opinion or view, not that of any organization.
• Special government employees must comply with government conflict of interest regulations and standards of ethical conduct for employees of the Executive Branch. They must protect confidential information and procurement integrity, file an annual confidential financial disclosure form, and recuse themselves from participating in any meeting to provide advice that would affect their financial interests.

Discussion. Further clarification provided in discussion included: 1) The committee's scope addresses health issues inside and outside the site fence line, all of which interest ATSDR. However, any worker issues directly involved would be addressed by the National Institute for Occupational Safety and Health (NIOSH); and 2) FACA requires detailed minutes. Any transcripts done in addition are also publicly available. Both minutes and transcript will be distributed to the members, certified by the Chair, and placed in the DoE reading room, as well as made available for public distribution and use.

Overview of the Subcommittee Charter

Ms. Marilyn Palmer, of the ATSDR Committee Management Office, provided an overview of the Subcommittee's charter. The ORRHES can have up to 30 members; 20 are currently seated. The members are technical experts knowledgeable about the site area's concerns, represent diverse community viewpoints. Consultants and nonvoting liaisons are involved as needed. The members have overlapping 4-year terms and serve until replaced. The meetings are determined by ATSDR's needs and are announced through outreach to the public, which the members were asked to assist. The minutes repose at the ATSDR archives and in the DoE Reading Room. Aside from the $250/day, the members are paid a per diem and travel expenses. The charter must be renewed every two years (current expiration is July 2, 2002). Ms. Palmer provided her contact information and e-mail address (myr4@cdc.gov).

Ethics Video and Discussion

Ms. Paula Kocher, Senior Coordinating Attorney for CDC's Office of General Counsel (OGC), introduced a video tape developed by the U.S. Office of Government Ethics that discusses the general rules and ethical aspects of serving on FACA committees. It explains the seven rules applicable to FACA members as special government employees, which address: 1) conflict of financial interest, appearances of same, use of..., acceptance of gifts, outside activities in which the members may or may not engage while a member, restrictions on seeking employment while a member, and post-employment restrictions. There were no questions from the members after the video.

Letter from NIOSH to the ORRHES

Dr. Davidson read a letter from Mr. Larry Elliott of the NIOSH Health Effects Research Branch. He conveyed his congratulations on the ORRHES' first meeting, which he was unable to attend. However, he requested agenda time at the second meeting to outline NIOSH's mission and research agenda at Oak Ridge, and its role in the Energy Employees' Occupational Illness Compensation Program.

Overview Presentation of ATSDR

Mr. Williams is also the Public Health Service's Chief Engineer, advising on public health engineering matters to the Surgeon General and >1100 PHS engineers. As Director of the Division of Health Assessment and Consultation, he ensures that public health assessments are conducted at every site listed on the National Priority List (NPL) nationally.

He explained that ATSDR's mission is to conduct public health assessments, establish and maintain toxicological databases, disseminate information on exposures, and provide medical education to health care providers on the health effects of environmental contamination. ATSDR has about 500 employees and an annual budget of $80-90 million. Most staff are in Atlanta, although some are assigned to each of the EPA regions. The agency was created by the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA – the Superfund) Act), in response to the events at Love Canal and the barrel fire in Elizabethtown, NJ. In 1986, ATSDR's responsibilities were expanded by the Superfund Amendments and Reauthorization Act (SARA). This made ATSDR the lead public health agency under Superfund to identify the extent/nature of health hazards at NPL sites, help prevent further exposures/illness, and establish/expand the knowledge of health effects related to exposures. This work is done with state and local health departments and other federal agencies, particularly EPA and CDC. He shared an organizational chart showing its placement under the DHHS.

Public Health Assessment Activities. ATSDR's primary goals are to: 1) identify people at health risk from exposures, 2) evaluate the relationship between hazardous substances and adverse human health outcomes, and 3) to intervene to prevent or mitigate the adverse health outcomes from such exposures. Their activities are either site- or substance-specific in four main areas:

• Public health consultations respond to narrow or specific health questions. They normally provide a rapid response (verbal or written), with a recommendation on what to do about that concern.
  
  
• Public health assessments are used to triage sites: who's been exposed, to what, and what more rigorous activities might be needed. It examines environmental, medical, and community population information to decide a course of action. It examines exposure pathways (how a contaminant is released and then proceeds through air, water, or soil to reach/affect people.). This could result in a public health assessment recommendations such as health education, medical monitoring, exposure investigations, health studies, research, exposure/disease registries, toxicological profiles, health surveillance, and health advisories. A public health assessment would be used by the health department, EPA, etc., to help inform decisions about sites to protect their communities and workers around or in the sites.
  
  
• Exposure investigations: collect a limited amount of data to better define the exposures in a community (e.g., blood and urine samples to get snapshot of current health status. They do not indicate past or future events or effects. Unfortunately, there are few tools available to detect exposures.
  
  
• Health investigations look for any association between an exposure to a contaminant/hazardous substance and an health outcome. These could result in other activities such as a disease registry, medical monitoring, etc.

Toxicological Profiles. From lists of hazardous substances, ATSDR develops toxicological profiles ("tox profiles"), now totaling about 200 of 275 identified chemicals of concern at sites (e.g., lead, benzene, arsenic, cyanide, etc.). They initiate substance-specific research to fill data gaps. In a manner easily understood by anyone, the tox profiles summarize information to explain how the material could affect individuals/communities. While the agency also can do hazardous substance research to fill data gaps, they do not conduct lab analyses; instead, they work with partners such as CDC, academic institutions, etc.

Health education/health promotion activities are conducted with medical and other health care professionals, to help them diagnose and treat patients with symptoms related to exposures. Case studies, published in environmental medicine journals to train in the diagnosis, treatment, and tracking of progress after exposure, also provided Continuing Medical Education (CME) credits. To date, the agency has addressed only 33 substances in this medical education activity.

Community health education is done after it has been determined what a community needs and/or wants to know. A responsive, program is developed to convey that, which can also involve experts external to ATSDR. Health promotion activity blends health education; risk communication; environmental, medical, and promotional activities, to give the community information and access or referral to other services to promote health and prevent disease.

Among their partners are the Association of Occupational and Environmental Clinics (AOEC), which have technical laboratory abilities. The AOEC is setting up pediatric environmental health specialty units to provide pediatricians knowledgeable in environmental health in every EPA region. ATSDR is also working with NACCHO to build/ensure the capacity of local health agencies to continue work on these issues after the federal agencies leave.

Discussion. In response to Subcommittee questions, Mr. Williams explained the following points:

• What interactions among chemicals is ATSDR exploring? Work is beginning on mixtures of contaminants and within different media, using a pharmacokinetic model to predict what effects may occur in people. While the listed chemicals are only 275 of the thousands used, they are those most prominent at sites, and the list is routinely reviewed to see if others should be added.
  
  
• Why was Oak Ridge not assessed, as is required of every Superfund site? Since the Oak Ridge Health Assessment Steering Panel (ORHASP) study and the state's dose reconstruction work was underway, ATSDR delayed beginning the public health assessment to avoid potential duplication of work. Congress agreed to this plan, as long as ATSDR addressed the most important NPL work within a year.
  
  
• How is an area chosen for an environmental health clinic; and areas being considered now; and is this an ongoing process? The AOEC is a private organization of health clinics located predominantly at university settings throughout the U.S. ATSDR's cooperative agreement with the AOEC enables them to refer people to those clinics. They are also implementing the pediatric environmental health specialty units in each EPA regions. And, while ATSDR does not set up clinics, the Health Resources and Services Administration (HRSA) Does. They could be invited to explain that process.
  
  
• Can ATSDR apply information on classified materials and their production? ATSDR staff with clearances can review such records, but that information has to be declassified before it can be used. And, since ATSDR is not a regulatory agency, it cannot require companies to record and report malfunctions leading to releases, in order to relate that to environmental aspects such as wind, temperature, etc. and evaluate potential community exposures. But that is the type of information they seek and use, and they can strongly0 recommend in support other agencies' appropriate address of such issues (e.g., EPA). If ATSDR's Division of Toxicology can identify the chemicals used in a plant, they can work to model/duplicate those processes to explore synergistic effects.
  
  
• It was noted that the Resource Conservation and Recovery Act of 1984 (RCRA) requires active facilities to address releases. This could be discussed in the Subcommittee.
  
  
• Complex mixtures have been of interest for some time, but are hard to study. What combinations Does ATSDR study and in what ratios? The outcomes change with each variation. Experts could be invited to discuss with the Subcommittee what is doable.
  
  
• Mr. Washington recalled reports by many old site chemists that 2-3 boxcars of mercury were released, but Scarboro residents were never warned of air releases or about using produce from their vegetable gardens. He had heard that the Savannah River study had indicated that metal mercury can be released under the right conditions, and that the synergistic effects could be more damaging than thought.
  
  
• Could any exposures (e.g., to multiple materials) have put the community in more danger than workers and vice versa? Since workers might have had more shielding from protective equipment, it is possible that the community could have greater effects. That will be examined. Mr. Akin stated that regulatory levels for the public are higher to provide greater protection, since workers are presumed to be healthy adults.
  
  
• Can ATSDR look at cumulative impacts from low background (e.g., TVA's present 2 tall stacks used to be 8 small ones and their emissions are fairly well known. Since their primary purpose was to supply power to ORNL, those cumulative impacts should be considered. ATSDR's predominant work will focus Oak Ridge releases' potential affect on the communities, but other such materials that could have impacted the public health will be addressed as possible in the toxicological discussion, as well as those to workers. Mr. Akin explained an epidemiological study's use of control and test communities to compare health outcomes, which could manifest effects from the synergism resulting from different exposure sources. A pure research study would have to factor in each contaminant specifically, a very different task.
  
  
• The relationship of the pediatric clinics to the U.S. clinics of the National Institute of Environmental and Health Sciences (NIEHS), which study health impacts, was inquired by Ms. Kaplan. Mr. Williams was unaware of NIEHS clinics, but was interested to know more about that.
  
  
• Are the elements of the public health assessment conducted simultaneously (yes), and how were the 275 chemicals selected? They were selected by EPA and ATSDR, according to the frequency with which they were found at sites, whether their exposure pathway was complete, etc. The two agencies created an algorithm considering a number of factors to prioritize and decide which to profile.
  
  
• If not on the list/profiled, how is this material addressed? ATSDR and EPA would do a limited toxicological profile on a chemical in a smaller, focused document.

Public Comment

Mr. Robert Peale is an Oak Ridge resident and was a member of the former committee, the Oak Ridge Health Agreement Steering Panel. They oversaw a DoE-financed study started prior to the HEW study that was grandfathered to be conducted by the state of Tennessee. They produced 7 reports through three contractors (ChemRisk, SENES/Oak Ridge, and Tchonka? Research/Atlanta) which detailed histories of contaminants, pathways, and likely risk. They tried to do the highest priority work. Comments received expressed a wish that other work was included, such as on-site exposures. He hoped that this Subcommittee and others will make the best use of this work, at least its summary, which might help indicate where something might be found. He expressed his and other ORHASP members' willingness to help the Subcommittee.

Mr. Ephraim Farmer was 38-year K-25 worker, now retired for 10 years. He worked with many different chemicals without knowing what they were or what they would do. Many were still not even labeled when he left. He asked how to find out what and how much he might have been exposed to, and whether the mercury project was completed. He also noted that two decades of radiation monitoring never found anything. But the radiation counters of the researchers from Pittsburgh alarmed constantly and people kept being moved out of areas, including in a lunchroom used to cook/serve food for 20 years. He has been diagnosed with asbestosis and berylliosis, and wondered about other conditions as well. Dr. Davidson invited him to return to the next meeting, when Mr. Larry Elliott of NIOSH would address occupational exposure issues. She was also confident that the Subcommittee would be addressing mercury exposures as they help ATSDR develop their health assessment. Ms. Kaplan told him of a report from a DOE Headquarters Oversight Office to DOE/EH, which discusses worker areas and exposures; and the ORHASP report, although fairly controversial, included a tremendous amount of research. She is preparing a white paper on off-site releases and risk, and is summarizing the EH report.

Mr. Larry Gibson, a 35-year employee at ORNL, 10 of those in the coal program, testing compounds, chemicals, etc. He hoped this committee would help facilitate closure of the debate about health effects in Scarboro. Testing has been done of the soil, the children, etc. but no subsequent closure resulted. It is greatly needed to reduce the community's anxiety, and any further tests must be very careful on how they are conducted and reported to avoid further damage to the reputation of the Scarboro community. He would prefer reference to the "greater Oak Ridge area," stressing, for example, that Poplar Creek Does not run through the Scarboro community; it runs by Scarboro Road. He lamented that no tangible good had resulted from the millions spent; in fact, he felt that more harm had been done. He asked the Subcommittee to try to ensure that future studies do as little harm as possible. Dr. Davidson expected that this Subcommittee would remain sensitive to the concerns of the entire Oak Ridge area and make every effort to be fair. She reiterated that the opportunity to give input to the front end of the ATSDR public health assessment can influence what it addresses and concludes.

Mr. Lewis commented that meaningful communication needs to be facilitated between community leaders, residents, and the Subcommittee to avoid domination by an interested few. Dr. Frome and Mr. Hill noted that these public comments were from people who are both residents and workers. The workers of decades past probably were less protected from exposures and were more highly exposed, so exploring effects with workers exposed to high levels of contaminants seemed logical.

Dr. Brooks observed the amount of distress in this area about the data, the reports issued, and the issuing organizations. Closure involves more than an understandable, well-done report, but also the community's faith that they have received factual information worthy of confidence. It takes constant work with the community to explain what these complex problems mean to them as individuals. The casual issuances of reports has been done for over 20 years now, with unsatisfactory results.

Ms. Kaplan commented the importance of the point that, although flawed, worker protection and compensation at least exists, but nothing similar for Oak Ridge residents. Among the questions to be dealt with is how to address the residents not being attended to?

Scope of the Subcommittee

After lunch, Mr. Jerry Pereira stated his expectation that the agency's work will be greatly assisted by the institutional memory, technical knowledge, and commitment of the Subcommittee. He presented for Ms. Bush the aspects of communications to the Oak Ridge National Laboratory and the Subcommittee.

He emphasized the importance that everyone be aware that the science is insufficient to provide all the answers; this is critical to credibility. The ORRHES will be successful if after reviewing whatever documents are produced through this process, they can have confidence in the findings. He advised conducting regular reality checks along the way to ensure that communication remains clear to produce a credible, coherent result that all can understand.

To provide a forum for that, the Oak Ridge Reservation Public Health Work Group was formed in 1998, with representation from 7 federal and 2 state/local agencies. A series of meetings were held with community members and stakeholders in April, June, and September 1999. The process of developing a plan is critical to ensure that communication is maintained. The ORRHES was officially established on December 28, 1999, as the fifth Subcommittee of the Citizens Advisory Committee on Public Health Service Activities and Research at Department of Energy (DoE) sites. Its members were selected from the pool of nominees by ATSDR and CDC in a multi-tiered process based on the selection criteria developed with input from the three Public Health Work Group meetings: 1) the members must be balanced in terms of points of view and function to be performed, provide equitable geographic, ethnic and gender representation as required by law, and be nominated from the community.

The purpose of the ORRHES is to provide advice and recommendations concerning public health activities and research conducted by ATSDR and CDC at the Oak Ridge Reservation site. It provides advice on the selection, design, scope, prioritization, and adequacy of ATSDR's public health activities for the Oak Ridge Reservation. It will provide critical input to the public health assessment process, community needs assessment process, and any recommendation for follow-up public health activities. However, recommending on activities of any other federal, state, or local agency are not within its charter.

ATSDR is committed to take a proactive approach in establishing and maintaining good communication among all parties: the ORRHES; community members; federal, state, and local agencies; and other identified stakeholders. Mr. Pereira added that the community should not need to be present to remain updated on the work being done, but should be able to remain informed. Whether by Internet, media, outreach to the community, or other venue, ATSDR will support that process.

Discussion. The ensuing discussion with Mr. Pereira included the following points:

What is the relationship of the ORRHES to the other agencies that were on the Public Health Work Group? ATSDR will invite any other agency to address any issue becoming an agenda item that requires another agency's input.

Is there a listing of the recommendations made over time by the other Subcommittees, and the response to them? CDC and ATSDR will arrange that.

Will you forward recommendations pertaining to another agency? (Yes) NIOSH should have a liaison member. That will be raised with Mr. Elliott at the next meeting.

There seem to be different points of view on the Subcommittee and in the community; has anyone surveyed the ORNL community asking if people are concerned about their health? Not scientifically, but the needs assessment will explore this. Most communities have people knowing of many ill people; those disturbed that their property values might be affected; and those undecided without further information on which side they belong. For all of them, trust is earned incrementally. Losing it even once will send you back to square one, and take twice as long to regain it, if you even can. For that reason, ATSDR staff is urged never to deviate from communication based on a solid strategy and consistency in delivering what is promised.

Ms. Kaplan noted great distrust of DoE and its contractors' data. If a committee such as the ORHASP discovers discrepancies, some community members will see a conspiracy, but others will see this as part of the scientific process. It is a challenge to deal with that.

Mr. Brooks suggested review of a 1994 survey of the 8-county area, the report of which cited about 3400 concerns. He also expected that some will say the wrong people were appointed to the ORRHES. The appointment process must be conveyed to reach the people hearing those opinions.

With Oak Ridge's history and the magnitude of composition of this committee, a) once it's bonded, do you think this will serve to support trust; and b) how can consensus be reached? Although no one expects universal agreement, everyone should leave satisfied that their opinion has been voiced and heard. Continuing engagement and communication with the agency staff until that satisfaction is reached was urged. And, reasonable people can disagree. An evenly-divided committee indicates insufficient information, but ATSDR will not ignore advice given in a minority report if a division persists. But hammering the issues out to minimize disagreement, and discuss why the difference of opinion exists, is greatly preferred.

Several of the members addressed the trust issue, noting a lack of trust over the "knowns" and the "unknowns." Scientists often seem arrogant in how they interpret the latter when reported by the community, perhaps perceiving it as "unscientific." Emotions as well as numbers have to be dealt with. People are afraid. Many of the scientists have taken a lot of abuse, and the Subcommittee members may have to as well. The degree of trust depends on the area being addressed; the information needs of the community have to be addressed in a targeted fashion. Expectations should not be raised; the lack of knowledge base in some areas of science must be acknowledged.

Presentation of the Public Health Assessment Process

Mr. Jack Hanley, an environmental scientist in the Division of Health Assessment and Consultation, discussed the public health assessment process. As background, he related the ORNL's addition to the NPL in 1989. In 1990, ATSDR and DoE signed a Memorandum of Understanding (MOU) making ATSDR responsible to conduct public health activities and follow-up at NPL sites. ATSDR planned to use the dose reconstruction and other studies underway in their public health assessment. In 1992, they began their public health activities with a focus on current exposures, specifically in East Fork Poplar Creek and Watt's Bar Reservoir. That work was completed in January 2000, and will be presented in detail at subsequent meetings. ATSDR is now ready to begin the public health assessment with this Subcommittee's help.

Public health assessment is defined as "an evaluation of data and information on the release of hazardous substances into the environment in order to assess any current or future impact on public health, develop health advisories or other recommendations, and identify studies or action needed to evaluate and mitigate or prevent human health effects." Basically, it is an analysis and statement of the public health implications posed by the release of hazardous substances into the environment. Its purpose is to assesses the public health impact on off-site populations from releases of hazardous substances, and determine the need for public health actions or studies. It can trigger several possible recommendations (e.g., medical monitoring). One future challenge could be to explain why some activity that the public might desire is not done.

The Oak Ridge Reservation is a very complex site with numerous public health issues and environmental concerns addressed by various agencies over the years in separate approaches. In the end, the public health assessment will identify and characterize exposures of off-site populations. It will identify people exposed at levels of health concern, identify increased rates of health outcomes, address community health concerns, and recommend follow-up public health actions or studies.

In the Oak Ridge public health assessment, ATSDR will analyze and evaluate the information, data, and findings from previous studies and investigations on the radiological and chemical contaminants released from the Oak Ridge Reservation. They will be reviewed one by one with the Subcommittee for their strengths and weaknesses, and to determine what can be used in the public health assessment.

The primary sources of information for the public health assessment will be environmental and health data and the expressed community concerns. Environmental data is used to identify and characterize exposure to releases of hazardous substances in off-site populations. A pathway analysis is used to determine if people have been exposed to material causing health effects. This evaluation helps narrow down the contaminants of concern and enable a focus on the most important exposures.

Past exposures will be explored by reviewing the dose reconstruction and the CDC mercury studies' data. The health data (e.g., cancer and birth defects registries) will be used as possible to identify excess health outcomes associated with contaminants of concern. The limitations of using this type of information will be discussed, but there is some potentially available (the Tennessee Cancer Registry and clinical data from CDC's Scarboro investigation).

Expressed community concerns help to help prioritize public health issues and focus work to address specific health concerns. These are collected in public meetings, availability sessions, in the conduct of a community needs assessment, in previous surveys conducted, etc. The Subcommittee will be another primary route to collect the community's concerns and to communicate back to them.

Assessing and characterizing the exposures will be tough choices. Assistance from the Subcommittee will be needed to make the right decisions down the line. Mr. Hanley compared the public health assessment process to assembling a puzzle until the picture is clear. Remaining gaps are likely, but ATSDR will work with the Subcommittee, other agencies and organizations, to try to resolve those.

Discussion: The subsequent discussion with Mr. Hanley included the following points:

• The cancer registry only specifies a number of cancers per county; how can that health data be associated to contaminant outcomes? This is part of the limitations that will be explained. But sub-county data levels such as census tracts can be accessed, but registries are still problematic small areas need to be addressed.
• Can you give examples of follow-up actions? ATSDR finished a consultation on the Watt's Bar Reservoir contaminants in the late 1990s, indicating only PCBs in fish as of concern. This was also concluded by two other DoE assessments with oversight from EPA and the TDEC. A subsequent consultation determined a high risk (1:1000) of cancer to those eating a lot of those fish. About 116 persons at moderate- to high risk were found, and their blood serums were compared to CDC's national range levels. (Ms. Sonnenburg commented that with only 1-2 people finally affected, the Watts Bar residents want those advisories changed now; but that is a state decision. ATSDR suggested methods to minimize exposure from fish and turtles to minimize the risk.) In another example for education, a national expert from Chicago was brought to Spring City to address about 40 people about the risks. Physician education was done on the ORNL cyanide issues, and medical monitoring work has been done at other sites. The exposure is key, guiding the focus on what needs to be looked for, and how to mitigate any further exposures and potential outcomes.
• Oak Ridge-specific surveys have been done by the Tennessee Health Department (telephone surveys), and focus groups, and random and two door-to-door surveys were also done in Scarboro. An ORHASP region-wide telephone study done by the University of Tennessee staff, perhaps one of the encompassing survey of all of Oak Ridge and surrounding areas previously questioned, was to be addressed on the following day.
• What is the relationship of the ORRHES and the development of the public health assessment? Are we a peer review group, or consultants, or to sanction the final report? Will the public health assessment be done before this committee is done? Mr. Hanley expected to go through this evolving process step by step with the full involvement of the Subcommittee (e.g., to review the studies that have been done and advise whether they may have missed a pathway unique to this community). The health assessment should be completed in this committee's tenure, because it will help to implement the resulting recommendations.
• If ATSDR offers no medical treatment, what do we tell those members of the community who don't want any more surveys/research, but practical help? Ideally, this process will identify who might have been exposed and potential ensuing health problems, which will help to direct people to their physicians based on their exposures, help to educate physicians about the patient's higher risk, suggested screening and treatment, etc. The outcome might be so specialized as to enable referral to the specialty clinics. When asked if that would allow referral for screening, as done by the PACE and Building Trades programs, Mr. Hanley was unsure. He hoped to have an answer by the next meeting. One certainty was that the exposure must have occurred to focus on particular screens. And, while ATSDR Does not do medical care, they can offer referrals, screening, education, discussion of insurance options, referral to proper local agency, etc.
• What is expected to be found from the survey? Small numbers of cancers? Further discussion of model, data, limitations of the science involved, etc., is needed before jumping to such a question. For example, the registry only begins in 1990 and Does not go back to previous years. Once the pathway analysis identifies a risk, and a cohort potentially affected, one of the Subcommittee recommendations could be to locate that cohort for follow-up.
• Some in this frustrated community, with a history of being sampled and studied, are unlikely to cooperate fully. How can that be addressed? ATSDR hopes not to re-interview unless that is unavoidable, but rather to use the information already there; to carefully explain what is being done, assembling the pieces to provide clarity and focus on the issues needing to be addressed. ATSDR also will rely on the Subcommittee, if it agrees a study is needed, to communicate with the community and convey what ATSDR needs to do to be successful in doing that.
• Dr. Frome asked directly if the viewpoint of not wanting just more studies, but also care, was represented on this Subcommittee? Mr. Hill and Ms. Kaplan said yes. He stated that uninsured people probably won't care if their illness is related to ORNL or not, except that a link might allow for some emotional or financial relief. Mr. Hanley responded that one individual who did not accept membership on this committee probably was in that category.
• Mr. Akin raised the proof of causation for discussion. An association might be provable, but probably not causation. What can this Subcommittee conclude without one or both of those? Most cancers are not associated with any known genetic or environmental exposure, and for example, a PCB's 1:1000 link to cancer cannot be shown epidemiologically. The Subcommittee will have to deal with such issues.
• Ms. Kaplan noted the science-based public accountability reflected in the new compensation bill before Congress. But the only relevant data available are on radiation; what is being done to develop similar information on chemicals? If the bottom line is a minimum level of health care, people should be able to access a clinic, state their exposures, and get care.
• Frustration at the delineation of work in surveys that only tell part of the story at a time was expressed. A comprehensive survey whose data could be shared was preferred.
• The scope of this committee must be made very clear. Great care must be exercised to avoid raising expectations, while at the same time doing everything possible to refer people with needs that the ORRHES cannot meet to appropriate sources. The degree to which this Subcommittee can clarify the causes of risk and perhaps health outcomes also will help the community, or it will be seen as just another committee that said it would help and didn't.

Public Comment. Mr. Peele appreciated the interesting and important points of the discussions. He expressed his hope the Subcommittee would neither exaggerate nor disregard risk in its work, but rather "just play it straight."

Closing Discussion. Each member provided an assessment of the day's meeting:

Mr. Kuhaida and Mr. Lewis came with interest and a willingness to listen. The meeting's organization was helpful in conveying what the committee members need to know. The afternoon's touching on the issues was not only interesting, but indicates that the members can differ and still move ahead.

Dr. Lands, a clinician, felt the need to learn the "language" clearly well known by the experts on the Subcommittee.

Dr. Malmquist expressed the hope that the Subcommittee could help the area to address its problems, but had no illusion that they could heal all of society's ills.

Mr. Manley appreciated the information provided. He was unsure that all the ideas raised could be brought together, but hoped they could. With such a diverse group, he expected that to be difficult.

Ms. McNally hoped to learn enough to be helpful, and to impact the future of this wonderful community.

Ms. Kaplan was just thrilled to have gotten to this point, after 5 years of work, and was gratified to be moving forward.

Mr. Pardue compared this meeting to that of another FACA on which he serves, which was contentious in both subject and group. He appreciated and was very encouraged by this group's civility and honesty.

Ms. Sonnenburg was impressed with knowledge of the Subcommittee members. She thought that much could be accomplished, and was interested to see how often they would meet, the kind of work groups set up and their activity. She expressed concern that meeting only 3-4 times a year would prevent accomplishing much.

Mr. Washington was encouraged that everyone seemed to believe that science works and provides some truth to what is being done. If disagreement arose, he expected it on be on the depth of the science, not the methods to get there. Ultimately, the community and the Subcommittee just want to know if contaminants were emitted with potential to cause illness to the public or damage to the environment.

Overall, many believe that possible, and he hoped to get to the root of many sick workers' health problems. He was also impressed at the expressed concern about synergistic effects, which have differing impacts between people. He believed that the committee could get to the bottom of what Oak Ridge has faced for over 50 years, and expected the effects to be shown as ranging over 100 miles from the site. The final question will be, what can be done about all this?

Mr .Johnson also appreciated the discussions and was glad they touched on community capacity building.

Mr. Hill hoped to learn, and felt he was doing so already.

Mr. Nwangwa appreciated the Subcommittee's work.

Dr. Frome related the overriding factor for him that trust is important within the group and with the community. He agreed that first step from a scientific point of view would be to determine if hazardous substances affected community health.

Dr. Eklund was ready to be educated, and hoped this process would result in clarification for the community. He also was glad at the absence of contention, anger and righteousness; but rather the offering of information.

Mr. Creasia appreciated the ATSDR presentations in to provide him direction on what he was supposed to do.

Ms. Vowell stated that this was a learning process for her as well. She was amazed at the knowledge represented on the committee and appreciated hearing it. From a public health standpoint, she expected challenges to getting the answers desired.

Mr. Akin welcomed the good groundwork laid for this process, including the Subcommittee's operational guidelines. He related EPA's experience, in conducting community relations, to never underestimate the speed with which lay people become knowledgeable in addressing technical issues; and appreciated this day's experience as another example of where diversity works.

Dr. Brooks said that he is normally unimpressed with first meetings, but he was impressed with this committee's member selection and its chairing. His only disappointment was that ill workers are not represented, but it appeared to him that the members had enough understanding of and compassion for the ill worker problem. He hoped that their needs as well as others could be met. While this will be a big effort, he had heard it said that this is the last hope for Oak Ridge to reach a reasonable understanding of its problems. If this Subcommittee cannot do it, he did not expect the community to achieve a resolution.

Mr. Pereira reported his good impression of the reception to much of what he had said, some of which was deliberately controversial to gauge the members' response. He felt that the committee was off to a good start.

Mr. Robinson commended this committee for an exceptional day's work, and the staff for facilitating that. He appreciated Mr .Manley's expression of doubt but hope. As a Designated Federal Official for the Idaho Subcommittee, he expected that the members would have to struggle to learn how to work with one another, but nothing is worth having without a struggle.

Dr. Davidson appreciated the members' different experiences, and expressed her confidence that they could work together. She accepted that arguments may happen, as long as they occur in an atmosphere of dialogue and respect for each other.

With no further comment, the meeting adjourned at 4:17 p.m., followed by a social meeting at the Oak Ridge Museum.

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