ORRHES Meeting Minutes
September 11-12, 2001

Table of Contents

December 3, 2001

Call to Order, Opening Remarks, and Introduction of Subcommittee Members
Agenda Review, Correspondence, and Announcements
Approval of June, July, and September Meeting Notes
Status of Action Items
Update on the Health Education Needs Assessment
Health Needs Assessment Work Group Report
Presentation and Discussion: ORRHES Process and Administrative Issues
Discussion of ORRHES Evaluation
Work Group Reports
Update on the Scarboro Soil Sampling Project
Public Comment
Presentation and Discussion: Epidemiology Workshop Part II: Discussion of the Mongano Report

Summary Report
December 3 - 4, 2001

Present in the 12/3 and 12/4/01 Meeting of the Oak Ridge Reservation Health Effects Subcommittee (ORRHES) were the following Subcommittee members: Elmer Akin, Bob Craig, Don Creasia, Kowetha Davidson (Chair), Karen Galloway, Jeff Hill, David H. Johnson, Susan Kaplan, Jerry Kuhaida, James F. Lewis, Peter Malmquist, LC Manley, Therese McNally, Donna Mims Mosby, Chudi Nwangwa, Bill Pardue, Barbara Sonnenburg, Brenda Vowell, and Charles Washington, Sr. Other attendees included: LaFreta Dalton (ATSDR Designated Federal Official), Jack Hanley (CDC/ATSDR), Timothy Joseph (Department of Energy), Kendra Myers (Writer/Editor, Cambridge Communications), and Jerry Pereira (CDC/ATSDR).

Call to Order, Opening Remarks, and Introduction of Subcommittee Members

The Oak Ridge Reservation Health Effects Subcommittee (ORRHES) convened on December 3 and 4, 2001. Dr. Kowetha Davidson, Chair, called the meeting to order at 8:15 am on December 3. She asked that all meeting attendees identify themselves for the record.

Agenda Review, Correspondence, and Announcements

Dr. Kowetha Davidson, Chair
Oak Ridge Reservation Health Effects Subcommittee (ORRHES)

Dr. Davidson reminded the group that the September 11, 2001 meeting had been abbreviated due to the terrorist attacks. Therefore, many agenda items from that meeting had been carried forward to the agenda for December 3-4, 2001. She gave a brief overview of the Subcommittee's agenda, which was adopted as written.

She then directed the group's attention to the following correspondence:

• A letter from Norman Mulvenon, Chair of the Local Oversight Committee (LOC), expressed concern about the Subcommittee meetings which conflict with the LOC meetings. The Subcommittee would avoid these conflicts whenever possible.
• A letter was written to Mr. Patrick Lipford of the Tennessee Department of Health requesting documents that were referenced in the Iodine-131 Dose Reconstruction Report.

Dr. Davidson made the following announcements:

• The work group chairs would be available during the lunch hour to discuss work group activities.
• Subcommittee members are asked to re-sign lists for work groups. These lists would be used as the official membership list for the groups.
• A copy of the mailing list would be circulated for updates. If members of the public do not want their information to be viewed by others, then they should notify Marilyn Palmer before the list is circulated..

Ms. LaFreta Dalton made the following announcements:

• Group members should complete the checklist for consensus-building behavior in preparation for the next day's evaluation.
• The hiring freeze at CDC has been lifted, so they are now free to proceed with the selection process for new members for the Subcommittee.
• She directed the group's attention to a handout about the ORRHES meeting minutes. The members of ORRHES voted to use detailed minutes rather than verbatim transcripts. Public comments made during the meeting as well as after the meeting become part of the public record.
• The recommendations regarding an ORRHES Mission Statement were also available.

Discussion Summary:

• Mr. James Lewis asked about meeting minutes for work groups. He felt that work groups would benefit for some guidance in keeping minutes. Ms. Dalton noted that only Subcommittee meeting minutes are subject to FACA regulations, so each work group can create its own system for keeping minutes.
• Mr. William Pardue wondered about how to address suggested corrections from the public. Appending these suggestions to the minutes does not indicate whether they are valid.
• Ms. Dalton said that based on citizen input during the September meeting and also on information from a presenter, the minutes of the June, 2001 meeting would not be presented for vote. They are in the process of reviewing the tapes and will make appropriate changes for Subcommittee approval.
• Ms. Dalton said that public comments become part of the public record and are included with the meeting minutes in the Oak Ridge Field Office. If the minutes include a misstatement from a presenter, then the tapes are reviewed and necessary corrections made in the minutes. This policy is consistent with other FACAs.
• Mr. Charles Washington said that statements made in the FACA meetings are part of the public record. Corrections made in writing also become part of the public record, but do not change what was said.
• Ms. Dalton noted that public comments regarding the minutes can be shared at subsequent meetings and will thus be part of the public record.

Approval of June, July, and September Meeting Minutes

Dr. Davidson asked the Subcommittee to review the July and September meeting minutes, as the June minutes are still under review.

Motion 1

Mr. Jeff Hill moved that the Subcommittee approved the July and September meeting minutes. Dr. Robert Craig seconded the motion. The motion carried unanimously.

Discussion Summary:

• Mr. Lewis wondered about an operating procedure and deadline for modifying meeting minutes. He was concerned about leaving the June minutes unapproved.
  
  
• Ms. Dalton replied that the normal time to review minutes and to respond with comments is two to three weeks. The June minutes represent an exception.

Status of Action Items

Dr. Davidson directed the Subcommittee's attention to a table provided by ATSDR that listed the status of action items from the September meeting and from previous meetings.

Discussion Summary:

• Mr. Lewis commented that action items from the work groups have an impact on the Subcommittee. He wondered whether there was a mechanism for capturing these work group action items. Dr. Davidson responded that the Subcommittee addresses action items for the Subcommittee only. The work groups address their own action items. Mr. Lewis felt that since many of the action items fall to the work groups, it would make sense to integrate them.
• Ms. Dalton noted that the table reflects action items on which ATSDR was asked to act. The table provides a way to track ATSDR's progress. Dr. Davidson added that ATSDR does not respond to action items from the work groups, but to Subcommittee action items.
• Mr. Pardue inquired as to how to tell which items are recommendations and which are action items. Ms. Dalton replied that the table includes all items to which ATSDR has responded. In some cases, they are a combination of action items and recommendations.
• Ms. Susan Kaplan wondered if there is a similar list of major recommendations from other Subcommittees. She was curious as to which ATSDR activities came as a result of requests from the community. Ms. Dalton said that recommendations from the Subcommittee usually come as a result of discussion in work groups.
• Ms. Dalton offered to note which items on the chart were recommendations and which were action items. She also offered to include a statement about speakers on the minutes process.

Update on the Health Needs Assessment

Dr. Rebecca Parkin
George Washington University

Dr. Parkin presented an update on the Health Education Needs Assessment. She explained that the purposes of the Health Education Needs Assessment are to:

• Identify the community's current health concerns and information needs; and
• Provide a current data summary for the timely implementation of a health education action plan.

There are seven steps in the process, and they are continuing to conduct document reviews and site visits. Key resource interviews were conducted from July through October. Telephone interviews are forthcoming, as are focus groups.

Three Institutional Review Boards (IRBs) are involved in this project:

• George Washington University Medical Center IRB
• The MCP Hanneman University IRB
• The Tennessee Department of Health (which is serving as a repository of information)

These boards ensure that the research is ethical and scientifically sound in its structure and operations. They also ensure the confidentiality and protection of individuals who participate. The initial reviews were done in October, 2000, and final approval for the research methods has been received. The telephone survey questionnaire is under review. The focus group materials are in draft form, as they cannot be finalized without data from the telephone survey.

The goal of the key resource interviews was to reach 25 - 30 people in each of three main categories:

• Health officials
• Healthcare providers
• Key resources in the community

This part of the process is designed to collect information from people who have responsibility in their jobs for health-related issues. 156 individuals were contacted and 74 interviews were completed, as the IRB protocol limits contact attempts to two.

Telephone exchanges to be included in the telephone survey have been identified and the forms have been pre-tested. The questionnaire is being computerized for rapid collection and analysis of the data. There will be a completed rate of 400. The telephone survey is intended to collect a broad view of residents' concerns. The Public Health Assessment (PHA) work group has been helpful in shaping the focus group aspect of the Assessment Project. Information from key resource interviews and telephone surveys will feed into the groups. These two methods of collecting information present opportunities to understand residents' issues more deeply. Eight groups will be scheduled in a compressed time period. IRB approval is expected in January, 2002 so the focus groups will likely be held in late February or early March.

The final report will include background information, documentation of methods used, technical results from each of the three research components, and a recommendation for a Health Education Action Plan. The Plan will document current health issues, the views that people have about the issues, the health education information that people are looking for, and how they would like to get that information. Developing an Action Plan includes the following elements:

• Defining the desired outcome(s)
• Identifying forces that can help and limit the Plan's implementation
• Assessing how these forces can be used
• Advising how an Action Plan can be conducted
• Suggesting alternative strategies

The Plan also includes resource and time-frame estimates for recommended actions and evaluation activities. Stakeholders include the Subcommittee, community leaders and other individuals in the community, healthcare providers, and community organizations. Subcommittee and PHA work group input on the draft report will be needed.

Discussion Summary:

• Mr. Washington asked if a grid could be created to identify where certain questions came from. For instance, members of some communities might not attribute an illness to their proximity to a nuclear facility. Dr. Parkin answered that the telephone survey will make that information accessible via telephone exchanges. The key resource interviews do not include that information, as the individuals interviewed were assumed to have broad experience. The geographic analysis will depend on the richness of the information. Being too specific with this information runs the risk of identifying the personalities involved in the survey and thus breaching confidentiality.
• Mr. Lewis asked whether the telephone interviews will collect distinctions between residents who are workers, who self-identify as "sick workers," and other types. Dr. Parkin was not sure that the questionnaire asks whether participants have worked at the site, but there are opportunities within the questions' structure for interviewees to let it be known that they worked at the site. It is important to remember that answers cannot be prompted in the interview in order to ensure that the responses are not biased.
• Mr. Lewis commented that the Subcommittee focuses on residents, not on self-identified sick workers. He hoped to gather information on those who feel that their health issues are as a result of being off-site, not on-site. Dr. Parkin replied that the telephone survey will use a random sample of residents, so it is not focused on workers.
• Mr. Lewis commented on the word "education" and what constitutes it. An "Education Action Plan" seemed predetermined. Dr. Parkin replied that "education" can be a component of a risk communication strategy. It is a particular method for transferring information from individuals who have special knowledge about a topic of concern to people who want that information.
• Ms. Barbara Sonnenburg recalled that part of the project would include concerns that do not involve education. Dr. Parkin answered that the telephone survey includes collecting health issues for individuals and families as well as health education and information concerns.
• Mr. Lewis asked about the document review. He wondered if they could capture concerns from this part of the process. Dr. Parkin said that these concerns would be documented in the final report.
• Mr. Lewis hoped that the PHA work group concerns could be connected to issues of contaminants of concern. Dr. Parkin observed that these issues might not be captured in a telephone survey of limited length. The telephone survey will assess beginnings of concerns about connectedness between health issues and contaminants, and the focus groups will then probe the issues more deeply.
• Ms. Sonnenburg hoped that the types of focus groups would be brought to the work group before the final decision is made about what the groups are. Dr. Parkin said that they would.
• Dr. Davidson asked whether the rationale for selecting focus groups would be shared. Dr. Parkin replied that it would, without revealing results from previous parts of the survey.

Health Needs Assessment Work Group Report

Donna Mosby, Member
Oak Ridge Reservation Health Effects Subcommittee (ORRHES)

Ms. Mosby reported that the Health Needs Assessment Work Group had assisted in the planning for the needs assessment in the following ways:

• They estimated travel time and distance that people would be willing to travel for focus groups.
• They identified major events in the communities, which will be helpful in planning the focus group meetings.
• They are providing suggestions for appropriate meeting locations in the various communities.
• They are providing input regarding public notification for the focus groups.

Mr. Lewis added that the work group had been concerned about the possibility that the focus groups might be too large. Alternatives such as "availability sessions" or a town meeting will assure community input.

Presentation and Discussion: ORRHES Process and Administrative Issues

Dr. Jerry Pereira
CDC/ATSDR

Dr. Pereira described a recent meeting that he, Sandy Isaacs, and Bert Cooper conducted in Oak Ridge. He suggested that the Subcommittee wait to conduct their self-evaluation, as many of the issues that emerged from his meetings were being addressed currently.

The ORRHES is established to advise ATSDR, and possibly other federal agencies. For this function to be effective, the agency should not give a series of presentations to the Subcommittee. The Subcommittee needs good information, but it is also incumbent upon the agency to request input and assistance from the Subcommittee. The agency should take responsibility for achieving closure on these topics.

There should be thought given to collapsing work groups. Accurate work group minutes are important, but the work groups do not supplant the Subcommittee. Decisions have to be made in the Subcommittee.

Budget talks are beginning, and the funds available for Oak Ridge will not be certain until February or early March. Fiscal responsibility is required. Dr. Pereira said that he would assess the budget available and the needs of the Subcommittee and ask for more funds if they are needed. He will keep the Subcommittee informed.

When the Oak Ridge Field Office was established, the agency selected Bill Murray to be the Field Officer because of his experience and because of the technical issues of Oak Ridge. The agency, however, did not consider the need for administrative and logistical support in the office. Dr. Pereira hoped to establish an absolute process for, and system of, maintaining files and records. There is also the possibility of using a software package for this maintenance. There will be new staff in the Community Involvement Branch in Atlanta, and these staff members might be able to provide additional support.

He explained that Jack Hanley is the lead for this site. Sandy Isaacs and Dr. Pereira have overall management responsibility for the site. Dr. Paul Sharpe is the Senior Health Physicist in Atlanta. Ms. Dalton, as the Designated Federal Officer, advises the Subcommittee regarding the federal aspect of the law. She assists with other tasks, but her key role is this advisory one. Marilyn Palmer is the Committee Management Specialist. Coordination is critical between this Subcommittee and other agencies. Dr. Pereira recommended the following changes in the field office hours:

• Mondays: Noon - 8:30 pm
• Tuesdays, Wednesdays, and Thursday: 10:30 am - 7 pm
• Fridays: 7:00 am - 3:30 pm

The agency will strive to keep the office open in the event of Dr. Murray having to be away.

Subcommittee meetings usually occur every three months. This timing does not lend itself to process or to steady progress. The agency considered benefits and limitations to the current, two-day format for the meetings and has created new formats for consideration. The new options are:

• Option A: One, 4-hour meeting per month. This option would be very difficult to manage logistically. It is also not fiscally feasible.
  
  
• Option B: One, full-day meeting approximately every six weeks. This option this will increase efficiency and put pressure on the agency and the Subcommittee to be prepared.

Dr. Pereira supported Option B and assured the Subcommittee that they would not "stuff the agenda." For instance, if the full Subcommittee does not have a full day of agenda items, then the remaining time could be spent in work group meetings. Costs for each option were circulated. Option B was the most cost-effective. Other methods for conserving budget dollars includeusing a local recorder and meeting in a location that does not charge a fee, such as the YMCA.

He observed that Oak Ridge is the most committed community in which he has worked. Because of that commitment, he is focused on helping the Subcommittee get its work done and on facilitating the work group activities.

Discussion Summary:

• Ms. Dalton reminded the group that they are paid $250 per day, regardless of the length of the meeting. They cannot pay "half days" at present, but Committee Management is assessing the possibility of pro-rating the salaries. The language in the charter would have to be amended to pay half-days. At this point, however, Option A is not possible. If Option B is selected, and it is possible to hold work group meetings on the same day as full Subcommittee meetings, then the work groups would only have one additional meeting per month.
• Ms. Sonnenburg supported Option B, but pointed out that if the Subcommittee's agenda is full, then it will not be possible to hold a work group meeting that day. She did not want to meet for more than ten hours in a day. Dr. Pereira agreed, adding that work group meetings would only be included if the Subcommittee meeting agenda is not full.
• Ms. Sonnenburg asked about the procedure by which the Subcommittee could request, for instance, a person from an agency to speak at a Subcommittee. Dr. Pereira sais that the first question is whether the requested agenda item is germane to the work of the agency and the purpose of the Subcommittee. Dr. Davidson added that the work group chairs could communicate these questions to Ms. Sonnenburg as the chair of the Agenda Work Group. Ms. Sonnenburg wondered whether a Subcommittee vote was needed to set an agenda item. Dr. Davidson replied that a full Subcommittee vote was not necessary.
• Ms. Sonnenburg observed that outside consultants had accounted for over half of the past year's budget. She wondered whether the Subcommittee or Agenda Work Group could be consulted in the future before these consultants were brought on. Dr. Pereira answered that part of the large figure was due to Subcommittee start-up. He expected the figure to drop in the year 2002. Dr. Hanley added that much of the budget was devoted to preparing for the Health Needs Assessment. Dr. Pereira felt that the Subcommittee should approve future expenditures on lecturers or contractors.
• Dr. Jerry Kuhaida felt that having an administrative assistant in the field office would have a major impact on the work of the Subcommittee. The ability to keep track of Subcommittee and work group progress will help them be prepared for meetings every six weeks. He also offered to suggest meeting locations that were free of charge.
• Ms. Kaplan said that the Subcommittee had asked that budget information be made available on the website. Openness in government is crucial to public acceptance. She wondered about other ways to save money, such as not flying consultants in to meetings and having video- or tele-conferences. Dr. Pereira noted that teleconferencing is very expensive, but he appreciated Ms. Kaplan's point. He said he planned to take responsibility for how money was spent and he encouraged the group to focus on getting closure on items.
• Ms. Dalton was aware of previous requests for budget information. The agency has to get approval before releasing any of that information. She reiterated that the majority of funds were connected to the Subcommittee start-up. She noted that usually, speakers are invited to the Subcommittee based on requests from the work groups. These speakers are given an honorarium. If external speakers who require compensation are requested, then Dr. Pereira wants the request to be justified.
• Mr. Pardue was encouraged by the proposed changes. He suggested hiring part-time administrative support for the Oak Ridge Field Office. Dr. Pereira hoped to use his existing staff to create a process to manage the office. The possibility of having local, part-time help would be considered, along with the possibility of using Atlanta staff on occasion, when the budget information becomes final in February, 2002.
• Mr. Pardue asked about potential disagreements between agency branches, the Subcommittee, or development of the PHA. He wondered whether Mr. Hanley had the authority to resolve discrepancies and budgetary responsibility as a Project Manager. Dr. Pereira replied that Mr. Hanley has a responsibility to complete the Public Health Assessment. Decisions involving personnel, time, or money may require approval.
• Mr. Hill reflected on Option B, suggesting that the days be eight hours long, not ten. He also supported conducting meetings from 12:00 pm until 7:00 pm. A problem with conducting meetings at the YMCA is having adequate time for lunch, as restaurants are not accessible. Also, the meetings do not necessarily have to be in Oak Ridge. If they are held in other communities, then those communities' participation level might go up.
• Mr. Lewis complemented Dr. Pereira for capturing key issues that had been addressed at the meetings. He feels that the ability to generate detailed minutes from the work groups is critical, and that project planning will help them plan their budgets. He advocated for establishing a community health-related concerns database with sorting capabilities that would allow for links between concerns and findings. He pointed out the difficulty in addressing and closing issues if they have not identified the issues themselves. These issues are integral to having an infrastructure in place and to make their work effective not just for the Subcommittee, but also for the members of community. He suggested that the work groups comment on the proposed changes before they take effect. He also supported a periodic "lessons learned" meeting with the ATSDR management team.
• Dr. Pereira felt that a work group should help create the Standard Operating Procedure (SOP) for the field office. There is also the potential for using project management software. He again suggested that the Subcommittee wait to conduct its evaluation.
• Dr. Davidson asked the Subcommittee to make a recommendation to ATSDR for their meeting format.

Motion 2

Ms. Sonnenburg moved that the Subcommittee recommend adopting "Option B" to the agency; that is, meeting every six weeks, and that attempts be made to ensure that the meetings last no longer than eight hours. Mr. Hill seconded the motion, and the Subcommittee had the following discussion.

Discussion Summary:

• Mr. Hill suggested that the meetings should be held from 12:00 pm until 8:00 pm, or from 11:00 am until 7:00 pm. He also asked for discussion regarding rotating meeting locations.
  
  
• Mr. Lewis expressed concerned that rotating the meeting locations would conflict with the goal of saving money. The upcoming focus group meetings and other community meetings might capture the issues that would be addressed by rotating the meeting locations. Dr. Davidson said that the purpose of rotating meeting locations was so that community members could be introduced to the Subcommittee process and so that the Subcommittee could see the members of other communities.
  
  
• Dr. Craig suggested that the motion not demand that meeting locations rotate, but indicate that rotation is a priority.
  
  
• Mr. David Johnson felt that potential locations should be considered in the nine counties that make up the area of concern. Dr. Pereira said that rotating meeting locations shows good faith on the part of the Subcommittee and the agency.
  
  
• Ms. Sonnenburg wondered if the motion could incorporate wording to indicate that meetings would move locations occasionally.
  
  
• Mr. Lewis approved of Option B as an interim measure, but felt that Option A should also be considered as a possibility for the future, perhaps in a work group.
  
  
• Dr. Davidson was not in favor of Option A because of logistical and administrative problems such as filing in the federal register.
  
  
• Ms. Kaplan said that a work group should examine the options, but that the Subcommittee should adopt Option B now, knowing that it could change in the future.

Motion 2 - Amended

This motion was amended as follows: The Subcommittee recommends adopting "Option B" to the agency; that is, meeting every six weeks. The meetings will last from approximately 12 noon until 8 pm, and ATSDR will consider rotating the meeting locations at its discretion. Dr. Davidson called for the vote. The amended motion passed by a vote of 13 in favor and 1 opposed.

Discussion of ORRHES Evaluation

Ms. Jan Connery
Eastern Research Group (ERG)

Ms. Connery addressed the group via telephone, explaining that the self-evaluation would focus on the Subcommittee's function and involve Subcommittee members and liaisons. Ms. Connery offered the following reasons to conduct this evaluation:

• The proposed evaluation complements ongoing efforts and contrasts ongoing feedback mechanisms. Often, mechanisms for offering feedback or making changes or improvements rely on spontaneous communication. While this communication among Subcommittee members is important, it may only occur in one work group. Not all members, therefore, have the opportunity to contribute. It is impossible to involve all members in meetings, and comments offered are not anonymous, so some members may not feel comfortable sharing their thoughts. This evaluation would dovetail into the extant mechanisms for gathering feedback. With this system, all Subcommittee members will lend their anonymous input. They will have time to reflect on issues, rather than having to offer their initial thoughts in a meeting.
• Timing is good. The Subcommittee has been in existence for one year and has been able to experience the four stages of becoming a functioning unit:
  
  
  • Forming: The initial coming-together
  • Storming: The difficult stage of getting adjusted and developing ground rules
  • Norming: "Getting in the groove" to function effectively
  • Performing: When the group is able to produce

    She suggested that the Subcommittee is in the "performing" stage, which lends an opportunity to reflect on the first three stages and to think about how the Subcommittee's function can be improved. As it is still a young group, the Subcommittee is still flexible.

• It is recommended by COSMOS report. The COSMOS report represents a "mega-evaluation" commissioned by CDC. It involved four other subcommittees, and amongst its conclusions was the suggestion that "periodic evaluation of the advisory process should identify areas of concern early (before they impede the advisory process), and, as a result, improve the cost-effectiveness of the advisory process (currently a major concern to agencies)."

There are several goals for the evaluation:

• Obtain constructive feedback
• Generate ideas for improving Subcommittee function
• Give all members a chance to participate
• Provide a baseline

Since the evaluation will include all members' input, the final report will discover themes and similarities in what members feel should be improved and in what works well. If evaluations are done in the future, then this initial report will provide a baseline by which progress and improvement can be measured. The self-evaluation will be open-ended. It will be comprehensive because the questions will prompt feedback in a variety of areas.

The process for the evaluation begins with a collection of proposed areas that it should cover. All Subcommittee members will have a chance to contribute to the evaluation's substance. Then, ERG creates the format for the evaluation. Subcommittee members complete the evaluation, and ERG creates a summary report from all of the comments, which will be provided at the next Subcommittee meeting. There are three ways to participate in the evaluation so that it will be convenient. Subcommittee members can respond by e-mail, fax, or via telephone with an ERG staff member.

The anonymity of the evaluation is very important, so responses can be sent via postal mail. Further, anonymity will be assured when ERG blacks out identifying information on the responses. The report will not include names or even genders. Copies of individual evaluations will not be available.

Areas that have already been suggested for inclusion in the evaluation include:

• Subcommittee meeting format and procedures
• Effectiveness of the chair
• Effectiveness of work groups
• Interaction of Subcommittee with ATSDR, liaison members, and members of the public
• The Subcommittee's access to consultants

Next steps for the Subcommittee are to:

• Decide whether the Subcommittee will conduct the evaluation;
• Provide input on evaluation topics; and
• Participate in the evaluation.

As Subcommittee participation is so important, Ms. Connery suggested that voting in favor of doing the evaluation implies a commitment to participate, and she suggested a time-line and provided her contact information.

Discussion Summary:

• Mr. Peter Malmquist observed that the Subcommittee had already conducted a self-evaluation in the meetings with Dr. Pereira and other ATSDR staff. He felt that hiring ERG at this time would be a waste of money. Mr. Lewis agreed that Dr. Pereira had already addressed the Subcommittee's issues that had emerged after the series of meeting. He suggested that the Subcommittee take time to see how the changes work before conducting a self-evaluation.
• Dr. Davidson noted that the work is only proposed at this point, noting that the proposed self-evaluation would have more detail than the meetings with Dr. Pereira. The format also lends itself to getting more feedback from more members of the Subcommittee, as not all members participated in the meetings. This evaluation would yield a written report that could be used as a baseline.
• Ms. Kaplan complemented the use of the telephone for Ms. Connery's presentation. She also proposed compiling the information from the meetings with ATSDR staff into a report.
• Ms. Connery was not familiar with how the information was captured, but if the notes were written or on tape, she said she could prepare a summary report from them. She asked whether the evaluation with ATSDR was comprehensive.
• Dr. Davidson observed that the meetings were focused on concerns rather than on both positive and negative aspects of Subcommittee function. She hoped that Subcommittee members would evaluate their individual participation.
• Mr. Lewis commented that when the Subcommittee has direct access to consultants, work goes more smoothly. He also felt that work group function should be examined.
• Dr. Davidson noted that in the meetings with ATSDR staff, she did not receive feedback on her effectiveness as the chair. Mr. Lewis added that the chairs of the work groups would benefit from feedback as well. They should consider how to get better participation from all Subcommittee members in work groups.
• Ms. Dalton said that discussions with ATSDR were helpful, but an evaluation from ERG gives the opportunity to capture everyone's comments and concerns.
• Dr. Kuhaida said that going through another evaluation process would be duplicative. He did not participate in the meetings with ATSDR staff members, but the issues and proposed changes represent a major step for the Subcommittee.
• Dr. Davidson observed that the Subcommittee did not appear to want to pursue the self-evaluation at this time.
• Ms. Connery reflected on the possibility of creating a report from the ATSDR staff meetings. She suggested that such a report could be created and then circulated to members of the Subcommittee for additional comments. With this approach, Subcommittee members who were not at the meeting could provide input. ERG could consolidate those comments into an addendum to the report. This idea relied on clear records from the meetings and on whether Dr. Pereira is willing to share his notes. Mr. Lewis suggested interviewing the ATSDR staff who participated in the meetings to supplement the notes.
• Mr. Washington felt that having an unbiased person create the evaluation was preferable. He had not known of the ATSDR staff meetings, so his input would not be reflected in the notes from the meetings. He supported adding a sick worker who is receiving Social Security to the Subcommittee. He had participated on FACA committees that included members who were receiving Social Security benefits. Dr. Davidson said that the ATSDR staff visits were announced via e-mail and postal mail. She was sorry that the information had not reached Mr. Washington.
• Mr. Washington said that e-mail is not a good medium for communication. He noted that members of the public may feel that the Subcommittee is working in areas that are not in the interest of the Oak Ridge communities. Dr. Davidson said that this project is a self-evaluation, so it is conducted only by Subcommittee members.

Motion 3

Mr. Malmquist moved that the Subcommittee not enter into a self-evaluation at this time. The motion received a second.

Motion 3 - Amendment

Ms. Mosby amended the motion, adding that a summary of comments from the ATSDR staff meetings be created, that the Subcommittee assess the effectiveness of the new changes in format and procedure, and that the Subcommittee then evaluate its work in mid-year, 2002. The amendment received a second. The amendment passed with a vote of 12 in favor to 2 opposed.

Motion 3 - Amended

The Subcommittee would not enter into a self-evaluation at this time. Instead, a summary of comments from the ATSDR staff meetings will be created. The Subcommittee will assess the effectiveness of the new changes in format and procedure and evaluate its work in mid-year, 2002. The motion was approved with 11 in favor, 2 opposed, and 1 abstention.

Ms. Dalton reminded the group that work group chairs would be available during the lunch hour to discuss ongoing activities and to provide updates.

Dr. Davidson reminded the group to re-commit to the work groups. Mr. Hill said that work groups require a quorum, so he hoped that people who signed up would attend meetings. Mr. Lewis added that work group members should take on responsibilities. Mr. Washington noted that any member of the public can become a member of a work group.

Work Group Reports

Chair's Presentation

Dr. Kowetha Davidson, Chair
Oak Ridge Reservation Health Effects Subcommittee (ORRHES)

Dr. Davidson began the Work Group Reports with a presentation from the Guidelines and Procedures Work Group. The Subcommittee did not vote until the next day. The Guidelines and Procedures Work Group had set to the task of amending the Subcommittee bylaws. This review was scheduled for the September meeting, but was postponed. The first proposed change was in Article 9, Section 4, which currently reads:

"The Work Groups shall include the Guidelines and Procedures Work Group, the Agenda Work Group, and the Communications and Outreach Work Group."

The proposed change:

"The Work Groups shall include the Guidelines and Procedures Work Group, the Agenda Work Group, the Communications and Outreach Work Group, the Health Needs Assessment Work Group, and the Public Health Assessment Work Group."

The rationale for this change is that these two additional work groups will be active for some time.

The second proposed change was to this extant statement:

"A quorum at work group meetings shall consist of a simple majority of Subcommittee members who are members of the work group."

The proposed change:

"A quorum at work group meetings shall consist of two Subcommittee present in person at the meeting."

The rationale for this change comes from the difficulty that some work groups have experienced in reaching a quorum. This amendment will allow the business of the work group to continue even if the majority of Subcommittee members are present. This proposed change is not designed to circumvent establishing work group meetings at a time which a majority of members can attend. Meetings are best scheduled after 4:00 pm.

The last proposed change was an addition to Article 9, Section 14 and addressed Subcommittee members who sign up for work groups but who do not attend work group meetings:

"Subcommittee members who are absent in person or by conference phone from three consecutive work group meetings and who do not provide advance notification of their absence to the work group chair shall have their name removed from the roster of the work group. The member may be reinstated after providing notification to the work group chair prior to the next work group meeting of their intention to join the work group."

Subcommittee members should recommit to the work groups so that there is no question as to the work group's membership. Communication with the chair is key.

Discussion Summary:

• Mr. Lewis wondered about the possibility of combining some of the work groups. Dr. Davidson said that if the Subcommittee elects to combine work groups, then the bylaws can be amended as needed.
• Mr. Washington felt that the third change made work group functions excessively difficult. Each work group should determine its procedures within the purview of the FACA charter. He felt that the simpler the procedures, the more work that can get done.
• Dr. Davidson commented that work groups do not function under FACA, but operate according to guidelines established by the Subcommittee. Few bylaws pertain to work groups, and the proposed changes offer some structure for them.
• Mr. Washington felt that if structure is left to the discretion of the work group, then more work will be accomplished. For instance, other FACA groups' work groups keep detailed minutes.
• Ms. Kaplan said that the third change might be irrelevant if the changes in how quorum is achieved are adopted.
• Dr. Pereira said that the issue is not how many Subcommittee members attend each work group meeting, since Subcommittee members who are not officially members of work groups are still welcome to attend work group meetings as citizens. The issue is defining the original members of the work groups.
• Dr. Davidson felt that if a Subcommittee member commits to a work group, he or she should take responsibility for participating in the work group meetings or at least inform the chair if he or she is unable to attend a meeting.
• Mr. Lewis likes work groups because they help clarify issues to bring to the Subcommittee for resolution. He feels that work groups need Standard Operating Procedures (SOPs). Their function will then be more efficient. Dr. Davidson said that work groups can establish their own SOPs, as the Subcommittee bylaws are general in their guidance.
• Mr. Pardue described the process used by the end-use working group. Any member of the public can participate in meetings, voting and contributing their expertise. The work group deliberated on issues. He favored as informal a structure as possible, but recognized that there has to be some structure. The current process works well.
• Dr. Davidson emphasized that these bylaws only apply to Subcommittee members, not to members of the public.
• Ms. Mosby commented that work group business cannot be conducted if members are not present. The suggested changes support getting work done in the work groups.

Agenda Work Group Report

Ms. Barbara Sonnenburg, Member
Oak Ridge Reservation Health Effects Subcommittee (ORRHES)

Ms. Sonnenburg presented a report from the Agenda Work Group, explaining that she is newly appointed to her position as chair. The group met twice before the current meeting and made few changes, as many of the agenda items were carried over from the abbreviated September 11^th meeting. She asked Subcommittee member to approach her with ideas for the agenda, whether specific items or general areas that need to be addressed.

Communications and Outreach Work Group

Mr. James F. Lewis, Member
Oak Ridge Reservation Health Effects Subcommittee (ORRHES)

Mr. Lewis reported that his co-chair in the work group had resigned. The work group met on November 8^th and focused its discussion in three areas:

• The status of website
• The fact sheet
• Concern forms

The work group created a recommendation for adopting a website layout and linkages. The fact sheet is intended to describe the essence ORRHES. It includes information about the Needs Assessment, the Public Health Assessment, and how the work groups work together to get information to the public. Members of the work group identified a sample form that could be made available to the public to capture concerns. Approval for these forms is necessary, and work is being done to obtain this approval.

A non-Subcommittee member recommended developing a database to capture concerns that have been raised both by historical work and by ongoing work. It is critical to capture these issues, consolidate them, and provide linkages to resolutions or findings related to them.

Ms. Dalton previously circulated drafts of a fact sheet and a community health concerns sheet. Since then, the Communications and Outreach work group developed its own sheet, so they were combined. The concern sheet may not include questions, because it could then be construed as a survey. A draft of the combined sheet would be available soon, including language suggested by the work group.

Mr. Lewis commented that the process of creating the website had been frustrating. He hoped that a formal communication strategy could be developed for the work group and for the Subcommittee as a whole. There is an existing website that is not an official ATSDR, ORRHES website. It is important, therefore, to get their site "up and running."

Discussion Summary:

• Dr. Davidson clarified that ORRHES does not have a website, official or unofficial.
• Ms. Dalton indicated that they are awaiting approval from the Subcommittee on the proposed templates for the website. Everyone has had the opportunity to evaluate the draft templates. The Communications and Outreach work group recommendations on site maps and templates were indicated in the pre-meeting materials. Once the templates are approved, the contractor has to apply the links, then pilot-testing can begin. She estimated this time at two weeks.
• Dr. Davidson reminded them that the work group had recommended that the Tennessee Department of Health (TDH) and Environmental Protection Agency (EPA) links be included. Ms. Dalton said that links can be added later, but the larger headings cannot be changed.
• Ms. Kaplan asked whether budget information could be included. Ms. Dalton replied that information that has been presented as public information could be included.
• At Mr. Lewis's request, Ms. Dalton described the process by which the site would be controlled and maintained. Once it is finalized by the contractor, it still has to be approved by the internal ATSDR website committee. It can then be included on the ATSDR home-page.
• Dr. Davidson wondered if the Communications and Outreach Work Group would consider places in outlying areas where the Subcommittee could put its information.
• Mr. Lewis suggested that HRSA might be a "related link." Dr. Davidson added that NIH could be included because of their work with iodine.

Public Health Assessment (PHA) Work Group Report

Mr. Bill Pardue, Member
Oak Ridge Reservation Health Effects Subcommittee (ORRHES)

Mr. Pardue referred to a memo which summarizes the work group's recent activities. They meet twice a month and the meetings are well-attended. Meeting summaries are available, as Ms. Galloway has served as their recorder. Having a defensible, factual, permanent record will be important as the group will work for some time and have personnel changes.

Their work began by examining the PHA process. They also considered the technical issues associated with the Iodine-131 reconstruction part of the PHA. After an epidemiological workshop, the work group engaged in a "dry run" evaluation of an epidemiological report by Dr. Joseph Mangano. Dr. Mangano's report concludes that increases in cancer rates in Oak Ridge are attributable to radiation releases from the Oak Ridge Reservation. Dr. Lucy Peipins led the work group through an evaluation of that report, which led to the work group's assessment that the information in the report does not support the conclusions reached.

The PHA group also developed a case history file, which is a systematic capturing of concerns that the public brings to the Subcommittee. Mr. Lewis added that this approach provides summaries of their efforts, including reports. When conclusions are reached, it will be possible to retrace the logic and process that led to them.

Mr. Pardue listed the PHA's recommendations:

• The Mangano paper should not be considered in the development of the Public Health Assessment.
• EPA is undertaking a soil sampling program in Scarboro. The Subcommittee was under the impression that a wider program would cover a larger community area, which most citizens seem to support. The status of this larger program is still uncertain. Therefore, the PHA work group has drafted a letter to Dr. Koplan, Director of CDC/ATSDR, which includes recommendations as to how that program should be designed and conducted.
• The PHA work group supports the need for administrative help in the Oak Ridge Field Office, particularly in maintaining files and records.

Discussion Summary:

• Mr. Washington commented on the range of uncertainty in the data used in the Mangano report due to the time that numbers of deaths in Oak Ridge began to be counted. There are also uncertainties in exposure numbers. He asked about how decreases in cancer deaths in Oak Ridge compare to the general population of the United States. Mr. Pardue replied that he did not have the exact numbers. Dr. Davidson added that in the evaluation, they did not use numbers or information that was not included in the report.
• Mr. Pardue explained that the work group considered the reasonableness of the interpretations made in the report. Deficiencies in the report were included in a matrix. Some members of the work group had consulted the National Cancer Institute (NCI) website to gather other data regarding cancer deaths. Mr. Washington noted that data regarding cancer deaths in the Oak Ridge vicinity have just recently been kept. Mr. Pardue said that the work group pointed out that data were uncertain in the 1950's.
• Ms. Kaplan commented on the work group's struggle with finding a person to keep their minutes. She expressed her appreciation for Ms. Galloway's work.
• Mr. Washington wondered about the appropriate level of detail for work group meeting minutes. Dr. Davidson replied that work groups decide the level of their minutes. Mr. Pardue said that the PHA work group had opted for detailed minutes because of the complexity of the technical issues that they address.
• Dr. Akin asked that he be copied on the memo to Dr. Koplan. Dr. Davidson apologized for the oversight.
• Mr. Lewis expressed hope that by documenting technical issues in detailed minutes, issues can be captured in a database and eventually resolved.

Ad Hoc Mission Statement Work Group Report:

Ms. Karen Galloway, Member
Oak Ridge Reservation Health Effects Subcommittee (ORRHES)

In the July meeting, it was decided that the Subcommittee needed a mission statement, said Ms. Galloway. An ad hoc committee comprised of Subcommittee members and members of the public held three meetings to answer this need. Using a model from another group, they developed a draft of a vision statement, a mission statement, goals, and objectives.

The work group has offered a vision, mission, and goals. The vision statement is the absolute or ideal perception for the group. The mission statement addresses the scope and purpose of the Subcommittee's work. Goals are broad statements of how the Subcommittee will achieve its mission, and the objectives identify measurable ways in which the goals are achieved. The objectives will require more refinement to make them measurable.

The draft mission statement is:

"To provide ATSDR and CDC with advice regarding public health studies and activities relating to people who may have been exposed to radioactive and chemical emissions from the ORR."

The draft vision statement is:

"To promote the health and well-being of all residents in the communities surrounding the ORR."

The draft goals are to:

"Conduct an unbiased and objective review of the previous studies;

"Evaluate information on the release of hazardous substances into the environment from the ORR;

"Assess current or future impacts on public health;

"Identify, review, and advise on follow-up studies and actions needed;

"Review the Public Health Assessment document; and

"Assure that information is made available to the healthcare providers as well as the public to allow them to make informed decisions about health issues that may be related to their off-site exposures from the ORR."

Discussion Summary:

• Dr. Davidson felt that the statements should be kept general. She commended the Ad Hoc Work Group for their efforts.
• Mr. Pardue suggested eliminating "well-being" from the vision statement, as "well-being" includes issues such as finances that are outside the scope of the Subcommittee. He also suggested adding "affected by ORR activities," as the Subcommittee focuses on residents of the community that have been affected by releases.
• Mr. Lewis commented that the goals and objectives have to be linked.
• Dr. Craig did not feel that one of the Subcommittee's goals was to conduct the review of previous studies or to assess the PHA. The Subcommittee is assisting ATSDR in these efforts. He also offered that part of the Subcommittee's mission is to identify health issues and to assess health needs in the community affected by releases.
• Ms. Mosby observed that in the self-evaluation in mid-year 2002, it might be possible to measure progress on some of the goals. Either the Communications and Outreach Work Group or an ad hoc work group could meet to formulate some measurable objectives. Dr. Davidson added that other work groups might want to formulate objectives as well, such as the PHA Work Group.
• Mr. Washington said that the affected communities should be named and it should be specified whether they were addressing 5, 7, or 9 counties. Dr. Davidson noted that the Subcommittee had voted on a map of the potentially affected area. There are portions of eight counties included on the map on which they are basing their work. Mr. Washington added that the counties should be identified in the statements.
• Ms. Sonnenburg was hesitant about adopting the goals, but was prepared to adopt the vision and mission statements. She suggested that the committee review the goals further, offering the following potential goal: "to conduct a review of the delivery of medical services and any real or perceived obstacles to this delivery."
• Dr. Davidson said that some goals could be adopted while others could be sent back to the work group for further refinement. Additional goals could also be added at a later time.
• Dr. Akin commented on the last goal, which he read as a "watchdog" function. He felt that if they plan to provide information to the public, then they should also take steps to ensure that the maximum amount of information is made available to the public and to practitioners.
• The group offered ideas for wording. Mr. Lewis advised them to be careful with the words that they choose, considering what information is reasonable and adequate.
• Dr. Akin reworded the goal to read as follows: "to assure that comprehensive (or another modifier) information is made available to the healthcare providers and the public to the end that information decisions may be made about health issues that may relate to off-site exposures to the ORR." He was not sure about separating the public and healthcare providers, Dr. Davidson noted that this goal relates to the Health Education Needs Assessment output.
• Ms. McNally felt that the last goal was one of the most important. She suggested that educating healthcare providers be listed as a separate goal from educating the public, as they are two different issues. If the healthcare providers are educated and informed, then the public will be able to rely on them to be knowledgeable about their problems so that their concerns will be heard. Ms. Kaplan related a recent experience with her doctor in which she mentioned her exposures to see how he reacted. He ignored her concern and did not try to educate her.
• Mr. Lewis wondered about the definition of the "public" and whether it referred to the general public or to individuals. Dr. Akin reflected on the line between the general public and individuals. The extent to which individuality can be addressed by a public, government-funded activity is an age-old question that is central to public health and medical practice.
• Dr. Davidson understood that the amount information needed would be included in the Health Needs Assessment process, which would result in recommendations regarding what education is needed, where it is needed, and where it should be targeted.
• Mr. Lewis recalled a community member's suggestion that the Subcommittee present information in a manner similar to the way that the Surgeon General presents information.
• Dr. Creasia noted that the idea of "sufficient data" is difficult to use, as data changes and grows over time. Also, better information about chemicals of concern will likely emerge in the future.

Update on the Scarboro Soil Sampling Project

Cheryl Smith
Environmental Protection Agency (EPA)

Ms. Smith told the group that EPA is starting to get raw data packages from the Scarboro sampling effort that occurred on September 24^th. It is the intent of the agency to present this information in January, 2002. This presentation will not be a final report, but an update to the Subcommittee and perhaps to the public in general. The timing and format of this update has not been decided. There will then be an opportunity to compare these initial findings to the May 1998 sampling performed by the Department of Energy (DOE).

Discussion Summary:

• Mr. LC Manley asked whether EPA had enough preliminary data to tell whether there is any difference between the samples. Ms. Smith replied that the evaluation had not yet been made.
• Mr. Lewis expressed hope that, if there is a major discrepancy between the efforts, DOE and EPA would be available to discuss it at the same time to achieve closure. Ms. Smith said she did not have the authority to make such a commitment, but she felt that the idea was sound. EPA's sampling effort was independent, so comparisons will come from EPA's technical expertise. DOE will receive EPA's results. She emphasized that EPA's work was in response to requests from the public and was not designed to show that "anything was wrong" with the DOE work.
• Dr. Akin volunteered to take the suggestion to the people who would be responsible for this coordination. He agreed that if there are discrepancies, a coordinated response from the agencies will be less confusing to the community. As the EPA work was not an attempt to verify the DOE work, it was done at similar, but not identical locations. The samples could be different and both be right. The agencies could then present reasons for discrepancies.
• Mr. Manley asked how differences could be explained, since differences will be perceived as one agency being "right" and the other being "wrong." Dr. Akin replied that they would assess the known variables that might lead to different answers. For example, the sampling could have been done at different depths. There may be samples that cannot be explained, but the agencies will offer their best scientific guesses.
• Mr. Pardue commented that DOE had been offered the opportunity to participate in the EPA soil samplings. Ms. Smith responded that DOE had accepted the opportunity, sending an off-site DOE representative to conduct split samplings.
• Dr. Davidson said that the Subcommittee members would be interested in attending the January public update. She asked when the final report would be completed. Ms. Smith anticipated completion by May, including input from the public, stakeholders, and DOE.
• Mr. Lewis noted that no transcript of minutes from the Scarboro effort was provided. He suggested that the next meeting be recorded.

Public Comment

Ms. Linda Gass
Member of the Public

Ms. Gass addressed the group, pointing out that the Subcommittee still needs to have a member with a history of interacting with sick workers. These stakeholders have not been represented. The Subcommittee also needs a member with a history of interacting with sick residents. An explanation for not having these representatives, that the White House liaison will not allow it, does not make sense. She commented on having a waiver so that a disabled person can serve on the Subcommittee. She introduced an example of a prior FACA committee which interacted with Social Security to get a waiver. She felt that this step would be reasonable on the path to creating fair and balanced representation on the Subcommittee.

She later showed the group the Phase One Report, Volume Two, Part A of the Dose Reconstruction Feasibility Study: Tasks One and Two, Summary of Historical Activities, Emphasis on Information Concerning Offsite Emission of Hazardous Material. The report was prepared by ChemRisk. She thanked Mr. Hanley for helping her to obtain the report after much effort. She has been through several requests for information. Some people in the public do not want much information, but Ms. Gass is a member of the public who appreciates background information and who checks references.

She said that it is extremely important to realize the "company town" effect in Oak Ridge given that, in Oak Ridge, there is not only the "company town" effect contributing to the suppression of information, but there is also the effect of DOE's role as a long-term, major player in the economy of the entire state of Tennessee. She posed the question, "How do you get to the truth, when the employees being interviewed have strong disincentives to reveal information about releases that could affect their careers as well as their bosses' careers and the state of the contractor?" Employees could even be considered to be unpatriotic if they talk about these facilities.

The state of Tennessee commissioned the Dose Reconstruction Study, and the Oak Ridge Health Agreement Steering Panel (ORHASP) worked for nine years. Ms. Gass told the PHA work group that she wanted to check these references before there was more discussion on the Iodine-131 Dose Reconstruction. She was asked to put this suggestion in writing and to make it a motion. The next meeting was in violation of the spirit of FACA. She was not asking for a "stop work" order; she only wanted access to the interviews to check the references. It was decided that she had the right to check the references, and she thanked Dr. Albert Brooks for supporting her in her efforts. The integrity of the Dose Reconstruction rests on these interviews with company employees.

Iodine-131 discussions have run their course, and Ms. Gass was concerned about setting a precedent for efforts regarding other contaminants of concern. She was told that the state of Tennessee contracted with ChemRisk to conduct these interviews. Subsequently, primary sources were destroyed. She has continued to ask for the interviews. If they are not headed toward a "whitewashed report," she said it was unclear to her why she could not get those interviews. She then read from the Phase One Report, Volume Two, Part A, page 59: Personnel Interviews, "Interviews have conducted as of September of 1993 with approximately 50 individuals with extensive experience at the Oak Ridge reservation." Ms. Gass noted that eventually, over 150 people were actually interviewed. "The names of initial interviewees were provided by facility managers for key functional areas identified by ChemRisk." Ms. Gass commented that if facility managers provided the interviewees, then there are questions about whether the interviewees had strong disincentives for information on releases to emerge.

"Each interviewee identified additional points of contact. Candidates for interviews were also identified from association with key historical documents. Some have not yet been located, and not all desired interviews have been completed at this time." Ms. Gass added that more interviews were done. "While several individuals thought it necessary to obtain approval from Martin/Marietta and DOE, or from their current employer prior to consenting to an interview, only one individual has declined to be interviewed. Notes taken in the course of the interviews were reviewed by appropriate classification reviewers. The information obtained in the interviews is being summarized and entered into the project repository and the associated database." She has tried to get those interviews, and has been told different things in trying to gain access to the project repository mentioned about.

Upon thanking the people who had helped her so far, she listed some of the places where she had been told to go for the interviews, including OSTI. The documents are public and owned by the state of Tennessee. History Associates, Inc. (HAI) was a DOE contractor that did work on missing mercury information. She has been able to get some response from them, and she implored the Subcommittee to help her get the interviews.

Discussion Summary:

• Ms. Dalton pointed out that as the CDC hiring freeze has been lifted, the procedure is underway to advertise for and select new members for the Subcommittee. She then addressed the topic of a waiver. Anytime a worker proposes to participate in the Subcommittee, the agency recommends that the individual seek legal counsel and make a decision based on his or her situation. It would not be ethical or legally practical to predict what benefits or compensation to which a person may or may not be entitled in the future. Issues with Social Security, for instance, should be addressed individually. In the past, such an individual was approved for the Subcommittee, but declined the position.
• Dr. Davidson emphasized that individual members of the Subcommittee should encourage people to apply for membership on the Subcommittee. Members of the public are also encouraged to apply.
• Ms. Dalton described ATSDR efforts to locate the documents in question. A letter to Patrick Lipford at the Tennessee Department of Health formalized these requests. The Communications Work Group forwarded a recommendation to ATSDR in September.
• Ms. Gass noted that part of the documents have been in Nashville and parts have been at OSTI. She recognized state budgetary problems that could be a contributing factor, but she reiterated that she had never gotten any interviews.
• Dr. Timothy Joseph offered insight into potential problems with the ChemRisk records. When the interviews started, each individual being interviewed had the right to say anything, classified or not. If the interviews contained classified information, or if the interviewee did not want his or her name associated with what was said, then there could be complications in getting the interviews.
• Dr. Albert Brooks noted that this situation was the first time that he had not been permitted access to information based on a reasonable request. Some of the operational staff of the project were interviewed and asked to give their impression as to the efficiency of the scrubber. Sometime later, they were interviewed again, and they reduced their numbers. Without knowing why these interviewees changed their numbers, it is impossible to give an opinion regarding the validity of the conclusions that were drawn. The interviews are still important, but even more important is the perception that this information is being suppressed. If the information is classified, then that should be made known and the non-classified information should be released.
• Dr. Davidson presented an action item for ATSDR, asking that they continue to make a concerted effort to obtain the references that Ms. Gass has requested.
• Ms. Gass said that the list on the table was not complete, as she had been told that she had to request all items separately. She said that she wanted all of the interviews: the list on the table is an example. She was recently told by the state of Tennessee that not all materials were kept. In addition, the ORHASP meeting minutes indicate that classification issues have already been resolved.
• Ms. Kaplan served as chair of the liaison subcommittee of the Local Oversight Committee in 1995. She took on the task of interacting with retirees and requested those interviews from Tom Widner, from ChemRisk. He had the information, and she offered to locate it in her records.
• Ms. Sonnenburg wondered about an appropriate contact at the state level to get the issue resolved. Ms. Dalton replied that Patrick Lipford was the contact with the state, and a letter to him was included with the pre-meeting packet.
• Mr. Lewis recalled his work in checking and validating records. Sometimes, there are record retention clauses in the body of contracts. If the right clause is not in the contract, then even professionals may discard even primary sources. It might be possible to assess what was in those contracts.
• Dr. Creasia pointed out that often, materials get thrown away for other reasons, such as moving or retiring. He asked Dr. Brooks to provide more detail on the scrubbers who changed their numbers.
• Dr. Brooks replied that the same people were interviewed twice. Apparently, they were presented with other opinions or calculations that caused them to change their minds. It is important to learn what they were told and why they changed their minds. On the topic of data availability, he felt that there can be no report without backup data.

Motion 4

Mr. Pardue moved that the Subcommittee recommend that ATSDR continue to pursue this information in all possible manners. The motion received a second, and discussion continued.

• Ms. Dalton noted that a recommendation from the July 31^st Subcommittee meeting resulted in the responses that she had described.
• Mr. Lewis commented that a properly-worded letter that goes through the appropriate system channels can force actions. The letter should ask a specific question and expect a detailed response.
• Ms. Dalton reviewed the July 31^st recommendation, which asked ATSDR to pursue Iodine-131 references from the Tennessee Department of Health. The ATSDR responded at the September meeting, and Ms. Dalton and Mr. Lipford had been in communication since August.
• Ms. Kaplan pointed out that the list of requested references came under pressure. Those references should be in an archive.
• Dr. Brooks asked about the state's response. Ms. Dalton replied that the state is working with ChemRisk to locate several of the documents. ATSDR has been searching for some of the documents on the list as well. Due to matters at another site, the principals at ChemRisk have not been able to locate this information yet.
• Dr. Bill Murray said that he has contacted Mr. David Hamrin at the Oak Ridge National Central Laboratory files. Mr. Hamrin has records of what references are available at the DOE Reading Room and at the IRC. Dr. Murray has nine memoranda resulting from this search, which he will copy and provide to Ms. Gass. He has been told that the other references are in the DOE Reading Room.
• Dr. Akin understood that the original request was not a comprehensive list of documents. He suggested that the request should be made again, including a complete list of documents. The importance of acquiring these documents should be re-emphasized.
• Ms. Dalton reiterated that ATSDR had been working to obtain the documents, but that ATSDR policy is to make documents that they have generated in the past available. Requests for documents from other agencies are referred to that generating agency. They will do everything they can to request documents.
• Dr. Akin wondered if the request could come from the Subcommittee, not from ATSDR.
• Mr. Lewis suggested that they invite Mr. Patrick Lipford to address the Subcommittee on the issue.

Motion 4 - Amended

Dr. Davidson proposed a re-wording of the motion: ATSDR, at the recommendation of the Subcommittee, should pursue to the extent possible the whole list of references for the interviews from the Dose Reconstruction Study. Those interviews should be placed in the Oak Ridge Field Office. After the following discussion, the motion and amendment were withdrawn and replaced.

• Ms. Mosby commented that if they cannot get a few of the references, it was unlikely that they would be able to get them all.
• Dr. Akin felt that this issue was critical to the credibility of the Subcommittee and was unclear about why the information could not be requested from the Tennessee Department of Health. If the request could not or should not be made by ATSDR, or put the agency in an awkward position, then the Subcommittee should devise another way to make it.
• Dr. Davidson said that the Subcommittee cannot make direct requests to the Tennessee Department of Health, but it can make requests through ATSDR staff or through Dr. Koplan.
• Ms. Dalton noted that ATSDR had acted on the recommendation from July 31^st as it was written. The new recommendation represents an expansion on the old one, and the request would be forwarded.
• Dr. Davidson commented that another way to pursue the documents is to direct the request to the heads of the agencies involved: Dr. Koplan and the head of the Tennessee Department of Health.
• Ms. Mosby said that more than one avenue should be pursued to get the documents. They could work as individuals, as members of the Subcommittee, or other ways.
• Dr. Pereira advised that the list of documents requested and the reason for requesting them be forwarded to the director of DHAC for Dr. Falk's signature. From Dr. Falk, the letter would then go to the director of the Tennessee Department of Health. Justifying why the documents are needed is key to get the proper signature.
• Dr. Pereira also reflected on the mentality of a "company town," in which the tendency for workers to want to protect their jobs is a reality. He urged the Subcommittee and the public to judge the credibility of the information in the interviews based on what they know about the community.
• Mr. Pardue asked whether FACA prevents the Subcommittee from making a request from another agency. Dr. Pereira did not see a problem with the Subcommittee writing a letter, but added the risk that the Tennessee Department of Health might not recognize what ORRHES is, and therefore not respond to the letter.
• Ms. Sonnenburg suggested that Dr. Al Brooks write the letter and copy it to the Tennessee Governor's Assistant.
• Mr. Pardue retracted his motion and its amendment.
• Ms. Kaplan said that the request for the interviews is not just for the data or to assess the credibility of the report. The request is also a process issue, as taxpayers spent a great deal of money on the ORHASP committee. If that committee could not maintain the integrity of their references, then how could other committees expect to.

Motion 5

Ms. Mosby moved that the Subcommittee recommend that ATSDR continue to pursue the request for all interviews. A letter should be written to the heads of the agencies in question. The ORRHES should also issue a letter requesting all interviews. The letters should include rationales for why the information is requested. The following discussion ensued.

• Dr. Davidson was concerned about potential redundancies in the different methods for requesting.
• Ms. Kaplan wondered whether they were also asking for references. Dr. Davidson said that the request was for the interviews. She suggested that the Subcommittee forward this request to Dr. Falk.
• Ms. Mosby was concerned that Dr. Falk might not sign the letter or that action might not occur. Dr. Davidson said that their request could not be ignored, and that if their rationale is strong for the information, then they will get whatever action Dr. Falk can accomplish. Ms. Mosby favored more attempts to get action.
• Dr. Brooks suggested that the rationale include the statement that the credibility of the state is in question.
• Dr. Davidson suggested that the PHA work group work with the details of the letter. She also asked that the motion ensure that the letter is drafted, finalized, and sent.
• Ms. McNally reminded the group of the suggestion that the Subcommittee send its own, direct request to the Tennessee Department of Health. Dr. Pereira did not recommend that the Subcommittee ask Dr. Falk to sign a letter and then send one of their own that is, essentially, requesting the same thing. He suggested that the letter go through Dr. Falk. If Dr. Falk does not respond to the letter, then Dr. Pereira will inform the Subcommittee, but he expected that Dr. Falk would respond.
• Dr. Bob Peele responded to the discussion, as he is a former ORHASP member. The committee wanted all records kept in this area. Mr. Lipford worked on an agreement for storage, but was not able to form an agreement, so the information is in Nashville. There have been other complications, such as a flood in the building where the records were kept. It is unfortunate that the records are not all in one, easily accessible place, as was ORHASP's intention.
• Ms. Barbara Brooks of the Department of Energy, also a former member of ORHASP, described efforts to locate the information requested by Ms. Gass. As ORHASP had intended for the information to be available, copies of their materials and references were kept in the public document room. The materials were organized in a database of information about them and also scanned into electronic form. They are available on the Internet with a permanent URL. The descriptive database is bibliographic. The interviews are a small part of the information used by the researchers. Now, all materials belong to the state, other than what is kept in the public reading room. The public reading room is under-staffed and not policed, making it difficult to find materials there. She was not sure if more than what exists in that public database exists, and in what form. In the next week, the state has asked that Tom Widner come and organize all of the paper materials. She wondered whether this activity would make it possible for Mr. Lipford to respond to the original letter from ATSDR.
• Mr. Malmquist called for the question.

Motion 5 - Amended

The PHA work group of ORRHES will draft, finalize, and send a letter for Dr. Falk's signature requesting all interviews used in the Dose Reconstruction Report. This letter will include rationales for why the information is requested. The motion passed with a vote of 10 in favor and 1 opposed.

Presentation and Discussion: Epidemiology Workshop Part II:
Discussion of the Mangano Report

Dr. Lucy Peipins
Dr. John Merkle
Dr. Albert Brooks

Dr. Peipins spoke about how to evaluate and critique an epidemiologic study. She reminded the group that every scientific study and its scientific analyses are built on a body of knowledge and conducted to expand that body of knowledge. What is already known determines what needs to be known - studies "fill in the gaps." The body of knowledge represents the consensus of science. Once a study is completed, the author of the study and analysis publishes the results. The purpose of scientific publication is to present a new finding or insight into a problem. The results are shared and debated with scientists and the public.

Publication also demonstrates the quality and validity of the study by presenting the study's methods, design, analysis, and interpretation. This information allows other scientists and the public to judge the quality of the study. Authors are responsible for providing information on each component of the study so that readers can adequately evaluate the study. All assumptions and references must be justified and stated in the article. Epidemiologists have criteria to judge the quality of an epidemiologic study. There is no "perfect" epidemiological study. There are even limitations to clinical studies. The better the study meets the criteria, the more likely the readers are to accept the author's conclusions.

The author submits an article to a medial journal, which forwards the article to its peer reviewers. Peer review is an essential component of scientific work. These reviewers read the article and recommend whether it should be published. They can request additional information as well. The author must address all peer review comments before the article is published.

To illustrate the principles of evaluating an epidemiological study, Dr. Peipins used the article, "Cancer Mortality Near Oak Ridge, Tennessee" by J. Mangano, published in the International Journal of Health Services. These criteria should be applied to every article that is evaluated:

• Why was the study done?
• What hypothesis did the author have?

The question is usually found in that article's title or in the introduction. The main purpose of the Mangano article was to examine change in cancer mortality in 94 counties located within 100 miles surrounding Oak Ridge, Tennessee. Change from 1950 to 1952 was compared to changes from 1987 to 1989. That magnitude of change was then compared to change in the United States as a whole and the Southeast. The exposure of interest was radiation from Oak Ridge weapons production, which began in the early 1940's. Mangano included more specific hypotheses

Hypothesis 1:
An increase in all cancer mortality near Oak Ridge should be larger than the national and regional areas due to this radiation.

The following issues arise with regard to the first hypothesis:

• What type of study is this?
  
  • A descriptive study describes the health outcomes alone and answers the questions, what is the disease? Who got it? When were they sick? Where were they sick?
  • An analytic study attempts to answer the question of why one population gets a particular disease. The Mangano study is essentially descriptive, as exposure is largely based on location or residence in a county. However, because the study compares the rate of change in cancer mortality to the United States and to the Southeast, it also has an analytic component.
    
    
• Who was in the study? The Mangano population was the white population living less than 100 miles from Oak Ridge, in the 94 counties specified, between 1950 and 1952 compared with 1987 - 1989. The comparison population was the white population in the Southeast and the United States in that period.
• What was the exposure of interest? The article mentions several exposures from radiation, including chronic, low-level, ingested, emissions, and more. There are a variety of pathways and types of exposure.
• How is exposure defined and measured? Mangano did not measure exposure per se; however, exposure was defined as residents in a county near the weapons plant, residents in mountainous counties, residents in downwind counties, and residents in rural counties. Exposure measurement is often the "weakest link" in epidemiological studies. An individual can be assigned an exposure number anywhere along the pathway from when the radiation is emitted to when it is taken into the body. The goal is to have the most precise measure of exposure to reduce mis-classification. Residents in a geographical area is considered the poorest approximation to actual exposure on the hierarchy of exposure measurement. The numbers can be further refined with proxy measures such as drinking water use or length of time lived in an area. The best measurement is quantifiable personal measurement. The Mangano article exposure characterization is based on residence in a county in proximity to sites.
• What are some limitations or criticisms to how exposure was measured? Residence in a county is a poor measure of exposure. In the Mangano study, everyone who lived in the 94 counties was assigned the same exposure. It is assumed in the comparison with the rest of the United States that everybody was not exposed. In considering proximity, Mangano did not clearly define distance from the site. Roane County was not included, and the counties chosen for comparison were unclear. There was no justification for why these counties were chosen. Different pathways of exposure may exert a stronger influence than vicinity alone. The author assumes that rainfall may affect exposure, so he compares mountainous with non-mountainous counties. This approach seems general, as there is a great deal of variation in the rainfall in mountainous counties. These counties also have residents living in the valleys, so there is a mix of exposures. No previous studies were cited to support these assumptions in the article.

Hypothesis 2:
Within the Oak Ridge area, increase in cancer mortality should be greatest in rural areas, near the weapons plant, in mountainous areas, and downwind of the weapons plant.

The second hypothesis addresses differences between exposures in urban versus rural areas, but the author provides no rationale for the assumptions in the article. There is no rationale for not including Kentucky and Virginia. Rural areas are not free of risk. Information from dose reconstructions contradicts some wind patterns assumed in the article. It may be reasonable to assume that downwind counties will have higher cancer rates, but there are wind patterns affecting the four quadrants differently. The following issues arise with regard to the second hypothesis:

• What is the health outcome? The outcome of interest in the Mangano study was deaths from all cancers among whites in the specified counties in the specified times, compared with cancer deaths among whites in the United States and in the Southeast during the same times. It is important to measure outcome accurately. The study collected data from NCI. The study looked at all cancer mortality rather than specific cancers. Cancer is not one disease, but different types of diseases. Grouping them together may not get the appropriate information. There are a number of causes for cancers, and not all of them can be linked to the environment. Death certificate data are easily available, but there are problems with accuracy. This accuracy varies by causes of death and by regions of the country, according to who fills out the certificate. Accuracy varies by time as well: it is likely that cancer was under-reported in the earlier time frames.
• Was there selection bias in this study? Mangano used existing data, so this question is not relevant to this article. In evaluating other studies, however, it is important to discern how get into the study. Recruitment is particularly important, particularly if the exposed group is included on a volunteer basis and the unexposed group is not.
• Was there information bias in this study? Information bias concerns how information is collected on individuals. Questions must be asked and data must be collected in the same way for everybody. This aspect is not directly relevant to the Mangano study, but it should be recognized that the accuracy of cause of death certification can vary by region.
• What were the confounding factors? There is a possibility that the relationship shown in the study could be due totally or in part to other differences or risk factors between the two study groups. The author must address confounders and can do so in a number of ways. The study can be restricted to certain types of people or other risk factor information can be collected, for instance. Because Mangano's study was based on extant data, these measures were not possible. The potential confounders associated with cancer risk, then, are large. The author said that there was little or no migration in this area, and yet there was a large influx of people into the area when the plant first opened, and then a decline in population. Regional differences in life expectancy are another confounder. There are other regional sources of environmental contamination that might account for differences in mortality rates. The author should adjust or control for these confounders, and Mangano could not in this study.
• What statistical analysis was conducted? What method was used to measure the relationship between exposure and disease? In this study, the author calculated age-adjusted mortality rates for selected counties in the hypotheses area and compared them to the Southeast and the United States. The article provided little information on the actual statistical analysis or the justification for it. The selection of years was not justified, nor was the choice not to evaluate specific cancers as opposed to all cancers.

With regard to the results, Mangano found positive results for each of the hypotheses. Given other concerns with the study, though, these conclusions may not be justified.

A 1965 article by Sir Austin Bradford Hill, called "The Environment and Disease: Association or Causation?" presents a number of criteria by which to judge a body of evidence or study. These criteria are guidance for understanding a study and include:

• Strength of association. How strong is the relationship between exposure and disease? In the Mangano study, there is a large difference.
• Consistency with the weight of evidence. Has this association been seen in other studies with different study designs? Has this relationship been seen in different populations? The association between radiation and cancers have been studied, both among workers and residents near sites.
• Is there a biologically plausible explanation between the exposure and the disease? In this case, there is: ionizing radiation mutates DNA and causes cancer. However, county of residence was used as a surrogate for radiation. The radiation was never measured for these individuals.
• Does risk of the disease increase with increasing exposure? As no doses were calculated in the Mangano study, it is not possible to see this association.
• Temporality: has the exposure occurred before the disease? This point is critical to understanding a study. This study cannot address this issue because it is impossible to assess whether individuals moved into the area and had cancer, or moved out of the area and had cancer.

The final questions that one must ask when evaluating a study are: Has the author convinced us of his conclusions? Does this study advance our knowledge about the relationship between exposure and disease? Some of the guidance criteria were met; however, the article includes no exposure measurement. The study also focuses on all cancers rather than on specific cancers. Use of death certificate data and the lack of potential confounders further limit the study. Because of these limitations, this study does not demonstrate a relationship between cancer mortality and radiation exposure as effectively as it could. This conclusion does not mean that the relationship does not exist, but this study fails to provide strong evidence for that relationship.

Dr. Merkle then addressed the group regarding statistical issues with the Mangano report. A Karns resident and retired civil engineer, he became interested in the Mangano report after reading an article in the Oak Ridger. He stressed that an important question to ask at the beginning of an epidemiological study is: Are the differences involved in the measurements likely random, or are they likely not random? This procedure is called "testing the null hypothesis."

Dr. Merkle spoke to Dr. Mangano to obtain more information with which to evaluate his statistical analysis. Dr. Merkle used Dr. Mangano's rates and populations to re-do the statistical analyses. He gave the group an overview of how he conducted these analyses. In the early 1950s, he concluded, the differences between cancer mortality rates in the Oak Ridge area and in the Southeast could have been, and likely were, due to randomness. In the late 1980s, however, the differences in cancer mortality rates appear not to be random.

The differences in the rates are very small, he reminded the group. These numbers must be approximate because the populations are not stratified by age, gender, length of exposure, or according to other contributing factors. These calculations are important to consider in evaluating studies, and Dr. Merkle advised the group to ask qualified epidemiologists or statisticians to assess the figures in studies.

Dr. Brooks then addressed the group on the topic of wind patterns. There is no actual measurement of exposure in Mangano's work: the same results would be obtained regardless of what the cause was assumed to be. Mangano assumes an airborne release and a wind effect from the southwest to the northeast. Oak Ridge wind patterns have been studied in detail by NASA and are well understood. They are probably 2/3 to the northeast and 1/3 to the southwest; therefore, Mangano's assumption that "downwind" is one direction is erroneous.

The rates of cancer mortality from 1990-1994 in the different counties do not seem to correlate to wind direction. The rates are the lowest "downwind" to the northeast and to the southwest, and highest to the northwest and the southeast. Counties also appear to be "skipped." Knox County has high rates, Cox County has low rates, then Greene County rates are high again. The study's presumptions are not borne out by other information that is available. Mangano would have to explain why wind patterns lead to mortality figures that are different from what is expected.

Discussion Summary:

• Dr. Brooks inquired about the variance of the difference between Oak Ridge 5 and Southeast 5. He pointed out that if C was the average, and the average rate were zero, then the variance would be zero independent of the scatter of the data, which is not correct, because they are measured rates, not true rates.
• Dr. Merkle replied a binomial distribution was assumed. Dr. Brooks pointed out that when numbers are large, a binomial distribution approaches a normal distribution. Dr. Merkle noted that the variance of a linear combination of these variables is taken as the sum of the variances of the individual terms for a normal distribution. The derivation comes from epidemiologic books.

At this point, members of the public were invited to comment.

• Ms. Gass understood that a null hypothesis can never be proven. It can only be rejected at a certain level of probability, which is frequently .01. Dr. Merkle replied that a range of ratios must be established. If a difference is random, then 95 percent of the differences will fall between the limits. The reversal of the logic indicates that if the difference falls within the limits, then it is most likely random. There is a 5 percent possible error in that a number could fall outside the limits and still be random. The calculation cannot reveal the relative probabilities of randomness and non-randomness in a given situation.
• Ms. Gass recalled Dr. Peipins' stress on the importance of data quality in evaluating an epidemiological study. She was concerned because the Mangano report uses county data: sometimes epidemiological studies springboard other studies, so there are other implications for the study. There does not seem to be another study to which the Mangano study could be compared, nor does it seem that any other studies have "spring-boarded" from the Mangano study. Dr. Peipins said that there have been other studies of populations around nuclear facilities, but none that have resulted from the Mangano study. The Mangano study is rarely cited anywhere, she added, and the journal in which it was published is not in MedLine.
• Ms. Gass observed that a large amount of time was spent on proving that the study was based on weak data, which was established at the beginning of the process. She asked for comment on the availability of data, particularly the fact that county of residence is the most readily available research opportunity for an epidemiologist. Dr. Peipins agreed that the county data is easily available, which contributes to its attractiveness to a researcher. There are always trade-offs, though. Her purpose was not specific to the Mangano article, but to provide criteria for evaluating other epidemiologic studies and interpreting different data based on different exposures. All studies will have limitations.
• Ms. Gass asked how to design a better project to measure radiation dose and to develop data on an outcome and what such a study might cost. It did not seem feasible to her. Dr. Peipins agreed that such a study would be difficult. Ms. Gass acknowledged that the Mangano study is based on weak data, but it is all that they have so far, as it has not inspired further studies.
• Ms. Gass emphasized that cancer is not the only outcome from radiation exposure. The Iodine-131 work is almost entirely focused on cancer as the only endpoint, but cancer is not the only health concern that people have in Oak Ridge. She suggested that ATSDR solicit community people by advertising: "Exposure Health Concerns?" Many people in the community are not aware that the issues are being discussed or that the field office exists. She read the following from minutes from a Subcommittee meeting from the previous year: "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 within different media." The listed chemicals are only 275 out of the thousands used, but they are the most prominent at the sites. She observed that often, they are told that work is "beginning." She asked what work is beginning. She was particularly concerned about chemicals and the interactive effects with radiation and repeated a comment that she had made when ATSDR staff was in Oak Ridge, conducting meetings. The toxicological literature includes information on work with synergistic effects that should be coming to the Subcommittee. These data gaps are critical data.
  
  
• Dr. Davidson commented that in working with mixtures and synergistic action with chemicals, they can be additive or antagonistic. In this work, the particular chemical mixture of interest must be examined, as information about another chemical mixture does not provide enough information. Ms. Gass felt that the toxicologists on the Subcommittee should bring this information to the Subcommittee and that it would be helpful in the area of health concerns to keep the Subcommittee informed.
• Mr. Hanley said that the Division of Toxicology puts out "Tox Profiles." Mixtures, synergism, and additive effects in environmental toxicology is in the infancy stage. He did not know how much was available. A toxicologist works with ATSDR, and as the screening process begins and the contaminants of concern are evaluated, they will see other compounds that may have an impact or an additive effect. First, they will evaluate individual compounds, then as part of the health implications, other compounds will be assessed as well. He said that he would follow up with the Division of Toxicology to ascertain to what Mr. Williams was referring in those comments.
• Dr. Creasia has been working on synergism for some time. Toxicological studies include dose-response studies, which almost always show that a single compound is synergistic by itself unless the dose has an exponent of one. Very few chemicals have a toxicological exponent of one.
• Dr. Brooks reported that in the early 1970's, ORNL started the Mao study to determine the effects of low-level radiation. This study was to involve a million mice and was carefully controlled and designed. Before the experiment was completed, funds for the work were redirected to the war in Vietnam so that the number of mice was reduced so far as to be insignificant. Any epidemiological study that hopes to take a definitive look at low-level radiation will have to include approximately one million people. Normal, background radiation in the Oak Ridge area is approximately 300 milli-rems. The maximum airborne exposure outside the plant area is usually less than one milli-rem. There is no way that a study will be able to detect the effect of the normal, airborne radiation releases compared to background radiation on the general public.
• Ms. Sonnenburg shared a response from Dr. Mangano. She had felt that it was fair to ask him to provide with a chance to comment on his report and on their assessment of his study. She called Dr. Mangano and mailed him the minutes from the work group meeting as well as the matrix. In addition, she asked for the new data to which he referred in his letter to the editor in the Oak Ridger. His response asked the committee to look at the changes that have taken place in his figures. Rates have increased in the counties around the Oak Ridge area in relation to Tennessee and the rest of the United States. She pointed out that the one column adds population for five years, and the other the population for four years. The cancer rates for the four-year time are higher, even with one less year in the count. He also separated data by age and lung versus non-lung cancer. She also has the raw data available.

Dr. Davidson thanked Dr. Peipins. She reminded the group to complete their checklists for consensus-building. She noted that the Communications and Outreach Work Group needs more members and asked Subcommittee members to sign up for that work group. With that, the meeting was adjourned at 6:15 pm.

End of Day 1

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