ORRHES Meeting Minutes
March 19, 2001

March 20, 2001

The Agency for Toxic Substances and Disease Registry (ATSDR) and the Centers for Disease Control and Prevention (CDC) convened the third meeting of the Oak Ridge Reservation Health Effects Subcommittee (ORRHES) on March 19-20, 2001. The meeting, which was held at the Oak Ridge Mall, began at 12:00 p.m.

Members present were:

Alfred A. Brooks, Ph.D.
Robert Craig, Ph.D.
Donald A. Creasia, Ph.D.
Kowetha A. Davidson, Ph.D., Chair
Robert Eklund, M.D.
Edward L. Frome, Ph.D.
Karen H. Galloway
Jeffrey P. Hill
David H. Johnson
Susan A. Kaplan
Ronald H. Lands, M.D.
James F. Lewis
Lowell P. Malmquist, D.V.M.
L.C. Manley
Donna Mims Mosby
William Pardue
Barbara Sonnenburg
Charles A. Washington

Members Therese McNally and Andrew J. Kuhaida were absent.

All the liaisons to the Subcommittee attended:

Elmer Warren Akin, U.S. Environmental Protection Agency (EPA)Brenda Vowell, R.N.C., Tennessee Department of Health
Chudi Nwangwa, Tennessee Department of Environmental Conservation (TDEC)

Agency staff present were:

ATSDR: Bert Cooper; La Freta Dalton, Designated Federal Official and Executive Secretary of the Subcommittee; Michael Grayson; Jack Hanley; Sandy Isaacs; Karl Markiewicz; Bill Murray; Theresa NeSmith; Marilyn Palmer; Jerry Pereira.

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

DOE/Oak Ridge Reservation: Timothy Joseph

EPA: Cheryl Walker-Smith

Others present over the course of the meeting included:

John Bajek?, Site Specific Advisory Committee
Gordon Blacock
J.W. Fouse, PACE
Meg Gwaltney, COSMOS
Ann Henry, Methodist Medical Center
Marie Murray, Recorder
Dwight Napp, SOCM
Grace Paranzino, Hahnemann University
Rebecca Parkin, George Washington University
Robert Peele
Melanie Russo, Eastern Research Group
John Stewart
John Stockwell, DHHS, PHS
Thérèse Van Houton, COSMOS

Opening Discussion

Mr. Jerry Pereira introduced Ms. La Freta Dalton, the new Executive Secretary of the Subcommittee. Dr. Brooks moved to approve the agenda, and was seconded by Mr. Manley. With all in favor, the motion passed.

Correspondence: Dr. Davidson reported receipt of a letter from Ms. Janice Stokes, Chair of Save Our Cumberland Mountains, expressing concern about the Subcommittee and the Health Assessment process. It was distributed to the Subcommittee members and is attached to this document (Attachment #1). Ms. Dalton announced that the nomination for a worker representative member was completed. The public solicitation for nominations was to begin on this day, and was distributed (Attachment #2). Dr. Davidson announced that the action items from the previous meeting had all been completed. Comments on the minutes of the last meeting were sent to the recorder and incorporated. With no objections, Dr. Davidson stated that she would sign them as approved. There was no objection.

Presentation on Roberts Rules of Order

Dr. Al Brooks referred to the Agenda Work Group report and Introduction to Robert's Rules included in the members' packets. The rationale for using these rules is that they are recommended by the General Services Administration for Subcommittee work, and they are a complete set of tested, flexible rules for efficiently running a meeting. There are both formal and informal levels of application, from the most formal "committee of the whole," then a "quasi-committee of the whole," and then informally. The only real difference is the rule of how long a person can speak.

The main motions in order of precedence are 1) to make a main motion (for a specific action) which can be amended; 2) a motion to amend the original motion; 3) a motion to refer it to committee ("motion to refer/commit," which sends the whole topic including the amendment to a work group); 4) motion to call the question, which ends debate and requires a two-thirds vote because it changes the rights of the group; and 5) motion to adjourn.

Processing a debatable, amendable motion. When a motion is made (and described, if needed), it is seconded. Suggestions for minor changes or corrections are made if acceptable to the mover and are not considered to be debate. When finished, the Chair states the motion and requests discussion. This puts the question on the floor and makes it the property of the assembly; the maker cannot arbitrarily change it. When the Chair senses that discussion is finished, s/he asks if the members are ready to vote by voice, show of hands, or ballot, and the results are announced. Or, the Chair can ask if there is any exception to the motion (as done with the minutes on this day. If none is voiced, it is considered passed. There also is a motion to suspend the rules; if two-thirds of the members agree, all the rules are suspended.

Dr. Brooks outlined in order of precedence from lowest to highest, the motions likely to be used for most of the business of a small committee as this one: 1) Motion, 2) postpone indefinitely (if not supported); 3) amendment (the original motion can be changed once); 4) motion to commit or refer (the kinds of changes needed and a time table to report back can be specified); 5) postpone indefinitely or for a certain time; 6) extend or limit debate (if the allotted time for discussion expires (this requires a two-thirds vote because it changes the rights of the assembly); 7) previous question is in order (closes debate and calls for a vote); 8) table the motion (if left tabled through the next meeting, the motion expires); 9) call for the order of the day (a call to return to the agenda can be done by one person unless the committee votes it down and decides to stay off the agenda); 10) order of privilege (a very high priority, e.g., if a member cannot see or hear well enough to participate in the discussion); 11) motion to recess (not debatable, can be done to discuss an amendment for 5-10 minutes); and 12) motion to adjourn.

Another rule is the point of order, which is not a motion, but interrupts a discussion to ask the rules or to note that they are not being followed. Generally, Roberts Rules should not be abused if the Chair and the Parliamentarian attend to them. The latter can be hired or appointed by the Chair.

Committee discussion included:

• The motion to reconsider was used at last meeting. That, and the motion to reconsider in place of the minutes have a high priority, being intended to stop a possible mistake. If motion to reconsider a motion passes, the motion and vote cannot be effected until the next day. When recalled to the floor, it need not be seconded again; the previous second indicates that discussion is desired by more than one person. There is no time limit for reconsideration, which may not necessarily be done at the same meeting.

• The rules sometimes can appear to be intimidating or constraining, particularly in addressing the real-life process the Subcommittee will address. If more discussion is needed, substance was favored procedure.

• The most common mistake of meetings is to have discussion first, then to make a motion and vote. If a topic is on the floor for which there is no motion, it is left to the Chair to decide what the topic is. The rules are generally agreed to by all and provide a reasoned process for member participation without limiting the Chair, who administers them with the Parliamentarian's help.

• If there are experts in the audience who could contribute, any person can request that that member of the audience be allowed to speak. This issue is actually a question of bylaws, but the ORRHES Chair has reserved the right to hear from an attendee who can contribute technical expertise (as opposed to the opinion expressed in the public comment period).

• Ms. Sonnenburg suggested, before voting on any issues discussed for some time, that the Chair ask if members of the audience would like to address the issue first, rather than waiting for the public comment period. Dr. Davidson agreed, if the comment is technical, but not if it would detract from the public comment period. Any member can move to suspend the rules for an audience comment. The Chair would allow that with no objection; if none, the person speaks.

• The main concern expressed about using Roberts Rules was that they not be used to stifle the process. If facilitation is needed, it should be arranged. The problem may not be the length of time for speaking, but helping to draw out someone who may feel intimidated.

• There are other rules of order (e.g, Sturges' rules), which Mr. Washington used in another group, that were adapted to a two-page summary. No repeated input is allowed until everyone has spoken. Roberts Rules also prohibits speaking again until anyone else who wants to speak and has not yet, does so.

• Mr. Pereira sensed discomfort by some members with using Roberts Rules and suggested using whatever the lowest common denominator is, just to help everyone stay on task and accomplish their work. Dr. Davidson agreed, and asked for the members' help to ensure that nothing hinders the members' opportunity to speak during the discussion.

Dr. Brooks solicited members as volunteers to conduct a skit which he had written to illustrate the use of Roberts Rules, which they did. Dr. Malmquist moved to adopt Roberts Rules of Order for the ORRHES' procedures and Dr. Creasia seconded the motion. Dr. Davidson noted that the bylaws already specify the use of Roberts Rules unless otherwise indicated, so Dr. Malmquist withdrew the motion.

Presentation of the Public Health Assessment, Steps 1 and 3

Mr. Jack Hanley reviewed the purpose of ATSDR's public health assessment: to identify off-site populations exposed to hazardous substances at levels of health concern, and to recommend follow-up public health actions or studies needed to evaluate and mitigate or prevent health effects. The process has seven steps: 1) evaluate site information; 2) identify health concerns; 3) determine contaminants of concern; 4) identify and evaluate exposure pathways; 5) determine public health implications; 6) determine conclusions and recommendations, and 7) develop a public health action plan.

As of this meeting day, ATSDR was beginning Steps 1 and 3. ATSDR has collected data on #2 in community meetings (which the George Washington University staff will document) and hopes to gather more through the Subcommittee.

The work done in Step 3 determines the contaminants of concern (site-specific chemicals and radionuclides that are further investigated for potential public health effects in steps 4 and 5). The contaminants used at the facility are identified, as well as any significant releases. A contaminant cannot be considered a health hazard until the pathway of exposure has been analyzed to indicate that they may have impacted off-site populations. Step 3 determines which contaminants may have done so, and Step 4 evaluates which exposure pathways may have been completed. This work will identify each contaminant's important pathways, across all media, and those contaminants with the greatest potential to impact off-site populations.

After that, Step 5 will determine the public health implications; and the Step 6, public health assessment document will communicate the completed pathways of the overall site and indicate what should be done to address these exposures. Finally, Step 7 will develop a public health action plan for subsequent work.

Steps 1 and 3 of the public health assessment process will begin by using the 1993 Tennessee dose reconstruction feasibility study, which was composed of four tasks: 1) describe historical operations and releases; 2) identify available environmental data; 3) identify complete exposure pathways; and 4) evaluate environmental exposure pathways. Mr. Hanley had sent to the committee members the prior week the documents from the dose reconstruction. Its Steps 3 and 4 are similar to ATSDR's public health assessment process.

Task 1. The objectives of the Task 1 feasibility study described the historical operations that used and released contaminants; and identified activities that have likely been associated with significant off-site releases of chemicals and radionuclides, that were used and released in quantities sufficient to cause harm even after dilution and dispersion to the environment. They also looked at any documentation of offsite releases or presence of contaminants in offsite environments.

The major categories of activities investigated and reported on in Task 1 were the historical operations of: 1) X-10, whose original mission was nuclear reactor development (>15 reactors), the nuclear materials separation process, and radionuclide production; 2) Y-12, whose original operations missions were weapons production, lithium separation and enrichment, zirconium production, disposal, and steam generation; 3) K-25, which was a gaseous diffusion plant that conducted atomic vapor laser isotope separation, operated a liquid thermal diffusion plant, the TSCA incinerator, the steam plant, the recirculating cooling water system, and waste disposal.

Task 2: The work of Task 2 was to identify available environmental data; provide an inventory (from the state, EPA, TVA, and others) of what was collected and analyzed for environmental data over the years (air, surface and drinking water, soil, etc.). The Task 2 objectives were to: 1) identify/evaluate available environmental monitoring and research data; and 2) develop abstracts on ~100 environmental monitoring and research projects.

A time line was distributed at the last meeting for the X-10, K-25,and Y-12 activities, demonstrating the materials by air, water, soil, etc. used and potentially released over time. For example, X-10's plutonium recovery operations, before routine treatment and monitoring systems were in place, released uranium, plutonium, and various fission products in the first few years. The reactor released uranium, argon, plutonium, and other fission products over 20 years' time. The stack also was unfiltered for the first five years, something the feasibility study recommended examining. The Thorex process had some short decay runs that produced fallout in the X-10 facility area. One of the more important processes was the Radioactive Lanthanum (RaLa) process, which released iodine and other fission products. More than half of all that work was done before filtering of the process began.

Y-12 conducted nine different processes, which released a large quantity of uranium that most likely went offsite. East Fork Poplar Creek received contaminated liquid effluent in the first year (1944). The major weapons production operations were of such magnitude that offsite releases are likely, primarily of uranium. Also important were the lithium separation/enrichment operations' release of mercury into the water and air, especially from 1956-1963. The K-25 gas diffusion processes released uranium and magnesium 99, and the liquid thermal process of the mid-1940s was plagued with many mechanical problems in the early years.

All of these processes were further evaluated in Task 4.

Task 3: Used the information collected in Tasks 1 and 2 to identify important contaminants at the facilities and important related pathways. Materials mailed the previous week included a list those contaminants (Table 1). Table 2 listed those not warranting further investigation because they either were used in small quantities or in processes not believed to be associated with offsite releases (radionuclides, lithium, benzene, and chloroform). The other group not warranting further investigation included contaminants of little or no toxicological impact, even in large quantities (Freon and other materials found to be dispersed in the environment, such as acids and bases like fluorine and fluorine-type compounds -- irritants associated only with acute exposure). Table 3 listed the contaminants used in the processes with high risk of offsite contamination, which were further explored in Tasks 3 and 4. In the dose reconstruction report, Table 3-5 assigned all the table 3 contaminants to pathways (Attachment #3).

Task 4: This Task's work evaluated the completed exposure pathways. Screening analysis was done to: 1) identify important pathways for each contaminant within each media; 2) and identify, across all media, the ones important for each contaminant; and 3) identify contaminants with the greatest potential to impact offsite populations.

In the previously mentioned mailout, Table 4 listed the screening's identified highest priority contaminants and sources, recommending media and exposure routes: I-131 from X-10's RaLa process, conveyed through the milk pathway; 2) Cesium from the X-10 separation process, to White Oak Creek, the Clinch River, and surface water, to the fish, soil sediments; vegetables, dairy cows, and milk pathways; 3) mercury from Y-12; and 4) polychlorinated biphenols (PCBs) from K-25 and Y-12.

The Oak Ridge Health Assessment Steering Panel (ORHASP) received a detailed dose reconstruction analysis of these four priority contaminants.  They also received additional screening analyses for other contaminants that were screened out in Task 4. The first cut of the latter did not produce any results indicating a potential for further dose reconstruction work. Additional screening was done due to concerns about historical accuracy of records (uranium) and because conclusive screening analysis was not done on uranium, arsenic, beryllium copper, lithium, other radioactive products. The ORHASP also recommended a more detailed analysis of asbestos and plutonium. A report was produced on the re-evaluation of those contaminants.

The initial list of contaminants of concern for further evaluation, based on the dose reconstruction study are: I-131, mercury, cesium-137, PCBs, uranium, fluorine and various fluorides. ATSDR will look at the latter due to the large quantities used on site and released. Re-screening of the other contaminants will be discussed at a future meeting.

The next steps in the Public Health Assessment process are to: 1) present and discuss information on contaminants that received additional screening (a Subcommittee work group to assist ATSDR could be helpful); and 2) present and discuss information on contaminants of concern for further evaluation (overview of available information and their assessment). In June, work will begin with review of the state reconstruction of I-131 releases and ATSDR's technical comments.

Mr. Hanley was thanked for an excellent report. The committee's discussion with him included the following:

• Ms. Sonnenburg requested ATSDR's consideration of cumulative effect from coal burning that was done under the regulatory limit per ton, but amassed a huge tonnage over time that has never been totaled. She expected that Mr. Earl Lemming and Ms. Kaplan would have data that ATSDR could add to its own for at least a quick analysis. Mr. Hanley said that this could be discussed with the Subcommittee, but such cumulative comprehensive assessment is not typically what ATSDR does, being limited to Superfund sites. He also agreed to meet with the members to discuss specific areas of the report. Mr. Lewis said, if effects from another agency such as TVA are considered, they should be invited to provide their interpretation of those releases.

• Will the Nevada Test Site (NTS) I-131 and I-133 exposures were be included in the analysis?  (Eklund) Mr Hanley responded that ATSDR will provide an overview of this topic, as covered in the dose reconstruction study.

• Are the Oak Ridge radionuclide releases much higher or similar to other sources? (Frome) Most of the other radionuclides were <1% of the iodine; the report presents a relative risk to I-131. Are the ORR iodine releases substantially larger than the Nevada Test Site (NTS)? When the ORHASP document is reviewed, ATSDR can discuss the effect of those other sources on the area. Were K-12 and X-10 monitoring data used to determine the workers' level of exposure on site; were their doses as high as people offsite might have received? It is not certain that on-site monitoring was reviewed at this stage.

• Will ATSDR examine the potential impact of changing the initial assumptions used in the calculations of scrubber efficiencies? (Also, the NTS data are not in the summary, although they are in the report.) (Kaplan) Ms. Kaplan agreed to provide ATSDR with two related white papers she has written. ATSDR will present the feasibility study's findings and the technical reviewers' comments, then discuss next steps.

• Recent studies indicate beryllium is highly toxic in small quantities; how did it rank in the Task 4 evaluation? (Johnson) It was included as a carcinogenic chemical, and so was compared to PCBs, which posed the highest risk. Beryllium's relative risk was 0.4% of the risk of PCBs. Beryllium exposure mostly pertained to workers and involves sensitivity issues. But ATSDR could look into why that contaminant fell out of the process regarding offsite exposures. Beryllium's major impact is on lung capacity, not a cancer issue; PCBs may not be the proper comparison. (Kaplan/Davidson)

• ATSDR should consider that the gasoline facility was originally on the ORR, and consider offsite releases of carbon tet from Y-12 which blew east. (Brooks)

• Did ATSDR review Dr. Kathleen Teeson's list and consider her concerns? (Sonnenburg). Yes; fluorine was one, which ATSDR added. Copies of that correspondence will be provided.

• Who is doing, and at what stage is, the document review? Are the documents considered acceptable? The ORHASP membership was similar to this Subcommittee, and they reviewed everything. ATSDR will check their minutes to ensure that the questions raised were documented and addressed.

• How did they/are we looking at the X-10's major processes that may still delivering an effect? (Hill) There were cesium releases from the dam in 1985, (Kaplan) and a flood in 1964 along with regular releases. (Bob Peele). The dose reconstruction focused on historical exposures. The radioiodine is long gone, but radioactive products such as cesium were also released to White Oak Creek. In the last ten years, a lot of work has been done on the Clinch River and Watts Barr Reservoir environments, and ATSDR is involved in that work. Step 3 will combine the dose reconstruction's historical data with the data collected in the past 20 years (e.g., state, EPA) and combine that into one evaluation. The published health assessment will include both historical and current exposures offsite.

• A peer review of the ORHASP studies is needed. They had informal reviews, and it is not clear that a number of controversial points were corrected (e.g., higher and lower levels that suggest some study and evaluation). The "peer review" done is only a compilation of every comment received. (Brooks)

• There are levels of peer review. Please ensure that anything given to the Subcommittee has its peer review status clear, and please supply a list of any peer reviewed documents about offsite effects from ORR exposures (e.g. worker studies published in the literature). (Frome) The unpublished documents reviewed by the state and EPA could be supplied, and all the Public Health Assessments are peer reviewed by a panel of neutral scientists. Any subsequent health assessments (from protocols on) will also be peer reviewed. All comments received from the public are included in the public health assessment with a response. The technical comments are not included, but are publically available.

• Has the porosity of the limestone bedrock below K-25, Y-12, and X-10 been quantified? (Eklund)  Ms. Kaplan thought she had that data in two papers, one on equity regarding buried waste. In many cases, DOE does itself not know what is buried. The sites where most of the releases are occurring is where the remediation is being done. Mr. Hanley stated that X-10 waste is moving offsite in surface water, and DOE is monitoring where it enters the Clinch River (permits monitored by EPA and TDEC) ATSDR will look at those data. They will not look at the burial sites, but if such documents are found, they will provide them.

• Clarification of "peer review" is needed, which differs from "peer input" on documents. "Peer review" requires independence and expertise, and must be responded to in a publicly available document. (Akin) Mr. Akin added that little of the latter was done; the Subcommittee will have to decide what it wants. EPA uses mostly peer input and comment by peers; but it may not be independent and does not require formal response.

• How do we capture all these concerns to address them formally by the experts generating the documents, rather than piecemeal? (Lewis) Dr. Davidson hoped to establish a Public Health Assessment Work Group to establish priorities with ATSDR and report/recommend back to the Subcommittee on the process.

• The problems of the buried waste include little documentation on low-level waste, and that the X-10 records on high-level waste were destroyed on 1984. Some were reconstructed, but in general that is not an accurate inventory. That makes more important the good records of the outflows off the reservation. This is a complex subject that would take several months to study thoroughly. (Brooks)

• What does "significant" mean? (Washington) Mr. Washington stated that the ORR scientists, aware of the materials' toxicity, at some point began recording what was buried, but not necessarily how much. The surface and ground water at Oak Ridge interchange. As a manufacturing plant, Y-12 in the past used many chemicals (benzene, carbon tet, xylene, toluene, all good solvents and all carcinogenic).  Some bomb components are still produced, even at a 20-25% production level; and past shifts ran the plant 24/7, with releases emitted in huge quantities. There often were no special precautions taken with toxic materials; and, while the effect of one or two contaminants may be known, the long-term synergistic effects of multiple combinations are not. Those must be determined, because they will skew the data. However, Dr. Brooks disagreed about the lack of waste disposal standards, based on his experience as a Y-12 chemist during the war. He said he had worked in some industries he considered far more dangerous.

• Is there any time boundary, or where is the disconnect, for this Subcommittee's function to evaluate the health effects of the ORR versus that of the public health assessment? (Akin) ATSDR will develop the public health assessment with advice from the Subcommittee; it is not an investigative body that develops its own documents. The ultimate product of this Subcommittee will be the public health and community needs assessments. The time frame includes past and current exposures, and those in future as much as possible, based on present knowledge (no new operation could be considered). However, Mr. Washington noted that the past is germane to the future. Workers in boots walked through mercury in the Y-12 process using it; and the vapor pressure imbued it into the walls; on a hot day, you can see it dripping. The problem is so great that there is an international committee examining it.
  

Dr. Craig moved to form a Public Health Assessment Work Group. All were in favor and none opposed.  The motion passed. Work Group volunteers were: Johnson, Craig, Brooks, Manley, Washington, Lewis, and Kaplan.

Public Comment

Dr. Bob Peele was an ORHASP member, and he offered several comments. The 1993 screening was a quick process done in only eight weeks. Because of that time limit, they only screened for relative (not maximum) risk, to avoid having to address pathway attenuation. The results were grouped by radiation and non-radiation, and the most important elements were chosen (iodine, mercury and PCBs); nothing else measured approached their levels. The more recent screening (Volume 6) did a still-conservative calculation of the maximum interval and plausible importance of absolute risk.

The Subcommittee may want to add more contaminants of concern; and he agreed that all the work should be reviewed. He thought that I-131 may be the more important ORR release. That was the biggest analysis, which was reviewed, and the comments were incorporated by Chem Risk. Everyone wished for better peer review. It was not done as well as it could have been, but is still very professional work.

Radiation. The workers' contaminants may sometimes be of concern to the public. They could inhale the iodine and residents with backyard cows would be affected through the milk pathway. That risk was neither understood nor monitored until the late 1950s. The Hoffman report details how this can be estimated, as well as adding in the NTS fallout. The estimates are comparable for sites equidistant to the ORR, with the ORNL releases more important closer the lab and the fallout more important further away. The fallout study results were delineated by county, but the real range of the fallout remains unknown.

The cesium in the Clinch river was the longest-lasting isotope, with a 30-year half-life. The report considered all of them; at certain times different ones were more important than the others. Regarding the scrubber, only one measurement was made, but the iodine released was well measured.

Chemicals. The mercury was discharged to protect the workers, but crossed the hills impelled by big fans and exposed residents. The biggest problem was from fish exposed in Poplar Creek. No one measured mercury in the fish, nor in sediment until 1985, which they tried to correlate to DOE plants in other areas to estimate the fish mercury content. Nearly everyone who ate those fish had a higher dose than the minimum risk level.

Dr. Davidson asked if Dr. Peele could participate in the work group. He declined to be a member, but might attend from time to time.

Presentation/Discussion of the Health Needs Assessment

Mr. James Lewis reported the work group's discussion of the questions raised to George Washington University at the January meeting: clarifications on how the focus groups worked, the telephone survey, key informants, and GWU's overall program. They provided these questions to ATSDR, who advanced them to GWU. They in turn met with the work group, which suggested two potential enhancements.

Two of the Principal Investigators, Dr. Rebecca Parkin of GWU, and Dr. Grace Paranzino, of Hahnemann University, defined the work group input as invaluable, and presented a proposal in response. Dr. Parkin reviewed the project's status: 1) the study proposal is almost done, as is 2) the document review; 3) two site visits have been done to date, and additional comments from community received on 4) the key resource interviews. The work group provided input to 5) the phone survey and 6) the focus groups, which all lead to 7) the final report.

Steps 4-6 involve interviews of individuals (key informants/phone survey) and groups (focus groups), which require Institutional Review Board (IRB) human subjects study review and approval. GWU granted that; and approvals are pending at Hahnemann University.

The key informant interviews of groups will include health officials, health care providers, and community members. There will be 25-30 members per group and 10-15 minutes spent per (confidential) interview. The questions will be open-ended (e.g., asking their experience of health problems). Then, to help develop a health education program, the project's purpose, the phone survey component will identify health issues and information needs and finalize the focus groups and question guides. The survey will be of the general population. They will be accessed by random digit dialing to households, the protocol to obtain a final sample of respondents representative of the general population. Staff of the GWU Medical Center for Survey Research will do the survey. About 400 interviews (again, confidential) are planned, at 10-15 minutes per interview using closed-ended questions.

The focus groups are to gain knowledge about sub-groups who have health issues and need health information; to clarify the health issues; and to identify the information they need and how they want to receive it. Up to eight groups are planned, composed of up to 12 people per group with similar characteristics. The group discussions will be moderated by project staff and last 1-2 hours; open-ended questions will be used to allow as much interaction as possible. Confidentiality is maintained in the final report.

Steps 5 and 6 were the modifications made after the meeting with the work group. Per Ms. Mosby's suggestion, the term "key informant" will be changed to "key resource."

Committee discussion with Drs. Parkin and Paranzino included:

• Why are only adults eligible (age 21)? (Frome) Household phone answering patterns of previous studies were reviewed to ensure a good representative sample of the population. This will be continually adjusted as the survey goes on; the interviewer will ask for a particular type of person to be the respondent.

• What is the opening language? (Frome) That approved by the IRB identifies the interviewer as from GWU, explains why they are calling, and gets their informed consent. They will be asked about broad health issues in general to capture the breadth of health concerns, what they would like to know, and how they get their health information (e.g., the Web, newspaper, etc., to see how to design the educational program). However, the interview instrument is not yet set up.

• Dr. Brooks said the new version of step 5 answers all his concerns about statistics; which he now withdrew.

• Be aware; they might expect GWU to do something about those health issues. In view of such dashed expectations in the past, they may not want to participate unless they believe the interviewer credibly needs this information and/or can help. (Washington) GWU will identify available health information resources for people to access; and ATSDR has set aside some funding for the AOEC clinics to do some follow-up (but what that will be is not yet known). A risk management tool kit can be applied in any of the interviews/focus groups. The concerns or wishes expressed will be documented and passed on to the Subcommittee and ATSDR.

• Great concern was expressed that the random digit dial method described would place most calls in Knox County, the least impacted, but with most of the phone numbers. If the criteria are changed, (e.g., to a specific phone exchange for a portion of a county) GWU could refine the survey further.

• How will you balance the representation in the groups, or reflect the primary focus of the most affected group; where will the groups be held; and are they open to the public? (Lewis) The process will be refined as it proceeds; each part informs the next component. For example, the phone survey might indicate worry about one particular health concern in one geographic area, so all the counties need not be represented. The groups are not open to public; they have only 12 people to be able get all the information desired in the time allotted. The strategy might also rest on who the partners are (e.g., if asthma is a concern, physicians seeing asthma patients might suggest participants).

• Many of the agencies on the GWU advocacy list are underfunded and cutting services. (Galloway) The resources will be determined in the data gathering phase, and the focus groups can use this opportunity to advise what services are desired. But GWU would avoid telling people specifically where to go until Phase II, the implementation of the health plan. Phase I is only to research information and combine it in such as way as to guide services to the community.

• Some physicians will not diagnose contamination-related illness, or the individual may not make the connection to self-identify. (Eklund) GWU will focus on providers already known to see people who may be so affected. But the community representatives will also be solicited for such concerns that may not have been presented to a health care provider. Dr. Parkin expressed her own personal commitment not to do science that just sits on the shelf and is not useful. She will do all she can to ensure something comes of it, and will give that to the agencies to run with the ball. She also noted that the health education information is not just for residents, but could also be useful to health care providers who need more information about occupational illnesses.

• Ms. Kaplan asked who decided the community health education focus, and why? The community wants clinical evaluation, not education. The perception may be that this is just another government-funded educational study. The Subcommittee needs a mission statement to advise what it does; people want to be helped, and she was unsure this would do it. Dr. Davidson responded that the ORRHES mission statement is in its charter. Ms. Dalton stated that ATSDR's Congressional mandate is to examine site-related contaminants and any effects on the public. They cannot provide health care, but they can recommend to other agencies. Ms. Kaplan asked if there is there some flexibility between diagnosis and treatment.

Dr. John Stockwell stated that ATSDR's Memoranda of Understanding (MOU) with other agencies could provide such health care. For example, the Health Resources and Services Administration (HRSA) provides environmental medicine/consultation, but he did not know if those clinics are in the Knoxville area. He provided a copy of the MOU to Ms. Dalton to share with the board. She reported that when such issues are raised at other sites, ATSDR has tried to facilitate a discussion with HRSA to address them.

• Address health needs and concerns first, then health education. (Brooks) They cannot be discussed until first an assessment is done of what people's health issues are. GWU will not asking about health issues only in the framework of health education.
  

Health Needs Assessment Work Group Report

Mr. Lewis began the Health Needs Assessment Work Group report by expressing his irritation that the scope of the survey had suddenly changed with new information. The work group will now have begin anew. He called for communications to be improved, specifically stating that the people who walk out of this room and do not get involved [with the work group] in the interim, should not come back to complain and want to change it all later.

The work group had intended to address: 1) identifying as close to eight focus groups as possible for the Subcommittee to vote on this day; 2) to identify key informants; 3) to explain the logic of shifting the phone survey to be done before the focus groups; and 4) to discuss utilizing either the Work Group or the Subcommittee in developing a pilot program to review the questions to be asked.

Dr. Parkin reported GWU's amenability to the latter. While they cannot be too detailed to avoid hazarding the credibility of the study, they could interview the Work Group or Subcommittee as they would interview the residents, with the proviso that they would not divulge the questions. This could help in some areas, such as making sure the terminology is correct, and a pilot test questionnaire could ensure it captures the information needed.

Ms. Mosby preferred to select most of the 7-11 participants in this pilot from the Subcommittee, which would provide a better balance. She also noted that those who participate in the pilot test would no longer be involved in the survey (except as key resources). However, further involvement in either the phone survey or the focus groups was unlikely.

Dr. Brooks moved that the Subcommittee recommend to ATSDR that the Subcommittee members participate in a pilot test with George Washington University to determine the appropriateness of the survey questions. Ms. Sonnenburg seconded the motion. Ms. Mosby offered friendly amendment that the number involved be "a minimum of 7 and maximum of 11," to Dr. Brooks' agreement. Dr. Brooks moved that the Subcommittee recommend to ATSDR that a minimum of 7 and a maximum of 11 Subcommittee members participate in a pilot test with George Washington University to determine the appropriateness of the survey questions. The vote was 16 in favor and none opposed. The motion carried.

Dr. Brooks moved that the Needs Assessment Work Group choose the 7-11 members, the majority wishing to participate to be selected from the Work Group and the balance from the Subcommittee. Ms. Sonnenburg again seconded the motion. A voice vote showed all in favor and none opposed. The motion passed. The Pilot Test Work Group volunteers were: Vowell, Sonnenburg, Johnson, Galloway, Brooks, Creasia, Hill, Malmquist, Kaplan, Lewis, and Mosby.

Dr. Brooks then moved that the Subcommittee accept the Work Group's recommendation to do the phone survey before the focus groups, as explained in the modified submission from GWU (Attachment #4) and the presentation made today. Dr. Malmquist seconded the motion. In an amendment, Ms. Mosby moved that the Subcommittee accept the Work Group's recommendation to identify George Washington University's Step 4 as the Key Resource Group, Step 5 to be the Phone Survey, and Step 6 to be the Focus Groups. In a voice vote, all were in favor and none were opposed. The vote passed.

Mr. Lewis pointed out that the chart of suggested characteristics of focus groups had been distributed (Attachment #5), as had that of the key resource groups/individuals (Attachment #6). Dr. Paranzino noted that if the population is redefined, as per the preceding discussion, these focus group suggestions might change. Mr. Lewis agreed; this should be considered as a first cut.

Public Comment

Mr. Pereira hoped that GWU would be able to counter a potential bias to the process, by gaining the participation of those most likely to have been exposed but feeling "surveyed to death." He also stated that nothing is cast in stone that education must be the point of emphasis. The needs assessment could be and should be, and the health education component can follow.

Mr. John Stewart, the PACE union health representative for 400 active workers and 14,000 past workers, spoke. The PACE union is doing a medical surveillance survey. He invited the GWU and ATSDR to attend the meeting hall to find out what problems need assessing; they see it every day. Just the previous week, he had helped a worker with six weeks to live from multiple cancers to finalize his affairs; or he tries to find physicians to help the workers. He stated clearly, "Oak Ridge physicians do not, do not, help the workers;" they go elsewhere for treatment. (He later clarified that those doctors do not necessarily refuse to treat; but they are loath to define any problem as occupationally related). DOE studies have cost $156 million in the last ten years, and they are going to do another one. They asked the union's participation in a survey to "help the workers," that produced a stack of paper 10' tall but not a dime to help the workers. He felt there to be no need to ask what people think are health concerns; they can be seen. Many have hearing loss, the first sense lost by test animals exposed to methyl mercury. The workers feel like "a bunch of test animals." They only go to the union now; they are the only ones trying to help. He stated that what his members need is financial and medical help. Mr. Hill shared Mr. Stewart's concerns and frustrations about people with health concerns that he cannot help. But he was willing to stick with it and asked him to help any way he can.

Mr. Mike Napp asked several questions:

• Why were Blount and Merriwell counties not included in the survey?. Dr. Davidson explained the rationale for the selection of the seven counties in the Oversight Committee domain, and Knox County because many workers live there.

• How many of the Subcommittee members have health ORR-related effects? Dr. Davidson objected that the Subcommittee members were not present to self-identify. None did. Mr. Napp accepted that, but noted that "we" had nominated people with offsite contaminants in their bodies who consider themselves to be ill as a result.

• ORHASP report identified four contaminants; did EPA identify others, and will this Subcommittee address that? Dr. Davidson reported that as having been discussed earlier, and that the list of contaminants of concern would be provided to him.

Ms. Linda Lewis acknowledged the importance of discussions about scope, direction, charter, mission, etc.. but defined being proactive rather than reactive as more important. Quoting a song ("don't depend on the train from Washington, it's a 100 years overdue"), she advised the Subcommittee not to ask an organization for what it cannot provide. For example, disseminating information about the R.W. Johnson Foundation funding to help cancer patients would be more useful. She urged the Subcommittee to be proactive, find what takes care of the problems to be addressed, and working with that. She has immune disorders, and worked at the Oak Ridge National Laboratory (ORNL) for decades. But her focus is not whether it caused her illness; her focus is to get well and to be a victor, not a victim. She provided her phone number at work (524-8461) and offered her help to the Subcommittee.

With no further comment, the meeting adjourned at 6:57 p.m.

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