ORRHES Meeting Minutes
June 11-12, 2001
JUNE 11, 2001
Presentation of the ATSDR Division of Health Education and Promotion
Update of the Health Needs Assessment
Task One Report, Tennessee Oak Ridge Dose Reconstruction Study
JA Jones Perspective
Continuation of Subcommittee Discussion
JUNE 12, 2001
Presentation of the ATSDR Epidemiology Workshop
Public Health Assessment Process
Presentation of ATSDR Screening Process
Presentation of the ATSDR Program of Work
Work Group Reports
Agenda Work Group
Public Health Assessment Work Group (PHAWG)
Guidelines and Procedures Work Group
Health Needs Assessment Work Group
Communications and Outreach Subcommittee Work Group
Presentation of the ORRHES Website.
At the fourth meeting of the Oak Ridge Reservation Health Effects Subcommittee (ORRHES) on June 11-12, 2001, the minutes of the March meeting and the April 24, 2001 conference call were approved. A quorum of members were present, as were representatives of state and federal agencies and members of the public. The resignation of one member was regretfully announced. The DOE was thanked for a tour of the ORNL facility provided on the first morning of this meeting.
Presentations provided to the members included an overview of the Division of Health Education and Promotion by its Acting Director. The Subcommittee was reassured that the Division is committed to its work at Oak Ridge, regardless of leadership changes. Relevant to that, the committee requested ATSDR's attention over time to needed community communication, particularly if the study cannot prove that the health concerns believed to be ORR-associated are, in fact, so. ATSDR pledged to remain as long as it can make a reasonable contribution. The work of the Division's three Branches were outlined: the Risk Communication and Research Branch's case studies in environmental medicine; the Health Education Branch's development of strategies, models, and materials for educating the public and health care providers about environmental health matters; and the Health Promotion Branch's environmental health intervention programs, which includes the Oak Ridge needs assessment.
And Update of the Health Needs Assessment was provided. Revised survey tools will be submitted for Work Group, Subcommittee, and IRB approval. Work remaining includes the key resource interviews, telephone survey, focus groups, and final report. The time table includes key resource interviews to be done in June and July; the focus groups in September; and completion of the Health Needs Assessment at the end of December. The final report will be forwarded through the Work Group to the Subcommittee and ATSDR for comments, revisions and modifications as needed. In discussion, it was conveyed that the health education action plan will be a joint effort by the Division of Health Assessment and Consultation and the Division of Health Education and Promotion. It will be reported in December.
The Task One Report of the Tennessee Oak Ridge Dose Reconstruction Study, focusing on the technical issues of the dose calculation, risk estimates, probability of causation, excess cancer, and thyroid cancer analysis, was presented from four perspectives: the Project Director (Dr. Tom Widner, J.A. Jones Contracting), the ORHASP oversight and review panel (Dr. Bob Peelle), the dose reconstruction contractor (Dr. Owen Hoffman, SENES), and ATSDR (Dr. Michael Grayson). Some changes made to the I-131 report were described, some of which were a point of contention between J.A. Jones and SENES.
The ORHASP oversight and review pushed for a serious records search to investigate potential off-site releases; and strove to produce unbiased risk estimates and to address the public's concerns. They explicitly considered the study's many variables through the use of a Monte Carlo analysis to determine the 95% confidence level, since there is no evidence that the median value is either the real or the best answer. They also assumed that there was no threshold below which there was no risk of excess cancer. They addressed what appeared to be the most important pathways of contamination, and set the lesser ones aside for later study.
J.A. Jones provided more detail, focusing on the I-131 releases from the RaLa process, which was described in detail. Its emission points included a caustic scrubber, which was not always operated properly, and the processing equipment itself, which was used well beyond its design capacity. Since the RaLa process was unpredictable and monitoring was lacking, the study estimated iodine behavior in the system through the use of expert opinion, process modeling, and drawing from other sites' experience. Most of the iodine species of interest (94-99%) were elemental in form, with fractional amounts of volatile organic, non-volatile, and particulate forms. A scrubber model estimated 99% capture efficiencies when the caustic solution was used, which dropped by a factor of ten when water was used instead. However, the consultants thought those collection efficiencies to be overestimates; the estimated a 90-99% efficiency for elemental iodine and 50-99% when water was in the scrubber. Modeling of the elemental iodine releases estimated a line loss of 20-70%. An uncontrolled release in 1954 was outlined, but its releases were estimated to be small compared to routine releases. A description was provided of the process of modeling the I-131 deposition of the 1954 accident into a gridded circle with a 38km diameter around the X-10 central stack.
Short-term iodine releases recorded in site health physics reports were compared to the modeling results. The calculation of vegetation deposition was described, and the consideration of distribution of food products, as pertained to dose. The process of calculating the excess risk was also described, including the modifying factors, background risk, and other variables considered.
At points of exposure, females born in 1952 received the highest exposure, and was higher yet for those drinking milk from a "backyard cow." The influence of local fallout from the Nevada Test Site's (NTS) atmosphere weapons testing was added to the study doses. The calculations of average time and space concentrations, volumes of milk produced in the area, and the dose and risk factors earlier described, produced an expected 6-84 excess thyroid cancers within the 38 km area; 1-33 excess cases from backyard cow milk consumption; 14-103 excess cancers within 100 km, and 25-149 within 200 km. Most of those cancers could be expected to occur after 1970; a few could occur up to 2020.
The ORHASP noted the historical lack of monitoring and the late recognition of the milk pathway of contamination, but also that Oak Ridge city residents and workers were not highly exposed because the important pathway was milk ingestion, not air inhalation. Only those aged 5 years and drinking a lot of milk were at high risk, particularly those who drank goat's milk. There was a large range of risk. Some thyroid cancers, at most a couple of dozen, were estimated to have occurred as a result of exposure.
The ORHASP panel issued nine recommendations. Among them were to conduct a series of initiatives and public health activities in Oak Ridge; to strongly consider establishing a clinic to evaluate those who may have been affected; and to not do an epidemiological study of some of the contaminants due to low power. Ensuing discussion noted the controversy about the scrubber efficiencies, about the source of milk (even commercial milk) in the area, and the persistent unavailability of the tumor registry's data. The state epidemiologist, who was present, offered to help with the latter.
The SENES report has been programmed to code for individual use in estimating dose, which was demonstrated. The health implications of combined exposure to high levels of I-131, whether environmental or medical, can include destruction of the thyroid, requiring a lifetime of hormone replacement to offset hypothyroidism. Low levels of exposure can induce non-cancerous growths to the thyroid and benign nodules and thyroid function diseases such as autoimmune thyroiditis (under- and over-active thyroid). The evidence indicates that there is an elevated risk of autoimmune thyroiditis between 10-100 cGy.
Epidemiological detection is limited in its ability to find an effect between ~10-30cGy, even if it is present, because epidemiological studies have low statistical power due to the very high uncertainty of the dose estimate. But the NCI recently cited evidence that I-131, like other radiation exposures, has no dose threshold below which there is no risk. The sources of I-131 exposure were outlined (e.g., atmospheric weapons tests, medical treatments, nuclear facilities) which have produced considerable doses to individuals and populations. The gummed film network used to measure U.S. fallout during the atmospheric testing period was described.
The NCI's maps of all U.S. counties' I-131 exposures were shared. The difference between doses was shown according to average individuals and dates; children born in 1946 who drank milk with average consumption; children born in 1952 with average milk consumption; and those with the same birth date but higher-than-average milk consumption. The numbers of affected counties with dose ranges increased with each category, until the entire U.S. was shown to be affected.
The updated SENES dose and risk calculation program for combined exposures locally was demonstrated. It included I-131 released from X-10, the original estimates from the dose reconstruction, the caustic scrubbers and other ORR releases; and fallout from the NTS. The results showed minimal risk from a medical point of view, such that a person currently free of disease is likely to remain so. But the probability of causation comes into question for those with current thyroid cancer. The NTS fallout alone has been estimated to raise the chance of causing existing disease by 11-80%, and that from X-10, by 26-94%, when including the backyard cow scenario. Oak Ridge calculations were done for both regional and local commercial suppliers. The probability of causation for regionally-supplied milk was low, but was >50% for locally-supplied milk, due to Oak Ridge releases.
Importantly, the present estimates of the probability of causation exceed the eligibility criteria recommended for compensation and care of DOE workers (i.e., the upper 99th percentile of the probability of causation exceeding 50%). That means that if the present-day rules for compensation of workers were extended to children, those who were children in the 1950s would qualify for the compensation and health care if they drank milk and currently have thyroid cancer or a thyroid nodule.
SENES' opinion was that this provided a sufficient basis for the Subcommittee and ATSDR to consider a potential public health response, such as targeted population screening of those with thyroid disease who were exposed in childhood and who drank milk. SENES also called for quantification and adjustment of the RaLa releases with regard to the caustic scrubber; matching release data with meteorological, time, and terrain data (rather than using annual data); and consideration of the cumulative effect of exposure to all fallout radioiodines including the NTS, Marshall Islands, and Soviet Union.
ATSDR reported the results of their experts' technical review of the dose reconstruction document and the ORHASP report on the dose reconstruction's technical matter. The dose reconstruction technical review found the source term analysis to be complete and reasonable, although opinion was greatly divided over the sensitivity analysis. There was unanimity that the conclusions about public health effects were accurate: doses and the risks were too small to have significantly affected Oak Ridge residents, although certain groups had higher risks (females born in 1952, people between infancy and the age of five years during the times of the releases, etc.). The potential adverse health effects from iodine exposures were felt to be adequately described.
Their review of the ORHASP dose reconstruction report review found the technical information to be well conveyed for the general public and the recommendations to be reasonable. Improvements suggested included clarification for the general public of why an epidemiological study may not detect any increased risk; the inclusion of zero in the lower bound of the risk estimates; and emphasis on the central estimate and de-emphasis of the lower and upper bounds of uncertainty. They found some of the report's screening level methodologies to be internally inconsistent, and they thought that this type of screening index should not be used to determine relative risk or to identify important exposure pathways. It should be used to only to identify the contaminants posing a low health risk. They also noted the ingestion of contaminated vegetables and fish as primary pathways of concern (80-90% of dose), but allowed that this that may have resulted from the conservative screening, transfer, and bioconcentration factors used.
ORRHES discussion included confirmation that the Veterans Administration and the Labor Department are using the probability of causation in their adjudication of cancer claims; clarification that, although the uncertainty is present, it is not infinite, and some conclusions can be supported about past exposures; clarification that females are at higher risk from exposure than males, and children are at highest risk because they drink more milk and have smaller thyroids, which produces a difference of 10-20 times in the dose to the thyroid.
ATSDR presented an epidemiology workshop. What epidemiology can and cannot do was defined, and the common steps in establishing a relationship between exposure and disease were outlined. The basic principles of the use of statistics were presented, defining"rate", incidence, association (e.g., shown in a 2x2 table), relative risk, and standardized mortality ratios (SMR). The factors integral to measuring exposure and outcomes in environmental epidemiology were also outlined, defining what an outcome is, "body burden", and the relative value of varying measurements of exposure. Also described was how ATSDR explores biologically plausible outcomes: contaminant route of exposure, toxicity or level, and potential alternative explanations for an outcome. Importantly, it was noted that health effects are not uniquely caused by environmental exposures; 1 in 2 American men will develop cancer, as will 1 in 3 women. Cancer also is a complex disease to address. Americans have many voluntary risk factors such as smoking; and cancer is not one, but probably >100, different diseases that affect 40 anatomic sites.
The sources of information used to measure adverse health effects were outlined, along with their relative strengths and weaknesses. Finally, the basic criteria for considering the conduct of a health study were defined: that it is necessary, will advance knowledge about the relationship between exposure and disease; it is likely to be able to judge a cause-effect relationship; and likely to be able to judge the dose-response relationship.
Subcommittee Discussion included a request, if further epidemiology coaching is provided, that the presenters be familiar with the Hanford study; note that privacy issues can hamper studies by discouraging study participation; that the effect of the frequency and magnitude of exposure often depends on the contaminant; the benefit of large cohorts to a study's ability to find an outcome/association; that the nature of the design stage of study is to ensure that all the necessary data will be accessible; and that stratified analysis can help to address study confounders.
An update on the Public Health Assessment process was provided. Evaluation of all the site information gathered over the years, and identification of any contaminants of concern, were both initiated at the March ORRHES meeting. Ongoing and subsequent work includes the identification of community health concerns, determination/evaluation of a pathway of exposure, assessment of public health implications of exposure, and report on the conclusions and recommendations, including a site-specific action plan. In a related vein, the ORHASP's additional qualitative and quantitative screening of 18 other contaminants based on the quantities onsite and on expressed public concern was outlined. That study designated arsenic at K-25 and arsenic and lead at Y-12 as high-priority candidates for further study.
Subcommittee discussion ATSDR's agreement to investigate why X-10's coal burning was not shown as an arsenic source. It was questioned how the cumulative effects of combined materials could be addressed, noting that ATSDR will factor in NTS releases, but not those of the area power plants. The response was that that is a question of total risk, not that risk specific to ORNL that is ATSDR's mandate. While ATSDR can investigate what data are available to indicate total risk, their authority does not extend to doing detailed analyses of sites other than the Oak Ridge Reservation. Some members felt that, if all sources are not considered to indicate the true risk, the ORRHES final report should include a strong recommendation to look for all the contaminants' sources. ATSDR noted that their reanalyses, using updated maximum concentration transfer factors, can help to further establish the ORNL emission levels; and they can extrapolate potential contaminant spread to assess whether some contaminants could have come from another source. While detailed modeling of TVA or other sources is not within ATSDR's purview, if a public health hazard is determined, ATSDR will recommend a responsive public health action.
An overview of ATSDR's screening process was provided. Its three steps determine if the chemical concentrations are above acceptable screening levels, if they are above screening levels in areas of exposure, and if the calculated exposure doses exceed health values for each chemical in each area. The screening calculation is the Environmental Media Evaluation Guide (EMEG), used for water and soil. It multiplies the standard Minimal Risk Level times the Body Weight times the Ingestion Rate. Other factors such as bioavailability, cooking loss, chemical form of the contamination, etc., are considered later when the public health implications are examined.
Discussion included advice to ATSDR to be very clear that the limits of measurement are also a big factor, and that some conclusions may be based on equipment limitations rather than research; clarification about the origin of the ingestion rate data (for the first screening analysis, historical data from the site, state, and dose reconstruction; then for the second screening of more recent exposures, offsite sampling data); that some analysis has been done of the game living on the reservation (annual DOE monitoring reports, and Superfund cleanup ecological studies will include such data); and that, although the EMEG parameters are primarily for adults, any concerns particular to children are carried through in the analysis (e.g., lead).
The ATSDR Program of Work was presented in chart format and is attached to the minutes. Committee discussion included how to evaluate conflicting studies and how to solicit that kind of information
Work Group reports were provided by the Agenda, Public Health Assessment, Guidelines and Procedures, and Communications and Outreach Subcommittee Work Groups, all of whom were very active. The Health Needs Assessment Work Group reported initial discussion of some of the issues related to the assessment and the opening of communication links to help the work proceed better. A proposed Communications and Outreach Strategy was accepted by the Subcommittee, as was a proposed list of recommendations to ATSDR. A presentation of the ORRHES Website outlined the contents approved for placement to date (the Community Health Concerns Comment Sheet, the Oak Ridge Reservation Health Effects Subcommittee; and a summary of the March meeting). Subcommittee discussion included clarification that the health concerns collected will be retained as part of the record, but the format and contents of the database have not yet been determined; that the assessment could be broadened to collect other information on additional contaminants, pathways, or reports not addressed by ATSDR to date, if they relate to the public health assessment process; and advice that ATSDR include a few paragraphs about the many uses of this information and to invite the public's anonymous or attributed comment.
Public comment was provided by several members of the community and is detailed in the minutes. The comments included:
A denunciation of the I-131 study done of Oak Ridge releases, of the lack of progress made on the community's behalf after ten years of "community committees", of the need for a health study to show the exposures have been, and for health care for those already sick and dying. Funding should go to those priorities rather than further epidemiological study.
Doubt expressed about the scientific methods and the truthfulness of the DOE, ATSDR, and CDC documents used, which the panel was urged to not blindly accept as acceptable science.
A request that public comment be allowed throughout the meeting, and particularly during the presentations. (The Chair explained that the ORRHES had decided against the latter to allow uninterrupted full presentations and to ensure time for discussion.)
Advice to ATSDR to not only do the surveys, but also to listen to the information of offsite residents; to allow more comment than in only two 15-minute public comment periods; and questioned if any sick workers or sick residents were members.
The committee as reminded that DOE had publicly admitted that their records are flawed and inaccurate, and that is the basis of the much of the I-131 report. Other toxicants of concern also need to be addressed.
Note was take that the contamination from fish ingestion will not necessarily be measurable in the blood stream at high levels at all times, a challenge test is needed to detect it. This was not used by ATSDR and is not normally used in a standard physician's office visit test. It was reported that ATSDR formerly was chartered to set up health intervention clinic until Congress changed this 7-8 years earlier. That can be changed back; the Subcommittee was urged to recommend that, and to end "paralysis by analysis."
The ability of a clinic to provide data to the little available on additive or synergistic effects of contamination was noted.
An e-mail letter to the Environmental Quality Advisory Board was read from a person planning to move to the Oak Ridge area and worried about its environmental safety. The EQAB Chair's response was shared, reassuring him of no immediate threats to public health from the ORR, "unless surveillance and maintenance lapsesoccur and cleanup fails to occur." However, a member of the public disagreed, citing the potential of mercury vapor contamination from the incinerator.
Review of the state Health Department's gathered public input was advised.
A charge was lodged that the iodine release reports have been watered down.
Allowing an alternate member for a member who is ill was suggested.
The different issues of the workers from those of the residents ere noted. The perspectives of both ill workers and residents should be represented on the Subcommittee. The meetings would be improved by being less dominated by federal agency staff and certain committee members.
New Business included ATSDR's report of a planned Team Building Training Workshop for the Subcommittee members at the Children's Defense Fund Lodge in Clinton, on July 31. Alternative dates are also being explored. In Old Business a motion to table the topic of an ORRHES Vice-Chair indefinitely was unanimously carried. The applications for the ill-worker ORRHES member are now being considered. That seat will be filled when the federal hiring freeze is lifted. Noting that at almost every meeting there is public comment about no ORRHES member identified as a person ill with ORR-related health effects, ATSDR was advised to develop a collective biography of the Subcommittee to challenge those comments without needing to force anyone to self-identify. In addition, the members were united in a general feeling that the Subcommittee needs to exercise every effort to make the public feel welcome and as included in the meeting as possible. A motion to open the nomination process and to give preference (not exclusionary priority) to a sick resident as carried.
In closing comments, one member suggested setting a different meeting time outside of working hours, such as the evening, to encourage public attendance. However, it was noted that evening hours are ill-suited for the skilled craft workers, for example; and another member commented that the Subcommittee and Work Groups had already strenuously adjusted schedules to have meetings at times convenient to most people. Finally, ATSDR's new phone numbers and members' new e-mail addresses were shared. The members who volunteered for work groups were again asked to attend either in person or by conference call, to help the work group attain a quorum. The members also were again asked to be conscious of the need to maintain a quorum during Subcommittee meetings.
The action items, motions, and recommendations from this meeting are attached to the meeting minutes.