ORRHES Meeting Minutes,
June 11-12, 2001
Table of Contents
JUNE 11, 2001
Opening Comments
Presentation of the ATSDR Division
of Health Education and Promotion
Update of the Health Needs Assessment
Public Comment
Task One Report, Tennessee Oak
Ridge Dose Reconstruction Study
Perspective
JA Jones Perspective
SENES Perspective
Perspective
Committee Discussion
Public Comment
Continuation of Subcommittee
Discussion
Closing Comments
JUNE 12, 2001
Opening Comments
Presentation of the ATSDR Epidemiology
Workshop
Public Health Assessment Process
Presentation of ATSDR Screening
Process
Public Comment
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.
Unfinished Business
Public Comment
Closing Comments
Items
Housekeeping Issues
Attachments
Summary
of the Meeting
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.
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