ORRHES Meeting Minutes,
December 3 - 4, 2001
Table
of Contents December 3, 2001
Call
to Order, Opening Remarks, and Introduction of Subcommittee
Members
Agenda Review, Correspondence, and Announcements
Approval of June, July, and September Meeting Notes
Status of Action Items
Update on the Health Education Needs Assessment
Health Needs Assessment Work Group Report
Presentation and Discussion: ORRHES
Process and Administrative Issues
Discussion of ORRHES Evaluation
Work Group Reports
Update on the Scarboro Soil Sampling Project
Public Comment
Presentation and Discussion: Epidemiology Workshop Part
II: Discussion of the Mongano Report
Summary
Report
December 3 - 4, 2001
Present in the 12/3 and 12/4/01 Meeting of
the Oak Ridge Reservation Health Effects Subcommittee (ORRHES)
were the following Subcommittee members: Elmer Akin, Bob
Craig, Don Creasia, Kowetha Davidson (Chair), Karen Galloway,
Jeff Hill, David H. Johnson, Susan Kaplan, Jerry Kuhaida,
James F. Lewis, Peter Malmquist, LC Manley, Therese McNally,
Donna Mims Mosby, Chudi Nwangwa, Bill Pardue, Barbara Sonnenburg,
Brenda Vowell, and Charles Washington, Sr. Other attendees
included: LaFreta Dalton (ATSDR Designated Federal Official),
Jack Hanley (CDC/ATSDR), Timothy Joseph (Department of Energy),
Kendra Myers (Writer/Editor, Cambridge Communications),
and Jerry Pereira (CDC/ATSDR).
Call
to Order, Opening Remarks, and Introduction of Subcommittee
Members
The Oak Ridge Reservation Health Effects Subcommittee
(ORRHES) convened on December 3 and 4, 2001. Dr. Kowetha
Davidson, Chair, called the meeting to order at 8:15 am
on December 3. She asked that all meeting attendees identify
themselves for the record.
Agenda
Review, Correspondence, and Announcements
Dr. Kowetha Davidson, Chair
Oak Ridge Reservation Health Effects Subcommittee (ORRHES)
Dr. Davidson reminded the group that the September 11,
2001 meeting had been abbreviated due to the terrorist
attacks. Therefore, many agenda items from that meeting
had been carried forward to the agenda for December 3-4,
2001. She gave a brief overview of the Subcommittee's agenda,
which was adopted as written.
She then directed the group's attention to the following
correspondence:
- A letter from Norman Mulvenon, Chair of the Local Oversight
Committee (LOC), expressed concern about the Subcommittee
meetings which conflict with the LOC meetings. The Subcommittee
would avoid these conflicts whenever possible.
- A letter was written to Mr. Patrick Lipford of the
Tennessee Department of Health requesting documents that
were referenced in the Iodine-131 Dose Reconstruction
Report.
Dr. Davidson made the following announcements:
- The work group chairs would be available during the
lunch hour to discuss work group activities.
- Subcommittee members are asked to re-sign lists for
work groups. These lists would be used as the official
membership list for the groups.
- A copy of the mailing list would be circulated for
updates. If members of the public do not want their information
to be viewed by others, then they should notify Marilyn
Palmer before the list is circulated..
Ms. LaFreta Dalton made the following announcements:
- Group members should complete the checklist for consensus-building
behavior in preparation for the next day's evaluation.
- The hiring freeze at CDC has been lifted, so they are
now free to proceed with the selection process for new
members for the Subcommittee.
- She directed the group's attention to a handout about
the ORRHES meeting minutes. The members of ORRHES voted
to use detailed minutes rather than verbatim transcripts.
Public comments made during the meeting as well as after
the meeting become part of the public record.
- The recommendations regarding an ORRHES Mission Statement
were also available.
Discussion Summary:
- Mr. James Lewis asked about meeting minutes for work
groups. He felt that work groups would benefit for some
guidance in keeping minutes. Ms. Dalton noted that only
Subcommittee meeting minutes are subject to FACA regulations,
so each work group can create its own system for keeping
minutes.
- Mr. William Pardue wondered about how to address suggested
corrections from the public. Appending these suggestions
to the minutes does not indicate whether they are valid.
- Ms. Dalton said that based on citizen input during
the September meeting and also on information from a
presenter, the minutes of the June, 2001 meeting would
not be presented for vote. They are in the process of
reviewing the tapes and will make appropriate changes
for Subcommittee approval.
- Ms. Dalton said that public comments become part of
the public record and are included with the meeting minutes
in the Oak Ridge Field Office. If the minutes include
a misstatement from a presenter, then the tapes are reviewed
and necessary corrections made in the minutes. This policy
is consistent with other FACAs.
- Mr. Charles Washington said that statements made in
the FACA meetings are part of the public record. Corrections
made in writing also become part of the public record,
but do not change what was said.
- Ms. Dalton noted that public comments regarding the
minutes can be shared at subsequent meetings and will
thus be part of the public record.
Approval
of June, July, and September Meeting Minutes
Dr. Davidson asked the Subcommittee to review the July
and September meeting minutes, as the June minutes are
still under review.
Motion 1
Mr. Jeff Hill moved that the Subcommittee approved the
July and September meeting minutes. Dr. Robert Craig seconded
the motion. The motion carried unanimously.
Discussion Summary:
- Mr. Lewis wondered about an operating procedure and
deadline for modifying meeting minutes. He was concerned
about leaving the June minutes unapproved.
- Ms. Dalton replied that the normal time to review minutes
and to respond with comments is two to three weeks. The
June minutes represent an exception.
Status
of Action Items
Dr. Davidson directed the Subcommittee's attention to
a table provided by ATSDR that listed the status of action
items from the September meeting and from previous meetings.
Discussion Summary:
- Mr. Lewis commented that action items from the work
groups have an impact on the Subcommittee. He wondered
whether there was a mechanism for capturing these work
group action items. Dr. Davidson responded that the Subcommittee
addresses action items for the Subcommittee only. The
work groups address their own action items. Mr. Lewis
felt that since many of the action items fall to the
work groups, it would make sense to integrate them.
- Ms. Dalton noted that the table reflects action items
on which ATSDR was asked to act. The table provides a
way to track ATSDR's progress. Dr. Davidson added that
ATSDR does not respond to action items from the work
groups, but to Subcommittee action items.
- Mr. Pardue inquired as to how to tell which items are
recommendations and which are action items. Ms. Dalton
replied that the table includes all items to which ATSDR
has responded. In some cases, they are a combination
of action items and recommendations.
- Ms. Susan Kaplan wondered if there is a similar list
of major recommendations from other Subcommittees. She
was curious as to which ATSDR activities came as a result
of requests from the community. Ms. Dalton said that
recommendations from the Subcommittee usually come as
a result of discussion in work groups.
- Ms. Dalton offered to note which items on the chart
were recommendations and which were action items. She
also offered to include a statement about speakers on
the minutes process.
Update
on the Health Needs Assessment
Dr. Rebecca Parkin
George Washington University
Dr. Parkin presented an update on the Health Education
Needs Assessment. She explained that the purposes of the
Health Education Needs Assessment are to:
- Identify the community's current health concerns and
information needs; and
- Provide a current data summary for the timely implementation
of a health education action plan.
There are seven steps in the process, and they are continuing
to conduct document reviews and site visits. Key resource
interviews were conducted from July through October. Telephone
interviews are forthcoming, as are focus groups.
Three Institutional Review Boards (IRBs) are involved
in this project:
- George Washington University Medical Center IRB
- The MCP Hanneman University IRB
- The Tennessee Department of Health (which is serving
as a repository of information)
These boards ensure that the research is ethical and scientifically
sound in its structure and operations. They also ensure
the confidentiality and protection of individuals who participate.
The initial reviews were done in October, 2000, and final
approval for the research methods has been received. The
telephone survey questionnaire is under review. The focus
group materials are in draft form, as they cannot be finalized
without data from the telephone survey.
The goal of the key resource interviews was to reach 25
- 30 people in each of three main categories:
- Health officials
- Healthcare providers
- Key resources in the community
This part of the process is designed to collect information
from people who have responsibility in their jobs for health-related
issues. 156 individuals were contacted and 74 interviews
were completed, as the IRB protocol limits contact attempts
to two.
Telephone exchanges to be included in the telephone survey
have been identified and the forms have been pre-tested.
The questionnaire is being computerized for rapid collection
and analysis of the data. There will be a completed rate
of 400. The telephone survey is intended to collect a broad
view of residents' concerns. The Public Health Assessment
(PHA) work group has been helpful in shaping the focus
group aspect of the Assessment Project. Information from
key resource interviews and telephone surveys will feed
into the groups. These two methods of collecting information
present opportunities to understand residents' issues more
deeply. Eight groups will be scheduled in a compressed
time period. IRB approval is expected in January, 2002
so the focus groups will likely be held in late February
or early March.
The final report will include background information,
documentation of methods used, technical results from each
of the three research components, and a recommendation
for a Health Education Action Plan. The Plan will document
current health issues, the views that people have about
the issues, the health education information that people
are looking for, and how they would like to get that information.
Developing an Action Plan includes the following elements:
- Defining the desired outcome(s)
- Identifying forces that can help and limit the Plan's
implementation
- Assessing how these forces can be used
- Advising how an Action Plan can be conducted
- Suggesting alternative strategies
The Plan also includes resource and time-frame estimates
for recommended actions and evaluation activities. Stakeholders
include the Subcommittee, community leaders and other individuals
in the community, healthcare providers, and community organizations.
Subcommittee and PHA work group input on the draft report
will be needed.
Discussion Summary:
- Mr. Washington asked if a grid could be created to
identify where certain questions came from. For instance,
members of some communities might not attribute an illness
to their proximity to a nuclear facility. Dr. Parkin
answered that the telephone survey will make that information
accessible via telephone exchanges. The key resource
interviews do not include that information, as the individuals
interviewed were assumed to have broad experience. The
geographic analysis will depend on the richness of the
information. Being too specific with this information
runs the risk of identifying the personalities involved
in the survey and thus breaching confidentiality.
- Mr. Lewis asked whether the telephone interviews will
collect distinctions between residents who are workers,
who self-identify as "sick workers," and other types.
Dr. Parkin was not sure that the questionnaire asks whether
participants have worked at the site, but there are opportunities
within the questions' structure for interviewees to let
it be known that they worked at the site. It is important
to remember that answers cannot be prompted in the interview
in order to ensure that the responses are not biased.
- Mr. Lewis commented that the Subcommittee focuses on
residents, not on self-identified sick workers. He hoped
to gather information on those who feel that their health
issues are as a result of being off-site, not on-site.
Dr. Parkin replied that the telephone survey will use
a random sample of residents, so it is not focused on
workers.
- Mr. Lewis commented on the word "education" and what
constitutes it. An "Education Action Plan" seemed predetermined.
Dr. Parkin replied that "education" can be a component
of a risk communication strategy. It is a particular
method for transferring information from individuals
who have special knowledge about a topic of concern to
people who want that information.
- Ms. Barbara Sonnenburg recalled that part of the project
would include concerns that do not involve education.
Dr. Parkin answered that the telephone survey includes
collecting health issues for individuals and families
as well as health education and information concerns.
- Mr. Lewis asked about the document review. He wondered
if they could capture concerns from this part of the
process. Dr. Parkin said that these concerns would be
documented in the final report.
- Mr. Lewis hoped that the PHA work group concerns could
be connected to issues of contaminants of concern. Dr.
Parkin observed that these issues might not be captured
in a telephone survey of limited length. The telephone
survey will assess beginnings of concerns about connectedness
between health issues and contaminants, and the focus
groups will then probe the issues more deeply.
- Ms. Sonnenburg hoped that the types of focus groups
would be brought to the work group before the final decision
is made about what the groups are. Dr. Parkin said that
they would.
- Dr. Davidson asked whether the rationale for selecting
focus groups would be shared. Dr. Parkin replied that
it would, without revealing results from previous parts
of the survey.
Health
Needs Assessment Work Group Report
Donna Mosby, Member
Oak Ridge Reservation Health Effects Subcommittee (ORRHES)
Ms. Mosby reported that the Health Needs Assessment Work
Group had assisted in the planning for the needs assessment
in the following ways:
- They estimated travel time and distance that people
would be willing to travel for focus groups.
- They identified major events in the communities, which
will be helpful in planning the focus group meetings.
- They are providing suggestions for appropriate meeting
locations in the various communities.
- They are providing input regarding public notification
for the focus groups.
Mr. Lewis added that the work group had been concerned
about the possibility that the focus groups might be too
large. Alternatives such as "availability sessions" or
a town meeting will assure community input.
Presentation
and Discussion: ORRHES Process and Administrative Issues
Dr. Jerry Pereira
CDC/ATSDR
Dr. Pereira described a recent meeting that he, Sandy
Isaacs, and Bert Cooper conducted in Oak Ridge. He suggested
that the Subcommittee wait to conduct their self-evaluation,
as many of the issues that emerged from his meetings were
being addressed currently.
The ORRHES is established to advise ATSDR, and possibly
other federal agencies. For this function to be effective,
the agency should not give a series of presentations to
the Subcommittee. The Subcommittee needs good information,
but it is also incumbent upon the agency to request input
and assistance from the Subcommittee. The agency should
take responsibility for achieving closure on these topics.
There should be thought given to collapsing work groups.
Accurate work group minutes are important, but the work
groups do not supplant the Subcommittee. Decisions have
to be made in the Subcommittee.
Budget talks are beginning, and the funds available for
Oak Ridge will not be certain until February or early March.
Fiscal responsibility is required. Dr. Pereira said that
he would assess the budget available and the needs of the
Subcommittee and ask for more funds if they are needed.
He will keep the Subcommittee informed.
When the Oak Ridge Field Office was established, the agency
selected Bill Murray to be the Field Officer because of
his experience and because of the technical issues of Oak
Ridge. The agency, however, did not consider the need for
administrative and logistical support in the office. Dr.
Pereira hoped to establish an absolute process for, and
system of, maintaining files and records. There is also
the possibility of using a software package for this maintenance.
There will be new staff in the Community Involvement Branch
in Atlanta, and these staff members might be able to provide
additional support.
He explained that Jack Hanley is the lead for this site.
Sandy Isaacs and Dr. Pereira have overall management responsibility
for the site. Dr. Paul Sharpe is the Senior Health Physicist
in Atlanta. Ms. Dalton, as the Designated Federal Officer,
advises the Subcommittee regarding the federal aspect of
the law. She assists with other tasks, but her key role
is this advisory one. Marilyn Palmer is the Committee Management
Specialist. Coordination is critical between this Subcommittee
and other agencies. Dr. Pereira recommended the following
changes in the field office hours:
- Mondays: Noon - 8:30 pm
- Tuesdays, Wednesdays, and Thursday: 10:30 am - 7 pm
- Fridays: 7:00 am - 3:30 pm
The agency will strive to keep the office open in the
event of Dr. Murray having to be away.
Subcommittee meetings usually occur every three months.
This timing does not lend itself to process or to steady
progress. The agency considered benefits and limitations
to the current, two-day format for the meetings and has
created new formats for consideration. The new options
are:
- Option A: One, 4-hour meeting per month. This option
would be very difficult to manage logistically. It is
also not fiscally feasible.
- Option B: One, full-day meeting approximately every
six weeks. This option this will increase efficiency
and put pressure on the agency and the Subcommittee to
be prepared.
Dr. Pereira supported Option B and assured the Subcommittee
that they would not "stuff the agenda." For instance, if
the full Subcommittee does not have a full day of agenda
items, then the remaining time could be spent in work group
meetings. Costs for each option were circulated. Option
B was the most cost-effective. Other methods for conserving
budget dollars includeusing a local recorder and meeting
in a location that does not charge a fee, such as the YMCA.
He observed that Oak Ridge is the most committed community
in which he has worked. Because of that commitment, he
is focused on helping the Subcommittee get its work done
and on facilitating the work group activities.
Discussion Summary:
- Ms. Dalton reminded the group that they are paid $250
per day, regardless of the length of the meeting. They
cannot pay "half days" at present, but Committee Management
is assessing the possibility of pro-rating the salaries.
The language in the charter would have to be amended
to pay half-days. At this point, however, Option A is
not possible. If Option B is selected, and it is possible
to hold work group meetings on the same day as full Subcommittee
meetings, then the work groups would only have one additional
meeting per month.
- Ms. Sonnenburg supported Option B, but pointed out
that if the Subcommittee's agenda is full, then it will
not be possible to hold a work group meeting that day.
She did not want to meet for more than ten hours in a
day. Dr. Pereira agreed, adding that work group meetings
would only be included if the Subcommittee meeting agenda
is not full.
- Ms. Sonnenburg asked about the procedure by which the
Subcommittee could request, for instance, a person from
an agency to speak at a Subcommittee. Dr. Pereira sais
that the first question is whether the requested agenda
item is germane to the work of the agency and the purpose
of the Subcommittee. Dr. Davidson added that the work
group chairs could communicate these questions to Ms.
Sonnenburg as the chair of the Agenda Work Group. Ms.
Sonnenburg wondered whether a Subcommittee vote was needed
to set an agenda item. Dr. Davidson replied that a full
Subcommittee vote was not necessary.
- Ms. Sonnenburg observed that outside consultants had
accounted for over half of the past year's budget. She
wondered whether the Subcommittee or Agenda Work Group
could be consulted in the future before these consultants
were brought on. Dr. Pereira answered that part of the
large figure was due to Subcommittee start-up. He expected
the figure to drop in the year 2002. Dr. Hanley added
that much of the budget was devoted to preparing for
the Health Needs Assessment. Dr. Pereira felt that the
Subcommittee should approve future expenditures on lecturers
or contractors.
- Dr. Jerry Kuhaida felt that having an administrative
assistant in the field office would have a major impact
on the work of the Subcommittee. The ability to keep
track of Subcommittee and work group progress will help
them be prepared for meetings every six weeks. He also
offered to suggest meeting locations that were free of
charge.
- Ms. Kaplan said that the Subcommittee had asked that
budget information be made available on the website.
Openness in government is crucial to public acceptance.
She wondered about other ways to save money, such as
not flying consultants in to meetings and having video-
or tele-conferences. Dr. Pereira noted that teleconferencing
is very expensive, but he appreciated Ms. Kaplan's point.
He said he planned to take responsibility for how money
was spent and he encouraged the group to focus on getting
closure on items.
- Ms. Dalton was aware of previous requests for budget
information. The agency has to get approval before releasing
any of that information. She reiterated that the majority
of funds were connected to the Subcommittee start-up.
She noted that usually, speakers are invited to the Subcommittee
based on requests from the work groups. These speakers
are given an honorarium. If external speakers who require
compensation are requested, then Dr. Pereira wants the
request to be justified.
- Mr. Pardue was encouraged by the proposed changes.
He suggested hiring part-time administrative support
for the Oak Ridge Field Office. Dr. Pereira hoped to
use his existing staff to create a process to manage
the office. The possibility of having local, part-time
help would be considered, along with the possibility
of using Atlanta staff on occasion, when the budget information
becomes final in February, 2002.
- Mr. Pardue asked about potential disagreements between
agency branches, the Subcommittee, or development of
the PHA. He wondered whether Mr. Hanley had the authority
to resolve discrepancies and budgetary responsibility
as a Project Manager. Dr. Pereira replied that Mr. Hanley
has a responsibility to complete the Public Health Assessment.
Decisions involving personnel, time, or money may require
approval.
- Mr. Hill reflected on Option B, suggesting that the
days be eight hours long, not ten. He also supported
conducting meetings from 12:00 pm until 7:00 pm. A problem
with conducting meetings at the YMCA is having adequate
time for lunch, as restaurants are not accessible. Also,
the meetings do not necessarily have to be in Oak Ridge.
If they are held in other communities, then those communities'
participation level might go up.
- Mr. Lewis complemented Dr. Pereira for capturing key
issues that had been addressed at the meetings. He feels
that the ability to generate detailed minutes from the
work groups is critical, and that project planning will
help them plan their budgets. He advocated for establishing
a community health-related concerns database with sorting
capabilities that would allow for links between concerns
and findings. He pointed out the difficulty in addressing
and closing issues if they have not identified the issues
themselves. These issues are integral to having an infrastructure
in place and to make their work effective not just for
the Subcommittee, but also for the members of community.
He suggested that the work groups comment on the proposed
changes before they take effect. He also supported a
periodic "lessons learned" meeting with the ATSDR management
team.
- Dr. Pereira felt that a work group should help create
the Standard Operating Procedure (SOP) for the field
office. There is also the potential for using project
management software. He again suggested that the Subcommittee
wait to conduct its evaluation.
- Dr. Davidson asked the Subcommittee to make a recommendation
to ATSDR for their meeting format.
Motion 2
Ms. Sonnenburg moved that the Subcommittee recommend adopting "Option
B" to the agency; that is, meeting every six weeks, and
that attempts be made to ensure that the meetings last
no longer than eight hours. Mr. Hill seconded the motion,
and the Subcommittee had the following discussion.
Discussion Summary:
- Mr. Hill suggested that the meetings should be held
from 12:00 pm until 8:00 pm, or from 11:00 am until 7:00
pm. He also asked for discussion regarding rotating meeting
locations.
- Mr. Lewis expressed concerned that rotating the meeting
locations would conflict with the goal of saving money.
The upcoming focus group meetings and other community
meetings might capture the issues that would be addressed
by rotating the meeting locations. Dr. Davidson said
that the purpose of rotating meeting locations was so
that community members could be introduced to the Subcommittee
process and so that the Subcommittee could see the members
of other communities.
- Dr. Craig suggested that the motion not demand that
meeting locations rotate, but indicate that rotation
is a priority.
- Mr. David Johnson felt that potential locations should
be considered in the nine counties that make up the area
of concern. Dr. Pereira said that rotating meeting locations
shows good faith on the part of the Subcommittee and
the agency.
- Ms. Sonnenburg wondered if the motion could incorporate
wording to indicate that meetings would move locations
occasionally.
- Mr. Lewis approved of Option B as an interim measure,
but felt that Option A should also be considered as a
possibility for the future, perhaps in a work group.
- Dr. Davidson was not in favor of Option A because of
logistical and administrative problems such as filing
in the federal register.
- Ms. Kaplan said that a work group should examine the
options, but that the Subcommittee should adopt Option
B now, knowing that it could change in the future.
Motion 2 - Amended
This motion was amended as follows: The Subcommittee recommends
adopting "Option B" to the agency; that is, meeting every
six weeks. The meetings will last from approximately 12
noon until 8 pm, and ATSDR will consider rotating the meeting
locations at its discretion. Dr. Davidson called for the
vote. The amended motion passed by a vote of 13 in favor
and 1 opposed.
Discussion of
ORRHES Evaluation
Ms. Jan Connery
Eastern Research Group (ERG)
Ms. Connery addressed the group via telephone, explaining
that the self-evaluation would focus on the Subcommittee's
function and involve Subcommittee members and liaisons.
Ms. Connery offered the following reasons to conduct this
evaluation:
- The proposed evaluation complements ongoing efforts
and contrasts ongoing feedback mechanisms. Often, mechanisms
for offering feedback or making changes or improvements
rely on spontaneous communication. While this communication
among Subcommittee members is important, it may only
occur in one work group. Not all members, therefore,
have the opportunity to contribute. It is impossible
to involve all members in meetings, and comments offered
are not anonymous, so some members may not feel comfortable
sharing their thoughts. This evaluation would dovetail
into the extant mechanisms for gathering feedback. With
this system, all Subcommittee members will lend their
anonymous input. They will have time to reflect on issues,
rather than having to offer their initial thoughts in
a meeting.
- Timing is good. The Subcommittee has been in existence
for one year and has been able to experience the four
stages of becoming a functioning unit:
- Forming: The initial coming-together
- Storming: The difficult stage of getting
adjusted and developing ground rules
- Norming: "Getting in the groove" to function
effectively
- Performing: When the group is able to produce
She suggested that the Subcommittee is in the "performing" stage,
which lends an opportunity to reflect on the first three stages and
to think about how the Subcommittee's function can be improved. As
it is still a young group, the Subcommittee is still flexible.
- It is recommended by COSMOS report. The COSMOS report
represents a "mega-evaluation" commissioned by CDC. It
involved four other subcommittees, and amongst its conclusions
was the suggestion that "periodic evaluation of the advisory
process should identify areas of concern early (before
they impede the advisory process), and, as a result,
improve the cost-effectiveness of the advisory process
(currently a major concern to agencies)."
There are several goals for the evaluation:
- Obtain constructive feedback
- Generate ideas for improving Subcommittee function
- Give all members a chance to participate
- Provide a baseline
Since the evaluation will include all members' input,
the final report will discover themes and similarities
in what members feel should be improved and in what works
well. If evaluations are done in the future, then this
initial report will provide a baseline by which progress
and improvement can be measured. The self-evaluation will
be open-ended. It will be comprehensive because the questions
will prompt feedback in a variety of areas.
The process for the evaluation begins with a collection
of proposed areas that it should cover. All Subcommittee
members will have a chance to contribute to the evaluation's
substance. Then, ERG creates the format for the evaluation.
Subcommittee members complete the evaluation, and ERG creates
a summary report from all of the comments, which will be
provided at the next Subcommittee meeting. There are three
ways to participate in the evaluation so that it will be
convenient. Subcommittee members can respond by e-mail,
fax, or via telephone with an ERG staff member.
The anonymity of the evaluation is very important, so
responses can be sent via postal mail. Further, anonymity
will be assured when ERG blacks out identifying information
on the responses. The report will not include names or
even genders. Copies of individual evaluations will not
be available.
Areas that have already been suggested for inclusion in
the evaluation include:
- Subcommittee meeting format and procedures
- Effectiveness of the chair
- Effectiveness of work groups
- Interaction of Subcommittee with ATSDR, liaison members,
and members of the public
- The Subcommittee's access to consultants
Next steps for the Subcommittee are to:
- Decide whether the Subcommittee will conduct the evaluation;
- Provide input on evaluation topics; and
- Participate in the evaluation.
As Subcommittee participation is so important, Ms. Connery
suggested that voting in favor of doing the evaluation
implies a commitment to participate, and she suggested
a time-line and provided her contact information.
Discussion Summary:
- Mr. Peter Malmquist observed that the Subcommittee
had already conducted a self-evaluation in the meetings
with Dr. Pereira and other ATSDR staff. He felt that
hiring ERG at this time would be a waste of money. Mr.
Lewis agreed that Dr. Pereira had already addressed the
Subcommittee's issues that had emerged after the series
of meeting. He suggested that the Subcommittee take time
to see how the changes work before conducting a self-evaluation.
- Dr. Davidson noted that the work is only proposed at
this point, noting that the proposed self-evaluation
would have more detail than the meetings with Dr. Pereira.
The format also lends itself to getting more feedback
from more members of the Subcommittee, as not all members
participated in the meetings. This evaluation would yield
a written report that could be used as a baseline.
- Ms. Kaplan complemented the use of the telephone for
Ms. Connery's presentation. She also proposed compiling
the information from the meetings with ATSDR staff into
a report.
- Ms. Connery was not familiar with how the information
was captured, but if the notes were written or on tape,
she said she could prepare a summary report from them.
She asked whether the evaluation with ATSDR was comprehensive.
- Dr. Davidson observed that the meetings were focused
on concerns rather than on both positive and negative
aspects of Subcommittee function. She hoped that Subcommittee
members would evaluate their individual participation.
- Mr. Lewis commented that when the Subcommittee has
direct access to consultants, work goes more smoothly.
He also felt that work group function should be examined.
- Dr. Davidson noted that in the meetings with ATSDR
staff, she did not receive feedback on her effectiveness
as the chair. Mr. Lewis added that the chairs of the
work groups would benefit from feedback as well. They
should consider how to get better participation from
all Subcommittee members in work groups.
- Ms. Dalton said that discussions with ATSDR were helpful,
but an evaluation from ERG gives the opportunity to capture
everyone's comments and concerns.
- Dr. Kuhaida said that going through another evaluation
process would be duplicative. He did not participate
in the meetings with ATSDR staff members, but the issues
and proposed changes represent a major step for the Subcommittee.
- Dr. Davidson observed that the Subcommittee did not
appear to want to pursue the self-evaluation at this
time.
- Ms. Connery reflected on the possibility of creating
a report from the ATSDR staff meetings. She suggested
that such a report could be created and then circulated
to members of the Subcommittee for additional comments.
With this approach, Subcommittee members who were not
at the meeting could provide input. ERG could consolidate
those comments into an addendum to the report. This idea
relied on clear records from the meetings and on whether
Dr. Pereira is willing to share his notes. Mr. Lewis
suggested interviewing the ATSDR staff who participated
in the meetings to supplement the notes.
- Mr. Washington felt that having an unbiased person
create the evaluation was preferable. He had not known
of the ATSDR staff meetings, so his input would not be
reflected in the notes from the meetings. He supported
adding a sick worker who is receiving Social Security
to the Subcommittee. He had participated on FACA committees
that included members who were receiving Social Security
benefits. Dr. Davidson said that the ATSDR staff visits
were announced via e-mail and postal mail. She was sorry
that the information had not reached Mr. Washington.
- Mr. Washington said that e-mail is not a good medium
for communication. He noted that members of the public
may feel that the Subcommittee is working in areas that
are not in the interest of the Oak Ridge communities.
Dr. Davidson said that this project is a self-evaluation,
so it is conducted only by Subcommittee members.
Motion 3
Mr. Malmquist moved that the Subcommittee not enter into
a self-evaluation at this time. The motion received a second.
Motion 3 - Amendment
Ms. Mosby amended the motion, adding that a summary of
comments from the ATSDR staff meetings be created, that
the Subcommittee assess the effectiveness of the new changes
in format and procedure, and that the Subcommittee then
evaluate its work in mid-year, 2002. The amendment received
a second. The amendment passed with a vote of 12 in favor
to 2 opposed.
Motion 3 - Amended
The Subcommittee would not enter into a self-evaluation
at this time. Instead, a summary of comments from the ATSDR
staff meetings will be created. The Subcommittee will assess
the effectiveness of the new changes in format and procedure
and evaluate its work in mid-year, 2002. The motion was
approved with 11 in favor, 2 opposed, and 1 abstention.
Ms. Dalton reminded the group that work group chairs would
be available during the lunch hour to discuss ongoing
activities and to provide updates.
Dr. Davidson reminded the group to re-commit to the work
groups. Mr. Hill said that work groups require a quorum,
so he hoped that people who signed up would attend meetings.
Mr. Lewis added that work group members should take on
responsibilities. Mr. Washington noted that any member
of the public can become a member of a work group.
Work Group
Reports
Chair's Presentation
Dr. Kowetha Davidson, Chair
Oak Ridge Reservation Health Effects Subcommittee (ORRHES)
Dr. Davidson began the Work Group Reports with a presentation
from the Guidelines and Procedures Work Group. The Subcommittee
did not vote until the next day. The Guidelines and Procedures
Work Group had set to the task of amending the Subcommittee
bylaws. This review was scheduled for the September meeting,
but was postponed. The first proposed change was in Article
9, Section 4, which currently reads:
"The Work Groups shall include the Guidelines
and Procedures Work Group, the Agenda Work Group, and
the Communications and Outreach Work Group."
The proposed change:
"The Work Groups shall include the Guidelines
and Procedures Work Group, the Agenda Work Group, the
Communications and Outreach Work Group, the Health Needs
Assessment Work Group, and the Public Health Assessment
Work Group."
The rationale for this change is that these two additional
work groups will be active for some time.
The second proposed change was to this extant statement:
"A quorum at work group meetings shall
consist of a simple majority of Subcommittee members
who are members of the work group."
The proposed change:
"A quorum at work group meetings shall
consist of two Subcommittee present in person at the
meeting."
The rationale for this change comes from the difficulty
that some work groups have experienced in reaching a quorum.
This amendment will allow the business of the work group
to continue even if the majority of Subcommittee members
are present. This proposed change is not designed to circumvent
establishing work group meetings at a time which a majority
of members can attend. Meetings are best scheduled after
4:00 pm.
The last proposed change was an addition to Article 9,
Section 14 and addressed Subcommittee members who sign
up for work groups but who do not attend work group meetings:
"Subcommittee members who are absent in
person or by conference phone from three consecutive
work group meetings and who do not provide advance notification
of their absence to the work group chair shall have their
name removed from the roster of the work group. The member
may be reinstated after providing notification to the
work group chair prior to the next work group meeting
of their intention to join the work group."
Subcommittee members should recommit to the work groups
so that there is no question as to the work group's membership.
Communication with the chair is key.
Discussion Summary:
- Mr. Lewis wondered about the possibility of combining
some of the work groups. Dr. Davidson said that if the
Subcommittee elects to combine work groups, then the
bylaws can be amended as needed.
- Mr. Washington felt that the third change made work
group functions excessively difficult. Each work group
should determine its procedures within the purview of
the FACA charter. He felt that the simpler the procedures,
the more work that can get done.
- Dr. Davidson commented that work groups do not function
under FACA, but operate according to guidelines established
by the Subcommittee. Few bylaws pertain to work groups,
and the proposed changes offer some structure for them.
- Mr. Washington felt that if structure is left to the
discretion of the work group, then more work will be
accomplished. For instance, other FACA groups' work groups
keep detailed minutes.
- Ms. Kaplan said that the third change might be irrelevant
if the changes in how quorum is achieved are adopted.
- Dr. Pereira said that the issue is not how many Subcommittee
members attend each work group meeting, since Subcommittee
members who are not officially members of work groups
are still welcome to attend work group meetings as citizens.
The issue is defining the original members of the work
groups.
- Dr. Davidson felt that if a Subcommittee member commits
to a work group, he or she should take responsibility
for participating in the work group meetings or at least
inform the chair if he or she is unable to attend a meeting.
- Mr. Lewis likes work groups because they help clarify
issues to bring to the Subcommittee for resolution. He
feels that work groups need Standard Operating Procedures
(SOPs). Their function will then be more efficient. Dr.
Davidson said that work groups can establish their own
SOPs, as the Subcommittee bylaws are general in their
guidance.
- Mr. Pardue described the process used by the end-use
working group. Any member of the public can participate
in meetings, voting and contributing their expertise.
The work group deliberated on issues. He favored as informal
a structure as possible, but recognized that there has
to be some structure. The current process works well.
- Dr. Davidson emphasized that these bylaws only apply
to Subcommittee members, not to members of the public.
- Ms. Mosby commented that work group business cannot
be conducted if members are not present. The suggested
changes support getting work done in the work groups.
Agenda Work Group Report
Ms. Barbara Sonnenburg, Member
Oak Ridge Reservation Health Effects Subcommittee (ORRHES)
Ms. Sonnenburg presented a report from the Agenda Work
Group, explaining that she is newly appointed to her position
as chair. The group met twice before the current meeting
and made few changes, as many of the agenda items were
carried over from the abbreviated September 11th meeting.
She asked Subcommittee member to approach her with ideas
for the agenda, whether specific items or general areas
that need to be addressed.
Communications and Outreach Work Group
Mr. James F. Lewis, Member
Oak Ridge Reservation Health Effects Subcommittee (ORRHES)
Mr. Lewis reported that his co-chair in the work group
had resigned. The work group met on November 8th and
focused its discussion in three areas:
- The status of website
- The fact sheet
- Concern forms
The work group created a recommendation for adopting a
website layout and linkages. The fact sheet is intended
to describe the essence ORRHES. It includes information
about the Needs Assessment, the Public Health Assessment,
and how the work groups work together to get information
to the public. Members of the work group identified a sample
form that could be made available to the public to capture
concerns. Approval for these forms is necessary, and work
is being done to obtain this approval.
A non-Subcommittee member recommended developing a database
to capture concerns that have been raised both by historical
work and by ongoing work. It is critical to capture these
issues, consolidate them, and provide linkages to resolutions
or findings related to them.
Ms. Dalton previously circulated drafts of a fact sheet
and a community health concerns sheet. Since then, the
Communications and Outreach work group developed its own
sheet, so they were combined. The concern sheet may not
include questions, because it could then be construed as
a survey. A draft of the combined sheet would be available
soon, including language suggested by the work group.
Mr. Lewis commented that the process of creating the website
had been frustrating. He hoped that a formal communication
strategy could be developed for the work group and for
the Subcommittee as a whole. There is an existing website
that is not an official ATSDR, ORRHES website. It is important,
therefore, to get their site "up and running."
Discussion Summary:
- Dr. Davidson clarified that ORRHES does not have a
website, official or unofficial.
- Ms. Dalton indicated that they are awaiting approval
from the Subcommittee on the proposed templates for the
website. Everyone has had the opportunity to evaluate
the draft templates. The Communications and Outreach
work group recommendations on site maps and templates
were indicated in the pre-meeting materials. Once the
templates are approved, the contractor has to apply the
links, then pilot-testing can begin. She estimated this
time at two weeks.
- Dr. Davidson reminded them that the work group had
recommended that the Tennessee Department of Health (TDH)
and Environmental Protection Agency (EPA) links be included.
Ms. Dalton said that links can be added later, but the
larger headings cannot be changed.
- Ms. Kaplan asked whether budget information could be
included. Ms. Dalton replied that information that has
been presented as public information could be included.
- At Mr. Lewis's request, Ms. Dalton described the process
by which the site would be controlled and maintained.
Once it is finalized by the contractor, it still has
to be approved by the internal ATSDR website committee.
It can then be included on the ATSDR home-page.
- Dr. Davidson wondered if the Communications and Outreach
Work Group would consider places in outlying areas where
the Subcommittee could put its information.
- Mr. Lewis suggested that HRSA might be a "related link." Dr.
Davidson added that NIH could be included because of
their work with iodine.
Public Health Assessment (PHA) Work Group Report
Mr. Bill Pardue, Member
Oak Ridge Reservation Health Effects Subcommittee (ORRHES)
Mr. Pardue referred to a memo which summarizes the work
group's recent activities. They meet twice a month and
the meetings are well-attended. Meeting summaries are available,
as Ms. Galloway has served as their recorder. Having a
defensible, factual, permanent record will be important
as the group will work for some time and have personnel
changes.
Their work began by examining the PHA process. They also
considered the technical issues associated with the Iodine-131
reconstruction part of the PHA. After an epidemiological
workshop, the work group engaged in a "dry run" evaluation
of an epidemiological report by Dr. Joseph Mangano. Dr.
Mangano's report concludes that increases in cancer rates
in Oak Ridge are attributable to radiation releases from
the Oak Ridge Reservation. Dr. Lucy Peipins led the work
group through an evaluation of that report, which led to
the work group's assessment that the information in the
report does not support the conclusions reached.
The PHA group also developed a case history file, which
is a systematic capturing of concerns that the public brings
to the Subcommittee. Mr. Lewis added that this approach
provides summaries of their efforts, including reports.
When conclusions are reached, it will be possible to retrace
the logic and process that led to them.
Mr. Pardue listed the PHA's recommendations:
- The Mangano paper should not be considered in the development
of the Public Health Assessment.
- EPA is undertaking a soil sampling program in Scarboro.
The Subcommittee was under the impression that a wider
program would cover a larger community area, which most
citizens seem to support. The status of this larger program
is still uncertain. Therefore, the PHA work group has
drafted a letter to Dr. Koplan, Director of CDC/ATSDR,
which includes recommendations as to how that program
should be designed and conducted.
- The PHA work group supports the need for administrative
help in the Oak Ridge Field Office, particularly in maintaining
files and records.
Discussion Summary:
- Mr. Washington commented on the range of uncertainty
in the data used in the Mangano report due to the time
that numbers of deaths in Oak Ridge began to be counted.
There are also uncertainties in exposure numbers. He
asked about how decreases in cancer deaths in Oak Ridge
compare to the general population of the United States.
Mr. Pardue replied that he did not have the exact numbers.
Dr. Davidson added that in the evaluation, they did not
use numbers or information that was not included in the
report.
- Mr. Pardue explained that the work group considered
the reasonableness of the interpretations made in the
report. Deficiencies in the report were included in a
matrix. Some members of the work group had consulted
the National Cancer Institute (NCI) website to gather
other data regarding cancer deaths. Mr. Washington noted
that data regarding cancer deaths in the Oak Ridge vicinity
have just recently been kept. Mr. Pardue said that the
work group pointed out that data were uncertain in the
1950's.
- Ms. Kaplan commented on the work group's struggle with
finding a person to keep their minutes. She expressed
her appreciation for Ms. Galloway's work.
- Mr. Washington wondered about the appropriate level
of detail for work group meeting minutes. Dr. Davidson
replied that work groups decide the level of their minutes.
Mr. Pardue said that the PHA work group had opted for
detailed minutes because of the complexity of the technical
issues that they address.
- Dr. Akin asked that he be copied on the memo to Dr.
Koplan. Dr. Davidson apologized for the oversight.
- Mr. Lewis expressed hope that by documenting technical
issues in detailed minutes, issues can be captured in
a database and eventually resolved.
Ad Hoc Mission Statement Work Group Report:
Ms. Karen Galloway, Member
Oak Ridge Reservation Health Effects Subcommittee (ORRHES)
In the July meeting, it was decided that the Subcommittee
needed a mission statement, said Ms. Galloway. An ad hoc
committee comprised of Subcommittee members and members
of the public held three meetings to answer this need.
Using a model from another group, they developed a draft
of a vision statement, a mission statement, goals, and
objectives.
The work group has offered a vision, mission, and goals.
The vision statement is the absolute or ideal perception
for the group. The mission statement addresses the scope
and purpose of the Subcommittee's work. Goals are broad
statements of how the Subcommittee will achieve its mission,
and the objectives identify measurable ways in which the
goals are achieved. The objectives will require more refinement
to make them measurable.
The draft mission statement is:
"To provide ATSDR and CDC with advice regarding public
health studies and activities relating to people who
may have been exposed to radioactive and chemical emissions
from the ORR."
The draft vision statement is:
"To promote the health and well-being of all residents
in the communities surrounding the ORR."
The draft goals are to:
"Conduct an unbiased and objective review of the previous
studies;
"Evaluate information on the release of hazardous substances
into the environment from the ORR;
"Assess current or future impacts on public health;
"Identify, review, and advise on follow-up studies and
actions needed;
"Review the Public Health Assessment document; and
"Assure that information is made available to the healthcare
providers as well as the public to allow them to make
informed decisions about health issues that may be related
to their off-site exposures from the ORR."
Discussion Summary:
- Dr. Davidson felt that the statements should be kept
general. She commended the Ad Hoc Work Group for their
efforts.
- Mr. Pardue suggested eliminating "well-being" from
the vision statement, as "well-being" includes issues
such as finances that are outside the scope of the Subcommittee.
He also suggested adding "affected by ORR activities," as
the Subcommittee focuses on residents of the community
that have been affected by releases.
- Mr. Lewis commented that the goals and objectives have
to be linked.
- Dr. Craig did not feel that one of the Subcommittee's
goals was to conduct the review of previous studies or
to assess the PHA. The Subcommittee is assisting ATSDR
in these efforts. He also offered that part of the Subcommittee's
mission is to identify health issues and to assess health
needs in the community affected by releases.
- Ms. Mosby observed that in the self-evaluation in mid-year
2002, it might be possible to measure progress on some
of the goals. Either the Communications and Outreach
Work Group or an ad hoc work group could meet to formulate
some measurable objectives. Dr. Davidson added that other
work groups might want to formulate objectives as well,
such as the PHA Work Group.
- Mr. Washington said that the affected communities should
be named and it should be specified whether they were
addressing 5, 7, or 9 counties. Dr. Davidson noted that
the Subcommittee had voted on a map of the potentially
affected area. There are portions of eight counties included
on the map on which they are basing their work. Mr. Washington
added that the counties should be identified in the statements.
- Ms. Sonnenburg was hesitant about adopting the goals,
but was prepared to adopt the vision and mission statements.
She suggested that the committee review the goals further,
offering the following potential goal: "to conduct a
review of the delivery of medical services and any real
or perceived obstacles to this delivery."
- Dr. Davidson said that some goals could be adopted
while others could be sent back to the work group for
further refinement. Additional goals could also be added
at a later time.
- Dr. Akin commented on the last goal, which he read
as a "watchdog" function. He felt that if they plan to
provide information to the public, then they should also
take steps to ensure that the maximum amount of information
is made available to the public and to practitioners.
- The group offered ideas for wording. Mr. Lewis advised
them to be careful with the words that they choose, considering
what information is reasonable and adequate.
- Dr. Akin reworded the goal to read as follows: "to
assure that comprehensive (or another modifier) information
is made available to the healthcare providers and the
public to the end that information decisions may be made
about health issues that may relate to off-site exposures
to the ORR." He was not sure about separating the public
and healthcare providers, Dr. Davidson noted that this
goal relates to the Health Education Needs Assessment
output.
- Ms. McNally felt that the last goal was one of the
most important. She suggested that educating healthcare
providers be listed as a separate goal from educating
the public, as they are two different issues. If the
healthcare providers are educated and informed, then
the public will be able to rely on them to be knowledgeable
about their problems so that their concerns will be heard.
Ms. Kaplan related a recent experience with her doctor
in which she mentioned her exposures to see how he reacted.
He ignored her concern and did not try to educate her.
- Mr. Lewis wondered about the definition of the "public" and
whether it referred to the general public or to individuals.
Dr. Akin reflected on the line between the general public
and individuals. The extent to which individuality can
be addressed by a public, government-funded activity
is an age-old question that is central to public health
and medical practice.
- Dr. Davidson understood that the amount information
needed would be included in the Health Needs Assessment
process, which would result in recommendations regarding
what education is needed, where it is needed, and where
it should be targeted.
- Mr. Lewis recalled a community member's suggestion
that the Subcommittee present information in a manner
similar to the way that the Surgeon General presents
information.
- Dr. Creasia noted that the idea of "sufficient data" is
difficult to use, as data changes and grows over time.
Also, better information about chemicals of concern will
likely emerge in the future.
Update
on the Scarboro Soil Sampling Project
Cheryl Smith
Environmental Protection Agency (EPA)
Ms. Smith told the group that EPA is starting to get raw
data packages from the Scarboro sampling effort that occurred
on September 24th. It is the intent of the agency
to present this information in January, 2002. This presentation
will not be a final report, but an update to the Subcommittee
and perhaps to the public in general. The timing and format
of this update has not been decided. There will then be
an opportunity to compare these initial findings to the
May 1998 sampling performed by the Department of Energy
(DOE).
Discussion Summary:
- Mr. LC Manley asked whether EPA had enough preliminary
data to tell whether there is any difference between
the samples. Ms. Smith replied that the evaluation had
not yet been made.
- Mr. Lewis expressed hope that, if there is a major
discrepancy between the efforts, DOE and EPA would be
available to discuss it at the same time to achieve closure.
Ms. Smith said she did not have the authority to make
such a commitment, but she felt that the idea was sound.
EPA's sampling effort was independent, so comparisons
will come from EPA's technical expertise. DOE will receive
EPA's results. She emphasized that EPA's work was in
response to requests from the public and was not designed
to show that "anything was wrong" with the DOE work.
- Dr. Akin volunteered to take the suggestion to the
people who would be responsible for this coordination.
He agreed that if there are discrepancies, a coordinated
response from the agencies will be less confusing to
the community. As the EPA work was not an attempt to
verify the DOE work, it was done at similar, but not
identical locations. The samples could be different and
both be right. The agencies could then present reasons
for discrepancies.
- Mr. Manley asked how differences could be explained,
since differences will be perceived as one agency being "right" and
the other being "wrong." Dr. Akin replied that they would
assess the known variables that might lead to different
answers. For example, the sampling could have been done
at different depths. There may be samples that cannot
be explained, but the agencies will offer their best
scientific guesses.
- Mr. Pardue commented that DOE had been offered the
opportunity to participate in the EPA soil samplings.
Ms. Smith responded that DOE had accepted the opportunity,
sending an off-site DOE representative to conduct split
samplings.
- Dr. Davidson said that the Subcommittee members would
be interested in attending the January public update.
She asked when the final report would be completed. Ms.
Smith anticipated completion by May, including input
from the public, stakeholders, and DOE.
- Mr. Lewis noted that no transcript of minutes from
the Scarboro effort was provided. He suggested that the
next meeting be recorded.
Public
Comment
Ms. Linda Gass
Member of the Public
Ms. Gass addressed the group, pointing out that the Subcommittee
still needs to have a member with a history of interacting
with sick workers. These stakeholders have not been represented.
The Subcommittee also needs a member with a history of
interacting with sick residents. An explanation for not
having these representatives, that the White House liaison
will not allow it, does not make sense. She commented on
having a waiver so that a disabled person can serve on
the Subcommittee. She introduced an example of a prior
FACA committee which interacted with Social Security to
get a waiver. She felt that this step would be reasonable
on the path to creating fair and balanced representation
on the Subcommittee.
She later showed the group the Phase
One Report, Volume Two, Part A of the Dose Reconstruction
Feasibility Study: Tasks One and Two, Summary of Historical
Activities, Emphasis on Information Concerning Offsite
Emission of Hazardous Material. The report was
prepared by ChemRisk. She thanked Mr. Hanley for helping
her to obtain the report after much effort. She has been
through several requests for information. Some people
in the public do not want much information, but Ms. Gass
is a member of the public who appreciates background
information and who checks references.
She said that it is extremely important to realize the "company
town" effect in Oak Ridge given that, in Oak Ridge, there
is not only the "company town" effect contributing to the
suppression of information, but there is also the effect
of DOE's role as a long-term, major player in the economy
of the entire state of Tennessee. She posed the question, "How
do you get to the truth, when the employees being interviewed
have strong disincentives to reveal information about releases
that could affect their careers as well as their bosses'
careers and the state of the contractor?" Employees could
even be considered to be unpatriotic if they talk about
these facilities.
The state of Tennessee commissioned the Dose Reconstruction
Study, and the Oak Ridge Health Agreement Steering Panel
(ORHASP) worked for nine years. Ms. Gass told the PHA work
group that she wanted to check these references before
there was more discussion on the Iodine-131 Dose Reconstruction.
She was asked to put this suggestion in writing and to
make it a motion. The next meeting was in violation of
the spirit of FACA. She was not asking for a "stop work" order;
she only wanted access to the interviews to check the references.
It was decided that she had the right to check the references,
and she thanked Dr. Albert Brooks for supporting her in
her efforts. The integrity of the Dose Reconstruction rests
on these interviews with company employees.
Iodine-131 discussions have run their course, and Ms.
Gass was concerned about setting a precedent for efforts
regarding other contaminants of concern. She was told that
the state of Tennessee contracted with ChemRisk to conduct
these interviews. Subsequently, primary sources were destroyed.
She has continued to ask for the interviews. If they are
not headed toward a "whitewashed report," she said it was
unclear to her why she could not get those interviews.
She then read from the Phase One Report,
Volume Two, Part A, page 59: Personnel Interviews, "Interviews
have conducted as of September of 1993 with approximately
50 individuals with extensive experience at the Oak Ridge
reservation." Ms. Gass noted that eventually, over
150 people were actually interviewed. "The
names of initial interviewees were provided by facility
managers for key functional areas identified by ChemRisk." Ms.
Gass commented that if facility managers provided the interviewees,
then there are questions about whether the interviewees
had strong disincentives for information on releases to
emerge.
"Each interviewee identified additional
points of contact. Candidates for interviews were also
identified from association with key historical documents.
Some have not yet been located, and not all desired interviews
have been completed at this time." Ms. Gass added
that more interviews were done. "While
several individuals thought it necessary to obtain approval
from Martin/Marietta and DOE, or from their current employer
prior to consenting to an interview, only one individual
has declined to be interviewed. Notes taken in the course
of the interviews were reviewed by appropriate classification
reviewers. The information obtained in the interviews
is being summarized and entered into the project repository
and the associated database." She has tried to
get those interviews, and has been told different things
in trying to gain access to the project repository mentioned
about.
Upon thanking the people who had helped her so far, she
listed some of the places where she had been told to go
for the interviews, including OSTI. The documents are public
and owned by the state of Tennessee. History Associates,
Inc. (HAI) was a DOE contractor that did work on missing
mercury information. She has been able to get some response
from them, and she implored the Subcommittee to help her
get the interviews.
Discussion Summary:
- Ms. Dalton pointed out that as the CDC hiring freeze
has been lifted, the procedure is underway to advertise
for and select new members for the Subcommittee. She
then addressed the topic of a waiver. Anytime a worker
proposes to participate in the Subcommittee, the agency
recommends that the individual seek legal counsel and
make a decision based on his or her situation. It would
not be ethical or legally practical to predict what benefits
or compensation to which a person may or may not be entitled
in the future. Issues with Social Security, for instance,
should be addressed individually. In the past, such an
individual was approved for the Subcommittee, but declined
the position.
- Dr. Davidson emphasized that individual members of
the Subcommittee should encourage people to apply for
membership on the Subcommittee. Members of the public
are also encouraged to apply.
- Ms. Dalton described ATSDR efforts to locate the documents
in question. A letter to Patrick Lipford at the Tennessee
Department of Health formalized these requests. The Communications
Work Group forwarded a recommendation to ATSDR in September.
- Ms. Gass noted that part of the documents have been
in Nashville and parts have been at OSTI. She recognized
state budgetary problems that could be a contributing
factor, but she reiterated that she had never gotten
any interviews.
- Dr. Timothy Joseph offered insight into potential problems
with the ChemRisk records. When the interviews started,
each individual being interviewed had the right to say
anything, classified or not. If the interviews contained
classified information, or if the interviewee did not
want his or her name associated with what was said, then
there could be complications in getting the interviews.
- Dr. Albert Brooks noted that this situation was the
first time that he had not been permitted access to information
based on a reasonable request. Some of the operational
staff of the project were interviewed and asked to give
their impression as to the efficiency of the scrubber.
Sometime later, they were interviewed again, and they
reduced their numbers. Without knowing why these interviewees
changed their numbers, it is impossible to give an opinion
regarding the validity of the conclusions that were drawn.
The interviews are still important, but even more important
is the perception that this information is being suppressed.
If the information is classified, then that should be
made known and the non-classified information should
be released.
- Dr. Davidson presented an action item for ATSDR, asking
that they continue to make a concerted effort to obtain
the references that Ms. Gass has requested.
- Ms. Gass said that the list on the table was not complete,
as she had been told that she had to request all items
separately. She said that she wanted all of the interviews:
the list on the table is an example. She was recently
told by the state of Tennessee that not all materials
were kept. In addition, the ORHASP meeting minutes indicate
that classification issues have already been resolved.
- Ms. Kaplan served as chair of the liaison subcommittee
of the Local Oversight Committee in 1995. She took on
the task of interacting with retirees and requested those
interviews from Tom Widner, from ChemRisk. He had the
information, and she offered to locate it in her records.
- Ms. Sonnenburg wondered about an appropriate contact
at the state level to get the issue resolved. Ms. Dalton
replied that Patrick Lipford was the contact with the
state, and a letter to him was included with the pre-meeting
packet.
- Mr. Lewis recalled his work in checking and validating
records. Sometimes, there are record retention clauses
in the body of contracts. If the right clause is not
in the contract, then even professionals may discard
even primary sources. It might be possible to assess
what was in those contracts.
- Dr. Creasia pointed out that often, materials get thrown
away for other reasons, such as moving or retiring. He
asked Dr. Brooks to provide more detail on the scrubbers
who changed their numbers.
- Dr. Brooks replied that the same people were interviewed
twice. Apparently, they were presented with other opinions
or calculations that caused them to change their minds.
It is important to learn what they were told and why
they changed their minds. On the topic of data availability,
he felt that there can be no report without backup data.
Motion 4
Mr. Pardue moved that the Subcommittee recommend that
ATSDR continue to pursue this information in all possible
manners. The motion received a second, and discussion continued.
- Ms. Dalton noted that a recommendation from the July
31st Subcommittee meeting resulted in the
responses that she had described.
- Mr. Lewis commented that a properly-worded letter that
goes through the appropriate system channels can force
actions. The letter should ask a specific question and
expect a detailed response.
- Ms. Dalton reviewed the July 31st recommendation,
which asked ATSDR to pursue Iodine-131 references from
the Tennessee Department of Health. The ATSDR responded
at the September meeting, and Ms. Dalton and Mr. Lipford
had been in communication since August.
- Ms. Kaplan pointed out that the list of requested references
came under pressure. Those references should be in an
archive.
- Dr. Brooks asked about the state's response. Ms. Dalton
replied that the state is working with ChemRisk to locate
several of the documents. ATSDR has been searching for
some of the documents on the list as well. Due to matters
at another site, the principals at ChemRisk have not
been able to locate this information yet.
- Dr. Bill Murray said that he has contacted Mr. David
Hamrin at the Oak Ridge National Central Laboratory files.
Mr. Hamrin has records of what references are available
at the DOE Reading Room and at the IRC. Dr. Murray has
nine memoranda resulting from this search, which he will
copy and provide to Ms. Gass. He has been told that the
other references are in the DOE Reading Room.
- Dr. Akin understood that the original request was not
a comprehensive list of documents. He suggested that
the request should be made again, including a complete
list of documents. The importance of acquiring these
documents should be re-emphasized.
- Ms. Dalton reiterated that ATSDR had been working to
obtain the documents, but that ATSDR policy is to make
documents that they have generated in the past available.
Requests for documents from other agencies are referred
to that generating agency. They will do everything they
can to request documents.
- Dr. Akin wondered if the request could come from the
Subcommittee, not from ATSDR.
- Mr. Lewis suggested that they invite Mr. Patrick Lipford
to address the Subcommittee on the issue.
Motion 4 - Amended
Dr. Davidson proposed a re-wording of the motion: ATSDR,
at the recommendation of the Subcommittee, should pursue
to the extent possible the whole list of references for
the interviews from the Dose Reconstruction Study. Those
interviews should be placed in the Oak Ridge Field Office.
After the following discussion, the motion and amendment
were withdrawn and replaced.
- Ms. Mosby commented that if they cannot get a few of
the references, it was unlikely that they would be able
to get them all.
- Dr. Akin felt that this issue was critical to the credibility
of the Subcommittee and was unclear about why the information
could not be requested from the Tennessee Department
of Health. If the request could not or should not be
made by ATSDR, or put the agency in an awkward position,
then the Subcommittee should devise another way to make
it.
- Dr. Davidson said that the Subcommittee cannot make
direct requests to the Tennessee Department of Health,
but it can make requests through ATSDR staff or through
Dr. Koplan.
- Ms. Dalton noted that ATSDR had acted on the recommendation
from July 31st as it was written. The new
recommendation represents an expansion on the old one,
and the request would be forwarded.
- Dr. Davidson commented that another way to pursue the
documents is to direct the request to the heads of the
agencies involved: Dr. Koplan and the head of the Tennessee
Department of Health.
- Ms. Mosby said that more than one avenue should be
pursued to get the documents. They could work as individuals,
as members of the Subcommittee, or other ways.
- Dr. Pereira advised that the list of documents requested
and the reason for requesting them be forwarded to the
director of DHAC for Dr. Falk's signature. From Dr. Falk,
the letter would then go to the director of the Tennessee
Department of Health. Justifying why the documents are
needed is key to get the proper signature.
- Dr. Pereira also reflected on the mentality of a "company
town," in which the tendency for workers to want to protect
their jobs is a reality. He urged the Subcommittee and
the public to judge the credibility of the information
in the interviews based on what they know about the community.
- Mr. Pardue asked whether FACA prevents the Subcommittee
from making a request from another agency. Dr. Pereira
did not see a problem with the Subcommittee writing a
letter, but added the risk that the Tennessee Department
of Health might not recognize what ORRHES is, and therefore
not respond to the letter.
- Ms. Sonnenburg suggested that Dr. Al Brooks write the
letter and copy it to the Tennessee Governor's Assistant.
- Mr. Pardue retracted his motion and its amendment.
- Ms. Kaplan said that the request for the interviews
is not just for the data or to assess the credibility
of the report. The request is also a process issue, as
taxpayers spent a great deal of money on the ORHASP committee.
If that committee could not maintain the integrity of
their references, then how could other committees expect
to.
Motion 5
Ms. Mosby moved that the Subcommittee recommend that ATSDR
continue to pursue the request for all interviews. A letter
should be written to the heads of the agencies in question.
The ORRHES should also issue a letter requesting all interviews.
The letters should include rationales for why the information
is requested. The following discussion ensued.
- Dr. Davidson was concerned about potential redundancies
in the different methods for requesting.
- Ms. Kaplan wondered whether they were also asking for
references. Dr. Davidson said that the request was for
the interviews. She suggested that the Subcommittee forward
this request to Dr. Falk.
- Ms. Mosby was concerned that Dr. Falk might not sign
the letter or that action might not occur. Dr. Davidson
said that their request could not be ignored, and that
if their rationale is strong for the information, then
they will get whatever action Dr. Falk can accomplish.
Ms. Mosby favored more attempts to get action.
- Dr. Brooks suggested that the rationale include the
statement that the credibility of the state is in question.
- Dr. Davidson suggested that the PHA work group work
with the details of the letter. She also asked that the
motion ensure that the letter is drafted, finalized,
and sent.
- Ms. McNally reminded the group of the suggestion that
the Subcommittee send its own, direct request to the
Tennessee Department of Health. Dr. Pereira did not recommend
that the Subcommittee ask Dr. Falk to sign a letter and
then send one of their own that is, essentially, requesting
the same thing. He suggested that the letter go through
Dr. Falk. If Dr. Falk does not respond to the letter,
then Dr. Pereira will inform the Subcommittee, but he
expected that Dr. Falk would respond.
- Dr. Bob Peele responded to the discussion, as he is
a former ORHASP member. The committee wanted all records
kept in this area. Mr. Lipford worked on an agreement
for storage, but was not able to form an agreement, so
the information is in Nashville. There have been other
complications, such as a flood in the building where
the records were kept. It is unfortunate that the records
are not all in one, easily accessible place, as was ORHASP's
intention.
- Ms. Barbara Brooks of the Department of Energy, also
a former member of ORHASP, described efforts to locate
the information requested by Ms. Gass. As ORHASP had
intended for the information to be available, copies
of their materials and references were kept in the public
document room. The materials were organized in a database
of information about them and also scanned into electronic
form. They are available on the Internet with a permanent
URL. The descriptive database is bibliographic. The interviews
are a small part of the information used by the researchers.
Now, all materials belong to the state, other than what
is kept in the public reading room. The public reading
room is under-staffed and not policed, making it difficult
to find materials there. She was not sure if more than
what exists in that public database exists, and in what
form. In the next week, the state has asked that Tom
Widner come and organize all of the paper materials.
She wondered whether this activity would make it possible
for Mr. Lipford to respond to the original letter from
ATSDR.
- Mr. Malmquist called for the question.
Motion 5 - Amended
The PHA work group of ORRHES will draft, finalize, and
send a letter for Dr. Falk's signature requesting all interviews
used in the Dose Reconstruction Report. This letter will
include rationales for why the information is requested.
The motion passed with a vote of 10 in favor and 1 opposed.
Presentation
and Discussion: Epidemiology Workshop Part II:
Discussion of the Mangano Report
Dr. Lucy Peipins
Dr. John Merkle
Dr. Albert Brooks
Dr. Peipins spoke about how
to evaluate and critique an epidemiologic study. She reminded
the group that every scientific study and its scientific
analyses are built on a body of knowledge and conducted
to expand that body of knowledge. What is already known
determines what needs to be known - studies "fill in the
gaps." The body of knowledge represents the consensus of
science. Once a study is completed, the author of the study
and analysis publishes the results. The purpose of scientific
publication is to present a new finding or insight into
a problem. The results are shared and debated with scientists
and the public.
Publication also demonstrates the quality and validity
of the study by presenting the study's methods, design,
analysis, and interpretation. This information allows other
scientists and the public to judge the quality of the study.
Authors are responsible for providing information on each
component of the study so that readers can adequately evaluate
the study. All assumptions and references must be justified
and stated in the article. Epidemiologists have criteria
to judge the quality of an epidemiologic study. There is
no "perfect" epidemiological study. There are even limitations
to clinical studies. The better the study meets the criteria,
the more likely the readers are to accept the author's
conclusions.
The author submits an article to a medial journal, which
forwards the article to its peer reviewers. Peer review
is an essential component of scientific work. These reviewers
read the article and recommend whether it should be published.
They can request additional information as well. The author
must address all peer review comments before the article
is published.
To illustrate the principles of evaluating an epidemiological
study, Dr. Peipins used the article, "Cancer Mortality
Near Oak Ridge, Tennessee" by J. Mangano, published in
the International Journal of Health
Services. These criteria should be applied to every
article that is evaluated:
- Why was the study done?
- What hypothesis did the author have?
The question is usually found in that article's title
or in the introduction. The main purpose of the Mangano
article was to examine change in cancer mortality in 94
counties located within 100 miles surrounding Oak Ridge,
Tennessee. Change from 1950 to 1952 was compared to changes
from 1987 to 1989. That magnitude of change was then compared
to change in the United States as a whole and the Southeast.
The exposure of interest was radiation from Oak Ridge weapons
production, which began in the early 1940's. Mangano included
more specific hypotheses
Hypothesis 1:
An increase in all cancer mortality near Oak Ridge should
be larger than the national and regional areas due to
this radiation.
The following issues arise with regard to the first hypothesis:
- What type of study is this?
- A descriptive study describes the health outcomes
alone and answers the questions, what is the disease?
Who got it? When were they sick? Where were they
sick?
- An analytic study attempts to answer the question
of why one population gets a particular disease.
The Mangano study is essentially descriptive, as
exposure is largely based on location or residence
in a county. However, because the study compares
the rate of change in cancer mortality to the United
States and to the Southeast, it also has an analytic
component.
- Who was in the study? The Mangano population was the
white population living less than 100 miles from Oak
Ridge, in the 94 counties specified, between 1950 and
1952 compared with 1987 - 1989. The comparison population
was the white population in the Southeast and the United
States in that period.
- What was the exposure of interest? The article mentions
several exposures from radiation, including chronic,
low-level, ingested, emissions, and more. There are a
variety of pathways and types of exposure.
- How is exposure defined and measured? Mangano did not
measure exposure per se; however, exposure was defined
as residents in a county near the weapons plant, residents
in mountainous counties, residents in downwind counties,
and residents in rural counties. Exposure measurement
is often the "weakest link" in epidemiological studies.
An individual can be assigned an exposure number anywhere
along the pathway from when the radiation is emitted
to when it is taken into the body. The goal is to have
the most precise measure of exposure to reduce mis-classification.
Residents in a geographical area is considered the poorest
approximation to actual exposure on the hierarchy of
exposure measurement. The numbers can be further refined
with proxy measures such as drinking water use or length
of time lived in an area. The best measurement is quantifiable
personal measurement. The Mangano article exposure characterization
is based on residence in a county in proximity to sites.
- What are some limitations or criticisms to how exposure
was measured? Residence in a county is a poor measure
of exposure. In the Mangano study, everyone who lived
in the 94 counties was assigned the same exposure. It
is assumed in the comparison with the rest of the United
States that everybody was not exposed. In considering
proximity, Mangano did not clearly define distance from
the site. Roane County was not included, and the counties
chosen for comparison were unclear. There was no justification
for why these counties were chosen. Different pathways
of exposure may exert a stronger influence than vicinity
alone. The author assumes that rainfall may affect exposure,
so he compares mountainous with non-mountainous counties.
This approach seems general, as there is a great deal
of variation in the rainfall in mountainous counties.
These counties also have residents living in the valleys,
so there is a mix of exposures. No previous studies were
cited to support these assumptions in the article.
Hypothesis 2:
Within the Oak Ridge area, increase in cancer mortality
should be greatest in rural areas, near the weapons plant,
in mountainous areas, and downwind of the weapons plant.
The second hypothesis addresses differences between exposures
in urban versus rural areas, but the author provides no
rationale for the assumptions in the article. There is
no rationale for not including Kentucky and Virginia. Rural
areas are not free of risk. Information from dose reconstructions
contradicts some wind patterns assumed in the article.
It may be reasonable to assume that downwind counties will
have higher cancer rates, but there are wind patterns affecting
the four quadrants differently. The following issues arise
with regard to the second hypothesis:
- What is the health outcome? The outcome of interest
in the Mangano study was deaths from all cancers among
whites in the specified counties in the specified times,
compared with cancer deaths among whites in the United
States and in the Southeast during the same times. It
is important to measure outcome accurately. The study
collected data from NCI. The study looked at all cancer
mortality rather than specific cancers. Cancer is not
one disease, but different types of diseases. Grouping
them together may not get the appropriate information.
There are a number of causes for cancers, and not all
of them can be linked to the environment. Death certificate
data are easily available, but there are problems with
accuracy. This accuracy varies by causes of death and
by regions of the country, according to who fills out
the certificate. Accuracy varies by time as well: it
is likely that cancer was under-reported in the earlier
time frames.
- Was there selection bias in this study? Mangano used
existing data, so this question is not relevant to this
article. In evaluating other studies, however, it is
important to discern how get into the study. Recruitment
is particularly important, particularly if the exposed
group is included on a volunteer basis and the unexposed
group is not.
- Was there information bias in this study? Information
bias concerns how information is collected on individuals.
Questions must be asked and data must be collected in
the same way for everybody. This aspect is not directly
relevant to the Mangano study, but it should be recognized
that the accuracy of cause of death certification can
vary by region.
- What were the confounding factors? There is a possibility
that the relationship shown in the study could be due
totally or in part to other differences or risk factors
between the two study groups. The author must address
confounders and can do so in a number of ways. The study
can be restricted to certain types of people or other
risk factor information can be collected, for instance.
Because Mangano's study was based on extant data, these
measures were not possible. The potential confounders
associated with cancer risk, then, are large. The author
said that there was little or no migration in this area,
and yet there was a large influx of people into the area
when the plant first opened, and then a decline in population.
Regional differences in life expectancy are another confounder.
There are other regional sources of environmental contamination
that might account for differences in mortality rates.
The author should adjust or control for these confounders,
and Mangano could not in this study.
- What statistical analysis was conducted? What method
was used to measure the relationship between exposure
and disease? In this study, the author calculated age-adjusted
mortality rates for selected counties in the hypotheses
area and compared them to the Southeast and the United
States. The article provided little information on the
actual statistical analysis or the justification for
it. The selection of years was not justified, nor was
the choice not to evaluate specific cancers as opposed
to all cancers.
With regard to the results, Mangano found positive results
for each of the hypotheses. Given other concerns with the
study, though, these conclusions may not be justified.
A 1965 article by Sir Austin Bradford Hill, called "The
Environment and Disease: Association or Causation?" presents
a number of criteria by which to judge a body of evidence
or study. These criteria are guidance for understanding
a study and include:
- Strength of association. How strong is the relationship
between exposure and disease? In the Mangano study, there
is a large difference.
- Consistency with the weight of evidence. Has this association
been seen in other studies with different study designs?
Has this relationship been seen in different populations?
The association between radiation and cancers have been
studied, both among workers and residents near sites.
- Is there a biologically plausible explanation between
the exposure and the disease? In this case, there is:
ionizing radiation mutates DNA and causes cancer. However,
county of residence was used as a surrogate for radiation.
The radiation was never measured for these individuals.
- Does risk of the disease increase with increasing exposure?
As no doses were calculated in the Mangano study, it
is not possible to see this association.
- Temporality: has the exposure occurred before the disease?
This point is critical to understanding a study. This
study cannot address this issue because it is impossible
to assess whether individuals moved into the area and
had cancer, or moved out of the area and had cancer.
The final questions that one must ask when evaluating
a study are: Has the author convinced us of his conclusions?
Does this study advance our knowledge about the relationship
between exposure and disease? Some of the guidance criteria
were met; however, the article includes no exposure measurement.
The study also focuses on all cancers rather than on specific
cancers. Use of death certificate data and the lack of
potential confounders further limit the study. Because
of these limitations, this study does not demonstrate a
relationship between cancer mortality and radiation exposure
as effectively as it could. This conclusion does not mean
that the relationship does not exist, but this study fails
to provide strong evidence for that relationship.
Dr. Merkle then addressed the
group regarding statistical issues with the Mangano report.
A Karns resident and retired civil engineer, he became
interested in the Mangano report after reading an article
in the Oak Ridger. He stressed
that an important question to ask at the beginning of an
epidemiological study is: Are the differences involved
in the measurements likely random, or are they likely not
random? This procedure is called "testing the null hypothesis."
Dr. Merkle spoke to Dr. Mangano to obtain more information
with which to evaluate his statistical analysis. Dr. Merkle
used Dr. Mangano's rates and populations to re-do the statistical
analyses. He gave the group an overview of how he conducted
these analyses. In the early 1950s, he concluded, the differences
between cancer mortality rates in the Oak Ridge area and
in the Southeast could have been, and likely were, due
to randomness. In the late 1980s, however, the differences
in cancer mortality rates appear not to be random.
The differences in the rates are very small, he reminded
the group. These numbers must be approximate because the
populations are not stratified by age, gender, length of
exposure, or according to other contributing factors. These
calculations are important to consider in evaluating studies,
and Dr. Merkle advised the group to ask qualified epidemiologists
or statisticians to assess the figures in studies.
Dr. Brooks then addressed the
group on the topic of wind patterns. There is no actual
measurement of exposure in Mangano's work: the same results
would be obtained regardless of what the cause was assumed
to be. Mangano assumes an airborne release and a wind effect
from the southwest to the northeast. Oak Ridge wind patterns
have been studied in detail by NASA and are well understood.
They are probably 2/3 to the northeast and 1/3 to the southwest;
therefore, Mangano's assumption that "downwind" is one
direction is erroneous.
The rates of cancer mortality from 1990-1994 in the different
counties do not seem to correlate to wind direction. The
rates are the lowest "downwind" to the northeast and to
the southwest, and highest to the northwest and the southeast.
Counties also appear to be "skipped." Knox County has high
rates, Cox County has low rates, then Greene County rates
are high again. The study's presumptions are not borne
out by other information that is available. Mangano would
have to explain why wind patterns lead to mortality figures
that are different from what is expected.
Discussion Summary:
- Dr. Brooks inquired about the variance of the difference
between Oak Ridge 5 and Southeast 5. He pointed out that
if C was the average, and the average rate were zero,
then the variance would be zero independent of the scatter
of the data, which is not correct, because they are measured
rates, not true rates.
- Dr. Merkle replied a binomial distribution was assumed.
Dr. Brooks pointed out that when numbers are large, a
binomial distribution approaches a normal distribution.
Dr. Merkle noted that the variance of a linear combination
of these variables is taken as the sum of the variances
of the individual terms for a normal distribution. The
derivation comes from epidemiologic books.
At this point, members of the public were
invited to comment.
- Ms. Gass understood that a null hypothesis can never
be proven. It can only be rejected at a certain level
of probability, which is frequently .01. Dr. Merkle replied
that a range of ratios must be established. If a difference
is random, then 95 percent of the differences will fall
between the limits. The reversal of the logic indicates
that if the difference falls within the limits, then
it is most likely random. There is a 5 percent possible
error in that a number could fall outside the limits
and still be random. The calculation cannot reveal the
relative probabilities of randomness and non-randomness
in a given situation.
- Ms. Gass recalled Dr. Peipins' stress on the importance
of data quality in evaluating an epidemiological study.
She was concerned because the Mangano report uses county
data: sometimes epidemiological studies springboard other
studies, so there are other implications for the study.
There does not seem to be another study to which the
Mangano study could be compared, nor does it seem that
any other studies have "spring-boarded" from the Mangano
study. Dr. Peipins said that there have been other studies
of populations around nuclear facilities, but none that
have resulted from the Mangano study. The Mangano study
is rarely cited anywhere, she added, and the journal
in which it was published is not in MedLine.
- Ms. Gass observed that a large amount of time was spent
on proving that the study was based on weak data, which
was established at the beginning of the process. She
asked for comment on the availability of data, particularly
the fact that county of residence is the most readily
available research opportunity for an epidemiologist.
Dr. Peipins agreed that the county data is easily available,
which contributes to its attractiveness to a researcher.
There are always trade-offs, though. Her purpose was
not specific to the Mangano article, but to provide criteria
for evaluating other epidemiologic studies and interpreting
different data based on different exposures. All studies
will have limitations.
- Ms. Gass asked how to design a better project to measure
radiation dose and to develop data on an outcome and
what such a study might cost. It did not seem feasible
to her. Dr. Peipins agreed that such a study would be
difficult. Ms. Gass acknowledged that the Mangano study
is based on weak data, but it is all that they have so
far, as it has not inspired further studies.
- Ms. Gass emphasized that cancer is not the only outcome
from radiation exposure. The Iodine-131 work is almost
entirely focused on cancer as the only endpoint, but
cancer is not the only health concern that people have
in Oak Ridge. She suggested that ATSDR solicit community
people by advertising: "Exposure Health Concerns?" Many
people in the community are not aware that the issues
are being discussed or that the field office exists.
She read the following from minutes from a Subcommittee
meeting from the previous year: "In response to Subcommittee questions, Mr. Williams explained
the following points: what interactions among chemicals
is ATSDR exploring? Work is beginning on mixtures of
contaminants within different media." The listed
chemicals are only 275 out of the thousands used, but
they are the most prominent at the sites. She observed
that often, they are told that work is "beginning." She
asked what work is beginning. She was particularly concerned
about chemicals and the interactive effects with radiation
and repeated a comment that she had made when ATSDR staff
was in Oak Ridge, conducting meetings. The toxicological
literature includes information on work with synergistic
effects that should be coming to the Subcommittee. These
data gaps are critical data.
- Dr. Davidson commented that in working with mixtures
and synergistic action with chemicals, they can be additive
or antagonistic. In this work, the particular chemical
mixture of interest must be examined, as information
about another chemical mixture does not provide enough
information. Ms. Gass felt that the toxicologists on
the Subcommittee should bring this information to the
Subcommittee and that it would be helpful in the area
of health concerns to keep the Subcommittee informed.
- Mr. Hanley said that the Division of Toxicology puts
out "Tox Profiles." Mixtures, synergism, and additive
effects in environmental toxicology is in the infancy
stage. He did not know how much was available. A toxicologist
works with ATSDR, and as the screening process begins
and the contaminants of concern are evaluated, they will
see other compounds that may have an impact or an additive
effect. First, they will evaluate individual compounds,
then as part of the health implications, other compounds
will be assessed as well. He said that he would follow
up with the Division of Toxicology to ascertain to what
Mr. Williams was referring in those comments.
- Dr. Creasia has been working on synergism for some
time. Toxicological studies include dose-response studies,
which almost always show that a single compound is synergistic
by itself unless the dose has an exponent of one. Very
few chemicals have a toxicological exponent of one.
- Dr. Brooks reported that in the early 1970's, ORNL
started the Mao study to determine the effects of low-level
radiation. This study was to involve a million mice and
was carefully controlled and designed. Before the experiment
was completed, funds for the work were redirected to
the war in Vietnam so that the number of mice was reduced
so far as to be insignificant. Any epidemiological study
that hopes to take a definitive look at low-level radiation
will have to include approximately one million people.
Normal, background radiation in the Oak Ridge area is
approximately 300 milli-rems. The maximum airborne exposure
outside the plant area is usually less than one milli-rem.
There is no way that a study will be able to detect the
effect of the normal, airborne radiation releases compared
to background radiation on the general public.
- Ms. Sonnenburg shared a response from Dr. Mangano.
She had felt that it was fair to ask him to provide with
a chance to comment on his report and on their assessment
of his study. She called Dr. Mangano and mailed him the
minutes from the work group meeting as well as the matrix.
In addition, she asked for the new data to which he referred
in his letter to the editor in the Oak Ridger. His response asked the committee to look at
the changes that have taken place in his figures. Rates
have increased in the counties around the Oak Ridge area
in relation to Tennessee and the rest of the United States.
She pointed out that the one column adds population for
five years, and the other the population for four years.
The cancer rates for the four-year time are higher, even
with one less year in the count. He also separated data
by age and lung versus non-lung cancer. She also has
the raw data available.
Dr. Davidson thanked Dr. Peipins. She reminded
the group to complete their checklists for consensus-building.
She noted that the Communications and Outreach Work Group
needs more members and asked Subcommittee members to sign
up for that work group. With that, the meeting was adjourned
at 6:15 pm.
End of Day 1
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