ORRHES Meeting Minutes
March 26, 2002

Table of Contents

• Call to Order/ Opening Remarks
• Introductions
• Agenda Review, Correspondence, and Announcements
• Approval of March 26, 2002 ORRHES Meeting Minutes
• Status of Action items – list provided
• Work Group Sessions
• Public Comment
• Break
• Work Group Sessions cont
• Public Comment
• Presentation and Discussion: ATSDR Radiation Screening Process
• Presentation and Discussion: Chelation Therapy
• Public Comment
• Work Group Recommendations
• Unfinished Business/New Business/Issues/Concerns
• Identification of Action Items
• Housekeeping Issues and Closing Comments

Call to Order/ Opening Remarks

The Oak Ridge Reservation Health Effects Subcommittee (ORRHES) convened on August 27, 2002, at the YWCA at 1660 Oak Ridge Turnpike, Oak Ridge, Tennessee. Chairperson Kowetha Davidson called the meeting to order at 12:15 PM, welcoming all attendees.

Introductions

Kowetha Davidson asked the attendees to introduce themselves. The attendees present at this time were:

Kowetha Davidson, Chairperson, ORRHES
La Freta Dalton, DFO, ATSDR
Brenda Vowell, Tennessee Department of Health
Chudi Nwangwa, Tennessee Department of Environment and Conservation
Elmer Akin, Environmental Protection Agency (EPA)
David Johnson, ORRHES member
Bob Craig, ORRHES member
Susan Kaplan, ORRHES member
James Lewis, ORRHES member
Don Creasia, ORRHES member
LC Manley, ORRHES member
Karen Galloway, ORRHES member
Jeff Hill, ORRHES member
Barbara Sonnenburg, ORRHES member
Pete Malmquist, ORRHES member
Donna Mosby, ORRHES member
Charles Washington, ORRHES member
Peggy Mustain Adkins, ORRHES member
Tony Malinauskas, ORRHES member
George Gartseff, ORRHES member
Don Box, ORRHES member
Herman Cember, ORRHES member
Jerry Pereira, ATSDR
Burt Cooper, ATSDR
Jack Hanley, ATSDR
Bill Murray, ATSDR
Marilyn Palmer, ATSDR
John Steward, Paper, Allied-Industrial, Chemical, and Energy (PACE ) Workers Union
John Merkle, Karns resident
Al Brooks, Oak Ridge resident
Bob Peelle, Oak Ridge resident
Tim Joseph, Oak Ridge Office, Department of Energy

The recorders are Ken Ladrach and Amylane Duncan, Auxier & Associates, Inc.

Agenda Review, Correspondence, and Announcements

Agenda Review

Kowetha Davidson reviewed the agenda dated August 27, 2002, noting the following:

• Work Group presentation sessions
• Guidelines and Procedures Work Group report on facilitating meetings
• Communications and Outreach Work Group demonstration of ORRHES website
• Health Needs Assessment Work Group report on a community clinic
• Public Health Assessment Work Group presentation on combining I-131 doses
• Public comment periods
• Video presentation on chelation therapy in place of presentation by Paul Charp
• Work Group recommendation sessions
• Community Concerns Database presentation
• James Lewis presentation

Correspondence

Kowetha Davidson reported a letter received from Dr. Falk regarding the Subcommittee’s recommendations from the March 26, 2002 Subcommittee meeting. Letters dated June 5, 2002, and June 14, 2002, were received from Owen Hoffman; response dated July 18, 2002, was provided by Jerry Pereira.

Announcements

Kowetha Davidson reported that there were no announcements.

Approval of March 26, 2002 ORRHES Meeting Minutes

Kowetha Davidson referred to the March 26, 2002, meeting minutes distributed previously to the Subcommittee members. Comments on the draft minutes have been incorporated and revised minutes distributed to Subcommittee members.

A motion was received and seconded to approve the March 26, 2002 meeting minutes. A vote was taken by voice with none opposed. The minutes were declared approved.

Status of Action items – list provided

The table listing the status of action items has been distributed to the Subcommittee members. The table of action items was reviewed.

James Lewis asked whether ATSDR will make a presentation about the budget and the five-year plan. Kowetha Davidson responded that it would be discussed during the “Unfinished Business” section of the agenda.

Work Group Sessions

AGENDA WORK GROUP PRESENTATION
Barbara Sonnenburg reported that the Agenda Work Group has no recommendations, the Work Group has worked with Subcommittee members to produce the agenda for the meeting. There were no comments on the agenda.

GUIDELINES AND PROCEDURES WORK GROUP
Karen Galloway reported that the Guidelines & Procedures Work Group decided not to pursue revision of a recommendation to change bylaws regarding membership, which was brought before the Subcommittee at the March 26, 2002 meeting, and referred back to the Work Group.

The Guidelines and Procedures Work Group has assembled information containing suggestions for chairs to conduct meetings in a more effective manner. The first recommendation of the Work Group recommends adoption of this information to a Work Group chairs in facilitation of more effective meetings.

The second recommendation of the Work Group addresses the job description for an administrative assistant in the field office. The Work Group recommends also considering ‘facilitation skills’ of the administrative assistant candidates. Attached to this recommendation are three documents that the Work Group recommends the Subcommittee send to ATSDR for their consideration.

Jeff Hill suggested that the use of a “concerns sheet”, outlined in recommendation number one may inhibit expression of concerns, and requested that the use of the “concerns sheet” not be made too rigid. Karen Galloway responded that the concerns sheet would not be mandatory, but is intended to ensure that concerns will be addressed, followed up and tracked. Jeff Hill expressed concern that some dialogue will be lost and/or not captured. Karen Galloway responded that hopefully the “concerns sheet” will make the concerned person comfortable that their concern will be addressed.

James Lewis asked the questions “What constitutes a concern? How do we formally capture those?” The ‘concerns sheet’ is optional, however, enough specific information about the concern is needed so that someone can provide a meaningful response to the concern which makes the ‘concern form’ an important tool for responding to concerns raised.

Barbara Sonnenburg suggested adding a sentence to the form stating that a note-taker can fill out the form for the concerned person. Kowetha Davidson responded that currently ATSDR captures concerns as recorded within minutes of the meetings.

Donna Mosby commented that much thought went into the ‘concern sheet’, and it was designed to be sensitive to people raising concerns, and it is not a requirement that everyone fill out form.

Susan Kaplan commented that the person taking Work Group minutes is usually not present at the meetings, and takes notes by speakerphone. Therefore the person designated to fill out the form should be a member of the Work Group. David Johnson commented that much time and energy went in to developing the ‘concerns sheet’, and it has not been put into use yet. It is important to begin using the form to track concerns in order to determine the timeliness of response to concerns.

James Lewis commented that ATSDR is developing a concerns database and is currently capturing concerns from meeting minutes, and asked for a presentation from ATSDR on the concerns database. Kowetha Davidson mentioned that the presentation for the concerns database is on the agenda for today.

COMMUNICATIONS AND OUTREACH WORK GROUP
James Lewis reported that the Communications and outreach Work Group has not had a recent meeting. Since the last Work Group meeting the ORRHES web site is up.

La Freta Dalton began presentation of the ORRHES website and noted that the website was developed by Eastern Research Group (ERG) and placed on the ATSDR server in June 2002 (www.atsdr.cdc.gov).

La Freta Dalton demonstrated navigation through the website on screen for the Subcommittee. Pages accessed included:

• Home Page – Welcome letter from Kowetha Davidson
  
• Linked pages:
  • General Information about the Subcommittee
  • Mission Statement, Vision, Goals and Objectives
  • History and Activities
  • Bylaws
  • Compendium of Public Health Activities
  • Information about other agencies’ activities
  • State of Tennessee activities
  • ChemRisk Dose Reconstruction
  • Related links
  • Other Federal Government Agencies
  • Pocket Guide to Chemical Hazards
  • Local media, local government organizations
  • Membership of the Subcommittee with biographies
  • List of Meetings
  • Frequently Asked Questions, Acronyms
  • Link to e-mail ATSDR staff (Bill Murray and La Freta Dalton)
  • Organization charts for ATSDR/roster of ATSDR staff

Herman Cember asked the intended audience of the website. La Freta Dalton responded that the intended audience is the general public, public officials, professionals. ATSDR has attempted to make site user friendly for a wide variety of audiences. Elmer Akin asked how often the site will be updated. La Freta Dalton responded that the update is once each month.

Jack Hanley pointed out that activities of the Subcommittee, including workshops handouts, meeting minutes, calendars, and recommendations of the Subcommittee, are included on the website.

James Lewis commented that the website could be helpful for people to find/ keep up with issues and asked if it would be possible to list “identified issues” and have cross-links to particular sets of meeting minutes (or other documents) that address each issue. Currently it can be difficult to find issues within the listed agenda. La Freta Dalton responded that that option is still being examined. Susan Kaplan suggested that a link entitled “issues addressed” could be added to the links available for each meeting.

Jeff Hill requested that “The Roane County News” be added to the list of links on the web site, and asked that future e-mail messages sent out to Subcommittee members concerning meetings include a hot link to the ORRHES web site to encourage use of the web site.

Pete Malmquist asked whether the status of recommendations and action items is accessible on the web site. La Freta Dalton acknowledged that the recommendations and action items are on the web site because they are included in Subcommittee meeting minutes on the web site but that the status chart has not yet been added. James Lewis commented that the action items from Work Group meetings are not on the web site. La Freta Dalton clarified that Work Group action items are on the site in the context of the Work Groups minutes there. Action items are on the web site to the extent that they were captured in meeting minutes.

Jack Hanley highlighted the Compendium of Public Health Activities on the site containing information on all the public health activities of ATSDR, CDC, DOE, and other public health agencies giving comprehensive information on health study activities in the Oak Ridge area.

Elmer Akin commented that the Subcommittee should use the site as a major communication tool and asked what time during each month the site would be updated and whether a notation stating the most recent date of update would be visible to the viewer. La Freta Dalton responded that the site includes display of the most recent date of update.

Bill Murray suggested that until Subcommittee members become familiar with the site, ERG could send an e-mail to Subcommittee members notifying them when the site has been updated.

Susan Kaplan asked if the community input/concerns form is on the site to allow people to submit concerns to the site. La Freta Dalton reported that the form is not part of the site but that the possibility of including the input form on the site will be explored.

James Lewis, commenting on the option of including the community concerns form on the site, asked how the concerns raised coming through several different mechanisms will be managed/controlled so that issues and concerns are not lost. La Freta Dalton responded that concerns brought forth through any of the available mechanisms will all be channeled into the ATSDR Community Concerns Database.

Peggy Adkins asked whether the site could have a link to information about the potential health effects of toxins/substances that members of the public may be concerned about. La Freta Dalton reported that a link to toxicity profiles is available on the ATSDR homepage, but that a direct link is planned for the ORRHES web site as well.

Kowetha Davidson asked whether the ORRHES site has a link to the Association of Occupational and Environmental Clinics (AOEC). La Freta Dalton believes the link is there.

Charles Washington pointed out that one way to address concerns would be to create on the web site a chart of concerns raised, the name of the concerned individual, and the subsequent response to the concern following research into the concern. This method is used by the Oak Ridge Site Specific Advisory Board (SSAB), giving everyone access to each particular concern. Charles Washington added that the ATSDR and the Subcommittee are making an assumption that the best method for communicating is through the Internet. There may be a need to consider alternatives for communicating information.

Donna Mosby asked whether the format of documents viewed on the site is consistent and whether the site includes information about sites other than the Oak Ridge Reservation. La Freta Dalton clarified that the documents are made available on the site as the exact same electronic files submitted by those who create them, and that the ORRHES site addresses only the Oak Ridge Reservation.

Jeff Hill asked if links to web sites for sites other than Oak Ridge could be included, in order to see the progress other sites have made in their Public Health Assessment process. La Freta Dalton reported that the only similar site pertains to the Hanford, Washington site and that the information on that Subcommittee’s site is 2 to 3 years old and has not been updated. A link for the Hanford Subcommittee’s site is in the index of the ATSDR homepage.

La Freta Dalton encouraged everyone to visit and view the site and provide comments/suggestions for improvements.

HEALTH EDUCATION NEEDS ASSESSMENT WORK GROUP

Donna Mosby reported that:

• George Washington University has completed the solicitations for focus groups.
• James Lewis will make a presentation on the issue of a clinic in Oak Ridge.

Discussion of clinical services in Oak Ridge:

James Lewis, Pete Malmquist, and Brenda Vowell made a presentation to the Subcommittee regarding clinical services for the local community. The presentation followed a series of handout materials distributed to each member of the Subcommittee and a portion of the videotape of the January 18, 2001 ORRHES meeting.

Handout A- Summary of Questions/Concerns Regarding Clinical Programs

Overview of Handout A summarizing:

• Questions raised during December 3-4, 2001 presentation by Dr. Robert Jackson of the Health Resources and Services Administration (HRSA) regarding establishing a HRSA clinic locally.
• Questions raised during March 13, 2002 meeting of the Health Needs Assessment Work Group regarding establishing a clinic to diagnose, treat, and research illness.
• Questions raised during DOE Former Worker Program presentation March 26, 2002 regarding how DOE provided medical surveillance/care for workers.

Handout B- Glossary of Medical Terms

James Lewis highlighted the definitions of Health Surveillance and Medical Monitoring.

ATSDR Public Health Assessment Flow Diagram

James Lewis highlighted the steps of the ATSDR Public Health Assessment (PHA):

1. Evaluate Site Information
2. Collect Community Health Concerns
3. Determine Contaminants of Concern
4. Identify and Evaluate Exposure Pathways
5. Determine Public Health Implications
6. Determine Conclusion and Recommendation/Follow-up Action

Community involvement is tied in with several of the steps shown on the diagram. These six steps complete the PHA process. If the conclusion is “no action required” the PHA is submitted for review and comment. If the conclusion is “action is required” there could be pilot studies, epidemiological studies or surveillance/registry. The primary focus is on the community.

Charles Washington asked whether the community was divided into workers and non-workers. James Lewis responded that the PHA process focuses on impacts outside the DOE facility boundary.

Videotape of ORRHES meeting January 18, 2001

A portion of the videotape of the January 18, 2001 ORRHES meeting was viewed. This portion of the videotape captured public comments/concerns from members of the community expressing the need for a clinic in the Oak Ridge area to serve exposed/ill persons, and responses from officials of HRSA (Dr. Paul Seligman) and ATSDR (Dr. Henry Falk). James Lewis pointed out the emphasis in the video tape of a desire for a clinic among members of the community.

Handout C- Presentations and Documents Reviewed

James Lewis gave an overview of presenters brought before the Subcommittee to address issues about community clinics and medical surveillance programs:

• January 18, 2001 – Dr. Paul Seligman, Dr. Henry Falk, Katherine Kirkland (AOEC)
• December 4, 2001 – Dr. Robert Jackson (HRSA)
• March 12, 2002 – Presentation on ATSDR/PACE program comparison
• March 26, 2002 – Kathleen Taimi (DOE), Donna Cragle (ORISE), Lyndon Rose (Queens College)

James Lewis highlighted the response from Donna Shalala (Secretary of Health & Human Services) that CDC, ATSDR and NIH do not provide direct primary medical services to communities, and they are working with DOE to plan appropriate public health follow-up activities to address the concerns of communities regarding the nuclear weapons complex. In addition, Dr. Robert Jackson’s historical review of HRSA programs found no examples of HRSA grant dollars supporting the development of environmental health clinics.

James Lewis highlighted the document reviewed by the Subcommittee entitled “Proposed Criteria for Selection of Appropriate Medical Resources to Perform Surveillance of Employees Engaged in Hazardous Waste Operations and a list of qualified doctors in Tennessee (available on ORRHES website).

Handouts E1 – E3

Pete Malmquist presented criteria for establishing a HRSA clinic. HRSA would not establish an environmental clinic. There are three types of HRSA clinics: Community Health Center, Federally Qualified Health Center, and Rural Health Clinic. The type of HRSA clinic that the Work Group evaluated for the Oak Ridge area is a Rural Health Clinic (Handout E3). Rural Health Clinics are located in the most rural areas, and are established under the authority of the Rural Health Clinic Services Act (Public Law 95-210).

The HRSA website was consulted for guidelines to determine eligibility for a clinic in the Oak Ridge area. Eligibility criteria to calculate the Index of Medical Underservice (IMU) include:

• County population
• Percent below poverty level
• Percent of population over age 65
• Ratio of primary care physicians to population

Calculation of the IMU for this area includes 8 counties: Anderson, Blount, Loudon, Knox, Meigs, Rhea, Morgan, and Roane. Data for each county are presented in Handout E1.

Brenda Vowell explained the calculation details for Anderson County in Handout E3 resulting in an IMU value of 83.2. The eligibility for this type of clinic is an IMU value not exceeding 62. The only county out of the eight listed which holds a value of 62 or less is Morgan, which already has a clinical site.

Pete Malmquist summarized that under the HRSA guidelines this area does not qualify for a Rural Health Clinic.

Peggy Adkins commented that the situation of exposure in this area is exceptional and has not been dealt with before, old forms of clinics would not work in this situation. Environmental factors have been tested, however people have not been tested. Concern was expressed that a clinic should be used for testing people, not just treatment of people who have health problems.

Charles Washington agreed with Peggy Adkins on testing people. In the past workers were exposed to mixtures of many naturally occurring elements and other chemicals which have effects on human systems. Data on these exposures should be considered, but may not be applicable to today’s conditions. Charles Washington stated that in Oak Ridge there has never been documentation of a death resulting from exposure to toxins from any of the facilities in the Oak Ridge area, and it would not be in the economical interest of a physician to document cause of death as a result of a specific toxin.

Jeff Hill commented that he is a beryllium worker, radiation worker and asbestos worker, and he is not eligible for any of the medical screening programs that DOE offers.

James Lewis pointed out to the Subcommittee that comments about testing people and establishing clinics are all actions that may follow after the PHA process is completed.

Handout F- Clinical Program Comparison

James Lewis presented an overview of a comparison of programs and emphasized that each agency is limited by the Congressional mandates that specifies what they can do within their programs. The clinical program comparison highlights target populations, types of assessments, and criteria for screening /medical evaluation, and follow-up actions/benefits for each agency. James Lewis emphasized that the Congressional mandate for ATSDR does not provide for diagnosis or treatment and individuals are directed to their personal physicians or AOEC clinics for follow-up diagnosis and treatment.

Handout G- ATSDR/PACE Program Comparison

James Lewis highlighted a comparison of the ATSDR versus PACE union programs and drew attention to the distinctions between the programs; the ATSDR program addressing exposure outside the DOE facilities and the PACE union program addressing workers at the DOE facilities. Each program is charged with specific tasks, ATSDR’s tasks are controlled by congressional mandates. The program comparison highlights the types of assessments and the target populations of each program. The PACE worker program involves a Needs Assessment to determine if a medical surveillance program is needed while the ATSDR program involves a PHA to determine the need for follow-up public health action. James Lewis highlighted the overall similarity of the two programs regarding their exposure assessment processes, sources of data used (both programs are using the ChemRisk Oak Ridge dose reconstruction information), and health outcome identification processes.

James Lewis summarized the conclusion aspects of the Public Health Assessment program:

• Determine the degree of public health hazard,
• Identify illnesses from exposure to contaminants,
• Identify data gaps,
• Determine what public health actions or studies should be undertaken.

Emphasis was placed on the fact that the congressional mandate for ATSDR does not provide for diagnosis or treatment and ATSDR must complete its PHA process before developing public health conclusions or making any recommendations (refer back to the flow diagram of the ATSDR PHA process).

James Lewis highlighted a draft fact sheet (dated 8/20/02) developed for distribution to the public presenting information about environmental & occupational medical resources and medical resources for ORR workers.

Donna Mosby read for the Subcommittee the proposed recommendation that the Health Needs Assessment Work Group brings to the Subcommittee for vote today.

Discussion:

Janet Michel commented regarding the proposed Health Needs Assessment Work Group recommendation, disagreeing very strongly with the recommendation statement that clinical evaluation and medical monitoring are premature at this point in the ATSDR process in light of 11 years of residents coming forward with health concerns. Why should there not be any medical screening begun by now? Janet Michel also asked for an explanation of the current status of progress in the ATSDR PHA process.

Kowetha Davidson responded that the ATSDR is in the midst of the PHA process and that in fact the Subcommittee is an integral part of conducting the PHA process, which will be followed by ATSDR recommendations. James Lewis added, with visual reference to the flow diagram of the ATSDR PHA process, that the Subcommittee and the ATSDR are not in a position to make any recommendations until completion of the steps of the process outlined in the flow diagram.

Janet Michel noted for the Subcommittee that among six of her friends raised locally, 3 of them are on Synthroid medication for thyroid anomalies/cancers now, and asked why disease registry information is not being gathered. For example, Dr. Elaine Bunick, a local endocrinologist, has diagnosed over 1200 thyroid problems in the area and has reported this to the State of Tennessee and contacted MD Anderson Hospital for assistance.

Janice Stokes reported that pharmacists have said to her that synthroid medication is distributed from their pharmacies by the truckload each month.

Barbara Sonnenburg asked for an estimate of when the ATSDR PHA process will be completed for I-131 and when will it be completed for other substances. James Lewis recalled that the original schedule called for completion after six months. Burt Cooper added that the schedule is approximately one year behind and a detailed plan with schedule will be presented to the Subcommittee soon. Completion of PHAs for selected contaminants are to be completed within two years.

Jeff Hill commented regarding the fact sheet (dated 8/20/02 Environmental & Occupational Medical Resources and Medical Resources for ORR Workers ) that a statement needs to be added to the fact sheet stating that workers need to report health problems to their employers.

Regarding the PHA Process Flow Diagram, Elmer Akin stated that it is important to distinguish between determining contaminants of concern historically versus determining contaminants in the environment currently, and disease resulting from historical exposures versus current exposures. James Lewis pointed out that the Subcommittee and ATSDR have determined to address past exposures (prior to 1990 – dose reconstruction studies) separately from current exposures (since 1990).

Public Comment

Mike Knapp commented on the history of events leading to the development of the workers compensation program. In 1992 reviews of historical documents revealed that in the 1940’s doctors and lawyers took steps to limit liability from worker exposures in order to continue bomb production. The Nuclear Workers Compensation Program was enacted in the late 1990’s to compensate workers for the actions in the 1940’s. In order for a worker to be compensated under the current workers compensation program medical records must indicate exposure to certain toxins, and in the past DOE lost, manipulated, and destroyed health-related documents. Today the workers compensation program is limited to specific disease types (berylliosis, asbestosis, silicosis, and radiogenic cancers) and does not address modern disease types/new illnesses from exposure to unknown toxins. Residents living in this area must also bear the burden of proof of exposure, which requires documentation to backup illnesses. The reason a clinic is desired is because workers have diseases which have not been diagnosed, studied and treated, and residents face the same problem. ATSDR is looking at the need for a clinic or public health action while people want to have a clinic first to study and record disease patterns, actions that follow the public health assessment in the ATSDR process. Mike Knapp commended the Subcommittee for recommending to ATSDR that exposures to I-131 from Oak Ridge be added to exposures to I-131 from the Nevada Test Site. Mike Knapp also commented that the concept of a clinic is one that can be an integral part of the PHA process on the front end. The burden of proof of exposure to workers has already been met. The clinic would benefit residents and also workers who are not compensable under the workers compensation program.

James Lewis responded that Dr. Bob Eklund (former member of the Subcommittee) has stated in the past that a physical facility (clinic) does not need to be located here in order to conduct clinical intervention. Hopefully the public health assessment process, if it finds public health impacts associated with exposure, will provide the community at large with information to assist in getting appropriate medical care.

John Steward agreed with Mike Knapp’s comments, and further commented that DOE is not supporting the process, citing a particular case of a worker (30 years at K-25) who has been denied under the workers compensation program due to lack of documentation of employment. There are similar examples. John Steward related his own experience with his personal doctor who refused to accept/examine his CAT scan (performed under the PACE union worker program) because he did not want to become involved with the worker exposure controversies. Workers continue to have to pay for their own medical testing and treatment. John Steward asked the Subcommittee when a clinic for workers would be recommended.

BREAK

Work Group Sessions (continued)

PUBLIC HEALTH ASSESSMENT WORK GROUP

Presentation and discussion:

Kowetha made a presentation to the Subcommittee entitled “Should ATSDR Combine Iodine-131 Doses from the Oak Ridge Releases with Those from the Nevada Test Site”.

Kowetha Davidson began the presentation with an overview of the thyroid gland, its location and function in the human body, and the mechanism of control of thyroid hormone levels. The presentation then addressed benign thyroid tumors (95% of all thyroid tumors) versus cancerous thyroid tumors (5% of all thyroid tumors), and detailed the prevalence of types of cancerous thyroid tumors. The majority of thyroid cancers are the papillary type. Follicular cell cancers, C-cell or medullary cancers, and anaplastic thyroid cancers are far less prevalent. The risk factors presented for thyroid cancer incidence include:

• Radiation exposure (either external exposure to the head/neck or from intake of radioactive iodine),
• Family history (presence of altered RET gene),
• Female gender (females are at higher risk),
• Age (risk increases with age),
• Race (risk is greater among blacks), and
• Iodine deficiency.

Kowetha Davidson reviewed the evidence for the link between thyroid cancer and exposure to I-131 based on studies performed after the Chernobyl nuclear accident. These studies indicate: a four year latency period for thyroid cancer in children, thyroid cancer incidence in children exposed in utero, peak incidence in children 8 to 9 years old, and the highest incidence in the Ukraine, Belarus, and Russia.

The 1997 National Cancer Institute (NCI) study (“Estimated Exposures and Thyroid Doses Received by the American People from Iodine-131 in Fallout Following Nevada Atmospheric Nuclear Bomb Tests”) and the 1999 National Academy of Sciences (NAS) review of that study were discussed during the presentation. The study developed dose estimation methods and thyroid dose estimates to individuals from NTS releases but did not estimate risks of thyroid cancer. The NAS review of the study reported that:

• The study was generally reasonable,
• National collective dose estimates are unlikely to greatly under/over-estimate actual doses,
• County-specific dose estimates are likely too uncertain to use to estimate individual doses,
• Direct measurements of fallout are too sparse to make precise county/state dose estimates for all of the U. S.,
• A minority of the population had significant exposure,
• The highest risk was among young children that drank milk from backyard cows/goats at the time,
• Cancer risk estimates for individuals are more uncertain than dose estimates due to the uncertainties in risk at low doses,
• Thyroid cancer risk estimates can only be made with a wide range.

Synopsizing information presented by Owen Hoffman to the Subcommittee June 11, 2001:

• The range of consequences of various levels of radiation dose to the thyroid,
• I-131 releases from “other” sources in Oak Ridge will likely not change dose estimates by more than a factor of 3,
• Dose estimates are adequate for general conclusions regarding dose in the community but not for probability of causation (PC) calculation,
• The range of dose estimates is slightly greater than a factor of 10,
• The impact of adding doses from NTS I-131 releases to doses from Oak Ridge I-131 releases varies for different locations in the Oak Ridge vicinity,
• The primary risk factors for thyroid cancer are age at exposure, I-131 levels in milk, dietary source of milk, milk consumption rate, and gender,
• The risk of thyroid cancer from releases is low except for individuals who consumed goat’s milk.

Synopsizing information presented by Charles Miller to the Subcommittee in September 2001:

• It is possible to combine I-131 thyroid doses contributed from multiple sources,
• Is important to consider whether I-131 thyroid doses contributed from multiple sources should be combined,
• If doses are combined it is important to communicate the information so that people can make informed health decisions,
• Numerical dose estimates are less important than the risk factors: gender, age at exposure, and consumption of milk from a back yard cow/goat.

Kowetha Davidson summarized the results of a 2001 “Feasibility Study of the Health Consequences to the American Population of Nuclear Weapons Tests Conducted by the U. S. and Other Nations”. In summary:

• CDC and NCI were the lead agencies
• The study involved document retrieval, dose estimation, review of epidemiological literature, risk assessment, and development of health communication strategies
• The study will be reviewed by the NAS, with formal recommendations to follow that review
• The study concludes that exposure of the U. S. population by location and time can be estimated
• Estimates for individuals are imprecise because of variations in exposure within counties
• The study concludes that cancer risks from fallout can be estimated for representative exposure scenarios but with large uncertainties
• Accurately determining risk for specific individuals is not possible.

Discussion followed the presentation.

Charles Washington commented that on slide 18 of the presentation the statement that “…I-131 releases from other sources in Oak Ridge will likely not change estimates by more than a factor of factor of three” is statistically significant and asked for an explanation of the statement that “does estimates range slightly greater than a factor of ten”. Kowetha Davidson responded that the factor of three from other Oak Ridge sources would be less than the factor of 10 range in the dose estimates. Charles Washington also asked for explanation of the statement in slide 17 “Mode of action for thyroid cancer caused by I-131 is non-threshold linear”. Kowetha Davidson responded that the non-threshold linear model means that there is no exposure to I-131 that would not be associated with some risk of cancer. The alternative model is that there is a threshold dose below which there would be no risk. Herman Cember commented on the explanation of non-threshold that it is more correct to say that the model postulates a zero threshold rather than no threshold.

Susan Kaplan commented that her understanding is that the I-131 releases from ORNL from the RaLa program range from 3.3 to 6.7 times, assuming 90-95% retention efficiency, where 3.3 refers to 95 percent efficiency and 6.7 refers to 90 percent efficiency. Kowetha Davidson commented that this factor of three statement was not in reference to the RaLa program releases. Susan Kaplan emphasized the importance of correctly clarifying words from Owen Hoffman’s presentation. Kowetha Davidson replied that the factor of three statement was not specifically about RaLa releases.

Following the I-131 presentation Kowetha Davidson read the recommendations of the Public Health Assessment Work Group.

RECOMMENDATION ONE:

ORRHES recommends that CDC/ATSDR present the public health implications of I-131 thyroid doses (and risks, if feasible) due to releases from the Department of Energy’s (DOE) Oak Ridge Reservation (ORR), the Nevada Test Site (NTS), and the combined doses (and risks, if feasible) from the ORR and NTS in its Public Health Assessment for I-131. ATSDR should present the doses (and risks, if feasible), their ranges of uncertainty, and an explanation of the level of uncertainty for public understanding.

Rationale:
Presenters Owen Hoffman and Charles Miller presented background information on the dose reconstruction for I-131, including the issue of combining doses of I-131 from Oak Ridge with doses of I-131 from the NTS. Neither presenter specifically recommended combining the doses. It is technically possible to combine the doses, but the issue is should the doses be combined? ATSDR is asked to present the total doses from the Oak Ridge and NTS and provide separate health implications from those exposures. ATSDR will determine the feasibility of estimating the risk for developing thyroid cancer or present their rationale if it is determined that risk estimation is not feasible.

RECOMMENDATION TWO:

ORRHES recommends that CDC/ATSDR establish an online calculator so that individuals may obtain estimates of their thyroid doses (and risks, if feasible) due to releases of I-131 from the Oak Ridge Department of Energy Reservation and from the Nevada Test Site along with an option for adding the doses (and risks, if feasible). CDC/ATSDR should provide information to the public on interpretation, uncertainty, and credibility of the results from the calculator and any follow-up action the individual should take as a result of the estimate.

Rationale:
The public has an interest in individuals estimating their I-131 doses. Dose estimates with health implication information will aid in making healthcare decisions.

Public Comment

Bob Peelle stated that at the time the Oak Ridge Health Assessment Steering Panel (ORHASP) study was performed various experts believed that the contribution from other sources from X-10 would be approximately 20%, far less than a factor of three, but the ORHASP committee was aware of the controversy about the efficiency of filtration of I-131 from the RaLa program. Perhaps the releases from the RaLa program varied by a factor of three. Bob Peelle commented regarding the combining of doses from radio-iodine from Oak Ridge and from the Nevada Test Site, it may be impossible to produce risk estimates from the doses. Bob Peelle’s opinion is that if risk estimates cannot be produced, time should not be spent producing the dose estimates because people do not know how to interpret dose estimates, but risk estimates are meaningful. Bob Peelle’s recommendation consisted of eliminating the addition of I-131 doses from Oak Ridge and the Nevada Test Site if the risks cannot be estimated.

Kowetha Davidson responded that a calculated risk estimate (e.g. 1/1,000,000) is less meaningful to a physician trying to recommend follow-up public health actions than defining age at exposure, gender, and whether milk was consumed from a backyard cow or goat.

Regarding Handout G (ATSDR/PACE Program Comparison), Janet Michel commented that the PACE union worker program was inadequate and therefore a poor comparison. Testing was minimal, information was lacking, health physics dosimetry is not accurate. A Portsmouth, Ohio, health physicist reported to a Senate Committee that he was instructed to falsify reports, and that dosimeters were intentionally left on top of sources to test responses. Janet Michel reported that while working at K-25 with cyanide compounds personal monitoring and testing were promised, yet never happened. The medical monitoring programs are far from perfect.

Janet Michel’s health problems consist of an enlarged thyroid and auto-immune disease. The condition began when handling uranium samples for school and civic demonstrations. The ATSDR PHA process gives ATSDR something to do, and makes the public feel as though they have input, but asked the Subcommittee how many of their recommendations have been acted upon? While ATSDR is conducting their PHA, waiting a year or more for information to be complete, sick people are dying.

Kowetha Davidson noted that the Subcommittee is sensitive to comments from the public, and stated that the Subcommittee is limited to it’s mandate from Congress.

Barbara Sonnenburg asked how the Subcommittee can change people’s minds in Congress. Janice Stokes responded that it is possible to change people’s minds in Congress, by recommendations from panels such as this ATSDR Subcommittee. A clinic for Oak Ridge is not premature; however it would have been premature in 1940-1950 when little was known about exposure to harmful substances. Large doses from releases of iodine have been acknowledged as having occurred and as being harmful. Effects on the thyroid resulting from doses of iodine are evident in the community, as well as thyroid diseases, cancers and other maladies. The Subcommittee and community members can work together to change people’s minds in Congress. There is a need to take a step beyond the workers compensation program for the benefit of people who have lived around the nuclear sites. As a minimum people should be given the opportunity to be diagnosed, treated and monitored. In regard to monitoring of emissions from incinerator stacks, there is not real-time monitoring at the Duratek incinerator or at the DOE incinerator in Oak Ridge, health physics monitoring data are unreliable. For example, Bud Aerosmith (Duratek) is quoted as stating that dirty filters work better than those that are clean, and their stack filters were changed every six months. People’s lives are at stake on these issues.

Kowetha Davidson invited members of the public to attend and participate in the Subcommittee’s Work Group meetings, in person or by telephone.

Janet Michel posed the questions “How soon would any of the federal agencies be able to do something such as helping people monitor their water wells?” and “Could the Subcommittee request from the Tennessee Department of Health (TDH) any statistics that they may have on disease registries?” Janet Michel reported that the TDH has encountered obstacles to their efforts at collecting such information (e.g. lack of cooperation from neurologists in the Oak Ridge area in the past). Kowetha Davidson reported that the Subcommittee will be having a visit from staff of the TDH to make a presentation on TDH disease registries.

La Freta Dalton commented that, before ATSDR can make any public health recommendations, it must first document exposure; that is accomplished through the PHA process. The purpose of the Subcommittee is to provide input to ATSDR on the PHA. Documenting exposure is the result of evaluation of available evidence. If necessary, additional data collection to fill data gaps can be requested. While ATSDR and the Subcommittee hear these concerns brought forth by members of the public, the Subcommittee and ATSDR are required to proceed through the PHA process and document exposure before making public health recommendations.

Janice Stokes replied that this process (PHA) does not work for the people of the community, and a new approach should be developed by the Subcommittee to do something different that will work for and benefit the people.

Janet Michel stated that exposure can be documented by examining the endpoint, the people affected.

Herman Cember offered the comment that dirty filters are more efficient filters due to the buildup of material on the filter and the filter must be changed once the buildup has reduced airflow rate to a certain level.

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