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Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


The Advisory Board on Radiation and Worker Health 


National Institute for Occupational Safety and Health 


Centers for Disease Control and Prevention 


Summary Minutes of the Thirty-fifth Meeting 


January 24-26, 2006 


The Thirty-fifth Meeting of the Advisory Board on Radiation and Worker 


Health (ABRWH or the Board) was held at The Doubletree Oak Ridge, Oak 


Ridge, Tennessee, January 24-26, 2006. The meeting was called by the 


Centers for Disease Control and Prevention (CDC’s) National Institute 


for Occupational Health and Safety (NIOSH), the agency charged with 


administering the ABRWH. These summary minutes, as well as a verbatim 


transcript certified by a court reporter, are available on the 


internet on the NIOSH/Office of Compensation Analysis and Support 


(OCAS) web site located at www.cdc.gov/niosh/ocas. Those present and 


who identified themselves included the following: 


ABRWH Members: Dr. Paul Ziemer; Chair; Dr. Henry Anderson; Dr. Roy 


DeHart; Mr. Richard Espinosa; Mr. Michael Gibson; Mr. Mark Griffon; 


Dr. James Melius; Ms. Wanda Munn; Mr. Robert Presley; and Dr. 


Genevieve Roessler 


Designated Federal Official: Dr. Lewis Wade, Executive Secretary 


Federal Agency Attendees: 


Department of Health and Human Services: 


Mr. Jason Broehm, Ms. Chia-Chia Chang, Mr. Larry Elliott, Ms. Chris 


Ellison, Mr. Stuart Hinnefeld, Ms. Liz Homoki-Titus, Ms. Emily Howell, 


Mr. Ted Katz, Dr. Jim Neton, Mr. David Staudt, Dr. Brant Ulsh 


Department of Labor: 


Dr. Diane Case, Mr. Peter Turcic 


Congressional Representatives: Ms. Elizabeth Howell, Ms. Livia Lam, 


Ms. Jennifer Stansbury 


Contractors:
 

Oak Ridge Associated Universities: Ms. Kate Kimpan, Mr. Bill 


Tankersley 


Stanford Cohen and Associates: Dr. Hans Behling, Ms. Kathy Behling, 


Mr. Joe Fitzgerald, Dr. Arjun Makhijani, Dr. John Mauro 


Public Attendees: See Registration. 


1
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


* * * * * 


Tuesday, January 24, 2006
 

Dr. Paul Ziemer, Chairman of the Advisory Board on Radiation and 


Worker Health, called the meeting to order noting that most members of 


this Board have been members since it began its series of meetings in 


January, 2002. Retiring members will be recognized later in the 


meeting. Present are three individuals recently named by the White 


House as new appointees to this Board: Mr. Brad Clawson from Idaho 


National Laboratory; Dr. Jim Lockey of the University of Cincinnati 


Medical Center; and Professor John Poston from Texas A&M University. 


They will be at the next meeting in April; today they are observing. 


Dr. Ziemer welcomed their participation. 


Dr. Lewis Wade, the Designated Federal Official, introduced Ms. Kate 


Kimpan, the new Project Director for Oak Ridge Associated Universities 


(ORAU), who will be replacing Dr. Richard Toohey. She will serve as 


the principal ORAU contact to NIOSH. Dr. Wade thanked Dr. Toohey for 


his contribution. 


Dr. Ziemer requested registration by all attendees and sign ups for 


today’s public comment period. Although the Board does not deal with 


individual claims, NIOSH staff members are available to assist in 


answering related questions. The Chair deferred approval of the 


minutes until Board members receive and read them, with action likely 


be taken Thursday afternoon. 


***** 


Dr. Wade clarified conflict of interest issues and then gave context 


for the Y-12 discussions. Conflicts of interest are expected to exist 


on the Board as it is comprised of people with valuable experience at 


the sites in question. Board members with conflicts for the Y-12 site 


profile are Dr. Roy DeHart, Mr. Robert Presley and Mr. Mark Griffon
 

B- Mr. Griffon only when there are issues pertaining directly to the 

Atomic Trades and Labor Council. The policy with regard to conflict 

of interest on site profiles allows conflicted Board members to 

participate in table discussions but prohibits their making or voting 

on motions. 

*****
 

2
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


Y-12 NATIONAL SECURITY COMPLEX 


SITE PROFILE DISCUSSION/PLAN OF ACTION 


Mr. Joe Fitzgerald, 


Sanford Cohen & Associates 


Mr. Fitzgerald presented an overview of the issue resolutions for the 


Y-12 site profile, one of the first profiles to be reviewed by the 


Board's contractor. The review is aggressive. Of particular urgency is 


the site profile technical issues relating to a subclass of workers: 


steamfitters, pipefitters, and plumbers who worked from October, 1944 


through December, 1957. The Board desires to bring a timely resolution 


to that portion of a pending SEC petition. This Board earlier 


recommended approval of a petition for Y-12 employees who worked in 


uranium enrichment or other radiological activities from March, 1943 


through December, 1947. The Secretary of the Department of Health 


and Human Services (HHS) has acted positively on that recommendation. 


The Board intends to resolve these technical issues and bring the 


portion of the petition that has not been acted upon to a vote at the 


April Board meeting. 


Mr. Fitzgerald urged resolution of remaining issues so the Board will 


have necessary guidance and technical support for making a decision on 


the petition. He gave a chronology of Board, SC&A and NIOSH 


interactions aimed at narrowing issues and differences and producing 


resolutions. These entities have been meeting or conferencing almost 


monthly with robust analysis and data-gathering in the meantime. Key 


issues for both the SEC petition and the site profile reviews begin 


with data validity or reliability to assure that data used for dose 


reconstruction can be validated as representative of the plant, time 


period and processes. SC&A and NIOSH have not given up on obtaining 


some data from the files in Atlanta or elsewhere which might give a 


better handle on this issue, but so far the search has not proven 


fruitful. Various compensatory sources can provide some measure and 


test of consistency. Reliability of data is essential to the issue of 


adding a class to the Special Exposure Cohort. 


A second issue is that the scope of review for the site did not 


narrowly consider Y-12 to be a uranium plant. Y-12 is one of many 


Department of Energy (DOE) sites with a diverse history including 


numerous activities with Cyclotron and Calutron in terms of generating 


different radioisotopes, handling plutonium -- in short a number of 


sources of radiation other than uranium. The focus now is how that may 


have contributed to the overall source term for the plant. The 


implications are important in the SEC petition context, as the class 


of workers in question may have moved throughout the plant and been 


exposed to non-uranium sources. SC&A is concerned about the lack of 


3
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


any database to help clarify this issue. NIOSH is making available 


this week 6,000 pages of bioassay data from the X-10 side of the plant 


which can inform this analysis for identifying an appropriate coworker 


model. However, even if the bioassay data proves to be reliable, it 


will not answer all questions. As regards SEC petition consideration, 


resolution of this issue would assure that all the sources were 


accounted for in relation to this mobile worker class which includes 


pipefitters, plumbers and others. 


Regarding job functions, NIOSH has provided immensely helpful 


information for determining dose distribution by virtue of job titles 


and categories. SC&A finds difficult to accept that the population 


under consideration is homogeneous with similar exposures. Instead, 


the exposure potential is actually higher than the average, a broad 


mean somewhere between 50 and 95 percent which needs continued 


examination. The working group has had good discussions about what the 


data indicates. The most useful practice is to actually look at the 


data and determine if the 50th percentile is appropriate or perhaps to 


take a more conservative approach and handle certain job categories 


separately. This determination could be facilitated with information 


on departments. While this matter may not be primary for upcoming 


discussions or the SEC petition, it is important for dose 


reconstruction. 


Next, Mr. Fitzgerald moved on to three action items that SC&A took 


from the January 5th workgroup meeting. 


1. The first item was to review factors used in Table 5-2 through 5­

8 dealing with parameters on recycled uranium, with more on that 


later. 


2. The second item was the 147 dose records from monitored workers 


used in the regressive statistical analysis and whether in fact that 


model was representative. This analysis took data from the 1960’s and 


applied it to the 1950’s for which data is sparse. 


Dr. Ziemer paused the presentation to notify Board members that 


comments on January 19th were distributed via e-mail. Those comments 


will be made available today to the public. 


3. The third action item was the OTIB-51 which deals with how to 


arrive at correction factors for early NTA film and angular dependence 


so that dose estimates can be accurately determined. Those comments 


were provided on the 19th . This issue was raised not only for the Y4
 
 

Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


12 site profile but also during the past three reviews worked on by 


Dr. Hans Behling and Ms. Kathy Behling. It would be a fundamental step 


forward to have OTIB-51 contain this information and provide these 


factors. He said the approach is sound but the analysis should be run 


for energies beyond 700 keV; 800 and 900 offer other benchmarks and 


it might be appropriate to have additional curves provided. This is a 


loose-end issue. The chemical operators were appropriately considered 


in the analysis but whether by oversight or intention were not cited 


in method two, and he would like to find out about that. The OTIB did 


not address some issues relative to neutron flux below the NTA 


threshold. Site-wide workers at Y-12 may have been exposed to those 


thermal neutrons. The preceding are very specific technical comments. 


Mr. Fitzgerald expressed general support for the approach provided in 


the OTIB. 


4. Also of note is the action item concerning revisiting the tables 


in the TBD for Y-12 dealing with recycled uranium. Comments center on 


whether one can be very generic or whether current data would support 


generation of more tailored information for particular operations and 


processes. He also raised the question on whether badging was based on 


maximum exposure workers. Although SC&A hasn't seen the 147 dose 


records, they are beginning to go through the expanded CER database 


through 1965. They feel that some of the lower numbers just below 


1,000 millirem per quarter suggest a group of workers who may not have 


been maximally exposed in the early period. There are appreciable 


differences in the numbers at the pre-criticality/post-criticality 


juncture. The data is not conclusive but does suggest that a sub-group 


of workers who were not badged may have been maximally exposed or 


there may have been cohort badging in certain activities. This issue 


is similar to one relative to bioassay and whether one can be assured 


that this is not random sampling on a department-wide basis. SC&A 


will focus on the reliability, robustness and applicability of the 


6,000 pages of X-10 data. Along with NIOSH, they will examine what the 


data suggests to determine whether U-233, radon and other nuclides 


elsewhere in the plant would be significant in helping answer that 


question and in corroborating the reliability of the electronic 


database. The review calls for clarity in determining whether or not 


the basis for coworker models and the maximally exposed individuals 


can be established. 


In SC&A’s view, everything else is clearly appropriate for a site 


profile. The detailed review contains over 100 findings, many of which 


are factual accuracy and technical issues not likely to bear on the 


SEC petition determination but important enough to be second priority. 


*** 


5
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


Discussion began with Mr. Griffon seeking clarification from Dr. Jim 


Neton about the availability of a disk for SC&A and the Board. Dr. 


Neton will try to have an answer by the end of the day to expedite 


release of the disk. Dr. Ziemer said the document will be made 


available to the public before long. Dr. Henry Anderson then asked 


about whether a portion of the 6,000 records will be abstracted or by 


what means this information will be provided in a timely fashion. Dr. 


Neton said that not having seen the 6,000 records, he did not know, 


but the concept was that these records include data for radionuclides 


other than uranium, specifically plutonium and possibly polonium. 


NIOSH intends to gather enough data make a robust coworker matrix to 


apply to workers at processes such as the Calutron and the Cyclotron 


and other operations involving non-uranium activities, provided 


identification can be made of who was monitored for those nuclides. 


In addition to these 6,000 records, NIOSH is looking at Department 


4000 records from the X-10 facilities. Those are people who worked on 


operations at Y-12. These two datasets may provide the basis for some 


quality analyses that would allow dose reconstructions for non-uranium 


radionuclides at Y-12. Dr. Anderson asked for a time frame. Dr. Neton
 

replied that ORAU is currently reviewing the data, then it will be 


decided if the data can or cannot be used in a timely manner. 


Dr. Ziemer next reminded the Board of the conference call scheduled 


for March 14th. One of the items will be an update on the status of 


these issues for the Y-12 SEC petition and pertinent issues. At that 


point the Board must determine if it will be ready to have a vote on 


the petition for the April 25th through 27th full Board meeting. 


With issues fresh in mind and all parties present, Dr. Wade wanted to 


make detailed plans for interactions between NIOSH and SC&A to ready 


the vote on an SEC petition at the end of April. Mr. Robert Presley
 

found problematic the SEC petition’s mentioning of only pipefitters 


while leaving out large groups of workers who had likely worked with 


uranium issues, such as machinists and chemical workers, particularly 


considering that Y-12 was ramped up from a chemical operation into a 


production operation at that time. Mr. Larry Elliott clarified that 


the current language is only a starting point based on a definition 


put forward by the petitioner. During evaluations of petitions, the 


definition tends to expand to cover other site workers who should be 


considered in that class. He echoed the importance of resolving these 


issues because it goes directly to the first prong of the two-pronged 


test for considering adding a class B can dose be sufficiently 

reconstructed for that class. 

Dr. Ziemer asked if the job categories or individuals from Y-12 during 


the time period are well known, perhaps well established in the work 


records. Dr. Wade clarified for the record this discussion resides in 


6
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


the context of the site profile evaluation. Mr. Presley said that in 


the past four or five years examining records he has come across a 


tremendous amount of job description material. He said Dr. Neton has a 


list up to 60 pages long in which the information exists to properly 


categorize jobs. Dr. Neton said the working group is aware of having 


a title for almost every exposure measurement in these exposure 


records; however, the titles were not standardized, so ORAU has made 


judicious choices in collapsing these data down from hundreds to 


perhaps 40 relevant job types. Dr. Neton also noted that the monitored 


workers seem to have been the more highly exposed. Mr. Griffon said 


that despite having job titles and work locations, a cross-link of 


where they worked is lacking. These possible multiple exposures might 


still be covered in a blanket distribution type model, but that level 


of detail is not currently available. Dr. Neton affirmed Mr. 


Griffon’s statements and said NIOSH is getting near the proof of the 


principle that these job categories can be collapsed. It will be 


difficult to decide who was potentially exposed to the non-uranium 


operations. If such workers cannot be binned into the right categories 


then the usual assumption that they could have been exposed will 


apply. These decisions can be made; the primary task is to identify 


how the group will go about it. These considerations are seen in the 


comment resolutions in the matrix B how NIOSH will use the 95th 

percentile, which categories of workers will go in there and specifics 

on the nuts and bolts of how this will be accomplished. 

Dr. Wade highlighted the importance of framing those nuts and bolts 


issues because this will be the Board’s last chance to instruct the 


principles in terms of the degree of specificity sought. Mr. Griffon
 

requested a few more examples from NIOSH on how the dose 


reconstruction models are applied to different situations, now that 


the working group has more data about other radionuclide issues. Dr. 


Wade and Dr. Ziemer agreed that this can all get done. Dr. Neton said 


he totally agrees with Mr.Griffon on the need for more examples. He 


also wanted make several points. Voluminous records exist for uranium 


urinalysis, film badge results and TLDs, and it will be a key task to 


establish the credibility or reliability of these datasets. 


Furthermore, although the presence of non-uranium nuclides must be 


considered, they were not routine operations and did not involve a 


major percentage of the workforce, despite the focus that issue is 


receiving. 


Thirdly, Dr. Neton wanted to be clear that the 6,000 page set of 


information is not full records but bioassay data, some full pages and 


some nearly blank and possibly some redundant pages. He did not want 


people’s expectations for this information to be too high. 


7
 
 

Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


Mr. Griffon commented that NIOSH had done at least a cursory analysis 


of the claimants and determined that about ten to 12 percent would 


rely on urinalysis records for dose reconstruction, whereas the other 


88 percent would rely at least to some extent on the coworker models. 


Dr. Neton continued, explaining that the further back one goes before 


1961, the more sparse the data. That means fewer and fewer samples 


are available thus necessitating the use of coworker data, which 


spotlights the issue of which percentile to use for coworker data. 


Whether to use 50th or 95th percentile is a matter of detail for the 


dose reconstruction process as opposed to something that would prevent 


doing a dose reconstruction at all. It is a matter for the working 


group. 


Dr. Ziemer expressed concern that the working groups remain ad hoc 


groups rather than becoming institutionalized as committees. He then 


asked the current working group to continue on the Y-12 site profile 


as it relates to the SEC petition, specifying along with Dr. Wade that 


the task relates only to the site profile, and working with SC&A and 


NIOSH in the resolution of identified issues. Dr. Ziemer asked the 


working group to make preparation for both the upcoming conference 


call and the next meeting. He asked Mr. Griffon to work out a 


schedule for the working group, NIOSH and SC&A. 


Dr. Wade noted that the upcoming suite of working group meetings would 


need to be available to representatives of the petitioner and those 


people who have a particular interest in these matters. Mr. Presley
 

asked if the site profile is to be considered from 1944 to 1957 or 


1943 to the present. There are years beyond 1957 that he feels should 


be looked at. Dr. Ziemer said the petition itself covers 1944 to 1957, 


period. Ms. Munn felt the site profile should run from initial 


operations to the current date, although the immediate priority would 


be those questions affecting the period of time covered by the SEC 


petition. Dr. Wade emphasized that the working group will only be 


looking at the site profile, even though they are likely to focus on 


certain areas for reasons of the SEC petition. Their task is the site 


profile review, not an SEC petition activity. Otherwise, the workgroup 


would have to be reconstituted. Dr. Ziemer said to proceed on that 


basis. 


***** 


8
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


PROCEDURES FOR BOARD EVALUATIONS OF SEC PETITIONS 


DISCUSSION, PART I 


Dr. James Melius, Chair 


Special Exposure Cohort Review working group 


Dr. Melius presented the revised version of the January 9th conference 


call report on SEC petition procedures along with subsequently 


collected comments from the Board. The working draft report was 


produced from Dr. Wade’s outline of a half-day November workgroup 


meeting in Cincinnati with Dr. DeHart, Mr. Griffon, Dr. Ziemer and Dr. 


Melius along with several members of NIOSH staff. The purpose of this 


working group report is to streamline the petition evaluation process, 


particularly steps three and four. Comments of other Board members and 


the public are welcome following the presentation. 


Dr. Melius noted this is a simplified schematic of the steps in the 


petition process. First, the SEC petition is sent to NIOSH. 


Secondly, the petition is reviewed to see if it qualifies, and 


thirdly, after it has been accepted and deemed appropriate for follow-


up, NIOSH does an evaluation of the petition to determine if it meets 


SEC requirements to be a member of the cohort. Fourthly, the NIOSH 


evaluation report is transmitted to the Board for review. In simple 


terms, based on its review, the Board then makes a recommendation to 


the Secretary on whether or not to accept that group as a class into 


the Special Exposure Cohort. 


The workgroup had focused on steps three and four, namely how NIOSH 


conducts its evaluation of an accepted petition and how the Board 


reviews that evaluation. Their goal was to clarify the steps and 


increase efficiency because the petition process has required several 


meetings for deliberations and much work in between meetings to reach 


conclusions. They first focused on the steps from evaluation to 


recommendation, making the assumption for purposes of this report that 


the current regulations regarding the SEC qualifications stay in 


place. The main task at hand was to clarify the criteria and the 


procedures the Board would use in reviewing the NIOSH petition 


evaluation report to expedite the process without compromising the 


scientific basis. 


The workgroup arrived at four considerations. One: timeliness, so 


petitioners would not have to wait too long for a review and to reduce 


the Board and NIOSH’s time and effort. Second: fairness, to ensure 


each petition gets due effort in evaluation and review. Third: 


criteria understandable for the public and everyone involved. Fourth: 


consistency, or application of the same criteria to each petition to 


ensure equal treatment for all sites. 


9
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


A key point is that these evaluations focus on exposure data sets, 


such as biological testing and external radiation sources collected 


over a period of time. The workgroup dealt with how to evaluate the 


credibility and validity of each data set in question. To that end 


they concern themselves with pedigree of that data, its quality, how 


it is generated; the methodology, whether up-to-date or not and how 


methods from 50 years ago compare to current ones; how to assess 


quality control from decades past and monitoring methods which were 


under development, and the relationship of the data under 


consideration to other sources of exposure information about the 


facility or the workers. Although some of these data sources may not 


be as comprehensive as the set intended for current use in individual 


dose reconstruction, the data need to point to the same thing. 


Internal consistency is needed. The basic dataset needs to make sense 


based upon what is known about the facility’s operations as well as 


the methods used for monitoring. Another key consideration is the 


representativeness of the data and whether they cover all areas of the 


facility. Monitoring in only one portion, for example, may not be 


applicable to exposures elsewhere in the facility. 


This group is also interested in whether the data adequately cover all 


time periods of interest in the petition and whether the dataset can 


be used to calculate individual doses during a given time period or 


are there gaps in data. Much time is spent trying to figure out the 


time span fairly and reliably covered by particular datasets. 


Another point of focus concerns whether the dataset can be generalized 


or used to cover mobile workers with varied tasks. If it does not, 


there are options in terms of splitting up the Special Exposure Cohort 


or accessing other appropriate datasets. The group also put focus on 


subsets of the data and how robust the data can be as it gets broken 


down into smaller and smaller subsets. 


Regarding data, Dr. Melius said the use of several different sets of 


data is usually not simple. There is a need to be able to focus on 


key sets of data critical to assessing whether or not individual dose 


reconstruction can be conducted reasonably within the constraints of 


timeliness, accuracy and fairness to the exposed workers. Feasibility 


points to readily available data. Timeliness requires access to the 


data and calculations necessary to do dose reconstruction without 


waiting years. Fairness requires that NIOSH demonstrate not only the 


ability to dose reconstruction but also the ability to appropriately 


reconstruct doses for all the different groups covered under the 


Special Cohort petition or evaluation. 


10
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


Additionally, in recent evaluations of Special Exposure Cohort reports 


NIOSH has been asked for sample dose reconstructions using actual 


representative data. These demonstrations show that it is possible to 


do dose reconstruction for the various groups involved. The workgroup 


report contains further discussion to try to set out the criteria for 


this. 


The report also recommends a couple of procedural changes. One is that 


NIOSH provide a mid-point evaluation done after the petition has been 


certified. Currently, as soon as a petition is qualified, NIOSH 


prepares a very general report on their plans for doing the 


evaluation. It is general because NIOSH has not had time to look at 


the different datasets. A more detailed evaluation plan later in the 


process would be helpful both for NIOSH and the Board in reviewing the 


evaluation. This mid-point report could specify what datasets and 


types of information were going to be critical in assessing whether or 


not dose reconstruction is possible or whether the group would qualify 


to be part of the Special Exposure Cohort. 


A second recommendation, whenever possible, would be to complete a 


site profile before evaluation of a petition from that site, or at 


least review relevant portions of the site profile, because that 


information is very helpful in resolving issues about the petition 


evaluation. Admittedly, this must be done on a case by case basis. The 


Board’s contractor could also be asked to follow a procedural approach 


appropriate for the Board’s review of the SEC petitions, thus 


increasing efficiency and fairness. 


Dr. Ziemer asked Board members for questions, comments or concerns 


about the document. Dr. DeHart wanted to be sure the public 


understands that an SEC petition could be divided and sub-grouped so 


that one group would be certified and another group would wait for 


determination on calculation of dose. Dr. Melius added that even 


within the petition the groups could be sub-grouped; in fact that has 


already been done by demarcating different time periods of exposure, 


and NIOSH already does this to some extent. 


Dr. Wade offered comments. Tomorrow, SC&A will present recommended 


procedures for the Board to follow which will mesh well with today’s 


discussion. SC&A will also report on its initial review of NIOSH’s 


procedures in terms of reviewing the SEC petitions, so that will 


inform the discussion. He reminded the group that they’re an advisory 


committee to the Secretary of HHS, and when he briefed the Secretary’s 


advisors on the agenda for this meeting, they were very interested in 


this item in particular and had some thoughts to share. They do want 


to give this important issue a full vetting. They want to be sure 


incoming Board members have an opportunity to participate in this 


11
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


process by which they will be governed. He suggested that as 


background for this discussion he can ask counsel tomorrow to address 


what timeliness means in the context of the Rule and of the law and 


applauded the working group’s willingness to work on this very 


important issue. 


***** 


INDIVIDUAL DOSE RECONSTRUCTION REVIEWS (SETS 1, 2 AND 3) 


Dr. Hans Behling, 


Ms. Kathy Behling, 


Sanford Cohen & Associates 


Concerning the first set of 20 cases, Ms. Behling reported that all 


have been reviewed and put through the full resolution process. She 


was not sure if the Board had any final issues to be addressed, 


although she believed there was a discussion point on a possible 


letter for the HHS. The report on the second set of 18 cases has been 


submitted, Board meetings have been held, and the working group met 


with NIOSH to discuss the associated findings. SC&A was hoping to get 


the written responses from NIOSH prior to this meeting but these have 


not yet been reviewed. For the third set of 22 cases, SC&A has 


submitted a draft report and held a conference call with the assigned 


Board members. Changes based on those comments have been made and 


SC&A’s matrix regarding the associated findings was recently submitted 


to the Board and NIOSH. 


Currently SC&A is nearing completion on the fourth set of 20 cases. 


Ms. Behling said SC&A is hoping during this meeting to establish a 


more efficient process of sending out individual reports with the 


assigned Board members and having discussion with them prior to 


publishing the report. SC&A will possibly be in a position to set up 


those meetings the second week in February. 


Ms. Behling offered an overview of the third set for the benefit of 


new Board members and as a reminder to all present of the stops 


involved in the dose reconstruction process. First, SC&A looks at the 


data studied by NIOSH and ORAU. They take NIOSH’s Interactive 


RadioEpidemiological Program (IREP) input sheets and attempt to 


reproduce the doses. If they can’t reproduce all the doses, they do a 


spot check or a selection, a process to be detailed later on today. 


In addition to reconstructing the dose, SC&A examines whether or not 


the dose reconstructor correctly used, understood and applied the 


12
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


appropriate procedure. They try to ensure that the regulations and 


assumptions used in the dose reconstructions are fair, consistent, 


well-grounded, and based on the best available science. 


Lastly, they check to see if all the data received and looked at by 


NIOSH appears on the Computer-Assisted Telephone Interview (CATI) 


report. They want to ensure that all the Department of Energy (DOE) 


records and any monitoring and bioassay data is being used to address 


all aspects of activity submitted by the claimant. For example, for 


the third set of cases, 20 of the 22 cases were considered advanced 


reviews. Looking at the CATI report enabled SC&A to make a 


determination and suggest areas in which SC&A and NIOSH could or could 


not expand on the information available. 


Ms. Behling noted that confusion abounds over the issue of which 


procedures are being used and how the entire dose reconstruction 


process goes forward. She explained that for dose reconstruction, it 


is first looked at by a group at ORAU that makes a determination based 


on the cancer and a preliminary look at the dose to fit it into one of 


three categories: 


#1Minimized dose reconstruction, which for the sake of efficiency does 


not have to calculate the entire dose because there is sufficient 


dose to put the individual over the 50 percent POC; 


#2The maximizing approach, most common in these 60 cases, where the 


dose reconstructor uses a set of procedures specific to that case 


and situation in attempt to show that the claimant does not go 


over the 50 percent POC even when receiving all the benefit of 


the doubt; 


#3and the last approach, to be covered by Dr. Behling at the end of 


this presentation, the best-estimate dose reconstruction. 


The fourth set of reviewed cases exemplified some true best-estimate 


dose reconstructions. NIOSH looks at all the records to make a 


painstaking and very detailed assessment for internal and external. 


Using IREP summary sheets to reproduce doses for these best-estimate 


cases has become much more tedious for SC&A reviewers due to the 


computer programs and workbooks used by the NIOSH dose reconstructors. 


Ms. Behling next broke down the categories of types of information 


used in the SC&A review checklist. For data collection issues they 


review whether NIOSH did get all the data they requested from DOE and 


had enough data including external, internal and CATI information to 


adequately complete this dose reconstruction. Misinterpretation of 


procedures is the root cause of 30 percent of the findings. Currently 


13
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


ORAU is using the workbook dose reconstruction tools which provide an 


easier, much more efficient and consistent dose reconstruction 


approach than ever before. Many of the findings will be eliminated or 


at least reduced when the workbooks are used almost exclusively. 


Under Task III SC&A has begun to look at the workbooks and Ms. Behling 


noted it will be critical in the future to ensure that the workbooks 


are appropriately using the information in the procedures and in the 


Technical Basis Documents. The statistics on these 60 cases largely 


stays the same as last time, even given a few minor calculation 


errors, procedures not referenced and similar problems early on within 


the third set of 22 cases. The only significant change in statistics 


arises where, as reviewer, they could not reproduce the dose. In 


earlier findings that number was two percent, and now the number is 14 


percent. When SC&A encountered for the first time a best-estimate done 


for the external dose, it raised many questions. SC&A didn't know the 


dose reconstructor was using a workbook and the reviewer ultimately 


was unable to reproduce a lot of information there, which raised the 


statistic. 


Dr. Ziemer asked what number of findings would have resulted in a 


change to the compensation of a worker. Dr. Behling said that of all 


60 cases to date, he could say with a high degree of certainty that 


not one of them would be changed. Ms. Behling elaborated on an 


earlier comment that much conservatism is built into these maximum 


dose reconstructions and that reassessments for neutron doses will be 


based on best-estimate procedures rather than ORAU TIB 2, 8 and 10. 


The benefit of these 60 cases has been to give the dose reconstructor 


the option of doing the dose reconstruction manually, using the 


aforementioned procedures. This process facilitated part of Task III, 


to identify where the procedures are unclear and complex. NIOSH has 


conceded they will try to clarify the procedures, which will address 


the finding concerning misinterpretation of procedures in 30 percent 


of cases. 


Dr. Behling summarized what they have learned to date. Having reviewed 


almost all of the four sets, they can conclude that most of the audits 


were maximized, assigning far more dose than would reasonably have 


been received. Only a few cases involved partial dose reconstructions 


needed to get over the 50 percent mark. The impact of findings 


concerning a deficiency, a few missed doses, is overshadowed by the 


huge dose that has been assigned. It comes to the point where in 


context with these errors one approaches or exceeds 50 percent and 


NIOSH has recourse to say the gift is coming back. 


Nevertheless, these findings do point to things which need to be 


looked at for the sake of process credibility. It does not look right 


14
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


to continuously commit the same errors even if they are marginal 


errors with no impact. The checklist has made that clear; the 


reviewers do not anticipate anything that would potentially have 


converted a non-compensable to a compensable case. 


For the first time, Dr. Behling said, we have encountered the best-


estimate methodology, which is impressive for its detail and 


complexity. It must be very tedious for the dose reconstructor who 


must actually model and assess a volume of records decades in the 


making. That is time-consuming for the dose reconstructor and the 


reviewers. Now, best estimates are usually invoked in situations where 


the potential exposures will lead to a POC of between 45 and 50 


percent. This calls for great care in looking at every aspect of the 


dose reconstruction process, because there is no buffer. 


SC&A will not do the POC calculation. That will go back to NIOSH. 


However, there will be some instances of 48 POC and the findings will 


be dangerously close if not over that limit. SC&A will not proceed 


beyond the point of identifying these findings. Dose audits are at a 


new position wherein more and more best estimates will be used, 


requiring much more detailed scrutiny for the assessment. The use of 


workbooks has all but eliminated many of the errors found under the 


min/max approach. They are extremely useful and relatively easily 


audited. Their use of computer codes--Crystal Ball-- to calculate 


uncertainty will eliminate many of the concerns found in the first 60 


cases, where few people could understand the procedures for 


determining uncertainty. Dr. Wade thanked them for their presentation. 


***
 

In the brief comment period afterward, Dr. Ziemer and Dr. Wade
 

ascertained that NIOSH has provided responses on cases 21 through 30 


but nothing beyond that so tomorrow the workgroup will place a 


different course of action for each of the 20 sets, bringing them to 


resolution and closure. Dr. Ziemer announced the public comments 


period will start an hour earlier than scheduled but assured everyone 


that it would still be in session at the designated start time of 5:30 


p.m. today. 


***** 


PUBLIC COMMENT PERIOD 


15
 
 

Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


Dr. Ziemer offered remarks and ground rules. He called for concise 


comment and said the Board is seeking to identify if the system is 


working well and where fixes are needed. He reminded the public that 


this Board does not do the dose reconstructions or determine who is 


eligible for compensation, nor does it review denied cases. This is 


not an appeals board. Its well-defined responsibilities include 


reviewing the work of NIOSH to ensure adherence to proper procedures. 


For detailed concerns about an individual case, members of the public 


can talk to NIOSH people who are available here today to provide or 


obtain information and answers. Dr. Ziemer then took public comment 


in the order of the sign-ups. 


The following is the list of the members of the public who spoke. A 


full transcript of the public comment is available on the OCAS web 


site, www.cdc.gov/niosh/ocas. 


Mr. Larry Jones, ATLC health and safety representative, Y-12; Ms. 


Barbara Walton, Bethlehem Steel survivor; Ms. Kathy Bates, daughter of 


survivor; Ms. Janet Michele*, Coalition for a Healthy Environment and 


the Alliance for Nuclear Worker Advocacy Groups; Ms. JoNell Barton, 


claimant; Ms. Doris Henline, claimant; Ms. R. L. Ayers, survivor; Mr. 


George Eldridge, survivor; Mr. Gary Foster, son of claimant; Mr. 


Forrest Johnson, claimant; Mr. Kenny Cook, ATLC; Ms. Eliza Robinson, 


claimant; Mr. Bob Warren, claimants; attorney; Ms. Beulah Lindsey and 


Mr. Alvin Lindsey, survivor children; Mr. Glenn Bell, Chair, Y-12 


Chronic Beryllium Disease Support Group; Mr. Richard Miller, GAP. 


*****
 

With no further comments, the Board officially recessed until the 


following morning. 


***** 


Wednesday, January 25, 2006
 

Dr. Ziemer welcomed all to day two of the Advisory Board on Radiation 


and Worker Health in Oak Ridge, Tennessee, encouraging registration of 


attendance and sign ups for the public comment period at 7:30 tonight. 


Copies of today’s documents are available in the room. Board members 


should have received copies of minutes of the August and October 


meetings which will be reviewed tomorrow. Dr. Wade thanked the Board 


for its difficult work and commended the high level of transparency, 


which reflects well on the quality as well as the quantity of the 


work. 


16
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


***** 


PACIFIC PROVING GROUNDS SPECIAL EXPOSURE COHORT 


No conflicts of interest on the Board were announced concerning the 


petition for Special Exposure Cohort by the petitioners for the 


Pacific Proving Grounds. Ms. Daniella Karo, representing the 


petitioners, was present via telephone, and Dr. Paul Blake was also 


present on behalf of the Defense Threat Reduction Agency (DTRA) which 


is involved in a counterpart program concerning compensation for 


atomic veterans. Board members were provided a recent document 


containing comments and concerns raised by DTRA to be discussed in 


connection with this petition. Dr. Wade added that Dr. Neton’s
 

presentation will be proof that there are no simple SEC petitions. 


Dr. James Neton, 


NIOSH/OCAS 


Dr. Neton addressed the evaluation of SEC Petition No. 20, received by 


NIOSH under a different definition. NIOSH is now evaluating the 


Pacific Proving Grounds in total and not just Operation HARDTACK 1, 


which was the basis for that petition. The Pacific Proving Grounds is 


a series of atolls and islands in the Marshall Islands where the U.S. 


military conducted a series of nuclear weapons tests from 1946 to 


1962, starting with Operation CROSSROADS and ending with DOMINIC. The 


petition received by NIOSH, initial class, was for all scientists and 


couriers employed at Enewetak Atoll during Operation HARDTACK from 


July 1st, 1958 through August 31st, 1958 -- a very narrow window of 


time. As is usual with petition evaluations, NIOSH looked beyond the 


established class to see if any additional exposure scenarios and time 


periods should be evaluated and possibly covered under the petition. 


Following the procedures and guidelines established by 42 CFR 83, the 


Special Exposure Cohort rule, a petition for SEC status was submitted 


for Pacific Proving Grounds and was qualified on April 11, 2005. The 


petitioners and the Board were notified, and a Federal Register notice 


was published on May 5, 2005. The NIOSH evaluation of the petition is 


summarized in their report of October 20, 2005, sent to both the 


petitioners and the Board. On January 18, 2006 a Federal Register 


notice advised that the report would be discussed by the Board at its 


upcoming meeting. 


In December Dr. Blake had written NIOSH expressing his concern that 


several misrepresentations in a Nuclear Regulatory Commission (NRC) 


report on DTRA's program may lead to misconceptions by NIOSH about the 


operating status of said program. On January 20 NIOSH filed a 


17
 
 

Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


supplement to their evaluation in which they attempted to address the 


issues raised and to slightly narrow both their proposed class 


definition and the focus of the petition. 


Dr. Neton reported that the required steps in the evaluation process 


included the application of the two-pronged test for feasibility and 


health endangerment. He described the types of data reviewed in 


determining feasibility, including the availability of resources. He 


explained the results of such efforts in determining if there were 


sufficient sources of ionizing radiation and how these sources were 


delivered in concluding whether workers' health could have been 


endangered through such exposures. 


NIOSH conversed by phone and later shared a site visit with DTRA 

personnel engaged in a similar program of dose reconstructions for 

military personnel who were at these test sites. NIOSH evaluated 

DTRA’s process for possible use in reconstructing doses for purposes 

of Energy Employees Occupational Illness Compensation Program 

(EEOICPA.) DTRA’s example dose reconstructions used the ICRP-30 models 

for internal dose and estimated a 50-year committed dose rather than 

the annual doses NIOSH uses under this program for IREP calculations. 

Dr. Neton also noted that dose reconstructions for the DTRA’s Nuclear 

Test Personnel Review program are conducted for non-presumptive 

cancers. 

As for affidavits and documentation provided by the petitioners, there 


was no monitoring for internal exposure from ingestion or inhalation 


during these time periods and no evidence to link the considerable 


external data to internal exposure. NIOSH could not find bioassay 


sample records from Operation CROSSROADS, and the quality and 


reliability of that data was questioned in the publicly available 


records, as these measurements were done on board ship with available 


survey instruments, with no long-range plan for measurement. Data for 


off-site air sampling was insufficient to enable dose reconstruction 


for workers, as they were primarily environmental samples related to 


possible civilian exposures. 


When NIOSH found nothing available for bioassay sampling and the 


environmental monitoring data was insufficient, they looked to DTRA’s 


approach of using a sophisticated computer program to estimate 


internal dose from external dose results on the badge. However, in 


considering this whole program, NIOSH recognized that a lengthy 2003 


review by the National Research Council questioned the credibility of 


the upper bounds raised and the reliability of the methods. Although 


the NRC review did not invalidate the model in question, it raised 


questions about the multiple sources of uncertainty and whether the 


method is valid for making these assumptions. 


18
 
 

 

Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


Dr. Neton noted that in NIOSH’s review they were evaluating DTRA’s 


program only for purposes of reconstructing doses with sufficient 


accuracy under EEOICPA. They were not questioning DTRA’s ability to 


reconstruct doses for their own program. That finding and numerous 


others, however, indicated that doses could be either underestimated 


or overestimated, but the report made no real indication of the 


magnitude of corrections or the uncertainties in either direction, so 


sufficient accuracy cannot be assured. 


DTRA’s plan of action to evaluate these issues and complete their 


analysis was slated for June 2006. Although interim guidance issued 


July 16th allows DTRA to move forward with dose reconstructions by 


multiplying the internal doses by a factor of ten, NIOSH has not seen 


scientific analysis of that approach and feels it would not constitute 


sufficient accuracy under the requirements of this program. 


NIOSH then revised the class definition from covering Operation 


HARDTACK 1 to all employees of DOE, DOE contractors or subcontractors 


employed there from 1946 through 1962 who were monitored or should 


have been monitored for exposure to ionizing radiation as a result of 


nuclear weapons testing at the Pacific Proving Grounds. 


Sources of internal exposure from multiple detonations resulted from 


fallout contamination rather than direct exposure to the criticality 


event. Even though NIOSH believes health was endangered due to 


accumulated internal exposures through episodic intakes of 


radionuclides, they lack access to sufficient bioassay or air 


monitoring to properly estimate doses. 


Discussion ensued with Dr. Ziemer and Dr. Neton clarifying points. 


Some dose reconstructions were completed from this newly-defined class 


of 65 but under SEC regulations it turns out they lacked sufficient 


accuracy. 


Concerning DTRA’s suggestion of missed data sources, Dr. Ziemer asked 


if those new bioassay sources would be readily available at least for 


determination of usefulness. Dr. Neton said he’ll defer that question 


to the Department of Labor (DOL.) 


Dr. Melius questioned how an operational determination will be made 

regarding the SEC definition involving a Amonitored or should have 

been monitored.@ Dr. Neton explained that NIOSH held discussions with 

the DOL and decided to narrow the class of workers to those fitting 


this description who were actually exposed. Otherwise, site employees 


who did not even work in the presence of radioactive materials would 


be eligible. 


19
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


Mr. Peter Turcic from the Department of Labor said the provision, 


present in all Congressionally-mandated SECs, is handled for all sites 


by occupation. The exception was Amchitka where it was handled by 


policy. 


Mr. Griffon asked if the DTRA case reviewed by NIOSH included internal 


dose estimates and whether those models could not credibly bound doses 


for claimants in this population. Dr. Neton replied that based on the 


NRC review questioning the reliability and uncertainty of the method, 


NIOSH determined that DTRA’s models could not bound the internal 


exposures with accuracy sufficient for this program. 


Dr. DeHart wondered, given the 65 case definitions and perhaps 1,000 


civilians involved, if there has been any active program to notify or 


contact prior workers. Dr. Neton did not know of any. 


***
 

PETITIONERS RESPONSE 


Ms. Daniella Karo, petitioner 


Ms. Karo indicated she had no presentation per se but, having read the 


evaluation, she did have questions to ask. She wanted to know how 


Congress came up with an upper limit of 250 days of exposure needed to 


establish this kind of class, why Amchitka Island employees were not 


held to this requirement, and what happens with individuals who were 


there for several weeks but less than 250 days. Dr. Ziemer mentioned 


that the episodic nature of testing at Pacific Proving Grounds might 


argue for a different approach than that used at a workplace where 


exposures were chronic; nonetheless, there is rationale for the 250 


related to other sites where that has been the criteria based on 


Congressional mandates. 


Dr. Neton said he could not speak to the legislatively-created SEC 


requirement of presence for Amchitka Island. Within NIOSH’s regulation 


the 250-day requirement covers almost chronic-based exposures rather 


than discrete health-endangering short term events. Although a nuclear 


detonation is arguably a criticality incident, these people were 


removed from the blast itself to exclusion zones and their exposures 


due to fallout from inhalation or resuspension are classified as 


chronic. That was the basis for NIOSH’s decision to apply the 250-day 


criteria. 


Ms. Karo repeated her concern about how individual petitions will be 


treated for claimants who did not meet the 250-day criteria and asked 


20
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


why Amchitka Island was an exception. Dr. Neton said Amchitka Island 


was legislatively added by Congress and he did not know why they were 


excluded from the 250-day requirement. As with other SEC classes, if 


a claimant or case does not have 250 days aggregate exposure, there 


would still be an attempt to do dose reconstruction using other 


techniques deemed sufficiently accurate. In this case, NIOSH does not 


have a technique to do internal dose reconstruction to the required 


degree of accuracy. 


Ms. Karo inquired how NIOSH can proceed without the formula to figure 


out internal dose. Dr. Neton replied that NIOSH would reconstruct the 


external dose and if the persona did not meet the POC criteria based 


on external, the case would be denied. 


Mr. Griffon asked for a description of the nature of these employees’ 


work. Dr. Neton observed the range of activities was varied. Dr. Wade
 

clarified that the people considered for this class were removed from 


the blast but were exposed, through their work, to radiation for at 


least 250 days afterwards. 


*** 


Dr. Ziemer welcomed Dr. Paul Blake, program manager for the Nuclear 


Test Personnel Review (NTPR) program at DTRA, who offered an account 


of how the Department of Defense (DOD) currently conducts dose 


reconstructions with regard to the Pacific Proving Ground and its 


plans for the future. The Defense Threat Reduction Agency, a combat 


support agency of the DOD, functions as the executive agent for DOD 


supporting radiogenic disease claims brought forth by former DOD 


personnel who participated in atmospheric nuclear weapons testing from 


1945 through 1962 or served as U.S. occupation forces of Hiroshima and 


Nagasaki, or prisoners of war in those vicinities when the detonations 


occurred in 1945. DTRA supports the Department of Veterans Affairs 


and, to a lesser extent, the Department of Justice in evaluation of 


radiogenic disease claims. Since its inception in 1978, the NTPR 


program has accumulated a wealth of documentation associated with 


these nuclear events and developed methods for generating associated 


dose reconstructions. 


DTRA has been working to overcome the technical challenges of 


generating dose reconstructions for atomic veterans. These challenges 


are well documented in the 2003 National Academy of Sciences National 


Research Council report that Dr. Neton referenced earlier. One of the 


consequences of the NRC report was for the Department of Veterans 


Affairs to return to DTRA over 1,200 previously-generated dose 


reconstructions for reworking and correcting challenges noted in that 


report. 


21
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


DTRA is concerned about timeliness of the work as many veterans are 


elderly and do not have many years to live. DTRA has made a decision 


to immediately address these concerns, modify procedures and begin 


releasing revised dose reconstructions while also publishing articles 


on the revised techniques on their public web site and in peer-review 


journals at an admittedly slower pace. This decision has led to the 


current situation in which NIOSH has determined it lacks sufficient 


information to estimate internal doses for Pacific proving Ground 


personnel while DTRA is currently in process of performing that very 


function. Dr. Blake expects the problems to be resolved by the end of 


calendar year 2006, when DTRA’s technical reports addressing the NRC 


2003 report will be published. 


Many of the internal dose challenges noted for the current site become 


even more challenging in context of the Nevada Test Site, specifically 


the scenario of the nuclear detonation blast wave resuspending 


radioactive fallout from previous detonations and complicating the 


determination of inhalation dose. Dr. Blake observed both NIOSH and 


this Board are in the difficult position of needing to make a timely 


decision, but caught in the dilemma of two federal agencies proposing 


two very different solutions, a challenge hopefully to be resolved by 


the end of calendar year 2006. 


*** 


BOARD DISCUSSION/RECOMMENDATION 


Discussion began with Dr. Ziemer asking if the 250-day requirement 


applies to DTRA dose reconstructions. Dr. Blake explained DTRA's 


requirements are of a much more episodic nature; a certain time period 


is defined for each atmospheric atomic test, and if a person was in 


that area at a certain period of time they qualify. DTRA’s 


requirements, mandated by Public Law and published in the Code of 


Federal Regulations, differ slightly as issued by two agencies, the 


Department of Veterans Affairs and Department of Justice. They can 


qualify someone for either presumptive or non-presumptive cancers, 


primarily prostate and skin cancer. Therefore, presence at even one 


test could rate consideration. Most of the 250,000 military personnel 


at Pacific Proving Ground and Nevada Test Site were part of the Navy 


sent there for weapons effects tests. The Atomic Energy Commission’s 


group under consideration by this Board was smaller. Dr. Ziemer and 


Dr. Blake’s discussion clarified that for military personnel who were 


closer to the detonations, external dose is the driver, whereas for 


the Atomic Energy Commission (AEC) personnel who were on the islands 


away from the blast, internal dose is more critical, yet data for 


these calculations are lacking. 


22
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


Dr. Melius wondered if the Board’s group of concern might have some 


workers better addressed through the veterans program. Dr. Ziemer
 

thought that kind of specificity is lacking from the information 


database. Dr. DeHart asked how DTRA is handling dose reconstruction 


for military personnel or civilians who were in fact removed from the 


blast. Dr. Blake said internal dosimetry calculations are primarily 


based on radioactive fallout. Mr. Griffon asked about the interim 


rules of thumb guiding these calculations until the end of 2006 when 


resolution is expected. Dr. Blake replied that the preferable method 


is doing full uncertainty analysis as called for by the NRC report, 


but for expediency and due to large uncertainties DTRA is calculating 


a maximum radiation credible dose out to a 95 percent credibility 


limit and then forwarding them to the Department of Veterans Affairs 


to do the probability of causation calculation with similar software. 


NIOSH’s challenge arises from DTRA implementation of procedures not 


yet published. The conservative factor of ten mentioned in statements 


has a statistical basis and after looking at and bounding these 


concepts of fractionation, DTRA considers this a good figure. 


Dr. Wade commented that two federal agencies taking different 


positions can result from starting at different points and moving 


towards a common objective. He commended Dr. Blake and DTRA for their 


professionalism and commended the full vetting of issues in this 


debate. 


Dr. Ziemer emphasized the Board’s intent to give a full airing of the 


issues raised by differences between agencies and how things are 


calculated. He noted that even within the U.S. legal system, different 


laws can conflict so it’s not amiss that not all agencies are 


parallel. Everyone is working together but timeliness pushes the 


issues. Discussion focused on the possibility of a pre-publication 


sharing of information by DTRA to expedite NIOSH’s efforts. It would 


take time and possible perturbation of NIOSH’s process, and not all 


the consequences are foreseeable, but it is possible. During the 


exchange it was established that NIOSH lacks specifics on the workers’ 


living conditions, their only criteria to work with being little more 


than a case file, a job title in some instances, evidence of an 


external badge, and duration at the site. Dr. Blake detailed his 


interactions with his advisory board in preparation for their formal 


plan to be presented this summer in Austin, Texas. 


Dr. Melius had two comments. First, he felt the need for follow-up 


with claimants or survivors of Amchitka Island to gather information 


concerning how their 24-hour exposures were weighted; these workers 


were given an exemption from the 250-day rule because they lived 


there. Second, he understands the time limits but feels the dose 


reconstructions in these two programs may not be reconciled because of 


23
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


different legislative mandates and methods. He cautioned against 


institutionalizing differences between the programs and their 


approaches simply out of not wanting to wait a few months to get the 


report. The results of the SEC petition decision will last a long time 


and it may turn out that some of the issues used as a basis for 


approving it may be addressed within the next few months. Consistency 


is desirable. He would feel much more comfortable waiting for clarity 


on some of these technical issues. Dr. Dehart also cautioned against 


potentially creating two different systems for the same kinds of 


exposure settings. Dr. Ziemer supported Mr. Espinosa’s suggestion of 


follow up with Amchitka Island workers to see if the 250-day issue 


might apply in a somewhat different way for them. 


Mr. Elliott commented for the Board’s consideration that at least 57 


claims remain to be dealt with, some from the first batch received in 


October, 2001, and these claimants await a decision. He also noted 


that of the three with dose reconstructions, one found to be 


compensable had multiple skin cancers and that was done using external 


dose. The other two were found to be non-compensable cancers from the 


presumptive list. 


Mr. Gibson pointed out the extensive listing of entertainment 


facilities at Enewetak Island which indicates workers were to stay 


there for extended time. Dr. Ziemer asked if there weren’t air samples 


giving an idea of the levels that people on the Marshall Islands were 


living with every day. Dr. Blake affirmed that radioactive fallout was 


measured fairly effectively using data from film badges, actual 


measured fallout in water, land and biological samples. Dr. Melius
 

reiterated his earlier concern, the issue of being badged or should 


have been badged, and possibly not qualifying people in the correct 


way for a Special Exposure Cohort. He felt a better and fairer job 


could be done using the scientific work underway for the veterans 


along with further work by NIOSH in describing this group of people in 


this cohort. 


Ms. Munn expressed concern that military and civilian personnel with 


the same work and exposures may be treated differently since internal 


dose cannot be assessed. She questioned whether the DTRA process will 


end up being applicable for this program, and emphasized that some 


claimants have already waited four years. Ensuing discussion revealed 


that during detonations at the Pacific Proving Grounds, both AEC and 


DOD personnel worked together as a joint task force such that the 


external dosimetry records are quite consistent; however, that still 


does not provide a solution for internal dosimetry. It may have been 


the case that the military personnel were more transient than those of 


the Atomic Energy Commission/Energy Research & Development 


Administration (AEC/ERDA.) Dr. Roessler expressed discomfort in 


24
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


lacking enough information to vote now, but was less concerned than 


others about the difference in agency approaches because the more 


critical difference resides in the types of population and their 


exposures. Dr. Neton said despite joint efforts at monitoring, the 


dilemma of trying to reconstruct internal dose from reconstructed 


external data is compounded by lack of knowing the whereabouts of 


these civilians. 


Dr. Melius felt that it would be worthwhile for NIOSH to take the few 


months needed to see if DTRA’s developing information would address 


the main technical basis for SEC determination on the issue of 


internal monitoring. He preferred not voting on the petition now when 


these concerns may be addressed shortly. He suggested asking NIOSH to 


address the 250-day issue by the next meeting, taking care with this 


circumstance in terms of qualifying these people. 


A motion was made and seconded that the Board thank NIOSH for its 


report on the SEC petition and table further discussion to allow time 


for communication between NIOSH and DTRA and to address other issues 


previously stated by the Board.
 

Dr. Ziemer explained that a motion to table is not debatable. A yes 


vote to table will force resolution at the next face-to-face Board 


meeting in April. Those wishing not to table can vote no and an 


alternate motion could be made. However, a proposed action must first 


be made which could then be tabled. Dr. Neton pointed out that NIOSH 


is unlikely to have a detailed plan ready for the April meeting. Mr. 


Gibson expressed concern about the 180-day limit and wondered if 


waiting would gain anything. 


A motion was made and seconded to accept the petition as presented. 


Dr. Ziemer explained the motion to accept the petition is a motion to 


accept the recommendation of NIOSH to grant the SEC petition, and if 


it passed it would be a recommendation to the Secretary of Health and 


Human Services that SEC status be granted. Debate ensued. 


Ms. Munn said if we can make the assumption that resuspension and 


internal dosimetry for individuals on those islands would vary from 


location to location on the islands, she believes it will be 


impossible to come to an acceptable conclusion on internal dose. Dr. 


Melius and Dr. Neton clarified that the uncertainty associated with 


the resuspension factor arises more from ships versus the island 


rather than from worker location within the islands; even so, if that 


is a basis for an SEC, that point needs to be captured specifically 


within the Board’s recommendation. 


25
 
 

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NIOSH/CDC Advisory Board on Radiation and Worker Health 


Dr. Wade, Dr. Ziemer and Dr. Blake discussed what NIOSH and DTRA could 


do before the end of April that would shed light on the issue of 


internal exposure. With technical work still in development there is 


no guarantee of what the end product will look like or whether the 


work available in time for April will inform NIOSH’s efforts, even 


though Dr. Blake believes he is authorized to share such information. 


A motion to table the motion under consideration was made and 


seconded.
 

The vote was five yes to four no with one abstention. Tabling would 


require a majority of those voting, but the abstention is not ignored. 


Six votes are needed to carry the motion. Mr. Presley spoke to change 


his vote. 


Upon the second round of voting, six yes votes carried the motion. The 


vote is to table the action until the next meeting, and it is so 


ordered. 


*** 


Having tabled the action on Pacific Proving Ground, Dr. Ziemer said 


the Board would need to provide instructions for its expectations 


within the coming week. Dr. Ziemer and Ms. Liz Homoki-Titus of HHS 


established that if another department provides information to HHS 


that is not available publicly, its degree of potential usefulness 


could be summarized by Dr. Neton or his designee without necessarily 


releasing classified information. If such information comes fully to 


the Board, however, it will be made public. 


A motion was made and seconded to request that NIOSH follow up on 


three items in relation to this petition: 


#1 to gather further information and evaluate DTRA’s technical work 


on addressing monitoring and evaluation of internal dose; 


#2 to conduct further evaluation of the types of work and nature of 


exposures for people in different work categories, including 


clarification regarding residence; 


#3 to determine how best to address this issue of qualification for 


the cohort, i.e. monitored or should have been monitored, and possible 


adjustment of the 250-day requirement for full time residents. 


Debate ensued. Dr. Melius wanted to word part three so as to ensure 


that this requirement makes it applicable for all the categories of 


26
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


workers who might be considered for inclusion in a Special Exposure 


Cohort. Dr. Ziemer asked if monitoring for 24 hour resident workers 


differed from that of badged workers who left their badge at the gate 


when leaving a facility, and Mr. Presley said the badge was worn 


everywhere on site, 24 hours a day. Mr. Espinosa spoke in favor of the 


motion, his greatest concern being that many under the class would be 


denied on the basis of 250 days. 


Mr. Gibson spoke in favor and offered a friendly amendment that a 


member of the Board with clearance be present during discussions 


between NIOSH and DTRA. 


The mover and seconder accepted the friendly amendment and it was 


agreed that item one of the motion would include the caveat that this 


be done with Board member or members present. 


The motion passed without opposition, with one abstention. 


Ms. Karo was thanked and left the conversation. 


***** 


 CLASSIFIED DATA: 


IMPACT ON BOARD SEC PETITION RECOMMENDATION 


Dr. Lewis Wade, 


Executive Secretary/Designated Federal Official 


Dr. Wade addressed this item as a result of the Board’s questions 


about due process considerations. He met with representatives of both 


the Secretary’s office and the HHS Office of General Council. The HHS 


position, based on a verbal opinion from the Department of Justice, 


concludes that non-disclosure to the public of classified information 


does not qualify a class for addition to the SEC if a sufficiently 


accurate dose reconstruction is otherwise feasible using restricted 


information. Therefore, HHS has no legal authority to grant a Special 


Exposure Cohort petition because classified or restricted information 


was used to determine that a sufficiently accurate dose reconstruction 


can be done. The Department of Justice holds that access by claimants 


or the public to classified information on which HHS may rely in 


making a feasibility determination is not required by due process 


considerations. Mr. Gibson wanted to know why the office of Legal 


Counsel is resistant to put it in writing. Dr. Wade could not answer 


that question but he did offer go back and ask again to get it in 


writing if the Board wishes. His main concern was that the Board be 


not limited in its ability to do its business. Dr. Melius argued this 


does disenfranchise the Board wherever there is classified or 


27
 
 

Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


restricted information, precluding the Board from evaluating NIOSH’s 


review of the SEC petition. Ms. Homoki-Titus clarified that this 


simply limits public access to classified information; EEOICPA gives 


the Department of Energy authority to provide a grant of access to 


sensitive compartmented information (Q clearances) for Board members. 


Due to the high proportion of Board members with conflicts of 


interest, it was felt that the Board would benefit from having a much 


larger number of Q clearances. 


Dr. Ziemer asked that Mr. Gibson and Dr. Melius draft a proposed 


motion and letter for the Board to act on tomorrow regarding its need 


for an increased number of Q-clearances. 


***** 


BOARD CORRESPONDENCE RESPONSE TO LETTERS FROM SENATOR CLINTON, SENATOR 


SCHUMER, REPRESENTATIVE HIGGINS, REPRESENTATIVE SLAUGHTER, 


AND MIKE WRIGHT, STEEL WORKERS 


Regarding Congressional correspondence, Dr. Ziemer drafted some 


responses according to Board rules. Board members have copies of the 


draft response to Senator Clinton’s November 7th letter concerning 


Bethlehem Steel. 


A motion was made and seconded to accept the draft, along with 


proposed amendments using NIOSH’s updated figures. Discussion included 


modification of wording, after which the motion to transmit the letter 


carried unanimously. 


*** 


A motion was made and seconded to transmit Dr. Ziemer’s response to 


Senator Schumer’s November 14th letter. Discussion resulted in 


modification of wording in the same manner as in the Clinton letter. 


The motion passed unanimously.
 

Dr. Ziemer will re-draft a response to Senator Schumer’s January 19th 


letter requesting the Board to rescind its action of January 9. The 


new letter to be emailed to the Board will clarify that NIOSH’s 


actions will come back to the Board in the revised site profile which 


will include more recent information such as issues raised by Mr. Ed 


Walker, the seeming omission of which is the basis for Senator 


Schumer’s request to rescind. 


28
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


The Board agreed without objection to look at the e-mail draft, 


transmit as-is if there are no wording issues or delay transmission if 


re-wording is needed. 


It was decided that no action is needed on the letters from 


Congresswoman Slaughter and Congressman Higgins, as these written 


statements were already read into the record. Dr. Wade concurred. The 


Hanford letter will be covered during the Hanford agenda item. 


*** 


WORKER INTERACTIONS 


Presentation by NIOSH/ORAU 


In preparation for the letter from Mike Wright of the steelworkers' 


union, Ms. Kate Kimpan, project director for the ORAU team for this 


effort, presented a briefing on efforts with regard to collecting and 


taking into account worker information. 


Mr. Wright’s letter to the Board exemplifies a growing need felt by 


both ORAU and NIOSH to respond to information and comments. At ORAU’s 


ongoing worker outreach meetings a NIOSH representative and the site 


profile’s team leader are always present, dedicated to taking 


immediate action. ORAU and OCAS have developed the Worker Input to 


Site Profile Revisions (WISPR) database which captures all comments 


and assures that the commenter and public understand the team’s 


response. Ms. Kimpan acknowledged there is room for improvement in 


coordinating the responses and conveying the value of those comments 


to those making them. Commenters need to know they are being heard and 


what is being done with the information. It’s easiest to convey 


feedback to unions and on the web, but other methods are needed to 


reach individuals who may not have internet access or belong to a 


unified group. Ms. Kimpan welcomed all suggestions for improvement. 


For the record, this relates to ORAU Procedure 0097, Revision 00, 


AConduct of the Worker Outreach Program,@ approved on December 29, 

2005. 

Dr. Ziemer requested some more formal means by which the Board could 


track the wealth of information emerging from the public comment 


periods. ORAU’s Top Hat database had captured relevant information 


from transcripts but the Agency for Toxic Substances and Disease 


Registry (ATSDR)’s software package was unusable outside of ORAU. That 


information has been transferred to WISPR. Dr. Ziemer acknowledged 


that follow-up is occurring but felt a formalized process would 


29
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


prevent comments from falling through the cracks. Mr. Elliott said 


that much of what they hear is not ultimately relevant but the people 


making comment need feedback on why it was not useful. Plans are 


underway to give SC&A access to the WISPR database. Mr. Elliott said 


written comments get a written response; verbal comments during worker 


outreach meetings are captured in the minutes and posted on the web; 


but people making comment need to be notified, appreciated, and told 


why the comments may not be relevant for dose reconstruction purposes. 


Another source of input is town hall meetings, which will be held 


again this summer; Mr. Elliott wanted that to go on record. The WISPR 


database does have comment and resolution; in fact, resolution is 


essential before an item can be closed out. Dr. Wade offered to make 


sure the SC&A task to review procedures is modified to include 0097 


Rev. and at the request of Ms. Kimpan he will also add Revised Proc. 


0031, the TBD which has been revised to accommodate these other 


changes. Dr. Wade will ask that the WISPR database be made available 


to the Board and SC&A and that the Board by emailed when availability 


is granted. Comments from this meeting should be reviewed thoroughly 


and entered in to the WISPR database. Dr. Melius questioned lack of 


response on comments made two years ago by union representative Mr. 


Glenn Bell. Mr. Elliott said Mr. Bell’s submission included maps of 


the site and other information which an ORAU classification officer 


must review before it goes on their web site. It is under review. Dr. 


Melius emphasized the need for a formalized process to address the 


increasing frustration from people who sense that their comments are 


ignored or largely discounted. People at the sites need reassurances 


that significant changes will not be made without an opportunity for 


their input. Mr. Elliott and Ms. Kimpan agreed on the pressing need to 


assure people but they asserted that the comments are indeed taken 


extremely seriously and have resulted in many changes to actual 


operations for thousands of dose reconstructions. Ms. Kimpan will 


provide to the Board and the public her lengthy list of comments that 


have resulted in changes. 


It was agreed Dr. Ziemer will send a formal reply to Michael Wright at 


the United Steelworkers’ summarizing ORAU's efforts toward formal 


tracking of comments and follow up. 


***** 


ROCKY FLATS SITE PROFILE 


DISCUSSION/PLAN OF ACTION 


Discussion of the Rocky Flats site profile matrix included remote 


participants Tony DeMaiori of the United Steelworkers and staff of the 


Colorado Congressional delegation: David Hiller from Senator Salazar’s 


30
 
 

Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


office, Jeanette Alberg with Senator Allard’s office, Carolyn Boller
 

from Congressman Udall’s office and Amy Warder with Congressman 


Beauprez.
 

SITE PROFILE REVIEW 


Mr. Joe Fitzgerald, 


Sanford Cohen & Associates 


The site profile review consisted of highlights of the December 15 


matrix focusing on issues significant from a dose reconstruction 


standpoint. NIOSH will detail its preliminary responses to each of the 


21 findings later, although these have not yet been discussed in the 


working group. 


#1 The primary issue is that the use of urine bioassay MDA median 


values may not be appropriate for plutonium and americium, due to 


primitive internal bioassay techniques in the 1950’s and early 1960’s. 


They are unduly low and likely to underestimate internal dose. SC&A 


asks NIOSH to revisit the parameters and come up with more 


appropriately conservative Minimum Detectable Activity (MDAs), perhaps 


taking two of the four parameters and using the more extreme values to 


come up with higher MDA values. 


#2 Another primary issue says the TBD approach to low or insoluble 


plutonium compounds needs review, due to the question of acute intakes 


of such compounds and whether or not this might be a significant 


contributor in certain target organs such as the GI tract. A claimant 


favorable approach will depend on the type of concern, per ORAUT-PROC0003, which is not referenced in this TBD. 


#3 A third primary issue addressed by SC&A is the inadequacies in 


neutron exposure characterization: how to extend correction factors 


beyond the nuclear track emulsion-type A (NTA) film energies below the 


700 and 800 keV threshold and to apply such correction factors to 


other workers. The NTA film study focused on workers in plutonium 


operations. It did not include non-plutonium operations or workers 


possibly exposed to specific neutron sources beyond those production 


facilities. SC&A wants to identify correction factors that are broadly 


applied for neutron exposures across the Rocky Flats operations. NIOSH 


is working diligently to get University of Colorado’s job-specific 


neutron exposure data. 


#4 SC&A is also concerned about other issues, including addressing 


potential data reliability concerns; potential problems with 


algorithms and dosimeter calibrations; the placement of dosimeters in 


31
 
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NIOSH/CDC Advisory Board on Radiation and Worker Health 


relation to aprons; dosimeters not worn or not properly worn; 

assignment of Azero@ doses at a time when everybody had a combination 

security/dosimetry badge. Suitable explanations for these issues are 

needed now to assure reliability of the data. Mr. Fitzgerald paused to 

take any questions. 

In answer to Mr. Hiller’s query about impact of unanswered questions 


if these issues cannot be answered satisfactorily, NIOSH would have to 


address that issue as a gap in the database and weigh the implications 


on the reliability of the overall data. Tony DeMaiori said the term 


Ano current data available@ was historically used at Rocky Flats for 

unexplained dose, even a high one. Mr. Fitzgerald said SC&A would be 

concerned about that and in fact such reports appear in the 

documentation from coworkers. SC&A has recommended that NIOSH look 

into it further. 

More minor issues include concerns over the assumed default particle 


size of 5 micron AMAD; uncertainties not addressed for americium 241 


material assay and how lung counting was calibrated with these values; 


the non-claimant-favorable assumption of full equilibrium in 


methodologies to assess internal exposure to depleted uranium; the 


assignment of isotropic and rotational instead of anterior-posterior 


geometry which may not fit some Rocky Flats workplace exposure 


circumstances; inadequate consideration of contaminant radionuclides 


present from uranium and other radionuclides shipped or processed 


onsite, particularly U-233 with the U-232. 


Mr. Fitzgerald again paused for questions. 


Dr. Ziemer pointed out to the Colorado delegation that exchanges 


between SC&A and NIOSH have been taking place over the past two or 


three months to address these issues. The Board will extend an 


invitation to a representative of the petitioners to take part in the 


face-to-face meetings. Of the six chapters in the site profile each 


has its own revision number; some are at Revision 1 and most are still 


Revision 0 in an ongoing process of updating the site profile as new 


information is gained. 


*** 


In the Board questions and comments period, Dr. Wade expressed his 


desire to have the Board presented with an evaluation plan before the 


April meeting and have the Board make a recommendation to the 


Secretary on Rocky Flats. 


*** 


32
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


NIOSH RESPONSE 


Dr. Jim Neton, 


NIOSH 


NIOSH’s draft responses to the 21 individual issues identified in the 


consolidated matrix issued in mid-December were covered in detail 


yesterday. Copies of the matrix are on the table. Dr. Neton’s main 


message is that the consolidated matrix and all NIOSH efforts now will 


be directed towards resolving issues of specific relevance to the SEC 


petition at hand. Dr. Neton commended Mr. Fitzgerald’s summary of the 


five key issues. Regarding the first two, the MDA issue and the super 


insoluble material, NIOSH has already come a long way towards coming 


to terms with SC&A and he looks forward to working with them and 


addressing the other issues in the upcoming working group meetings. 


*** 


Discussion Topics:
 

#The importance of keeping Mr. DeMaiori and his people actively 

involved in the process. 

#Clarification on finding number two on the matrix, where Type S and 

Type M are compared without reference to super S class. 

#In the analysis, super S had been determined to be synonymous with 

S. 

#The doses to the lung are adequately covered by S because they’re 

already more than likely over 50 percent. 

#Is there a coworker model for the claimants in the SEC petition 

class and what percentage of the class might this affect. 

#NIOSH does not typically include coworker models in the site 

profiles. 

#Progress made toward exploring ways to validate the data. 

#NIOSH is working towards that with ORAU, recognizing this will be a 

recurring issue. 

#Whether a recommendation on the SEC petition will be ready for the 

Board’s April meeting. 

#NIOSH is working towards the pedigree of the data, providing an 

approach to dealing with ancillary nuclides, and example dose 

reconstructions. 

#The reliability issue is essential because if that issue cannot be 

addressed then the other ones are not relevant. 

#Is matrix issue nine on questions of reliability and validity of 

data critical in terms of the accuracy of the radiation dose. 

33
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


#It is, but NIOSH is revising its response to comment number nine, as 

they had mistakenly addressed an internal rather than external 

dosimetry issue. 

#The Colorado delegation is focused on that issue, and believes if 

there is insufficient information to determine the dose to this 

class, the petition must be resolved immediately. 

#Premature review of an SEC petition only increases tension, wastes 

time and detracts from credibility of both the SEC process and 

overall program. 

*****
 

The working groups for upcoming projects were self-selected. Mr. 


Griffon raised the concern that the current working group is becoming 


a standing committee, but he acknowledged that the tasks do change, so 


it was decided Mr. Griffon, Mr. Presley, Mr. Gibson and Ms. Munn could 


continue at least through Rocky Flats to function as a workgroup and 


coordinate with NIOSH and SC&A. Tony DeMaiori with United Steel 


Workers (USW) will represent the petitioners. For the record, Colorado 


delegates asked for notification of when the working group meets, and 


Dr. Ziemer agreed it will be done. 


*****
 

Ms. Livia Lam, legislative assistant for Senator Cantwell, joined the 


meeting by telephone for discussion of the Hanford site profile. Dr. 


Wade reported that the only Board member conflicted on Hanford is Ms. 


Munn. She was instructed and agreed that she may participate in the 


table discussion but cannot make or vote on motions. 


HANFORD SITE PROFILE B PRESENTATION 

HANFORD SITE PROFILE REVIEW 


Dr. John Mauro, 


Sanford Cohen & Associates 


Dr. Mauro presented the Hanford site profile review using an issues-


tracking matrix as requested by the Board. Eleven issues were 


summarized and submitted January 16 of 2006. 


#1 The major concerns have to do with neutron doses, especially in 


the early years, and exposures to exotic radionuclides. Neutron doses 


were calculated using the neutron-to-photon ratio gleaned from seven 


workers who had both neutron detector film (NTA film) and regular film 


34
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


badges. Given the complexity and size of the site, the first question 


here is whether or not a seven-worker basis is good enough. 


#2 Secondly, because NIOSH had been concerned that the NTA film 


itself was not a good detector, presumably catching only 28 percent of 


the exposure, they used a multiplier of 3.57. SC&A questions that 


adjustment factor, because the vast majority of neutrons leaving the 


reactor were below .7 MeV and would not register, and of the larger 


0.3 particles needed to register, most would not score a direct hit to 


the badge. SC&A also takes issue with NIOSH’s seven-fold reduction of 


that same neutron-to-photo ratio in the N reactor because it was based 


on an unsubstantiated assumption that shielding had been installed. 


#3 SC&A challenges NIOSH’s application of post-1972 data from the 


186 Hanford Multi-Purpose Dosimeters (HMPD) to prior operations 


because pre-1972 there were more hands-on operations, and NIOSH’s 


assumptions do not adjust for design and operational changes that 


occurred. Also, NIOSH used a dataset with measured values above 20 


millirem even though the minimum detectable limit was 50 millirem. 


On the issue of neutrons, Dr. Ziemer asked if Hanford didn’t have 


spectral data. Dr. Behling said that is explained in SC&A’s TBD 


review. The 28 percent or 3.52 correction factor for NTA film used a 


tissue equivalent proportional counter rather than a spectral 


analysis. 


Dr. Neton pointed out regarding neutrons that the issue of sodium 24 


doesn’t necessarily mean it was an activation product in the body. 


There was sodium 24 in the drinking water. Regarding detection 


limits, he said they were generating distributions. In generating a 


lognormal distribution, the detection limit is not relevant as long as 


one is rank ordering doing cumulative probability plots. You can still 


pick off the 50th percentile in the geometric standard of deviation. 


Dr. Ziemer was struck, he said, by the implication that they had no 


spectral information because he knows some of those HPs who were there 


in the early days and he was certain it existed. Dr. Behling
 

commented on the paradox of saying NTA film was not reliable to 


monitor people but it’s regarded as good enough to measure neutron-tophoton ratios. 


Dr. Mauro continued the Rocky Flats site profile review with an 


overview of the issues related to internal dose. SC&A questions 


whether the default values capture the full distribution of recycled 


uranium and trace levels of plutonium, americium and neptunium in a 


way that accounts for all the uncertainties. Prior to 1988 the 


bioassay data is not great for getting a full appreciation of intakes 


of these radionuclides. Also, the supporting literature indicates 


35
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


there was much experimental work or special campaigns involving 


fissile material uranium-233 and its associated uranium-232, as well 


as large quantities of cobalt-60, carbon-14, yttrium and polonium-210. 


SC&A is not convinced that the TBD addresses the rich mix of 


radionuclides and the associated uncertainties. Without bioassay data, 


surrogate approaches must be used, so how well do the instructions for 


dose reconstructors hold up. The TBD covers three different time 


periods, and Dr. Mauro opined NIOSH has used a pretty conservative set 


of assumptions; however, how reliable was the judgment of those taking 


air samples, considering that the full of array of radionuclides was 


not disclosed. Can this incredible gap for internal exposure be 


filled by a one size fits all measure. 


Regarding lesser issues, ambiguity on instructions for interpretation 


of film badge data may have already been solved by use of the 


workbooks. Little attention was given to extremity dose. SC&A feels 


there is room for improvement on bounding the environmental exposure, 


noting that even though NIOSH used the RATCHET computer program, they 


did not use its puff invection modeling feature. More discussion is 


needed regarding exposures associated with tank farms, especially 


during the extensive D & D operations, along with better guidance for 


dose reconstructors on exposures particularly with regard to 


incidents. Ms. Munn commented on Dr. Mauro’s refinement of the issues 


to a manageable size and the in-depth record-keeping continuum at the 


Hanford site providing a depth of information not available at all 


other sites. Dr. Ziemer spoke to assure that copies of this report 


will be made available. 


*** 


HANFORD SITE PROFILE /PLAN OF ACTION 


Discussion followed regarding timeline targets for resolution on the 


work at hand. 


It was decided that SC&A and NIOSH will engage in a technical 


discussion to which a Board member would also be invited, with SC&A to 


provide its transcript and summary to the Board, followed by rough 


draft responses from NIOSH available for further discussion. 


***** 


Dr. Ziemer requested reversal of two agenda items so the Board can 


hear the SC&A report before holding discussion on its own SEC 


procedures involving the recently developed Task Five which allows 


SC&A to assist the Board in various aspects of Special Exposure Cohort 


reviews. SC&A will be asked to review the procedures used by NIOSH and 


36
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


its contractor, ORAU, on the SEC evaluation process. Subtask two asks 


the contractor to provide its thoughts on how the Board itself should 


proceed in handling SEC petitions. The working group has 


simultaneously developed some criteria for evaluating SEC petitions. 


REPORT FROM SC&A ON SEC TASK 


Subtask one 


Dr. Arjun Makhijani, 


Sanford Cohen & Associates
 

Dr. Makhijani gave a presentation on both the subtask one and two 


findings of the Board’s contractor. They looked at the rule, 42 CFR 83 


and the main procedures in OCAS PR-004 and reviewed the forms A and B 


which prospective petitioners would use to file the petitions, along 


with OCAS IG-001 and 2, external and internal dose procedures for use 


in SEC petition evaluation. 


Noted strengths include NIOSH’s logical step by step procedures 


allowing NIOSH to divide the proposed class into sub-classes, useful 


examples for early designation of a certain sub-class and dose 


reconstruction for non-SEC cancers. 


Regarding findings, the NIOSH procedures lack detailed guidance on how 


to calculate maximum dose-- that is, they lack definition of criteria 


where maximum doses might be considered reasonable so that maximum 


doses do not become arbitrary, and guidelines are needed for job 


categories, evaluating data integrity, and for conducting a 


scientifically reliable maximum dose estimation for unmonitored 


workers. 


One of the most important and difficult points arose from conflicted 


rules for maximum dose calculations. Maximum dose under 42 CFR 83 


methods could be used to compensate as well as deny, so that should 


not end up being higher than the highest worst-case assumption that 


will involve no uncertainty under 42 CFR 82. To clarify this problem, 


SC&A suggests that an uncertainty which requires that the worst-case 


dose under 42 CFR 82 always be higher than the maximum dose under 42 


CFR 83. NIOSH does have provision for working extensively with 


petitioners but SC&A feels that survivors who are not claimants but 


who may want to become petitioners need special assistance in terms of 


incidents, working conditions, explanation of site profiles and the 


like. There is post-petition assistance but more pre-petition help is 


needed. SC&A also recommends that a detailed interview with at least 


one of the petitioners be part of the guidelines, so as to obviate 


misunderstandings if an SEC petition is denied and to provide NIOSH 


with greater clarity as to the petitioners’ concerns. The guidelines 


37
 
Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


could use some examples to clarify the basis for sufficiently accurate 


dose estimation. This advice is offered without criticism and with 


recognition of the benefit of hindsight. The final issue relates to 


health endangerment. The example in the rule and guidelines concerns 


external criticality accidents but there is no corresponding example 


for internal dose. Neither is there one for how to proceed for people 


who worked less than 250 days. That completed the review of the 


guidelines. 


*** 


In the discussion that followed, Dr. Neton offered clarification on 


what he perceives as an ongoing misunderstanding about maximum dose 


used to compensate or deny. 42 CFR 83 establishes the fact of the need 


to establish a maximum dose with plausible assumptions in order to 


deny a class. However, if the class were denied, that maximum dose 


would not necessarily be used to do dose reconstructions under 42 CFR 


82; it would just be a bounding, plausible analysis to demonstrate 


ability to put some plausible upper limit. If a more refined method 


becomes available, a better estimate can be used. Without additional 


information, the maximum plausible dose used to deny the class could 


become the best estimate. At that point it is no longer a maximum 


dose. The maximum plausible dose for SEC petition and analysis is very 


different than the maximum dose used in the efficiency process to deny 


cases. Dr. Makhijani replied that the point of this finding is that 


whatever the terminology, a certain plausible dose method was 


developed as was the case of Mallinckrodt, and if that had been denied 


and no further information was available, doses would then have been 


calculated by that method to compensate or deny people, depending on 


POC. SC&A maintains that doses being used to deny people should be 


less than doses used to compensate people. There should be some 


restriction in going from the SEC rule after denial as to how those 


cases are handled, even recognizing the distinction in terms. Dr. 


Neton then conceded the point and agreed that if cases are denied 


based on maximum plausible, there should not be a higher maximum 


plausible for SEC. Dr. Ziemer said it is really a terminology issue. 


Dr. Wade highlighted the value of Dr. Makhijani’s point as it relates 


to the Board’s ability to communicate consistently with people. 


Dr. Melius thinks clarification on the issue of the 250 days will come 


out of work on the Pacific Proving Grounds. He asked for comment on 


the last point, lack of procedures on determining the breadth of the 


class when NIOSH finds that it cannot reconstruct a claimant’s dose. 


Dr. Neton agreed about the lack of such a procedure but said this is 


driven by the availability of the data, which speaks for itself. He 


said he could not envision how to proceduralize that. Discussion 


followed on how classes and sub-classes are intuited by sifting 


38
 
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NIOSH/CDC Advisory Board on Radiation and Worker Health 


through data and created through the petition process, the issue being 


how to recognize the right subsets to define the class and whether for 


efficiency that can be codified in some way. Dr. Neton thought that 


the working group’s draft guidelines may help with that because they 


look not only at what and who was monitored but also what was not 


monitored. The addition of ancillary nuclides of exposure may result 


in definition of a class by nuclide type. Careful evaluation of data 


can spare the need for later re-working. Dr. Wade suggested inviting 


colleagues from the DOL who are left to make these decisions on the 


recommendations. This is an evolving process. 


***** 


Subtask two 


Dr. Makhijani’s report on subtask two contains three phases suggested 


for SC&A’s own procedures. The preliminary step for Phase one, to be 


taken immediately after NIOSH qualifies a petition for evaluation, 


calls for NIOSH to submit an implicit evaluation plan so the review 


can be done serially by NIOSH and the Board. Phase two, during the 


time NIOSH is evaluating the petition, suggests compressing the 


procedure by having NIOSH provide example dose reconstructions 


illustrating the issues relevant to feasibility so that both NIOSH and 


the Board could arrive at a conclusion as to feasibility. After NIOSH 


has submitted an evaluation for the Board’s consideration, Phase three 


is already in place. As delineated in 42 CFR 83, NIOSH and 


petitioners and all other points of view are considered for a decision 


on either further review or action. SC&A also suggests draft 


procedures by which the Board contractor can review the petition and 


associated documents and determine what kinds of partial dose 


reconstructions would be needed in order to clarify issues on 


feasibility of dose reconstruction. Here are their proposals for 


various scenarios. 


1 When there is no site profile review, they would do a targeted 


review of the site profile only for issues relevant to maximum dose 


reconstructions. 


2 When there is no site profile, SC&A would perform a focused 


review of the conditions at the site including such factors as 


radionuclides and job types to target what is relevant for maximum 


dose reconstruction under plausible assumptions for that site. 


3 Partial reviews would follow steps like the ones described for 


phase two of the Board procedure. 


39
 
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NIOSH/CDC Advisory Board on Radiation and Worker Health 


Dr. Wade added that part of the task put in place with SC&A allows for 


the Board to ask for SC&A’s assistance in a petition evaluation 


review, whether it be a full or task-specific review. 


During the comments, Dr. Melius said he’d prefer to use the term 


targeted rather than partial. He suggested that after reviewing the 


materials, NIOSH could prepare a more specific plan for what they 


regarded as the critical datasets, particularly regarding the SEC 


evaluation, to be discussed at a meeting with NIOSH, a workgroup and 


the contractor. This approach would be parallel rather than serial. 


Dr. Ziemer, Mr. Griffon and Dr. Melius brought forth that this is 


already happening to some extent, but the current terms such as 


partial, full, and targeted can be confusing in context of the SEC 


review. Mr. Elliott acknowledged that the plan given today and on 


every evaluation of a petition is intentionally generic and hopefully 


comprehensive in its generality. It’s a struggle within the 180 day 


time frame to provide a scientific basis for making a recommendation 


to add or deny a class. Rather than provide a make-work, additional 


detailed plan, he can see better benefit in a coordinated effort 


involving NIOSH, the working group and SC&A, meeting to discuss the 


salient issues for evaluating a petition. Dr. Mauro noted that the 


closeout process, for which his team allocates 150 hours, has now 


become part of the much more demanding SEC process. Dr. Makhijani
 

supported the need for more site-specific information from NIOSH, 


particularly on dose reconstructions for SECS in conjunction with site 


profile reviews. Feasibility under SEC requires that the methods be 


actually applicable in real dose reconstructions. The other big 


difference is that in site profile reviews, vertical issues are 


highlighted but not covered in detail, whereas for the SEC petition 


review, every detail on feasibility must be covered for the answer on 


all cancers and all members of the class. He feels there is great 


merit in having something focused on SEC reviews. 


Mr. Griffon echoed the spirit of the intent to have earlier 


involvement with the Board and SC&A rather than a detailed plan which 


could become obsolete within the 180-day limit. Dr. Makhijani made 


assurances there is no bureaucratic intent in their proposal. Dr. 


Melius said NIOSH does have access to information that is available to 


no one else -- completed dose reconstructions for a particular site, 


which would be helpful in developing a more focused plan earlier in 


the process. Mr. Elliott agreed on the benefit of that. NIOSH is 


taking seriously the Board’s need to see example dose reconstructions 


if NIOSH is saying to deny the class. Dr. Wade said the discussion has 


been useful and he thinks the spirit of Mr. Elliott’s suggestion is 


the same as those presented by Dr. Makhijani. To facilitate the 


process of earlier interaction, he pointed out the Board’s opportunity 


now to choose one site to use as a first example of trying to put this 


40
 
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NIOSH/CDC Advisory Board on Radiation and Worker Health 


process in place, as the current targets of opportunity are limited. 


From the standpoint of limited resources, Mr. Elliott asked the record 


to show which site petitions are currently being evaluated. They are 


the Pacific Proving Ground, the Rocky Flats petition, Chapman Valve, 


the Oak Ridge Institute for Nuclear Studies -- almost all of the ORAU 


folks are conflicted there so his group is doing that, which presents 


yet another resource-limiting problem -- and Ames, Iowa. Dr. Ziemer
 

suggested completing the framework for that decision today and then 


making a specific site choice tomorrow. 


***** 


PROCEDURES FOR BOARD EVALUATION OF SEC PETITIONS 


DISCUSSION PART II 


(including pending Y-12 Petition and SC&A SEC Task) 


Concerning the item called procedures for Board evaluation of SEC 


petitions, Dr. Ziemer felt this was the time to identify any 


substantive changes to the document. Dr. Wade reminded the Board that 


the Secretary wants full vetting of the document along with the 


opportunity to comment on the procedures before they are finalized by 


the Board. Dr. Melius began the discussion listing issues raised 


yesterday: feasibility, timeliness, regulations, and use of data from 


other sites for a site profile. Ms. Homoki-Titus could not at this 


point give a legal interpretation of timeliness, but she read a 


portion of the actual statute which uses the term and cited the two 


new deadlines that have been added, the 180 days to make a 


recommendation and 30 days for the President to provide a 


determination to Congress, once this Board provides a positive 


determination to the Secretary. She also stated that the current and 


recommended SEC rule gives the Director of OCAS the ability to 


determine that records are not available in the timely manner. Ms. 


Munn spoke for accepting the document as is, explaining that 


specificity will reduce both fluidity and timeliness of the process. 


She offered to move it. Dr. Melius first wanted to come up with 


criteria for how to use data from other sites. Dr. Ziemer suggested 


accepting the document provisionally, soliciting input from the 


Secretary’s office and having a caveat that it’s open to additional 


amendments as the Board sees fit. 


A motion was made and seconded that the Board accept the document 


before it as a provisional document, with the understanding that the 


input of the Secretary's office will be used to help expand the 


document and complete it. The motion carried unanimously. 


41
 
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NIOSH/CDC Advisory Board on Radiation and Worker Health 


***** 


PUBLIC COMMENT 


Dr. Ziemer greeted attendees for the Public Comment period and 


explained what the Board does and does not do. 


The following is a list of the members of the public who spoke. A full 


transcript of the public comment is available on the OCAS web site, 


www.cdc.gov/niosh/ocas.
 

Mr. Jim Phelps, son of Y-12 employee; Mr. T. L. Dishman, retired Y-12 


employee; Mr. Ray Beatty, Fernald employee; Ms. Johnnie Sue Goodman, 


survivor wife; Ms. Helen (last name not given), survivor wife; Mr. 


Franklin Tucker, retired Y-12 employee; Ms. Dorothy Thompson, Y-12 


widow; Mr. Thomas Duncan, claimant; Mr. Paul Royster, son of Y-12 


employee; Ms. Florene Robertson, X-10 widow; Ms. Gail Burgess, 


survivor daughter; Ms. Sharon Slackey, survivor daughter; Ms. Kathy 


Miller, survivor daughter; Ms. Faye Holt, survivor wife; Ms. Lindsay 


Long, claimant; Mr. Earl O'Neal, former Y-12 employee; Ms. Diane 


Boinet, survivor sister; Ms. Shirley Moody, Y-12 widow; Mr. Dennis 


Brown, K-25 survivor ;Ms. Diane McKeethan, claimant; Mr. Frank Scott, 


Y-12 employee; Ms. Valerie Maner, daughter of Y-12 employee; Ms. Ellen 


Foster, claimant's daughter; Ms. Janice Allen, claimant's daughter; 


Mr. M. L. Russell, claimant; Mr. Otis Lee, retired DOE employee; Ms. 


Debra Kiley, survivor daughter; Mr. Martin Delozier, claimant's son; 


Mr. James Hackworth, brother of former Y-12 employee; Mr. Leonard 


Bowers, retired Y-12 employee. 


With no further comments, the Board officially recessed until the 


following morning. 


Thursday, January 26, 2006
 

Dr. Ziemer opened the third day of sessions on the Advisory Board on 


Radiation and Worker Health, reminding all to register attendance and 


pick up a copy of the agenda and related documents. Mr. Elliott read 


a written statement into the record on behalf of Ms. Beulah J. Lindsey 


and her brother Alvin, who could not stay for last night’s public 


comment session. That statement appears in the transcript of the 


meeting available on the OCAS web site, www.cdc.gov/niosh/ocas. 


*****
 

42
 
 

Summary Minutes January 24-26, 2006 


NIOSH/CDC Advisory Board on Radiation and Worker Health 


In his conflict of interest statement Dr. Wade said that for Nevada 


Test Site the only conflicted person would be Mr. Griffon when dealing 


with an action filed by building trades union. For Savannah River Site 


there are no conflicts. 


*** 


STATUS REPORTS AND DEVELOPMENT OF PLANS FOR SITE PROFILE REVIEWS B
 NEVADA TEST SITE, SAVANNAH RIVER SITE 


Nevada Test Site Profile Review 


Dr. Arjun Makhijani, 


Sanford Cohen & Associates 


Dr. Makhijani gave a first look and status report of the two 


preliminary site profile reviews now underway, Nevada Test Site and 


the Savannah River Site, for which matrices have been submitted. 


Revision 0 has been reviewed and Revision 1 is in the works. Regarding 


major internal dose issues, the review found there is no internal 


monitoring data until late 1955 or 1956, and NIOSH has not published a 


method by which those doses would be estimated. Radionuclide lists are 


incomplete particularly regarding short-lived radionuclides. The site 


profile recommends use of Technical Information Bulletin 002 for post1971 tunnel re-entry workers although the TIB itself says it is not to 


be used for that purpose. Currently, photon doses are used to estimate 


internal doses, raising issues on data integrity and large hot 


particle. Data integrity is in question due to the apparent practice 


of some personnel removing their badges so as not to exceed the 


quarterly dose limit thereby keeping themselves eligible for the high 


pay offered for working in forward areas. 


SC&A’s review questions correction factors used for external dose in 


regard to badge location and job locations. The assumption that 


atmospheric test workers were not exposed to neutrons is unvalidated. 


Although it is true that most workers were kept well away from the 


tests, there were pressures to put personnel in forward areas. Large 


hot particles greater than 10 microns could wind up in the GI tract, a 


situation which Dr. Makhijani’s team feels would be complicated by 


oro-nasal breathing of non-respirable particles. Extensive Naval 


Radiological Defense Laboratory (NRDL) research on the issue of large 


hot particles was cited in the site profile but not discussed. Dr. 


Makhijani offered a correction; the matrix should read Aventing of 

underground tests@ not atmospheric tests. 

The review found many issues regarding environmental dose; these 


methods and models could significantly underestimate the environmental 


43
 
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NIOSH/CDC Advisory Board on Radiation and Worker Health 


dose by an order of magnitude or more. The resuspension model used in 


the site profile is appropriate only for early re-entry within weeks 


or months but not re-entry after years. Fractionization of 


radionuclides, in which non-volatile radionuclides are deposited 


closer to the test site and volatile radionuclides travel farther, 


needs to be taken into account in environmental dose calculations. 


Gaps in extrapolations in the environmental dose record were not 


deemed appropriate. 


The Nevada Test Site is admittedly complicated but in some essential 


respects the record review and interview process was not complete, 


resulting in gaps in the site profile. The review team was told that 


in interviews, NIOSH only records what it considers important, whereas 


the importance of information is not always evident until later, so 


better documentation of site expert interviews is required. Other 


major issues include radon issues for G-tunnel workers, the status of 


the Gravel Gertie workers, and lack of discussion of radon dose 


issues. 


*** 


DEVELOPMENT OF PLANS FOR NEVADA SITE PROFILE REVIEW 


Questions and comments on the Nevada Site Profile review presentation 


followed. Dr. Makhijani said the information about badges not being 


worn came up in two independent site expert interviews. There are a 


whole set of documents validating these kinds of employment practices.
 

Dr. Ziemer mentioned that before the late 1950’s, lifetime doses were 


not kept. Only weekly limits were noted. Dr. Makhijani said the 


introduction of the integral identification and film badge in 1966 may 


have helped alleviate the situation, but more research is needed. 


Workers in forward areas were given hazard pay. 


Dr. Neton expressed his appreciation for SC&A’s consolidation of the 


report to manageable significant issues. On the monitoring issue, he 


said he’s seen that workers without badge results continued to have 


tritium excreted from the urine, a detail which supports SC&A’s 


contention that badges were often removed. Dr. Ziemer said that would 


be another good way to cross-validate. NIOSH recognizes the gaps in 


the site profiles and is for that reason moving very cautiously with 


dose reconstructions at Nevada Test Site, particularly during the 


above-ground, atmospheric testing era. 


Dr. Makhijani clarified to Dr. Roessler that the radon accumulation 


owed not to the soil, as at Iowa, but to the enclosed structure at 


Nevada. Speaking from the audience, Mr. Mike Molino did not reveal 


his affiliation, but interjected he has been to the test site numerous 


44
 
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times and could attest that a Gravel Gertie was used for cover at 


Nevada Test Site for seven balloon shots during the early years. 


***** 


SAVANNAH RIVER SITE PROFILE REVIEW 2 


Dr. Makhijani presented the Savannah River Site Profile Review 2, 


completed in October of 2004, explaining that SC&A has not yet 


reviewed NIOSH’s Revision 3 published April 5, 2005, so some of the 


issues to be addressed here will likely have already been resolved. 


Recycled uranium was one issue. Coverage of radionuclides from the 


transplutonium coverage needs to be fuller; exposure to cobalt-60 and 


an array of other radionuclides need to be considered. Dosimeter 


calibration is on normal incidence, so the question of exposure angles 


needs consideration. Dosimeter adjustment factors used in the Savannah 


River site profile are not consistent with the DOE complex-wide 


recommended factors. Some familiar neutron-to-photon ration and 


neutron dose questions are at issue. The geometric mean and standard 


deviation is not technically defensible or claimant-favorable. 


Variations of these ratios within a given facility, such as the FB-


line, need to be taken into account. SC&A recommended use of the 95th
 

percentile values for the period where there are TLND neutron dose 


data. 


There was an incomplete characterization of the Tank Farms. Many of 


the spills were not entered into a databank. Exposure from ground 


spills relative to badge location could be important. These are 


significant issues and it’s important to try to establish a complete 


list of incidents. This review also details inadequacies in the early 


internal and external monitoring programs. 


Coworker models for early workers have not been developed. Some 


recorded intakes were higher than the high five, so the high five 


seems not always to be an actual high five. There seemed to be an 


inconsistency with the regulation 42 CFR 82. There’s an assumption 


that the high five approach is necessarily the worst-case approach. 


Various factors led SC&A to conclude that its use may result in a very 


high overestimation of the dose in most or all cases, but it is not 


clear this could be demonstrated given the present state of the 


documentation reviewed. 


SC&A also questions the applicability of an off-site source term to 


on-site exposures; it may be appropriate in some but not all 


situations. The review finds a need to improve internal dosimetry with 


regard to radionuclide solubility. Some sources of external dosimetry 


are not being used in the dose reconstruction process. Special 


45
 
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NIOSH/CDC Advisory Board on Radiation and Worker Health 


exposure circumstances for subcontractors and construction workers 


need to be considered. 


*** 


In the discussion on this review, Dr. Makhijani agreed to provide 


information on additional external dose dosimetry to the Board and 


NIOSH via e-mail. Dr. Ziemer and others attended to wording in the 


minutes regarding a motion and agreement to hold a face-to-face 


session on development of the matrix. It was decided that the minutes 


need to be reworded to indicate it was not an official response. Dr. 


Ziemer did want the Board to be aware that there was an action already 


in place in moving forward on the resolution process, this matrix 


being the first step. Dr. Wade commented that the Board has a great 


deal on its plate and the group must keep the entire field of play in 


view so that other priorities such as SEC petitions do not stop 


progress on any project. He suggested talking about a possible course 


of action for the Nevada and Savannah River Test Sites. 


Dr. Ziemer conducted the formation of workgroups and team leaders for 


each site. (Team leaders are listed first.) Nevada Test Site: Presley, 


Clawson, Munn, Roessler; Savannah River Site: DeHart, Gibson, 


Griffon, Lockey; Hanford Site: Melius, Clawson, Poston, and Ziemer. 


Dr. Mauro offered to prepare a revised matrix that reflects Revision 


3. Without objection, the contractor was ordered to proceed along 


those lines. 


***** 


CONFLICT OF INTEREST DISCUSSIONS 


Dr. Lew Wade, Executive Secretary 


This issue was initiated by a February 20th, 2005 communication from 


Mr. Richard Miller to Dr. Neton at NIOSH and Dr. Toohey at ORAU, 


raising issues about the Paducah site profile conflict of interest 


issues and also technical issues. A contract oversight team issued a 


report dated October 11, 2005. It was made available at the last 


Board meeting, although not discussed. In light of that report, on 


December 9 Mr. Miller corresponded further with Dr. John Howard, 


Director of NIOSH, and Mr. Michael Leavitt, Secretary of HHS, a copy 


of which was provided in the Board members' packets. Dr. Howard
 

responded to Mr. Miller on December 29. As Mr. Miller requested, Dr. 


Howard took a personal interest in this issue, in this case as it 


relates to the ORAU contract. The two basic issues are conflict of 


46
 
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NIOSH/CDC Advisory Board on Radiation and Worker Health 


interest issues as currently embodied n the draft policy for ORAU, and 


the technical issues raised by Mr. Miller regarding the Paducah site 


profile. Dr. Wade’s suggestion for a format addressing these concerns 


was accepted by Dr. Ziemer. 


***
 

Mr. Elliott began the discussion, explaining he commissioned the 


October review by the assessment team of Mr. Michael Rafky out of the 


Office of General Counsel on the NIOSH radiation legal team; Ms. Lauri 


Ishak, a Presidential management fellow at NIOSH; and Mr. Robert 


Daniels, a health physicist with NIOSH. Their charge was to evaluate 


the concerns raised in the February 20 letter to Dr. Toohey and Dr. 


Neton and determine whether a conflict of interest (COI) policy 


violation occurred during the development of the TBD for the Paducah 


Gaseous Diffusion Plant and whether or not data was purposely excluded 


that should have been incorporated in that site profile. The findings 


of that report are so stated. 


The conflict of interest policy employed during the approval of this 


site profile was found to contain ambiguous language. In the interim, 


this Board raised concerns and ORAU complied with the need to make a 


change in their conflict of interest policy to address site profile 


development. Violation of the then-current COI policy did not occur. 


Although the language was ambiguous, the assessment team felt that the 


underlying intent of the policy was followed. 


Besides ambiguous language, the team identified lack of clear 


definitions of roles, responsibilities, and terms such as subject 


expert, document owner, and primary author. Regarding the technical 


basis of the Paducah site profile, concerns were raised that the 


subject expert did not include a careful consideration and inclusion 


of all data, such as data on ash receivers in the pulverizer area, 


into the presentation of information in the site profile. 


The revised policy as presented today provides much clearer 


explanation and definition of roles and responsibilities and clear 


definitions of terms such as conflict and bias. It identifies clearly 


what the review process is and what level of attribution and 


disclosure is required. 


Ms. Kimpan was invited to speak on this. She expressed pride in the 


work that ORAU is performing for NIOSH on behalf of sick workers and 


said this issue is important to ORAU. It goes to ORAU’s credibility, 


public standing and the quality of the work. Full disclosure is 


paramount. ORAU fully embraces and is implementing this policy even in 


its draft form. ORAU is following the full spirit of the policy, which 


47
 
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NIOSH/CDC Advisory Board on Radiation and Worker Health 


is that no one who is in a potentially or actually biased or 


conflicted role will be a document owner for any part of the work. 


Mr. Elliott added that his group feels so strongly about this policy 


and its clarity and comprehensiveness that once ORAU finalizes it, it 


will be modified to become the OCAS policy. The policy itself requires 


NIOSH approval. Mr. Elliott welcomes Board input also. 


Board members expressed a need for more time to digest the information 


before taking action on it. 


The dearth of experts in this field could lead to conflicts of 


interest. Proper attribution, transparency and objective, scientific 


criteria will be used to minimize the potentially compromised effect 


of having such a small pool of qualified site experts. Mr. Elliott
 

elected to read the definitions of key distinctions from the draft. 


Offered an opportunity to speak, Mr. Miller said conflict of interest 


taints the science that comes out the door and all associated 


organizations. He opined that this Advisory Board is here today with 


NIOSH doing this work because Congress found they couldn’t rely on the 


Department of Energy to do it. The burden is on this conflict of 


interest policy to have adequate checks and balances due to the 


paucity of a pool of available experts. He suggested conflict of 


interest is not merely financial, as outlined in the newly proposed 


draft. It involves organizational and professional conflicts of 


interest, both of which are omitted from this policy. He urged his 


listeners to treat the draft as a work in progress. He agreed to 


provide his ten-page white paper to Dr. Wade for the Board. It lays 


out in detail a critique of the October conflict of interest draft 


policy and provides, in a side-by-side analysis, guidance on what the 


new policy ought to look like. 


***
 

PADUCAH SITE PROFILE/TECHNICAL ISSUES 


Mr. Stuart Hinnefeld, 


NIOSH 


Numerous items of a technical or scientific nature prompt additional 


investigation. A recent data capture including early documents speaks 


to this issue -- the analysis and identification of non-uranium 


contaminants in the uranium materials in various places. NIOSH has 


instructed ORAU to synthesize this and give NIOSH the best product 


available in light of this discussion. 


48
 
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*** 


Discussion Points:
 

#This issue should be resolved quickly for the credibility of the 

program. 

#A plan for NIOSH to develop a procedure for investigating any 

conflict of interest issues that arise. 

#NIOSH staff is being put in the difficult position of investigating 

themselves. 

#Need for an outside involvement mechanism for evaluating the portion 

of COI situations that pertain to NIOSH. 

#Should SC&A also review the revision of the Paducah technical 

document. 

#Dr. Howard's letter requests the Board undertake review of the 

technical quality of the document. 

#The entire document should be reviewed to ensure corrective action 

called for in the assessment report was attended to in the 

revision and all technical information was provided in a new 

revised site profile. 

#Conflict of interest addresses perception, as well as technical or 

legal violations, and even the possibility of a conflict needs to 

be addressed. 

#Perceptions may or may not be valid, such as the assumption that the 

individuals who know most about a topic are the ones to be least 

trusted. 

#A need for management to be up front about possible perceptions and 

state how the issue is being handled. 

#The importance of transparency and how disturbing that conflict of 

interest statements have not been consistently made available. 

#Concern about the terminology limiting conflict of interest to 

financial interest. 

#The policy is written to fit how ORAU works and is not easily 

understood by people outside that group. 

#Conflict of interest training for federal agencies focuses on 

financial conflicts, while this program is more concerned with 

programmatic and related issues. 

#This proposed policy applies to every aspect of ORAU's operations. 

Following Dr. Ziemer's call for a motion to delineate the task to be 


undertaken in response to Dr. Howard's request for Board review, Dr. 


Wade announced the only Board member conflicted on the Paducah site 


was Mr. Leon Owens, who was not present at the meeting. 


49
 
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A motion was made and seconded that the Board give SC&A the task of 


reviewing the revised Paducah site profile, with particular attention 


to the issues raised in Mr. Miller's February 2005 letter, as well as 


in the NIOSH assessment of the conflict of interest issues related to 


the original site profile. 


Following discussions related to timing and slowing down work on other 


sites, the sense of the motion was refined to reflect that the work 


would get underway at such time as the materials are available, and 


that the Board will be kept apprised of the status. Even if there is 


a delay of a couple of months to fit the work in, there should be no 


dropping of current plans as this becomes additional work. 


With that clarification, the motion carried unanimously. 


Further Discussion Points:
 

#ORAU's intent to apply the policy retrospectively. 


#It applies to things not actively in the review process, as well as 


what is in the formal review process. 

#The need to keep Board members and the public informed when a change 

is made on a site profile. 

#An obligation to follow up on changing disclosure statements, with 

ORAU making assurances of full status updates and transparency. 


***** 


TASK III REVIEW B DISCUSSION/CLOSURE 

Mr. Griffon gave an update on Task III, the review of the procedures 


task. On Tuesday, the subcommittee, having previously reviewed the 


procedures related to external dose, reviewed the procedures focused 


on internal dose and the CATI interview procedures. Any comments not 


agreed upon in the NIOSH response column of this matrix were pushed 


into the workgroup process for in-depth discussion. They want to 


cross-walk any procedures that have been replaced to be sure none were 


lost. At behest of the Board, Dr. Wade amended the contract to see 


that OTIB-4, the latest release, is added to the list; ORAU-0097, Rev. 


00; and ORAU-0031. These will be added to the new list or procedures 


to review that is already in place. When it is completed, Ms. Behling
 

will e-mail to the Board the list of new procedures containing 


information on where there are workbooks associated with the various 


documents. Dr. Mauro said work and assignments on the originally 


authorized 33 procedures has begun, but they have found that some of 


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those do not need review and some have already been reviewed so he 


will transmit to the Board a recommendation for replacements and 


additions and the reasoning behind them. Mr. Griffon hopes to finalize 


these internal dose and CATI interview resolutions at the next 


workgroup meeting, date yet to be set so a determination of the scope 


can first be made. 


*****
 

INDIVIDUAL DOSE RECONSTRUCTION REVIEWS 


Mr. Griffon summarized the status of individual dose reconstruction 


reviews. The Board has closed out on the first set of 20 cases and the 


Board’s acceptance letter is drafted and hopefully en route to the 


Secretary of the HHS. It will also be posted on the internet. The 


second set of 18 is the next case review item for the workgroup as 


they have not had a chance to review NIOSH’s responses. NIOSH has just 


received the findings for the third set of cases so time is needed for 


their response, and SC&A has competed reviews on the fourth set and is 


ready to do the team conference calls with the groups for which new 


assignments are needed. 


*** 


REVIEW AND APPROVAL OF BOARD MINUTES
 

Discussion was held on minutes for the August 2005 meeting. Dr. 


Ziemer noted that although the minutes are abbreviated from 


transcripts, the motions themselves should be full and complete. 


A motion was made and seconded that the minutes for the August meeting 


be approved as modified. The motion carried unanimously. 


*** 


It was agreed the minutes for the October meeting would be modified to 


add Mr. Leon Owens' name to the list of attending Board members. 


A motion was made and seconded to approve the minutes for the October 


meeting as modified. The motion carried unanimously. 


***** 


BOARD WORKING TIME 


Recognition of Departing Members 


Future Meetings and Plans 


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Dr. Ziemer formally recognized the careers and contributions of two 


outgoing Board members, Mr. Richard Espinosa and Dr. Henry Anderson. 


Both were awarded a certificate of recognition from the HHS and a 


letter signed by Dr. Julie Gerberding, Director of the CDC, and Dr. 


John Howard, Director of NIOSH. 


*** 


Ms. Kimpan updated the group on her response to a substantive concern 


raised this morning concerning a new disclosure form that had less 


information that the prior form. She tasked her people to check for 


consistency of the first and second forms. Information is being 


corrected on the ORAU web site. 


***** 


SEC RULE REWRITE 


Mr. Ted Katz, 


NIOSH 


Dr. Wade proposed options for dealing with the rule comment period 


closing February 21. He asked Mr. Ted Katz to describe the changes for 


elucidation only. 


As background, Mr. Katz explained that in December 2005 HHS published 


amendments to its Special Exposure Cohort rule. That rule is presently 


open to public comment until February 21st, but was made effective 


immediately as a provisional rule and open to changes on the basis of 


public comment before it is finalized. He read verbatim Section 


73.84(q)(c), the rules on deadlines. Two changes were made to make it 


compliant with new statutory requirements. The first was to establish 


the definition of a petition in the rule. Under 83.8 it means a 


submission that meets all the requirements and has incorporated any 


revisions made and added any material needed for the petition to 


qualify. 


After a petitioner works with NIOSH and submits a petition and makes 


whatever revisions are needed, if the petition still doesn't quality 


at the end of that process, NIOSH notifies them and they have the 


right to request a review of that decision. Previously there was a 


30-day period to request that review. The second change reduced that 


period to seven days. 


The reason for the change is because the 180-day counting period for 


action on the petition is based on when the petition met the 


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requirements and became a proper petition. In the event NIOSH 


determined the petition didn't qualify and the petitioner's appeal for 


review determined NIOSH to be in error so that the petition had 


actually qualified earlier, the period of time expended on appeal and 


review would have eaten into the 180-day period for evaluation. This 


is important because the time constraints are already great. 


Another provision is regarding the finding of feasibility and health 


endangerment. After a petition is evaluated and the Board has made a 


recommendation and there's been a proposed decision by the Director of 


NIOSH, the petitioner had an opportunity to seek a review of that 


proposed decision. However, the 30 days allotted wouldn't allow for 


the petitioner to bring the request, let along do the review and come 


to a final decision. That has now been moved to the end of the 


process and the Secretary will make final decisions. However, those 


decisions will have the same review rights the proposed decision had 


before. 


Additionally Congress is requiring a report of both affirmative and 


negative decisions or determinations. And finally Congress has 


changed their 180-day period to review the Secretary's proposals to 


add new classes to 30 days, so that change is included in the rule. 


The Board devoted considerable discussion to the reduction of a 


petitioner’s review request time to come to a full comprehension of 


what this means in terms of process and fairness. It was decided that 


the language is not clear. Five issues of strong concern over this 


rewrite emerged, including the 7-day petitioner appeal, the meaning of 


timeliness, the interpretation of the 180-day limit and the issue of 


the time frame to qualify. Dr. DeHart suggested that a lead be 


appointed to gather the proposed comments, and Dr. Melius volunteered. 


Dr. Ziemer suggested he put together a categorized response for Board 


consideration prior to a conference call. Without objection, the Board 


will follow that pattern with Dr. Melius having the lead. 


It was then decided to request extension of the public comment period 


past March 14th, at which time this will be one of the items for the 


Board phone call scheduled for that date. 


***** 


Dr. Melius read into the record his proposed letter for the Department 


of Justice concerning the Board’s desire for written legal advice 


while maintaining a process consistent with the original intent of the 


EEOICPA legislation. 


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A motion was made and seconded that the subject letter be sent to the 


Secretary of HHS. 


Discussion followed, during which the wording rather than intention of 


the letter seemed to be at issue; Board members were concerned about 


how to express, acknowledge and work with the fact that petitioners 


may want what is in fact classified information. 


The letter was amended to include the comment that AWhile the Board is 

fully supportive of the need for preventing the release of classified 

or restricted information and recognizes the necessary use of such 

information in the DOE nuclear program, the Board also recognizes..@ 

With that change, the motion carried. 

*****
 

TASK III REVIEW B DISCUSSION/CLOSURE 

The Board entered discussion to formulate its decision on Task III 


concerning assignments to make to the contractor on their SEC petition 


evaluation task. Participants clarified the status of various site 


projects, terminology for the work to be done and its relation to SEC 


work now underway, the nexus of SC&A’s involvement with NIOSH in terms 


of timing and series or parallel efforts, options for the tasking 


procedures, consideration of personnel resources given time 


constraints, the formation of workgroups for the various sites, and 


the spirit and intent of Task III. It was determined that Y-12, Rocky 


Flats and Ames, all of which have qualified SEC petitions, are the 


most suitable choices for concurrent additional work by SC&A due to 


their upcoming 180-day deadlines and relative clarity of issues for 


SEC petitions at the first two. Site profile work and SEC petition 


questions can be addressed concurrently and efficiently by early 


information sharing between SC&A, NIOSH and possibly a workgroup. The 


workgroup assignments include Mr. Griffon’s workgroup for Y-12 and 


Rocky Flats and a new workgroup for Ames including Dr. Melius as 


chair, Dr. Lockey and Ms. Munn. Dr. Wade summarized by saying he would 


deal with the contracting officer to issue three tasks under the SEC 


task of the SC&A contract. One will be a total review of Ames. The 


specific action there will be to schedule a meeting of NIOSH, SC&A and 


the Ames workgroup, respectful of peoples schedules. Also, two task 


orders will be ordered for focused SEC reviews for Y-12 and Rocky 


Flats, and the substance of those will be the opened issues identified 


by the workgroup in the high priority matrices. 


Mr. Griffon asked if the Board will be asking SC&A to assist with 


Pacific Proving Ground. Dr. Ziemer said Mr. Presley has volunteered to 


54
 
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represent the Board at the meeting with DTRA. Dr. Neton will FedEx a 


copy of the Y-12 CD data to the working group and SC&A; there is no 


problem in sharing it under the provisions of the Privacy Act. SC&A 


will have it in case the workgroup needs to ask their assistance for 


the meeting tentatively set for February 27th . Dr. Melius made the 


point that Task V authorization requires direction. Dr. Wade clarified 


that any immediate work can be done under the site profile task and he 


will work with dispatch to get an SEC focused task for Y-12 that will 


cover the continuation of work. Dr. Mauro commented that during the 


presentations of Rocky and Y-12 it’s not always apparent which of the 


items represent site profile issues. One of the big challenges in 


streamlining and expediting the process will be to quickly come to a 


common mind regarding which issues are SEC issues so a focused assault 


can be designed. He didn’t know if there would be universal agreement 


right now if a discussion were held on this matter. He has a clearer 


idea of what he believes to be SEC issues on Rocky Flats than on Y-12. 


Dr. Wade said he’ll take his lead on that task order from the chair of 


the working group and then dialogue with Dr. Mauro, who expressed his 


sense that the process will involve a great deal of iteration because 


the investigations will lead to a point where it’s believed a dose 


reconstruction can be done but they do not know exactly how to do it. 


It will be a matter of identifying SEC issues as clearly as possible 


and agreeing on what degree of conservatism can be used. 


*****
 

PROGRAM UPDATE -- NIOSH
 

Mr. Larry Elliott, Director 


Office of Compensation Analysis and Support 


Mr. Elliott presented NIOSH’s program and science issues updates 


according to the slide presentation and handouts. He reported the 


completion of 12,264 draft dose reconstruction reports as of January 


13, 2006, although he wished they could have done more. The number of 


active claims, 486, has changed since January; all these numbers are 


fluid. Of note are the proposed changes to the target organ for 


reconstructing dose for lymphoma cases about which the Board approved 


a draft of this OCAS TIB on January 9th. The comment period closes 


February 4th, he believes. About 1,000 claims will be affected one way 


or another by this change. Mr. Elliott is working closely with Ms. 


Kimpan on making sure comments from the public comment period are 


being addressed, and she in fact will be following up on items from 


this Board meeting tomorrow. He noted that NIOSH still takes many 


claimant and stakeholder phone calls as well as e-mails, to which they 


try to respond within 24 hours. There were no questions. 


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***** 


PROGRAM UPDATE -- DEPARTMENT OF LABOR 


Dr. Diane Case, 


Department of Labor
 

Dr. Case’s statistics were represented on her slide show and handouts. 


She elucidated on the terms claims and cases. A case refers to an 


individual employee’s case, which can contain more than one medical 


condition and have one or more claimants on that, the survivors. Most 


of the claims they receive are for conditions that are non-covered. 


The next majority of claims they receive are for cancers. 


After her presentation, Dr. Melius commented on the difficulty of 


communicating these programs to the claimants, who have been told it’s 


an easy process with NIOSH ready to assist them. Once they get into 


Subtitle E program, they suddenly have to produce a great deal more 


information on disabilities as well as sometimes on medical and 


exposure. He wondered if anything can be done to facilitate the 


process beyond the town meetings. He also wanted to put on the agenda 


for the next meeting the issue of how to deal with the non-SEC 


cancers, such as determining when it will be feasible to reconstruct 


certain types of cancer and certain exposures in the situation where 


we are also approving a Special Exposure Cohort. It’s tricky and could 


create a lot of unnecessary work. Finally, he wanted to be sure that 


future presentations include the number of cases coming back from the 


DOL to NIOSH for reworks so any potential problems in the program can 


be addressed. Dr. Case replied that her rough estimate is 450. A small 


percentage get through that never should have gotten through and they 


were fine, but a majority of them have to do with the claimant not 


bringing information forward after the dose reconstruction has been 


performed. She will be sure to include that information in the next 


presentation. 


*** 


In the spirit of transparency, Dr. Wade made an update that in the 


fourth round of reviews by SC&A they identified three cases where 


overestimating assumptions were used in error which could possibly 


impact compensation decisions, so the cases will be re-opened and reevaluated. He will keep the Board posted. He thanked SC&A for that 


effort and felt it indicates the benefit of the audit program. Dr. 


Ziemer clarified that although the audit is not intended to be a 


process for reopening claims, if something is identified that could 


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have a significant impact, it is prudent that the contractor at least 


alert NIOSH to this as soon a possible before the review process has 


been completed. This type of early alert, although not covered in 


procedures per se, exemplified the intent to identify systemic issues 


and process procedures. 


***
 

Scheduling plans were announced for a March 14 phone call at 10 a.m. 


Eastern time which will include new Board members; the face-to-face 


Board meetings April 25, 26 and 27; other Board meetings to be set for 


June and early October. Board members will be contacted with exact 


dates once the new members are fully vested and clearances complete; a 


phone call in between the face-to-face meetings to deal with items 


requiring immediate attention. Mr. Griffon’s workgroup meetings are 


scheduled for February 13th, 9:00 to 4:00 in Cincinnati for a 


procedures review, the second and third sets of cases; February 27th
 

9:00 to 4:00 for Y-12 and Rocky Flats SEC. Because those meetings will 


be open to the public and not held in NIOSH’s offices, Dr. Wade
 

suggested that the other chairs of working groups look at those dates 


and consider combining meetings to simplify logistics since a hotel 


facility will need to be secured. He agreed to e-mail dates and 


committee information to everyone. 


Dr. Ziemer adjourned the meeting at 4:05 p.m. 


* * * * * 

With no further business to come before the Board, the meeting was adjourned. 

End of Summary Minutes 

Ë Ë Ë Ë Ë 

I hereby confirm these Summary Minutes are 

accurate, to the best of my knowledge. 

Paul L. Ziemer, Ph.D., Chair 

57
 
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Date 

58