THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

PUBLIC HEALTH SERVICE 

CENTERS FOR DISEASE CONTROL AND PREVENTION 

NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH 

convenes the 

ADVISORY BOARD ON 

RADIATION AND WORKER HEALTH 

The summary minutes of the meeting of the Advisory Board on Radiation and 

Worker Health held at The Westin Cincinnati, 21 East Fifth Street, Cincinnati, 

Ohio, on March 7, 2003. 
 

 

Advisory Board on Radiation and Worker Health March 7, 2003 

C O N T E N T S 

March 7, 2003 

REGISTRATION AND WELCOME 

Dr. Paul Ziemer, Chair. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 

Mr. Larry Elliott, Executive Secretary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 

SPECIAL EXPOSURE COHORT - NOTICE OF PROPOSED RULE MAKING 

Mr. Ted Katz. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 

DOSE RECONSTRUCTION REVIEW PROCESS WORKGROUP 

Mr. Mark Griffon, Workgroup Chair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 

PUBLIC COMMENT PERIOD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 

BOARD DISCUSSION/WORK SESSION SPECIAL EXPOSURE COHORT - NPRM . . . . . 39 

FORMAL MOTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 

CLOSING REMARKS/ADJOURNMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57 

ABRWH CHAIR’S CERTIFICATION. . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . .59 
 

 

Advisory Board on Radiation and Worker Health March 7, 2003 

SUMMARY REPORT LEGEND 

The following summary report was derived from the certified verbatim transcript, the 

March 7, 2003 version of the Rulemaking (in two formats, once of which was the published 

Federal Register version), and other handouts such as PowerPoint presentations. The legend in 

the verbatim transcript indicated the following, “In the following transcript a dash (--) indicates 

an unintentional or purposeful interruption of a sentence. An ellipsis (. . .) indicates halting 

speech or an unfinished sentence in dialogue or omission(s) of word(s) when reading written 

material. In the following transcript (sic) denotes an incorrect usage or pronunciation of a word 

which is transcribed in its original form as reported,” and also, “In the following transcript 

(inaudible) signifies speaker failure, usually failure to use a microphone.” 

There were numerous occasions where one or more of these issues occurred. This summary has 

been written with an effort to complete the discussion of those speaking for ease of reading and a 

professional report; however, there may be times where reporting is inadvertently not written as 

the speaker intended. At points in the discussion where there was definite concern that the 

summary may not accurately capture the discussion, referral has been made to the location in the 

certified verbatim transcript (CVT), and the area in question has been highlighted in yellow in 

the summary for quick reference. 

Although sometimes questions and/or comments were raised during a speaker’s presentation, all 

questions/comments are included under Discussion Points for each section for ease of reading. 

Although the Public Comment Period for this meeting occurred between the two Board 

Discussion/Work Sessions at midday, the Public Comment Period appears in the document prior 

to the deliberations from the two Board Discussion/Work Sessions which have been combined to 

better capture the discussion regarding the new NPRM. 
 

 

 

 

Advisory Board on Radiation and Worker Health March 7, 2003 

P A R T I C I P A N T S
 

(By Group, in Alphabetical Order) 

BOARD MEMBERS 

CHAIR 

ZIEMER, Paul L., Ph.D. 

Professor Emeritus 

School of Health Sciences 

Purdue University 

Lafayette, Indiana 

EXECUTIVE SECRETARY 

ELLIOTT, Larry J. 

Director, Office of Compensation Analysis and Support 

National Institute for Occupational Safety and Health 

Centers for Disease Control and Prevention 

Cincinnati, Ohio 

MEMBERSHIP 

ANDERSON, Henry A., M.D. 

Chief Medical Officer 

Occupational and Environmental Health 

Wisconsin Division of Public Health 

Madison, Wisconsin 

ANDRADE, Antonio, Ph.D. 

Group Leader 

Radiation Protection Services Group 

Los Alamos National Laboratory 

Los Alamos, New Mexico 

DeHART, Roy Lynch, M.D., M.P.H. 

Director 

The Vanderbilt Center for Occupational and Environmental Medicine 

Professor of Medicine 

Nashville, Tennessee 
Advisory Board on Radiation and Worker Health March 7, 2003 

ESPINOSA, Richard Lee 

Sheet Metal Workers Union Local #49 

Johnson Controls 

Los Alamos National Laboratory 

Espanola, New Mexico 

GIBSON, Michael H. 

President 

Paper, Allied-Industrial, Chemical, and Energy Union 

Local 5-4200 

Miamisburg, Ohio 

GRIFFON, Mark A. 

President 

Creative Pollution Solutions, Inc. 

Salem, New Hampshire 

MELIUS, James Malcom, M.D., Ph.D. 

Director
 

New York State Laborers' Health and Safety Trust Fund 

Albany, New York 

MUNN, Wanda I. 

Senior Nuclear Engineer (Retired) 

Richland, Washington 

OWENS, Charles L. (via telephone) 

President 

Paper, Allied-Industrial, Chemical, and Energy Union 

Local 5-550 

Paducah, Kentucky 

PRESLEY, Robert W. 

Special Projects Engineer 

BWXT Y12 National Security Complex 

Clinton, Tennessee 

ROESSLER, Genevieve S., Ph.D. 

Professor Emeritus 

University of Florida 

Elysian, Minnesota 
Advisory Board on Radiation and Worker Health March 7, 2003 

AGENDA SPEAKERS 

Mr. Ted Katz, Special Exposure Cohort 

Mr. Mark Griffon, Workgroup Chair 

STAFF 

HHS: 

Martha DiMuzio 

Russ Henshaw 

Cori Homer 

Liz Homoki-Titus 

Ted Katz 

David Naimon 

Jim Neton 

David Sundin 

DOL: 

Jeffrey L. Kotsch 

Rose Toufexis 

VENDORS 

Steven Ray Green, Certified Merit Court Reporter 

Kristin Jones, Writer/Editor 

PUBLIC PARTICIPANTS 

Brock, Denise 

Cofelt, Evelyn 

Darnell, Peter 

DeHart, Julia 

Fowee, Steven R 

Hinnefeld, Stu 

McGowan, William J 

Miller, Richard 

Presley, Louise S 

Rolfes, Mark 

Rutherford, LaVon 

Tabor, Bob 

Taulbee, Tim 
 

 

 

Advisory Board on Radiation and Worker Health March 7, 2003 

Tomes, Thomas 

Toohey, R E 

Ziemer, Marilyn 

8:30 a.m.
 

REGISTRATION AND WELCOME
 

Call to Order 

ZIEMER, Paul L., Ph.D. 

Professor Emeritus 

School of Health Sciences 

Purdue University 

Lafayette, Indiana 

Dr. Ziemer called the twelfth meeting of the Advisory Board for Radiation and Worker Health 

(also referred to as the Board) to order, noting that he was Chairman of the Board. He requested 

that the record show that all of the Board members were present with the exception of Leon 

Owens, who was in attendance via telephone. 

Dr. Ziemer indicated that the primary focus of this meeting was to be on the Notice of Proposed 

Rulemaking (NPRM), 42 CFR Part 83, dealing with the Procedures for Designating Classes of 

Employees as members of the Special Exposure Cohort (SEC) under the Energy Employees 

Occupational Illness Compensation Program Act of 2000 (EEOICPA). The reference document 

utilized for the discussion was the Federal Register/Vol. 68, No. 45/Friday, March 7, 

2003/Proposed Rule. 

Preliminary Comments 

ELLIOTT, Larry J. 

Director, Office of Compensation Analysis and Support 

National Institute for Occupational Safety and Health 

Centers for Disease Control and Prevention 

Cincinnati, Ohio 

Mr. Elliott reminded those present that NIOSH produced a NPRM last summer, and that the 

NPRM which meeting participants had before them was being published that day in the Federal 

Register, and that it would be open for public comment for 30 days hence. He explained that 

because of the public comments NIOSH received on that NPRM last summer, and the changes 

that NIOSH made in addressing those comments, NIOSH needed to publish a second NPRM 

rather than finalize that NPRM from last summer. 
 

 

 

 

Advisory Board on Radiation and Worker Health	 March 7, 2003 

SPECIAL EXPOSURE COHORT: 

NOTICE OF PROPOSED RULE MAKING
 

Mr. Ted Katz 

Agenda Speaker 

Special Exposure Cohort 

Mr. Katz reviewed the major elements of the rule and summarized relevant recommendations of 

the Board and comments of the public. He noted that there were two statutory criteria for 

considering additions to the Class, namely that: 1) It is not feasible to estimate with sufficient 

accuracy the radiation dose that the Class received; 2) There is a reasonable likelihood that such 

radiation dose may have endangered the health of the members of the Class. 

Mr. Katz summarized provisions of the first NPRM concerning feasibility and noted that the 

Board had recommended the rule provide clearer criteria. He noted that the Board also 

suggested that NIOSH develop operational guidelines outlining criteria, including time limits, to 

address the issue of feasibility. 

Mr. Katz also summarized a variety of public comments concerning feasibility. 

Mr. Katz identified two new provisions, consistent with comments received: 

‘	 It is “Feasible . . . if we have access to sufficient information to estimate the maximum 

radiation dose that could have been incurred in plausible circumstances by any member 

of the class.” He noted that in circumstances when information is limited to this extent, 

an enormous amount of benefit of the doubt would go to the claimants. 

‘	 “In some circumstances, feasibility could be cancer site-specific and hence cancerspecific.” Mr. Katz explained that since dose reconstructions are tissue-specific, they do 

not estimate doses generally. They estimate doses to the tissue related to the cancer that 

has been incurred. Hence, in certain circumstances, it is possible that feasibility will 

hinge on the particular cancer site. To illustrate, Mr. Katz shared the following two 

examples: 

Example 1: If NIOSH could estimate all radiation doses for an individual except for 

doses associated with exposure to radon daughters, then the organ that is exposed to 

radiation from radon would be the lung. For practical purposes, other tissues, other 

organs, would not be exposed to the radiation from radon. NIOSH could cap the dose 

associated with radon for those individuals with cancers other than lung cancer. In that 

case, NIOSH could establish a Class that included anyone who had, or incurred in the 

future, lung cancer and who was exposed to radon at the site. For all other individuals, 

NIOSH could complete a dose reconstruction. 

Example 2: In circumstances involving partial body irradiation, such as when there is 

shielding; as when workers use a glove box, then only certain cancer sites would be at 
 

 

Advisory Board on Radiation and Worker Health	 March 7, 2003 

issue for dose reconstruction. With the glove box, the skin would be exposed as would 

the bones in the hand, and that possibly could relate to three cancers: skin cancer, bone 

cancer, and leukemia. However, dose reconstruction could be completed for individuals 

who incur lung cancer, for example, because the exposure of concern is not an exposure 

to the lungs. 

Mr. Katz stated that the Board wanted the rule to provide as much guidance as possible to the 

public regarding feasibility. The hierarchy of information outlined in 42 CFR Part 82 provides 

some of that guidance. It explains that if there are no personnel monitoring data, they go to the 

next step, and so on. NIOSH also made a couple of statements in the NPRM that are intended to 

be helpful, including the following: 

‘	 “In general, [one] must be able to specify the types and quantities of radioisotopes to 

which the workers were potentially exposed. Or, [one] must know the design and 

performance information for radiation generating equipment, such as particle 

accelerators.” (Mr. Katz noted that without such basic information, it would be unlikely 

NIOSH could complete a dose reconstruction, even calculating the maximum dose); and 

‘	 “In general, data from personal dosimetry and area monitoring are not essential.” (Mr. 

Katz explained that it was important for the public to understand that there is a hierarchy 

of information that can be used for a dose reconstruction, and that while NIOSH prefers 

good personnel monitoring data, dose reconstructions can be completed, that are fair to 

claimants, which are based on more general information). 

NIOSH committed to additional guidance in the Preamble of the NPRM, specifically in that 

NIOSH will publicize summaries of circumstances in which doses cannot be estimated, as these 

arise through the dose reconstruction program. Mr. Katz said that these will be illustrative cases 

to help the public understand where the limits are and what circumstances result in being unable 

to estimate doses. He stressed that NIOSH was committed to working with the Board to do 

whatever they could to expand guidance for the public on this topic. 

Concerning feasibility with respect to time limits, Mr. Katz indicated that NIOSH would 

consider establishing a time limit or guidelines for completing dose reconstructions once the 

dose reconstruction program reaches its full operating capacity. 

Mr. Katz then discussed the next major element of the NPRM, health endangerment. He 

summarized relevant provisions of the first NPRM regarding health endangerment and noted that 

the Board recommended that NIOSH consider other suitable criteria. 

Mr. Katz also summarized some of the public comments concerning health endangerment and 

explained the relationship between the feasibility of dose reconstruction and limitations 

concerning the evaluation of health endangerment. 
Advisory Board on Radiation and Worker Health March 7, 2003 

Mr. Katz summarized the current proposal for determining health endangerment HHS made the 

following changes: 1) Eliminated the use of cancer risk models, 2) Limited determination to an 

employment duration requirement for exposed employees, 3) Retained the 250-day employment 

criterion as the default requirement; and 4) Allowed HHS to specify “presence” as sufficient 

employment duration for discrete incidents in which doses were likely to have been 

exceptionally high. 

Mr. Katz also summarized a variety of public comments on petition requirements. 

In response to public comments regarding petition requirements, HHS proposed the following 

changes to the petition requirements in the first NPRM: 

‘ Expanded the scope of eligible petitioners (Mr. Katz indicated that now, any individual or 

entity who is authorized in writing by the workers or survivors, could serve as a 

petitioner. 

‘ Made the use of petition form(s) voluntary. 

‘ Eliminated the requirements to obtain verification of record deficiencies from DOE or an 

AWE. 

‘ Eliminated the requirement to address health endangerment in the petition justification. 

‘ Simplified the petition justification concerning feasibility to a set of specific, discrete 

options. 

Another major issue is timeliness. Mr. Katz indicated that the public expressed concern about 

expediting consideration of petitions for which NIOSH has already found that dose 

reconstruction is not feasible. In response, HHS proposed measures that would minimize the 

time required to consider petitions for a class with an employee whose dose reconstruction they 

cannot complete (see §83.14). Mr. Katz said that the basic strategy was that NIOSH would 

evaluate the petition based on the information it had already collected from attempting to 

complete that dose reconstruction. 

If the information at hand only allowed NIOSH to define a class of a limited scope, but NIOSH 

had some indication that it feasibility issues could extend beyond that scope, NIOSH would 

evaluate that issue separately without delaying the advance of the petition evaluation to the 

Board. The evaluation would cover that claimant who has cancer and all similarly situated 

employees. Mr. Katz also noted that HHS intends to convene the Board as frequently as 

necessary and possible to minimize the delays with respect to the Board’s role in advising the 

Secretary on Cohort decisions. 

Mr. Katz indicated that the Board and public had commented on the roles of the Board and the 

Secretary. One suggestion was to limit or eliminate the Secretary's discretion to apply nonspecified procedures. Mr. Katz pointed out that at the end of the earlier NPRM, the Secretary 

had the right to invoke such procedures. He also indicated that the Board recommended limiting 

the Board's role in reviewing NIOSH decisions to deny evaluations of petitions that do not meet 

the petition requirements. A public comment, on the other hand, recommended retaining the 
Advisory Board on Radiation and Worker Health	 March 7, 2003 

Board's role. Mr. Katz indicated that HHS eliminated the Secretary’s discretion to apply the 

non-specified procedures, and eliminated the Board's review of petitions that NIOSH decides do 

not meet the minimum requirements. 

Discussion Points: 

 ̃	 Dr. Melius said that, if he recalled correctly, a claimant whose dose reconstruction could 

not be completed would still have to submit a petition, and that then justification would 

really be the NIOSH finding that it was not feasible to reconstruct the dose. Mr. Katz 

responded that this was accurate, and that this is addressed in the NPRM. He pointed out 

that the claimant would be notified and encouraged to petition and that all the claimant is 

required to do is affirm that they wish to petition because the NIOSH finding is the entire 

justification for the petition. 

 ̃	 Dr. Melius requested that Mr. Katz comment on an administrative review of a petition 

that has been turned down. Mr. Katz responded that NIOSH asked for public comment 

regarding whether people thought they should have an administrative review of NIOSH 

decisions if these were not going to go to the Board. He explained that the process has 

changed somewhat in other ways, too, because if a petition does not meet requirements, 

NIOSH will specifically identify to the petitioner why it does not meet the requirements 

and provide the petitioner with guidance for what would be required to make that petition 

meet the requirements. The petitioner would then have 30 days then to address those 

specific components. 

 ̃	 Dr. DeHart asked Mr. Katz to expand on the elimination of cancer risk models for the 

determination of health endangerment. Mr. Katz responded that the purpose of originally 

including the cancer risk models was to establish a dose level benchmark and then 

determine whether doses could have exceeded it. If doses exceeded the benchmark, that 

would satisfy the requirement that the health of the class may have been endangered. 

However, under the current proposal, If NIOSH cannot put an upper limit on the dose 

that someone might have received, then any benchmark becomes irrelevant because 

whatever the benchmark, the dose could have exceeded. 

 ̃	 With regard to benchmarking, Dr. Ziemer said it seemed somewhat semantic to him that 

if they did benchmark in the sense discussed before, and found that every member of the 

class was very high and there was a number, under the change they would be saying that 

it was a dose reconstruction that fit in the other category. In that circumstance, they 

would end up compensating every individual in any event, as a group, and they simply 

would not call it a “Special Exposure Cohort.” Mr. Katz responded that this was not 

quite what was meant. He explained that NIOSH would complete the dose reconstruction 

if they could cap the dose, but if NIOSH can cap the dose, it does not mean that everyone 

who incurs that dose would be compensated. It means NIOSH would complete the dose 

reconstruction based on that maximum dose, and whether someone were to be 

compensated would depend on the specific cancer incurred. 
 

 

Advisory Board on Radiation and Worker Health	 March 7, 2003 

 ̃	 Mr. Griffon said he was trying to grapple with the notion of tissue-specific cancer sites, 

noting that one of the examples given in the Preamble (Page 15) was that radon progeny 

or uranium, would only concentrate and significantly irradiate certain organs and tissues. 

He wondered how the term "significantly" was defined, or whether this was left open to 

case-by-case analysis. Mr. Katz responded that it would certainly come before them 

case-by-case because the Board would see each of these petitions and the NIOSH 

evaluation for each. 

 ̃	 Mr. Griffon, Dr. Andrade, Mr. Katz, and Dr. Neton discussed the issue of whether one 

can estimate a maximum dose for certain tissues and organs when one cannot for other 

organs, using the examples of radon progeny and plutonium. 

 ̃	 Dr. Melius expressed concern that the Board was going to spend a lot of time trying to 

decide where to make the cutoff, which organ systems would be covered in these 

situations, which cancers of other organ systems would not be covered. While he did not 

necessarily disagree with the simple examples that had been presented, he was not sure 

how practical or common those would be. 

 ̃	 Dr. Melius asked whether the new NPRM had addressed the question of what would be 

done for individuals who are in the Cohort but have a type of cancer that is not eligible 

for compensation under the provisions of EEOICPA covering members of the Cohort. 

 ̃	 Dr. Mr. Katz responded that these issues were addressed in the Preamble. He explained 

that, where an individual has doses outside of the window of exposure for the Cohort, 

coupled with the fact that the individual has a cancer that is not compensable as a 

member of the Cohort, NIOSH has to complete a dose reconstruction. Discussed in the 

Preamble is that there is not an answer currently regarding what to do in a dose 

reconstruction with that window for which you cannot estimate doses 

 ̃	 Mr. Griffon requested clarification on the definition of “sufficient accuracy,” wondering 

if it was when one could calculate a maximum dose to be used in the determination of 

probability of causation. Mr. Katz responded that if one could calculate a maximum dose 

to the Class, then a dose reconstruction could still be completed with sufficient accuracy. 

Dr. Neton clarified that it would not necessarily be the maximum dose. If they could 

develop a distribution, the maximum credible dose would be used in the analysis. 

 ̃	 Mr. Espinosa and Dr. Melius expressed concern regarding the amount of time allowed for 

review of the NPRM, and for the public comment timeframe. He believed that the public 

comment period should be extended to 60 days. Mr. Espinoza also wondered whether 

there was a stakeholders meeting planned regarding the NPRM. Mr. Elliott responded 

that the comment period would be 30 days, which was a Department decision. He 
Advisory Board on Radiation and Worker Health March 7, 2003 

explained that there were no town hall meetings scheduled to deliver this NPRM like 

there were for the last NPRM. 

DOSE RECONSTRUCTION REVIEW PROCESS WORKGROUP
 

GRIFFON, Mark A. 

Chair, Dose Reconstruction Review Process Workgroup 

President, Creative Pollution Solutions, Inc. 

Salem, New Hampshire
 

Mr. Griffon indicated that during the previous Board meeting, the Dose Reconstruction Review 

Process Workgroup (also referred to as the Workgroup in this presentation), as a newlyestablished working group, was tasked with the following dose reconstruction review process 

activities: 1) Develop draft procedures for the review process; 2) Develop procedures for case 

selection; and 3) Develop individual task orders to be released after the task order contract is 

awarded. 

Mr. Griffon noted that during the previous Board meeting, Dr. Ziemer distributed a first cut of a 

draft for the basic review which delineated how the contractor and the Board would move 

through the process for the basic review of a individual dose reconstruction. They now have 

draft procedures currently in place for basic review and advanced review case reviews which 

include: the Report Form, the Executive Summary Form, and the Board Summary Report Form. 

He explained that the Executive Summary would be a summary of the case review. This report 

will not have as many details, and will probably be distributed to the entire Board for 

consideration. The Board Summary Report is what the Workgroup envisioned as the Board's 

report to HHS, which would be a summary of an aggregate number of cases, including 

information regarding findings or concerns in aggregate from the cases that have been reviewed 

during the agreed upon timeframe (e.g., during a particular quarter, during half a year). 

Mr. Griffon indicated that during the Workgroup’s ORAU site visit, they were first briefed by 

NIOSH regarding the database structure of the NIOSH-OCAS Claims Tracking System 

(NOCTS) and the Administrative Record for each case file. The Workgroup then engaged in a 

preliminary review of cases, for which decisions have been made, against the draft procedures. 

They reviewed the Administrative Record for each case file, taking into consideration the various 

components in order to gain insight into the types of records actually captured. The components 

include a Dose Reconstruction Folder, a Correspondence Folder, a Department of Energy (DOE) 

Correspondence Folder, and a Department of Labor (DOL) Correspondence File. All records 

used for the individual dose reconstruction case are captured within those folders. Given that 

most other forms are in PDF format, while the data is there, should a reviewer wish to use said 

data, they would have to re-enter the raw data to conduct their own assessment. Mr. Griffon said 

that NIOSH did indicate a willingness to create Excel files for certain items to reduce re-keying 

efforts. 
Advisory Board on Radiation and Worker Health March 7, 2003 

Another issue considered by the Workgroup pertained to how to schedule the case reviews and 

the coordination of the Board and the contractor or contractors. In the past, there have been 

discussions of designating Board members (which could be a rotating basis) who would meet 

with the contractors on groups of cases prior to presentations back to the full Board. The 

contractor would engage in the bulk of the legwork, but the designated Board members would 

then have an opportunity to work with the contractor prior to presenting to the full Board. 

With regard to case selection, given that the plan is to review cases only after final decision, the 

Workgroup engaged in discussions about how many cases would be available and when, and 

they compared this against the calendar and the timing of when the contract is likely to be 

awarded. In addition, they further discussed Case Selection Criteria. 

The final activity will be to develop individual task orders. The Workgroup will probably focus 

on the initial task orders that they perceive as most urgent, which include the Basic Review Task 

Order, the Advanced Review Task Order and the Procedures Review Task Order. They believe 

this can be done in parallel so that they can have the final drafts of these task orders in final form 

by the time the contract is awarded. 

The anticipated timeline was delineated as follows: 

Task Order Contractor Timeline 

Description Date 

5-member technical evaluation panel identified/ incorporated into the procurement 

2/18/03 

Task Order RFP published in Commerce Business Daily 3/18/03 

RFP released for bid 4/21/03 

Final proposals due End of May 

Bidder Meeting To be determined 

Workgroup completes draft task orders To be determined 

Technical review and past performance review To be determined 

Contract award To be determined 

Task orders awarded To be determined 

Discussion Points: 
 

 

 

Advisory Board on Radiation and Worker Health	 March 7, 2003 

 ̃	 Dr. DeHart noted that the entire Board would have an opportunity to review these cases 

as they come through the contractor, working with the contractor. There will be two to 

three reviewers for each cycle, which they envision occurring on a monthly basis. Time 

must be set aside in August/September for training so that each member can observe how 

the data files exist, how they can access the files, and what the files mean. 

 ̃	 Dr. Melius inquired as to how many contracts would be awarded, and the determination 

criteria for making the awards. Mr. Elliott responded that multiple awards could be made 

based upon who bids and how the Technical Evaluation Panel qualifies them. If there are 

two equally technical, capable contractors, multiple awards can be made under this 

procurement. The Board will need to give their advice regarding the number of 

contractors desired at the time of the Best and Final Offer (BAFO). 

 ̃	 Dr. Melius expressed concern regarding the timeline, particularly given OMB regulations 

which may need to be considered. He reminded the group that there is an option for only 

part of the document to be public, so they could focus on the interview section without 

violating procurement rules. Mr. Elliott indicated that he would check into the 

requirements. 

 ̃	 Mr. Presley recommended that the full Board make a site visit to ORAU as soon as 

possible to become familiar with the procedures, so that they are ready at the time the 

contract is awarded. 

 ̃	 Dr. Melius noted that one of the next steps for the Workgroup would be to consider 

options for reviewing the interviews. Mr. Griffon responded that they will have to flesh 

this out, indicating that he would try to schedule a conference call with the Workgroup 

prior to the Oak Ridge meeting. 

PUBLIC COMMENT PERIOD
 

As noted in the Summary Report Legend, although the Public Comment Period for this meeting 

occurred between the two Board Discussion/Work Sessions at midday, the Public Comment 

Period appears in the document prior to the deliberations from the two Board Discussion/Work 

Sessions which have been combined to better capture the discussion regarding the new NPRM. 

Members of the public presented comments on the following topics: 
 

 

 

Advisory Board on Radiation and Worker Health	 March 7, 2003 

Mrs. Evelyn Cofelt 

Claimant, St. Louis, Missouri 

Mrs. Coefelt presented a statement, read by her daughter Denise Brock, relating information about the 

work experiences and health issues of her late husband, Christopher Davis, who had worked at 

Mallinckrodt Chemical Co. 

Ms. Denise Brock 

United Nuclear Weapons Workers of St. Louis, Missouri 

Ms. Brock summarized her efforts to address concerns raised by many potential claimants, and she 

indicated that she has a number of specific questions about the proposed rulemaking on the SEC, 

interpretation of the term “facility” as used in the rule, 

Discussion Points: 

 ̃	 Ms. Brock wondered what effect having multiple job titles would have on the 250-day 

requirement. Mr. Katz responded that it would depend on how a class is defined. The 

Class could be defined to cover any number of jobs over multiple locations at the facility. 

 ̃	 Ms. Brock understood that a witnesses was needed in reference to the SEC (only in the 

case of an alleged exposure incident for which NIOSH has no records or information 

from DOE or other sources), but she wondered if that same was true for dose 

reconstruction. Dr. Neton responded that in the dose reconstruction process, NIOSH 

would try to ascertain the names of workers who were present at an alleged incident. If 

they were still alive and able to be interviewed, NIOSH would pursue that.. 

 ̃	 With regard to a Hematite facility in Missouri, Ms. Brock said she understood that the 

years of coverage are only through 1968 and that they are no longer under a DOE 

contract. She wondered what they needed to do to expand coverage beyond 1968. Dr. 

Neton explained that “coverage” meant that while the DOE may have established that a 

facility was under contract for a certain period of time, for example 1958 through 1964, 

that represents the eligibility window for a person to be eligible to file a claim. However, 

the dose reconstruction would actually be performed through that period up until the date 

of diagnosis. 

 ̃	 Dr. Melius requested clarity on the NIOSH policy for expediting interviews for people 

who are ill or may become incapacitated. Mr. Elliott responded that it is the intent of 

NIOSH to capture the story of the individuals, and if their death is imminent and NIOSH 

is made aware of that, they do attempt in all cases to capture that person’s interview as 

quickly as possible. 

 ̃	 Mr. Espinosa asked Ms. Brock to speak to the issues raised in the 150 telephone calls she 

had received. Ms. Brock answered that most were acknowledging receipt of her letter 

and indicating that they have difficulty understanding the NPRM as well. 
Advisory Board on Radiation and Worker Health	 March 7, 2003 

 ̃	 Dr. Ziemer inquired as to whether NIOSH has considered crafting a simplified brochure, 

once the NPRM is in place, that would describe the NPRM in laymen's terms so that the 

burden was not on individuals such as Ms. Brock. Mr. Elliott responded that NIOSH 

anticipated this and that they have an effort underway. 

Richard Miller 

The Government Accountability Project 

Mr. Miller provided a number of comments concerning extending of the public comment period 

for the proposed rulemaking, clarification of the 250 day requirement for eligibility for the SEC, 

limitations on the specified cancers in an SEC, methods for estimating upper bound maximum 

doses, and the appeals process for unsuccessful petitioners. 

Discussion Points: 

 ̃	 Regarding Mr. Miller’s concern about whether NIOSH would apply a distribution when 

estimating the maximum potential dose, Dr. Neton responded that the issue of whether 

they would use a distribution or a maximum value really depended upon the data that are 

available to evaluate the case. If dose reconstructionists had some monitoring 

information at all that would allow them to generate a distribution with some best 

estimate of the exposure, they would assign a distribution. Lacking that information, 

though, they would be required to calculate some upper bound maximum dose that would 

not likely have a distribution. So, it really is a case-specific scenario based on the amount 

of data available. 

Bob Tabor 

Fernald Atomic Trades and Labor Council 

Mr. Tabor raised concerns about limiting the specific cancers in a class of the SEC. 

BOARD DISCUSSION/WORK SESSION 

SPECIAL EXPOSURE COHORT - NPRM
 

Overview 

As noted in the Summary Report Legend, although the Public Comment Period for this meeting 

occurred between the two Board Discussion/Work Sessions at midday, the Public Comment 

Period appears in the document prior to the deliberations from the two Board Discussion/Work 

Sessions which have been combined to better capture the discussion regarding the new NPRM. 

Although the group considered beginning by reviewing the Preamble, a decision was made that 

Mr. Katz would first walk the group through the new NPRM section-by-section, reviewing 

exactly what was changed and explaining why, and referring to the Preamble as necessary. Two 
Advisory Board on Radiation and Worker Health	 March 7, 2003 

versions of the NPRM were circulating during this meeting: 1) The unpublished version 

numbered pages 1 to 91; and 2) The Federal Register version (Federal Register/Vol. 68, No. 

45/Friday, March 7, 2003/Proposed Rule) numbered pages 11294 to 11310. These deliberations 

began with Subpart A: Introduction on page 66 of the unpublished version, and page 11306 of 

the published version. To delineate where in the NPRM deliberations were taking place, the 

page number, sections, and any subsections are denoted based on the official published version 

of the NPRM. Discussion points raised during this meeting in each section are signified by the 

iconic symbol ‘. 

Subpart A—Introduction 

Pg. 11306, §83.0 

Mr. Katz indicated that in §83.0, minor clarifications were made, and legal citations were added. 

He said that there was nothing substantive changed from what the group had reviewed 

previously. 

‘	 No further questions, comments, or changes were offered by the participants of this 

meeting regarding this section. 

Pg. 11306, §83.1 

Mr. Katz indicated that in §83.1, NIOSH added an explanation clarifying that the SEC rule is not 

intended as an alternative compensation avenue for cancer claims that have received dose 

reconstructions and have been denied under the non-Cohort procedures, and indicate that there is 

a DOL procedure under 20 CFR Part 30 for a claimant to contest a finding of a NIOSH dose 

reconstruction. This was done in response to the Board’s recommendation that NIOSH make 

this clarification. 

‘	 No further questions, comments, or changes were offered by the participants of this 

meeting regarding this section. 

Pg. 11306, §83.2 

Mr. Katz indicated that minor clarifications were made to §83.2, and that NIOSH dropped a 

section. He explained that in the original NPRM, there was a §83.2 entitled, "How would cancer 

claimants be affected by the procedures in this part?" This was non-procedural and was 

redundant of other explanation in the rule, so it was removed. 

‘	 Dr. Melius said that while he had no problem with the deletion of 83.2 from the old 

NPRM, it was helpful to have some sort of explanatory information for people in terms of 

what their options are et cetera. While he did not think that this information necessarily 

had to be in the regulation, he did believe it was important to include in outreach 

materials (e.g., web site and so forth). 
Advisory Board on Radiation and Worker Health	 March 7, 2003 

Subpart B—Definitions 

Pgs. 11306-11307, §83.5 

In §83.5, Mr. Katz indicated that NIOSH revised the definition of (c) Class of employees to 

delete the requirement that the employees of a class be similarly exposed to radiation. He 

explained that all that was important was that NIOSH could not reconstruct their doses, but that 

they do not have to be similarly exposed to be within the class. NIOSH deleted the definitions 

for endangered the health, IREP, and probability of causation. These are no longer needed 

given the way the NPRM is now constructed. NIOSH also revised the definition of (k) Specified 

cancer to be consistent with the definition under the DOL regulation that was finalized in 

December 2002. A definition was added for (l) survivor under EEOICPA given that this term is 

used in the NPRM. 

‘	 Dr. Andrade commented that under the definition of (c) Class of employees “facility” 

should be changed to “facilities” in this section. Mr. Katz pointed out that this language 

came from the legislation wherein the legislation specifically discusses classes at a 

facility using the singular form of “facility.” 

‘ The issue of including the term health endangerment was raised. Mr. Katz responded 

that the term was used in the 1st NPRM because they were using IREP to establish a 

health endangerment benchmark. Given that this benchmarking approach is not included 

in the 2nd NPRM, the definition for health endangerment is excluded as well. 

Subpart C—Procedures for Adding Classes 

Pg. 11307, §83.6 

Mr. Katz indicated that in §83.6, HHS made only minor clarifications. 

‘	 No further questions, comments, or changes were offered by the participants of this 

meeting regarding this section. 

Pg. 11307, §83.7 

In §83.7, Mr. Katz indicated that HHS made two changes: 1) It clarified that the eligibility of one 

or more employees or survivors of a petition on behalf of a class is limited to members of the 

proposed class or their survivors. In other words, employees and survivors cannot petition on 

behalf of a proposed class in which they are not included (e.g., on behalf of another class); and 

2) It added a third group of eligible petitions comprised of one or more individuals or entities 

authorized by employees or survivors of the proposed class. Mr. Katz indicated that this was 

responsive to the request from non-union advocacy groups to have the authority to petition as 

well on behalf of a class. HHS allowed for as broad a possible interpretation as possible. 

‘	 No further questions, comments, or changes were offered by the participants of this 

meeting regarding this section. 
Advisory Board on Radiation and Worker Health	 March 7, 2003 

Pg. 11307, §83.8 

Regarding §83.8, how a petition is submitted, HHS made one change, which was to eliminate the 

requirement for the use of a petition form. It received comments saying that they should not 

require people to use the petition form, so NIOSH has made use of the form voluntary. He 

explained that petitioners will have to address the informational requirements of the petition 

either way, but they will not be required to use the form NIOSH is providing. 

‘	 Dr. Ziemer asked whether the OMB-cleared petition form would become part of the rule 

by reference. Mr. Katz responded that the form would not become part of the rule by 

reference—use of the form is voluntary. However, instructions will be included which 

will be useful for petitioners regardless of whether they use the petition form. 

‘	 Dr. DeHart thought it would be important for the Board to see the form as soon as it was 

OMB-cleared. Mr. Katz clarified that the form would cover all of the questions that are 

delineated in §83.9. It also provides explanation to help the petitioner understand what 

is being requested. 

Pg. 11307-11308, §83.9 

Mr. Katz indicated that there were several changes made to §83.9, including: 1) The requirement 

for submitting a report to NIOSH was eliminated for those people for whom dose reconstructions 

were attempted but could not be completed. They now only need to indicate the basis of the 

petition; 2) The requirement was eliminated for the petitioners to provide information 

specifically related to the determination of health endangerment; 3) New maximally objective 

requirements have been established for the petitioners to justify their concern that it might not be 

feasible for NIOSH to estimate their radiation doses with sufficient accuracy; 4) A requirement 

was deleted concerning the feasibility of dose reconstruction (the requirement for petitioners to 

seek verification from DOE or an AWE with respect to their information on what data is 

available; and 5) If a petition is based on an exposure incident versus normal operations, NIOSH 

included the option of requiring the petitioner to provide evidence of the incident in cases when 

NIOSH cannot confirm the occurrence of the incident through any other sources. NIOSH does 

not think this situation will be common. 

‘	 Dr. Anderson noted that as part of the applications, a proposed case or class definition 

would ultimately be decided by HHS. He pointed out that if someone filed and then as 

part of the definition was excluded, it would mean that they created a class, but there 

would be no one in it because it would not apply to the person making application. He 

wondered if it would still go forward as a class. Mr. Katz acknowledged that this type of 

situation was possible, and said that it the petition would still go forward. He explained 

that the point of a petition is to initiate the consideration of a class that should be 

considered. A petitioner might be determined to be in a separate class for whom they 

NIOSH can complete dose reconstructions. Hence, NIOSH may add a class to the Cohort 

that does not include the original petitioner. That petitioner would still have had his/her 
Advisory Board on Radiation and Worker Health	 March 7, 2003 

proposed class considered, but the result of that consideration could be two distinct 

classes, one that is added and one that is not. 

‘	 Dr. Melius inquired as to who could represent that class in terms of whether there should 

be an appeal. Mr. Katz responded that the petitioner would not be excluded from the 

process. If they do not like the outcome, they can appeal. 

‘	 Dr. Melius wondered what the process would be if there was another part of the outcome 

that somebody else might object to who was not a party to the original petition. He was 

concerned that someone might not be represented. For example, if they were going to do 

organ-specific cancer, but all people who had kidney cancer were turned down. Mr. Katz 

responded that regardless of whether a petitioner is adversely affected, the petitioner can 

appeal the final decision of the Secretary. 

‘	 Dr. Andrade commented that the other side of this issue was that multiple petitions could 

be filed by different people or groups of people, and what HHS could do is combine 

petitions if they are similar in nature. 

‘	 Dr. DeHart requested clarification regarding a situation in which NIOSH has evaluated a 

claimant’s dose and is unable to complete a dose reconstruction, and whether that 

claimant would be entered into a petition automatically, or if he or she must file a petition 

specifically. Mr. Katz responded that the claimant must submit a petition. He said that 

when NIOSH cannot complete a dose reconstruction, they will directly encourage the 

individual to submit the petition, and provide them with the form to submit the petition. 

‘	 Dr. Anderson wondered if NIOSH would be able to identify, up front, that someone was 

part of a class so that they did not go through all of the process of attempting to 

reconstruct, only to find out after the fact that they could not do so. Mr. Katz responded 

that he did not think those would come to NIOSH for dose reconstruction. DOL would 

identify them as part of that class. Class will be defined sufficiently so that even people 

who do not know they are part of the Cohort will be treated as a member of the Cohort by 

DOL. In addition, NIOSH plans to do as much as they can to get the word out to the 

claimant population that they have added a class to the Cohort. 

‘	 Dr. Melius noted that there appeared to be some reorganization of the way the 

information is presented about short-term over incidents of exposure, suggesting that the 

Board members should take a look at that to determine whether it was clear. 

‘	 Referring to page 11307, §83.9, (2)(iii) and (iv), Mr. Griffon expressed concern that they 

might be setting the expectations too high for information to come from petitioners, for 

example, at the end of 11307, §83.9, (2)(iii) regarding a health physicist or other 

individual with expertise in dose reconstruction documenting the limitations of existing 

records on radiation exposure at the facility as relevant to the petition. Specifying the 

basis for finding these documented limitations might prevent the completion of dose 

reconstructions for members of the class. The same is true for 11307, §83.9, (2) (iv). 

There may not be that many peer-reviewed journal articles that are specific for a 

subgroup of workers at a certain facility. Mr. Katz responded that (iv) was not in the 

previous version of the NPRM. It was added at the behest of the Board. He explained 

that it is an either/or requirement. The DOE would come in under this, and they do not 

have to be published in a peer-reviewed journal. 

‘	 Dr. Ziemer thought the intent was that it was a scientific or technical report from a 

government agency, so the wording will need to be clarified. 
Advisory Board on Radiation and Worker Health	 March 7, 2003 

‘	 Dr. Melius thought that perhaps page 11307-11308, §83.9, (3) (i) (ii) should be included 

in 11308, §83.11. To him, this seemed informational and should be fleshed out in terms 

of what constitutes confirmation of the incident. Dr. Andrade agreed, but thought it was 

a matter of a simple addition to §83.11 that says that further information contained in this 

particular section may be requested during the period of time that NIOSH assists with the 

development of a petition. Dr. Anderson added that rather than requiring the person as a 

part of the petition to go out and find support, they could say that if someone alleges an 

incident, they may ultimately have to provide other information as part of the validation. 

Mr. Katz agreed, pointing out that they were merely letting people know that NIOSH 

may come back to them for further verification at some point. Ultimately, it was agreed 

that when NIOSH drafts the final version of the NPRM, they should clarify §83.9, (3) (i) 

(ii) and determine the best position for this section. 

‘ Mr. Griffon, Dr. DeHart, Dr Andrade, and Ms. Munn discussed a variety of approaches 

for clarifying the wording of §83.9 (2) (iii). 

‘	 Dr. Melius thought the Board should recommend that in §83.9 (2) (ii), the petitioner 

should be included as one of the two employees who can submit an affidavit regarding 

witnessing an incident. This may be particularly important where there are no exposed 

persons surviving. Dr. Ziemer pointed out that the case where there were no witnesses or 

only one is not really addressed in this section. He also thought the issue of hearsay 

evidence should be addressed. Dr. Anderson pointed out the petitioner could be a union. 

Two changes were suggested by individual Board members for §83.9 (2): 

o The wording in §83.9 (2) (ii) should be changed to read “ two witnesses, one of 

whom could be the petitioner if the petitioner actually witnessed the exposure” 

and 

o A §83.9 (2) (iii) should be added to deal with the lack of a second witness and 

lack of any witnesses. 

Pg. 11308, §83.10 

Mr. Katz indicated that §83.10 was a new section which was not included in the previous version 

of the NPRM. He explained that it was intended to clarify the distinction between the role of 

petitioners in providing sufficient justification for a petition and the role of HHS in determining 

whether to add a class to the Cohort. Some members of the public are under the impression that 

meeting the informational requirements for a petition means that the class will be added to the 

Cohort; however, this is not the case. Satisfying the requirements means that the petition will 

receive a full evaluation by NIOSH, the Board, and HHS. This is an addition which serves as a 

clarification in response to confusion they heard from the public on this matter. 

‘	 No further questions, comments, or changes were offered by the participants of this 

meeting regarding this section. 

Pg. 11308, §83.11 
Advisory Board on Radiation and Worker Health	 March 7, 2003 

Mr. Katz indicated that there were a number of changes to this section: 1) §83.11 and §83.12 

were split out of the original §83.10. They wanted to separate the procedures for dealing with 

inadequate petitions from the procedures for notifying interested parties of petitions that 

qualified for evaluation. There is a notification component. They wanted to break that out 

because it was cumbersome the way it was; 2) They no longer require the Board to consider and 

recommend the disposition of petitions that NIOSH finds do not meet the basic requirements; 

and 3) NIOSH will provide guidance and assistance to petitioners in addressing the deficiencies 

of their petitions. 

‘	 This section was flagged to ensure that the issue of an inadequate number of witnesses 

was addressed. 

‘	 Regarding §83.11 (b), Dr. Ziemer, Dr. Melius, and Ms. Munn discussed whether a 

recommendation should be made that there should be a review process delineated here 

(e.g., perhaps there should be some mechanism for petitioners whose petitions fail to 

meet the requirement for evaluation to have that decision be reviewed). 

Pg. 11308, §83.12 

In §83.12, Mr. Katz indicated that NIOSH simplified the provisions concerning NIOSH/Board 

interactions on the development of evaluation plans. The Board's involvement in evaluating 

petitions inherently provides for the Board to review the NIOSH evaluation and provide NIOSH 

with related recommendations if more research is needed et cetera. 

‘	 Recognizing that this is going to go on over time, Dr. Anderson wondered what would 

occur should a petition come in which does not meet the criteria, and which is denied, but 

then a similar petition is presented at a later date by someone else. Mr. Katz responded 

that it would depend on whether the new petitioner brought forth new information. 

However, it would be treated the same as the previously denied petition. It would still be 

reviewed; it would not be summarily dismissed due to precedent. Dr. Andrade noted that 

this issue was covered under Pg. 11308, §83.11(c). 

‘	 Dr. Anderson pointed out that there still needed to be an integrating function of “putting 

two-and-two together” if a subsequent petitioner filed an incident not knowing that the 

first person existed. Rather than going back to the petitioner to tell them they need to 

find someone to verify, the two should be matched together. 

‘	 Dr. Melius asked for clarification regarding whether the requirement for confirmation by 

affidavit had to be from two others aside from the petitioner. Mr. Katz responded that 

they are not specifying who the two are, but clarified that it would be read as two 

individuals in addition to the petitioner. Dr. Ziemer added that it was not fully clear 

whether two or three affidavits were required, and that this should be clarified. 

‘	 Mr. Gibson wondered if only survivors were available to serve as witness, whether that 

could preclude someone from becoming a member of an SEC. Mr. Katz responded that it 

could preclude them from making the case that the incident occurred if there are no 

records and only survivors are asserting that the incident occurred. Dr. Ziemer added that 

it was similar to how to handle what the courts might call “hearsay.” It is removed from 
 

 

Advisory Board on Radiation and Worker Health	 March 7, 2003 

the direct evidence, although sometimes that can be established as being credible 

depending on the situation. 

‘	 With regard to §83.12 (c) and (d), Dr. Roessler requested an example of when (d) would 

be acted upon rather than (c). Mr. Katz responded that it would depend on the 

coincidence of timing that they would want to get to work on these petitions as quickly as 

possible, and the timing of the next Board meeting NIOSH would initiate work without 

waiting on the Board. 

Pg. 11308-11309, §83.13 

Mr. Katz indicated that the changes made in §83.13 included: 1) Pg. 11309, §83.13 (3): NIOSH 

made the determination of health endangerment contingent on finding that it is not feasible to 

conduct dose reconstructions. 2) Pg. 11309, §83.13(b)(1): They clarified the criterion for finding 

that dose reconstructions are feasible, provided other guidance; 3) They included provisions to 

allow for a determination that it is not feasible to estimate radiation dose that is specific to one or 

a limited set of cancer sites; 4) They have omitted the use of IREP. They are not using cancer 

risk models as provided in 1st NPRM; 5)11308-113109, §83.13 (2) (i-iii) and (3) (i-ii): Health 

endangerment includes a change to defining class solely by duration of exposure or presence at 

an exposure incident. 

‘	 Ms. Munn pointed out that her first impression of 11308, §83.13 (1) (iii) was that the 

wording was very dismissive of dosimetry and area monitoring data. Mr. Katz responded 

that it was specifically not necessary to estimate the maximum radiation doses that could 

have been incurred, which is different from saying not necessary to do a focused dose 

reconstruction. Dr. Ziemer suggested rewording in some way to remove the connotation 

of concern to Miss Munn that it sounds dismissive of the data. Ms. Munn agreed to craft 

a revision to be presented during the teleconference the next Friday. 

‘ Dr. Melius suggested that there were three major issues on which they needed to spend 

some time: 1) 11308, §83.13 (1) (iii): Not feasible to, with sufficient accuracy, dose 

reconstruction, for which they have been provided with a very vague definition and very 

little guidance in the draft regulation; 2) 11308-11309, §83.13 (1) (iv): The organ-specific 

determination that is going to be made, which is new and is described very briefly and 

without any guidelines; and 3) 11308-113109, §83.13 (2) (i-iii) and (3) (i-ii): The health 

endangerment where there has been a major change from the approach used before to a 

way of defining class by duration of work or duration of exposure at an exposure 

incident. Dr. Melius’s concern was that the wording in these areas of §83.13 could lead to 

arbitrary and inconsistent decisions because the wording does not provide enough 

framework or guidance on whether a dose can be determined with “sufficient accuracy.” 

Other suggestions/comments regarding the three issues raised by Dr. Melius: 

o Mr. Griffon noted that the definition of “sufficiently accurate” differed somewhat 

in this section from in the Preamble. 

o Dr. Andrade thought the problem was an issue with the definition of 

“sufficiency.” However, he also pointed out that this would likely have to be 

handled on a case-by-case basis, and that if they belabored the issue or tried to 
Advisory Board on Radiation and Worker Health	 March 7, 2003 

include exact definitions of what constitutes sufficiency, the result would be a 

1000-page document. 

o	 Dr. Neton suggested inserting the key word “plausible” should be added to read 

“plausible dose.” Conversely, there could be implausible doses that do not pass 

the reasonableness test that one could assign for dose reconstruction to other 

organs. For example, in the case of uranium inhalation, it is implausible to come 

up with an upper limit when there is no data at all. It may be known that the 

person was exposed to uranium, which concentrates in the lungs and can lead to 

lung cancer. Though a dose reconstruction could not be done for the lung, one 

could come up with implausible exposure scenarios wherein a person would have 

to inhale five pounds of uranium, which would choke the person. One could still 

calculate a dose and demonstrate that the dose reconstruction was done, and that 

the probability of causation was very small for certain remaining organs. One 

could not assume that people inhaled five pounds of uranium and say that other 

organs should be considered for the SEC. This provision would be used on a 

limited basis when they knew there were certain scenarios that did not pass some 

reasonableness test. Dr. Melius felt that this section needed to be worded far 

more clearly. 

Pg. 11309, §83.14 

Mr. Katz indicated that this is a new section added to deal with petitions arising when NIOSH 

cannot complete a dose reconstruction out of that situation. 

‘	 Dr. Melius said he found this section confusing. 

‘	 No further questions, comments, or changes were offered by the participants of this 

meeting regarding this section. 

Pg. 11309-11310, §83.15 

Mr. Katz noted that there were three changes made to this section, namely: 1) Pg. 11309, §83.15 

(c) NIOSH clarified that the Board may obtain and consider additional information not addressed 

in the petition or the initial NIOSH evaluation report, 2) They eliminated the use of the term 

"evidence;” and 3) They eliminated the term "consensus" which was used to characterize the 

recommendations of the Board, but which was confusing to the public. 

‘	 Ms. Munn requested clarification on the issue of petitioners appearing before the Board 

with regard to privacy. Mr. Elliott responded that if the petitioner is a claimant who 

wants to talk about his or her own claim, they can do so at their own volition. However, 

if the petitioner wants to talk about others who are in the system, the Board cannot 

respond with discussion of information covered by the Privacy Act. If information is 

submitted that is Privacy Act-related, the petition will be summarized to the Board in a 

fashion that will not reveal the confidential information. 

‘	 Dr. Melius noted that there needed to be a procedure in place for how information goes 

back to the petitioner and how the Board’s recommendations should go to the Secretary. 
Advisory Board on Radiation and Worker Health	 March 7, 2003 

Dr. Ziemer said there was certainly nothing to preclude the Board from individually 

transmitting a decision to a petitioner, although he stressed that the Board's 

recommendation is not the decision; it is a piece of information the Secretary uses in 

making the final decision. 

‘	 Dr. Anderson raised the procedural issue of timelines to invite the petitioner to comment, 

for NIOSH evaluation of findings, et cetera, and whether that needed to be included in 

the NPRM itself. Mr. Elliott responded that this was a procedure they needed to put in 

place, and that they needed to develop a meeting cycle that is practical, appropriate, and 

not so rushed. If they could achieve the required 30-day Federal Register Notice timeline 

in advance of a meeting, this would be beneficial. However, he did not believe this 

needed to be part of the NPRM. 

Pg. 11310, §83.16 

Mr. Katz indicated that there were a number of changes in §83.16, including: 1) Pg. 11310, 

§83.16 (a): They clarified that the Secretary will take into consideration the NIOSH evaluation, 

the Board report, and information presented to the Board in its deliberations. This came out of a 

recommendation that the Board made to NIOSH; 2) Pg. 11310, §83.16 (a): They revised the 

reporting provisions to report all decisions to the Secretary at this time, including affirmative 

decisions to add classes. This was in response to a public comment suggesting that they add this; 

3) They eliminated the Secretary's discretion to employ procedures and consider factors not 

specified in the rule. 

‘	 Dr. Andrade referred to §83.11 which indicates that after 30 days of review, NIOSH will 

notify the petitioners of its decision to evaluate the petition or its final decision that the 

petition has failed to meet the requirements. However, in 83.16 it appears that either the 

Secretary is the one who bears this burden on the notification and/or there is no final 

decision because a petitioner can actually submit, in writing, information that they 

believe that factual or procedural errors have occurred in the evaluation of their petition. 

Not clear to Dr. Andrade was how the petitioner was going to know whether factual or 

procedural errors occurred. He asked for a claimant-friendly explanation for that. He also 

noted that toward the bottom of §83.16 no date or time period is given during which the 

Secretary has to respond to the claimant or to the petitioner, as is done for NIOSH in 

§83.11. Mr. Katz responded that §83.11 and §83.16 are separate. In §83.11, if they 

decide the petition does not go forward, it is never evaluated, and never goes to the 

Secretary. The Secretary makes no decisions on the petition in this case. Dr. Ziemer 

noted that since these two sections led to some confusion, perhaps some of the wording 

needed to be revised. Dr. Andrade suggested adding a deadline to §83.16 (c) 

‘	 Dr. Melius noted that some of the sub-headings were somewhat confusing throughout the 

document. 
 

 

 

Advisory Board on Radiation and Worker Health	 March 7, 2003 

Pg. 11310, §83.17 

Mr. Katz indicated that in §83.17, they reduced from 20 to 5 days the time allowed for HHS to 

report to DOL the results of any Congressional action, or lack thereof, concerning the Secretary's 

decision. This was in response to a public comment. 

‘	 No further questions, comments, or changes were offered by the participants of this 

meeting regarding this section. 

Pg. 11310, §83.18 

Mr. Katz pointed out that changes made to this section included: 1) Pg. 11310, §83.18 (b) (3) and 

(b) (4): NIOSH added provisions to the section to specify that the Board would advise the 

Secretary in these cases and that members of the class would be provided an opportunity to 

contest such decisions. 

‘	 Dr. Melius requested clarification on whether this modification happens before it goes to 

Congress or simultaneous with it going to Congress. Mr. Katz responded that this was 

not a decision to add a class to the Cohort. This is for a class that has already been added 

to the Cohort, with the hypothetical situation here that might find a cache of records that 

allows NIOSH to reconstruct doses for a class of workers for whom, previously, doses 

could not have been reconstructed. 

11302-11305, Preamble 

‘	 Referring to A. Dose Reconstruction for Members of the Cohort, Dr. Anderson said she 

was not clear what the line on 11303 meant which reads, “NIOSH will discuss with the 

Board this option to assign doses.” Mr. Katz responded that this was the question 

Dr. Melius raised about what to do with people in the Cohort with cancers not 

compensable under EEOICPA provisions regarding compensation for members of the 

Cohort. He said that this was not an issue for the NPRM; it is an issue for dose 

reconstruction, which is why it is not addressed in the NPRM. 

FORMAL MOTIONS
 

Dr. Ziemer reminded everyone that there had been concerns expressed regarding the 30-day 

comment period for the current version of the NPRM. He requested that Mr. Elliott check into 

the possibility of extending the comment period. While they wish to be expeditious in finalizing 

the NPRM, they also want to ensure accuracy. 
Advisory Board on Radiation and Worker Health	 March 7, 2003 

Motion 1 

Dr. Melius moved to make a formal recommendation to NIOSH to extend the 30-day comment 

period. Mr. Owens seconded the motion. Dr. Ziemer made a friendly amendment that they 

couch the recommendation in terms of recognizing comments from the general public that 

indicated that the extension would be helpful in getting the NPRM right. 

Discussion Points: 

 ̃	 Dr. Andrade inquired as to whether the motion would need to be specific at this time, or 

if they could act on the motion and vote at a later date. 

 ̃	 Dr. Melius wanted to make the recommendation strong, and he did not perceive that 

waiting to learn the Secretary’s pleasure regarding the issue would be beneficial. He 

thought the request had to be made soon, given that notification needed to be made to the 

public. 

 ̃	 Dr. DeHart did not think a week's delay would have an impact, and in view of 

Mr. Elliott’s comments, there may be some political advantage perhaps with a delay, so 

he moved to table this motion to the next Friday. 

Motion 2 

Dr. DeHart moved to table the first motion until the next Friday, March 14, 2003. Dr. Andrade 

seconded this motion. Dr. Ziemer called for a vote to table Motion 1. The motion to table failed. 

Further Discussion Points on the original motion (Motion 1): 

 ̃	 Mr. Espinosa suggested that it would help the Board to convene a stakeholders meeting 

of some sort to entertain public comment, rather than simply reviewing e-mails et cetera. 

 ̃	 Dr. Anderson commented that they had really not had an opportunity to hear public 

comments, and he thought it would be potentially helpful to hear more from the public. 

 ̃	 Ms. Munn said the public comment that she heard most frequently from every site was, 

“Will you please get on with what you're doing?” For that reason, she opposed any 

extensions of time that they did not feel absolutely necessary for whatever reason. 

Hence, she spoke against the motion to request additional public comment time. 

 ̃	 Dr. Gibson said that during this meeting, he heard almost 100% from the public that they 

want an extension because of the potentially significant changes in certain areas that need 

to be fleshed out. 

Motion 1: Amended 

Dr. Melius moved to make a formal recommendation to NIOSH to extend the 30-day comment 

period. Mr. Owens seconded the motion. Dr. Ziemer made a friendly amendment that they 
Advisory Board on Radiation and Worker Health	 March 7, 2003 

couch the recommendation in terms of recognizing comments from the general public that 

indicated that the extension would be helpful in getting the NPRM right. Dr. Andrade made a 

friendly amendment to limit the additional time period to 15 days, for a total public comment 

period of 45 days. Dr. Ziemer called for a vote. The motion carried unanimously. 

There was no further discussion regarding this issue. 

CLOSING REMARKS
 

Dr. Ziemer said he thought they had pretty well framed out the issues that they needed to discuss 

the next time the Board convened, and that perhaps they would be fairly near closure at the next 

meeting. It was suggested that participants review the previous NPRM and the docket that 

contains all of the comments, which can be found on the website. 

The following upcoming meetings are scheduled: 

‘	 A telephone conference call is scheduled for March 14, 2003, 1:00 to 4:00 p.m. Eastern 

Standard Time. 

‘	 A telephone conference call is scheduled for April 4, 2003, 1:00 to 4:00 p.m. Eastern 

Standard Time. 

‘	 A face-to-face meeting is scheduled for May 19th and 20th in Oak Ridge, Tennessee. 

Discussion Points: 

 ̃	 Ms. Munn inquired as to whether they anticipated addressing the Preamble during their 

next discussion. Dr. Ziemer responded that the Preamble is not really part of the NPRM. 

However, if there are errors or changes that should be made in that, he thought they 

should try to identify those. 

 ̃	 Mr. Presley asked whether they wanted to set a date for the Board to meet in Cincinnati 

for training. Dr. Ziemer pointed out that this would have to be after the Oak Ridge 

meeting in May, and that they may encounter some Privacy Act issues, so they will have 

to look into whether the meeting will be announced and open to the public. 

 ̃	 Mr. Elliott stressed that it was important for all Board members to experience what the 

Workgroup had at ORAU. His suggestion was to identify two Working Groups so that 

no quorum and no public forum would be required given that they will not be conducting 

business. 

 ̃	 Dr. Anderson suggested that the two groups come on separate days so that they were not 

too disruptive. Mr. Elliott indicated that he would have Cori Homer poll everyone for 

possible dates, and Dr. Ziemer identified the following Working Groups: 

Group 1: Dr. Andrade, Chair; Dr. Melius, Ms. Munn, Mr. Owens 

Group 2: Dr. Anderson, Chair; Dr. DeHart; Mr. Gibson 
Advisory Board on Radiation and Worker Health March 7, 2003

With no further business posed; Dr. Ziemer officially adjourned the twelfth meeting of the

ABRWH at 5:00 P.M

End of Summary Minutes

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CERTIFICATION

I hereby confinn that these Summary Minutes are accurate to the best of my knowledge:

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