Centers for Disease Control and Prevention
 

National Institute for Occupational Safety and Health
 

Seventh Meeting of the 

Advisory Board on Radiation and Worker Health
 

August 22, 2002
 

Conference Call Meeting
 
Centers for Disease Control and Prevention 

National Institute for Occupational Safety and Health 

Office of Compensation Analysis and Support 

Records of the Telephone Conference of the 

Advisory Board on Radiation Worker Health
 

August 22, 2002
 

A telephone conference of the Advisory Board on Radiation Worker Health (ABRWH) was 

convened by the National Institute for Occupational Safety and Health’s (NIOSH) Office of 

Compensation Analysis and Support (OCAS) on August 22, 2002. A notice of the 

teleconference had been published in the Federal Register to allow for public input to the 

discussions. Under discussion in this conference were the Board’s final recommendations to the 

Secretary of the Department of Health and Human Services (DHHS) on the Proposed Rule 42 

CFR Part 83, “Procedures for Designating Classes of Employees as Members of the SEC,” as 

well as a letter to the Secretary about: 1) the Memorandum of Understanding (MOU) between 

NIOSH and the Department of Energy (DOE) that governs the Rule’s process and 2) about 

retention of documents. A copy of the final letters and documents are attached to this report. 

ABRWH Chair Dr. Paul Ziemer called the meeting to order at 1:18 p.m. 

Members participating were: 

Paul Ziemer, Chair Roy DeHart James Melius 

Larry Elliott, Executive Richard Espinosa Wanda Munn 

Secretary Sally Gadola Bob Presley 

Henry Anderson Mark Griffon 

Antonio Andrade 

Member Dr. Genevieve Roessler was not in attendance, but had e-mailed her comments on the
 

document, which were generally supportive. Mr. Mike Gibson and Mr. Leon Owens, new
 

ABRWH members approved by the White House but not yet seated, also participated in the call.
 

NIOSH staff on line were: Larry Elliott, Cori Homer, Ted Katz, David Naimon, Liz HomokiTitus
 

Mark Reinhold of the Department of Labor also was on the teleconference.
 

Members of the public or others attending the call were:
 

Vina Colley, Portsmouth Gaseous Diffusion Plant (GDP) 

Ken Crase, Savannah River Site
 

Joy Gest, Hanford Site
 

Richard Miller, Government Accountability Project (GAP) 

Frank Morales, Government Accountability Project (GAP)
 

Bob Tabor, Fernald Site
 

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Jerry Tudor, Oak Ridge Site 

Letter to the Secretary 

Dr. Ziemer read the draft August 22, 2002, letter to Secretary Thompson about the MOU and 

retention of records. Mr. Elliott reported that the citation of the relevant October 28, 1991 DOE 

memo will be inserted to this letter and the memo attached. The letter cited the Board’s open 

public meetings, discussions about the importance of having complete exposure and other 

available site records provided in a timely manner to facilitate NIOSH’s work. It asked that 

DOE be urgently requested to continue the retention of such records by each DOE office and 

present/former DOE contractors. Minor edits were provided in discussion. 

In public comment, Ms. Joy Gest reported receiving two letters from NIOSH indicating that they 

have requested her records from DOE. She wanted to know if DOE was holding up the process. 

Mr. Elliott explained that NIOSH’s ongoing notification to claimants about their claim status 

requires multiple letters. Ms. Gest commented that the slowness of the process made it appear as 

if the “right hand doesn’t know what the left hand is doing.” Dr. Ziemer responded that this 

conference and the letter to the Secretary were designed to improve the timely response of DOE 

and to remind new contractors about the mandated records retention. 

Ms. Gest asked how many claims had been processed to date by NIOSH staff. Mr. Elliott 

reported that the difficulty of the compensation program and its associated legal process requires 

great care and deliberation, but the process is expected to greatly speed up when the contractor is 

in place. They will be staffed/equipped to handle at least 8000 claims per year. Of the ~6700 

claims filed to date, NIOSH has sent ~7 files to DOL for a recommended decision, and was to 

send more this week. 

Ms. Vina Colley reported Portsmouth workers were upset with this process, as well as suspicious 

that efforts were underway to get them to “sign away their rights.” She asked for a public 

meeting to be held at Portsmouth and that all DOE sites be included in the Special Exposure 

Cohorts (SEC), since all workers were exposed to various types of chemicals as well as 

radioactive materials. 

Mr. Richard Miller suggested that the DOE Secretary be copied on this letter, since the 

recommendation may be beyond the DHHS Secretary’s purview, and asked if the sufficiency of 

NIOSH staffing was addressed. Mr. Elliott responded that NIOSH will send it according to the 

agencies’ protocol for correspondence between agencies. The letter also will be posted on the 

NIOSH Website. Dr. Ziemer reported the NIOSH staffing was discussed at the ABRWH 

meeting the previous week. It is also included on the agenda for next meeting, along with 

evaluating the status of the dose reconstruction contractor. 

Dr. Ziemer called for a vote to approve the letter to the Secretary regarding the 

NIOSH/DOE MOU and DOE’s retention of personnel records with the two minor changes in 

wording suggested. The motion was unanimously approved by the Board with no members 

abstaining. 

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Recommendations on Rule 42 CFR, Part 83 

The Board’s comments on the proposed rulemaking of 42 CFR, Part 83 were sent via a cover 

letter along with two attachments containing both general and specific comments. The cover 

letter, which was read by Dr. Ziemer, included the dates the Board reviewed and discussed the 

Rule, and noted that they heard a number of presentations and public comments. Dr. Anderson 

had to leave the call early, but supported the contents of the letter and the two attachments, and 

voted in favor of sending them. 

In one change to the letter, the Board agreed to modify its recommendation to clarify that since 

the Rule’s provisions were not ready for examination, paragraph 1 should state that the Board 

“examined the issues relevant to . . .” the Rule during the May 2-3 meeting. 

Attachment #1 

Several changes and clarifications were suggested to Attachment #1, the Board’s general 

comments on the Rule: 

Inclusion of non-SEC listed cancers. Clarify, regarding compensation for non-SEC listed 

cancers, that the proposed regulation should “ensure that these do not preclude . . .” 

“Health endangerment” definition. The definition of “health endangerment” had been 

extensively discussed at the last meeting and no consensus was yet apparent. Dr. Ziemer 

strongly preferred sending a consensus recommendation to the Secretary. Although the Federal 

Advisory Committee Act requires consensus advice of committees chartered under it, the 

Board’s operational guidelines only require a majority opinion to be reached by eligible 

members to allow a vote to go forward. However, advice from individuals is also accepted, and 

Mr. Elliott expected that a statement of such concerns by “some members” would also capture 

the Secretary’s attention. 

In this discussion, there was some agreement that the ABRWH should “recommend that NIOSH 

consider suitable criteria” (e.g., a facility with poor/no monitoring and holding the potential for 

external or internal dose) or “consider this issue,” to express the concern but leave it sufficiently 

open-ended to allow time to work on the issue. There was clearly a majority of the Board 

concerned about the definition of health endangerment, although the solution to it differed 

among members. 

Dr. DeHart moved that the Board suggest that the proposed rule for determining if a 

potential SEC class meets the health endangerment criteria is not adequate. If not 

adequately justified, this could lead to arbitrary decisions. The Board recommended that 

NIOSH consider other suitable criteria. Mr. Presley seconded the motion. 

The vote on the issue of the “health endangerment” definition showed eight in favor and one 

opposed. The vote passed. 

Dose Reconstruction Guidelines 

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Dr. Ziemer read the Board’s draft recommendation that, in the Rule’s preamble, NIOSH clarify 

the criteria that determine whether completion of a dose reconstruction with sufficient accuracy 

is not possible, and clarify the criteria to be used to evaluate an application. Also recommended, 

to ensure the consistency/fairness of the process, was NIOSH’s development of operational 

guidelines to determine the adequacy of the data to complete a dose reconstruction, also to be 

reviewed by the Board. Several clarifying edits and a substantive change (to include time limits 

in the guidelines) were offered. 

Interim Final Rule 

Dr. Ziemer read the proposed Board recommendation that NIOSH issue this as an Interim Final 

Rule. This would allow adjustments as needed and provide time for resolution of issues not yet 

fully worked out by the Board and NIOSH. However, the text specified that “if this would 

prevent the Secretary from certifying classes, then the Board would ask that this option not be 

considered.” The last phrase resolved several of the the members’ primary concern. However, 

since there was lingering unease that perhaps not all the implications of the difference between 

an interim and final rule were known, Dr. DeHart moved to state that the “Board recommends 

that DHHS consider issuing this regulation as an interim final rule...” Mr. Presley 

seconded the motion, and upon a vote, the motion unanimously passed. 

Mr. Griffon raised the question of assigning the dose of an SEC category to another 

reconstructable dose, and was satisfied that this was addressed under Section 1 of Attachment 

#2, under non-SEC listed cancers. 

Ms. Munn moved to accept Attachment #1 as amended and Mr. Presley seconded the motion. 

With no opposition or abstentions, the vote unanimously passed. 

Attachment #2 

Dr. Andrade, who had to leave the conference early, voiced his support of this attachment as 

long as it was not modified beyond minor editorial changes. Since only Section 83.9 had been 

altered (everything else remained unchanged since the last meeting and had been distributed 

publicly), that Section was addressed first. 

Sec 83.9: 

# In the last sentence addressing the applicant’s submission of a “government or other
 

research report,” add “published scientific research report” after “other.” Applicants’
 

requirements to submit to NIOSH are that: 1) the individual tried to get their dose record and
 

could not; 2) provides a report from a health physicist or dose reconstruction expert that they
 

were involved in the specific situation; or 3) submits a research paper report about the adequacy
 

of available dose information. 

Other changes agreed to included:
 

# 83.1, correct spelling in last line. 

# 83.2 (b): change the sequence of the first sentence to “... dose reconstruction performed
 

and who have had a claim denied.” 

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# Clarify that a cancer claimant who dose reconstruction is completed but whose claim 

does not qualify them for compensation “cannot reapply as a member of a special cohort or use 

the procedures for designating such classes as a route for appealing a decision.” (Underline 

indicates new text). 

However, concern was expressed about both this and the original wording. If the dose 

reconstruction is denied and it is later found that a dose reconstruction could not be done 

for the applicant’s particular work experience, they should be able to apply for a special 

class. Since the Board had no wish to prevent an appeal based on insufficient accuracy, 

alternative language was suggested to prohibit using “... the procedures for designating a 

special cohort class specifically as a route for appealing a decision,” but again it was 

questioned how this would be determined 

It was agreed that the intent was clear that the Board wished the DHHS attorneys to craft 

appropriate language, such as by adding “this does not preclude them from filing an 

appeal under (cite Section)” to be clear that this route still remains. 

With Dr. Melius’ second, Ms. Munn moved to adopt the text: “A cancer claimant whose dose 

reconstruction is completed but whose claim does not qualify them for compensation 

cannot use the procedures for designating a special cohort class specifically as a route for 

appealing a decision. This does not preclude them from filing an appeal as provided for 

elsewhere by the DOL rules.” 

Upon a vote, the motion was unanimously approved.
 

# 83.5, correct typo “addition”to “additional.” 

# 83.10, first sentence to read “the wording of all those items infers” rather than “appears”,
 

which “are appropriately DHHS or NIOSH functions.”
 

# 83.13: Remove the parentheses in sentence one and make it a separate sentence. 

Mr. Presley moved to approve Attachment #2 with the above changes. Dr. DeHart seconded
 

the motion, which was unanimously approved with no abstentions.
 

Dr. Ziemer agreed to e-mail a marked up copy of these document to Ms. Homer, to be attached
 

to the final reports. With no further comment and the Chair’s thanks, the meeting adjourned at
 

3:08 p.m 

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I hereby confirm that these Minutes are accurate to the best of my knowledge. 

/s/ 

Paul L. Ziemer, Ph.D. 

October 31, 2002 

Date 

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DRAFT 

Report Attachment #1: Letter to the DHHS Secretary 

August 20, 2002 

The Honorable Tommy G. Thompson
 

Secretary, Department of Health and Human Services
 

Washington, D.C.
 

Dear Secretary Thompson: 

Since my last communication to you on February 22, 2002, The Advisory Board 

on Radiation and Worker Health has held three additional meetings. The sessions 

were open to the public in accordance with FACA requirements and were 

attended by a variety of individuals representing themselves or interest groups. 

Copies of the meeting Agendas are attached for your information. 

During the Advisory Board meeting in Cincinnati on August 14 and 15, two of the issues under 

consideration relating to past records were deemed to be of sufficient substance to require your 

attention. The Board continues to be seriously concerned about the critical need to have 

complete personnel exposure records and other related site records available in a timely manner. 

The dose reconstruction processes being conducted by NIOSH, as required by law, cannot 

function fairly and quickly in the absence of those data. As the bulk of the required information 

is accessible almost exclusively through the Department of Energy, the Board recommends that: 

§	 A Memorandum of Understanding between DHHS and DOE be pursued 

as expeditiously as possible to assure NIOSH is provided timely and 

appropriate DOE exposure records required by Section 3623(e) of 

EEIOCPA. 

§	 DOE be urgently requested to reissue its directive on retention of 

personnel records (DOE Number ?????) to each of their offices, 

contractors, and former contractors to ensure that all necessary data are 

appropriately retained and accessible. 

If there are questions, or if further explanations of the Board's concerns are desired, 

please advise accordingly. 

Sincerely, 

Paul L. Ziemer, Ph.D., CHP
 

Chairman
 

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DRAFT
 

Report Attachment #2: Transmission Letter Re. SEC Rule 

August 20, 2002 

The Honorable Tommy G. Thompson 

Secretary, Department of Health and Human Services 

Washington, D.C. 

Dear Secretary Thompson: 

During meetings held May 2-3, 2002, July 1-2, 2002 and August 14-15, 2002, The 

Advisory Board on Radiation and Worker Health examined the provisions of the 

Department of Health and Human Services proposed rule 42 CFR Part 83 entitled 

Procedures for Designating Classes of employees as Members of the Special Cohort 

Under the Energy Employees Occupational Illness Compensation program Act of 

2000. 

At the Board sessions, formal presentations were provided by NIOSH staff members 

concerning the Special Exposure Cohort issues. In addition, presentations were made by 

outside experts, including individuals from the Department of Veterans Affairs. Members 

of the public also provided valuable input on this matter. 

Under the provisions of the President’s Executive Order of December 7, 2000, the 

Advisory Board has very specific responsibilities on advising the Secretary of Health and 

Human Services. In accordance with those responsibilities, I am pleased to provide the 

Advisory Board’s comments and recommendations concerning the proposed procedures 

set forth in 42 CFR Part 83. These comments and recommendations are summarized in 

Attachments 1 and 2. Attachment 1 provides general comments on certain aspects of the 

proposed rule. Attachment 2 provides more specific comments on particular sections of 

the proposed rule. 

Please let me know if additional information or clarification is needed. 

Sincerely 

Paul L. Ziemer, Ph.D., CHP 

Chairman 

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DRAFT
 

Report Attachment #3; Rule Comment Attachments 

Attachment 1. 

General Comments
 

Non-SEC Listed Cancers 

The Board noted that there were a number of unresolved issues concerning how to handle 

claimants who were part of a SEC class but who developed a non-SEC listed cancer. The Board 

recommends that NIOSH carefully review the proposed regulations to ensure that they do not 

preclude appropriate handling of these cases. The Board also recommends that NIOSH develop 

appropriate procedures to address situations where part but not all of a claimants dose history is 

included in a SEC class. 

Health endangerment 

Some of the Board members felt that the proposed rule for determining whether a potential SEC 

class meets the criterion of “health endangerment” was not adequate. In particular, the proposed 

method for estimating whether the cohort met the criterion for “health endangerment” was not 

adequately justified and could lead to arbitrary and unfair decisions. These members 

recommended that NIOSH consider criteria similar to those used for the current SEC classes 

based on duration of work in a facility in a situation where the monitoring of radiation exposures 

was required or should been required (after first determining that the information was not 

adequate for individual dose reconstruction). 

Dose Reconstruction Guidelines 

The Board recommends that NIOSH clarify the criteria for determining that it was not possible 

to complete an individual dose reconstruction with sufficient accuracy. These criteria should be 

more completely outlined in the preamble to the final rule in order to assist potential SEC class 

applicants to understand the criteria that will be used for evaluating an applicant for SEC class 

designation. The Board also recommends that NIOSH develop operational guidelines outlining 

the criteria for determining that the available data are not adequate for conducting individual 

dose reconstruction. These guidelines should be reviewed by the Board. The Board believes 

that these guidelines are necessary for ensuring consistency and fairness in these important 

determinations. 

Interim Final Rule 

Some of the Board members recommended that NIOSH issue these regulations as an interim 

final rule rather than a final rule. The former would allow later modifications to the rule without 

necessarily going through the full rule making process. Given that some elements of this rule 

(e.g., health endangerment criteria, how to handle SEC class members with non-SEC listed 

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cancers, etc.) have not been fully worked out and will need further development by NIOSH and 

review by the Board, this may be a prudent approach. If issuing this rule as an interim final rule 

would inhibit the Secretary of DHHS from certifying new SEC classes, then the Board would 

recommend that this option not be considered. 

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Attachment 2.
 

Specific Comments 

Section 83.1 

The proposed rule states that “HHS will consider adding new classes of employees only in 

response to petitions by or on behalf of such classes of employees....” This wording gives the 

impression that the burden for adding new classes lies completely on the individual employees. 

The Board believes that it would be beneficial if the rule made it clear that NIOSH intends to be 

proactive in identifying and assisting employees who may be in such categories to develop the 

appropriate petitions. Accordingly, we reco7mmend that a new statement be added to Section 

83.1 that could read as follows:

 “Because NIOSH itself may be in a better position to identify classes of employees 

that may comprise special cohorts (based on its own findings from collections of 

individual dose reconstruction efforts or from new findings that result from site 

profiles), NIOSH intends to be diligent in identifying and assisting employees who 

may be in such categories to develop the appropriate petitions.” 

The Advisory Board is also concerned that some individuals may misunderstand the purpose and 

role of the Special Exposure Cohort. Although the language of the Rule clearly states that it 

applies to individuals for whom doses cannot be estimated by the completion of a dose 

reconstruction, it seems likely that some individuals may simply regard this as a route for 

appealing a decision where a claim did not qualify for compensation. Thus, the Board is 

suggesting that an additional statement be added in this section that states explicitly that the 

purpose of the Rule is not to serve as an appeal for those whose dose reconstructions did not lead 

to compensation. 

Section 83.2 

A statement addressing our concerns about individuals who have had a claim denied AND who 

have had a thorough dose reconstruction performed, might appear as item "b" in Section 83.2 

(requiring that the current item b become item c). This could read as follows. 

"A cancer claimant whose dose reconstruction was completed but whose 

claim did not qualify for compensation cannot reapply for or use the 

procedures for designating classes of employees as members of the special 

cohort as a route for appealing a decision." 

Section 83.5 

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In item (c), in addition to the parameters specified, it is important to add an addition parameter, 

namely that of a common time period for the work. The addition of the phrase “during similar 

time periods” after “at the same DOE or AWE facility” would remedy this matter. 

Section 83.9 

The Board recommends that NIOSH change the requirements for petitioning for SEC class 

consideration to modify the proposed requirement that “DOE or the AWE responded indicating 

the records do not exist” in response to a request for records relevant to the class petition. 

Obtaining such a response is not possible for most AWE facilities and may be difficult for some 

work at many DOE facilities. Rather, the applicant should be required to have made a “good 

faith effort” to obtain such records. Even this may be difficult for AWE facilities. The Board 

also recommends adding a third element to this section indicating that the applicant may submit 

a government or other research report indicating that such historical records are not available for 

that facility. 

Section 83.10 

In items (b) (2), (b)(3), and (b)(4), it appears the Advisory Board is directly involved at an early 

stage in processes which should be HHS (or NIOSH) staff functions. This can be remedied by 

deleting the last sentence of item (b)(2), deleting the last sentence of item (b)(3), and deleting the 

last phrase of item (b) (4). Additionally, in item (c) sentence 1, insert the phrase “together with 

its evaluation plans” after the word “evaluation” so as to read: 

“NIOSH will present petitions selected for evaluation, together with its evaluation 

plans, to the Board for review.” 

Section 83.13 

The Board is concerned that the language in this Section makes it appear that the Board’s role is 

ad judicatory in nature, and the review of petitions by the Board may be regarded as a formal 

hearing (see, for example, the language in paragraph 83.13 (b) concerning the presentation of 

“evidence”). We understand that the language of the Public Law does specify certain 

responsibilities for the Board in terms of evaluating petitions for Special Exposure Cohort status. 

At the same time, the Board’s role is advisory to the Secretary of HHS. Thus, we would 

recommend language that makes it clear that, while petitioners will be invited to meetings where 

they can present pertinent information to the Board, the Board’s report is simply one piece of 

information that the Secretary will consider in making a final decision on the petition. 

Section 83.15 

We assume that the intent of this Section is to provide the Secretary of HHS with flexibility in 

considering other factors (perhaps procedures or information not even thought of at the time of 

the rule-making) in reaching a final decision. However, insofar as this statement opens the door 

for any number of arbitrary issues to be introduced into the process, the Board is concerned that 

the statement may be too open-ended. As a minimum, perhaps it could be specified that the 

“other procedures” must not be in conflict with the procedures established in the Rule. 

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