CHAIRMAN: 

Paul L. Ziemer, Ph.D. 

 Lafayette, Indiana 

MEMBERS: 

Bradley P. Clawson 

 Idaho Falls, Idaho 

Roy L. DeHart, M.D., M.P.H. 

 Nashville, Tennessee 

Michael H. Gibson 

 Franklin, Ohio 

Mark A. Griffon 

 Salem, New Hampshire 

James E. Lockey, M.D. 

 Cincinnati, Ohio 

James M. Melius, M.D., Ph.D. 

Albany, New York 

Wanda I. Munn

 Richland, Washington 

Charles L. Owens 

 Paducah, Kentucky 

John W. Poston, Sr., Ph.D. 

 College Station, Texas 

Robert W. Presley

 Clinton, Tennessee 

Genevieve S. Roessler, Ph.D. 

 Elysian, Minnesota 

STAFF: 

EXECUTIVE SECRETARY: 

Lewis V. Wade, Ph.D. 

 Washington, DC 

COMMITTEE MANAGEMENT : 

LaShawn D. Shields 

Atlanta, Georgia 

ADVISORY BOARD ON RADIATION AND WORKER HEALTH
 

4676 Columbia Parkway, MS: C-46 

Cincinnati, Ohio 45226
 

(513) 533-6825 

March 14, 2006 

NIOSH Docket Office 

Robert A. Taft Laboratories 

MS-C34 

4676 Columbia Parkway 

Cincinnati, OH 45226 

Subject: COMMENTS ON PROPOSED AMENDEMENTS TO 42 CFR 

PART 83, SPECIAL EXPOSURE COHORT RULE 

The Advisory Board on Radiation and Worker Health submits the following 

comments on the proposed changes to the Special Exposure Cohort 

Regulations at 42 CFR Part 83 which were included in the Interim Final 

Rule (IFR) published on December 22, 2005. The purpose of this 

rulemaking is to harmonize the HHS rule with the new time limits included 

in the Conference Report for the FY 05 Defense Authorization Act (P.L. 

108-375) which were set forth to ensure that evaluations of Special 

Exposure Cohort petitions are completed in a timely fashion by NIOSH and 

the Advisory Board, and that Special Exposure Cohort determinations will 

be decided by the Secretary of HHS within 30 days of receipt of a 

recommendation from the Advisory Board. 

The amendments to the Energy Employees Occupational Illness 

Compensation Act enacted as part of the Ronald W. Reagan National 

Defense Authorization Act for Fiscal Year 05 P.L. 108-375 state: 

“DEADLINES—(1) Not later than 180 days after the date on which the 

President receives a petition for designation as members of the Special 

Exposure Cohort, the Director of the National Institute for Occupational 

Safety and Health shall submit to the Advisory Board on Radiation and 

Worker Health a recommendation on that petition, including all supporting 

documentation.” 

The Conference Report States: 

“To ensure that applications to be a SEC member are processed 

promptly, new timelines have been included. Within 180 days of receipt 

of a petition for designation as members of a SEC, the Director of 

NIOSH must submit to the Advisory Board a recommendation on that 

petition, including all supporting documentation. During the 180 day 

period when NIOSH is preparing the petition for review by the Advisory 

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NIOSH Docket Office March 14, 2006 

Board, NIOSH should identify all deficiencies in the petition within the first 30 days. When 

the President receives an affirmative recommendation from the Advisory Board to designate 

a class to the SEC, the President shall have a period of 30 days in which to accept or reject 

the recommendation and notify Congress. If the President does not send a determination 

notice within 30 days, and if there is an affirmative Board recommendation, the class 

recommended to be a SEC will automatically become a SEC, subject to a 30 day notification 

period in Congress.” 

We have a number of comments about the proposed amendments and their implementation: 

1.	 In reference to Sec. 83.11(c), we do not believe that the proposed seven-day time 

period in the IFR is adequate for petitioners to appeal the disqualification of an SEC 

petition. Given the limited resources of most petitioners and the potential need for 

them to gather more technical information to address the reasons for their 

disqualification, the 30 days in the existing CFR Part 83.11 is a more reasonable time 

period for such appeals. 

2.	 The text of the rule does not specify the 180 day time period required in P.L. 108-

375. The 180 day time period is only mentioned in the Preamble of the rule, a part of 

the rule that is explanatory not binding. This is confusing and needs to be clarified. In 

addition, the current proposal includes a new definition of petition that appears to 

initiate the 180 day time period only after the petition has qualified and ends it with 

the presentation of just the evaluation report (but not necessarily a complete 

recommendation). This leaves no specified time period for petition qualification or 

for the development and presentation of a NIOSH recommendation based on the SEC 

petition evaluation. We note that the conference report also indicates that during the 

180 day time period for SEC petition evaluation, NIOSH should “identify all 

deficiencies” within 30 days of receipt of that petition. Appropriate changes should 

be made within the rule to clarify these problems with the IFR and to make the Final 

Rule consistent with the Conference Report. 

3.	 The Board is supportive of the need for the SEC petition process to proceed in a 

timely fashion, consistent with the Conference Report. Petitioners and interested 

parties should know how long each step will take in order to better understand how 

the evaluation of their petition will progress. Having this information will help avoid 

concerns that their petitions are being inappropriately delayed. This information 

should include expected time periods for initial petition qualification, the NIOSH 

evaluation of qualified petitions including recommendations, the Board’s review of 

the NIOSH evaluation, the development of the Board’s recommendation to the 

Secretary of HHS, the submission of the Board’s recommendation to the Secretary of 

HHS (usually 21 days), and finally the Secretary’s decision and transmission of that 

decision to Congress (30 days in the amended regulations). 

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NIOSH Docket Office March 14, 2006 

The Board believes that providing expected time periods in the regulation and some 

additional published guidelines would be useful. Such guidelines and regulations 

should recognize the need for timely responses to petitions. Therefore, the Board 

recommends that NIOSH develop guidelines for the entire SEC petition process 

including regulations covering at least the portions required by the new law. 

These comments represent a consensus of the Advisory Board on Radiation and Worker Health 

and were discussed at the Board’s March 14, 2006 meeting. Further elaboration on these 

comments is included in the transcript of this meeting. 

Thank you for the opportunity to comment on the proposed amendments to 42 CFR Part 43. 

 Sincerely,

 Paul L. Ziemer, Ph.D. 

 Chairman 

Cc: Larry Elliott, Director 

Office of Compensation Analysis Support 

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