Enc.

ADVISORY BOARD ON RADIATION AND WORKER HEALTH

4676 Columbia Parkway, MS: C-46 

Cincinnati, Ohio 45226

(513) 533-6825

CHAIRMAN

James M. Melius, M.D., Dr. PH.

 Albany, New York

MEMBERS

Henry Anderson, M.D.

 Madison, Wisconsin

Josie Beach

 Kennewick, Washington 

Bradley P. Clawson

 Rexburg, Idaho

R. William Field, Ph.D. 

 Iowa City, Iowa

Michael H. Gibson

 Franklin, Ohio

Mark A. Griffon

 Salem, New Hampshire

Richard Lemen, Ph.D.

 Canton, Georgia

James E. Lockey, M.D.

 Cincinnati, Ohio

Wanda I. Munn

 Richland, Washington

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

 College Station, Texas

Robert W. Presley

 Seymour, Tennessee

David B. Richardson, Ph.D.

Chapel Hill, North Carolina

Genevieve S. Roessler, Ph.D.

 Elysian, Minnesota

Phillip Schofield

 Bosque Farm, New Mexico

Paul L. Ziemer, Ph.D.

 Lafayette, Indiana

STAFF

EXECUTIVE SECRETARY

Theodore M. Katz, MPA

 Atlanta, Georgia

COMMITTEE MANAGEMENT 

Zaida Burgos

 Atlanta, Georgia

July 19, 2011

The Honorable Kathleen Sebelius

Secretary 

Department of Health and Human Services

200 Independence Avenue, S.W.

Washington, D.C. 20201

Dear Madam Secretary:

The Advisory Board on Radiation and Worker Health (ABRWH) is submitting 

comments to you pertaining to Department of Health and Human Services 

Regulation proposed changes to 42 CFR Part 81, Guidelines for Determining 

Probability of Causation Under the Energy Employees Occupational Illness 

Compensation Program Act of 2000; Revision of Guidelines on Non-Radiogenic 

Cancers. [Docket Number NIOSH-209 (RIN 0920-AA39)] These comments 

were approved by the Board at its recent meeting on July 11, 2011.

1. The ABRWH offers the following comments on the question “Does 

epidemiological and other scientific research support finding that 

Chronic Lymphocytic Leukemia (CLL) is caused by radiation?”

 Although most members of this Board do not have expertise in 

epidemiological research, several do and with their expertise we 

were able, as a Board, to assess the approach used by NIOSH to 

answer this specific question. That approach has been detailed in 

Docket Number NIOSH-209. Through the use of recognized experts, 

NIOSH has been able to demonstrate that the available limited 

epidemiological evidence is supportive of a possible association 

between ionizing radiation and CLL.

 Including CLL as radiogenic is appropriate in that it follows NIOSH’s 

approach of erring on the side of the claimant when scientific 

knowledge is lacking.

2. The ABRWH agrees with the NIOSH position set forth in the docket 

as follows:

 “Given that the law requires the use of the upper 99 percent 

credibility level in making compensation decisions, the inclusion of 

CLL despite the limited evidence of radiogenicity, is considered 

appropriate by NIOSH.”

3. The ABRWH offers the following comments on the question “If CLL were 

to be covered under EEOICPA, does the risk model proposed by the 
The Secretary July 19, 2011

National Institute for Occupational Safety and Health use the best available science and 

methodological approaches to express the dose-response relationship between 

radiation exposure and CLL?”

 We agree that the use of the lymphoma and multiple myeloma risk models as a starting 

point is appropriate, given the fact that CLL is now classified by the National Cancer 

Institute and by the World Health Organization as a form of non-Hodgkin’s lymphoma. 

 The proposed risk model makes use of the available scientific literature concerning the 

latency period for CLL and selects a conservative (claimant favorable) value for the 

midpoint of the latency period and is therefore appropriate.

 The proposed uncertainty band for the midpoint of the latency period is sufficiently large 

so as to fairly reflect the spread seen in the available studies.

 We concur with the approach of using the weighted radiation dose to the B 

lymphocytes, based on the dose to a given site and the probability that a B cell 

precursor for CLL will occupy that site.

The ABRWH appreciates the opportunity to comment on the proposed revision of the 

Guidelines for Determining Probability of Causation under the Energy Employees Occupational 

Illness Compensation Program Act of 2000.

 Sincerely,

 [Signature on file]

James M. Melius, M.D., Dr. PH

 Chairman, ABRWH