POC – Nonradiogenic Cancer Reconsideration

The Department of Health and Human Services (HHS) is proposing to treat chronic lymphocytic leukemia (CLL) as a radiogenic cancer under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA). Under current guidelines HHS promulgated as regulations in 2002 (42 CFR Part 81), all types of cancers, except for CLL, are treated as being potentially caused by radiation and hence as potentially compensable under EEOICPA. HHS proposes to reverse its decision to exclude CLL from such treatment. The following documents provide the background information used by NIOSH in reconsidering the classification of CLL as a non-radiogenic cancer.

Federal Register Notice

Guidelines for Determining Probability of Causation Under the Energy Employees Occupational Illness Compensation Program Act of 2000; Revision of Guidelines on Non-Radiogenic Cancers; 76 FR 15268; 3/21/11 [PDF – 223 KB]

Notice of proposed rulemaking; extension of comment period; 76 FR 36891; 6/23/11 [PDF – 1,053 KB]

Final rule; 77 FR 5711; 2/6/12 [PDF – 145 KB]

Subject Matter Expert Reviews of CLL Radiogenicity

Charge to reviewers: Chronic lymphocytic leukemia: reconsideration of exclusion from eligibility for compensation under EEOICPA, undated. [PDF – 480 KB]

Crowther MA (2004). Letter to Centers for Disease Control and Prevention from Mark A. Crowther, McMaster University and St. Joseph’s Hospital, 11/17/04 [PDF – 345 KB]

Ozonoff D (2004). Letter to Russell Henshaw, NIOSH, from David Ozonoff, Boston University School of Public Health, 12/01/04 [PDF – 9 KB]

Zablotska (2004). Comments on the arguments for covering chronic lymphocytic leukemia under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA) advanced by its stakeholders in the Chronic Lymphocytic Leukemia: Reconsideration of Exclusion from Eligibility for Compensation under EEOICPA, 12/16/04 [PDF – 681 KB]

Boice JD Jr (2005). Reconsideration of chronic lymphocytic leukemia for purposes of compensation, 1/7/05. [PDF – 1,958 KB]

Richardson D (2007). Chronic lymphocytic leukemia: Reconsideration of exclusion from eligibility for compensation under EEOICPA, 1/29/07. [PDF – 1,266 KB]

Opinion summary and OCAS recommendation on Chronic lymphocytic leukemia (CLL): Reconsideration of exclusion from eligibility for compensation under EEOICPA, 8/19/05. [PDF – 32 KB]

Subject Matter Expert Review of CLL Risk Model

Richardson D (2009). Review of Development of a CLL Risk Model for NIOSH-IREP, August 25, 2009. [PDF – 99 KB]

Wakeford (2009). Review of the report, Development of a CLL risk model for NIOSH-IREP, draft dated December 21, 2007; amended January 30, 2009 (reformatted June 30, 2009). [PDF – 93 KB]

Schubauer-Berigan (2009). Memo to James Neton (NIOSH) from Schubauer-Berigan (NIOSH) regarding Comments on Development of a CLL risk model for NIOSH-IREP; Trabalka and Apostoaei, Draft July 2009, August 28, 2009. [PDF – 2,008 KB]

Zablotska (2009). Evaluation of a prototype CLL risk model for potential inclusion in the computer program NIOSH-IREP, September 2009. [PDF – 68 KB]

DHHS (2009). Report to the Senate Appropriations Committee on the radiogenicity of specific cancers under the Energy Employees Occupational Illness Compensation Program Act of 2000 as amended, December 2009. [PDF – 53 KB]

Response to review comments on the draft report: Development of a CLL Risk Model for NIOSH-IREP, December 1, 2009. [PDF – 236 KB]

NIOSH (2010). Development of a risk model for chronic lymphocytic leukemia for NIOSH-IREP, January 5, 2010. [PDF – 416 KB]

NIOSH (2010). Review, synthesis, and application of information on the human lymphatic system to radiation dosimetry for chronic lymphocytic leukemia. Developed under NIOSH contract 200-2006-218097 by Apostoaei AI and Trabalka JR, SENES Oak Ridge, Inc [PDF – 7,045 KB]

References Cited in the NPRM

Darby SC, Doll R et al. (1987). Long-term mortality after a single treatment course with X-rays in patients treated for ankylosing spondylitis. Br J Cancer 55:179-190. [PDF – 303 KB]

Curtis RE, Boice JD et al (1994). Relationship of leukemia risk to radiation dose following cancer of the uterine corpus. J Natl Cancer Inst 86:1315-1324. [PDF – 1,063 KB]

Muirhead CR, Goodill AA et al. (1999). Occupational radiation exposure and mortality: second analysis of the National Registry for Radiation Workers. J Radio Prot 19(1):3-26. [PDF – 144 KB]

Cardis E, Gilbert ES et al. (1995). Effects of low doses and low dose rates of external ionizing radiation: cancer mortality among nuclear industry workers in three countries. Radiat Res 142:117-132. [PDF – 143 KB]

Preston DL, Kusumi S et al. (1994). Cancer incidence in atomic bomb survivors. Part III: Leukemia, lymphoma and multiple myeloma. Radiat Res 137:S68-S97. [PDF – 703 KB]

Hamblin TJ (2008). Have we been wrong about ionizing radiation and chronic lymphocytic leukemia? Leuk Res 32:523-525. [PDF – 177 KB]

NIOSH (2006). Report of the public meeting to seek input on gaps in chronic lymphocytic leukemia (CLL) radiogenicity research, held July 21, 2004. DHHS (NIOSH) Publication No. 2006-100. [PDF – 13,241 KB]

NIOSH (2005). Chronic lymphocytic leukemia (CLL): reconsideration of exclusion from eligibility for compensation under EEOICPA. Developed by the Office of Compensation Analysis and Support (OCAS). [PDF – 480 KB]

NIOSH (2009). Response to review comments on the draft report: development of a CLL risk model for NIOSH-IREP. Developed by the Office of Compensation Analysis and Support (OCAS). [PDF – 236 KB]

Richardson DB, Wing S et al. (2005). Ionizing radiation and chronic lymphocytic leukemia. Environ Health Persp 113:1-5. [PDF – 263 KB]

Richardson DB (2004). Chronic lymphocytic leukemia: reconsideration of exclusion from eligibility for compensation under EEOICPA. [PDF – 38 KB]

NIOSH (2010). Development of a risk model for chronic lymphocytic leukemia for NIOSH-IREP. Developed under NIOSH contract 200-2006-18097 by Trabalka JR and Apostoaei AI, SENES Oak Ridge, Inc. [PDF – 416 KB]

NIOSH (2009). Table 4: Number of basal cell carcinoma claims at each currently-designated SEC site (as of March 18, 2009). In response to a request in Senate Report 109-103 (issued in 2005), [PDF – 115 KB]
/niosh/ocas/pdfs/irep/radio2sen1209.pdf

Web link only — NCI (2010). Adult non-Hodgkin lymphoma treatment (PDQ®): health professional version. Bethesda: MD: National cancer Institute, http://www.cancer.gov/cancertopics/pdq/treatment/adult-non-hodgkins/healthprofessional/allpages/

Harris NL, Jaffe ES et al. (1999). World Health Organization classification of neoplastic diseases of the hematopoietic and lymphoid tissues: Report of the clinical advisory committee meeting—Airlie House, Virginia, November 1997. J Clin Oncol 17:3835-3849. [PDF – 152 KB]

Silver SR, Hiratzka SL et al. (2007). Chronic lymphocytic leukemia: a systematic review. Cancer Causes Control 18:1077-1093. [PDF – 152 KB]

The British Journal of Haematology: The CLL Issue. Published by Blackwell Publishing, Volume 139, Issue 5, December 2007. [PDF – 836 KB]

NRC (2006). Health risks from exposure to low levels of ionizing radiation: BEIR VII Phase 2. National Research Council, Board on Radiation Effects Research. Washington, DC: National Academies Press. [PDF – 1,201 KB]

Web link only — NCI (2010). Surveillance epidemiology and end Results (SEER) Program. http://seer.cancer.gov. Accessed July 15, 2010.

IARC (1997). Cancer incidence in five continents. Volume VII. Lyon, France: International Agency for Research on Cancer, World Health Organization. Parkin DM, Whelan SL et al. (eds). IARC Scientific Publications No. 143. [PDF – 327 KB]

Land CE, Gilbert ES et al. (2003). Report of the NCI-CDC working group to revise the 1985 NISH radioepidemiological tables. Bethesda, MD: US Department of Health and Human Services, National Institutes of Health, National Cancer Institute, NIH Publication No. 03-5387. [PDF – 1,076 KB]

Kocher DC and Apostoaei JA (2007). Screening doses for induction of cancers calculated with the interactive radioepidemiologic program (IREP). Fort Belvoir, VA: US Department of Defense, Defense Threat Reduction Agency, Technical Report DTRA-TR-07-4. [PDF – 373 KB]

NCI (2010). SEER Cancer Statistics Review, 1975-2007, National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2007/, based on November 2009 SEER data submission, posted to the SEER web site, 2010. [PDF – 24 KB]

Submissions in Order of Receipt

Submission to the docket from Frowiss (Independent Claims Analyst) – 3/22/11 [PDF – 60 KB]

Submission to Regulations.gov from Knight (Western Washington University); 5/10/11 [PDF – 892 KB]

Submission to Regulations.gov from Fischer (Private person); 5/10/11 [PDF – 423 KB]

Submisson to the docket from Clary (private person); 6/11/11 [PDF – 438 KB]

Submission to the docket from Edmunds (private person); 6/14/11 [PDF – 952 KB]

Submission to the docket from Weiner (private person); 7/11/11 [PDF – 525 KB]

Submission to the docket from Melius (Advisory Board on Radiation and Worker Health); 7/19/11 [PDF – 1,140 KB]