15268 Federal Register / Vol. 76, No. 54 / Monday, March 21, 2011 / Proposed Rules 

1The name of the NIOSH Office of Compensation 

Analysis and Support (OCAS) was changed to the 

Division of Compensation Analysis and Support 

(DCAS) in March 2010. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 81 

[Docket Number NIOSH–209] 

RIN 0920–AA39 

Guidelines for Determining Probability 

of Causation Under the Energy 

Employees Occupational Illness 

Compensation Program Act of 2000; 

Revision of Guidelines on NonRadiogenic Cancers 

AGENCY: National Institute for 

Occupational Safety and Health, Centers 

for Disease Control and Prevention, 

DHHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: 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, 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. 

DATES: The Department invites written 

comments on this Notice of Proposed 

Rulemaking from interested parties. 

Comments must be received by June 20, 

2011. 

ADDRESSES: You may submit comments, 

identified by ‘‘RIN 0920–AA39,’’ by any 

of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• E-mail: NIOSH Docket Officer, 

nioshdocket@cdc.gov. Include ‘‘RIN 

0920–AA39’’ and ‘‘42 CFR 81.30’’ in the 

subject line of the message. 

• Mail: NIOSH Docket Office, Robert 

A. Taft Laboratories, MS–C34, 4676 

Columbia Parkway, Cincinnati, OH 

45226. 

Instructions: All submissions received 

must include the agency name and 

docket number or Regulatory 

Information Number (RIN) for this 

rulemaking. All comments will be 

posted without change to http:// 

www.regulations.gov and http:// 

www.cdc.gov/niosh/docket/archive/ 

docket209.html, including any personal 

information provided. For detailed 

instructions on submitting comments 

and additional information on the 

rulemaking process, see the ‘‘Public 

Participation’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov or http:// 

www.cdc.gov/niosh/docket/archive/ 

docket209.html. 

FOR FURTHER INFORMATION CONTACT: 

Stuart Hinnefeld, Director, Division of 

Compensation Analysis and Support,1

National Institute for Occupational 

Safety and Health (NIOSH), 4676 

Columbia Parkway, MS–C46, 

Cincinnati, OH 45226, Telephone 513– 

533–6800 (this is not a toll-free 

number). Information requests can also 

be submitted by e-mail to dcas@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Public Participation 

II. Background 

A. Introduction 

B. NIOSH Reconsideration of CLL Basis for 

Reconsideration Risk Model 

C. Purpose of the Rule 

D. Technical Review by the Advisory 

Board on Radiation and Worker Health 

III. Summary of Proposed Rule 

IV. Regulatory Assessment Requirements 

A. Executive Order 12866 

B. Regulatory Flexibility Act 

C. Paperwork Reduction Act 

D. Small Business Regulatory Enforcement 

Fairness Act 

E. Unfunded Mandates Reform Act of 1995 

F. Executive Order 12988 (Civil Justice) 

G. Executive Order 13132 (Federalism) 

H. Executive Order 13045 (Protection of 

Children From Environmental, Health 

Risks and Safety Risks) 

I. Executive Order 13211 (Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

J. Plain Writing Act of 2010 

I. Public Participation 

Interested persons or organizations 

are invited to participate in this 

rulemaking by submitting written views, 

arguments, recommendations, and data. 

Comments are invited on any topic 

related to this proposal. In addition, 

HHS invites comments specifically on 

the following questions related to this 

rulemaking: 

(1) Does epidemiological and other 

scientific research support finding that 

CLL is caused by radiation, and what 

are the major limitations of the 

determination (whether affirmative or 

negative)? 

(2) If CLL were to be covered under 

EEOICPA, does the risk model proposed 

by the National Institute for 

Occupational Safety and Health 

(NIOSH) use the best available science 

and methodological approaches to 

express the dose-response relationship 

between radiation exposure and CLL? 

Does the approach NIOSH is taking in 

this package appropriately account for 

the uncertainty associated with the 

limited evidence of radiogenicity? In 

this context, did NIOSH make use of 

appropriate biological and 

epidemiological information in the 

development of its proposed model? If 

not, please cite specific research studies 

that NIOSH should have considered as 

well as alternative modeling approaches 

that could also be considered. 

Comments submitted by e-mail or 

mail should be addressed to the NIOSH 

Docket Officer, titled ‘‘NIOSH Docket 

#209,’’ and should identify the author(s), 

return address, and a phone number, in 

case clarification is needed. Comments 

can be submitted by e-mail to: 

nioshdocket@cdc.gov. E-mail comments 

may be provided as e-mail text or as a 

file attachment. Printed comments can 

be sent to the NIOSH Docket Office at 

the address above. All communications 

received on or before the closing date 

for comments will be fully considered 

by HHS. 

All comments submitted will be 

available for examination in the rule 

docket (a publicly available repository 

of the documents associated with the 

rulemaking) both before and after the 

closing date for comments. A complete 

electronic docket containing all 

comments submitted will be available at 

http://www.cdc.gov/niosh/docket/ 

archive/docket209.html and http:// 

www.regulations.gov, or comments will 

be available in hard-copy by request. 

NIOSH includes all comments received 

without change in the docket, including 

any personal information provided. 

II. Background 

A. Introduction 

The Energy Employees Occupational 

Illness Compensation Program Act of 

2000 (EEOICPA), 42 U.S.C. 7384–7385, 

established a compensation program to 

provide a lump-sum payment of 

$150,000 and prospective medical 

benefits as compensation to covered 

employees suffering from designated 

illnesses incurred as a result of their 

exposure to radiation, beryllium, or 

silica while in the performance of duty 

for the Department of Energy (DOE) and 

certain of its vendors, contractors, and 

subcontractors. This legislation also 

provided for lump-sum payments for 

certain survivors of these covered 

employees. 

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Federal Register / Vol. 76, No. 54 / Monday, March 21, 2011 / Proposed Rules 15269 

2An interactive version of NIOSH–IREP is 

available on the Internet at: https:// 

www.niosh-irep.com/irep_niosh/. 

3 67 FR 22296, 22302 (May 2, 2002) (codified at 

42 CFR part 81). 

4 Darby SC, Doll R, Gill SK, et al. Long-term 

mortality after a single treatment course with X-rays 

in patients treated for ankylosing spondylitis. Br. J. 

Cancer. 1987;55:179–190. 

5Curtis RE, Boice JD, Stovall M, et al. 

Relationship of leukemia risk to radiation dose 

following cancer of the uterine corpus. J. Natl. 

Cancer Inst. 1994;86:1315–1324. 

6Muirhead CR, Goodill AA, Haylock RGE, et al. 

Occupational radiation exposure and mortality: 

second analysis of the National Registry for 

Radiation Workers. J. Radiol. Prot. 1999;19:3–26. 

Cardis E, Gilbert ES, Carpenter L, et al. Effects of 

low doses and low dose rates of external ionizing 

radiation: cancer mortality among nuclear industry 

workers in three countries. Radiat. Res. 

1995;142:117–132. 

7Preston DL, Kusumi S, Tomonaga M, et al. 

Cancer incidence in atomic bomb survivors. Part III: 

Leukemia, lymphoma and multiple myeloma, 

1950–1987. Radiat. Res. 1994;137:S68–S97. 

8A dose-response relationship between radiation 

and CLL would be a finding that the incidence of 

CLL among populations increases with increases in 

the amount of radiation dose. With such a 

relationship, populations with a moderate amount 

of radiation dose would be found to have a 

moderate frequency of CLL, populations with a high 

amount of radiation dose would be found to have 

a high frequency of CLL, and populations with a 

very high amount of radiation dose would be found 

to have a very high frequency of CLL. 

9NIOSH publication 2006–100. Report of the 

public meeting to seek input on gaps in chronic 

lymphocytic leukemia (CLL) radiogenicity research, 

held July 21, 2004. 

10A summary of the proceedings of this meeting 

can be found in: NIOSH Publication 2006–100. 

Report of the public meeting to seek input on gaps 

in chronic lymphocytic leukemia (CLL) 

radiogenicity research, held July 21, 2004. 

11NIOSH, Office of Compensation Analysis and 

Support (OCAS). Chronic lymphocytic leukemia 

(CLL): reconsideration of exclusion from eligibility 

for compensation under EEOICPA. 2005. This 

document is included in the docket for this 

rulemaking. 

Under Executive Order 13179 

(‘‘Providing Compensation to America’s 

Nuclear Weapons Workers’’), the 

Department of Labor (DOL) has primary 

responsibility for administering the 

compensation program. HHS performs 

several technical and policymaking 

roles in support of the DOL program. 

One of these is to develop guidelines, by 

regulation, to be used by DOL to assess 

the likelihood that an employee with 

cancer developed that cancer as a result 

of exposure to radiation in performing 

his or her duty at a DOE facility or an 

atomic weapons employer facility. HHS 

published a final rule establishing these 

‘‘probability of causation’’ guidelines on 

May 2, 2002 (67 FR 22296) under 42 

CFR part 81. 

The HHS probability of causation 

guidelines comprise a set of policies and 

procedures by which DOL determines 

whether it is ‘‘at least as likely as not’’ 

that the cancer of a nuclear weapons 

employee was caused by radiation doses 

the employee incurred while employed 

at a facility both involved in the 

production of nuclear weapons and 

covered under EEOICPA. These 

procedures direct DOL to use one or 

more appropriate quantitative risk 

assessment models to calculate the 

probability that a cancer was caused by 

the relevant radiation doses. The risk 

models, originally developed by the 

National Cancer Institute (NCI) and 

again revised by an expert work group, 

chaired by NCI, in 2002 for use under 

EEOICPA, are contained within a 

computer program called the NIOSH 

Interactive RadioEpidemiological 

Program (NIOSH–IREP).2 NIOSH–IREP 

contains a risk model for every type of 

cancer covered by an EEOICPA claim, 

except for CLL. The guidelines 

designate CLL as non-radiogenic, and 

hence require DOL to assign a 

probability of causation value of ‘‘zero.’’ 

There were two related scientific 

reasons for designating CLL as nonradiogenic at the time the HHS 

guidelines were promulgated in 2002. 

The first was that the epidemiological 

studies did not demonstrate radiation as 

the cause of CLL, a conclusion reached 

by a number of expert scientific 

committees, as well as by NIOSH.3 This 

evidence included studies of a variety of 

designs on populations with a variety of 

high radiation exposures, including 

British ankylosing spondylitis patients 

treated with x-rays; 4 U.S., Canadian, 

and European women exposed to 

radiation during treatment for uterine 

cancer; 5 nuclear workers in the United 

Kingdom and internationally; 6 and 

Japanese atomic bomb survivors from 

World War II.7 No major 

epidemiological study as of that date 

had found a statistically significant 

increase in the risk of CLL associated 

with radiation exposure, let alone a 

dose-response relationship.8

The second reason was that, even if 

NIOSH had determined that CLL should 

be treated as radiogenic, NIOSH 

scientists judged it would not have been 

feasible to develop a quantitative risk 

model, specifying a dose-response 

relationship between radiation and CLL, 

given the existing scientific evidence at 

that time. Hence, it was not feasible to 

include CLL as a radiogenic cancer 

under the guidelines. 

B. NIOSH Reconsideration of CLL 

Basis for Reconsideration 

In the original technical 

documentation for NIOSH–IREP, the 

discussion of the rationale for excluding 

CLL from consideration under EEOICPA 

stated that this decision would be 

revisited as new scientific information 

became available. Although HHS 

received little comment on the 

designation of CLL as non-radiogenic 

during the rulemaking that established 

the probability of causation guidelines 

under EEOICPA, NIOSH has steadily 

since heard concerns about this policy 

decision from EEOICPA claimants, their 

representatives, and others. 

In response to stakeholder input, the 

Congressional appropriations language 

for fiscal year 2004 directed NIOSH to 

conduct epidemiological research and 

other activities to ‘‘establish the 

scientific link between radiation 

exposure and the occurrence of chronic 

lymphocytic leukemia.’’ 9 To this end, a 

focus on the radiogenicity of CLL was 

added to existing research conducted 

under the NIOSH Occupational Energy 

Research Program (OERP). On July 21, 

2004, OERP convened a public meeting, 

during which a panel of six experts in 

epidemiologic and molecular CLL 

research, unaffiliated with NIOSH, met 

to: (1) Discuss available research 

strategies for investigating the potential 

relationship between the incidence of 

CLL and worker exposures to ionizing 

radiation; and (2) identify gaps in 

current research.10 The consensus 

among the panelists was that the current 

scientific evidence was inconclusive 

with respect to CLL’s association with 

ionizing radiation and additional 

research was required to definitively 

answer this question. 

Subsequent to the July meeting, five 

additional subject matter experts 

unaffiliated with NIOSH were asked by 

NIOSH’s Division of Compensation 

Analysis and Support to provide their 

individual judgments as to whether 

the evidence of an association, or lack 

thereof, between radiation exposure and the 

risk of developing CLL [is] sufficient to 

continue to regard CLL as a non-radiogenic 

cancer and to continue to exclude it, a priori, 

from eligibility for compensation under 

EEOICPA.11

This second round of review was 

undertaken because the purpose of the 

July 2004 expert panel convened by 

OERP was focused on how to 

definitively address the question of 

radiogenicity, rather than on the 

narrower context of the continued 

exclusion of CLL from consideration 

under the unique conditions prescribed 

under EEOICPA. That is, EEOICPA 

requires that consideration be given to 

the uncertainty associated with risk 

models and, in fact, requires that 

probability of causation (and hence, the 

compensation decision) be evaluated at 

the upper 99th percentile of the 

credibility level of the distribution of 

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15270 Federal Register / Vol. 76, No. 54 / Monday, March 21, 2011 / Proposed Rules 

12Crowther, MA. Letter to Centers for Disease 

Control and Prevention. Report submitted to 

NIOSH, November 17, 2004. A copy of this report 

is available in the docket for this rulemaking. 

13Zablotska, L. 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 ‘‘Chronic 

Lymphocytic Leukemia: Reconsideration of 

Exclusion from Eligibility for Compensation under 

EEOICPA.’’ Report submitted to NIOSH, December 

16, 2004. A copy of this report is available in the 

docket for this rulemaking. 

14 Id. 

15 Id. 

16Richardson DB. Chronic lymphocytic leukemia: 

Reconsideration of exclusion from eligibility for 

compensation under EEOICPA. Report submitted to 

NIOSH, November 2004. A copy of this report is 

available in the docket for this rulemaking. 

17 Id. 

18Ozonoff, D. Letter to Russell Henshaw, NIOSH, 

regarding Reconsideration of CLL. Report submitted 

to NIOSH, December 1, 2004. A copy of this report 

is available in the docket for this rulemaking. 

19Boice, JD. Reconsideration of chronic 

lymphocytic leukemia for purposes of 

compensation. Report submitted to NIOSH, January 

7, 2005. A copy of this report is available in the 

docket for this rulemaking. 

20 Id. 

21 Id. 

22NIOSH. Charge to reviewers: Chronic 

lymphocytic leukemia: reconsideration of exclusion 

from eligibility for compensation under EEOICPA. 

Undated. This document is available in the docket 

for this rulemaking. 

23NIOSH, Office of Compensation Analysis and 

Support (OCAS). Response to review comments on 

draft report: development of a CLL risk model for 

NIOSH–IREP. December 1, 2009. This document is 

available in the docket for this rulemaking. 

possible outcomes. Because of this, the 

IREP program was designed to include 

cancers whose central estimate of the 

risk coefficient, while not statistically 

significant, may be significantly greater 

than 1 at the upper uncertainty limit 

and thus produce a probability of 

causation greater than or equal to 50 

percent (i.e., be compensable). 

The experts chosen for this review 

were selected by NIOSH based on their 

past experience in the area of radiation 

epidemiology, with the goal of obtaining 

a diverse range of perspectives on the 

matter. Each of the five experts 

consulted posited a scientific opinion 

about the weight of the evidence. The 

full text of these opinions is available in 

the docket for this rulemaking. 

One reviewer concluded that ‘‘the 

available evidence is insufficient to rule 

out an association between ionizing 

radiation and CLL.’’ 12

A second reviewer found no evidence 

on epidemiologic grounds to support 

the contention that CLL is induced by 

radiation, stating that: 

From the scientific point of view, this 

evidence could be interpreted as the absence 

of a convincing association between radiation 

exposure and subsequent CLL. If risks are 

present, but, are not identified in 

epidemiological studies, then they are 

certainly much smaller than the risks 

estimated for other types of leukemia.13

The reviewer did comment, however, 

that CLL remains one of the most 

controversial issues in radiation 

epidemiology: 

Though in the past it was thought to be 

definitely non-radiogenic, recent discoveries, 

particularly from genetic and molecular 

studies, provide evidence that lymphatic 

cancers may differ to a great degree from 

other types of leukemia. If risks are present, 

they are probably so small as to render them 

virtually undetectable in individual studies 

under currently available scientific 

epidemiological methods.14

This reviewer refrained from offering an 

opinion on whether CLL should be 

included in the list of cancers that are 

potentially compensable under 

EEOICPA and concluded ‘‘from an 

epidemiological point of view it is not 

possible to prove that there is no risk of 

CLL due to occupational radiation 

exposure. It is only possible to say that 

currently we do not have solid scientific 

evidence to say that CLL is 

radiogenic.’’ 15

A third reviewer concluded that 

In fact, the scientific evidence pertaining to 

the molecular mechanisms of CLL induction 

weighs heavily towards the conclusion that 

CLL is similar to other hematological 

malignancies whose etiology involves 

structural changes on the chromosomal level 

that cause mutational changes on the 

molecular level, altering important cellular 

functions, and, ultimately, leading to 

malignant transformation of a cell. The 

weight of this scientific evidence is in 

support of the conclusion that the somatic 

mutations that contribute to the genesis of 

CLL can be produced by ionizing radiation 

exposure.16

He concluded by stating: 

Available scientific evidence suggests that 

CLL incidence will be increased by exposure 

to ionizing radiation. Scientific evidence 

does not provide a sufficient basis for 

regarding CLL as non-radiogenic.17

A fourth reviewer concluded his 

review by stating ‘‘my expert opinion 

supports including CLL as a radiogenic 

cancer and against the continuing, and 

it seems to me, arbitrary practice of 

exclusion.’’ 18

A fifth reviewer found that ‘‘[t]he body 

of scientific evidence indicates that 

chronic lymphocytic leukemia (CLL) is 

not caused by exposure to ionizing 

radiation at any level of dose.’’ 19 He 

concluded that, 

based on epidemiologic studies of radiation 

finding no evidence for an association with 

CLL, coupled with the etiologic and clinical 

differences between CLL and the other forms 

of leukemia that are caused by radiation, CLL 

should not be considered a radiationinducible cancer.20

This reviewer also provided a 

counterargument to Reviewer #3’s 

position that the type of genetic damage 

that may be involved in the 

carcinogenesis of CLL, namely deletions 

of chromosomal material, can be caused 

by radiation, which is a known 

clastogen (an agent that breaks 

chromosomes). According to Reviewer 

#5, other carcinogenic clastogens 

besides radiation (e.g., benzene and 

tobacco smoke) found by 

epidemiological studies to cause 

myeloid leukemia, have also been found 

not to cause CLL, and hence proposes 

that another, unspecified carcinogenic 

mechanism must operate for CLL.21

In sum, of the five reviewers, three 

offered their support for the 

consideration of CLL as radiogenic for 

the purposes of potential compensation. 

Three reviewers, Reviewer #1, Reviewer 

#2, and Reviewer #3, offered the 

opinion that, while the evidence 

presented by the epidemiology studies 

reviewed in 2002 might not have 

provided conclusive proof that CLL is 

caused by ionizing radiation, genetic 

studies offer a perspective much 

different from that demonstrated by 

epidemiology studies and should be 

considered. The only stated opposition 

to including CLL came from Reviewer 

#5, who recognized that the conclusions 

reached by NIOSH with regard to other 

cancers deemed potentially 

compensable were based on NIOSH’s 

stated policy to ‘‘err on the side of the 

claimant when the state of scientific 

knowledge is lacking.’’ 22

Finally, NIOSH asked four subject 

matter experts to review a 2009 draft 

report of the CLL risk model. Of those 

reviewers, two also provided reviews in 

2004 (Reviewers #2 and #3). The 2009 

reviewers were not charged specifically 

with reviewing the evidence of 

radiogenicity and were asked to 

evaluate the proposed risk model 

(discussed below) based on the premise 

that CLL has a probability of causation 

greater than zero. According to the 

NIOSH summary of the 2009 reviews, 

[t]he reviewers did not disagree with our 

basic conclusion, namely that CLL could be 

radiogenic, and that, from an epidemiological 

perspective, we can only conclude that we 

currently do not have solid scientific 

evidence of a well-defined dose-response 

from the LSS [Life Span Study of Japanese 

atomic bomb survivors] data, but not that 

there is no risk of CLL due to occupational 

radiation exposure.23

Of these reviewers, only one premised 

his opinion about CLL radiogenicity on 

the compensation program’s inclusion 

of other cancers with similarly weak 

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Federal Register / Vol. 76, No. 54 / Monday, March 21, 2011 / Proposed Rules 15271 

24Zablotska LB. Evaluation of a prototype CLL 

risk model for potential inclusion in the computer 

program NIOS–IREP. Report submitted to NIOSH, 

September 2009. A copy of this report is available 

in the docket for this rulemaking. 

25A timeline of the various reviews initiated by 

NIOSH is available in Appendix A. 

26Richardson DB, Wing S, Schroeder J, et al. 

Ionizing radiation and chronic lymphocytic 

leukemia. Environ. Health Persp. 113:1–5. 2005. 

27 Id. 

28Hamblin TJ. Have we been wrong about 

ionizing radiation and chronic lymphocytic 

leukemia? Leuk. Res. 2008;32:523–525. 

29 42 U.S.C. 7348n(c)(3)(A). 

30National Academy of Sciences. A Review of the 

Draft Report of the NCI–CDC Working Group to 

Revise the 1985 Radioepidemiological Tables. 

National Academies Press. 2000. 

31 42 U.S.C. 7348n(c)(3)(A). 

32Harris NL, Jaffe ES, Diebold J, Flandrin G, 

Muller-Hermelink HK, Vardiman J, Lister TA, and 

Bloomfield CD. 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. 

Boice JD. Reconsideration of chronic lymphocytic 

leukemia for purposes of compensation. January 7, 

2005. 

National Cancer Institute. Adult non-Hodgkin 

lymphoma treatment (PDQ®): health professional 

version. Modified July 8, 2010. http:// 

www.cancer.gov/cancertopics/pdq/treatment/adultnon-hodgkins/healthprofessional/allpages. 

Accessed July 15, 2010. 

33National Cancer Institute. Adult non-Hodgkin 

lymphoma treatment (PDQ ®): health professional 

version. Modified July 8, 2010. http:// 

www.cancer.gov/cancertopics/pdq/treatment/adultnon-hodgkins/healthprofessional/allpages. 

Accessed July 15, 2010. 

Harris NL, Jaffe ES, Diebold J, et al. 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. 

1999;17:3835–3849. 

34 Kocher DC and Apostoaei JA. Screening doses 

for induction of cancers calculated with the 

Interactive RadioEpidemiologic Program (IREP). 

Fort Belvoir, VA: U.S. Department of Defense, 

Defense Threat Reduction Agency, March 2007. 

Technical Report DTRA–TR–07–4. 

evidence of radiogenicity; the other 

2009 reviewers addressed only the 

science. One of those individuals, 

Reviewer #2 in the 2004 review, 

reversed her prior opinion that 

epidemiological evidence in support of 

CLL’s radiogenicity is lacking and stated 

that 

new evidence that came into light in the year 

since the report has been issued, provides 

evidence for the hypothesis advocated by 

[the report’s authors] that CLL may be 

radiogenic and that its risk profile may be 

similar to that previously observed for other 

types of leukemia and/or [non-Hodgkin’s 

lymphoma]. These studies are of particular 

importance because they provide evidence 

from the low-dose studies, a dose range of 

primary interest for occupationally exposed 

workers in the U.S.24

These reviews 25 have led NIOSH to 

better appreciate some of the possible 

limitations of the epidemiological 

evidence, and particularly the 

substantial reliance on mortality studies 

for a disease that may not always be 

recorded as the primary cause of death, 

being principally a slowly developing 

cancer of old age. An examination of the 

long latency period between initial 

radiation exposure and CLL diagnosis 

has led some researchers to conclude 

that many epidemiology studies fail to 

‘‘appropriately account for a protracted 

induction latency, and morbidity period 

between radiation exposure and CLL 

mortality.’’ 26 Another limitation stems 

from the low incidence of CLL, resulting 

in studies limited by low statistical 

power.27 NIOSH’s review of both 

epidemiological and biological research 

has demonstrated that evidence for the 

radiogenicity of CLL is growing, and 

that ‘‘[i]rradiation may have been given 

a clean bill of health with respect to CLL 

with less than adequate evidence.’’ 28

Under EEOICPA, NIOSH is required 

to develop guidelines using the 1985 

radioepidemiological tables (or its 

successor) in computing probability of 

causation. The Act further requires that 

the probability of causation decision be 

made at the upper 99 percent credibility 

level.29 When the original 1985 

radioepidemiological tables were 

revised in 2002, the expert working 

group (chaired by NCI) included 

additional cancers that did not have 

statistically significant excess relative 

risk coefficients. The logic for doing so 

is based on the fact that, if one accounts 

for uncertainty, it is possible for the 

upper limit for the risk coefficient to be 

greater than 1, even if the central 

estimate of risk is not statistically 

significant. The technical basis behind 

the revised radioepidemiological 

tables,30 including the provision for 

including cancers with non-statistically 

significant central estimates of risk, was 

documented in a report reviewed by the 

National Academy of Sciences (NAS). 

NAS supported the inclusion of cancers 

without demonstrated radiogenicity, but 

proposed an approach for calculating 

the Assigned Share for those cancers 

that differed from the approach used for 

cancers with demonstrated 

radiogenicity in the 1990 draft report of 

the working group to revise the 

radioepidemiological tables. NIOSH– 

IREP includes models and calculates 

probability of causation for all cancers 

except CLL. It does so by considering 

the uncertainty associated with the 

excess relative risk (ERR) values and 

using the 99th percentile of that 

probability distribution in the 

probability of causation calculation. 

Given that the law requires the use of 

the upper 99 percent credibility level in 

making compensation decisions, 31 the 

inclusion of CLL despite the limited 

evidence of radiogenicity, is considered 

appropriate by NIOSH. In short, the 

NIOSH–IREP risk models for those 

cancers lacking statistically significant 

central estimates of risk account for the 

uncertainty inherent in epidemiological 

studies of the association between 

ionizing radiation exposure and cancer. 

NIOSH also considered the 

classification of CLL in relation to other 

lymphomas (although CLL is designated 

a leukemia, clinically and etiologically 

it appears to be a lymphoma 32) of 

primary importance to this effort. CLL is 

now classified as a form of nonHodgkin’s lymphoma (NHL) by both 

NCI and the World Health 

Organization.33 Under contemporary 

classification schemes, NHL comprises 

CLL and small lymphocytic lymphoma 

(SLL); SLL and NHL are both 

compensable under EEOICPA. 

Finally, in the Agency’s judgment, 

including CLL as a potentially 

compensable cancer would be in 

keeping with already-established 

Federal policy. The U.S. Department of 

Veterans Affairs (VA) recognizes CLL as 

a form of non-Hodgkin’s lymphoma, and 

thus a radiogenic cancer, for the 

purpose of compensation under the 

Nuclear Test Personnel Review 

Program.34

With respect to the radiogenicity of 

CLL, the Agency finds the evidence of 

radiogenicity offered by epidemiology 

studies to be non-determinative, but no 

longer believes that it is possible to state 

that the probability of causation equals 

zero. NIOSH has weighed the nondeterminative epidemiology evidence, 

the mechanistic argument for CLL 

causation, similarities between CLL and 

other compensated cancers, the 

classification of CLL, and the treatment 

of CLL as a potentially-compensable 

radiogenic cancer by the VA, and finds 

sufficient evidence to include CLL as a 

compensable cancer under EEOICPA, 

and thus allow claimants with CLL to be 

eligible for dose reconstruction. The 

remaining issue NIOSH had to address 

to pursue such a policy was the 

practical matter of developing a model 

with a quantitative dose-response 

relationship for CLL. 

Risk Model 

The NIOSH efforts to develop a 

quantitative radiation risk model for 

CLL began with a review of key papers 

on the epidemiological, molecular, and 

clinical bases of CLL, including but not 

limited to those cited by Richardson et 

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15272 Federal Register / Vol. 76, No. 54 / Monday, March 21, 2011 / Proposed Rules 

35Richardson DB, Wing S, Schroeder, J, et al. 

Ionizing radiation and chronic lymphocytic 

leukemia. Environ. Health Persp. 2005;113:1–5. 

36Boice, JD. Reconsideration of chronic 

lymphocytic leukemia for purposes of 

compensation. Report submitted to NIOSH, January 

7, 2005. 

37Silver SR, Hiratzka SL, Schubauer-Berigan MK, 

Daniels RD. Chronic lymphocytic leukemia: A 

systematic review. Cancer Causes Control. 

2007;18:1077–1093. 

38CLL special issue of British Journal of 

Haematology. December 2007;135:629–848. 

39National Research Council, Board on Radiation 

Effects Research. Health risks from exposure to low 

levels of ionizing radiation: BEIR VII Phase 2. The 

National Academies Press, Washington, DC, 2006. 

40National Cancer Institute. Surveillance 

Epidemiology and End Results (SEER) Program. 

http://seer.cancer.gov. Accessed July 15, 2010. 

41Parkin DM, Whelan SL, Ferlay J, Raymond L, 

Young J (eds.). Cancer incidence in five continents, 

Volume VII. Lyon, France: World Health 

Organization, International Agency for Research on 

Cancer, 1997. IARC Scientific Publication No. 143. 

42See Appendix C, Assessment of potential 

latency for incidence of CLL, lymphomas, and 

multiple myeloma, in Development of a risk model 

for chronic lymphocytic leukemia for NIOSH–IREP. 

January 5, 2010. A copy of this report is available 

in the docket for this rulemaking. 

43Land CE, Gilbert ES, Smith JM, et al. Report of 

the NCI–CDC Working Group to revise the 1985 NIH 

radioepidemiological tables. Bethesda, MD: U.S. 

Department of Health and Human Services, 

National Institutes of Health, National Cancer 

Institute, 2003. NIH Publication No. 03–5387. 

44The names of experts whose opinions were 

solicited, the request, and the responses from these 

experts are included in the NIOSH Docket for this 

rulemaking. 

45NIOSH, Office of Compensation Analysis and 

Support (OCAS). Response to review comments on 

draft report: Development of a CLL risk model for 

NIOSH–IREP. December 1, 2009. 46 42 U.S.C. 7384n(c). 

al.35 and by Boice; 36 the NIOSH 

Annotated Bibliography for CLL; 37 the 

CLL special issue of the British Journal 

of Haematology; 38 and the Biological 

Effects of Ionizing Radiation (BEIR) VII 

committee.39 NIOSH also compiled 

information pertinent to developing the 

new model: Sex and age-specific 

background incidence rates for CLL 

from the NCI’s Surveillance, 

Epidemiology, and End Results (SEER) 

registry for the U.S. population 40 and 

from the International Agency for 

Research on Cancer (IARC) databases for 

the Japanese population.41

NIOSH also evaluated epidemiology 

study data potentially bearing on the 

issue of latency of CLL,42 and created a 

risk model for CLL by modifying the 

existing NIOSH–IREP risk model for 

lymphoma and multiple myeloma 43 to 

include an extended latency period. Use 

of the lymphoma and multiple myeloma 

risk models as a starting point was 

considered appropriate, given the 

classification of CLL as a form of nonHodgkin’s lymphoma. 

The extended latency period for CLL 

was examined in some detail. After 

reviewing a number of studies, the 

midpoint of the latency period for CLL 

within the draft risk model was set at 15 

years, with an uncertainty band of ±5 

years. As with other cancers in the 

NIOSH–IREP model, the risk of 

developing CLL is considered to be very 

low for short times after exposure with 

the magnitude of the risk increasing by 

an adjustment factor that confers the 

maximum risk value at 20 years postexposure. 

A draft report entitled ‘‘Development 

of a Risk Model for Chronic 

Lymphocytic Leukemia,’’ which 

includes NIOSH’s analysis of the 

literature along with the justification for 

the proposed model, was provided to 

four subject matter experts for review in 

2009.44 Two of the four individuals 

previously were asked to provide their 

judgment regarding the evidence of 

radiogenicity of CLL in 2004. NIOSH 

received comments on many substantive 

issues with regard to CLL, including the 

potential radiogenicity of CLL; 

implications of reclassification as an 

NHL; the appropriateness of using the 

NIOSH–IREP lymphoma and multiple 

myeloma model for CLL; the 

appropriateness of extended latency for 

CLL; and a number of additional issues 

pertinent to this rulemaking. NIOSH 

addressed these comments in a report 

available in the regulatory docket for 

this rulemaking. The comments resulted 

in one major modification to the 

proposed risk model: The shortening of 

the midpoint of the latency period for 

CLL from 15 to 10 years, while 

maintaining the uncertainty in the 

midpoint at ±5 years.45

The CLL risk model was 

quantitatively tested by calculating 

probability of causation results for 

males between 20 and 40 years of age 

hypothetically exposed to 1 Sievert (Sv) 

of high-energy gamma radiation. 

Although the evaluations were 

restricted to exposures to males, the 

results for women are very similar, 

because the same risk coefficient is used 

and the age-specific incidence patterns 

in Japanese women and U.S. women are 

similar. The results of these evaluations 

indicate that the probability of causation 

exceeds 50 percent only at the 99th 

percentile, and then only for times since 

exposure greater than 15 years for men 

initially exposed at age 20. Doses higher 

than 1 Sv will be required to produce 

99th percentile values of probability of 

causation that equal or exceed a value 

of 50 percent for older ages at time of 

exposure or at time of diagnosis. 

CLL is considered a disease that 

originates from a population of antigenselected, mature B lymphocytes. As 

such, these cells could potentially 

undergo transformation to CLL clones 

anywhere within the hematopoietic or 

lymphatic system, thus complicating the 

reconstruction of the radiation dose to 

the target organ. This is particularly 

problematic for reconstructing doses 

due to internally deposited 

radionuclides, because the radiation 

dose in this case is most often not 

homogeneously distributed within the 

body. To resolve this issue, NIOSH 

proposes to use a probabilistic approach 

to dose reconstruction where the 

radiation dose to the B lymphocytes is 

a weighted average, based on the dose 

to a given site and the probability that 

a B cell precursor for CLL will occupy 

that site. A document that provides the 

scientific basis for this approach to 

reconstruction of dose has been 

prepared by NIOSH and is included in 

the NIOSH Docket for this rulemaking. 

C. Purpose of the Rule 

The purpose of this rule is to provide 

for coverage of CLL under part B of 

EEOICPA. Presently, the probability of 

causation guidelines at 42 CFR part 81 

designate CLL as non-radiogenic and 

require DOL to assign a probability of 

causation to CLL of zero, when 

presented in a claim for compensation 

under part B of EEOICPA. This 

proposed revision would remove the 

designation of CLL under § 81.30 of the 

guidelines. In concert with this change, 

NIOSH would add a CLL risk model to 

NIOSH–IREP and DOL would refer CLL 

claims under part B of EEOICPA to 

NIOSH for dose reconstructions, to be 

followed by determinations of 

probability of causation by DOL under 

these revised guidelines. 

D. Technical Review by the Advisory 

Board on Radiation and Worker Health 

EEOICPA required that HHS obtain a 

technical review by the Advisory Board 

on Radiation and Worker Health (the 

Board) prior to establishing the 

probability of causation guidelines to be 

amended through this rulemaking.46

HHS interprets this requirement also to 

apply to any revisions HHS would make 

to these guidelines. Hence, HHS will 

obtain a technical review by the Board 

and consider the findings of this review 

in promulgating the final regulation. 

III. Summary of Proposed Rule 

The proposed rule would remove 

§ 81.30 of 42 CFR part 81 thus rescind 

the designation of CLL as a nonradiogenic cancer under this part. The 

effect of this rescission would be that a 

qualified claim for CLL under part B of 

EEOICPA would be referred by DOL to 

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Federal Register / Vol. 76, No. 54 / Monday, March 21, 2011 / Proposed Rules 15273 

47National Cancer Institute. SEER Cancer 

Statistics Review 1975–2007; Table 1.14. Lifetime 

risk (percent) of being diagnosed with cancer by site 

and race/ethnicity: both sexes, 17 SEER areas, 

2005–2007. 48This figure represents the number of individual 

cases requiring dose reconstruction that have been 

forwarded to NIOSH by DOL. 

49NIOSH further estimates the upper bounds of 

potential costs associated with CLL compensation. 

To address any potential uncertainty in the 

incidence estimate, multiplying by a factor of 2 will 

increase the CLL incidence rate from 1.1 percent to 

2.2 percent. Doing so will result in a total of 990 

cases, or 198 CLL cases per year for the first 5 years. 

Reconstructing 198 cases per year will likely cost 

NIOSH $2,376,000 per year, DOL $1,584,000 per 

year, and DOE $112,860 per year for an estimated 

total cost to the 3 Federal agencies of $4,072,860. 

With an incidence rate of 2.2 percent, NIOSH 

predicts that 30 percent, or 60 cases, will be 

compensated. Given an award of $150,000 per case 

plus medical expenses, NIOSH estimates that the 

rule will result in compensation of $10,200,000. In 

total, NIOSH estimates that this rulemaking will 

cost the Federal government no more than 

$14,272,860 annually. 

NIOSH for radiation dose reconstruction 

and, upon completion of the dose 

reconstruction, DOL would determine 

the probability of causation and 

complete the adjudication of the claim 

on that basis. Presently, such claims are 

not referred to NIOSH for dose 

reconstruction, since under the current 

language of § 81.30(a), DOL is required 

to assign a probability of zero to CLL. 

Upon promulgation of the final 

regulation, DOL would identify open 

and closed cases (NIOSH estimates the 

number of closed cases to be about 363) 

under part B of EEOICPA involving CLL 

claims and attempt to notify the 

claimants of the new provision. In 

addition, NIOSH would assist DOL in 

identifying active and closed cases 

involving multiple primary cancers 

including CLL, to identify those whose 

outcome might be affected by the new 

provision. For all cases involving CLL, 

NIOSH would revise the dose 

reconstruction to take into account 

radiation doses relevant to CLL, and 

DOL would recalculate the probability 

of causation accordingly. 

IV. Regulatory Assessment 

Requirements 

A. Executive Order 12866 and Executive 

Order 13563 

Executive Orders 13563 and 12866 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order 13563 

emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. This rule 

has been designated a ‘‘significant 

regulatory action’’ although not 

economically significant, under section 

3(f) of Executive Order 12866. 

Accordingly, the rule has been reviewed 

by the Office of Management and 

Budget. 

The rule is consistent with the 

requirements of 42 U.S.C. 7384n(c). The 

rule does not interfere with State, local, 

or Tribal governments in the exercise of 

their governmental functions. 

The rule is not considered 

economically significant, as defined in 

§ 3(f)(1) of E.O. 12866. CLL is a rare 

cancer, with a lifetime risk of 0.48 

percent; according to data provided by 

NCI, an estimated 1.1 percent of all 

cancers will be CLL.47 This low risk 

among the U.S. population, coupled 

with the weak evidence for CLL’s 

radiogenicity, indicates DOL is unlikely 

to receive a substantial volume of claims 

for CLL, thus limiting the administrative 

expenses associated with such claims 

and the potential compensation costs. 

Since 2001, NIOSH has received 

approximately 33,000 cases 48 that 

included all cancers currently covered 

under EEOICPA; given that an estimated 

1.1 percent of all cancers occurring 

among adults are CLL, NIOSH estimates 

that approximately 363 of those cases 

would have sought compensation for 

CLL. NIOSH also receives an average of 

200 new cases per month from DOL, 

and therefore estimates an expected 

total of 12,000 cases over the next 5 

years; based on the 1.1 percent 

incidence rate, NIOSH estimates that 

approximately 132 of those cases will 

seek compensation for CLL. The Agency 

expects to review the 363 reopened 

cases plus 132 new CLL cases in the 

first 5 years after promulgation of this 

rule—a total of approximately 99 CLL 

cases per year for the first 5 years. The 

estimated cost to NIOSH of conducting 

dose reconstructions is $12,000 per 

reconstructed case ($1,188,000 per 

year); DOL estimates its direct cost per 

adjudicated case to be about $8,000 

($792,000 per year); and DOE estimates 

its cost per case to be $198 per each 

DOL request for employment 

verification, and $372 for responding to 

each NIOSH request for exposure data 

($56,430 per year). In sum, NIOSH 

estimates the administrative costs to the 

three Federal agencies associated with 

CLL cases to be $2,036,430 per year. 

Based on our knowledge of the 

exposure potential for the claimant 

population and the probability of 

causation guidelines discussed above, 

NIOSH expects that approximately 30 

percent of CLL cases—30 cases per 

year—will result in compensation. 

Compensated claimants receive 

$150,000 plus medical expenses, which 

are estimated to cost about $20,000 per 

year (costs tend to be higher in the first 

year of treatment, but benefits are 

payable only from the date of filing a 

claim, and most claimants have already 

begun treatment by that time). The 

financial award granted to successful 

claimants comes directly from the U.S. 

Treasury’s Energy Employees 

Occupational Illness Compensation 

Fund (42 U.S.C. 7384f); NIOSH 

estimates that annual compensation will 

amount to $5,100,000. In total, this rule 

is estimated to cost the Federal 

government (the three Federal agencies 

plus the U.S. Treasury) $7,136,430 per 

year, or just over 7 percent of the 

established $100 million annual 

threshold for economic significance.49

There are no feasible alternatives to 

this regulatory action. OMB has 

reviewed this probability of causation 

rule for consistency with the President’s 

priorities and the principles set forth in 

E.O. 12866 and E.O. 13563. 

B. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA), 

5 U.S.C. 601 et seq., requires each 

agency to consider the potential impact 

of its regulations on small entities 

including small businesses, small 

governmental units, and small not-forprofit organizations. We certify that this 

rule will not have a significant 

economic impact on a substantial 

number of small entities within the 

meaning of the RFA. The rule affects 

only DOL, DOE, HHS, and certain 

individuals covered by EEOICPA. 

Therefore, a regulatory flexibility 

analysis as provided for under RFA is 

not required. 

C. Paperwork Reduction Act 

The Paperwork Reduction Act (PRA), 

44 U.S.C. 3501 et seq., requires an 

agency to invite public comment on and 

to obtain OMB approval of any 

regulation that requires 10 or more 

people to report information to the 

agency or to keep certain records. This 

rule does not contain any information 

collection requirements. It provides 

guidelines only to DOL for adjudicating 

compensation claims and thus requires 

no reporting or record keeping. 

Information required by DOL to apply 

these guidelines is being provided by 

HHS and by individual claimants to 

DOL under DOL regulations at 20 CFR 

part 30. Thus, HHS has determined that 

the PRA does not apply to this rule. 

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15274 Federal Register / Vol. 76, No. 54 / Monday, March 21, 2011 / Proposed Rules 

D. Small Business Regulatory 

Enforcement Fairness Act 

As required by Congress under the 

Small Business Regulatory Enforcement 

Fairness Act of 1996 (5 U.S.C. 801 et 

seq.), the Department will report the 

promulgation of this rule to Congress 

prior to its effective date. The report 

will state that the Department has 

concluded that this rule is not a ‘‘major 

rule’’ because it is not likely to result in 

an annual effect on the economy of $100 

million or more. 

E. Unfunded Mandates Reform Act of 

1995 

Title II of the Unfunded Mandates 

Reform Act of 1995 (2 U.S.C. 1531 et 

seq.) directs agencies to assess the 

effects of Federal regulatory actions on 

State, local, and Tribal governments, 

and the private sector ‘‘other than to the 

extent that such regulations incorporate 

requirements specifically set forth in 

law.’’ For purposes of the Unfunded 

Mandates Reform Act, this rule does not 

include any Federal mandate that may 

result in increased annual expenditures 

in excess of $100 million by State, local 

or Tribal governments in the aggregate, 

or by the private sector, adjusted 

annually for inflation. For 2010, the 

inflation adjusted threshold is $135 

million. 

F. Executive Order 12988 (Civil Justice) 

This rule has been drafted and 

reviewed in accordance with Executive 

Order 12988, ‘‘Civil Justice Reform,’’ and 

will not unduly burden the Federal 

court system. Probability of causation 

may be an element in reviews of DOL 

adverse decisions in the United States 

District Courts pursuant to the 

Administrative Procedure Act. 

However, DOL has attempted to 

minimize that burden by providing 

claimants an opportunity to seek 

administrative review of adverse 

decisions, including those involving 

probability of causation. HHS has 

provided a clear legal standard for DOL 

to apply regarding probability of 

causation. This rule has been reviewed 

carefully to eliminate drafting errors and 

ambiguities. 

G. Executive Order 13132 (Federalism) 

The Department has reviewed this 

rule in accordance with Executive Order 

13132 regarding federalism, and has 

determined that it does not have 

‘‘federalism implications.’’ The rule does 

not ‘‘have substantial direct effects on 

the States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government.’’ 

H. Executive Order 13045 (Protection of 

Children From Environmental, Health 

Risks and Safety Risks) 

In accordance with Executive Order 

13045, HHS has evaluated the 

environmental health and safety effects 

of this rule on children. HHS has 

determined that the rule would have no 

effect on children. 

I. Executive Order 13211 (Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

In accordance with Executive Order 

13211, HHS has evaluated the effects of 

this rule on energy supply, distribution 

or use, and has determined that the rule 

will not have a significant adverse 

effect. 

J. Plain Writing Act of 2010 

Under Public Law 111–274 (October 

13, 2010), executive Departments and 

Agencies are required to use plain 

language in documents that explain to 

the public how to comply with a 

requirement the Federal Government 

administers or enforces. HHS has 

attempted to use plain language in 

promulgating the proposed rule 

consistent with the Federal Plain 

Writing Act guidelines. 

List of Subjects in 42 CFR Part 81 

Cancer, Government employees, 

Occupational safety and health, Nuclear 

materials, Radiation protection, 

Radioactive materials, Workers’ 

compensation. 

For the reasons discussed in the 

preamble, the Department of Health and 

Human Services proposes to amend 42 

CFR part 81 as follows: 

PART 81—GUIDELINES FOR 

DETERMINING THE PROBABILITY OF 

CAUSATION UNDER THE ENERGY 

EMPLOYEES OCCUPATIONAL 

ILLNESS COMPENSATION PROGRAM 

ACT OF 2000 

Subpart E—Guidelines To Estimate 

Probability of Causation 

1. The authority citation for part 81 

continues to read as follows: 

Authority: 42 U.S.C. 7384n; E.O. 13179, 65 

FR 77487, 3 CFR, 2000 Comp., p. 321. 

§ 81.30 [Removed] 

2. Remove § 81.30. 

Dated: December 9, 2010. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

Note: The following appendix will not 

appear in the Code of Federal Regulations. 

Appendix A 

CHRONOLOGY OF CLL-RELATED ACTIVITIES INITIATED BY NIOSH 

Date Description 

May 2002 ............................................................ NIOSH publishes Probability of Causation Rule (42 CFR part 81), excluding CLL for eligibility 

under EEOICPA. CLL is the only type of cancer granted an a priori probability of causation 

of 0%. 

July 2004 ............................................................ Based on direction from the U.S. Congress, the NIOSH Occupational Energy Research Program convenes a public meeting in Washington, DC to: (1) discuss available research strategies for investigating the potential relationship between the incidence of CLL and worker 

exposures to ionizing radiation and (2) identify gaps in the current research. 

September–October 2004 .................................. The NIOSH Office of Compensation Analysis and Support (now the Division of Compensation 

Analysis and Support (DCAS)) recruits five outside experts, not affiliated with NIOSH, to 

evaluate if: 

the evidence of an association, or lack thereof, between radiation exposure and the risk of 

developing CLL [is] sufficient to continue to regard CLL as a non-radiogenic cancer and 

to continue to exclude it, a priori, from eligibility for compensation under EEOICPA. 

November 2004–January 2005 .......................... NIOSH receives opinions on the radiogenicity of CLL from outside experts regarding and prepares summaries. 

July 2005 ............................................................ Because the opinion of a majority of subject experts is that CLL should not continue to be excluded from eligibility of compensation under EEOICPA, NIOSH begins the development of 

a model capable of quantifying the risk of developing CLL as a consequence of exposure to 

ionizing radiation. 

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Federal Register / Vol. 76, No. 54 / Monday, March 21, 2011 / Proposed Rules 15275 

CHRONOLOGY OF CLL-RELATED ACTIVITIES INITIATED BY NIOSH—Continued 

Date Description 

August 2005–June 2009 ..................................... NIOSH conducts research into an appropriate risk model for CLL, including selection of the 

appropriate target organ and methodology for reconstructing dose. 

July 2009 ............................................................ NIOSH completes draft report that describes the CLL risk model (and the scientific rationale 

behind it) and recruits four subject matter experts to review the draft model. 

September–August 2009 .................................... NIOSH receives subject matter expert comments on the draft CLL risk model. 

January 2010 ...................................................... NIOSH addresses subject matter expert comments on the CLL risk model and finalizes the 

risk model. 

[FR Doc. 2011–6329 Filed 3–18–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 622 

[Docket No. 110218148–1169–01] 

RIN 0648–BA83 

Fisheries of the Caribbean, Gulf of 

Mexico, and South Atlantic; Golden 

Crab Fishery Off the Southern Atlantic 

States; Control Date 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Advanced notice of proposed 

rulemaking; consideration of a control 

date. 

SUMMARY: NMFS announces that it is 

establishing a control date of December 

7, 2010, to control future access to the 

golden crab fishery operating in the 

exclusive economic zone (EEZ) of the 

South Atlantic. If changes to the 

management regime are developed and 

implemented under the MagnusonStevens Fishery Conservation and 

Management Act (Magnuson-Stevens 

Act), a control date could be used to 

limit the number of participants in the 

fishery. This announcement is intended, 

in part, to promote awareness of the 

potential eligibility criteria for future 

access so as to discourage speculative 

entry into the fishery while the South 

Atlantic Fishery Management Council 

(Council) and NMFS consider whether 

and how access to the golden crab 

fishery should be controlled. 

DATES: Written comments must be 

received on or before 5 p.m., local time, 

April 20, 2011. 

ADDRESSES: You may submit comments, 

identified by 0648–BA83, by any one of 

the following methods: 

• Electronic Submissions: Submit all 

electronic public comments via the 

Federal eRulemaking Portal http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: Attn: Karla Gore 727–824– 

5305. 

• Mail: Karla Gore, NMFS Southeast 

Regional Office, Sustainable Fisheries 

Division, 263 13th Avenue South, St. 

Petersburg, FL 33701. 

Instructions: All comments received 

are a part of the public record and will 

generally be posted to http:// 

www.regulations.gov without change. 

All Personal Identifying Information (for 

example, name, address, etc.) 

voluntarily submitted by the commenter 

may be publicly accessible. Do not 

submit Confidential Business 

Information or otherwise sensitive or 

protected information. 

To submit comments through the 

Federal e-rulemaking portal http:// 

www.regulations.gov, enter ‘‘NOAA– 

NMFS–2011–0044’’ in the keyword 

search, then check the box labeled 

‘‘Select to find documents accepting 

comments or submissions’’, then select 

‘‘Send a comment or submission’’. 

NMFS will accept anonymous 

comments (enter N/A in the required 

fields if you wish to remain 

anonymous). You may submit 

attachments to electronic comments in 

Microsoft Word, Excel, WordPerfect, or 

Adobe PDF file formats only. 

FOR FURTHER INFORMATION CONTACT: Kim 

Iverson, Public Information Officer, 

South Atlantic Fishery Management 

Council; toll free 1–866–SAFMC–10 or 

843–571–4366; kim.iverson@safmc.net. 

SUPPLEMENTARY INFORMATION: At their 

December 2010 meeting, the Council 

recommended a control date of 

December 7, 2010, for the golden crab 

fishery. The Council manages golden 

crab under the Fishery Management 

Plan for the Golden Crab Fishery of the 

South Atlantic Region. The control date 

would apply to persons who are 

contemplating entering the golden crab 

fishery in the EEZ of the South Atlantic 

region. If adopted, a control date would 

be established for the golden crab 

fishery. The Council requested that this 

control date be published in the Federal 

Register to notify fishermen that if they 

enter such a fishery after December 7, 

2010, they may not be assured of future 

access if the Council and/or NMFS 

decide to limit entry or impose other 

measures to manage these fisheries. 

Establishment of the control date 

would allow the Council to evaluate the 

level of participation in the subject 

fishery and address any level of 

overcapacity. Control dates are intended 

to discourage speculative entry into a 

fishery, as new entrants entering the 

fishery after the control date are 

forewarned that they are not guaranteed 

future participation in the fishery. 

Establishment of this control date 

does not commit the Council or NMFS 

to any particular management regime or 

criteria for entry into the golden crab 

fishery. Fishermen are not guaranteed 

future participation in the fishery 

regardless of their level of participation 

before or after the control date. The 

Council may recommend a different 

control date or it may recommend a 

management regime that does not 

involve a control date. Other criteria, 

such as documentation of landings or 

fishing effort, may be used to determine 

eligibility for participation in a limited 

access fishery. The Council and/or 

NMFS also may choose to take no 

further action to control entry or access 

to the fisheries, in which case the 

control date may be rescinded. Any 

action by the Council will be taken 

pursuant to the requirements for fishery 

management plan and amendment 

development established under the 

Magnuson-Stevens Act. 

This notification also gives the public 

notice that interested participants 

should locate and preserve records that 

substantiate and verify their 

participation in the golden crab fishery 

in the South Atlantic EEZ. 

Authority: 16 U.S.C. 1801 et seq. 

Dated: March 16, 2011. 

John Oliver, 

Deputy Assistant Administrator for 

Operations, National Marine Fisheries 

Service. 

[FR Doc. 2011–6583 Filed 3–18–11; 8:45 am] 

BILLING CODE 3510–22–P 

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