[Federal Register Volume 77, Number 24 (Monday, February 6, 2012)]
[Rules and Regulations]
[Pages 5711-5714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-2527]


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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 Non-Radiogenic Cancers

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Final rule.

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SUMMARY: In a notice of proposed rulemaking published in the Federal 
Register on March 21, 2011, the Department of Health and Human Services 
(HHS) proposed to treat chronic lymphocytic leukemia (CLL) as a 
radiogenic cancer under the Energy Employees Occupational Illness 
Compensation Program Act of 2000 (EEOICPA) (76 FR 15268). Under this 
final rule, CLL will be treated as being potentially caused by 
radiation and hence as potentially compensable under EEOICPA. HHS 
reverses its decision to exclude CLL from such treatment.

DATES: This final rule is effective March 7, 2012.

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 email to 
[email protected].
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    \1\ The 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.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Public Participation and Technical Review by the Advisory Board 
on Radiation and Worker Health
II. Background
    A. Introduction
    B. NIOSH Reconsideration of CLL
    C. Purpose of the Rule
III. Summary of Final Rule
IV. Regulatory Assessment Requirements
    A. Executive Order 12866 and 13563
    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 and Technical Review by the Advisory Board on 
Radiation and Worker Health

    On March 21, 2011, HHS published a notice of proposed rulemaking 
(76 FR 15268), proposing to treat CLL as a radiogenic cancer. HHS 
initially solicited public comments from March 21, 2011, to June 20, 
2011. Upon request, HHS extended the comment period to July 20, 2011 
(76 FR 36891, June 23, 2011).
    HHS received comments from seven stakeholders, including the 
Advisory Board on Radiation and Worker Health, which was required by 
EEOICPA to provide a technical review of a proposed amendment to the 
probability of causation guidelines.\2\ All of the comments offered 
support for the inclusion of CLL under the coverage provided by 
EEOICPA. Specifically, the Advisory Board concurred with the NIOSH 
position that ``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.'' Furthermore, the Advisory Board 
agreed that the risk model proposed by NIOSH is based on the best 
available science and methodological approaches to express the dose-
response relationship between radiation exposure and CLL. In addition 
to the technical review submitted by the Advisory Board, three of the 
seven comments were personal stories submitted by family members of 
deceased energy employees who developed CLL, and the remaining three 
comments argued that to be fair to claimants, CLL should be included as 
a radiogenic cancer under Part B of EEOIPCA. There were no comments 
opposing this change.
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    \2\ 42 U.S.C. 7384n(c)(2), 7384o(b)(1).
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II. Background

A. Introduction

    The Energy Employees Occupational Illness Compensation Program Act 
of

[[Page 5712]]

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.
    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. The guidelines are 
published in 42 CFR part 81, and 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. The guidelines being amended by this final rule designate CLL 
as non-radiogenic, and hence had required DOL to assign a probability 
of causation value of ``zero.''
    There were two related scientific reasons for designating CLL as 
non-radiogenic 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.
    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

    In the March 21, 2011, notice of proposed rulemaking, NIOSH 
discussed the results of a panel convened in 2005 to provide judgment 
on evidence of an association between exposure to ionizing radiation 
and the risk of developing CLL, and whether CLL should continue to be 
excluded from eligibility for compensation under EEOICPA (76 FR 15268, 
15269-70). NIOSH also discussed four subject matter expert reviews, 
conducted in 2009, of a draft report of the CLL risk model (76 FR 
15268, 15270-71).
    NIOSH's recent review found the evidence of radiogenicity offered 
by epidemiology studies to be non-determinative. NIOSH weighed the non-
determinative epidemiologic evidence, along with other factors that 
included: (1) The mechanistic argument for CLL causation; (2) the 
similarities between CLL and other compensated cancers; (3) the 
classification of CLL by the World Health Organization and the National 
Cancer Institute as a form of non-Hodgkin's lymphoma; and (4) the 
treatment of CLL as a potentially-compensable radiogenic cancer by the 
U.S. Department of Veterans Affairs. Upon review of these facts, the 
Agency no longer believes that it is possible to state that the 
probability of causation for CLL equals zero. Because NIOSH finds 
sufficient evidence to include CLL as a compensable cancer under 
EEOICPA, claimants with CLL will be eligible for dose reconstruction 
under EEOICPA.
    The notice of proposed rulemaking also discussed NIOSH's efforts to 
develop a quantitative radiation risk model for CLL.

C. Purpose of the Rule

    The purpose of this rule is to provide for coverage of CLL under 
part B of EEOICPA. This revision removes sec. 81.30 from the 
probability of causation guidelines. CLL is considered radiogenic for 
the purposes of this compensation program; DOL will no longer be 
required to assign a probability of causation for CLL of zero, when 
presented with a claim for dose reconstruction under part B of EEOICPA. 
In concert with this change, NIOSH adds a CLL risk model to NIOSH-IREP 
and DOL will 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.

III. Summary of Final Rule

    This final rule removes 42 CFR 81.30 from part 81, thus rescinding 
the designation of CLL as a non-radiogenic cancer under this part. The 
effect of this rescission will be that a qualified claim for CLL under 
part B of EEOICPA will be referred by DOL to NIOSH for radiation dose 
reconstruction and, upon completion of the dose reconstruction, DOL 
will 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 language of 
sec. 81.30, DOL was required to assign a probability of zero to CLL.
    Upon promulgation of this final regulation, DOL will 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 will 
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 will 
revise the dose reconstruction to take into account radiation doses 
relevant to CLL, and DOL will 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 sec. 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 
sec. 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.\3\ This low risk

[[Page 5713]]

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 \4\ 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.
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    \3\ National 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.
    \4\ This figure represents the number of individual cases 
requiring dose reconstruction that have been forwarded to NIOSH by 
DOL.
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    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.\5\
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    \5\ NIOSH 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 98 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.
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    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-for-profit 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.

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.''

[[Page 5714]]

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 final 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 amends 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

0
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.


Sec.  81.30  [Removed]

0
2. Remove Sec.  81.30.

    Dated: October 21, 2011.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2012-2527 Filed 2-3-12; 8:45 am]
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