[Federal Register Volume 85, Number 20 (Thursday, January 30, 2020)]
[Rules and Regulations]
[Pages 5330-5332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00636]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 81

[Docket Number CDC-2019-0050; NIOSH-329]
RIN 0920-AA74


Guidelines for Determining the Probability of Causation Under the 
Energy Employees Occupational Illness Compensation Program Act of 2000; 
Technical Amendments

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Final rule.

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SUMMARY: In August 2019, the Department of Health and Human Services 
(HHS) published an interim final rule to revise its regulations to 
update references to the International Classification of Disease (ICD) 
codes from ICD-9-CM to ICD-10-CM, and remove outdated references to 
chronic lymphocytic leukemia from Energy Employees Occupational Illness 
Compensation Program regulations. These technical amendments have no 
effect on the cancer eligibility requirement under the Program because 
all cancer types are eligible to receive a dose reconstruction from 
NIOSH. Thus, no eligible claimant will be adversely impacted by the 
rulemaking finalized in this document.

DATES: This rule is effective on January 30, 2020.

FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst; 1090 
Tusculum Ave., MS: C-48, Cincinnati, OH 45226; telephone (855) 818-1629 
(this is a toll-free number); email [email protected].

SUPPLEMENTARY INFORMATION:

I. Public Participation

    Interested persons or organizations were invited to participate in 
this rulemaking by submitting written views, arguments, 
recommendations, and data. Comments were invited on any topic related 
to this rulemaking.
    HHS received one public comment for this rulemaking from a 
professional organization of health physicists.

II. Review by the Advisory Board on Radiation and Worker Health

    As discussed in the August 2019 interim final rule (84 FR 37587), 
the Energy Employees Occupational Illness Compensation Program Act of 
2000 (EEOICPA) \1\ requires that HHS obtain a review by of that 
rulemaking the Advisory Board on Radiation and Worker Health. The Board 
conducted its review and submitted a letter to the docket stating its 
concurrence with the interim final rule as published.
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    \1\ 42 U.S.C. 7384n(c).
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III. Background

    As described in the August 2019 interim final rule, EEOICPA was 
established to provide financial compensation and prospective medical 
benefits to employees for illness caused by exposure to radiation, 
beryllium, silica, and toxic substances during their employment at 
facilities of the Department of Energy, its predecessor agencies, and 
certain of its contractors and vendors. It is administered by the 
Department of Labor's Office of Workers' Compensation Programs (OWCP) 
with radiation dose reconstructions for claims involving radiogenic 
cancers provided by CDC's National Institute for Occupational Safety 
and Health (NIOSH). HHS regulations in 42 CFR part 81 govern the NIOSH 
dose reconstructions.

IV. Summary of Final Rule

    In the August 2019 interim final rule, HHS updated the 
International Classification of Disease (ICD) codes required to 
identify specific cancer types used in determining the likelihood that 
an individual's cancer is associated with workplace radiation exposures 
using a number of factors, including the radiation doses estimated by 
NIOSH. Both the public commenter and the Board concurred with updating

[[Page 5331]]

references from ICD-9-CM to ICD-10-CM.
    Although supportive of the rulemaking, the public commenter 
objected to HHS's explanation in the interim final rule preamble that 
``the definition of the term `non-radiogenic cancer' is removed because 
all cancers are considered radiogenic.'' According to the commenter,

[t]his is a very claimant-favorable policy decision which is not 
supported by scientific evidence. According to UNSCEAR [citation 
omitted], `. . . for about 30% of tumour types . . . there is only a 
weak or no relationship between radiation exposure and risk at any 
age of exposure.' To be consistent with scientific evidence we 
recommend a revision to remove the assertion that there are no non-
radiogenic [cancers].

    HHS agrees that the explanation should properly have stated that 
the definition is being removed because there are no types of cancer 
ineligible for NIOSH dose reconstruction; accordingly, the revision is 
accepted and the explanation for the removal of the definition is 
revised below. No other changes are made to the rulemaking preamble or 
regulatory text.
    With this final rule, and for the reasons discussed in the August 
2019 interim final rule, HHS adopts as final amendments to the 
regulations in 42 CFR part 81 allowing NIOSH to update references and 
ICD codes. No substantive changes are made to part 81.
    In the existing definitions section, Sec.  81.4, the term 
``specified cancer'' includes a reference to a corresponding DOL 
regulation (i.e., 20 CFR 30.5(dd)). DOL has recently conducted a 
rulemaking to revise 20 CFR part 30 that resulted in the reordering of 
this reference from 20 CFR 30.5(dd) to 20 CFR 30.5(gg).\2\ Therefore, 
in Sec.  81.4, HHS has revised the reference to read ``20 CFR 
30.5(gg).'' In addition, the definition of the term ``non-radiogenic 
cancer'' is removed because there are no longer any types of cancer 
ineligible for receiving a dose reconstruction from NIOSH. Finally, 
Sec.  81.4 is revised by adding a new definition of ``ICD-10-CM,'' to 
include a reference and web link.
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    \2\ 84 FR 3026 (February 8, 2019).
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    In existing Sec.  81.5(b), the term ``ICD-9'' is replaced with 
``ICD-10-CM.'' In Sec. Sec.  81.21, 81.23, and 81.24, all references to 
ICD-9 codes are changed to ICD-10-CM codes. In Sec. Sec.  81.21(a) and 
81.24(a), outdated references to chronic lymphocytic leukemia are also 
removed.
    Finally, Appendix A is removed in its entirety because it is a 
glossary of ICD-9 codes and their cancer descriptions, and such 
reference tables, including tables of ICD-10 codes and their cancer 
descriptions, are readily available online.

V. Regulatory Assessment Requirements

A. Executive Orders 12866 (Regulatory Planning and Review) and 13563 
(Improving Regulation and Regulatory Review)

    Executive Orders 12866 and 13563 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). E.O. 
13563 emphasizes the importance of quantifying both costs and benefits, 
of reducing costs, of harmonizing rules, and of promoting flexibility.
    This final rule is not being treated as a ``significant'' action 
under E.O. 12866. It updates references and ICD codes in existing 42 
CFR part 81 to allow better administrative efficiency in the processing 
of dose reconstruction claims. The rule does not result in costs to the 
Program, claimants, or any other interested parties. Accordingly, HHS 
has not prepared an economic analysis and the Office of Management and 
Budget (OMB) has not reviewed this rulemaking.
    The rule does not interfere with State, local, or tribal 
governments in the exercise of their governmental functions.

B. Executive Order 13771 (Reducing Regulation and Controlling 
Regulatory Costs)

    Executive Order 13771 requires executive departments and agencies 
to eliminate at least two existing regulations for every new 
significant regulation that imposes costs. HHS has determined that this 
rulemaking is cost-neutral because it does not require any new action 
by stakeholders. The rulemaking ensures that the dose reconstructions 
developed by the Program can be conducted efficiently.
    Because OMB has determined that this rulemaking is not significant, 
pursuant to E.O. 12866, and because it does not impose costs, OMB has 
determined that this rulemaking is exempt from the requirements of E.O. 
13771. Thus it has not been reviewed by OMB.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act, 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. The rule affects only Federal 
agencies and certain individuals covered by EEOICPA. Therefore, HHS 
certifies that this final rule will not have a significant economic 
impact on a substantial number of small entities.

D. Paperwork Reduction Act

    The Paperwork Reduction Act, 44 U.S.C. 3501 et seq., requires an 
agency to invite public comment on and to obtain OMB approval of any 
rule of general applicability that requires recordkeeping, reporting, 
or disclosure requirements.
    NIOSH has obtained approval from OMB to collect information from 
claimants under ``Energy Employees Occupational Illness Compensation 
Program Act Dose Reconstruction Interviews and Forms (EEOICPA)'' (OMB 
Control No. 0920-0530, exp. January 31, 2022), which covers information 
collected under 42 CFR part 81. This rulemaking does not change the 
reporting burden on any respondents.

E. 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.

F. 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.

G. 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. This rule has been

[[Page 5332]]

reviewed carefully to eliminate drafting errors and ambiguities.

H. 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.''

I. 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.

J. 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.

K. 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, Nuclear materials, Occupational 
safety and health, Radiation protection, Radioactive materials, 
Workers' compensation.

Final Rule

    For the reasons discussed in the preamble, the Department of Health 
and Human Services adopts as final the interim final rule published on 
August 1, 2019, at 84 FR 37587 and further amends 42 CFR part 81 as 
follows:

PART 81--GUIDELINES FOR DETERMINING PROBABILITY OF CAUSATION UNDER 
THE ENERGY EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT 
OF 2000

0
1. The authority citation for part 81 continues to read as follows:

    Authority: 42 U.S.C. 7384n(c); E.O. 13179, 65 FR 77487, 3 CFR, 
2000 Comp., p. 321.

Appendix A to Part 81--[Removed]

0
2. Amend part 81 by removing Appendix A.

    Dated: January 10, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-00636 Filed 1-29-20; 8:45 am]
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