[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codes from ICD-9-CM to ICD-10-CM, and remove outdated references to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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