[Federal Register Volume 66, Number 194 (Friday, October 5, 2001)]
[Proposed Rules]
[Pages 50978-50991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-24879]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 82
RIN 0920-ZA00
Methods for Radiation Dose Reconstruction Under the Energy
Employees Occupational Illness Compensation Program Act of 2000;
Interim Final Rule With Request for Comments
AGENCY: Department of Health and Human Services.
ACTION: Interim final rule with request for comments.
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SUMMARY: This rule implements select provisions of the Energy Employees
Occupational Illness Compensation Program Act of 2000 (``EEOICPA'' or
``Act''). The Act requires the promulgation of methods, in the form of
regulations, for estimating the dose levels of ionizing radiation
incurred by workers in the performance of duty for nuclear weapons
production programs of the Department of Energy and its predecessor
agencies. These ``dose reconstruction'' methods will be applied by the
National Institute for Occupational Safety and Health, which is
responsible for producing the radiation dose estimates that the U.S.
Department of Labor will use in adjudicating certain cancer claims
under the Act.
DATES: Effective Date: This interim final rule is effective October 5,
2001. Compliance Dates: Affected parties are not required to comply
with the information collection requirements in Sec. 82.10 until the
Department of Health and Human Services publishes in the Federal
Register the control numbers assigned by the Office of Management and
Budget (OMB) to these information collection requirements. Publication
of the control numbers notifies the public that OMB has approved these
information collection requirements under the Paperwork Reduction Act
of 1995.
Comments: The Department invites written comments on the interim
final rule from interested parties. Comments on the rule must be
received by November 5, 2001. Comments on the collection of information
requirements should be received by October 22, 2001.
ADDRESSES: Address written comments on the interim final rule to the
NIOSH Docket Officer. Submit comments electronically by e-mail to
[email protected]. See SUPPLEMENTARY INFORMATION for file formats
and other information about electronic filing. Alternatively, submit
printed comments to the following address: NIOSH Docket Office, Robert
A. Taft Laboratories; M/S C34, 4676 Columbia Parkway, Cincinnati, OH
45226.
Written comments on the collection of information requirements
should be sent to Anne O'Connor, CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS-D24, Atlanta, GA 30333.
FOR FURTHER INFORMATION CONTACT: Larry Elliott, Director, Office of
Compensation Analysis and Support, National Institute for Occupational
Safety and Health, 4676 Columbia Parkway, MS-R45, Cincinnati, OH 45226,
Telephone 513-841-4498 (this is not a toll-free number). Information
requests may also be submitted by e-mail to [email protected].
SUPPLEMENTARY INFORMATION:
I. Comments Invited
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 rulemaking. Some generic topics for comment include the following
questions:
(1) Does the interim rule make appropriate use of current science
for conducting dose reconstructions to be used in an occupational
illness compensation program?
(2) Does the interim rule appropriately balance the potential
precision of dose reconstructions and the necessary efficiency of the
dose reconstruction process?
(3) Does the interim rule implement an appropriate process for
involving the claimant in the dose reconstruction?
Comments should identify the author(s), return address, and phone
number, in case clarification is needed. Comments can be submitted by
e-mail to: [email protected]. If submitting comments by e-mail, they
should be provided as a Microsoft Word or Word Perfect file attachment.
Printed comments can be submitted to the NIOSH Docket Office at the
address above. The Secretary will consider all communications received
on or before the closing date for comments before taking action on the
interim final rule. All comments submitted will be available for
examination in the Rule Docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
personnel involved in this rulemaking will be filed in the docket. An
electronic docket containing all comments submitted by e-mail will be
available over the Internet from the National Institute for
Occupational Safety and Health (NIOSH) homepage at www.cdc.gov/niosh.
II. Final Rule
The Department of Health and Human Services (``HHS'') expects to
issue a final rule within six months of publication of this interim
final rule. Upon publication of the final rule, dose reconstructions
completed under this interim final rule will be reviewed and revised,
as necessary, to conform with any substantive changes that might be
included in the final rule.
[[Page 50979]]
III. Background
A. Statutory Authority
The Energy Employees Occupational Illness Compensation Program Act
of 2000 (``EEOICPA''), Public Law 106-398, 114 Stat. 1654, 1654A-1231
(October 30, 2000), was enacted as Title XXXVI of the Floyd D. Spence
National Defense Authorization Act for Fiscal Year 2001. EEOICPA
established a compensation program to provide a lump sum payment of
$150,000 and 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 and certain of its vendors,
contractors, and subcontractors. This law also provided for payment of
compensation to certain survivors of covered employees.
EEOICPA instructed the President to designate one or more federal
agencies to carry out the compensation program. Pursuant to this
statutory provision, the President issued Executive Order 13179, titled
Providing Compensation to America's Nuclear Weapons Workers, which
assigned primary responsibility for administering the compensation
program to the Department of Labor (``DOL''). 65 FR 77487 (Dec. 7,
2000). DOL published an interim final rule governing DOL's
administration of EEOICPA on May 25, 2001 (see 66 FR 28948).
The executive order directed HHS to perform several technical and
policymaking roles in support of the DOL program:
(1) HHS is to develop methods to estimate radiation doses (``dose
reconstruction'') for certain individuals with cancer applying for
benefits under the DOL program. These methods are the subject of this
rule. HHS is also to apply these methods to conduct the program of dose
reconstructions required by EEOICPA. This program will be delegated to
the National Institute for Occupational Safety and Health (``NIOSH''),
an institute of the Centers for Disease Control and Prevention.
(2) HHS is also to develop guidelines 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 duties at a
DOE facility or atomic weapons facility. These guidelines are being
published simultaneously with this interim final rule as a notice of
proposed rulemaking under 42 CFR part 81 in this issue of the Federal
Register.
(3) HHS is to staff the Advisory Board on Radiation and Worker
Health and provide it with administrative and other necessary support
services. The Board, a federal advisory committee, will advise HHS in
implementing its roles under EEOICPA described here.
(4) Finally, HHS is to develop and apply procedures for considering
petitions by classes of employees to be added to the Special Exposure
Cohort established under EEOICPA. Employees included in the Special
Exposure Cohort who have a specified cancer and meet other conditions,
as defined by DOL regulations (66 FR 28948), qualify for compensation
under EEOICPA. HHS procedures for considering Special Exposure Cohort
petitions are under development. HHS expects to issue these procedures
within the next six months.
As provided for under section 3625 of EEOICPA, HHS is implementing
its responsibilities with the assistance of NIOSH.
B. What Legal Requirements Are Specified by EEOICPA for Dose
Reconstruction?
Section 3623(d) of EEOICPA requires that HHS establish, by
regulation, methods for arriving at reasonable estimates of the
radiation doses incurred by covered employees seeking compensation for
cancer, other than as members of the Special Exposure Cohort seeking
compensation for a specified cancer. These methods will be applied to
estimate radiation doses for the following covered employees seeking
compensation for cancer under EEOICPA: (1) An employee who was not
monitored for exposure to radiation at a DOE or Atomic Weapons Employer
facility; (2) an employee who was monitored inadequately for exposure
to radiation at such a facility; or (3) an employee whose records of
exposure to radiation at such facility are missing or incomplete.
EEOICPA requires the Advisory Board on Radiation and Worker Health
to independently review the methods established by this rule and to
verify a reasonable sample of dose reconstructions established under
these methods. The Advisory Board is a federal advisory committee
established and appointed by the President to advise HHS on its major
responsibilities under EEOICPA.
Sections 3623(e) and 3626(c) of EEOICPA require that DOE provide
HHS with relevant information on worker radiation exposures necessary
for dose reconstructions and require DOE to inform covered employees
with cancer of the results of their dose reconstructions. NIOSH, which
will be conducting the dose reconstructions, will inform covered
employees of the results of these dose reconstructions on behalf of
DOE.
Subject to provisions of the Privacy Act (5 U.S.C. 552a), HHS will
also make available to researchers and the general public information
on the assumptions, methodology, and data used in estimating radiation
doses, as required by Section 3623(e)(2) of EEOICPA.
Finally, HHS notes that EEOICPA does not authorize the
establishment of new radiation protection standards through the
promulgation of these methods, and these methods do not constitute such
new standards.
C. What Is the Purpose of Dose Reconstruction?
Dose reconstructions are used to estimate the radiation doses to
which individual workers or groups of workers have been exposed,
particularly when radiation monitoring is unavailable, incomplete, or
of poor quality. Originally dose reconstructions were conducted for
research on the health effects of exposure to radiation. In recent
decades, dose reconstruction has become an integral component of
radiation illness compensation programs in the United States and
internationally.
D. How Are Radiation Doses Reconstructed?
The procedures and level of effort involved in dose reconstructions
depend in part on the quantity and quality of available dose monitoring
information, the conditions under which radiation exposure arose, and
the forms of radiation to which the individual was exposed. If
individuals for whom dose estimates are needed were monitored using
present day technology and received only external radiation doses, dose
reconstruction could be very simple. It might only require summing the
radiation doses recorded from radiation badges and adding estimated
potential ``missed'' doses resulting from the limits of detection of
monitoring badges.
Dose reconstruction can require extensive research and analysis.
Such work is required if radiation doses were not monitored or there is
uncertainty about the monitoring methods involved; if there was
potential for internal doses through the ingestion, inhalation or
absorption of radioactive materials; or if the processes and
circumstances involved in the radiation exposures were complex. For the
most complex dose reconstructions, research and analyses may include
determining or
[[Page 50980]]
assuming specific characteristics of the monitoring procedures;
identifying events or processes that were unmonitored; identifying the
types and quantities of radioactive materials involved; evaluating
production processes and safety procedures employed; identifying the
locations and activities of exposed persons; identifying comparable
exposure circumstances for which data is available to make assumptions;
and conducting a variety of complex analyses to interpret the data
compiled or estimated.
E. How is Dose Reconstruction Conducted in a Compensation Program?
An additional, critical factor affecting how doses are
reconstructed is the amount of time available. For health research
studies dose reconstructions may take from months to years to complete.
In compensation programs, however, a balance must be struck between
efficiency and precision. Section 3611 of EEOICPA specifically states
that one of the purposes of the compensation program is to provide for
``timely'' compensation. As applied under EEOICPA, dose reconstruction
must rely on information that can be developed on a timely basis and on
carefully developed assumptions.
When conducting dose reconstruction for a compensation program, our
primary concern will be to ensure the assumptions used to estimate
doses are fair, consistent, and well grounded in the best available
science. To address fairness, the Defense Threat Reduction Agency
(``DTRA''), which conducts dose reconstructions for veterans and
Department of Defense civilian personnel who participated in U.S.
atmospheric nuclear testing and in the occupation forces of Hiroshima
and Nagasaki, applies certain assumptions that err reasonably on the
side of overestimating exposures (see 32 CFR part 218). These
assumptions substitute for more detailed information that would be
time-consuming and costly to develop. HHS will take an approach similar
to that of DTRA by using reasonable, fair, and scientifically based
assumptions as substitutes for additional research and analysis to
achieve an efficient dose reconstruction process.
F. How Will Dose Reconstruction Methods Under EEOICPA Differ From Dose
Reconstruction for Veterans?
The major differences for the HHS methods for dose reconstructions
arise from characteristics that distinguish the radiation exposure
experiences of nuclear weapons production workers from those of
veterans. Whereas veterans were primarily exposed to external sources
of radiation over brief periods in acute doses, employees covered by
EEOICPA frequently may have received both acute and chronic exposures
to internal and external radiation over periods as long as three to
four decades. Further, nuclear weapons production workers experienced
more diverse exposures and circumstances of exposure, on an individual
basis and as a group than did veterans. As a result, many HHS dose
reconstructions will be more complex than those conducted by DTRA,
making it necessary that HHS place a high premium on any efficiencies
that can be achieved.
Addressing the need for efficiency, HHS is establishing a dose
reconstruction process that limits the work performed in cases where it
is evident the outcome of the compensation claim will be unaffected.
HHS will rely on less detailed or precise estimates for claims for
which compensation would clearly be due based on the more limited dose
reconstruction, and for claims for which additional work clearly would
not result in compensation. In the former case, if it is evident from
limited dose reconstruction that the estimated cumulative dose is
sufficient to qualify the claimant for compensation, no additional work
will be performed. In the latter case, limited dose reconstructions
will be conducted only for claims for which it is evident that further
research and dose reconstruction is extremely unlikely to produce a
compensable level of radiation dose, because the use of worst-case
assumptions does not produce a compensable level of radiation dose. In
these latter cases, the decisive factors that result in NIOSH deciding
to limit the dose reconstruction process will be clearly set forth in
the draft of the dose reconstruction results reported to the claimant
under Sec. 82.25, and in the dose reconstruction results reported to
the claimant under Sec. 82.26.
A second important aspect of the HHS dose reconstruction process is
that it will involve interaction with the covered employee or survivor.
NIOSH will use information provided by the claimant to evaluate the
completeness and adequacy of dose information available, to locate
additional exposure or dose-related information, and to estimate
unmonitored doses.
G. How Will HHS Incorporate Scientific Methods Established by the
Radiation Safety Scientific Community in Internal Dose Estimation Under
EEOICPA?
The methods for calculating internal dose in this rule use current
models published by the International Commission on Radiological
Protection (ICRP). Specifically, NIOSH will use the new ICRP
respiratory tract model for assessing doses due to inhalation of
radioactive particles.\1\ In addition, NIOSH will use the new
biokinetic models for the radionuclides contained in publications
56,\2\ 67 \3\ and 69 \4\ in place of those described in previous ICRP
publications. These models provide the most widely accepted methods for
mathematically describing the uptake, transport and retention of
radionuclides in the body.
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\1\ International Commission on Radiological Protection (ICRP).
1994. Human Respiratory Model for Radiological Protection. ICRP
Publication 66, Annals of the ICRP 24(1-4). Elsevier Scientific
Ltd., Oxford.
\2\ International Commission on Radiological Protection (ICRP).
1989. Age Dependent Doses to Members of the Public from Intakes of
Radionuclides: Part 1. ICRP Publication 56, Annals of the ICRP
20(2). Pergamon Press, Oxford.
\3\ International Commission on Radiological Protection (ICRP).
1993. Age Dependent Doses to Members of the Public from Intakes of
Radionuclides: Part 2. ICRP Publication 67, Annals of the ICRP 23(2/
3). Pergamon Press, Oxford.
\4\ International Commission on Radiological Protection (ICRP).
1995. Age Dependent Doses to Members of the Public from Intakes of
Radionuclides: Part 3: Ingestion Dose Coefficients. ICRP Publication
69, Annals of the ICRP 25(1). Elsevier Scientific Ltd., Oxford.
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H. What Elements Underlying the Dose Reconstruction Process Are
Expected to Change With Scientific Progress?
ICRP periodically updates the models used to evaluate internal
doses, based on new research on the metabolic properties of radioactive
materials (radionuclides). These ICRP updates reflect the current state
of scientific knowledge on the uptake, transport, and retention of
radionuclides in the human body.
In addition, technological advances in the areas of retrospective
detection of radiation exposure or radiation exposure and dose
biomarkers (detectable changes in human tissues and/or physiologic
processes resulting from radiation exposure) may make it possible to
add new analyses to the dose reconstruction process in the future.
As outlined below, NIOSH will address the need to update the
scientific elements underlying dose reconstructions in a process that
permits input from the public.
[[Page 50981]]
I. How Will NIOSH Inform the Public of Any Plans to Change Scientific
Elements Underlying the Dose Reconstruction Process to Maintain Methods
Reasonably Current With Scientific Progress?
Periodically, NIOSH will publish a notice in the Federal Register
notifying the public of plans to change scientific elements underlying
the dose reconstruction process under EEOICPA to reflect scientific
progress. Notice will include a summary of the planned changes and the
expected completion date for such changes.
J. How Can the Public Recommend Changes to Scientific Elements
Underlying the Dose Reconstruction Process, as Scientific Progress
Makes Substantive Improvements in Methods Possible?
At any time, the public can submit written recommendations to NIOSH
for changes to scientific elements underlying the dose reconstruction
process, based on relevant new research findings and technological
advances. Recommendations will be provided to the Advisory Board on
Radiation and Worker Health and may be addressed at a public meeting of
the Advisory Board, with notification provided to the source of the
recommendations. Recommendations should be addressed to: Director,
Office of Compensation Analysis and Support, National Institute for
Occupational Safety and Health, 4676 Columbia Parkway, MS-R45,
Cincinnati, Ohio 45226.
The public can also submit recommendations by e-mail. Instructions
will be provided on the NIOSH Internet homepage at www.cdc.gov/niosh.
K. How Will NIOSH Make Changes in Scientific Elements Underlying the
Dose Reconstruction Process, Based on Scientific Progress?
Proposed changes will be presented to the Advisory Board on
Radiation and Worker Health prior to implementation. These proposed
changes will be summarized in the notice of the board meeting published
in the Federal Register. The public will have the opportunity to
comment on proposed changes at the meeting of the Advisory Board and/or
in written comments submitted for this purpose. NIOSH will fully
consider the comments of the Advisory Board and of the public before
deciding upon any changes.
L. How Will NIOSH Inform the Public of Changes to the Scientific
Elements Underlying the Dose Reconstruction Process?
NIOSH will publish a notice in the Federal Register informing the
public of changes and the rationale for the changes. This notice will
also provide a summary of the recommendations and comments received
from the Advisory Board and the public, as well as responses to the
comments.
IV. History of Rule Development
A. What Experience Does HHS Have in Dose Reconstruction?
NIOSH, an Institute of the Centers for Disease Control and
Prevention, has conducted a program of federally sponsored health
research on DOE employees since 1991. Dose reconstructions are an
integral element of this research. In fact, NIOSH will draw
substantially on records it has developed through its research on DOE
employees in conducting the program of dose reconstructions under
EEOICPA.
B. Did HHS Consult With Outside Experts and Interested Parties During
the Development of This Notice of Proposed Rulemaking?
HHS consulted individually with a wide variety of experts and
interested parties to help ensure the quality and practicality of these
methods. Reports on these consultations are available in the regulatory
docket for public review. While these consultations provided less
opportunity for initial public input than generally desired for
rulemaking, they served the purpose of ensuring that this interim final
rule was developed with reasonable information on the points of view of
individual experts and members of public directly affected by the rule.
HHS will fully consider comments from the public and from the Advisory
Board on Radiation and Worker Health in producing a final rule.
V. Summary of the Interim Rule
Congress, in enacting EEOICPA, created a new Energy Employees
Occupational Illness Compensation Program to ensure an efficient,
uniform, and adequate compensation system for certain employees. Under
Executive Order 13179, the President assigned primary responsibility
for administering the program to DOL. The President assigned various
technical responsibilities for policymaking and assistance to HHS.
Included among these is promulgation of this rule to establish methods
NIOSH will apply to conduct dose reconstructions for covered employees
seeking compensation for cancer, other than as members of the Special
Exposure Cohort seeking compensation for a specified cancer. NIOSH dose
reconstructions will be used by DOL to estimate the probability that
the cancers of these covered employees were related to radiation
exposures at covered facilities.
Introduction
Sections 82.0 and 82.1 briefly describe how these regulations
relate to DOL authorities under EEOICPA and the assignment of authority
for these regulations to HHS. In Sec. 82.2, HHS provides a general
introduction to dose reconstruction and describes the hierarchy of
information to be relied upon for dose reconstructions. This hierarchy
gives preference to individual radiation monitoring data, if complete
and adequate, and provides for use of information on the workplace
environment and radiation exposures for interpretation and as a
secondary source of data, and provides for use of reasonable and
scientific assumptions in lieu of certain data when the workplace
environment cannot be fully characterized. HHS believes this approach
would give due weight to the potentially most precise data, but would
take into account the limitations of such data and its availability.
Section 82.3 summarizes the specific provisions of EEOICPA
directing HHS in the development of this regulation and NIOSH in the
conduct of dose reconstructions under this regulation. Section 82.4
describes how DOL will use the results of NIOSH dose reconstructions
for the adjudication of claims.
Definitions
Section 82.5 defines the principal terms used in this part. It
includes terms specifically defined in EEOICPA that, for the
convenience of the reader of this part, are repeated in this section.
It clarifies the definition of radiation. Section 3621(16) of EEOICPA
defines radiation as ionizing radiation in the form of alpha or beta
particles, neutrons, gamma rays, or accelerated ions or subatomic
particles from accelerator machines. The rule elaborates upon this
definition, specifically including x rays, protons and other particles
capable of producing ions in the body, which are components of ionizing
radiation exposures experienced by nuclear weapons production workers.
In addition, for clarity the definition in this rule explicitly
excludes non-ionizing forms of radiation, such as radio-frequency
radiation and microwaves.
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Dose Reconstruction Process
Section 82.10 provides an overview of the major elements of the
dose reconstruction process that NIOSH will implement under EEOICPA. It
describes the steps in the process, the sources and types of
information that will be collected and analyzed, the role of the
claimants in developing a factual basis for dose reconstruction, the
types of analyses, and criteria that will direct NIOSH to ensure dose
reconstructions produce reasonable dose estimates and serve claimants
efficiently.
NIOSH will obtain available monitoring data and information on the
workplace environment and practices from DOE and other sources. NIOSH
will interview the claimant to obtain information and to report to the
claimant on dose reconstruction results and the methods and data used
to produce the results. NIOSH will take measures to produce results as
efficiently as possible, so that adjudication of the claim by DOL can
be resumed and completed in a timely fashion. These measures include
limiting the dose reconstruction process to use less detailed or
precise estimates for claims for which it is evident that further
research and analysis will not affect the outcome of the claim.
For example, under these proposed regulations, if it is evident
from the record of external radiation dose alone that an employee
incurred a sufficiently high level of dose to have the claim accepted
by DOL for compensation (a dose that would result in a probability of
causation of 50% or higher), NIOSH would conclude the process without
continuing with time consuming research and analysis to estimate
internal dose. Instead, NIOSH would immediately report the limited dose
estimate, based on external dose only, to the claimant and DOL, along
with an explanation of the reason for limiting the dose reconstruction
process.
Similarly, if, for example, records and information establish that
an employee incurred radiation doses evidently below a level that could
result in compensation, NIOSH would substitute worst-case assumptions
for additional research and analysis, to complete and report on the
dose reconstruction without delay.
This approach will provide more timely compensation for claims for
which it is evident the claimant will qualify for compensation, and
more timely results and adjudication for claims for which it is evident
further research and analysis is extremely unlikely to produce a
compensable level of radiation dose. The Department seeks public
comment on all aspects of this process.
Section 82.11 defines the subset of claimants under EEOICPA for
whom NIOSH will conduct dose reconstructions. NIOSH will attempt to
conduct dose reconstructions for all claims forwarded to NIOSH from
DOL. This includes all covered employees seeking compensation for
cancer, other than as members of the Special Exposure Cohort seeking
compensation for a specified cancer, as determined by DOL.
Section 82.12 describes NIOSH procedures for notifying any
claimants for whom a dose reconstruction cannot be completed because of
insufficient information to reasonably estimate the dose potentially
incurred by the covered employee. NIOSH will notify the claimant and
DOL that a dose reconstruction cannot be completed and describe the
basis for this finding. In these cases, the claimant would have the
opportunity to seek administrative review of this result after DOL
produces a recommended decision to deny the claim, based on the report
from NIOSH that there is insufficient evidence to complete a dose
reconstruction. For a claim in which the employee has a specified
cancer, the claimant might still be eligible for compensation under
EEOICPA. Classes of covered employees have the option to petition HHS
to be added to the Special Exposure Cohort. HHS will establish
procedures to consider such petitions, as required under section 3626
of EEOICPA and Sec. 2(b) of E.O. 13179. HHS expects to establish the
procedures within six months of publication of this rule.
Sections 82.13 and 82.14 describe in detail the sources and
examples of the types of information NIOSH will use in dose
reconstructions. DOE and claimants will be the primary sources of
information. Information types include: Subject and employment
information, worker monitoring data, monitoring program data, workplace
monitoring data, workplace characterization data, and process
descriptions for each work location. The actual use of this wide range
of information will be determined for each claim individually, based on
the types of information available and necessary.
Sections 82.15-82.17 describe how NIOSH will evaluate the
completeness and adequacy of monitoring data and how NIOSH would remedy
limitations, applying the general approach described in Sec. 82.2 and
making use of the data sources and types described in Secs. 82.13 and
82.14. NIOSH will evaluate the completeness and adequacy of monitoring
data by various means, such as evaluating associated information on the
workplace environment and practices, evaluating the monitoring
technology, and evaluating other sources of information. NIOSH will
remedy data limitations using established dose reconstruction
practices, such as interpolating from recorded doses to estimate
unrecorded doses, and substituting monitoring data from comparably
exposed workers. HHS seeks public comments suggesting alternative
approaches that NIOSH should consider.
Sections 82.18-82.19 describe how NIOSH will address salient
technical issues of calculating internal dose and taking into account
uncertainty with respect to dose information. Internal dose is the
radiation dose received by radioactive materials taken into the body,
such as by inhalation or ingestion. It is important because it
accumulates year after year, increasing the risk of certain cancers
over time. NIOSH will use current ICRP models for calculating internal
dose, and will accompany dose estimates with uncertainty distributions.
DOL will use these distributions with appropriate statistical methods
to take into account uncertainty about the dose when calculating
probability of causation for a claim.
Reporting and Review of Dose Reconstruction Results
Sections 82.25 and 82.26 describe in detail NIOSH procedures for
reporting the results of dose reconstructions to claimants and DOL,
specifying the timing, content, and form of the dose reconstruction
reports.
Section 82.27 describes how and when claimants can obtain reviews
of NIOSH dose reconstructions. NIOSH will review dose reconstructions
upon request by DOL under DOL procedures for claimants seeking review
of dose reconstructions. These procedures also allow for DOL to request
reviews of dose reconstruction upon its own initiative; for example, to
request review of previously completed dose reconstructions to reflect
updated scientific methods.
VI. Regulatory Procedures
The Department of Health and Human Services (HHS) follows the
Administrative Procedure Act (``APA'') rulemaking procedures specified
in 5 U.S.C. 553 in the development of its regulations. In most
circumstances, the APA requires a public notice and comment period and
consideration of the submitted comments prior to promulgation of a
final rule having the effect of law. However, the APA provides for
exceptions to its notice and
[[Page 50983]]
comment procedures when an agency finds that there is good cause for
dispensing with such procedures on the basis that they are
impracticable, unnecessary, or contrary to the public interest. In the
case of this interim final rule, HHS has determined that under 5 U.S.C.
553(b)(B), good cause exists for waiving the notice and comment
procedures. For these same reasons, HHS has also determined good cause
exists under 5 U.S.C. 553(d)(3) for these interim rules to become
effective immediately.
A number of courts have considered the circumstances under which an
agency can conclude that good cause exists for issuing regulations
without prior notice and comment. In American Transfer & Storage Co.,
et al v. Interstate Commerce Commission, 719 F.2d 1283, 1295 (5th Cir.
1983), the Fifth Circuit described the impracticability test as
requiring ``analysis in practical terms of the particular statutory-
agency setting and the reasons why agency action could not await notice
and comment.'' Similarly, the Seventh Circuit noted that the
``legislative history of the impracticability standard reveals that
Congress intended this exemption to operate when the regular course of
rulemaking procedure would interfere with the agency's ability to
perform its functions with the time constraints imposed by Congress.''
United States Steel Corporation v. United States Environmental
Protection Agency, 605 F.2d 283, 287 (7th Cir. 1979). Courts have also
recognized that while strict deadlines alone do not justify dispensing
with notice and comment, ``deviation from APA requirements has been
permitted where congressional deadlines are very tight and the statute
is particularly complicated.'' Methodist Hospital of Sacramento v.
Shalala, 38 F.3d 1225, 1236 (D.C. Cir. 1994).
Precisely such an ``analysis in practical terms'' demonstrates that
in this case, as with respect to changes in the Aid to Families with
Dependent Children program at issue in Philadelphia Citizens in Action
v. Schweiker, 669 F.2d 887, 894 (3rd Cir. 1982), ``Congress, by setting
an effective date so close to the date of enactment, expressed its
belief that implementation * * * was urgent.'' Legislation enacting
EEOICPA was signed by the President on October 30, 2000, and
responsibility for implementing EEOICPA was assigned to specific
agencies by Executive Order on December 7, 2000. In sections 3628 and
3629 of EEOICPA, however, Congress authorized the Secretary of Labor to
begin providing compensation to qualified claimants on July 31 2001. To
ensure qualified claimants who have cancer or survive employees who had
cancer caused by exposure to radiation in their employment by DOE or
its contractors or subcontractors receive the compensation to which
they are entitled as soon as possible after July 31, 2001, HHS has
determined it is necessary to implement the dose reconstruction methods
set forth here on an interim final basis.
Under Executive Order 13179, the President assigned HHS three
primary responsibilities in assisting the Department of Labor to make
determinations on claims for cancer. First, HHS must promulgate methods
for estimating the radiation doses incurred in the performance of duty
by covered employees who submit claims or are the subject of claims
submitted by their survivors. Second, pursuant to the methods
established by this interim final regulation, HHS must perform
individual dose reconstructions to determine the radiation dose
incurred by each covered employee for whom a claim is made. Third, HHS
must promulgate guidelines for DOL to use in determining whether the
cancers presented by the employees were ``as least as likely as not''
caused by the radiation doses they incurred. HHS is publishing these
probability of causation guidelines simultaneously with this interim
final rule as a notice of proposed rulemaking (NPRM) in this issue of
the Federal Register.
Completion of HHS work on dose reconstructions is a prerequisite
for DOL to begin using the HHS probability of causation guidelines to
make individual determinations. HHS has determined to publish the
methods for dose reconstruction as an interim final rule so that HHS
can initiate the lengthy process of dose reconstructions for individual
claimants. HHS must identify and gather relevant records, evaluate
their adequacy, and interact with the claimant in completing each dose
reconstruction. By publishing the dose reconstruction methods as an
interim final rule, HHS will be able to complete dose reconstruction
work to allow DOL to complete the adjudication of claims as soon as
possible after the HHS probability of causation guidelines are
published as final rules.
If HHS were to issue an NPRM proposing dose reconstruction methods,
HHS would be delayed in processing dose reconstructions for individual
claimants by at least 150 days, until a final regulation could be
issued.
HHS believes good cause exists to waive the notice and comment
procedures under the APA for the promulgation of these interim final
rules. There is a strong public interest in the expeditious
adjudication of claims that these workers, who served in this nation's
nuclear weapons programs, were harmed in the performance of their
duties. This public interest is clearly reflected in the mandate given
by Congress to swiftly initiate this program. Moreover, qualified
claimants should be given the opportunity to obtain their benefits,
including medical benefits, as soon as possible. This is especially
material given that many of the covered workers eligible to make claims
under this Act are elderly and ill. An undue delay in the processing of
their claims would result in real harm to these claimants.
With the publication of this interim final rule, HHS can begin the
labor intensive process of reconstructing the radiation doses of
employees covered by these claims. Once the probability of causation
guidelines are finalized, DOL will be able to expeditiously adjudicate
cancer claims requiring dose reconstructions.
Although HHS is adopting these dose reconstruction rules on an
interim final basis, it requests public comment on this rule. After
full consideration of public comments, HHS will publish a final rule
with any necessary changes. HHS expects to issue a final rule within
six months of the publication of this interim final rule, at the same
time as it expects to issue final guidelines regarding the probability
of causation. Since dose reconstructions completed under the interim
final rule cannot be used to finally adjudicate claims until those
guidelines are issued in final form, HHS will be able to review and
revise dose reconstructions completed under this interim final rule, as
necessary, to conform with any substantive changes that might be
included in the final dose reconstruction rule before any final action
is taken on a particular claim. By issuing the dose reconstruction
regulation as an interim final regulation, however, substantial time
can be saved and many more claims can be timely adjudicated, based on
the final regulation and guidelines, enabling covered employees or
their survivors to receive benefits to which they may be entitled as
expeditiously as possible.
VII. Significant Regulatory Action (Executive Order 12866)
This rule is being treated as a ``significant regulatory action''
within the meaning of Executive Order (E.O.) 12866 because it raises
novel or legal policy issues arising out of the legal mandate
established by EEOICPA. The rule is designed to establish practical
[[Page 50984]]
methods, grounded in current science, to fairly and efficiently assist
claimants and support DOL in the adjudication of applicable claims
seeking compensation for cancer under EEOICPA. NIOSH will apply the
methods to produce reasonable, scientifically supported estimates of
the radiation doses incurred by covered employees subject to the
claims, as permitted by available data and information. The financial
cost to the federal government of producing these estimates is expected
to be several thousand dollars per claim, on average.
The rule carefully explains the manner in which the regulatory
action is consistent with the mandate for this action under
Sec. 3623(d) of EEOICPA and implements the detailed requirements
concerning this action under this section of EEOICPA. The rule does not
interfere with State, local, and tribal governments in the exercise of
their governmental functions.
The rule is not considered economically significant, as defined in
section 3(f)(1) of the Executive Order 12866. It has a subordinate role
in the adjudication of claims under EEOICPA, serving as one element of
an adjudication process administered by DOL under 20 CFR parts 1 and
30. DOL has determined that its rule fulfills the requirements of
Executive Order 12866 and provides estimates of the aggregate cost of
benefits and administrative expenses of implementing EEOICPA under its
rule (see FR 28948, May 25, 2001). OMB has reviewed this rule for
consistency with the President's priorities and the principles set
forth in E.O. 12866.
VIII. 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.
This rule affects only DOL, DOE, HHS, and some individuals filing
compensation claims under EEOICPA. Therefore, a regulatory flexibility
analysis as provided for under RFA is not required.
IX. What Are the Paperwork and Other Information Collection
Requirements (Subject to the Paperwork Reduction Act) Imposed Under
This Rule, and How Are Comments Submitted?
Under the Paperwork Reduction Act of 1995, a Federal agency shall
not conduct or sponsor a collection of information from ten or more
persons other than Federal employees unless the agency has submitted a
Standard Form 83, Clearance Request, and Notice of Action, to the
Director of the Office of Management and Budget (OMB), and the Director
has approved the proposed collection of information. A person is not
required to respond to a collection of information unless it displays a
currently valid OMB control number. The Paperwork Reduction Act is
applicable to the data collection aspects of this rule.
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of projects. To
request more information on this project or to obtain a copy of the
data collection plans and instruments, call the CDC Reports Clearance
Officer at (404) 639-7090.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology.
NIOSH is requesting an emergency clearance from the Office of
Management and Budget (OMB) to collect data under EEOICPA. Send
comments to Anne O'Connor, CDC Assistant Reports Clearance Officer,
1600 Clifton Road, MS-D24, Atlanta, GA 30333. Written comments should
be received within 14 days of this notice. OMB is expected to act on
the request of HHS within 21 days of publication of this notice.
In performance of its dose reconstruction responsibilities under
the Act, NIOSH will interview claimants individually and provide them
with the opportunity, through a structured interview, to assist NIOSH
in documenting the work history of the employee (characterizing the
actual work tasks performed), identifying incidents that may have
resulted in undocumented radiation exposures, characterizing radiation
protection and monitoring practices, and identifying co-workers,
radiation protection management and staff, line managers, and other
witnesses, if NIOSH determines this is necessary, to confirm
undocumented information. In this process, NIOSH will use a computer
assisted telephone interview (CATI) system, which will allow interviews
to be conducted more efficiently and quickly than would be the case
with a paper-based interview instrument.
NIOSH will use the data collected in this process to complete an
individual dose reconstruction that accounts for radiation dose,
including unmonitored or inadequately monitored dose, incurred by the
employee in the performance of duty for DOE nuclear weapons production
programs. After dose reconstruction, NIOSH will provide a draft of the
dose reconstruction report to the claimant and perform a brief follow-
up interview with the claimant to explain the results and to allow the
claimant to confirm or question the record NIOSH has compiled. This
will also be the final opportunity for the claimant to supplement the
dose reconstruction record.
At the conclusion of the dose reconstruction process, the claimant
will be requested to submit to NIOSH a form (OCAS-1) to confirm that
the claimant has completed providing information to NIOSH for the dose
reconstruction. The form will notify the claimant that signing the form
allows NIOSH to provide a final dose reconstruction report to DOL and
closes the record on data to be used for the dose reconstruction. DOL
will use data from the dose reconstruction report to determine the
probability that the cancer(s) of the covered employee may have been
caused by radiation doses incurred in the performance of duty at a DOE
or AWE facility.
There will be no cost to respondents for this data collection. This
is a new data collection. The estimated burden of this data collection
is described in the table below.
[[Page 50985]]
----------------------------------------------------------------------------------------------------------------
Avg. burden
Number of Number of per
Respondents respondents responses response Total hours
(hrs.)
----------------------------------------------------------------------------------------------------------------
Initial interview........................................... 22,500 1 60/60 22,500
Conclusion form............................................. 22,500 1 5/60 1,875
---------------------------------------------------
Total................................................... ........... ........... ........... 24,375
----------------------------------------------------------------------------------------------------------------
X. 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 to Congress promulgation of this rule 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.
However, this rule has a subordinate role in the adjudication of claims
under EEOICPA, serving as one element of an adjudication process
administered by DOL under 20 CFR parts 1 and 30. DOL has determined
that its rule is a ``major rule'' because it will likely result in an
annual effect on the economy of $100 million or more.
XI. 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.
XII. 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. Dose reconstruction 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 dose reconstruction. This rule provides a clear legal
standard for HHS and DOL to apply regarding dose reconstruction. This
rule has been reviewed carefully to eliminate drafting errors and
ambiguities.
XIII. 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.''
XIV. 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. The
agency has determined that the rule will not affect children.
XV. 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 this rule is not likely to have a significant adverse
effect on them.
List of Subjects in 42 CFR Part 82
Cancer, Dose reconstruction, Government employees, Occupational
safety and health, Nuclear materials, Radiation protection, Radioactive
materials, Workers' compensation.
Text of the Rule
For the reasons discussed in the preamble, the Department of Health
and Human Services amends 42 CFR to add Part 82 to read as follows:
PART 82--METHODS FOR CONDUCTING DOSE RECONSTRUCTION UNDER THE ENERGY
EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT OF 2000
Subpart A--Introduction
Sec.
82.0 Background Information on this Rule.
82.1 What is the purpose of this rule?
82.2 What are the basics of dose reconstruction?
82.3 What are the requirements for dose reconstruction under
EEOICPA?
82.4 How will DOL use the results of the NIOSH dose
reconstructions?
Subpart B--Definitions
82.5 Definition of Terms Used in this Rule.
Subpart C--Dose Reconstruction Process
82.10 Overview of the Dose Reconstruction Process.
82.11 For which claims under EEOICPA will NIOSH conduct a dose
reconstruction?
82.12 Will it be possible to conduct dose reconstructions for all
claims?
82.13 What sources of information may be used for dose
reconstructions?
82.14 What types of information could be used in dose
reconstructions?
82.15 How will NIOSH evaluate the completeness and adequacy of
individual monitoring data?
82.16 How will NIOSH add to monitoring data to remedy limitations
of individual monitoring and missed dose?
82.17 What types of information could be used to supplement or
substitute for individual monitoring data?
82.18 How will NIOSH calculate internal dose to the primary cancer
site(s)?
82.19 How will NIOSH address uncertainty about dose levels?
Subpart D--Reporting and Review of Dose Reconstruction Results
82.25 When will NIOSH report dose reconstruction results, and to
whom?
82.26 How will NIOSH report dose reconstruction results?
82.27 How can claimants obtain reviews of their dose
reconstruction results by NIOSH?
82.28 Who can review NIOSH dose reconstruction files on individual
claimants?
Authority: 42 U.S.C. 7384n; E.O. 13179, 65 FR 77487.
[[Page 50986]]
Subpart A--Introduction
Sec. 82.0 Background Information on this Rule.
The Energy Employees Occupational Illness Compensation Program Act
(EEOICPA), Public Law 106-398, provides for the payment of compensation
benefits to covered employees and, where applicable, survivors of such
employees, of the United States Department of Energy, its predecessor
agencies and certain of its contractors and subcontractors. Among the
types of illnesses for which compensation may be provided are cancers.
There are two categories of covered employees with cancer under EEOICPA
for whom compensation may be provided. The regulations that follow
under this part apply only to the category of employees described under
(a) of this section.
(a) One category is employees with cancer for whom a dose
reconstruction must be conducted, as required under 20 CFR 30.115.
(b) The second category is members of the Special Exposure Cohort
seeking compensation for a specified cancer, as defined under EEOICPA.
The U.S. Department of Labor (DOL) which has primary authority for
implementing EEOICPA, has promulgated regulations at 20 CFR 30.210 and
30.213 that identify current members of the Special Exposure Cohort and
requirements for compensation. Pursuant to section 3626 of EEOICPA, the
Secretary of HHS is authorized to add additional classes of employees
to the Special Exposure Cohort.
Sec. 82.1 What is the purpose of this rule?
The purpose of this rule is to provide methods for determining a
reasonable estimate of the radiation dose received by a covered
employee with cancer under EEOICPA, through the completion of a dose
reconstruction. These methods will be applied by the National Institute
for Occupational Safety and Health (NIOSH) in a dose reconstruction
program serving claimants under EEOICPA, as identified under Sec. 82.0.
Sec. 82.2 What are the basics of dose reconstruction?
The basic principle of dose reconstruction is to characterize the
radiation environments to which workers were exposed and to then place
each worker in time and space within this exposure environment. Then
methods are applied to translate exposure to radiation into quantified
radiation doses at the specific organs or tissues relevant to the types
of cancer occurring among the workers. A hierarchy of methods is used
in a dose reconstruction, depending on the nature of the exposure
conditions and the type, quality, and completeness of data available to
characterize the environment.
(a) If found to be complete and adequate, individual worker
monitoring data, such as dosimeter readings and bioassay sample
results, are given the highest priority in assessing exposure. These
monitoring data are interpreted using additional data characterizing
the workplace radiation exposures. If radiation exposures in the
workplace environment cannot be fully characterized based on available
data, default values based on reasonable and scientific assumptions may
be used as substitutes. For dose reconstructions conducted in
occupational illness compensation programs, this practice may include
use of assumptions that represent the worst case conditions. For
example, if the solubility classification of an inhaled material can
not be determined, the dose reconstruction would use the classification
that results in the largest dose to the organ or tissue relevant to the
cancer.
(b) If individual monitoring data are not available or adequate,
dose reconstructions may use monitoring results for groups of workers
with comparable activities and relationships to the radiation
environment. Alternatively, workplace area monitoring data may be used
to estimate the dose. As with individual worker monitoring data,
workplace exposure characteristics are used in combination with
workplace monitoring data to estimate dose.
(c) If neither adequate worker nor workplace monitoring data are
available, the dose reconstruction may rely substantially on process
description information to analytically develop an exposure model. For
internal exposures, this model includes such factors as the quantity
and composition of the radioactive substance (the source term), the
chemical form, particle size distribution, the level of containment,
and the likelihood of dispersion.
Sec. 82.3 What are the requirements for dose reconstruction under
EEOICPA?
(a) Dose reconstructions are to be conducted for the following
covered employees with cancer seeking compensation under EEOICPA: An
employee who was not monitored for exposure to radiation at Department
of Energy (DOE) or Atomic Weapons Employer (AWE) facilities; an
employee who was monitored inadequately for exposure to radiation at
such facilities; or an employee whose records of exposure to radiation
at such facility are missing or incomplete. Technical limitations of
radiation monitoring technology and procedures will require HHS to
evaluate each employee's recorded dose. In most, if not all cases,
monitoring limitations will result in possibly undetected or unrecorded
doses, which are estimated using commonly practiced dose reconstruction
methods and would have to be added to the dose record.
(b) Section 3623(e) of EEOICPA requires the reporting of radiation
dose information resulting from dose reconstructions to the covered
employees for whom claims are being adjudicated. DOE is specifically
charged with this responsibility but the Department of Health and Human
Services (HHS), which will be producing the dose reconstruction
information, will implement this reporting responsibility on behalf of
DOE. HHS will also make available to researchers and the general public
information on the assumptions, methodology, and data used in
estimating radiation doses, as required by EEOICPA.
Sec. 82.4 How will DOL use the results of the NIOSH dose
reconstructions?
Under 42 CFR part 81, DOL will apply dose reconstruction results
together with information on cancer diagnosis and other personal
information provided to DOL by the claimant to calculate an estimated
probability of causation. This estimate is the probability that the
cancer of the covered employee was caused by radiation exposure at a
covered facility of DOE or an Atomic Weapons Employer (AWE).
Subpart B--Definitions
Sec. 82.5 Definition of Terms Used in this Rule.
(a) Atomic weapons employer (AWE) means any entity, other than the
United States, that:
(1) Processed or produced, for use by the United States, material
that emitted radiation and was used in the production of an atomic
weapon, excluding uranium mining and milling; and,
(2) Is designated by the Secretary of Energy as an atomic weapons
employer for purposes of EEOICPA.
(b) Bioassay means the determination of the kinds, quantities, or
concentrations, and in some cases, locations of radioactive material in
the human body, whether by direct measurement or by analysis, and
[[Page 50987]]
evaluation of radioactive material excreted or eliminated by the body.
(c) Claimant means the individual who has filed with the Department
of Labor for compensation under EEOICPA.
(d) Covered employee means, for the purposes of this rule, an
individual who is or was an employee of DOE, a DOE contractor or
subcontractor, or an atomic weapons employer, and for whom DOL has
requested HHS to perform a dose reconstruction.
(e) Covered facility means any building, structure, or premises,
including the grounds upon which such building, structure, or premise
is located:
(1) In which operations are, or have been, conducted by, or on
behalf of, the DOE (except for buildings, structures, premises,
grounds, or operations covered by Executive Order 12344, dated February
1, 1982, pertaining to the Naval Nuclear Propulsion Program); and,
(2) With regard to which the DOE has or had:
(i) A proprietary interest; or,
(ii) Entered into a contract with an entity to provide management
and operation, management and integration, environmental remediation
services, construction, or maintenance services; or
(3) A facility owned by an entity designated by the Secretary of
Energy as an atomic weapons employer for purposes of EEOICPA that is or
was used to process or produce, for use by the United States, material
that emitted radiation and was used in the production of an atomic
weapon, excluding uranium mining or milling.
(f) DOE: The U.S. Department of Energy, includes predecessor
agencies of DOE, including the Manhattan Engineering District.
(g) DOL: The U.S. Department of Labor.
(h) EEOICPA means the Energy Employees Occupational Illness
Compensation Program Act of 2000, Public Law 106-398, as amended.
(i) Equivalent dose is the absorbed dose in a tissue multiplied by
a radiation weighting factor to account for differences in the
effectiveness of the radiation in inducing cancer.
(j) External dose means that portion of the equivalent dose that is
received from radiation sources outside of the body.
(k) Internal dose means that portion of the equivalent dose that is
received from radioactive materials taken into the body.
(l) NIOSH: the National Institute for Occupational Safety and
Health, Centers for Disease Control and Prevention, U.S. Department of
Health and Human Services.
(m) Primary cancer means a cancer defined by the original body site
at which the cancer was incurred, prior to any spread (metastasis)
resulting in tumors at other sites in the body.
(n) Probability of causation means the probability or likelihood
that a cancer was caused by radiation exposure incurred by a covered
employee in the performance of duty. In statistical terms, it is the
cancer risk attributable to radiation exposure divided by the sum of
the baseline cancer risk (the risk to the general population) plus the
cancer risk attributable to the radiation exposure. This concept is
further explained under 42 CFR part 81, which provides guidelines by
which DOL will determine probability of causation under EEOICPA.
(o) Radiation means ionizing radiation, including alpha particles,
beta particles, gamma rays, x rays, neutrons, protons and other
particles capable of producing ions in the body. For purposes of this
rule, radiation does not include sources of non-ionizing radiation such
as radio-frequency radiation, microwaves, visible light, and infrared
or ultraviolet light radiation.
(p) Specified cancer is a term defined in section 3621(17) of
EEOICPA and 20 CFR part 30.5(dd) that specifies types of cancer that,
pursuant to 20 CFR part 30, may qualify a member of the Special
Exposure Cohort for compensation. It includes leukemia (other than
chronic lymphocytic leukemia), multiple myeloma, non-Hodgkin's
lymphoma, and cancers of the lung (other than carcinoma in situ
diagnosed at autopsy), thyroid, male breast, female breast, esophagus,
stomach, pharynx, small intestine, pancreas, bile ducts, gall bladder,
salivary gland, urinary bladder, brain, colon, ovary, liver (not
associated with cirrhosis or hepatitis), and bone. Pursuant to section
2403 of Public Law 107-20, this definition will include renal cancer.
(q) Uncertainty distribution is a statistical term meaning a range
of discrete or continuous values arrayed around a central estimate,
where each value is assigned a probability of being correct.
(r) Worst-case assumption is a term used to describe a type of
assumption used in certain instances for certain dose reconstructions
conducted under this rule. It assigns the highest reasonably possible
value, based on reliable science, documented experience, and relevant
data, to a radiation dose of a covered employee.
Subpart C--Dose Reconstruction Process
Sec. 82.10 Overview of the Dose Reconstruction Process.
(a) Upon receipt of a claims package from the Department of Labor,
as provided under 20 CFR part 30, NIOSH will request from the
Department of Energy (DOE) records on radiation dose monitoring and
radiation exposures associated with the employment history of the
covered employee. Additionally, NIOSH may compile data, and information
from NIOSH records that may contribute to the dose reconstruction. For
each dose reconstruction, NIOSH will include records relevant to
internal and external exposures to ionizing radiation, including
exposures from medical screening x rays that were required as a
condition of employment.
(b) NIOSH will evaluate the initial radiation exposure record
compiled to: Reconcile the exposure record with the reported employment
history, as necessary; complete preliminary calculations of dose, based
upon this initial record, and prepare to consult with the claimant. Any
discrepancies in the employment history information will be reconciled
with the assistance of DOE, as necessary.
(c) NIOSH will interview the claimant. The purpose of the interview
is to:
(1) Explain the dose reconstruction process;
(2) Confirm elements of the employment history transmitted to NIOSH
by DOL;
(3) Identify any relevant information on employment history that
may have been omitted;
(4) Confirm or supplement monitoring information included in the
initial radiation exposure record;
(5) Develop detailed information on work tasks, production
processes, radiologic protection and monitoring practices, and
incidents that may have resulted in undocumented radiation exposures,
as necessary;
(6) Identify co-workers and other witnesses with information
relevant to the radiation exposures of the covered worker to supplement
or confirm information on work experiences, as necessary.
(d) NIOSH will provide a report to the claimant summarizing the
findings of the interview, titled: ``NIOSH Claimant Interview under
EEOICPA.'' The report will also notify the claimant of the opportunity
to contact NIOSH if necessary, by a specified date, to make any written
corrections or additions to
[[Page 50988]]
information provided by the claimant during the interview process.
(e) Information provided by the claimant will be accepted and used
for dose reconstruction, providing it is reasonable, supported by
substantial evidence, and is not refuted by other evidence. In
assessing whether the information provided by the claimant is supported
by substantial evidence, NIOSH will consider:
(1) Consistency of the information with other information in the
possession of NIOSH, from radiation safety programs, research, medical
screening programs, labor union documents, worksite investigations,
dose reconstructions conducted by NIOSH under EEOICPA, or other reports
relating to the circumstances at issue;
(2) Consistency of the information with medical records provided by
the claimant;
(3) Consistency of the information with practices or exposures
demonstrated by the dose reconstruction record developed for the
claimant; and,
(4) Confirmation of information by co-workers or other witnesses.
(f) NIOSH will seek to confirm information provided by the claimant
through review of available records and records requested from DOE.
(g) As necessary, NIOSH will request additional records from DOE to
characterize processes and tasks potentially involving radiation
exposure for which dose and exposure monitoring data is incomplete or
insufficient for dose reconstruction.
(h) NIOSH will review the adequacy of monitoring data and
completeness of records provided by DOE. NIOSH will request
certification from DOE that record searches requested by NIOSH have
been completed.
(i) As necessary, NIOSH will characterize the internal and external
exposure environments for parameters known to influence the dose. For
internal exposures, examples of these parameters include the mode of
intake, the composition of the source term (i.e., the radionuclide type
and quantity), the particle size distribution and the absorption type.
When it is not possible to characterize these parameters, NIOSH may use
default values, when they can be established reasonably, fairly, and
based on relevant science. For external exposures, the radiation type
(gamma, x-ray, neutron, beta, or other charged particle) and radiation
energy spectrum will be evaluated. When possible, the effect of non-
uniformity and geometry of the radiation exposure will be assessed.
(j) For individual monitoring records that are incomplete, doses
may be imputed using techniques discussed in Sec. 82.16. Once the
resulting data set has been evaluated and validated, an occupational
exposure matrix will be constructed, using the general hierarchical
approach discussed in Sec. 82.2. This matrix will contain the estimated
annual equivalent dose(s) to the relevant organ(s) or tissue(s), for
the period from the initial date of potential exposure at a covered
facility until the date the cancer was diagnosed. The equivalent
dose(s) will be calculated using the current, standard radiation
weighting factors from the International Commission on Radiological
Protection (ICRP, Publication 60),\1\ indicated in Table 1.
---------------------------------------------------------------------------
\1\ International Commission on Radiological Protection (ICRP)
60: ``1990 Recommendations of the Interational Commission on
Radiological Protection.'' Ann. ICRP 21(1-3): 6.
Table 1.--Radiation Weighting Factors
------------------------------------------------------------------------
Radiation
Radiation type and energy range weighting
factor, wR
------------------------------------------------------------------------
Photons, all energies...................................... 1
Electrons and muons, all energies.......................... 1
Neutrons, energy 10 keV.................................... 5
10 keV to 100 keV.......................................... 10
>100 keV to 2 MeV.......................................... 20
>2 MeV to 20 MeV........................................... 10
>20 MeV.................................................... 5
Protons, other than recoil protons, energy >2 MeV.......... 5
Alpha particles, fission fragments and heavy nuclei........ 20
------------------------------------------------------------------------
(k)(1) At any point during steps in paragraphs (f)-(j) of this
section of dose reconstruction, NIOSH may determine that sufficient
research and analysis has been conducted to complete the dose
reconstruction. Research and analysis will be determined sufficient if
one of the following three conditions is met:
(i) From acquired experience, it is evident the estimated
cumulative dose is sufficient to qualify the claimant for compensation
(i.e., the dose produces a probability of causation of 50% or greater);
(ii) Dose is determined using worst-case assumptions related to
radiation exposure and intake, to substitute for further research and
analyses; or,
(iii) Research and analysis indicated under steps in paragraphs
(f)-(j) of this section have been completed.
(2) Worst-case assumptions will be employed under condition in
paragraph (k)(1)(ii) of this section to limit further research and
analysis only for claims for which it is evident that further research
and analysis will be extremely unlikely to produce a compensable level
of radiation dose (a dose producing a probability of causation of 50%
or greater), because even using worst-case assumptions it cannot be
determined that the employee may have incurred a compensable level of
radiation dose. For all claims in which worst-case assumptions are
employed under condition in paragraph (k)(1)(ii) of this section, the
reasoning that resulted in the determination to limit further research
and analysis will be clearly described in the draft of the dose
reconstruction results reported to the claimant under Sec. 82.25 and in
the dose reconstruction results reported to the claimant under
Sec. 82.26.
(l) After providing the claimant with a copy of a draft of the dose
reconstruction report to be provided to DOL, NIOSH will conduct a
closing interview with the claimant to review the dose reconstruction
results and the basis upon which the results were calculated. This will
be the final opportunity during the dose reconstruction process for the
claimant to provide additional relevant information that may affect the
dose reconstruction.
(m) Subject to any additional information provided by the claimant
under Sec. 82.10(l), the claimant is required to return form OCAS-1 to
NIOSH, certifying that the claimant has completed providing information
and that the record for dose reconstruction should be closed. Upon
receipt of the form and completion of any changes in the dose
reconstruction resulting from new information provided under
Sec. 82.10(l), NIOSH will forward a final dose reconstruction report to
DOL and to the claimant.
(n) NIOSH will not forward the dose reconstruction report to DOL
for adjudication without receipt of form OCAS-1 signed by the claimant
or a representative of the claimant authorized pursuant to 20 CFR
30.600. If the claimant or the authorized representative of the
claimant fails to sign and return form OCAS-1 within 60 days, after
notifying the claimant or the authorized representative, NIOSH may
administratively close the dose reconstruction and notify DOL of this
action. Upon receiving this notification by NIOSH, DOL may
administratively close the claim.
(o) Once actions under Sec. 82.10(m) are completed, the record for
dose reconstruction shall be closed unless reopened at the request of
DOL under 20 CFR part 30.
[[Page 50989]]
Sec. 82.11 For which claims under EEOICPA will NIOSH conduct a dose
reconstruction?
NIOSH will conduct a dose reconstruction for each claim determined
by DOL to be a claim for a covered employee with cancer under DOL
regulations at 20 CFR 30.210(b), subject to the limitation and
exception noted in Sec. 82.12. Claims for covered employees who are
members of the Special Exposure Cohort seeking compensation for a
specified cancer, as determined by DOL under 20 CFR 30.210(a), do not
require and will not receive a dose reconstruction under this rule.
Sec. 82.12 Will it be possible to conduct dose reconstructions for all
claims?
It is uncertain whether adequate information of the types outlined
under Sec. 82.14 will be available to complete a dose reconstruction
for every claim eligible under Sec. 82.11.
(a) NIOSH will notify in writing any claimants for whom a dose
reconstruction cannot be completed once that determination is made, as
well as in the closing interview provided for under Sec. 82.10(l).
(b) Notification will describe the basis for finding a dose
reconstruction cannot be completed, including the following:
(1) A summary of the information obtained from DOE and other
sources; and,
(2) A summary of necessary information found to be unavailable from
DOE and other sources.
(c) NIOSH will notify DOL when it is unable to complete a dose
reconstruction for the claimant. This will result in DOL producing a
recommended decision to deny the claim, since DOL cannot determine
probability of causation without a dose estimate produced by NIOSH
under this rule.
(d) A claimant for whom a dose reconstruction cannot be completed,
as indicated under this section, may have recourse to seek compensation
under provisions of the Special Exposure Cohort (see 20 CFR part 30).
Pursuant to section 3626 of EEOICPA, the Secretary of HHS is authorized
to add additional classes of employees to the Special Exposure Cohort.
Sec. 82.13 What sources of information may be used for dose
reconstructions?
NIOSH will use the following sources of information for dose
reconstructions, as necessary:
(a) DOE and its contractors, including Atomic Weapons Employers and
the former worker medical screening program;
(b) NIOSH and other records from health research on DOE worker
populations;
(c) Interviews and records provided by claimants;
(d) Co-workers of covered employees, or other witnesses with
information relevant to the covered employee's exposure, that the
claimant identified during the initial interview with NIOSH;
(e) Labor union records from unions representing employees at
covered facilities of DOE or AWEs; and,
(f) Any other relevant information.
Sec. 82.14 What types of information could be used in dose
reconstructions?
NIOSH will obtain the types of information described in this
section for dose reconstructions, as necessary and available:
(a) Subject and employment information, including:
(1) Gender;
(2) Date of birth; and,
(3) DOE and/or AWE employment history, including: job title held by
year, and work location(s): Including site name(s), building number(s),
technical area(s), and duration of relevant employment or tasks.
(b) Worker monitoring data, including:
(1) External dosimetry data, including external dosimeter readings
(film badge, TLD, neutron dosimeters); and,
(2) Pocket ionization chamber data.
(c) Internal dosimetry data, including:
(1) Urinalysis results;
(2) Fecal sample results;
(3) In Vivo measurement results;
(4) Incident investigation reports;
(5) Breath radon and/or thoron results;
(6) Nasal smear results; and,
(7) External contamination measurements.
(d) Monitoring program data, including:
(1) Analytical methods used for bioassay analyses;
(2) Performance characteristics of dosimeters for different
radiation types;
(3) Historical detection limits for bioassay samples and dosimeter
badges;
(4) Bioassay sample and dosimeter collection/exchange frequencies;
and,
(5) Documentation of record keeping practices used to record data
and/or administratively assign dose.
(e) Workplace monitoring data, including:
(1) Surface contamination surveys;
(2) General area air sampling results;
(3) Breathing zone air sampling results;
(4) Radon and/or thoron monitoring results;
(5) Area radiation survey measurements (beta, gamma and neutron);
and,
(6) Fixed location dosimeter results (beta, gamma and neutron).
(f) Workplace characterization data, including:
(1) Information on the external exposure environment, including:
Radiation type (gamma, x-ray, neutron, beta, other charged particle);
radiation energy spectrum; uniformity of exposure (whole body vs
partial body exposure); irradiation geometry; and work-required medical
screening x rays.
(2) [Reserved]
(g) Information characterizing internal exposures, including:
(1) Radionuclide(s) and associated chemical forms;
(2) Results of particle size distribution studies; and,
(3) Respiratory protection practices.
(h) Process descriptions for each work location, including:
(1) General description of the process;
(2) Characterization of the source term (i.e., the radionuclide and
its quantity);
(3) Extent of encapsulation;
(4) Methods of containment;
(5) Other information to assess potential for airborne dispersion.
Sec. 82.15 How will NIOSH evaluate the completeness and adequacy of
individual monitoring data?
(a) NIOSH will evaluate the completeness of an individual's
monitoring data provided by DOE through one or more possible measures
including, but not limited to:
(1) Comparisons with information provided by claimants, co-workers,
and other witnesses;
(2) Comparisons with available information on area monitoring,
production processes, and radiologic protection programs;
(3) Comparisons with information documented in the records of
unions representing covered employees;
(4) Comparisons with data available on co-workers; and
(5) Reviews of DOE contractor record systems.
(b) NIOSH will evaluate the instruments and procedures used to
collect individual monitoring data to determine whether they adequately
characterized the radiation environments in which the covered employee
worked, (adequately for the purpose of dose reconstruction,) based on
present-day scientific understanding. For external dosimeter
measurements, this includes an evaluation of the dosimeter response to
the radiation types (gamma, x-ray, neutron, beta, or other charged
particle) and the
[[Page 50990]]
associated energy spectrum. For internal exposure, the methods used to
analyze bioassay samples will be reviewed to determine their ability to
detect the radionuclides present in the work environment. An analysis
of the monitoring or exchange frequencies for the monitoring programs
will also be conducted to determine the potential for undetected dose.
Sec. 82.16 How will NIOSH add to monitoring data to remedy limitations
of individual monitoring and missed dose?
(a) For external dosimeter results that are incomplete due to
historical record keeping practices, NIOSH will use commonly practiced
techniques, such as those described in the NIOSH Research Issues
Workshop,\2\ to estimate the missing component of dose and to add this
to the total dose estimate. For monitoring periods where external
dosimetry data are missing from the records, NIOSH will estimate a
claimant's dose based on interpolation, using available monitoring
results from other time periods close to the period in question, or
based on monitoring data on other workers engaged in similar tasks.
---------------------------------------------------------------------------
\2\ NIOSH (1995). NIOSH research issues workshop: Epidemiologic
use of nondetectable values in radiation exposure measurements.
Cincinnati, OH: U.S. Department of Health and Human Services, Public
Health Services, Centers for Disease Control and Prevention,
National Institute for Occupational Safety and Health, DHHS (NIOSH)
Publication No. 224647 (NTIS-PB 95189601).
---------------------------------------------------------------------------
(b) NIOSH will review historical bioassay sample detection limits
and monitoring frequencies to determine, when possible, the minimum
detectable dose for routine internal dose monitoring programs. This
``missed dose'' will establish the upper limit of internal dose that a
worker could have received for periods when bioassay sample analysis
results were below the detection limit. Using ICRP biokinetic models,
NIOSH will estimate the internal dose and include an associated
uncertainty distribution.
Sec. 82.17 What types of information could be used to supplement or
substitute for individual monitoring data?
Three types of information could be used:
(a) Monitoring data from co-workers, if NIOSH determines they had a
common relationship to the radiation environment; or,
(b) A quantitative characterization of the radiation environment in
which the covered employee worked, based on an analysis of historical
workplace monitoring information such as area dosimeter readings,
general area radiation survey results, air sampling data; or,
(c) A quantitative characterization of the radiation environment in
which the employee worked, based on analysis of data describing
processes involving radioactive materials, the source materials,
occupational tasks and locations, and radiation safety practices.
Sec. 82.18 How will NIOSH calculate internal dose to the primary
cancer site(s)?
(a) The calculation of dose from ingested, inhaled or absorbed
radioactivity involves the determination of the types and quantities of
radionuclides that entered the body. NIOSH will use the results of all
available bioassay monitoring information as appropriate, based on
assessment of the technical characteristics of the monitoring program.
If bioassay monitoring data are unavailable, the dose reconstruction
will rely on the results of air sampling measurements.
(b) NIOSH will calculate the dose to the organ or tissue of concern
using metabolic models published by ICRP. Using data available to
NIOSH, the models will be based on exposure conditions representative
of the work environment. When NIOSH cannot establish exposure
conditions with sufficient specificity, the dose calculation will
assume exposure conditions that maximize the dose to the organ under
consideration.
(c) Internal doses will be calculated for each year of exposure
from the date of initial exposure to the date of cancer diagnosis.
Sec. 82.19 How will NIOSH address uncertainty about dose levels?
The estimate of each annual dose will be characterized with a
probability distribution that accounts for the uncertainty of the
estimate. This information will be used by DOL in the calculation of
probability of causation, under HHS guidelines for calculating
probability of causation estimates at 42 CFR part 81. In this way,
claimants will receive the benefit of the doubt in cases in which the
actual dose may have exceeded the best estimate calculated by NIOSH.
Subpart D--Reporting and Review of Dose Reconstruction Results
Sec. 82.25 When will NIOSH report dose reconstruction results, and to
whom?
NIOSH will report dose reconstruction results to DOL and to the
claimant, as provided for under Sec. 82.10. Draft results will be
reported to the claimant upon tentative completion of the dose
reconstruction. Final results will be reported to the claimant and DOL
after NIOSH receives certification from the claimant that the claimant
has completed providing information to NIOSH for the dose
reconstruction (Form OCAS-1).
Sec. 82.26 How will NIOSH report dose reconstruction results?
(a) NIOSH will provide dose reconstruction results to the claimant
and DOL in a report: ``NIOSH Report of Dose Reconstruction under
EEOICPA.'' The report itself will not provide information on
probability of causation, which DOL must calculate to determine a
recommended decision on the claim.
(b) The report will include the following information, as relevant:
(1) Annual dose estimates (or a fraction thereof) related to
covered employment for each year from the date of initial radiation
exposure at a covered facility to the date of cancer diagnosis;
(2) Separate dose estimates for acute and chronic exposures,
different types of ionizing radiation, and internal and external doses,
providing dose information for the organ or tissue relevant to the
primary cancer site(s) established in the claim;
(3) Uncertainty distributions associated with each dose estimated,
as necessary;
(4) Explanation of each type of dose estimate included in terms of
its relevance for estimating probability of causation;
(5) Identification of any information provided by the claimant
relevant to dose estimation that NIOSH decided to omit from the basis
for dose reconstruction, justification for the decision, and if
possible, a quantitative estimate of the effect of the omission on the
dose reconstruction results; and
(6) A summary and explanation of information and methods applied to
produce the dose reconstruction estimates, including any factual
findings and the evidence upon which those findings are based.
(c) As provided under Sec. 82.10(l), NIOSH staff will conduct a
closing interview with claimants to explain the dose reconstruction
report.
Sec. 82.27 How can claimants obtain reviews of their dose
reconstruction results by NIOSH?
Claimants can seek reviews of their dose reconstruction through the
processes established by DOL under 20 CFR part 30. DOL will request
NIOSH to review dose reconstructions under the following conditions, as
provided under 20 CFR 30.318:
(a) DOL may determine that factual findings of the dose
reconstruction do
[[Page 50991]]
not appear to be supported by substantial evidence; or,
(b) Although the methodology established by HHS under this Part is
binding on DOL, DOL may determine that arguments concerning the
application of this methodology should be considered by NIOSH.
Sec. 82.28 Who can review NIOSH dose reconstruction files on
individual claimants?
(a) Claimants and DOL will be provided individual dose
reconstruction files, upon request. Claimants should note, however,
that a complete summary of the data and methods used in a dose
reconstruction will be included in the ``NIOSH Report of Dose
Reconstruction under EEOICPA''.
(b) Researchers and the public will be provided limited access to
NIOSH dose reconstruction files, subject to provisions and restrictions
of the Privacy Act for the protection of confidential information on
individuals. Researchers will not receive names of claimants or covered
employees associated with dose reconstructions.
Dated: September 21, 2001.
Tommy G. Thompson,
Secretary, Department of Health and Human Services.
[FR Doc. 01-24879 Filed 10-4-01; 8:45 am]
BILLING CODE 4160-17-U