[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.

[[Page 50982]]

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