[Federal Register Volume 67, Number 85 (Thursday, May 2, 2002)]
[Rules and Regulations]
[Pages 22314-22336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-10763]


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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; Final 
Rule

AGENCY: Department of Health and Human Services.

ACTION: Final rule.

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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 final rule is effective May 2, 2002.
    Compliance Dates: Affected parties are required to comply with the 
information collection requirements in Sec. 82.10 May 2, 2002.

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. Background

A. Statutory Authority

    The Energy Employees Occupational Illness Compensation Program Act 
of 2000 (``EEOICPA''), 42 U.S.C. 7384-7385 [1994, supp. 2001], 
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 (i.e. cancer resulting from 
radiation exposure, chronic beryllium disease, or silicosis) incurred 
as a result of their exposures while in the performance of duty for the 
Department of Energy (``DOE'') 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 (20 CFR parts 1 and 30).
    The executive order directed the Department of Health and Human 
Services (``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 is 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

[[Page 22315]]

weapons facility. These guidelines were published as a notice of 
proposed rulemaking under 42 CFR Part 81 on October 5, 2001, and are 
being published as a final rule simultaneously with this rule 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, was appointed by the 
President in November 2001. It first convened on January 22, 2002, and 
is advising 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 at DOE or Atomic Weapons Employer 
facilities seeking 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 EEOICPA and DOL regulations (20 CFR 30), qualify for 
compensation under EEOICPA. Proposed HHS procedures for considering 
Special Exposure Cohort petitions will be published soon in the Federal 
Register. HHS will obtain public comment and a review by the Advisory 
Board on Radiation and Worker Health before these procedures are made 
final and implemented.
    As provided for under 42 U.S.C. 7384p, HHS is implementing its 
responsibilities with the assistance of NIOSH.

B. What Legal Requirements Are Specified by EEOICPA for Dose 
Reconstruction?

    EEOICPA requires that HHS establish, by regulation, methods for 
arriving at reasonable estimates of the radiation doses incurred by 
covered employees in connection with claims seeking compensation for 
cancer, other than as members of the Special Exposure Cohort. 42 U.S.C. 
7384n(d). These methods will be applied to estimate radiation doses for 
the following covered employees: (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 by the statute and appointed by the President which is 
advising HHS on its major responsibilities under EEOICPA.
    EEOICPA requires that DOE provide HHS with relevant information on 
worker radiation exposures necessary for dose reconstructions and 
requires DOE to inform covered employees with cancer of the results of 
their dose reconstructions. 42 U.S.C. 7384n(e) and 7384q(c). NIOSH, 
which will be conducting the dose reconstructions, will inform covered 
employees and DOE of the results of these dose reconstructions.
    Subject to provisions of the Privacy Act (5 U.S.C. 552(a)), HHS 
will also make available to researchers and the general public 
information on the assumptions, methodology, and data used in 
estimating radiation doses. 42 U.S.C. 7384n(e)(2).
    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 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 7384d 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

[[Page 22316]]

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 employees 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 will not 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 explained 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 under this rule use 
current models published by the International Commission on 
Radiological Protection (ICRP). Specifically, at this time 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 
currently 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 
Publicatiaon 66, Annals of the ICRP 24(1-4). Elsevier Scientific 
Ltd., Oxford.
    \2\ International Commission on Radological 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 described in Secs. 82.30-82.33 of the rule, NIOSH will address 
the need to update the scientific elements underlying dose 
reconstructions in a process that involves review by the Advisory Board 
on Radiation and Worker Health and permits and facilitates input from 
the public.

II. Summary of Public Comments

    On October 5, 2001, HHS promulgated an interim final rule issuing 
methods for conducting dose reconstructions under EEOICPA (42 CFR part 
82; see 66 FR 50978). Public comments were solicited initially from 
October 5, 2001 to November 5, 2001. The public comment period was 
reopened subsequently from January 17, 2002, to January 23, 2002; from 
January 17, 2002, to February 6, 2002, for comments from the Advisory 
Board on Radiation and Worker Health; and from February 14, 2002, to 
March 1, 2002.
    HHS received comments from 13 organizations and 23 individuals. 
Organizations commenting included several labor unions representing DOE 
workers, a community based organization, an administrative office of 
the University of California, several DOE contractors, and several 
federal agencies. A summary of these comments and HHS responses is 
provided below. These are organized by general topical area.

A. Purpose of the Rule

    HHS received various comments regarding the purpose of the rule.
    Several comments concerned the general issue of whether or not the 
rule includes sufficient technical detail. Several commenters 
recommended HHS specify the detailed assumptions and technical methods 
that might be used in a dose reconstruction. Another commenter 
supported retaining the general level of detail included in the interim 
rule. One commenter recommended the comment period on the rule remain 
open until the public has had opportunity to review the dose 
reconstruction technical procedures discussed in the interim final 
rule.
    The approach of this rule is to establish the principles, general 
procedures, and general criteria by which the NIOSH dose reconstruction 
program will operate. Very specific details about the technical 
procedures that may be involved in a dose reconstruction are 
established in NIOSH implementation guides and will be available for 
public review as discussed in this rule. These detailed technical 
procedures were presented in draft form

[[Page 22317]]

to the Advisory Board on Radiation and Worker Health on January 24 and 
February 13, 2002. Further detail will be established as standard 
operating procedures as procedural issues arise in performing dose 
reconstructions.
    This approach to regulation is necessary because the level of 
possible detail is far too great to encompass in a reasonably 
comprehensible regulation. Many specific circumstances that might arise 
in dose reconstructions either cannot be anticipated with reasonable 
certainty or cannot be identified and addressed without causing a great 
delay in the initiation of the dose reconstruction program, seriously 
harming claimants already awaiting decisions on compensation. This 
approach is appropriate because the public is provided a clear 
explanation of the general approach of the dose reconstruction 
procedures and the principles and criteria that will guide 
implementation of these procedures. And the public will have the 
opportunity to review the procedures set forth in the NIOSH 
implementation guides as they are developed and at any time thereafter.
    Several commenters requested HHS define what constitutes a 
``reasonable estimate'' of the radiation doses incurred by an employee. 
EEOICPA requires the dose reconstruction program to arrive at 
``reasonable estimates'' of these doses (42 U.S.C. 7384n(d)).
    HHS interprets this term to mean estimates calculated using a 
substantial basis of fact and the application of science-based, logical 
assumptions to supplement or interpret the factual basis. As discussed 
in the interim final rule, assumptions applied by NIOSH will give the 
benefit of the doubt to claimants in cases of scientific or factual 
uncertainty or unknowns.
    One commenter noted that the single purpose of dose reconstructions 
under EEOICPA is to support compensation decisions by DOL and 
recommended HHS clarify the limitations of the dose reconstruction 
findings arising from this circumstance.
    As discussed above and in the interim final rule, NIOSH is applying 
methods designed to support compensation decisions by DOL that are fair 
and as timely as possible. As a consequence, many of the NIOSH dose 
reconstruction results are likely to differ substantially from those 
that would be produced under a scientific research protocol, when the 
principal object is to produce maximally complete and precise 
estimates. Under the methods promulgated in this rule and consistent 
with the intent of Congress, NIOSH will give the benefit of the doubt 
to claimants when there is uncertainty or unknowns concerning radiation 
exposures. This will tend to overestimate radiation doses for 
employees, except for those employees for whom immediately available 
records reveal doses sufficiently high to produce a compensable level 
of probability of causation. For these employees whose dose levels can 
be immediately determined to be compensable, NIOSH will tend to 
underestimate their total cumulative doses by abbreviating the dose 
reconstruction process. Further dose reconstruction for these latter 
claimants, however, would be unnecessary and harmful. It would prolong 
the adjudication process without benefit to the claimant (since the 
abbreviated dose reconstruction has already estimated a compensable 
level of radiation dose), and at the cost of unnecessarily delaying 
dose reconstructions for other claimants.
    For the reasons discussed above, a dose reconstruction conducted by 
NIOSH will not always produce complete or best estimates of the actual 
doses received by an individual. HHS does not believe that the dose 
reconstruction results should be used for any purpose other than the 
probability of causation calculations required under EEOICPA.

B. Claimant Involvement

    HHS received various comments concerning the involvement of 
claimants in the dose reconstruction process and other related claims 
processes.
    Several commenters recommended that the claimant not be burdened 
with collecting the records needed for the dose reconstruction. Another 
commenter recommended that the claimant have an opportunity to 
contribute information for the dose reconstruction.
    The former comments appear to stem from a misunderstanding of the 
role of claimant interviews in the dose reconstruction process. As 
outlined in the interim final rule and this final rule, DOE will 
provide the records needed for dose reconstruction directly to NIOSH in 
response to requests by NIOSH. The claimant is generally not burdened 
with collecting dosimetry and related data.
    The purpose of the claimant interview is to capture any information 
or records available to the claimant that might not be initially 
identified by or available from DOE or AWEs; as well as information 
that would help NIOSH interpret DOE records, such as information on 
radiation dosimetry badge practices or placement of radiation area 
monitors or particulars of work practices; or information that might be 
missing from DOE records, such as radiation monitoring results, 
information connecting an employee with a radiation contamination 
incident, or medical records indicating the employee received medical 
treatment resulting from radiation exposure.
    The contribution of information from claimants (and also coworkers 
when the claimant is a survivor of a covered employee) is entirely 
voluntary. It is intended to improve, when possible and necessary, the 
dose reconstruction record that can be established using DOE records 
and the records and results of research conducted at DOE or AWE 
facilities or research evaluating the health of DOE or AWE employees.
    One commenter requested clarification of the interview options in 
cases when the claimant is a survivor.
    As noted above, when the claimant is a survivor, NIOSH will 
interview the claimant and will also attempt to interview one or more 
co-workers of the employee. HHS recognizes that survivors frequently 
will not know much, if anything, about working conditions, work 
procedures, or dosimetry practices at DOE facilities, even when the 
survivor is the spouse of an employee. Interviews with co-workers are 
intended to supplement information available from the survivor.
    One commenter recommended that when the federal compensation 
program of EEOICPA, administered by DOL, denies a cancer claim and the 
employee involved in the claim had a combination of radiation and 
chemical exposures, the federal government should itself submit a 
compensation claim on behalf of the claimant to the workers' 
compensation program in the state with jurisdiction. The commenter's 
intent is to reduce the burden on the claimant who has already filed 
for compensation once, under the federal EEOICPA compensation program.
    The federal government does not have legal authority to file 
compensation claims with state workers' compensation programs on behalf 
of nuclear weapons employees. On the other hand, the federal government 
has established a program to assist DOE contractor employees in 
obtaining compensation from state workers' compensation programs for 
any illnesses that may have been caused by toxic exposures at DOE 
facilities, including cancers potentially caused by a combination of 
radiation and chemical exposures or either of these types of exposures 
individually. The DOE Office of Worker Advocacy is authorized to 
conduct this program under Part D of

[[Page 22318]]

EEOICPA. The program includes the establishment of physicians panels, 
appointed by HHS, to evaluate the work-relatedness of such illnesses 
and the establishment of agreements between DOE and individual states 
to facilitate the consideration of these compensation claims.
    The public should note, however, that claimants under the federal 
EEOICPA compensation program are eligible to seek compensation from 
state workers' compensation programs regardless of the outcome of their 
federal claim. A decision by DOL to compensate a claimant under the 
federal program provides no guarantee, in and of itself, that a state 
compensation program will also compensate the claimant. These programs 
are legally and administratively independent, apart from any agreements 
that might be entered into by DOE and individual state workers' 
compensation programs.
    One commenter recommended NIOSH re-analyze completed dose 
reconstructions without a request by the claimant when NIOSH obtains 
new data or information that could substantially change the findings of 
the completed dose reconstruction. This comment is relevant to two 
foreseeable circumstances: (1) When NIOSH discovers records or 
information on previously unidentified or possibly underestimated 
radiation exposures at DOE or AWE facilities; and (2) when NIOSH 
modifies the scientific elements underlying dose reconstructions, such 
as the biokinetic models used to estimate internal radiation doses.
    HHS agrees with the comment and has added provisions under 
Sec. 82.27 of this rule to authorize NIOSH to review completed dose 
reconstructions on its own initiative, upon obtaining new information 
or changing scientific elements underlying dose reconstructions. HHS 
has targeted the added provisions to circumstances in which use of the 
new information or scientific element could increase the levels of 
radiation doses previously estimated, since the purpose of these 
provisions is to provide new information to DOL on claims that were 
denied based on outdated information.
    One commenter recommended that the federal government provide 
claimants with resources to obtain independent reviews of NIOSH dose 
reconstructions.
    HHS will not fund claimants to obtain independent reviews of dose 
reconstructions. EEOICPA already provides for an independent review of 
the NIOSH dose reconstruction program by the Advisory Board on 
Radiation and Worker Health, funded by HHS. This review will be 
periodic and include a sample of completed dose reconstructions. NIOSH 
will also establish several levels of quality assurance procedures 
integral to the dose reconstruction process. The proposal for HHS to 
fund further independent reviews is largely duplicative of these 
current efforts and hence, unlikely to benefit claimants or further 
improve the NIOSH dose reconstruction program.

C. Basics of Dose Reconstruction

    HHS received several comments addressing provisions on the basic 
approach of dose reconstructions described under Sec. 82.2 of the 
interim final rule.
    Several commenters were uncertain how to interpret the ``hierarchy 
of methods'' described under this section. The commenters were 
concerned that NIOSH might exclusively analyze monitoring data on 
individual workers, when such data are available, without taking under 
consideration other relevant data, such as area monitoring, information 
on monitoring practices and technology, or information on unrecorded 
exposures or missing records.
    It is first important to note, this section provides only a general 
outline on the basic approach of dose reconstructions. It is intended 
to introduce readers to the elementary concepts of dose reconstruction, 
which is why it is included in the ``Introduction'' subpart of the 
rule. Section 82.10 and following sections provide detail on the 
specific procedures NIOSH must follow in conducting a dose 
reconstruction.
    Second, the hierarchical use of dose reconstruction methods 
discussed in this section implicitly requires the consideration of data 
from various sources. The provision of this section which gives highest 
priority to individual monitoring data begins with the conditional 
statement: ``If found to be complete and adequate, individual worker 
monitoring data...are given the highest priority in assessing 
exposure.'' To evaluate whether individual monitoring data are complete 
and adequate, NIOSH may have to examine and consider the full scope of 
sources and types of data available and relevant, as described under 
the detailed procedural sections of the rule beginning with Sec. 82.10. 
NIOSH will have to examine other sources and types of data to properly 
interpret primary data, even when they are complete and adequate, as 
explained in Sec. 82.2.
    One commenter recommended HHS explain in detail in this section how 
NIOSH would evaluate data adequacy.
    As discussed above, this section is introductory and general. 
Section 82.15 of the rule explains in some detail how NIOSH will 
evaluate the completeness and adequacy of individual monitoring data. 
NIOSH has prepared implementation guides that provide additional 
detail, and will be preparing standard operating procedures as needed 
to address issues that arise as NIOSH conducts dose reconstructions. 
The implementation guides will be available to the public from the 
NIOSH addresses provided above and the standard operating procedures 
will also be made available as they are established.
    Several commenters requested HHS clarify the meaning of the 
expression used in this section: ``reasonable and scientific 
assumptions.'' This section explains that dose reconstructions use such 
assumptions in establishing default values to supplement existing data 
on workplace radiation exposures. This expression is intended to mean 
assumptions that follow logically from scientific experience and a 
factual basis. For example, dosimetrists assume that a process 
operating at different times or in different places but involving the 
same source term used under comparable conditions, controls, and 
practices will produce comparable radiation exposure levels and 
characteristics.
    One commenter suggested a substantive edit to the last sentence 
under Sec. 82.2(a), which provides an example of a situation in which a 
dose reconstruction would employ a worst case assumption to substitute 
for lack of information on the solubility of an inhaled material. The 
commenter recommended that HHS clarify in this example that the worst 
case assumption would be reasonable. HHS has clarified this sentence 
accordingly. The sentence now reads: ``For example, if the solubility 
classification of an inhaled material cannot be determined, the dose 
reconstruction would use the classification that results in the largest 
dose to the organ or tissue relevant to the cancer and that is possible 
given existing knowledge of the material and process.''

D. Who Receives Dose Reconstructions?

    HHS received various comments concerning who is eligible for dose 
reconstructions and the circumstances under which NIOSH would conduct a 
dose reconstruction.
    Several commenters suggested there may be covered employees who 
require dose reconstructions who do not fit

[[Page 22319]]

within the three statutorily-prescribed groups specified under section 
7384n(d)(1) of EEOICPA and reiterated under Sec. 82.3 of this rule to 
be eligible for dose reconstructions. The commenters recommended the 
rule should include all individuals filing compensation claims for 
cancer under EEOICPA.
    EEOICPA covers two groups of claims seeking compensation for 
cancer: claims seeking compensation under provisions of the Special 
Exposure Cohort and all others. Claims seeking compensation in the 
former group do not require dose reconstructions for DOL to adjudicate 
and hence DOL will not refer these claims to NIOSH for a dose 
reconstruction. Thus, the HHS rule should not be broadened to include 
all claims seeking compensation.
    Several other commenters stated that EEOICPA did not require dose 
reconstructions for employees who were monitored and for whom DOE has 
complete dose records. One commenter indicated that DOL should be able 
to use the dose of record from DOE instead of obtaining a dose 
reconstruction from NIOSH when the dose of record is sufficiently high 
to qualify the claimant for compensation.
    NIOSH is implicitly required by EEOICPA to evaluate the dose of 
record of every eligible claim, since without such an evaluation it 
could not be determined whether the monitoring data for the individual 
are complete and adequate. Moreover, the data provided in the dose of 
record from DOE are not in a form that can be used by DOL to calculate 
probability of causation. Nonetheless, HHS agrees that when the dose of 
record is itself very high, NIOSH should not expend resources on a dose 
reconstruction needlessly or cause unnecessary delay in DOL's 
adjudication of the claim. For this reason, the rule includes 
efficiency measures under Sec. 82.10 to limit the extent of the dose 
reconstruction depending on the circumstances. In the example given by 
the commenter, if the dose of record was evidently high enough to 
qualify the claimant for compensation, NIOSH would greatly abbreviate 
its effort, so that the claimant is not unnecessarily delayed in 
awaiting DOL to determine probability of causation and complete 
adjudication of the claim.
    One commenter questioned whether the definition of a ``covered 
employee'' under Sec. 82.5 is sufficiently inclusive. HHS specified 
more narrowly than EEOICPA that a covered employee, for the purposes of 
the HHS rules, is a DOE or AWE employee for whom DOL has requested HHS 
to perform a dose reconstruction.
    This distinction results practically from the separate 
responsibilities of DOL and HHS in implementing EEOICPA. DOL is solely 
responsible for initially reviewing each claim, evaluating whether the 
claim represents a covered employee with a covered illness, and 
determining whether or not the claim requires a dose reconstruction. 
The only claims DOL will forward to HHS for dose reconstructions are 
those for a cancer not covered by provisions of the Special Exposure 
Cohort. Hence, HHS retains its proposed definition in this rule to be 
clear that NIOSH will only conduct dose reconstructions under EEOICPA 
for the subset of claims submitted by DOL to HHS for dose 
reconstructions. This is intended to avoid the possible confusion and 
delay that would arise if claimants were to directly submit to NIOSH 
requests for dose reconstructions.
    One commenter recommended a change to the definition given in this 
rule for Atomic Weapons Employer (AWE). The commenter recommended the 
definition include entities that ``handled'' material that emitted 
radiation and include entities that processed, produced, or handled 
radiation-emitting equipment as well as material.
    The definition for AWE in the rule was established by Congress in 
EEOICPA. For a conclusive interpretation, the commenter should contact 
DOE, which is the only federal agency authorized to designate AWEs.
    One commenter recommended that HHS explain which employees at DOE 
or AWE facilities are not covered by EEOICPA and hence not eligible for 
dose reconstructions. The commenter specified Department of Defense 
employees as an example.
    As explained above, HHS does not determine whether an individual is 
a covered employee under EEOICPA. This is a responsibility of DOL. 
Potential claimants for individuals who worked at DOE or AWE facilities 
should consult with DOL to determine whether the individual might be a 
covered employee.

E. Establishing a Time Limit for Dose Reconstructions

    One commenter recommended HHS consider establishing a time limit 
for dose reconstructions.
    HHS is especially interested in ensuring that dose reconstructions 
are conducted on a timely basis, to allow the timely adjudication of 
claims by DOL. To this end, NIOSH is establishing performance standards 
for dose reconstructions that include time criteria for completion of 
dose reconstructions and for critical intermediate steps. And NIOSH is 
establishing capacity to conduct a high volume of dose reconstructions.
    It would not be in the interests of claimants, however, to 
establish rigid time requirements for dose reconstructions. A variety 
of parameters will affect the speed with which a dose reconstruction 
can be completed; these are not controlled or determined by NIOSH. For 
example: the first dose reconstructions conducted for employees at a 
particular facility or operation within a facility are likely to take 
longer than subsequent dose reconstructions, since a substantial 
factual basis relevant to the subsequent dose reconstructions will be 
established by the initial dose reconstructions; some facilities will 
have better organized and more accessible records than other 
facilities, making dose reconstruction more efficient; individual 
claims will require dose reconstructions that differ in complexity, 
depending on the employment history, the adequacy and completeness of 
the records available, and the radiation dose levels indicated by the 
records initially available; and the overall dose reconstruction 
program will become more efficient over time, as experience and data 
accrue to NIOSH, reducing the data collection phase of subsequent dose 
reconstructions.

F. Use of Records and Information

    HHS received a variety of comments concerning the use of records 
and information for dose reconstructions.
    Several commenters disagreed with HHS in requiring under 
Sec. 82.10(e) that for NIOSH to use information provided by the 
claimant, the information must be supported by ``substantial 
evidence,'' and not be ``refuted by other evidence.'' The commenters 
interpret the substantial evidence provision as placing the burden of 
proof on the claimant. They interpret the refutation provision as 
unfairly favoring information from DOE over information from the 
claimant.
    The provision concerning substantial evidence, when considered 
completely, should not place an unreasonable burden of proof on the 
claimant. The provision explains a variety of parameters that NIOSH 
will evaluate in determining whether information provided by the 
claimant is supported by substantial evidence. NIOSH, rather than the 
claimant, has the burden of conducting this evaluation, and most of the 
parameters relate to information held by NIOSH, rather than supplied by 
the claimant. The claimant may be requested to provide medical records, 
if relevant. Likewise, the claimant may be

[[Page 22320]]

able to identify coworkers who could confirm certain information 
provided by the claimant.
    The commenter did not indicate that any of the parameters NIOSH 
will consider, in evaluating information provided by the claimant, are 
unreasonable or unfair. Moreover, it would be irresponsible for NIOSH 
to make use of information provided by the claimant without considering 
its validity. In many cases, claimants and coworkers will be recalling 
procedures and conditions and incidents that occurred decades earlier.
    Similarly, HHS finds it reasonable to omit the use of information 
provided by a claimant that is refuted by other, more persuasive 
evidence available to NIOSH. If, for example, NIOSH establishes the 
period when a certain process was undertaken at a facility, based on a 
complete administrative record (purchase orders, shipment logs, 
production figures, etc.), this record might refute a claimant's 
recollection that a different process operated during this period.
    This provision does not, as suggested by the commenter, unfairly 
favor DOE information over that of the claimant. The dose 
reconstruction program established under this rule includes major 
elements to evaluate the adequacy and completeness of DOE or AWE 
records. A key purpose of NIOSH interviewing claimants and co-workers 
and making use of records from research and other sources, is 
specifically to support such an evaluation.
    Several commenters recommended NIOSH determine the availability of 
records from DOE facilities independently of DOE, versus relying on 
certifications by DOE as provided for under Sec. 82.10(h).
    As discussed in the rule, NIOSH will be determining the 
availability of records from a variety of sources, including NIOSH-
conducted and NIOSH-funded research, other researchers with experience 
at DOE facilities, and interviews with claimants and coworkers. 
Nonetheless, the DOE certifications are an important measure to assist 
NIOSH in ensuring it has employed as complete a record as possible in 
each dose reconstruction.
    Several commenters recommended NIOSH should be required to make use 
of data from NIOSH records in a dose reconstruction, versus having the 
option to do so, as provided for under Sec. 82.10 (a).
    NIOSH should not be compelled to make use of records from sources 
other than DOE in all dose reconstructions. There will be many dose 
reconstructions for which the records provided by DOE will be 
preferable for use in the dose reconstruction. NIOSH must have the 
discretion to use records from whichever source will support the 
completion of the highest quality dose reconstructions and timely dose 
reconstructions under efficiency measures, when applied.
    One commenter interpreted the text of Sec. 82.10(a) to limit the 
relevant types of information NIOSH would seek from DOE. The commenter 
recommended that this text be expanded to explicitly include all types 
of records, such as information on contamination incidents and work 
restrictions.
    HHS provides substantial detail under Sec. 82.14 on the types of 
data NIOSH will use, as necessary, in dose reconstructions. The text 
addressed by the commenter is intended to be general and inclusive.

G. Claimant and Coworker Interviews

    HHS received several comments concerning the claimant and coworker 
interviews covered under Sec. 82.10 of the rule.
    One commenter sought clarification about whom would be interviewed 
when the claimant is a survivor.
    When the claimant is a survivor, the claimant and one or more 
coworkers of the deceased employee may be interviewed, as necessary and 
possible. The interviews of coworkers are intended to substitute for 
information that would have been available from the employee.
    One commenter recommended that the claimant have multiple rounds of 
the closing interview, if the claimant provides additional information 
at these interviews that might be incorporated into the dose 
reconstruction.
    NIOSH will continue the closing interview until it is complete. The 
use of the term ``interview'' (singular) in this rule, for both the 
initial and closing interviews, is intended to cover as many interview 
sessions as required. NIOSH anticipates that the initial interviews 
will often be conducted over more than one session, allowing the 
claimant or coworker to recall information or, in the case of ill and 
aged individuals, to rest and recover between sessions. When claimants 
provide new information or notify NIOSH of the intent to obtain new 
information in closing interviews, these too will require multiple 
sessions to conclude.
    One commenter noted that the interviews will not meet the 
therapeutic or social counseling needs the claimant might require as a 
cancer patient.
    HHS agrees with the commenter. The interviewers will be sensitive 
to the perspectives of claimants but they will not be trained as 
counselors or therapists. This is outside the scope of these 
interviews.

H. Evaluating Exposure Characteristics

    HHS received one comment regarding Sec. 82.10(i), which describes 
generally that NIOSH will characterize internal and external exposure 
environments for parameters known to influence dose, as necessary, in 
conducting the dose reconstruction. A parameter for external dose is 
the non-uniformity and geometry of the radiation exposure, which 
relates to the fact that the location of a radiation source in relation 
to the worker can affect the level of exposure recorded by their 
radiation monitoring badge. The commenter asks how NIOSH will assess 
this factor.
    NIOSH will use process information available from DOE, an AWE, and/
or the claimant or coworkers to locate the worker in relation to the 
radiation source. NIOSH will use this information, along with 
conversion factors published by the ICRP and the International 
Commission on Radiation Units and Measurements, to calculate the level 
of radiation dose received based on the level recorded by the radiation 
badge. More details on this procedure will be provided in the NIOSH 
Implementation Guide for External Dose Reconstruction under EEOICPA, 
which will be available through the internet or direct addresses for 
NIOSH provided above.

I. Use of ICRP Models

    HHS received various comments concerning the use of ICRP models for 
calculating internal radiation doses.
    Most of the comments concerned differences between the use of the 
current ICRP models under this rule and the use of older ICRP models 
applied in DOE and other U.S. radiation protection programs. Commenters 
indicated that some of the older ICRP models produce higher dose 
estimates than current models, whereas other older ICRP models produce 
lower dose estimates than the current models. One commenter asserted 
these differences extend from one to two orders of magnitude (i.e., a 
difference of 10--100 times). Several commenters recommended that NIOSH 
use the dose of record, calculated using the older ICRP models, when 
these would produce a higher dose estimate. Another commenter 
recommended that NIOSH not diverge from the models used by DOE for 
radiation protection programs. Finally, one commenter recommended that 
NIOSH explain to claimants the difference between the doses estimated 
by NIOSH and the doses of record.

[[Page 22321]]

    As explained in the interim final rule and above, NIOSH is using 
current ICRP models because they represent improvements in the science 
of internal and external radiation dosimetry compared to older ICRP 
models. It is true that in some cases the current models will reduce 
the dose calculated and in other cases they will increase the dose 
calculated, but the differences should typically be far less than 
stated by the commenter. In any event, the estimates are more accurate 
when based on the current ICRP models.
    Moreover, it is not possible for NIOSH to use the dose of record 
from DOE, nor will it generally be possible to even compare the dose of 
record with the dose estimates produced by NIOSH. In general, the dose 
of record is not organ-specific, is not reported for the different 
forms of radiation required as an input for NIOSH-IREP, and applies to 
different time periods than the period from first exposure to the 
diagnosis of cancer, including 50 year committed doses, which are not 
useful for purposes of calculating probability of causation. These 
differences will be explained to the claimant in the final dose 
reconstruction report and during their closing interview.
    Several commenters recommended that NIOSH not rely exclusively on 
ICRP models, but allow the use of individual-specific models when 
available data are adequate.
    In rare individual cases the ICRP models will not be applicable, 
such as for workers with chronic emphysema, or who have undergone 
chelation therapy, or had their thyroids removed. Singular exposures 
might also fall outside the scope of ICRP models, such as a worker that 
inhaled metal tritides. In these cases, NIOSH will have to use 
alternate models or modify existing models. In all other cases, NIOSH 
will consistently apply the ICRP models, which are widely accepted and 
extensively peer-reviewed.
    One commenter questioned how NIOSH will handle cases for which the 
cancer is in a tissue not covered by existing ICRP models.
    In these cases, NIOSH will use the ICRP model that best 
approximates the model needed, while giving the benefit of the doubt to 
the claimant. For internal exposures, NIOSH will select the highest 
dose estimate from among the modeled organs or tissues that do not 
concentrate the radionuclide. This provision has been added to the rule 
under Sec. 82.18(b).
    One commenter questioned whether NIOSH intends to use original 
urine and fecal data and lung count data to recalculate the employee's 
dose.
    As outlined in this rule, NIOSH will be using original source data 
from DOE. These procedures are explained in detail in the NIOSH 
implementation guides for dose reconstruction, available from NIOSH 
through the internet or directly from the addresses provided above.
    One commenter recommended against using the ICRP weighting factors 
provided in Table 1 of Sec. 82.10(j) of the interim rule, which can 
differ from the weighting factors used by DOE in its radiation 
protection program. Another commenter suggested NIOSH obtain a peer-
review of these weighting factors. And a third suggested HHS remove 
Table 1 from the rule, since this would lock HHS into using these 
current ICRP weighting factors, some of which could change in future 
ICRP udpates.
    As discussed above with respect to use of ICRP models, NIOSH is 
using current ICRP weighting factors because they represent the best, 
thoroughly peer-reviewed, science. HHS agrees with the recommendation 
to remove Table 1, so that NIOSH can use new weighting factors at such 
time as ICRP updates them, without requiring HHS to re-promulgate a 
section of this rule. This is consistent with the overall construction 
of this rule, which allows NIOSH to update underlying scientific 
elements through a public process that does not require rulemaking.

J. Use of Efficiency Measures

    HHS received several comments addressing the use of efficiency 
measures under Sec. 82.10k this rule to enable NIOSH to complete dose 
reconstructions efficiently and on a timely basis for claimants. These 
measures are discussed in the summary of rule below.
    One commenter recommended against use of these measures out of 
concern that resulting dose reconstructions might provide the basis for 
appeals by claimants whose claims are denied. The same commenter was 
also concerned these dose reconstructions might cause difficulties if 
they were used as evidence in litigation between private parties.
    It is highly likely some denied claimants will contest the results 
of their dose reconstructions, regardless of whether or not their doses 
were reconstructed using efficiency measures. DOL has established an 
administrative process for claimants to object to recommended decisions 
under 20 CFR Part 30. The public should recognize, however, that the 
use of efficiency measures in these cases means the claim has been 
adjudicated using dose levels estimated on a worst-case basis. In other 
words, the claim has been assigned dose estimates that are likely to be 
substantially higher than the doses actually incurred by the covered 
employee. This same understanding, which will be clearly explained in 
the NIOSH dose reconstruction report for these claims, will be 
important to any litigation that might arise between private parties. 
HHS does not believe that the dose reconstruction results should be 
used for any purpose other than the probability of causation 
calculations required under EEOICPA.
    Several commenters recommended against NIOSH considering the level 
of probability of causation associated with dose information on claims, 
a recommendation which, if accepted, would effectively preclude NIOSH 
from applying any efficiency measures. One commenter indicated that 
consideration of probability of causation by NIOSH would detract from 
the credibility of NIOSH dose reconstructions. A second commenter 
reasoned it would be presumptive for NIOSH to evaluate probability of 
causation, when this is the role of DOL later in the adjudication 
process.
    NIOSH will not consider probability of causation on a routine 
basis, only for claims that evidently involve very high or low doses, 
as explained in the interim rule and this final rule. As HHS has 
explained above, without the use of efficiency measures HHS cannot 
complete dose reconstructions on a timely basis, which would harm all 
claimants, whether or not their claims are accepted. Furthermore, for 
the claims in which efficiency measures will be applied, it would be 
disingenuous to suggest NIOSH does not recognize the implications for 
probability of causation of the high or low doses that are evident.
    One commenter requested HHS define the meaning of the phrase under 
82.10(k): ``extremely unlikely to produce a compensable level of 
radiation dose.'' This phrase is used in the provision allowing the use 
of worst-case assumptions as an efficiency measure only for claims 
involving uncompensably low doses of radiation.
    Dose estimates sufficiently high to qualify a claimant for 
compensation definitively cannot be based on worst case assumptions 
employed as an efficiency measure to abbreviate research and analysis. 
Consequently, HHS has changed this phrase to be definitive. This 
provision now reads: ``Worst-case assumptions will be employed * * * to 
limit further research and analysis only for claims for which it is 
evident that further research and analysis will not produce a

[[Page 22322]]

compensable level of radiation dose (a dose producing a probability of 
causation of 50% or greater), because using worst-case assumptions it 
can be determined that the employee could not have incurred a 
compensable level of radiation dose.''

K. Types of Information To Be Used

    HHS received various comments addressing the types of information 
to be used by NIOSH in dose reconstructions. These comments primarily 
address provisions under Sec. 82.14 of the interim rule and this final 
rule.
    Several commenters recommended NIOSH include additional items under 
several of the types of information listed in Sec. 82.14. One of the 
commenters suggested NIOSH add an ``other'' option for each type of 
information, rather than specify each possibility.
    HHS has added an appropriate option for other, unspecified examples 
of information that NIOSH might use, where needed. This will avoid the 
risk of omitting a type of information that has not been considered but 
might be relevant.
    One commenter questioned how NIOSH would determine the radiation 
type using the summary radiation records produced by DOE.
    NIOSH is obtaining and using primary data on radiation sources, 
exposures, and doses, rather than the summarized data reported to 
employees. In cases in which NIOSH cannot identify the type of 
radiation, NIOSH will assume the radiation is of a type consistent with 
existing information and which results in a higher probability of 
causation, compared to the alternatives.
    One commenter recommended that NIOSH not assume that neutron 
exposures are chronic doses and that photon exposures are acute doses.
    The methods under this rule do not include any presumption of 
chronic or acute doses based on the radiation type. Doses will be 
characterized as chronic or acute based on the information available. 
If, however, NIOSH does not have information that distinguishes between 
chronic and acute doses, NIOSH will assume the type of dose that would 
result in a higher probability of causation.
    Several commenters recommended against HHS including medical 
screening x rays administered to nuclear weapons employees as a 
condition of employment. Similar comments were received on the HHS 
probability of causation notice of proposed rulemaking (42 CFR Part 
81), as well. Commenters argue that the benefit of these exposures 
justifies their attendant risks, and therefore they should not 
contribute to the acceptance of a claim for compensation.
    HHS will not exclude radiation exposures resulting from these 
medical screening x rays. The important factor in this decision is that 
the exposures were incurred ``in the performance of duty,'' as 
specified by EEOICPA. The employees were required to receive these x 
ray screenings and hence were exposed to radiation in the performance 
of duty.
    One commenter questioned how NIOSH would account for the doses 
associated with x ray administrations that were unsuccessful and thus 
had to be repeated, resulting in multiple doses. Similarly, the 
commenter asked whether individual factors affecting the x-ray dose 
would be taken into account, such as the weight of the employee.
    The rate of repeat exposures associated with unsuccessful 
administrations has been evaluated in the scientific literature. NIOSH 
will account for these rates in the uncertainty distribution for the 
medical x-ray dose. Generally, NIOSH will also use this approach to 
account for variation in individual factors affecting radiation dose. 
NIOSH will make use of information on individual factors when available 
and feasible, but expects such circumstances will be unusual.
    One commenter suggested HHS consider including the doses from 
diagnostic x rays that employees received in the treatment of work-
related injuries.
    EEOICPA authorizes HHS to account only for radiation exposures 
incurred by an employee in the performance of duty. The intent of 
Congress was to provide compensation for cancers arising from the 
unique radiation exposures incurred by covered employees in the 
performance of duty for U.S. nuclear weapons programs. Radiation 
exposures associated with medical treatment of work injuries are not 
incurred in the performance of duty and are not unique to the 
experience of nuclear weapons employees.
    Several commenters recommended NIOSH include radiation exposures to 
medical staff serving DOE or AWE facilities.
    NIOSH will include all radiation exposures incurred by covered 
employees in the performance of duty.
    Several commenters recommended NIOSH estimate non-covered radiation 
doses from community and personal exposures (e.g., sun, radon, 
diagnostic and therapeutic exposures in medical care). The commenters 
intended that DOL would adjust (reduce) probability of causation 
calculations to account for these non-covered exposures.
    The risks associated with these community and non-occupational 
exposures are already accounted for in the risk models DOL will use to 
calculate probability of causation. These are inherent in the 
background rates for cancer. DOL will not have access to personal data 
or related adjustment factors for the risk models that would be 
required to account for individual variation with respect to these non-
occupational radiation exposures.
    One commenter indicated that some of the information, particularly 
process information, that may be required by NIOSH for dose 
reconstructions will require substantial labor for DOE and its 
contractors to provide. The commenter indicated that DOE has not funded 
its contractors to provide this information and, hence, questions 
whether such information will be made available.
    HHS is aware that this program will make substantial informational 
demands on DOE and consequently on DOE contractors. NIOSH has 
experience obtaining information of types specified in the rule from 
DOE contractors for health studies on DOE populations. HHS, DOE, and 
DOE contractors are currently working together to collect records 
presently needed for dose reconstructions and to improve record and 
information collection procedures for dose reconstructions. The goal of 
the agencies is to establish procedures that are practical and 
efficient while ensuring NIOSH can complete high quality dose 
reconstructions on a timely basis.

L. Evaluating the Completeness and Adequacy of Records

    HHS received several comments regarding the procedures by which 
NIOSH is evaluating the completeness and adequacy of records available 
for a dose reconstruction, under provisions of Sec. 82.15.
    One commenter recommended the rule address the problem of 
incomplete dose records.
    This is one of the principal reasons for conducting a dose 
reconstruction. The interim final rule and this final rule directly 
address this issue under Sec. 82.15. NIOSH is determining when dose 
records are incomplete through comparisons between records available 
from DOE or the AWE and information provided by the claimant, 
coworkers, and the variety of other sources available. Sections 82.2, 
82.10, 82.16, and 82.17 generally address how NIOSH will conduct dose 
reconstructions making use of limited records and information.

[[Page 22323]]

    Several commenters questioned how NIOSH would weigh potentially 
conflicting evidence from different sources.
    NIOSH will conduct these evaluations on a case-by-case basis, 
evaluating the weight of the evidence from different sources. The NIOSH 
evaluation will be fully documented in the NIOSH dose reconstruction 
report provided to the claimant, DOL, and DOE. There are no strict 
criteria to be applied to this purpose. As Sec. 82.10(e) states, NIOSH 
will accept claimant information supported by substantial evidence, 
unless ``refuted'' by other evidence, which in the case of conflicting 
evidence places the burden on other sources to refute the claimant's 
information.
    For example, a claimant might assert involvement in a contamination 
incident that cannot be confirmed by DOE records addressing the 
incident. NIOSH might accept this assertion if it is consistent with 
work history information, claimant provided details about the incident, 
co-worker recollections, or other investigations of the incident (e.g., 
during research). Evidence that certain DOE records are incomplete or 
inaccurate is likely to weigh against reliance on such records.
    As NIOSH develops approaches to address conflicting evidence in 
dose reconstructions, NIOSH will document those that can be 
incorporated into standard operating procedures. NIOSH will make these 
available to the public through the NIOSH addresses provided above.
    One commenter raised concerns about possible recall difficulties 
and bias of employees with respect to past exposure incidents and 
conditions.
    It is well recognized from health, behavioral, and social research 
that there are substantial limitations and variation in the ability of 
people to accurately recall past events, and that these limitations 
generally increase with the time elapsed since the past event. However, 
all of the sources of information available to NIOSH in conducting dose 
reconstructions potentially involve substantial limitations. To conduct 
dose reconstructions, NIOSH will apply procedures available to it to 
mitigate these limitations to the extent possible. To improve the 
recall of employees, NIOSH will inform the employee of information 
available from employment and dosimetry records. NIOSH will also 
compare information obtained from the employee with other sources of 
information, such as coworkers or DOE records.
    One commenter recommended that the rule require concurrence with 
NIOSH by DOE and its contractors when NIOSH finds that individual 
monitoring data from DOE records are either incomplete or inadequate. 
The commenter was concerned that the complex information available from 
DOE might be misinterpreted by NIOSH.
    Under EEOICPA, NIOSH alone is authorized to determine which data to 
use in a dose reconstruction and how to interpret them. NIOSH will work 
closely with DOE and its contractors, however, to obtain the most 
useful and complete data available, which will ensure dose 
reconstructions are of the highest possible quality.

M. Remedying Limitations of Monitoring and Missed Dose

    HHS received various comments regarding how NIOSH would remedy 
limitations of monitoring and missed dose, including unmonitored doses. 
These comments relate to provisions of the interim final rule and this 
final rule under Secs. 82.16-82.18.
    Several commenters recommended NIOSH use coworker external 
monitoring data for a similarly exposed worker whose records omit such 
information. One of the commenters recommended that NIOSH 
preferentially use coworker data over data from area monitoring.
    The interim final rule and this final rule provide for NIOSH to use 
coworker data under Secs. 82.16 and 82.17. Use of coworker data depends 
on its availability and the extent to which coworkers shared similar 
exposures. Nonetheless, NIOSH will review area monitoring data to 
evaluate the adequacy of the personal dosimetry.
    Several commenters recommended NIOSH consider all relevant data, 
not only air sampling results, to estimate internal doses when 
biomonitoring data are unavailable. Another commenter indicated concern 
about the quality of early biomonitoring data.
    HHS agrees with the comments and recognizes the limitations of 
early biomonitoring data, which can be addressed. HHS has revised 
Sec. 82.18 to reflect the intent of NIOSH to consider all sources of 
relevant data to interpret or substitute for biomonitoring data.
    Several commenters advised concerning Sec. 82.16 that NIOSH cannot 
estimate missed dose by summing potential doses using the limit of 
detection of monitoring equipment. Missed dose is a term applied to the 
dose that is potentially undetected because of the detection limits of 
monitoring technology and procedures.
    Indeed, as indicated in this section, NIOSH will not sum potential 
doses to estimate missed dose; only to estimate the upper limit of 
missed dose. Missed dose will be evaluated statistically using standard 
dose reconstruction procedures, as detailed in the NIOSH implementation 
guide for reconstructing external doses.
    The commenters also remarked that NIOSH should consider the reason 
for missing records and generally the problem of noncompliance with 
official DOE procedures.
    These issues are important but separate, concerning the 
completeness and adequacy of records, and are addressed under 
Sec. 82.15.
    One commenter indicated concern that NIOSH might indiscriminately 
assign missed doses to employees, even if their work did not require 
them to enter areas of potential radiation exposure. Similarly, the 
commenter was concerned that NIOSH might not understand that certain 
employees were not monitored because they did not have potential 
radiation exposure.
    NIOSH is experienced in dose reconstruction and fully understands 
the variety of conditions of work at DOE and other nuclear weapons 
production facilities. NIOSH will evaluate the potential for radiation 
exposure in the work activities and locations of the employee and will 
not indiscriminately estimate missed dose for periods when monitored 
workers lack detected exposures, or indiscriminately estimate doses for 
unmonitored workers. Dose reconstructions will be based on the 
conditions and radiation levels of the areas in which the individual 
worked.
    One commenter recommended HHS identify radioactive contamination 
surveys as a source of information that may be used to supplement or 
substitute for individual monitoring data, under Sec. 82.17.
    HHS has revised this section of the rule to explicitly include 
these surveys, as intended.

N. Accounting for Uncertainty

    HHS received several comments concerning issues of statistical 
uncertainty and its ramifications for the dose reconstructions.
    Several commenters recommended NIOSH characterize uncertainty over 
the entire period of interest rather than estimating uncertainty 
parameters for each annual dose estimate. They reasoned that this would 
reduce uncertainty.
    NIOSH-IREP requires annual dose estimates with individual 
uncertainty parameters to calculate probability of causation. Since 
NIOSH-IREP uses

[[Page 22324]]

Monte-Carlo techniques to combine uncertainties, the propagated 
uncertainty based on annual uncertainties will be less than if the 
annual uncertainties were simply added. This issue will be addressed in 
detail in the NIOSH implementation guides.
    Several commenters indicated the dose reconstructions would be 
unfairly biased in favor of internally exposed workers. The commenters 
assumed there would be more uncertainty associated with internal doses.
    The extent and characteristics of uncertainty will differ on a 
case-by-case basis, depending on the completeness and adequacy of 
records and monitoring. Uncertainty will not always be greater for 
internal dose estimates. It is true, however, that a substantial degree 
of uncertainty is inherent to internal dose calculations. This is a 
scientific limitation without any remedy.
    Several commenters questioned at what point uncertainty associated 
with a dose reconstruction would be too great to be considered 
``reasonable.'' EEOICPA requires ``reasonable estimates'' of radiation 
doses. 42 U.S.C. 7384n(d)(1).
    As explained above, HHS interprets this term to mean estimates 
calculated using a substantial basis of fact and the application of 
science-based, logical assumptions to supplement or interpret the 
factual basis. Claimants will in no case be harmed by any level of 
uncertainty involved in their claims, since assumptions applied by 
NIOSH will consistently give the benefit of the doubt to claimants. 
Hence, the level of uncertainty is not an issue whenever there is a 
sufficient factual basis to establish the radiation source type and 
quantity and a basic understanding of the process in which the employee 
worked. This information can provide the basis for a reasonable 
estimate. When this basic information is lacking, however, then NIOSH 
may not be able to establish reasonable estimates. As discussed below, 
when NIOSH lacks sufficient information to complete dose 
reconstructions, claimants will be informed of procedures for 
petitioning HHS under the proposed Special Exposure Cohort procedures, 
which will be published soon in the Federal Register.

O. Completing and Reporting Dose Reconstructions

    HHS received several comments concerning the procedures by which 
NIOSH completes and reports dose reconstructions. These address 
Secs. 82.25 and 82.26 of the interim final rule and this final rule.
    One commenter recommended HHS establish a procedure for claimants 
who refuse to certify that they have completed providing information 
for the dose reconstruction, by refusing to sign the form OCAS-1. NIOSH 
requires this certification to close the record and conclude the dose 
reconstruction.
    The interim final rule and this final rule include a provision 
under Sec. 82.10(n) to address these circumstances. Claimants will have 
at least 60 days to sign OCAS-1. After the 60 days and after notifying 
the claimant or the authorized representative, NIOSH will 
administratively close the dose reconstruction for a claimant who, 
without good cause as described below, steadfastly refuses to sign 
OCAS-1. This provision will not be applied, however, while a claimant 
is attempting to obtain additional information relevant to the claim, 
notified NIOSH of this fact, and clearly specified the information 
being sought.
    One commenter recommended that NIOSH clarify that internal doses 
will only be estimated for the primary cancer sites covered in the 
claim.
    HHS agrees with this comment and has clarified the relevant 
provision under Sec. 82.26(b)(2).
    Several commenters recommended NIOSH not report separate doses for 
different radiation types, dose patterns, and other parameters, because 
these specifics may not be meaningful to claimants.
    NIOSH must provide this detailed information to DOL to calculate 
probability of causation. HHS believes this information will also be 
meaningful to claimants, since it is the precise basis for their 
probability of causation determination by DOL. NIOSH will explain this 
information to the claimant in the final dose reconstruction report and 
the closing interview, as provided for under Secs. 82.10 and 82.26 of 
the interim final rule and this final rule.
    One commenter requested that HHS define the term: ``as necessary,'' 
used under Sec. 82.26(b)(3) with respect to specifying uncertainty 
distributions associated with each dose estimated. The term is used in 
this provision because uncertainty distributions will not be applied to 
all doses estimated. Doses estimated using worst-case assumptions will 
not involve uncertainty.
    Several commenters questioned the basis for NIOSH notifying 
claimants of the results of its dose reconstructions on behalf of DOE, 
as indicated in the interim final rule. EEOICPA includes a requirement 
that DOE inform employees of the results of dose reconstructions under 
EEOICPA. 42 U.S.C. 7384n(e)
    HHS has proposed to DOE that it would inform claimants of dose 
reconstruction results on behalf of DOE to avoid duplication of effort 
and an unnecessary expenditure of federal resources. This arrangement 
can be established by agreement between the two federal agencies and 
would fulfill the statutory requirement. DOE may decide, however, to 
reserve this authority to itself and inform its employees independently 
of NIOSH. HHS has omitted the term ``on behalf of DOE'' in this final 
rule to allow DOE to reserve this authority to itself.

P. Reviews of Dose Reconstructions or Dose Reconstruction Methods

    HHS received several comments concerning the review of NIOSH dose 
reconstructions.
    One commenter recommended HHS describe the review process at NIOSH, 
as provided for under Sec. 82.27, in greater detail.
    The rule includes additional provisions describing that reviews can 
be initiated by NIOSH as well, as discussed above. HHS has also added 
provisions to this section to clarify that NIOSH will report on the 
review to the claimant, DOL, and DOE, describing the basis for the 
review, the methods applied and the results. However, HHS has not 
specified the details of review processes. These are likely to vary 
substantially, depending on the basis for the review and the issues 
that must be addressed. Review processes are likely to vary from 
simple, in which a NIOSH staff person or contractor makes identified 
technical or factual corrections, to extensive, requiring previously 
uninvolved NIOSH employees, contractor staff, or independent experts to 
collect additional data and re-conduct elements of a dose 
reconstruction. Standard operating procedures for different types of 
reviews will be established as needed, and made available to the 
public. In every case, however, it will be in the agency's interest to 
conduct an appropriate and credible review, since the review will be 
examined by DOL in order to exercise its discretion concerning whether 
the claim should be reopened.
    One commenter requested clarification of the review rights of DOL 
with respect to NIOSH dose reconstructions. Specifically, the commenter 
appeared to seek further explanation of the provision under 
Sec. 82.27(a) of the interim final rule and this final rule, which 
reads as follows: ``(2) although the methodology

[[Page 22325]]

established by HHS under this Part is binding on DOL, DOL may determine 
that arguments concerning the application [emphasis added] of this 
methodology should be considered by NIOSH.''
    This provision sets forth DOL's regulatory description of the scope 
of the review performed by DOL in considering objections to recommended 
decisions. Further clarification of that provision should come from 
DOL.
    One commenter recommended that NIOSH provide the draft dose 
reconstruction report to DOE for its review, prior to concluding the 
dose reconstruction. The commenter indicated that the familiarity of 
DOE with its own records makes it uniquely able to review the use of 
its data in the dose reconstruction.
    Under EEOICPA, Congress and the President specifically intended 
that the role of DOE in dose reconstructions be limited to providing 
records and information, and that an agency in a separate federal 
department conduct the dose reconstructions. The intent was to ensure 
that the agency conducting the dose reconstructions would have no 
actual or perceived interest in their outcomes. HHS has not authorized 
DOE to review NIOSH dose reconstructions because such a measure would 
conflict with this intent. The public should also be assured that 
NIOSH, which has the lead federal role in health research on DOE 
employees, is highly expert on DOE operations, records, and dosimetry 
practices.
    One commenter recommended this rule specify the percentage of NIOSH 
dose reconstructions to be reviewed by the Advisory Board on Radiation 
and Worker Health. A second commenter recommended this rule specify the 
procedures to be applied by the Board in their review.
    As described above under the discussion of statutory provisions 
related to this rule, EEOICPA requires the Board to conduct an 
independent review of a sample of NIOSH dose reconstructions. 42 U.S.C. 
7384n(d). Since this review is specified to be independent, the Board, 
rather than HHS, must determine the procedures for the Board's review 
of NIOSH dose reconstructions. Moreover, this level of autonomy is 
important for the credibility of the review.
    One commenter recommended NIOSH obtain peer review of the detailed 
dose reconstruction methods used under this rule but not specified in 
this rule. These methods are described in the NIOSH implementation 
guides for dose reconstructions and will be further specified as NIOSH 
develops standard operating procedures, as needed.
    NIOSH is obtaining peer review of specific implementation 
procedures for dose reconstructions by the Advisory Board on Radiation 
and Worker Health, which is authorized under EEOICPA to review these 
methods. 42 U.S.C. 7384n(d). In addition, NIOSH will obtain reviews 
from independent subject matter experts as necessary, and may also seek 
reviews periodically by other standing scientific bodies, such as the 
National Academy of Science.

Q. When Information Is Inadequate To Complete a Dose Reconstruction

    HHS received several comments concerning NIOSH actions when it 
cannot complete a dose reconstruction due to inadequate data, as 
provided for under Sec. 82.12 of this rule.
    Several commenters requested HHS to define the circumstances under 
which information would be inadequate to complete a dose 
reconstruction. One of the commenters recommended HHS establish a 
``checklist'' of potential informational sources that would serve as 
standardized criteria for determining whether information is adequate 
to complete a dose reconstruction.
    HHS does not expect this situation to arise frequently. In some 
cases, limited information about the radiation source term (type and 
quantity of radioactive material) and the process in which it was used, 
without any individual monitoring records, will be sufficient to 
complete a dose reconstruction, particularly when the potential level 
of radiation that was emitted is extremely low. In these cases, NIOSH 
can make use of worst case assumptions to fully account for the highest 
possible radiation doses that might have been incurred.
    Simplifying assumptions become more difficult to apply, however, 
when the potential level of radiation exposure for an individual ranges 
greatly, particularly when they range from low levels to potentially 
compensable levels (levels that produce a probability of causation of 
50% and above). In these circumstances, the ability of NIOSH to 
complete the dose reconstruction depends on the extent and quality of 
information available to substitute for monitoring data. This can be 
readily defined on a case-by-case basis but not using rigid criteria; 
the potential circumstances are not readily foreseeable. As explained 
in the interim final rule and in this final rule, when NIOSH cannot 
complete a dose reconstruction, the basis for this result will be 
clearly explained in a report to the claimant, DOL, and DOE.
    When NIOSH cannot complete a dose reconstruction, one commenter 
recommended HHS automatically provide any necessary forms required by 
the claimant to file a petition for addition of a class of employees to 
the Special Exposure Cohort. A second commenter recommended HHS file 
the petition on behalf of the employee.
    HHS agrees with the proposal to supply the claimant with 
information needed to file a petition with HHS, and has included this 
as a new provision in the final rule. HHS will not, however, file a 
petition to HHS on behalf of the claimant. EEOICPA requires that a 
petition be filed by a class of employees. 42 U.S.C. 7384q.

R. Definitions of Terms

    One commenter recommended HHS provide a more specific definition in 
the rule for the term ``uncertainty distribution.''
    This definition is intended to be general. Various forms of 
uncertainty distributions are relevant to the definition, including 
unique, unspecifiable forms derived from Monte Carlo simulations.

S. Special Exposure Cohort

    HHS received several comments that provide recommendations, 
criteria, or concerns related to adding members to the Special Exposure 
Cohort established under EEOICPA. These comments fall outside the scope 
of this rule and address related but separate procedures to be 
established by HHS.
    As discussed above, HHS is proposing procedures by which it will 
consider petitions by classes of employees at DOE or AWE facilities to 
be added to the cohort, with the advice of the Advisory Board on 
Radiation and Worker Health. These procedures will be published soon in 
the Federal Register. The proposed HHS procedures and their 
accompanying explanation will address the comments received and 
directly solicit additional public comments, which HHS will fully 
consider in establishing final procedures.

III. Review and Recommendations of the Advisory Board on Radiation 
and Worker Health

    HHS requested the Advisory Board on Radiation and Worker Health to 
review these HHS methods of dose reconstruction. The Board reviewed the 
methods during public meetings on January 22-23 and February 13-14, 
2002. In preparation for the meetings, the Board members individually 
reviewed the interim final rule as well as the HHS notice of proposed

[[Page 22326]]

rulemaking proposing guidelines for determining probability of 
causation (42 CFR Part 81), which will be applied by DOL using the 
radiation doses estimated under these methods. The members also 
reviewed public comments on these rules. In addition, NIOSH staff 
members gave formal presentations on the HHS rules, implementation 
procedures, and related issues during the Board meetings. The 
transcripts and minutes of these meetings are included in the NIOSH 
docket for this rule and are available to the public.
    All of the Board members participated in the review of these 
guidelines and they unanimously concurred in establishing the Board 
findings and recommendations. The Board provided general findings 
addressing the general questions for public comment HHS identified in 
the notice for proposed rulemaking. The Board also provided 
recommendations addressing details of the rule. The findings and 
recommendations are provided below, together with responses by HHS to 
the recommendations:

A. General Comments of the Board Responding to HHS Questions

    ``Interim proposed rule 42 CFR, part 82, makes appropriate use of 
current science in reconstruction of radiation dose scenarios to the 
extent practicable. The Board recognizes that if the efficient and 
expeditious consideration of claims is to be made, absolute precision 
is not possible. The methods proposed are intended to result in dose 
estimates favorable to the claimants and are appropriate to the 
occupational illness compensation program envisioned by the Energy 
Employees Occupational Illness Compensation Program Act (EEOICPA).
    The process for involving the claimant is fair and provides 
multiple opportunities for interaction with the involved agencies. 
Indeed, in cases where acceptably dependable personal exposure data do 
not exist, NIOSH will utilize other sources of information as the basis 
for dose reconstruction. This approach unavoidably introduces 
additional uncertainty into the calculation of dose. However, we view 
the proposed methods as being appropriate for the available 
information. There will be circumstances where NIOSH will not be able 
to estimate the dose with sufficient accuracy. Those circumstances need 
to be clarified in the implementation of the regulation and in the 
Board's review of NIOSH's dose reconstruction work. Groups whose 
exposure cannot be estimated with sufficient accuracy may be candidates 
for the Special Exposure Cohort.''

B. Specific Comments and Recommendations of the Board:

    Board Comment #1: ``The Advisory Board recommends that Section K of 
Part III, `background' concerning changes to scientific elements 
underlying the dose reconstruction process be moved to the main body of 
the Rule so as to formalize the updating process including the role of 
the Advisory Board. The rule does an admirable job of providing an 
objective process for conducting dose reconstruction. However, the 
assessment of the adequacy of the exposure information will involve 
professional judgment, and thus, some subjectivity. The Board plays an 
important role through its review of such decisions on dose 
reconstructions, and that role needs to be included in the main body of 
the Rule. Although this role is included in the Preamble `Background' 
(Section III, Subsection K) of 42 CFR Part 82, making it part of the 
rule itself would formalize the change process, significantly 
strengthening assurance that review by the Advisory Board of proposed 
changes will occur.''
    HHS Response: HHS accepts this recommendation by the Board. 
Accordingly, as discussed above in response to public comments on peer-
review, HHS has moved provisions for peer-review involving the Board 
from the preamble of the notice of proposed rulemaking into the body of 
the rule itself. These provisions can be found at 42 CFR 82.30-82.33 
(Subpart E).
    Board Comment #2: ``The Advisory Board requests that the term 
`validated', as used in Section 82.10(j), be either defined or 
clarified.''
    HHS Response: HHS has clarified this section by eliminating any 
reference to validation, which has a specific meaning in scientific 
work which was not intended. The point of the text, which is now 
revised, was to indicate that NIOSH would determine that these data are 
assigned correctly and complete, before developing the exposure matrix 
discussed under the provision.
    Board Comment #3: ``The Advisory Board recommends that NIOSH 
clarify 82.10(m), (n), and (o) in regards to the steps and timeline 
required for the claimants, or authorized representatives of the 
claimants, to provide information to NIOSH and to sign or submit form 
OCAS-1. NIOSH should ensure that the claimants, or authorized 
representatives of the claimants, have adequate time to obtain and 
submit additional information to NIOSH.''
    HHS Response: HHS has revised Secs. 82.10(l), (m), and (n) to 
clarify the procedure and time for the claimants or their authorized 
representatives to provide final information and sign and submit form 
OCAS-1, permitting NIOSH to complete the dose reconstruction. The new 
provisions clarify that NIOSH may allow claimants time to obtain and 
provide NIOSH with additional relevant information, after NIOSH has 
provided to the claimant OCAS-1, and before the 60 day deadline to 
submit OCAS-1 is applied. The public should also note that claimants 
will not receive OCAS-1 for signature before they have completed their 
initial interview session or sessions, received a summary of their 
initial interview for their review and revisions, and received for 
review a draft dose reconstruction report.
    Board Comment #4: ``The Advisory Board recommends that Sec.  82.18, 
concerning the use of ICRP models, be clarified so as to clearly 
indicate that NIOSH intends to use current ICRP models.''
    HHS Response: HHS has clarified its intent to use current ICRP 
models in the text of this section, consistent with discussion of this 
provision in the preamble of the interim final rule and this final 
rule.
    Board Comment #5: ``The Advisory Board recommends that the last 
sentence in Sec.  82.28 (b), be clarified in regards to the coverage of 
the Privacy Act.''
    HHS Response: The Board was concerned that the rule does not 
clearly indicate that certain researchers who follow specific 
procedures under the Privacy Act to protect confidential information 
may have access to names of claimants, covered employees, and other 
confidential information. HHS has clarified the text of this provision 
accordingly.

IV. Summary of the 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

[[Page 22327]]

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.
    The definition of EEOICPA has been revised to reflect the 
codification of the Act in the United States Code.

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 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 will not produce a compensable level of 
radiation dose.
    Section 82.10(j) has been revised, as indicated above in the 
discussion of public comments, to remove Table 1--Radiation Weighting 
Factors from the rule. Instead, this section simply indicates NIOSH 
will use current ICRP weighting factors. Inclusion of this table in the 
rule would require HHS to re-promulgate this section of the rule and 
the table as these weighting factors are updated by ICRP.
    Sections 82.10(l), (m), and (n) have been revised, as indicated 
above in the discussion of recommendations by the Advisory Board on 
Radiation and Worker Health, to clarify the opportunity for the 
claimant to provide additional information to NIOSH after NIOSH has 
provided the claimant with a draft dose reconstruction report. The 
revisions also clarify the application of a 60 day deadline for the 
claimant to certify that they have completed providing information, 
such that NIOSH can conclude the dose reconstruction.
    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. NIOSH will provide 
claimants for whom it cannot complete a dose reconstruction any 
information and forms provided by HHS for classes of employees to 
petition HHS. HHS is establishing procedures to consider such 
petitions, as required under Section 7384q of EEOICPA and Section 2(b) 
of E.O. 13179. Proposed

[[Page 22328]]

procedures will be published soon in the Federal Register.
    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. HHS has revised these 
sections in response to public comments discussed above to ensure the 
types of information that might be used in dose reconstructions under 
this rule include any possibilities HHS has not specified.
    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.
    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 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.
    As discussed in response to public comments above, HHS has added 
new language to Sec. 82.18 to specify how NIOSH will select from among 
existing ICRP models to calculate internal dose for a cancer site that 
has not been addressed by ICRP.

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.
    As discussed above in response to public comments, HHS has revised 
this section to allow NIOSH to review completed dose reconstructions on 
its own initiative, in response to new information or scientific 
updates that could substantially increase the radiation doses NIOSH had 
estimated. HHS also revised this section to clarify that NIOSH will 
report to claimants, DOL, and DOE on NIOSH reviews of completed dose 
reconstructions conducted under this section.

Updating the Scientific Elements Underlying Dose Reconstructions

    Section 82.30-82.33 describe the procedures NIOSH will follow to 
update the scientific elements underlying NIOSH dose reconstructions to 
maintain a dose reconstruction program that is reasonably current with 
progress in science. An example of such an update would be the 
incorporation of a newly published ICRP model for estimating internal 
dose. Updates may also be recommended by the public at any time.
    The Advisory Board on Radiation and Worker Health will consider all 
proposals for updates in its public meetings, and the public will have 
an opportunity to comment on the proposals. To facilitate public 
participation, NIOSH will periodically publish a notice in the Federal 
Register informing the public of proposed updates, as well as notifying 
the public of proposed updates to be considered at upcoming meetings of 
the Advisory Board. NIOSH will also publish a notice in the Federal 
Register notifying the public of the completion of updates. In the 
notice, NIOSH will address relevant public comments and recommendations 
from the Advisory Board.

V. 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 
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 section 
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.

VI. 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

[[Page 22329]]

flexibility analysis as provided for under RFA is not required.

VII. What Are the Paperwork and Other Information Collection 
Requirements (Subject to the Paperwork Reduction Act) Imposed Under 
This Rule?

    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.
    NIOSH has obtained clearance from OMB to collect data under 
EEOICPA.
    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.

VIII. 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.

IX. 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.

X. 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.

XI. 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.''

XII. 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.

XIII. 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.

XIV. Effective Date and Information Collection Approval

    The Secretary has determined, pursuant to 5 U.S.C. 553(d)(3), that 
there is good cause for this rule to be effective immediately to avoid 
undue hardship on and facilitate payment to eligible claimants.
    The Office of Management and Budget (OMB) approved these 
information collection requirements on October 30, 2001, and assigned 
control number 0920-0530.

List of Subjects in 42 CFR Part 82

    Cancer, Dose reconstruction, Government employees, Occupational 
safety and health, Nuclear materials,

[[Page 22330]]

Radiation protection, Radioactive materials, Workers' compensation.

Text of the Rule

    For the reasons discussed in the preamble, the Department of Health 
and Human Services revises 42 CFR 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 part.
82.1   What is the purpose of this part?
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 part.
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 NIOSH dose 
reconstruction results by NIOSH?
82.28   Who can review NIOSH dose reconstruction files on individual 
claimants?
Subpart E--Updating Scientific Elements Underlying Dose Reconstructions
82.30   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?
82.31   How can the public recommend changes to scientific elements 
underlying the dose reconstruction process?
82.32   How will NIOSH make changes in scientific elements 
underlying the dose reconstruction process, based on scientific 
progress?
82.33   How will NIOSH inform the public of changes to the 
scientific elements underlying the dose reconstruction process?

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

Subpart A--Introduction


Sec. 82.0  Background information on this part.

    The Energy Employees Occupational Illness Compensation Program Act 
(EEOICPA), 42 U.S.C. 7384-7385 [1994, supp. 2001], provides for the 
payment of compensation benefits to covered employees and, where 
applicable, survivors of such employees, of the United States 
Department of Energy (``DOE''), 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 paragraph 
(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 part?

    The purpose of this part 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 and that is possible given existing knowledge of the material 
and process.
    (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,

[[Page 22331]]

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 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 7384(n)(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 report its findings directly to the 
claimant, as well as to DOL and 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 part.

    (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 
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 part, 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 means the U.S. Department of Energy, and includes 
predecessor agencies of DOE, including the Manhattan Engineering 
District.
    (g) DOL means the U.S. Department of Labor.
    (h) EEOICPA means the Energy Employees Occupational Illness 
Compensation Program Act of 2000, 42 U.S.C. 7384-7385 [1994, supp. 
2001].
    (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 means 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 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

[[Page 22332]]

with cirrhosis or hepatitis), and bone. Pursuant to section 2403 of 
Public Law 107-20, this definition will include renal cancer effective 
October 1, 2001.
    (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 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 interview may be 
conducted in one or more sessions. 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 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, NIOSH 
may assign doses using techniques discussed in Sec. 82.16. Once the 
resulting data set is complete, NIOSH will construct an occupational 
exposure matrix, 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.1
---------------------------------------------------------------------------

    \1\ The current weighting factors of the International 
Commission on Radiological Protection are provided in ICRP 60: 
``1990 Recommendations of the International Commission on 
Radiological Protection.'' Ann. ICRP 21 (1-3):6.
---------------------------------------------------------------------------

    (k) At any point during steps of dose reconstruction described in 
paragraphs (f) through (j) of this section, 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:
    (1) 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);
    (2) Dose is determined using worst-case assumptions related to 
radiation exposure and intake, to substitute for further research and 
analyses; or,
    (3) Research and analysis indicated under steps described in 
paragraphs (f)-(j) of this section have been completed. Worst-case 
assumptions will be employed under condition 2 to limit further 
research and analysis only for claims for which it is evident that 
further research and analysis will not produce a compensable level of 
radiation dose (a dose producing a probability of causation of 50% or

[[Page 22333]]

greater), because using worst-case assumptions it can be determined 
that the employee could not have incurred a compensable level of 
radiation dose. For all claims in which worst-case assumptions are 
employed under condition 2, 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. The closing interview may require multiple 
sessions, if the claimant requires time to obtain and provide 
additional information, and to allow NIOSH time to integrate the new 
information into a new draft of the dose reconstruction report. NIOSH 
will determine whether to grant requests for time to provide additional 
information, based on whether the requests are reasonable and the 
claimant is actively seeking the information specified.
    (m) Subject to any additional information provided by the claimant 
and revision of the draft dose reconstruction report 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, NIOSH will forward a final dose reconstruction report to 
DOL, DOE, 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, or 60 
days following the claimant's final provision of additional information 
and receipt of a revised draft dose reconstruction report under 
Sec. 82.10 (l), whichever occurs last, 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.


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 and DOE 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 7384q of EEOICPA, the Secretary of HHS is 
authorized to add classes of employees to the Special Exposure Cohort. 
NIOSH will provide the claimant with any information and forms that HHS 
provides to classes of employees seeking to petition to be added 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 others 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 names(s), building 
numbers(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;
    (7) External contamination measurements; and
    (8) Other measurement results applicable to internal dosimetry.
    (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;
    (5) Documentation of record keeping practices used to record data 
and/or administratively assign dose; and,

[[Page 22334]]

    (6) Other information to characterize the monitoring program 
procedures and evaluate monitoring results.
    (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); 
and,
    (7) Other workplace monitoring results.
    (f) Workplace characterization data, including:
    (1) Information on the external exposure environment, including: 
radiation type (gamma, x-ray, proton, neutron, beta, other charged 
particle); radiation energy spectrum; uniformity of exposure (whole 
body vs partial body exposure); irradiation geometry;
    (2) Information on work-required medical screening x rays; and,
    (3) Other information useful for characterizing workplace radiation 
exposures.
    (g) Information characterizing internal exposures, including:
    (1) Radionuclide(s) and associated chemical forms;
    (2) Results of particle size distribution studies;
    (3) Respiratory protection practices; and
    (4) Other information useful for characterizing internal exposures.
    (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 irradiation by source 
or airborne dispersion radioactive material.


Sec. 82.15  How will NIOSH evaluate the completeness and adequacy of 
individual monitoring data?

    (a) NIOSH will evaluate the completeness and adequacy 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 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 Service, 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 and radioactive contamination 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 or inadequate, the dose 
reconstruction will rely on the results of air sampling measurements, 
radiation sources, work processes and practices, and incidents 
involving radiation contamination, as necessary.
    (b) NIOSH will calculate the dose to the organ or tissue of concern 
using the appropriate current 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. When the cancer covered by a claim is in 
a tissue not covered by existing ICRP models, NIOSH will use the ICRP 
model that best approximates the model needed, while giving the benefit 
of the doubt to the claimant. For internal exposures, NIOSH will select 
the highest dose estimate from among the modeled organs or tissues that 
do not concentrate the radionuclide.

[[Page 22335]]

    (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 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, DOL and 
DOE 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, 
DOL, and DOE 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 internal dose information only 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 NIOSH dose 
reconstruction results by NIOSH?

    (a) Claimants can seek reviews of their dose reconstruction through 
the processes established by DOL under 20 CFR 30. DOL will request 
NIOSH to review dose reconstructions under the following conditions, as 
provided under 20 CFR 30.318:
    (1) DOL may determine that factual findings of the dose 
reconstruction do not appear to be supported by substantial evidence; 
or,
    (2) 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.
    (b) NIOSH may review completed dose reconstructions on its own 
initiative and with the assistance of DOL to identify denied claims 
when either of the following circumstances arise:
    (1) NIOSH obtains records or information on radiation exposures of 
DOE or AWE employees that could substantially increase the level of 
radiation doses estimated in the completed dose reconstructions; or
    (2) NIOSH changes a scientific element underlying dose 
reconstructions according to the provisions of Subpart E of this rule 
and the change could substantially increase the level of radiation 
doses estimated in the completed dose reconstructions.
    (c) When NIOSH completes the review of a dose reconstruction, NIOSH 
will provide a report describing the basis for the review, the methods 
employed in the review, and the review findings to the claimant, DOL, 
and DOE.


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.

Subpart E--Updating the Scientific Elements Underlying Dose 
Reconstructions


Sec. 82.30  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.


Sec. 82.31  How can the public recommend changes to scientific elements 
underlying the dose reconstruction process?

    (a) 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. NIOSH will provide these recommendations to the 
Advisory Board on Radiation and Worker Health to 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.
    (b) The public can also submit recommendations by e-mail. 
Instructions will be provided on the NIOSH Internet homepage at 
www.cdc.gov/niosh/ocas.


Sec. 82.32  How will NIOSH make changes in scientific elements 
underlying the dose reconstruction process, based on scientific 
progress?

    NIOSH will present proposed changes to the Advisory Board on 
Radiation and

[[Page 22336]]

Worker Health prior to implementation. These proposed changes will be 
summarized in a notice 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.


Sec. 82.33  How will NIOSH inform the public of changes to the 
scientific elements underlying the dose reconstruction process?

    (a) 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.
    (b) NIOSH may take into account other factors and employ other 
procedures than those specified in this subpart, if circumstances arise 
that require NIOSH to implement a change more immediately than the 
procedures in this subpart allow.

    Dated: April 10, 2002.
Tommy G. Thompson,
Secretary, Department of Health and Human Services.
[FR Doc. 02-10763 Filed 5-1-02; 8:45 am]
BILLING CODE 4160-17-P