[Federal Register Volume 67, Number 122 (Tuesday, June 25, 2002)]
[Proposed Rules]
[Pages 42962-42973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-15824]



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Part VI





Department of Health and Human Services





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42 CFR Part 83



Procedures for Designating Classes of Employees as Members of the 
Special Exposure Cohort Under the Energy Employees Occupational Illness 
Compensation Program Act of 2000; Proposed Rule

  Federal Register / Vol. 67, No. 122 / Tuesday, June 25, 2002 / 
Proposed Rules  

[[Page 42962]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 83

RIN 0920-AA07


Procedures for Designating Classes of Employees as Members of the 
Special Exposure Cohort Under the Energy Employees Occupational Illness 
Compensation Program Act of 2000; Notice of Proposed Rulemaking

AGENCY: Department of Health and Human Services.

ACTION: Notice of Proposed Rulemaking.

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SUMMARY: This document describes how the Department of Health and Human 
Services (``HHS'') proposes to consider designating additional classes 
of employees to be added to the Special Exposure Cohort under the 
Energy Employees Occupational Illness Compensation Program Act of 2000 
(``EEOICPA''). Under EEOICPA, and Executive Order 13179, the Secretary 
of HHS is authorized to make such designations, which take effect 180 
days after Congress is notified unless Congress provides otherwise. An 
individual member (or the survivors of a member) of a class of 
employees added to the Special Exposure Cohort would be entitled to 
compensation if the Department of Labor (``DOL'') finds that employee 
incurred a specified cancer and the claim meets other requirements 
established under EEOICPA.

DATES: HHS invites comments on this notice of proposed rulemaking from 
interested parties. Comments must be received by August 26, 2002.

ADDRESSES: Address written comments on the notice of proposed 
rulemaking to the NIOSH Docket Officer. Submit comments electronically 
by e-mail to [email protected]. See SUPPLEMENTARY INFORMATION for 
file formats and other information about electronic filing. 
Alternatively, submit printed comments to NIOSH Docket Office, Robert 
A. Taft Laboratories, M/S C34, 4676 Columbia Parkway, Cincinnati, OH 
45226.

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 can also be submitted by e-mail to [email protected].

SUPPLEMENTARY INFORMATION:

I. Comments Invited

    Interested persons or organizations are invited to participate in 
this rulemaking by submitting written views, arguments, 
recommendations, and data. Comments are invited on any topic related to 
this proposal. Some specific topics for comment are identified under 
section III, which summarizes the proposed procedures.
    Comments should identify the author(s), return address, and phone 
number, in case clarification is needed. Comments can be submitted by 
e-mail to: [email protected]. If submitting comments by e-mail, they 
may be provided as e-mail text or as a Word or Word Perfect file 
attachment. Printed comments can also be submitted to the address 
above. All communications received on or before the closing date for 
comments will be fully considered by the Secretary. An electronic 
docket containing all comments submitted will be available online over 
the Internet on the National Institute for Occupational Safety and 
Health (``NIOSH'') homepage at http://www.cdc.gov/niosh.

II. Background

A. Statutory Authority

    The Energy Employees Occupational Illness Compensation Program Act, 
42 U.S.C. Secs. 7384-7385 [1994, supp. 2001]. EEOICPA established a 
compensation program to provide a lump sum payment of $150,000 and 
prospective medical benefits as compensation to covered employees 
suffering from designated illnesses incurred as a result of their 
exposure to radiation, beryllium, or silica while in the performance of 
duty for the Department of Energy (``DOE'') and certain of its vendors, 
contractors and subcontractors. This legislation also provided for 
payment of compensation for certain survivors of these 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 
(``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 (December 7, 
2000). DOL published an interim final rule governing DOL's 
administration of EEOICPA on May 25, 2001 (66 FR 28948).
    The executive order directed the HHS to perform several technical 
and policymaking roles in support of the DOL program:
    (1) HHS is to develop procedures for considering petitions to be 
added to the Special Exposure Cohort established under EEOICPA by 
classes of employees at DOE and Atomic Weapons Employer (``AWE'') 
facilities. HHS is also to apply these procedures in response to such 
petitions. Covered employees (and certain eligible survivors) included 
in the Special Exposure Cohort who have a specified cancer qualify for 
compensation under EEOICPA. The procedures HHS is proposing to use for 
considering Special Exposure Cohort petitions are the subject of this 
notice of proposed rulemaking.
    (2) HHS is to develop guidelines by regulation 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 
duty at a DOE or AWE facility. HHS published a notice of proposed 
rulemaking proposing these ``Probability of Causation'' guidelines on 
October 5, 2001 (66 FR 50967) and published a final rule on May 2, 2002 
(67 FR 22296).
    (3) HHS is also to develop methods by regulation to estimate 
radiation doses (``dose reconstruction'') for certain individuals with 
cancer applying for benefits under the DOL program. HHS published an 
interim final rule promulgating these methods under 42 CFR Part 82 on 
October 5, 2001 (66 FR 50978) and published a final rule on May 2, 2002 
(67 FR 22314). HHS is applying these methods to conduct the program of 
dose reconstruction required by EEOICPA.
    (4) Finally, HHS is to staff the Advisory Board on Radiation and 
Worker Health and provide it with administrative and other necessary 
support services. The Board, a federal advisory committee, will advise 
HHS in implementing its roles under EEOICPA described here.
    42 U.S.C. 7384p requires HHS to implement its responsibilities with 
the assistance of the National Institute for Occupational Safety and 
Health (NIOSH), an Institute of the Centers for Disease Control and 
Prevention, HHS.

B. What Is the Special Exposure Cohort?

    The Special Exposure Cohort (``the Cohort'') is a category of 
employees defined under 42 U.S.C. 7384l(14). EEOICPA specifies which 
employees comprise the Cohort initially, including employees of DOE, 
DOE contractors or subcontractors, or AWEs who worked an aggregate of 
at least 250 days before February 1, 1992 at a gaseous diffusion plant 
in (1) Paducah, Kentucky, (2) Portsmouth, Ohio, or (3) Oak Ridge, 
Tennessee and who were or could have

[[Page 42963]]

been monitored in those jobs using dosimetry badges; or (4) employees 
of DOE or DOE contractors or subcontractors employed before January 1, 
1974 on Amchitka Island, Alaska and exposed to ionizing radiation in 
the performance of duty related to the Long Shot, Milrow, or Cannikin 
underground nuclear tests. Employees included in the Cohort who incur a 
specified cancer \1\ qualify for compensation (see DOL regulations 20 
CFR 30 at 66 FR 28948 for details). Cancer claims submitted by these 
employees or their survivors do not require DOL to evaluate the 
probability that the cancer was caused by radiation doses incurred 
during the performance of duty for nuclear weapons programs of DOE, as 
is required for other cancer claims covered by EEOICPA.
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    \1\ Specified cancers are a limited group of cancers that are 
compensable under provisions governing compensation for members of 
the Cohort. The list of specified cancers and the provisions 
governing compensation for the Cohort can be found at 20 CFR Part 
30. In addition, Pub. L. 107-20 added renal cancer to the list of 
specified cancers, and Pub. L. 107-107 added leukemia, when initial 
exposure is before age 21, to the list.
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C. Purpose of the Proposed Procedures

    EEOICPA authorized the President to designate classes of employees 
to be added to the Cohort, while providing Congress with the 
opportunity to review these decisions and prevent their implementation. 
As noted previously, the President has delegated his authority in this 
matter to the Secretary of HHS. The purpose of this notice of proposed 
rulemaking is to establish procedures by which the Secretary of HHS 
will determine whether to add to the Cohort new classes of employees 
from DOE and AWE facilities. The procedures are intended to ensure that 
petitions for additions to the Cohort are given uniform, fair, 
scientific consideration, that petitioners and interested parties are 
provided opportunity for appropriate involvement in the process, and to 
comply with specific statutory requirements of EEOICPA.

D. Statutory Requirements for Designating Classes of Employees as 
Members of the Cohort

    EEOICPA includes several requirements for these procedures. The 
Advisory Board on Radiation and Worker Health (``the Board'') is 
authorized to provide advice to the President (delegated to the 
Secretary of HHS) concerning the designation of additional classes as 
members of the Cohort. The Board's advice is to be based on ``exposure 
assessments by radiation health professionals, information provided by 
DOE, and other such information as the Board considers appropriate.'' 
42 U.S.C. 7384q. Section 7384q specifies that HHS obtain the advice of 
the Board ``after consideration of petitions by classes of employees 
for such advice.'' This section also mandates two broad criteria to 
govern HHS decisions, which are to be made after receiving the advice 
of the Board. Members of a class of employees at a DOE or AWE facility 
may be treated as members of the Cohort for purposes of the 
compensation program if HHS ``determines that: (1) It is not feasible 
to estimate with sufficient accuracy the radiation dose that the class 
received; and (2) there is a reasonable likelihood that such radiation 
dose may have endangered the health of members of the class.'' Finally, 
42 U.S.C. 7384l(14)(C) requires the Secretary to submit a report to 
Congress for each class of employees the Secretary designates to be 
added to the Cohort. The report must define the class of employees 
covered by the designation and specify the criteria used to make the 
designation. This section requires that the designation take effect 180 
days after the date on which HHS submits the report to Congress unless 
Congress takes action to reverse or expedite the designation.

E. Relationship of Proposed Procedures to Rules Proposed and 
Promulgated by HHS To implement EEOICPA

    These procedures complement the two HHS rules promulgated by HHS on 
May 2, 2002, to implement EEOICPA for cancer claimants who are not 
members of the Cohort. These are the final rule: ``Guidelines for 
Determining the Probability of Causation Under the Energy Employees 
Occupational Illness Compensation Program Act of 2000'' promulgated at 
42 CFR Part 81 (67 FR 22296), and the final rule: ``Methods for 
Radiation Dose Reconstruction Under the Energy Employees Occupational 
Illness Compensation Program Act of 2000'' promulgated at 42 CFR Part 
82 (67 FR 22314).
    The final rule 42 CFR Part 82 provides the methods by which NIOSH 
is conducting dose reconstructions to estimate the radiation doses 
incurred by individual covered employees who have incurred cancer. 
These estimates are required by EEOICPA to adjudicate a non-Cohort 
cancer claim. The methods to arrive at these estimates, however, will 
be directly considered by HHS in reviewing petitions to add classes of 
employees to the Cohort. In particular, HHS will consider these methods 
in determining for a petitioning class of employees, as required by 
EEOICPA, whether ``it is not feasible to estimate with sufficient 
accuracy the radiation dose that the [individual members of] the class 
received.''
    HHS is requiring a finding that NIOSH would be unable to complete 
dose reconstructions for the individual members of a class of employees 
to satisfy this first statutory requirement concerning ``sufficient 
accuracy.'' In practical terms, if NIOSH can successfully reconstruct 
the radiation doses of members of the class under the requirements of 
42 CFR Part 82, then the doses of the class members can be estimated 
with ``sufficient accuracy'' for DOL to adjudicate claims.
    Commenters on 42 CFR Part 82 asked HHS to define the conditions 
under which NIOSH would not have sufficient information to complete a 
dose reconstruction, with the understanding that such conditions would 
be relevant to petitions to add classes to the Cohort. As HHS explained 
in response to the comments, these conditions will vary on a case-by-
case basis. 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 a dose reconstruction depends on the extent and quality of 
information available to substitute for monitoring data. This can be 
defined on a case-by-case basis but not by using rigid criteria; the 
potential circumstances are not readily foreseeable.
    Some of the methods of dose reconstruction under 42 CFR Part 82 
will also be applied in these procedures, to the limited extent 
feasible, to make the second statutorily required determination as to 
whether: ``there is reasonable likelihood that * * * radiation * * * 
may have endangered the health of members of the class.'' Although dose 
reconstructions would not be feasible for individual members of a 
petitioning class of employees, the process of determining that dose

[[Page 42964]]

reconstructions are not feasible should provide information to 
determine imprecisely the potential level of radiation to which the 
class could have been exposed. For example, the most limited 
information indicating the type, form, and quantities of radioactive 
materials present or used in a work operation would provide a basis for 
judging whether occupational exposures could have exceeded certain 
specific levels, as discussed further below.
    The HHS rule 42 CFR Part 81 establishes guidelines by which DOL 
will estimate the probability that the cancer of an employee was caused 
by ionizing radiation doses incurred by the employee in the performance 
of duty for DOE nuclear weapons programs. The guidelines are based in 
substantial part on scientific work of the National Cancer Institute, 
which has developed an important scientific tool, the Interactive 
RadioEpidemiological Program (IREP) for this purpose. IREP produces 
statistical estimates of the probability that a specific cancer was 
caused by specific amounts and types of ionizing radiation. NIOSH 
worked with NCI on IREP and developed a special application of IREP 
(``NIOSH-IREP'') to serve the needs of DOL in implementing EEOICPA for 
cancer claimants who are not members of the Cohort.
    NIOSH-IREP will be used by HHS in these procedures, in conjunction 
with dose estimating methods, as discussed above, in making the 
determination required by EEOICPA as to whether ``there is reasonable 
likelihood that * * * radiation * * * may have endangered the health of 
members of the class.'' In particular, NIOSH will use NIOSH-IREP to 
determine whether a radiation exposure to a class of employees was 
potentially high enough to cause any of the specified cancers for which 
members of the class could be compensated under provisions of EEOICPA 
and 20 CFR Part 30 concerning eligibility for compensation. Use of 
NIOSH-IREP for this purpose will provide a feasible degree of 
objectivity and consistency between the policies governing compensation 
for claims under provisions for the Cohort and under provisions for all 
other cancer claims. Additional detail on how HHS proposes using NIOSH-
IREP in evaluating Cohort petitions is provided under Section III of 
this Supplementary Information and Section 83.12 of the procedures.

III. Summary of Proposed Rule

    Congress, in enacting EEOICPA, created an Energy Employees 
Occupational Illness Compensation Program to ensure an efficient, 
uniform, and adequate compensation system for certain employees 
involved in nuclear weapons production and related activities. 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 the issuance and implementation of these 
proposed procedures for designating classes of employees to be added to 
the Cohort. This proposed rule includes procedures for the submission 
of petitions to add classes of employees to the Cohort and procedures 
by which HHS will consider such petitions and determine their outcome, 
with the advice of the Advisory Board on Radiation and Worker Health 
(``the Board'').

Subtitle A--Introduction

    Section 83.0 and 83.1 briefly describe how this proposal relates to 
DOL authorities under EEOICPA and report the assignment of 
responsibility for this proposal to HHS. Section 83.1 also outlines the 
purpose of the proposal and general principles guiding its development.
    Section 83.2 describes the relevance of this proposal for cancer 
claimants under EEOICPA. It explains the option of petitioning for a 
Cohort designation by cancer claimants for whom NIOSH attempted and was 
unable to complete dose reconstructions. The initial claims of these 
individuals will be denied by DOL, because for individuals who are not 
a member of the Cohort, DOL must determine the probability that their 
cancers were caused by their radiation exposures. DOL's determination 
relies upon NIOSH's ability to successfully produce radiation dose 
estimates through its dose reconstruction program under EEOICPA. 
Section 83.2 also explains that individuals who would be eligible to 
file a claim but have yet to incur a cancer, ``potential claimants,'' 
can also submit petitions on behalf of a class of employees.
    Section 83.3 summarizes the role of DOL in administering claims for 
individuals who are members of classes of employees added to the Cohort 
under this proposal. It identifies the principal criteria applied by 
DOL in reviewing each claim, and provides a reference locating the 
relevant regulatory requirements.

Subtitle B--Definitions

    Section 83.5 defines the principal terms used in this proposal. It 
includes terms specifically defined in EEOICPA that, for the 
convenience of the reader of this proposal, are repeated in this 
section.
    An important statutory term requiring interpretation by HHS is 
``endangered the health.'' This term is interpreted by HHS to mean 
``there is a reasonable likelihood that the radiation dose may have 
caused a specified cancer,'' since members of the Cohort cannot be 
compensated as Cohort members for any adverse health effects other than 
specified cancers. This definition and the related issue of 
establishing a ``reasonable likelihood'' are addressed below in the 
discussion of Section 83.12 under ``Procedures for Adding Classes of 
Employees to the Cohort.'' HHS invites comment on this definition.

Subtitle C--Procedures for Adding Classes of Employees to the Cohort

    Section 83.6 provides an overview of the procedures.
    Section 83.7 describes the qualifications for a person submitting a 
petition. A petition can be submitted by one or more DOE, DOE 
contractor or subcontractor, or AWE employees, their survivors, or a 
labor union representing the employees. Consideration was given to 
allowing other potential representatives of classes of employees to 
submit petitions, such as persons who have performed evaluations of 
radiation exposures and radiation protection programs at DOE sites on a 
contractual basis or in the course of research. These individuals may 
have sufficient expertise to identify classes of employees that should 
be added to the Cohort under this policy. However, HHS found it 
reasonable to require that such experts work on behalf and with the 
consent of one or more members of the class, who are the interested 
parties. Hence, the consenting member(s) of the class can submit the 
petition with the aid of the expert, who would assist the petitioners 
to provide justification for the petition, as provided for under 
Section 83.9. HHS invites public comment on these proposed 
qualifications. In particular, HHS seeks suggestions about any 
additional categories of individuals who might be authorized to submit 
a petition on behalf of a class of employees.
    Section 83.8 describes the procedure for submitting a petition. 
Petitioners are required to complete a form made available by NIOSH, 
which can be submitted in hard copy or electronically. The form is 
intended to enable HHS to provide clear and consistent guidance to 
petitioners efficiently, explaining the information required from the 
petitioners for HHS to evaluate the petition.

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    Section 83.9 summarizes the informational requirements of a 
petition. HHS requires a petitioner to establish a substantial basis 
for petitioning to be part of the Cohort. The type of information 
needed to establish a substantial basis differs, depending on the 
circumstances of the proposed class. The information is described 
generally in this section and specifically in the petition form to be 
provided to potential petitioners by NIOSH.
    If the proposed class includes one or more members who have already 
submitted claims and for whom NIOSH was unable to complete a dose 
reconstruction due to insufficient information, the informational 
requirements of the petition are minimal. The petitioner need only 
include a copy of NIOSH dose reconstruction report(s), together with 
information required by HHS to administer the petition evaluation.
    Petitions involving claims for which NIOSH has attempted 
unsuccessfully to complete dose reconstructions provide a substantial 
basis for HHS consideration. For this reason, HHS encourages potential 
petitioners qualified to submit claims to DOL (i.e., covered employees 
who have already incurred a cancer) to do so and allow NIOSH to attempt 
to complete individual dose reconstructions prior to submitting 
petitions.
    If NIOSH has not yet determined whether or not it can complete dose 
reconstructions for a class of employees, the petition must include 
detailed information defining the proposed class of employees on whose 
behalf the petition is being submitted, and information to justify the 
petition. This information must include positive evidence that records 
required to conduct dose reconstructions do not exist. NIOSH would 
assist potential petitioners in requesting information from their 
current or former employers on the availability of such records, if the 
employer were unresponsive to such requests by the petitioner.
    The information provided by the petitioner will help HHS and the 
Board make the required determinations of: (1) Whether or not the class 
was exposed to levels of radiation that may have endangered the health 
of the class; and (2) whether records and information available are 
adequate to estimate with sufficient accuracy the radiation doses 
incurred by individual members of the proposed class.
    HHS invites comments on the general scheme proposed here, 
particularly the different requirements for potential petitioners 
depending upon whether or not NIOSH has already determined it is not 
possible to conduct dose reconstructions for members of the proposed 
class. HHS also invites comments on the specific informational 
requirements. Do they achieve a fair and reasonable balance between the 
level of burden placed on potential petitioners and the information HHS 
and the Board need to consider petitions fairly and efficiently? Are 
there alternative approaches that HHS should consider?
    Section 83.10 describes the roles and procedures of NIOSH, HHS, and 
the Board in selecting petitions for evaluation and notifying the 
petitioners of the resulting decision. NIOSH will select petitions for 
evaluation that have met the requirements of this section. Petitioners 
who have not met the informational requirements for a petition will be 
notified of this finding in writing, after the opportunity to remedy 
any omissions. The Board will have the opportunity to review the 
petition and the finding of HHS and provide its recommendation before 
HHS makes a final decision. HHS will then notify the petitioner of the 
final decision to select or not select the petition for evaluation.
    NIOSH will present to the board petitions that are selected 
together with a plan for evaluating the petition. NIOSH will initiate 
the evaluation as soon as possible, but will consider any advice of the 
Board concerning the plan, when the Board gives such advice. The Board 
will have already provided NIOSH advice on a generic approach to such 
evaluations.
    Section 83.11 describes procedures that apply when HHS decides not 
to select a petition for evaluation. A cancer claim for a member of the 
class of employees proposed by the petition would continue to be 
adjudicated under provisions of 20 CFR Part 30 governing claims for 
compensation not based upon the Cohort. Under these provisions, NIOSH 
would attempt to conduct a dose reconstruction for the individual. HHS 
will reverse its decision not to evaluate the petition if NIOSH finds 
that dose reconstructions cannot be completed for members of the class 
proposed by the petition. HHS may also reconsider its decision to not 
select a petition at any time based on new information.
    Section 83.12 describes how NIOSH will evaluate petitions to 
support the Board in making recommendations and the Secretary in 
deciding the outcome of the petition. The section specifies the 
potential types of information, which are the same as those used for 
dose reconstruction under 42 CFR Part 82, and specifies the potential 
sources for this information. NIOSH will evaluate this information to 
make two determinations required by EEOICPA: (1) Whether there was ``a 
reasonable likelihood that such radiation dose may have endangered the 
health of members of the class'' and (2) whether the level of radiation 
exposures to individual members of the class can be estimated with 
``sufficient accuracy''--in other words, using the methods of dose 
reconstruction established under 42 CFR Part 82. If health was 
endangered and the level of radiation exposures to individuals cannot 
be estimated through dose reconstructions, these findings would provide 
the basis for the Board to advise and HHS to decide that a class of 
employees be added to the Cohort.
    HHS interprets ``endangered the health'' to mean a finding that 
there was a reasonable likelihood that such radiation dose may have 
caused a specified cancer since, as explained above, EEOICPA restricts 
compensation under provisions concerning the Cohort to those members of 
the Cohort who have incurred a specified cancer. To determine whether 
the potential level of radiation exposure is sufficient to produce ``a 
reasonable likelihood'' of having caused a specified cancer, HHS will 
apply an objective but necessarily less demanding standard than was 
established under EEOICPA and applied under 42 CFR part 81 \2\, as 
follows.
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    \2\ Under EEOICPA and 42 CFR Part 81, the standard for ``at 
least as likely as not'' is a 50% or greater probability at the 
upper 99 percent credibility limit. This standard is designed to 
provide a large margin of error in ensuring that an employee whose 
cancer was likely to have been caused by radiation would not be 
denied compensation under EEOICPA. For a full explanation of this 
statistical concept and its use in NIOSH-IREP, see the explanation 
in the preamble to 42 CFR Part 81 (66 FR 50967, 50968-9).
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    NIOSH would use NIOSH-IREP, a software tool which was developed 
under 42 CFR Part 81 for estimating the probability that specific 
radiation doses caused a specific type of cancer in a specific 
individual. Since use of NIOSH-IREP requires information about the type 
of cancer, the attributes of the individual, and the circumstances of 
the individual's exposure to radiation, information which may not be 
known or applicable to a class of employees, NIOSH will apply 
hypothetical values for these variables as necessary. The hypothetical 
values will reasonably represent what is known about the class of 
employees and its radiation exposure, while giving the benefit of the 
doubt to the employees with respect to what may be unknown. However, 
because the specified cancers differ according to the amount and type 
of radiation dose that will result in a probability of causation of 50% 
or higher calculated at the 99 percent credibility limit using NIOSH-

[[Page 42966]]

IREP, NIOSH will select the type of specified cancer that is most 
readily caused by the radiation exposures to which the employees were 
potentially exposed--the ``most radiogenic'' specified cancer.\3\ If 
leukemia is the most radiogenic cancer caused by the radiation 
exposures of concern to the class, however, NIOSH would select both 
leukemia and the most radiogenic solid tumor cancer, to reasonably 
account for the fact that leukemia is extremely radiogenic but also 
rare (it may not occur at all in the employee class). NIOSH will then 
use these variables and the selected type of cancer in NIOSH-IREP to 
determine the level of radiation dose to which a member of the proposed 
class of employees would have to have been exposed to reach a 
probability of causation of 50 percent at the 99 percent credibility 
limit.\4\ Using this level as the benchmark, NIOSH would determine 
whether the actual level of radiation to which members of a class may 
have been exposed could have reached or exceeded this benchmark, based 
on the radiation source term (the type and quantity of radioactive 
materials), the work processes, the radiation safety procedures, or 
other relevant information. If so, the class would satisfy the 
criterion for health endangerment.
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    \3\ Despite selection of the most radiogenic cancer to calculate 
probability of causation, once a class of employees has been added 
to the Cohort, members would be eligible for compensation for 
incurring any of the specified cancers, not only the cancer used for 
this calculation.
    \4\ In a case where NIOSH uses both leukemia and the most 
radiogenic solid tumor cancer, NIOSH would average the two doses 
resulting from the NIOSH-IREP analysis to produce a single dose 
level to use as the benchmark discussed subsequently in this 
paragraph.
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    The practical result of this approach is to establish an objective 
measure of health endangerment with minimal use of subjective expert 
judgment. Subjective judgment will grant petitioning classes the 
benefit of the doubt with respect to all assumptions about radiation 
exposure levels and characteristics required to substitute for the lack 
of dosimetry records and information from DOE or the AWEs. Given the 
sparsity of records and information required to substantiate a SEC 
petition, these assumptions should be relatively few and simple. They 
should provide an easy basis for review by the Board and other experts.
    By evaluating probability of causation using the most radiogenic 
cancer, HHS similarly gives the petitioning class a substantial benefit 
of the doubt with respect to the cancers that will actually be incurred 
by members of the class. This reasonably minimizes the level of 
radiation dose required to produce a probability of causation of 50 
percent at the 99 percent credibility limit, and thereby helps ensure 
HHS would approve a petition when there is a ``reasonable likelihood'' 
that the health of members of the class may have been endangered.
    The entire approach presented above is intended to ensure HHS makes 
determinations of health endangerment as fairly, transparently, and 
consistently as possible, and compliant with the statutory requirement 
that HHS establish a ``reasonable likelihood'' that the health of 
members of the class may have been endangered. HHS invites comment on 
its proposed interpretation of health endangerment and approach to 
evaluate it.
    Based on the findings of evaluations used to make the two 
determinations discussed above, NIOSH may propose revisions, as 
appropriate, to the proposed definition of the class of employees 
covered by the petition. For example, NIOSH might find through such 
evaluations that the definition of the class of employees should be 
broadened to include additional workers not identified previously, or 
that the individuals identified in several petitions should constitute 
a single class of employees. NIOSH might also find that more than one 
class of employees is proposed by the petition, for which the two 
determinations discussed above differ.
    The definition of the class will include a minimum duration of 
employment for an individual to be included in the class. Members of 
the gaseous diffusion plants included by statute in the Cohort must 
have been employed at the plants for a minimum of 250 days, as provided 
under EEOICPA. The same duration may be appropriate for other classes 
of employees added to the Cohort. NIOSH will propose a minimum 
duration, as appropriate, based on its findings concerning the 
circumstances, types, and potential levels of radiation exposure to 
each class of employees. In cases in which NIOSH cannot establish a 
substantial basis for specifying a duration of employment, NIOSH will 
use the 250 day duration of employment required for employees of the 
gaseous diffusion plants.
    With the completion of this evaluation, NIOSH will provide the 
Board and the petitioners with an evaluation report summarizing its 
methods and findings. The contents of the report are specified in this 
section.
    Section 83.13 describes how the Board will evaluate a petition. Its 
evaluation will be conducted in one or more public meetings that will 
be announced in the Federal Register, together with a summary of the 
petition and the NIOSH evaluation report. The Board will review the 
petition and the NIOSH report. In addition, the petitioner will have 
the opportunity to address the Board regarding its petition and the 
NIOSH evaluation report. If NIOSH subsequently conducts additional 
evaluation in response to the review and recommendation of the Board, 
NIOSH will provide a supplementary report to the petitioner(s) and the 
Board for further deliberation. At the conclusion of the Board's 
deliberation, the Board will prepare a report providing recommendations 
to the Secretary on whether or not to add the proposed class of 
employees to the Cohort, as well as on the definition of the class. The 
report will include the criteria and information that provide the basis 
for the Board's recommendations.
    Section 83.14 describes how the Secretary will produce final 
decisions on the outcome of petitions. The Secretary will issue 
proposed decisions to the petitioner(s), including a definition of the 
class or classes of employees effected and a summary of the criteria 
and information supporting the decision. The petitioner(s) will have 30 
days to challenge a proposed decision of the Secretary by requesting an 
administrative review of the record. After 30 days or resolution of a 
challenge, the Secretary will transmit a final decision to the 
petitioner(s). At this time, the Secretary will also publish in the 
Federal Register decisions to deny adding classes of employees to the 
Cohort. Decisions to add a class of employees to the Cohort will not be 
published in the Federal Register until expiration of the 180 day 
congressional review period addressed in Sec. 83.15 and discussed 
below.
    Section 83.15 describes the role of Congress in designating 
additional classes as members of the Cohort. As required by EEOICPA, 
the Secretary will notify Congress by report of final decisions to add 
classes of employees to the Cohort, including a definition of the class 
and the criteria and information upon which the decision was based. 
Congress will then have 180 days during which it may take an action to 
reverse or expedite the designation. Without action by Congress, the 
designation becomes effective automatically 180 days after the date 
Congress received the report of the Secretary. Within 200 days, the 
Secretary will transmit to DOL and publish in the Federal Register the 
definition of the class covered by the

[[Page 42967]]

designation and the outcome of the designation, reflecting any action 
taken by Congress.
    Section 83.16 describes how the Secretary would cancel a final 
decision to add a class to the Cohort or modify a final decision to 
reduce the scope of a class the Secretary had added to the Cohort. The 
addition of a class to the Cohort by the Secretary is premised on the 
lack of sufficient records and information to enable NIOSH to complete 
dose reconstructions for members of the class under 42 CFR Part 82. In 
the event that HHS subsequently obtains sufficient records and 
information for reconstructing the doses of some or all members of a 
class the Secretary has added to the Cohort (e.g., records that were 
deemed non-existent or missing at the time HHS decided to add the class 
to the Cohort), the provisions of Section 16 are intended to reverse or 
modify the decision. Covered employees who are no longer in the Cohort 
may still seek compensation by establishing that their cancer was at 
least as likely as not related to covered employment. Thus, their 
claims seeking compensation for cancers would be evaluated by DOL and 
forwarded to NIOSH for dose reconstructions under 42 CFR Part 82.

IV. Regulatory Assessment Requirements

A. Executive Order 12866

    Under executive order (E.O.) 12866 (58 FR 51735, October 4, 1993), 
the Agency must determine whether a regulatory action is 
``significant'' and therefore subject to review by the Office of 
Management and Budget (OMB) and the requirements of the Executive 
Order. Under section 3(f), the order defines a ``significant regulatory 
action'' as an action that is likely to result in a rule (1) Having an 
annual effect on the economy of $100 million or more, or adversely and 
materially affecting a sector of the economy, productivity, 
competition, jobs, the environment, public health or safety, or State, 
local, or tribal governments or communities (also referred to as 
``economically significant''); (2) creating serious inconsistency or 
otherwise interfering with an action taken or planned by another 
agency; (3) materially altering the budgetary impacts of entitlement, 
grants, user fees, or loan programs or the rights and obligations of 
recipients thereof; or (4) raising novel legal or policy issues arising 
out of legal mandates, the President's priorities, or the principles 
set forth in this Executive Order. This notice of proposed rulemaking 
is being treated as a ``significant regulatory action'' within the 
meaning of the executive order because it meets the criterion of 
Section 3(f)(4) in that it raises novel or legal policy issues arising 
out of the legal mandate established by EEOICPA. It proposes to 
establish practical procedures, grounded in current science, by which 
the Secretary of HHS can fairly consider petitions to add classes of 
employees to the Cohort. The financial cost to the federal government 
of responding to these petitions is likely to vary from several 
thousand dollars to as much as tens of thousands of dollars, depending 
on the availability of information and scope of the petition.
    The notice of proposed rulemaking carefully explains the manner in 
which the procedures are consistent with the mandate of 42 U.S.C. 7384q 
and implements the detailed requirements of that section. The proposal 
does not interfere with State, local, and tribal governments in the 
exercise of their governmental functions.
    The proposal is not considered economically significant, as defined 
in section 3(f)(1) of the E.O. 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 E.O. 
12866 and provides estimates of the aggregate cost of benefits and 
administrative expenses of implementing EEOICPA under its rule (see 66 
FR 28948, May 25, 2001). OMB has reviewed this proposal for consistency 
with the President's priorities and the principles set forth in E.O. 
12866.

B. 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 proposed rule will not have a significant economic impact on 
a substantial number of small entities within the meaning of the RFA. 
This proposal affects only DOL, DOE, HHS, and certain individuals 
covered by EEOICPA. Therefore, a regulatory flexibility analysis as 
provided for under RFA is not required.

C. What Are the Paperwork and Other Information Collection Requirements 
(Subject to the Paperwork Reduction Act) Imposed Under This Proposed 
Rule, and How Are Comments Submitted?

    Under the Paperwork Reduction Act of 1995, a Federal agency shall 
not conduct or sponsor a collection of information from ten or more 
persons other than Federal employees unless the agency has submitted a 
Standard Form 83, Clearance Request, and Notice of Action, to the 
Director of the Office of Management and Budget (OMB), and the Director 
has approved the proposed collection of information. A person is not 
required to respond to a collection of information unless it displays a 
currently valid OMB control number. The Paperwork Reduction Act is 
applicable to the data collection aspects of these proposed procedures.
    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of projects. To 
request more information on this project or to obtain a copy of the 
data collection plans and instruments, call the CDC Reports Clearance 
Officer at (404) 639-7090.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology.
    Send comments to Anne O'Connor, CDC Assistant Reports Clearance 
Officer, 1600 Clifton Road, MS-D24, Atlanta, GA 30333. Written comments 
should be received within 45 days of this notice.
    Under the proposed rule, NIOSH will provide an ``SEC Petition 
Form'' petitioners must use to submit a petition. The form and 
accompanying instructions will assist the claimants in meeting the 
informational requirements of these procedures for petitions to be 
selected for evaluation by HHS and the Board. The completed form can be 
submitted in hard copy or electronically over the internet.

[[Page 42968]]

    There will be no cost to respondents for this data collection. This 
is a new data collection. The estimated annual burden of this data 
collection is described in the table below.

----------------------------------------------------------------------------------------------------------------
                                                                                       Avg. burden
                       Respondents                          Number of     Number of   per response   Total hours
                                                           respondents    responses       (hrs.)
----------------------------------------------------------------------------------------------------------------
SEC Petition Form.......................................           90             1         68/60           103
----------------------------------------------------------------------------------------------------------------

D. 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 proposed rule prior to its 
effective date. The report will state that the Department has concluded 
that this proposed 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 proposed 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.

E. 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 proposed 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.

F. Executive Order 12988 (Civil Justice)

    This proposed rule has been drafted and reviewed in accordance with 
Executive Order 12988, Civil Justice Reform and will not unduly burden 
the Federal court system. HHS adverse decisions may be reviewed in 
United States District Courts pursuant to the Administrative Procedure 
Act. HHS has attempted to minimize that burden by providing petitioners 
an opportunity to seek administrative review of adverse decisions. HHS 
has provided a clear legal standard it will apply in considering 
petitions. This proposed rule has been reviewed carefully to eliminate 
drafting errors and ambiguities.

G. Executive Order 13132 (Federalism)

    The Department has reviewed this proposed rule in accordance with 
Executive Order 13132 regarding federalism, and has determined that it 
does not have ``federalism implications.'' The proposed 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.''

H. 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 proposed rule on 
children. HHS has determined that the proposed rule would have no 
effect on children.

I. 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 proposed rule on energy supply, distribution or use, 
and has determined that the proposed rule will not have a significant 
adverse effect on them.

List of Subjects in 42 CFR Part 83

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

Text of the Proposed Rule

    For the reasons discussed in the preamble, the Department of Health 
and Human Services proposes to amend 42 CFR to add Part 83 to read as 
follows:

PART 83--PROCEDURES FOR DESIGNATING CLASSES OF EMPLOYEES AS MEMBERS 
OF THE SPECIAL EXPOSURE COHORT UNDER THE ENERGY EMPLOYEES 
OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT OF 2000

Subpart A--Introduction
Sec.
83.0  Background information on the procedures in this part.
83.1  What is the purpose of the procedures in this part?
83.2  How would cancer claimants be affected by the procedures in 
this part?
83.3  How will DOL use the designations established under the 
procedures in this part?
Subpart B--Definitions
83.5  Definition of terms used in the procedures in this part.
Subpart C--Procedures for Adding Classes of Employees to the Cohort
83.6  Overview of the procedures in this part.
83.7  Who can submit a petition on behalf of a class of employees?
83.8  How is a petition submitted?
83.9  What information must a petition include?
83.10  How will HHS select petitions for evaluation?
83.11  What happens to petitions that HHS does not select for 
evaluation?
83.12  How will NIOSH evaluate a petition?
83.13  How will the Board evaluate a petition?
83.14  How will the Secretary decide the outcome of a petition?
83.15  What is the role of Congress in acting upon the final 
decision of the Secretary to add a class of employees to the Cohort?
83.16  How can the Secretary cancel or modify a final decision to 
add a class of employees to the Cohort?

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

Subpart A--Introduction


Sec. 83.0  Background information on the procedures in 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

[[Page 42969]]

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 methods set forth in the statute for claimants to 
establish that a cancer incurred by a covered worker is covered by the 
EEOICPA. The first is to establish that the cancer is at least as 
likely as not related to covered employment at a DOE or Atomic Weapons 
Employer (``AWE'') facility pursuant to guidelines issued by the 
Department of Health and Human Services (``HHS''), which are found at 
42 CFR Part 81. The other method to establish that a cancer incurred by 
a covered worker is covered by EEOICPA is to establish that the worker 
was a member of the Special Exposure Cohort (``Cohort'') who suffered a 
specified cancer after beginning employment at a DOE or AWE facility. 
Section 7384l(14) of the EEOICPA includes certain classes of employees 
in the Cohort. Section 7384q of the Act authorizes the addition to the 
Cohort of other classes of employees. This authority has been delegated 
to the Secretary of HHS by Executive Order 13179.


Sec. 83.1  What is the purpose of the procedures in this part?

    EEOICPA authorized the President to designate additional classes of 
employees to be added to the Cohort, while providing Congress with the 
opportunity to review and affect these decisions. The President has 
delegated authority to consider and make such designations to the 
Secretary. The purpose of this part is to specify the procedures by 
which HHS determines whether to add new classes of employees from DOE 
and AWE facilities to the Cohort. HHS will consider adding new classes 
of employees only in response to petitions by or on behalf of such 
classes of employees, as authorized under EEOICPA and described in 
these procedures. The procedures are intended to ensure petitions for 
additions to the Cohort are given uniform, fair, scientific 
consideration, that petitioners and interested parties are provided 
opportunity for appropriate involvement in the process, and that the 
process is consistent with statutory requirements specified in EEOICPA.


Sec. 83.2  How would cancer claimants be affected by the procedures in 
this part?

    This part implements provisions of EEOICPA intended to serve 
potential and current cancer claimants whose radiation doses (incurred 
by a covered employee in the case of a survivor claimant) cannot be 
estimated by the completion of a NIOSH dose reconstruction.
    (a) A current cancer claimant can petition on behalf of a class of 
employees to be added to the Cohort upon determination by NIOSH that it 
cannot complete a dose reconstruction for the claimant. The initial 
claim of the claimant must be denied by DOL, since compensation for a 
cancer claim not based on the Cohort provision requires the completion 
of NIOSH dose reconstruction. However, if a petition by the claimant is 
successful, the claimant could reapply and obtain compensation as a 
Cohort member (or survivor of a Cohort member), if the claim qualifies 
under requirements governing compensation to members of the Cohort.
    (b) A potential cancer claimant, a qualified DOE, DOE contractor or 
subcontractor, or AWE employee who has not incurred cancer, can also 
petition on behalf of a class of employees to be added to the Cohort. A 
successful petition would entitle the claimant, upon incurring a 
specified cancer, to submit a claim for compensation under provisions 
of the Cohort.


Sec. 83.3  How will DOL use the designations established under the 
procedures in this part?

    DOL will adjudicate claims for compensation for members of classes 
of employees added to the Cohort according to the same general 
procedures that apply to the statutorily defined classes of employees 
in the Cohort. In summary, this review by DOL will determine whether 
the claim is for a qualified member of the Cohort with a specified 
cancer, pursuant to the procedures set forth in 20 CFR Part 30.

Subpart B--Definitions


Sec. 83.5  Definitions of terms used in the procedures in this part

    (a) Advisory Board for Radiation and Worker Health (``the Board'') 
is a federal advisory committee established under EEOICPA and appointed 
by the President to advise HHS in implementing its responsibilities 
under EEOICPA.
    (b) Atomic Weapons Employer (``AWE'') is a statutory term of 
EEOICPA which 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.
    (c) Class of employees means, for the purposes of this proposal, a 
group of employees who work or worked at the same DOE or AWE facility, 
who may have experienced similar types and levels of exposure to 
radiation, and for whom the availability of information and recorded 
data on such exposures is comparable with respect to the informational 
needs of dose reconstructions conducted under 42 CFR Part 82.
    (d) HHS is the U.S. Department of Health and Human Services
    (e) DOE is the U.S. Department of Energy, which includes 
predecessor agencies of DOE, including the Manhattan Engineering 
District.
    (f) DOL is the U.S. Department of Labor
    (g) Employee, for the purposes of these procedures, means a person 
who is or was an employee of DOE, a DOE contractor or subcontractor, or 
an atomic weapons employer, as further defined in EEOICPA.
    (h) Endangered the health is a statutory term from EEOICPA which 
means, for the purposes of these procedures, ``there is reasonable 
likelihood that the radiation dose may have caused a specified 
cancer,'' determined according to these procedures using NIOSH-IREP.
    (i) Interactive RadioEpidemiological Program (``IREP'') is a 
computer software program that uses information on the dose-response 
relationship and specified factors such as a claimant's radiation 
exposure, gender, age at diagnosis, and age at exposure to calculate 
the probability of causation for a given pattern and level of radiation 
exposure.
    (j) NIOSH is the National Institute for Occupational Safety and 
Health, Centers for Disease Control and Prevention, U.S. Department of 
Health and Human Services.
    (k) Probability of causation means, for the purposes of these 
procedures, 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.

[[Page 42970]]

    (l) 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 the purposes of 
the proposed procedures, radiation does not include sources of non-
ionizing radiation such as radio-frequency radiation, microwaves, 
visible light, and infrared or ultraviolet light radiation.
    (m) Secretary is the Secretary of the Department of Health and 
Human Services.
    (n) Specified cancer (as defined in section 4(b) of the Radiation 
Exposure Compensation Act Amendments of 2000 (42 U.S.C. 2210 note) and 
section 7384l(17) of EEOICPA means:
    (1) Leukemia (other than chronic lymphocytic leukemia) if onset 
occurred more than two years after first exposure;
    (2) Primary or secondary lung cancer (other than in situ lung 
cancer that is discovered during or after a post-mortem exam);
    (3) The following diseases, provided onset was at least 5 years 
after first exposure:
    (i) Multiple myeloma;
    (ii) Lymphomas (other than Hodgkin's disease);
    (4) Primary cancer of the:
    (i) Thyroid;
    (ii) Male or female breast;
    (iii) Esophagus;
    (iv) Stomach;
    (v) Pharynx;
    (vi) Small intestine;
    (vii) Pancreas;
    (viii) Bile ducts;
    (ix) Gall bladder;
    (x) Salivary gland;
    (xi) Urinary bladder;
    (xii) Brain;
    (xiii) Colon;
    (xiv) Ovary;
    (xv) Liver (except if cirrhosis or hepatitis B is indicated).
    (5) Primary or secondary bone cancer.
    (6) Primary or secondary renal cancers.
    (o) The specified diseases designated in paragraph (n) of this 
section mean the physiological condition or conditions that are 
recognized by the National Cancer Institute under those names or 
nomenclature, or under any previously accepted or commonly used names.

Subpart C--Procedures for Adding Classes of Employees to the Cohort


Sec. 83.6  Overview of the Procedures in this Part.

    The procedures in this part specify who may petition to add a class 
of employees to the Cohort, the requirements for such a petition, how a 
petition will be selected for evaluation by NIOSH and for the advice of 
the Board, and the process by which NIOSH, the Board, and the Secretary 
will operate in considering a petition, leading to the Secretary's 
final decision to accept or deny the petition. The petition 
requirements differ for classes of employees including members who have 
submitted cancer claims already, for whom NIOSH attempted and was 
unable to complete individual dose reconstructions as specified under 
42 CFR 82.12. As required by EEOICPA, the procedures include formal 
notice to Congress of any decision by the Secretary to add a class to 
the Cohort, and the opportunity for Congress to change the outcome of 
the decision.


Sec. 83.7  Who can submit a petition on behalf of a class of employees?

    Petitioners must be one of the following:
    (a) One or more DOE, DOE contractor or subcontractor, or AWE 
employees or their survivors (as defined under EEOICPA and 20 CFR Part 
30); and/or
    (b) A labor union representing or formerly having represented DOE, 
DOE contractor or subcontractor, or AWE employees who would be included 
in the proposed class of employees.


Sec. 83.8  How is a petition submitted?

    (a) The petitioner(s) must send a completed ``SEC Petition Form'' 
to NIOSH/OCAS addressed as follows: SEC Petition, Office of 
Compensation Analysis and Support, National Institute for Occupational 
Safety and Health, 4676 Columbia Parkway, MS-R45, Cincinnati, OH 45226.
    (b) The SEC petition form is available from NIOSH by calling the 
NIOSH toll-free phone service at 1-800-35-NIOSH. The form is also 
available from the NIOSH homepage at: www.cdc.gov/niosh. The form can 
be completed and submitted electronically following instructions 
provided on the NIOSH homepage.


Sec. 83.9  What information must a petition include?

    The petition must include complete information according to the 
instructions on the SEC petition form. As explained by these 
instructions, in addition to identifying and contact information, the 
petitioner(s) must provide the substantive information described under 
paragraph (a) or (b) of this section before the petition is considered. 
These informational requirements are also summarized in Table 1 of this 
section.
    (a) The petition must transmit a copy of a report produced by NIOSH 
under 42 CFR 82.12 notifying the petitioner(s) that NIOSH attempted and 
could not complete a dose reconstruction for the individual(s) due to 
insufficient records and information; \1\ or, alternatively,
---------------------------------------------------------------------------

    \1\ A Cohort petition by an individual for whom NIOSH was unable 
to complete an individual dose reconstruction under 42 CFR Part 82 
will be selected for evaluation without requiring further 
information or documentation from the petitioner to justify 
consideration of the petition. NIOSH will have already collected 
related information from the claimant through a structured interview 
during the dose reconstruction process. NIOSH will establish an 
initial class definition based on records and information NIOSH 
obtained during the attempted dose reconstruction, which NIOSH would 
supplement with additional data collection, as necessary. HHS will 
establish a final class definition with the advice of the Board.
---------------------------------------------------------------------------

    (b) The petition must provide the following:
    (1) A proposed class definition \2\ specifying:
    (i) The DOE or AWE facility at which the class worked;
    (ii) The job titles and/or job duties of the class members;
    (iii) The period of employment relevant to the petition;
    (iv) Identification of any exposure incident(s) that was 
unmonitored, unrecorded, or inadequately monitored or recorded, if such 
incident(s) comprises the basis of the petition; and
---------------------------------------------------------------------------

    \2\ HHS will determine the final class definition for each 
petition (see Sec. 83.14 of these procedures).
---------------------------------------------------------------------------

    (2) A description of the petitioners' basis for believing the class 
was exposed to levels of radiation at the facility that may have 
``endangered the health of members of the class.'' \3\ An adequate 
basis must include the following:
---------------------------------------------------------------------------

    \3\ HHS interprets the statutory language ``endangered the 
health'' [see 42 U.S.C. Sec. 7384q(b)(2)] to mean ``there is a 
reasonable likelihood that the radiation dose may have caused a 
specified cancer,'' since claimants cannot be compensated as members 
of the Cohort for any adverse health effects other than certain 
cancers under the relevant provisions of EEOICPA [see 42 U.S.C. 
Sec. 7384l(9) and (17)].
---------------------------------------------------------------------------

    (i) A description of short-term radiation-related health effects or 
health care interventions that demonstrate special efforts to respond 
to a hazardous radiation exposure, such as a depressed white blood cell 
count associated with radiation exposure or the application of 
chelation therapy among members of the class; and/or
    (ii) The following two requirements:
    (A) An identification of radioactive materials and emissions; 
contaminated tools, equipment, or areas; and/or any other relevant 
information suggesting the class was potentially exposed; and
    (B) A description of shortcomings of radiation protection measures, 
including the deficiencies of particular measures used or the omission 
of measures that should have been used to

[[Page 42971]]

prevent hazardous radiation exposures at the facility; and
    (3) A description of the petitioner's basis for believing records 
and information available are inadequate to estimate the radiation 
doses incurred by any members of the proposed class of employees. An 
adequate basis must include at least one of the following elements:
    (i) Documentation indicating the petitioner(s) sought records on 
radiation exposures at the facility and relevant to the petition and 
that DOE or the AWE responded indicating the records do not exist; or
    (ii) A report from a health physicist or other individual with 
expertise in dose reconstruction documenting the limitations of 
existing DOE or AWE records on radiation exposures at the facility and 
relevant to the petition and specifying the basis for finding these 
documented limitations would prevent the completion of dose 
reconstructions for individual members of the class under 42 CFR Part 
82 and related NIOSH technical implementation guidelines.

           Table 1.--Informational Requirements for Petitions
------------------------------------------------------------------------
  Petitioner identifying and contact information and either (a) or (b):
-------------------------------------------------------------------------
                  (a)                                  (b)
------------------------------------------------------------------------
Copy of NIOSH dose reconstruction        (1) Proposed class definition
 report indicating that NIOSH was         identifying: (i) Facility,
 unable to reconstruct the radiation      (ii) Job titles/duties, (iii)
 dose of a worker included in the         Period of employment, and if
 proposed class.                          relevant, (iv) Exposure
                                          incident.
                                         (2) Basis for health
                                          endangerment; either: (i)
                                          Health effects or health care
                                          or (ii)(A) Identification of
                                          potential exposures, and (B)
                                          Shortcoming of radiation
                                          protection.
                                         (3) Basis for infeasibility of
                                          dose reconstruction; either:
                                          (i) Demonstrated lack of
                                          records or (ii) Expert report.
------------------------------------------------------------------------

Sec. 83.10  How will HHS select petitions for evaluation?

    (a) Where HHS finds the petition meets the requirements specified 
in Secs. 83.7 through 83.9, HHS will transmit a written report 
notifying the petitioner(s) that it has selected the petition for 
evaluation. The HHS report will also provide the petitioner(s) with 
information on the steps and expected duration of the evaluation and 
deliberative processes required pursuant to these procedures.
    (b) Where HHS finds the petition does not meet the requirements 
specified in Secs. 83.7 through 83.9,
    (1) HHS will notify the petitioner(s) of any requirements that are 
not met by the petition, and provide 30 days for the petitioner(s) to 
revise the petition accordingly.
    (2) After 30 days, for petitions that continue to fail to meet one 
or more requirements, HHS will transmit a written report notifying the 
petitioner(s) of the recommended finding to not select the petition for 
evaluation and the basis for this recommended finding. The report will 
also inform the petitioner(s) that this recommended finding will be 
reviewed by the Board.
    (3) HHS will report the recommended finding and its basis to the 
Board at its next meeting. HHS will consider the recommendations of the 
Board before producing a final decision on whether or not to select the 
petition for evaluation.
    (4) HHS will report the final decision to the petitioner, including 
the basis for the decision and the recommendation of the Board.
    (c) NIOSH will present petitions selected for evaluation to the 
Board with plans specific to evaluating each petition.\4\ Each specific 
evaluation plan will be based on a general plan for evaluating 
petitions which NIOSH will develop in consultation with the Board. Each 
specific evaluation plan will include the following elements:
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    \4\ NIOSH will combine separate petitions and evaluate them as a 
single petition if, at this or any point in the evaluation process, 
NIOSH finds such petitions represent the same class of employees.
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    (1) An initial proposed definition for the class being evaluated, 
subject to revision as warranted by evaluation conducted under 
Sec. 83.12; and
    (2) A schedule of activities for evaluating the radiation exposure 
potential of the class and the adequacy of existing records and 
information needed to conduct dose reconstructions for all class 
members under 42 CFR Part 82.
    (d) NIOSH may initiate work to evaluate a petition immediately, 
prior to presenting selected petitions and associated evaluation plans 
to the Board.
    (e) NIOSH will publish a notice in the Federal Register notifying 
the public of its plans to evaluate a petition and soliciting 
information relevant to the evaluation.


Sec. 83.11  What happens to petitions that HHS does not select for 
evaluation?

    (a) Qualified cancer claims by members of the class of employees 
proposed in the petition will be subject to NIOSH dose reconstructions 
under 42 CFR part 82. \5\ If NIOSH is unable to complete such dose 
reconstructions, a petitioner on behalf of the class can submit a new 
petition on this basis, as provided under Sec. 83.9(a).
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    \5\ Only claims which DOL determines involve a covered employee 
who has cancer can be adjudicated by DOL to receive dose 
reconstructions by NIOSH under the DOL and HHS rules cited.
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    (b) Based on new information, HHS may, at its discretion, 
reconsider a petition that was not selected for evaluation.


Sec. 83.12  How will NIOSH evaluate a petition?

    (a) NIOSH will collect information on the types and levels of 
radiation exposures that potential members of the class may have 
incurred, as specified under 42 CFR 82.14, from the following potential 
sources, as necessary:
    (1) The petition or petitions submitted on behalf of the class;
    (2) DOE;
    (3) Potential members of the class and their survivors;
    (4) Labor unions who represent or represented employees at the 
facility during the relevant period of employment;
    (5) Managers, radiation safety officials, and other witnesses 
present during the relevant period of employment at the DOE or AWE 
facility;
    (6) NIOSH records from epidemiological research on DOE populations 
and records from dose reconstructions conducted under 42 CFR Part 82;
    (7) Records from research, dose reconstructions, medical screening 
programs, and other related activities conducted to evaluate the health 
and/or radiation exposures of employees of DOE, DOE contractors or 
subcontractors, and the AWEs;
    (8) Information obtained from any public meetings NIOSH convenes; 
and
    (9) Other sources.

[[Page 42972]]

    (b) NIOSH will evaluate records and information collected to make 
the following determinations:
    (1) Is there a ``reasonable likelihood that such radiation dose may 
have endangered the health of members of the class?'
    (i) To make this determination, NIOSH will interpret the statutory 
term ``endangered the health'' [see 42 U.S.C. 7384q(b)(2)] to mean 
there is a reasonable likelihood that the radiation dose may have 
caused a specified cancer, since the Cohort claims based on provisions 
of the Act can only be approved for specified cancers under the 
relevant provisions of EEOICPA, [see 42 U.S.C. 7384l(9) and (17)].
    (ii) To determine whether radiation levels could have caused a 
specified cancer, NIOSH will determine the minimum level of radiation 
dose at which NIOSH-IREP will produce a probability of causation of 50% 
at the upper 99 percent credibility limit for the most radiogenic \6\ 
specified cancer or cancers that could have resulted from the types of 
radiation exposures potentially incurred by potential members of the 
class. NIOSH will use reasonable values that confer the benefit of the 
doubt to the class for demographic factors used by NIOSH-IREP cancer 
models, such as gender and age at time of radiation exposure, except 
when actual values are known for the class in general; when the actual 
values are known, NIOSH will use these values to the extent possible. 
Similarly, NIOSH will use reasonable values conferring the benefit of 
the doubt to the class in selecting any radiation exposure parameters 
that are unknown and that affect the probability of causation estimate. 
Using this procedure to establish a minimum radiation dose level, NIOSH 
will determine whether potential members of the class could have 
incurred at least this threshold dose.
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    \6\ The ``most radiogenic'' specified cancer will be the type of 
specified cancer that is most readily caused by the radiation 
exposures to which the employees were potentially exposed. In more 
technical terms, it will be the type of specified cancer which 
requires the lowest dose of the radiation types to which the 
employees were potentially exposed to produce a probability of 
causation of 50 percent at the upper 99 percent confidence limit 
using NIOSH-IREP. In a case in which the most radiogenic specified 
cancer is leukemia, NIOSH would select both leukemia and the most 
radiogenic solid tumor cancer and apply them separately in the 
NIOSH-IREP analysis discussed in this section, and then average the 
two resulting threshold doses to establish the threshold dose to be 
applied in evaluating health endangerment for the class.
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    (2) Can the level of radiation exposures to individual members of 
the class be estimated, using the methods of dose reconstruction 
established under 42 CFR Part 82?
    (3) How should the class be defined, to be consistent with the 
findings of paragraphs (b)(1) and (2) of this section?
    (c) NIOSH will submit a report of its evaluation findings to the 
Board and to the petitioner(s). The report will include the following 
elements:
    (1) An identification of the relevant petitions;
    (2) A proposed definition of the class or classes of employees to 
which the evaluation applies, and a summary of the basis for this 
definition, including any justification that may be needed for the 
inclusion of individuals who were not identified in the original 
petition(s), the identification of any individuals who were identified 
in the original petition(s) who should constitute a separate class of 
employees, and the merging of multiple petitions that represent a 
single class of employees; the proposed class definition(s) will 
address the following parameters:
    (i) The DOE or AWE facility that employed the class;
    (ii) The job titles and/or job duties and/or work locations of 
class members;
    (iii) The period of employment within which a class member must 
have been employed at the facility under the job titles and/or 
performing the job duties and/or working in the locations specified in 
this class definition;
    (iv) If applicable, an identification of an unmonitored or 
unrecorded exposure incident or incidents, when such an incident(s) 
comprises the basis of the petition; and
    (v) A minimum duration of employment for inclusion in the class; 
\7\ and
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    \7\ NIOSH will define the minimum duration of employment as 250 
days for classes for which NIOSH lacks a substantial basis to 
support establishment of a different minimum duration.
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    (vi) Any other parameters that serve to define the membership of 
the class.
    (3) a summary of the findings evaluating the potential for the 
health of members of the class to have been endangered by radiation 
exposures incurred in the performance of duty, and a description of the 
evaluation methods and information upon which these findings are based; 
and
    (4) a summary of the findings evaluating the adequacy of existing 
records and information to allow for the successful reconstruction of 
doses for individual members of the class under the methods of 42 CFR 
Part 82; and a description of the evaluation methods and information 
upon which these findings are based.


Sec. 83.13  How will the Board evaluate a petition?

    (a) NIOSH will publish a notice in the Federal Register in advance 
of a Board meeting, summarizing the petition(s) to be considered by the 
Board at the meeting and the findings of NIOSH from evaluating the 
petition(s).
    (b) The Board will review the petition(s) and the NIOSH evaluation 
report at the meeting, at which the petitioner(s) will be invited to 
present views and evidence regarding the petition(s) and the NIOSH 
evaluation findings.
    (c) NIOSH may decide to conduct additional evaluation addressing a 
petition(s), upon the request of the Board. If NIOSH conducts further 
evaluation, it will report new findings of this evaluation to the Board 
and the petitioner(s).
    (d) Upon the completion of NIOSH evaluation and deliberations of 
the Board concerning a petition, the Board will develop and transmit to 
the Secretary a consensus \8\ report containing its recommendations. 
The Board's report will include the following:
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    \8\ The term ``consensus'' as used with respect to the decisions 
of federal advisory committees established under the Federal 
Advisory Committee Act (FACA) does not necessarily mean 
``unanimity.'' These committees have broad parameters under which 
they can define the extent of agreement among members of the 
committee that will constitute consensus and allow a decision to be 
adopted as a decision of the committee.
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    (1) The identification and inclusion of the relevant petition(s);
    (2) The definition of the class of employees covered by the 
recommendation;
    (3) A recommendation as to whether or not the Secretary should 
designate the class as an addition to the Cohort;
    (4) The criteria and information upon which the recommendation is 
based, including NIOSH evaluation reports, information presented by 
petitioners, and the deliberation of the Board.


Sec. 83.14  How will the Secretary decide the outcome of a petition?

    (a) The Secretary will propose, and transmit to all affected 
petitioners, a decision to add or deny adding classes of employees to 
the Cohort.
    (b) HHS will provide the petitioner(s) 30 days to contest the 
proposed decision of the Secretary. If the petitioner submits to HHS a 
challenge that includes substantial evidence that the proposed decision 
relies on a record of either factual or procedural errors in the 
implementation of these procedures, then HHS will consider the evidence 
submitted by the petitioner prior to issuing a final decision. 
Challenges to

[[Page 42973]]

decisions of the Secretary under these procedures must be submitted in 
writing, with accompanying documentation supporting the assertions.
    (c) HHS will issue a final decision on the designation and 
definition of the class, and transmit a report of the decision and the 
criteria and information upon which the decision is based to the 
petitioner(s).
    (d) HHS will publish in the Federal Register at this time decisions 
to deny adding a class of employees to the Cohort, including a 
definition of the class and a summary of the criteria and information 
upon which the decision is based. HHS will not publish in the Federal 
Register affirmative decisions to add a class to the Cohort until 
expiration of the 180 day congressional review period, as specified 
under Sec. 83.15.
    (e) As a matter of discretion, the Secretary may consider other 
factors or employ other procedures not set forth in this part when he 
deems it necessary to do so to address the circumstances of a 
particular petition.


Sec. 83.15  What is the role of Congress in acting upon the final 
decision of the Secretary to add a class of employees to the Cohort?

    (a) If the Secretary designates a class of employees to be added to 
the Cohort, the Secretary will transmit to Congress a report providing 
the designation, the definition of the class of employees covered by 
the designation, and the criteria and information upon which the 
designation was based. \9\
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    \9\ See 42 U.S.C. 7384l(14)(C)(ii).
---------------------------------------------------------------------------

    (b) A designation of the Secretary will take effect 180 days after 
the date on which the report of the Secretary is submitted to Congress, 
unless Congress takes an action that reverse or expedite the 
designation.
    (c) Within 200 days after transmittal of the report to Congress, 
the Secretary will transmit to DOL and publish in the Federal Register 
the definition of the class and one of the following outcomes:
    (1) The addition of the class to the Cohort; or
    (2) The result of any action by Congress to reverse or expedite the 
decision of the Secretary to add the class to the Cohort.


Sec. 83.16  How can the Secretary cancel or modify a final decision to 
add a class of employees to the Cohort?

    (a) The Secretary can cancel a final decision to add a class to the 
Cohort, or can modify a final decision to reduce the scope of a class 
added by the Secretary, if HHS obtains records relevant to radiation 
exposures of members of the class that enable NIOSH to estimate the 
radiation doses incurred by individual members of the class through 
dose reconstructions conducted under the requirements of 42 CFR Part 
82.
    (b) Before cancelling a final decision to add a class or modifying 
a final decision to reduce the scope of a class, the Secretary intends 
to follow evaluation procedures that are substantially similar to those 
described above for adding a class of employees to the Cohort. The 
procedures will include the following:
    (1) Publication of a notice in the Federal Register informing the 
public of the intent of the Secretary to review the final decision on 
the basis of new information and describing procedures for this review;
    (2) An analysis by NIOSH of the utility of the new information for 
conducting dose reconstructions under 42 CFR Part 82; the analysis will 
be performed consistently with the analysis of a petition by NIOSH 
under Secs. 83.12(b)(2), 83.12(b)(3), 83.12(c)(2), and 83.12(c)(4);
    (3) A recommendation by the Board to the Secretary as to whether or 
not the Secretary should cancel or modify its final decision that added 
the class to the Cohort, based upon a review by the Board of the NIOSH 
analysis and any other relevant information considered by the Board;
    (4) Any additional procedures that the Secretary may deem 
appropriate, as specified in the notification provided for under 
paragraph (b)(1) of this section.

    Dated: June 12, 2002.
Tommy G. Thompson,
Secretary, Department of Health and Human Services.
[FR Doc. 02-15824 Filed 6-20-02; 2:46 pm]
BILLING CODE 4160-17-P