[Federal Register Volume 69, Number 104 (Friday, May 28, 2004)]
[Rules and Regulations]
[Pages 30764-30786]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11930]



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Part IV





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; Final Rule

  Federal Register / Vol. 69, No. 104 / Friday, May 28, 2004 / Rules 
and Regulations  

[[Page 30764]]


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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; Final Rule

AGENCY: Department of Health and Human Services.

ACTION: Final rule.

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SUMMARY: This document describes how the Department of Health and Human 
Services (``HHS'') will consider designating 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 eligible 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: Effective Date: This final rule is effective May 28, 2004.
    Compliance Date: Affected parties are required to comply with the 
information collection requirements in Sec.  82.9 effective May 28, 
2004.

FOR FURTHER INFORMATION CONTACT: Larry Elliott, Director, Office of 
Compensation Analysis and Support, National Institute for Occupational 
Safety and Health, 4676 Columbia Parkway, MS-C-46, Cincinnati, OH 
45226, Telephone 513-533-6800 (this is not a toll-free number). 
Information requests can also be submitted by e-mail to [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

A. Statutory Authority

    The Energy Employees Occupational Illness Compensation Program Act 
(EEOICPA), 42 U.S.C. 7384-7385, 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 lump sum 
payments 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, on December 7, 2000, 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 11, 2000). DOL published a final rule 
governing DOL's administration of EEOICPA on December 26, 2002 (67 FR 
78874).
    Executive Order 13179 directed HHS to perform several technical and 
policymaking roles in support of the DOL program:
    (1) HHS was to develop procedures for considering petitions by 
classes of employees at DOE and Atomic Weapons Employer (``AWE'') 
facilities to be added to the Special Exposure Cohort established under 
EEOICPA. These procedures are the subject of this rule. HHS is also to 
apply these procedures in response to such petitions. Covered employees 
included in the Special Exposure Cohort who have a specified cancer, 
and eligible survivors of these employees, qualify for compensation 
under EEOICPA.
    (2) HHS was 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 facility or AWE facility. HHS published a final rule 
establishing these ``Probability of Causation'' guidelines on May 2, 
2002 (67 FR 22296) under 42 CFR Part 81.
    (3) HHS was 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 a 
final rule promulgating these methods under 42 CFR Part 82 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 provide the Advisory Board on Radiation and 
Worker Health (``the Board'') with administrative and other necessary 
support services. The Board, a federal advisory committee whose members 
are appointed by the President, is advising 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). In this definition, 
Congress specified classes of employees to comprise the Cohort 
initially, including DOE employees, DOE contractor or subcontractor 
employees, who were (1) employed an aggregate of at least 250 work days 
before February 1, 1992 at a gaseous diffusion plant in Paducah, 
Kentucky, Portsmouth, Ohio, or Oak Ridge, Tennessee, and who were 
monitored using dosimetry badges or worked in a job that had exposures 
comparable to a job that is or was monitored using dosimetry badges; or 
(2) 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. As provided in 42 U.S.C. 
7384l(9)(A), employees included in the Cohort who incur a specified 
cancer \1\ qualify for compensation (see DOL regulations 20 CFR part 30 
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 
EEOICPA specifies are compensable under provisions governing 
compensation for members of the Cohort. Although the list of 
specified cancers is determined by statute, the list can also be 
found in this rule under Sec.  83.5.
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C. Purpose of the Rule

    EEOICPA authorized the President to designate additional classes of 
employees to be included in the Cohort, while providing Congress with 
the opportunity to review these decisions and expedite or reverse them. 
As noted previously, the President has delegated his authority in this 
matter to the Secretary of HHS. The purpose of this rule 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

[[Page 30765]]

intended to ensure that petitions for additions to the Cohort are given 
uniform, fair, scientific consideration, that petitioners and 
interested parties are provided the opportunity for appropriate 
involvement in the process, and to comply with specific statutory 
requirements of EEOICPA. The procedures also address, within their 
relevant scope, the stated congressional purpose of the compensation 
program to provide timely compensation to covered employees or their 
survivors for covered illnesses incurred by such employees in the 
performance of duty.

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

    EEOICPA includes several requirements for these procedures. The 
Board shall provide advice to the President (delegated by Executive 
Order 13179 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 the Department of Energy, and such other 
information as the Advisory 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 facility 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)(ii) 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 otherwise provides.''

E. Relationship of Procedures to an Existing Rule Promulgated by HHS To 
Implement EEOICPA

    These procedures complement the HHS final rule: ``Methods for 
Radiation Dose Reconstruction Under the Energy Employees Occupational 
Illness Compensation Program Act of 2000'' promulgated by HHS on May 2, 
2002 at 42 CFR Part 82 (67 FR 22314).
    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 for DOL to adjudicate a cancer claim for an 
employee who is not a member of the Cohort or whose claim is not 
covered by provisions of EEOICPA for compensating members of the 
Cohort. 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 class received.''

II. Summary of Public Comments

    HHS published a first notice of proposed rulemaking (``NPRM'') 
specifying procedures for adding classes of employees to the Cohort on 
June 25, 2002 (67 FR 42962). Public and Board comments on this first 
NPRM led HHS to make substantial changes in the proposal, which 
resulted in the publication of a second NPRM on March 7, 2003 (68 FR 
11294). HHS solicited public comments on this second NPRM from March 7, 
2003 to May 6, 2003.\2\ During this period, comments were also 
submitted by the Board.
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    \2\ HHS extended the public comment period from 30 to 60 days at 
the request of the Board and members of the public.
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    HHS received comments on the second NPRM from 11 organizations and 
19 individuals, including 14 Members of Congress. Organizations 
commenting included six national or local labor organizations 
representing DOE workers, the Health Physics Society, and four advocacy 
groups. A summary of these comments and HHS responses is provided 
below. These are organized by general topical area. The HHS responses 
in this section also serve to explain changes made to the proposed rule 
and to supplement explanations from both NPRMs concerning the intent of 
the final rule.

A. Feasibility of Dose Reconstructions: Timeliness, Cost, and 
Availability of Records

    As discussed above, EEOICPA requires HHS to find that it is ``not 
feasible to estimate with sufficient accuracy the radiation dose that 
the class received'' as a condition for adding the class to the Cohort. 
The NPRM proposed the criterion that this condition would be met if 
NIOSH were not able to establish ``that it has access to sufficient 
information to estimate the maximum radiation dose that could have been 
incurred in plausible circumstances by any member of the class'' (68 FR 
11308).
    HHS received comments from several labor organizations, an advocacy 
group, and Members of Congress recommending that the rule establish 
additional criteria defining when dose reconstructions would not be 
feasible. Some commenters recommended distinguishing this requirement 
as separate and apart from the requirement for ``sufficient accuracy.'' 
The most common recommendation was for HHS to establish a time limit 
for completing dose reconstructions, after which the dose 
reconstruction would be determined to be not feasible. Commenters 
recommended time limits ranging from 180 days to 24 months.
    HHS does not agree that a regulatory time limit on dose 
reconstructions would be appropriate in this rule, which establishes 
procedures for determining whether to add a class of employees to the 
Cohort. Some of the factors that could protract a dose reconstruction, 
such as a poorly defined employment history or work history, would be 
specific to the case of an individual employee, and would not be 
germane to a class of employees.
    HHS does not believe a time limit on the duration of a dose 
reconstruction to be an appropriate addition to the dose reconstruction 
rule, either. Such a limit would eliminate the flexibility to address 
special circumstances and could effectively nullify the statutory 
requirements for dose reconstruction and the determination of 
probability of causation in their entirety by deeming all DOE and AWE 
employees to be members of classes of employees for whom dose 
reconstruction is not feasible.
    In addition, a regulatory time limit could delay compensation for 
claimants whose dose reconstructions might exceed a regulatory deadline 
but would still be completed prior to the time at which a class of 
employees could be added to the Cohort. As this rule describes, 
Congress has 180 days to review any HHS decision to add a class to the 
Cohort, before such a decision could become effective.
    One of the most important factors presently affecting the 
timeliness of dose reconstructions is the current

[[Page 30766]]

backlog of dose reconstructions, which is a result of the extensive 
development requirements of the dose reconstruction program. NIOSH 
began receiving cases requiring dose reconstructions in October of 
2001, long before the dose reconstruction program could establish even 
minimal capacity for completing dose reconstructions. HHS completed 
final rules establishing the methods of dose reconstruction in May of 
2002. NIOSH awarded a contract to build external capacity for 
conducting dose reconstructions in September of 2002.
    NIOSH and its contractor for dose reconstructions are now employing 
more than 300 staff (including more than 100 health physicists) and are 
working to complete tasks necessary to eliminate the backlog. These 
tasks include the completion of ``site profiles,'' which summarize 
site-specific exposure conditions, dosimetry, and other relevant 
information. In parallel with this necessary developmental work, NIOSH 
is completing dose reconstructions at an increasing pace for cases 
involving sites for which NIOSH has already issued site profiles and 
for which site profiles are not needed. It took NIOSH 26 months to 
complete the first 1000 dose reconstructions. NIOSH completed the 
second 1000 in 14 weeks. This rate is continuing to improve.
    An advocacy group and some Members of Congress also recommended HHS 
consider the cost of dose reconstructions as a criterion for 
feasibility, to avoid incurring ``prohibitive expense'' in conducting a 
dose reconstruction.
    HHS has not included a cost criterion in the rule. The NIOSH dose 
reconstruction program is designed with procedures specifically 
intended to minimize the time and financial resources required for dose 
reconstructions. Individual dose reconstructions are presently costing 
an average of less than $10,000 each. A regulatory cost criterion would 
require HHS to incur unproductive expenses and might delay the 
consideration of petitions substantially, since HHS would have to 
estimate dose reconstruction costs related to each Cohort petition.
    Some Members of Congress also recommended that HHS consider the 
deficiency or complete absence of records as a criterion for 
feasibility.
    HHS included such provisions in the NPRM and in the final rule, as 
discussed in the following section discussing comments on ``sufficient 
accuracy.'' NIOSH internal procedures for evaluating petitions, 
available upon request from NIOSH (1-800-356-4674) or from the NIOSH 
Web page (www.cdc.gov/niosh/ocas), provide step-by-step practical 
information on how NIOSH will evaluate the availability of information 
needed to estimate the radiation doses of a class of employees with 
sufficient accuracy. These recommended internal procedures do not 
create any substantive rights on the behalf of petitioners. Comments 
may be provided at any time about these procedures to OCAS at 
[email protected]. Any subsequent revision of the internal procedures will 
be posted on the NIOSH Web site at www.cdc.gov/niosh/ocas. If there are 
any substantial revisions to these procedures, NIOSH will publish a 
Federal Register Notice including an indication that there have been 
substantial revisions, a paragraph summarizing the changes, and that 
the revised procedures can be found on the NIOSH Web site at 
www.cdc.gov/niosh/ocas. Comments regarding these internal procedures or 
any revisions thereto are invited.
    In addition, HHS has added a provision to section 83.13(c)(1)(i) of 
the rule, as part of the feasibility determination by NIOSH under this 
section, to require that NIOSH determine whether it has information 
regarding monitoring, source, source term, or process information from 
the site where the employees worked to serve as the basis for a dose 
reconstruction. EEOICPA requires that determinations of probability of 
causation for claimants under EEOICPA be based on the radiation dose 
received by the employee (or a group of employees performing similar 
work) at the facility where the employee(s) worked. 42 U.S.C. 
7384n(c)(3)(A). Consequently, for NIOSH to determine that dose 
reconstruction is feasible, dose reconstruction must, as a starting 
point, be based on some information from the site where the employee 
worked. This basis requirement does not limit NIOSH to using only or 
primarily information from the site where the employee worked, but it 
requires the use of some information from the site.
    HHS has also added a new Sec.  83.13(b) which authorizes the 
Director of the Office of Compensation Analysis and Support (OCAS) 
within NIOSH to determine that records and/or information requested 
from DOE, an AWE, or another source to evaluate a petition is not, or 
will not be, available on a timely basis. Such a determination will be 
treated, for the purposes of the petition evaluation, as equivalent to 
a finding that the records and/or information requested are not 
available. This will facilitate the efforts of NIOSH to evaluate 
petitions within a reasonable amount of time in relation to the records 
and/or information required to evaluate the petition and any other 
relevant factors.
    Some Members of Congress also recommended that the rule clarify 
that EEOICPA does not require a demonstration that no ``worst case 
estimate'' can be reached for inclusion in the Cohort.
    HHS has clearly and completely specified the statutory requirements 
of EEOICPA relating to the addition of classes of employees to the 
Cohort, under section I(D) above. The rule itself provides procedures 
by which HHS will implement these statutory requirements. Related 
specifically to the comment, to add a class of employees to the Cohort, 
EEOICPA requires that HHS find that ``it is not feasible to estimate 
with sufficient accuracy the radiation dose that the class received;* * 
* ;'' 42 U.S.C. 7384q(b). Subsection 83.13(c)(1) of this rule specifies 
clearly the approach HHS will use to evaluate feasibility. This 
approach, as it relates to the statutory requirement regarding 
feasibility, is discussed above, in sections B and C below, and in the 
second NPRM (68 FR 11296). The ability to estimate the maximum 
radiation dose received by members of a class is technically a critical 
distinction between circumstances in which it is feasible to estimate 
radiation doses through dose reconstruction and those in which it is 
not feasible to do so.

B. Feasibility of Dose Reconstructions: Relevance of Type of Cancer to 
Feasibility Determinations

    The NPRM included provisions that would have allowed NIOSH to 
define a class of employees that it would recommend be added to the 
Cohort according to the specific cancers for which dose reconstruction 
is not feasible and hence demonstrate a reasonable likelihood of a dose 
that may have endangered the health of members of the class. Several 
commenters questioned the scientific proposition that it could be 
feasible to estimate radiation doses for individuals with certain 
cancers, but not feasible to estimate doses for individuals with other 
cancers. The statutory provisions of EEOICPA neither require nor 
prohibit HHS from establishing cancer-specific classes.
    The Board, which specifically reviewed this issue, recognized that 
this situation ``may be scientifically and theoretically possible.'' 
Two theoretical examples of this situation, involving external 
radiation exposures (originating from outside of the body), were 
identified and considered during meetings of the Board and were not

[[Page 30767]]

contested by members of the Board (see Transcript of the Advisory Board 
on Radiation and Worker Health, March 7, 2003, page 17; Transcript of 
the Advisory Board on Radiation and Worker Health, March 28, 2003, 
pages 46-48).
    On the other hand, some members of the Board did contest the 
proposition that it could be feasible to estimate radiation doses from 
internal exposures (originating from radioactive materials that are 
taken into the body) for certain cancer sites and not others. This 
discussion clarified that all tissues and organs could be irradiated to 
some degree in cases involving internal exposures (see Transcript of 
the Advisory Board on Radiation and Worker Health, March 7, pages 36-
37; Transcript of the Advisory Board on Radiation and Worker Health, 
March 31, 2003, pages 42-66). As a result, a scientific finding 
concerning the feasibility of estimating doses in cases involving 
internal exposures would have to apply to all cancers. This reduces the 
practical applicability of a policy for establishing cancer-specific 
classes on the basis of the feasibility of dose reconstruction, since 
additions to the Cohort are likely to involve internal radiation 
exposures.
    A second scientific issue related to the issue of adding cancer-
specific classes to the Cohort but not related to the HHS proposal, is 
whether or not certain cancers should be excluded from a class because 
the radiation exposure of concern is unlikely to have caused those 
cancers. The Health Physics Society advocated such a policy, providing 
an example of situations in which one might reasonably conclude the 
probability of causation would be very low for certain cancers. An 
advocacy group and several labor organizations recommended against such 
a policy. HHS did not propose and has not established such a policy, 
which relates to health endangerment rather than the feasibility of 
dose reconstruction.
    The most prevalent comment HHS received on this rule did not 
concern the scientific justification for establishing cancer-specific 
classes, but argued that such a policy conflicted with EEOICPA and with 
congressional intent. These commenters included the 14 Members of 
Congress, advocacy groups, and labor organizations. Although the courts 
generally give little weight to statements by individual legislators 
when determining congressional intent, many of these commenters 
referenced an October 12, 2000 statement by Senator Jeff Bingaman to 
the full Senate. In this statement, Senator Bingaman said that groups 
of workers added to the Cohort ``would be eligible for compensation for 
a fixed list of radiation related cancers,'' meaning the list of 22 
``specified cancers'' established under EEOICPA and listed in section 
83.5(m) of this rule. S10377, Congressional Record, October 12, 2000.
    Many commenters also expressed the view that it would be unfair and 
contrary to EEOICPA for HHS to exclude from classes of employees to be 
added to the Cohort employees who incur certain specified cancers, 
since all specified cancers are compensable for members of the classes 
included in the Cohort by statute. The relevant portion of the 
statutory provision of EEOICPA reads as follows: ``The term `covered 
employee with cancer' means any of the following: [a]n individual with 
a specified cancer who is a member of the Special Exposure Cohort, * * 
*'' 42 U.S.C. 7384l(9)(A).
    In addition, while the Board indicated that it might be 
scientifically and theoretically possible for the situations addressed 
by the NPRM to exist, the Board recommended against the establishment 
of cancer-specific classes, as discussed below, stating that it was 
concerned about ``providing some level of equity between the definition 
of new SEC classes and those already defined in the legislation.''
    The provisions of EEOICPA that directly govern which classes of 
employees can be added to the Cohort are the feasibility and health 
endangerment provisions addressed under the ``statutory requirements'' 
section above. These provisions can be interpreted in different ways to 
either support or oppose the establishment of cancer-specific classes. 
They neither require nor prohibit HHS from establishing cancer-specific 
classes.
    As discussed above, in support of cancer-specific classes, HHS has 
identified possible situations in which the feasibility of estimating 
doses would differ by type of cancer. In addition, the Health Physics 
Society and a member of the Board identified possible situations in 
which a determination of health endangerment might differ by type of 
cancer.
    In opposition to including provisions for cancer-specific classes, 
one could interpret ``it is not feasible to estimate with sufficient 
accuracy the radiation dose that the class received'' to mean: it is 
not feasible to estimate with sufficient accuracy the radiation dose to 
any cancer site rather than the dose relevant to the cancer incurred by 
any particular employee. Similarly, health endangerment could be 
interpreted to mean an employee having been put at risk of certain 
types of cancers, regardless of whether the employee actually incurred 
one of the cancers for which the employee was at risk. Such 
interpretations would allow one to define a class without 
qualification, even when it would be feasible to estimate radiation 
doses for employees with all but one type of cancer, and even if most 
types of cancers were unlikely to have been caused by the radiation 
exposure of concern.
    In light of the ambiguity of the statute, the limited practical 
applications of the option to establish cancer-specific classes, the 
nearly unanimous public opposition, and the opposition of the Board, 
HHS has omitted from the final rule the provisions in the NPRM that 
would have allowed the addition to the Cohort by HHS of cancer-specific 
classes of employees. Furthermore, HHS has revised section 83.13(c)(1) 
of the rule to state explicitly that NIOSH will make determinations of 
feasibility based on whether or not NIOSH is able to reconstruct doses 
for every type of cancer for which radiation doses are reconstructed.
    The practical consequence of these changes is that HHS might 
designate classes of employees to be added to the Cohort under this 
rule despite the possibility that it might be feasible to estimate 
radiation doses with sufficient accuracy for some members of the class; 
specifically, that it might be feasible to estimate radiation doses 
with sufficient accuracy for a member of the class who incurs one of a 
subset cancer types for which there might be adequate dose-related 
information, as discussed above.

C. Accuracy of Dose Reconstructions

    HHS received various comments and recommendations that relate to 
the determination as to whether it is feasible to estimate doses to 
members of a class of employees with sufficient accuracy.
    The most frequent of these comments requested HHS provide 
additional detail, either in the rule or in guidelines, to define how 
NIOSH would establish, under Sec.  83.13(c)(1), ``that it has access to 
sufficient information to estimate the maximum radiation dose that 
could have been incurred in plausible circumstances by any member of 
the class* * *'' HHS was asked to provide the methods by which maximum 
radiation doses would be estimated, and to define ``sufficient 
information.'' The Board requested that NIOSH issue guidelines to 
provide additional clarification concerning sufficient accuracy, after 
promulgation of this final rule.

[[Page 30768]]

    As discussed above, NIOSH is issuing internal procedures 
concurrently with the promulgation of this rule that provide more 
detailed procedures for how it will evaluate petitions. While these 
procedures do not establish any substantive rights, they specify how 
NIOSH will identify available information and the general methods for 
determining whether such information will be sufficient to estimate 
maximum radiation doses for employees in the class, when such estimates 
are necessary. The internal procedures supplement the guidelines 
already provided in this final rule under section 83.13(c)(1). The 
internal procedures also provide limited generic information on how 
maximum radiation doses can be estimated when necessary. More specific 
detail outlining how available information would be used to conduct 
dose reconstructions would be provided within each NIOSH evaluation of 
a petition that finds that it is feasible to estimate radiation doses 
with sufficient accuracy for the class.
    One individual commented that the rule puts excessive emphasis on 
estimating the maximum possible doses of radiation.
    This emphasis was unintended. The proposed rule defined only the 
limits of dose reconstruction. The public should realize, however, that 
HHS may receive petitions for classes of employees for whom there is 
sufficient information to conduct dose reconstructions that provide 
more precise estimates than maximum doses, using, for example, personal 
or area monitoring records. For these petitions, methods for estimating 
maximum radiation doses would not be addressed in the NIOSH evaluation 
because they would not be relevant, since more precise dose 
reconstructions would be feasible. HHS has clarified the rule on this 
point, adding the following provision (identified below in italics) to 
section 83.13(c)(1):

    Radiation doses can be estimated with sufficient accuracy if 
NIOSH has established that it has access to sufficient information 
to estimate the maximum radiation dose, for every type of cancer for 
which radiation doses are reconstructed, that could have been 
incurred in plausible circumstances by any member of the class, or 
if NIOSH has established that it has access to sufficient 
information to estimate the radiation doses of members of the class 
more precisely than an estimate of the maximum radiation dose.

    HHS has also supplemented the guidelines previously included in the 
rule regarding the feasibility of estimating the radiation dose of a 
class of employees with sufficient accuracy. A new Sec.  
83.13(c)(1)(iii) specifies the following additional guidelines:

    In many circumstances, to establish a positive finding under 
paragraph (b)(1)(i) of this section would also require information 
describing the process through which the radiation exposures of 
concern may have occurred and the physical environment in which the 
exposures may have occurred.

    One labor organization interpreted the NPRM as indicating that 
NIOSH would use analytic models, presumably to estimate maximum doses 
when necessary, at the expense of the timely completion of dose 
reconstructions.
    The use of analytic models in such instances is efficient, not 
delaying. Dose reconstructions that rely more extensively on analytic 
exposure models can be completed far more quickly than dose 
reconstructions that require the collection and evaluation of extensive 
monitoring data, which may still involve the use of analytic exposure 
models as well.
    An individual commented that this rule should define how NIOSH 
determines the reliability of dosimetry information for use in dose 
reconstructions. The commenter correctly noted that the accuracy of 
dosimetry results is affected by a variety of factors, some of which 
the commenter enumerated. The commenter also asserted that it was a 
``fatal flaw'' of the NPRM to assume that maximum doses can be 
estimated 30 to 50 years after the fact.
    The HHS dose reconstruction rule (42 CFR Part 82) and related dose 
reconstruction guidelines specify how doses are reconstructed and 
explain how NIOSH takes into account various factors that affect the 
interpretation of dosimetry information, particularly the limitations 
of dosimetry programs from the early decades of nuclear weapons 
production. The types of studies the commenter cited, that have 
evaluated the shortcomings of dosimetry programs, are used by NIOSH to 
interpret the records of such dosimetry programs.
    The NPRM and this final rule, however, do not reflect an assumption 
that it will be feasible to estimate maximum doses or to more precisely 
estimate doses. The determination by NIOSH, the Board, and the 
Secretary of HHS as to whether dose reconstruction is feasible for a 
particular class of employees is a central element of this rule.
    Related to this latter point, an advocacy group and a labor 
organization questioned whether petitioning is ``futile'' under the 
provisions of this rule concerning feasibility, because, in the view of 
the commenters, NIOSH ``raised the bar'' for evaluating whether doses 
can be estimated with sufficient accuracy from the first NPRM to the 
second NPRM, from when a dose reconstruction cannot be completed to 
when maximum doses (nor more precise doses) cannot be estimated.
    The provisions of the second NPRM discussed in the comment are no 
more exclusive than those of the first NPRM, only more specific. The 
specificity was requested by the Board and sought by other public 
commenters as well.
    There is, however, a substantial difference between the minimal 
requirements for submitting a petition, when such a petition is not 
based on NIOSH having already found that a claimant's dose 
reconstruction cannot be completed, and the requirements for adding a 
class of employees to the Cohort. Such petitions provide NIOSH with 
basic information necessary to begin the determination process, but 
NIOSH is likely to have more extensive access to information for dose 
reconstructions than petitioners. NIOSH will consider all information 
as necessary, not only information provided by the petitioner, to 
determine whether or not the radiation doses of the class of employees 
can be estimated with sufficient accuracy.
    One labor organization commented that NIOSH had failed to address 
limitations of the NPRM. In explanation, the commenter asserted that 
the estimation of maximum doses would not be sufficient to estimate 
lifetime exposure and would not be valid in circumstances involving a 
mixture of radionuclides.
    If NIOSH can estimate the maximum quantity of a radionuclide that 
could have been inhaled, ingested, or absorbed by an employee, then the 
maximum doses resulting from such internal exposure can be estimated 
for the entire period between exposure and the occurrence of cancer, as 
is necessary for NIOSH dose reconstructions.
    With respect to mixtures of radionuclides, the critical issue is 
the extent of information about the mixture (e.g., quantities and 
identities). The involvement of multiple radionuclides is not 
inherently an obstacle to dose reconstruction. On the other hand, in 
situations involving exposure of a class of employees to a mixture of 
radionuclides of uncertain identity and quantity, NIOSH may not be able 
to estimate radiation doses and the class may be added to the Cohort, 
as provided for under this rule.
    Two labor organizations questioned how NIOSH could estimate 
radiation doses for workers who move between buildings or facilities 
and who may not, themselves, have any knowledge of radiation sources.

[[Page 30769]]

    If doses can be estimated for employees who worked steadily within 
a building or facility, then typically they could be estimated for 
employees who were in the building or facility episodically. A major 
difference in some such dose reconstructions, in cases in which the 
worker was not monitored at some or any of the locations, would be the 
need to allocate the worker's time among various locations. It is 
relatively straightforward to do so, using assumptions that give the 
benefit of the doubt to the worker when information concerning the 
duration of the worker's activities at different locations is 
insufficient.
    An advocacy group, a labor organization, and some Members of 
Congress asserted that the provision of the NPRM requiring that NIOSH 
have sufficient information to be able to estimate maximum radiation 
doses, at a minimum, is incompatible with a provision of the dose 
reconstruction rule (42 CFR 82.10(k)(2)). Some of these commenters 
interpret the provision of the dose reconstruction rule as limiting the 
use of worst-case assumptions, which must be used in estimating maximum 
radiation doses, to non-compensable cancer claims (i.e., claims for 
which the probability of causation is below 50 percent). Furthermore, 
the commenters conclude that this perceived incompatibility could 
result in a situation in which NIOSH might find that it could not 
complete a dose reconstruction for a claimant and yet NIOSH could find, 
under this rule, that the claimants' doses can be estimated, preventing 
HHS from adding a class of employees including the claimant to the 
Cohort. For this reason, the commenters recommended that HHS amend the 
dose reconstruction rule to be compatible with this rule.
    The dose reconstruction rule (42 CFR Part 82) does not require any 
revision with respect to this concern. It is not possible for NIOSH to 
determine that it cannot complete a dose reconstruction for a claimant 
under the dose reconstruction rule and simultaneously find the same 
dose reconstruction to be feasible under this rule (42 CFR Part 83).
    The dose reconstruction rule very specifically restricted the 
condition on the use of worst-case assumptions to the case when they 
are used as an efficiency measure to limit time-consuming and resource-
consuming additional research and analysis. This narrow restriction is 
stated in the dose reconstruction rule as follows (emphasis added):

    At any point during steps of dose reconstruction described 
[above], 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: * * * (2) Dose is determined using worst-case 
assumptions related to radiation exposure and intake, to substitute 
for further research and analysis; * * *
    * * * 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 greater), because using worst-case 
assumptions it can be determined that the employee could not have 
incurred a compensable level of radiation dose.'' 42 CFR Part 
82.10(k)

    In contrast, this Cohort rule implies the use of worst-case 
assumptions for dose reconstructions in essentially the opposite 
situation, to estimate maximum radiation doses in cases in which NIOSH 
lacks extensive information that could be used to conduct ``further 
research and analysis,'' rather than as an efficient substitute for 
such further research and analysis.
    The dose reconstruction rule does not assert or imply any 
restriction in circumstances in which the total information available 
is limited. In fact, the rule generally anticipates such circumstances 
in describing the hierarchy of information that might be used in a dose 
reconstruction, depending on availability. In the introductory section 
of the rule, it describes the dose reconstruction practice of using 
assumptions to substitute for a lack of data:

    ``For dose reconstructions conducted in occupational illness 
compensation programs, this practice may include use of assumptions 
that represent worst-case conditions.'' 42 CFR Part 82.2(a).

    Furthermore, the Cohort rule provides that whenever NIOSH finds 
under the dose reconstruction rule that it cannot complete a dose 
reconstruction, this finding will suffice, without exception or further 
consideration, to support a determination that it is not feasible to 
estimate the radiation doses of individual members of the class with 
sufficient accuracy. This was implicit in Sec.  83.14 of the NPRM but 
has been made explicit, to eliminate any uncertainty in interpretation, 
with the following inserted text (in italics):

    (b) NIOSH will determine the health endangerment criteria for 
adding the class under paragraph (a)(1) of this section to the 
Cohort, using the procedures outlined under Sec.  83.13. NIOSH will 
report to the Board the results of this determination, together with 
its finding under 42 CFR Part 82 that there was insufficient 
information to complete the dose reconstruction. HHS will consider 
this finding under 42 CFR Part 82 sufficient, without further 
consideration, to determine that it is not feasible to estimate the 
levels of radiation doses of individual members of the class with 
sufficient accuracy.

    Two labor organizations asserted, in contrast with the comments 
discussed immediately above, that the NPRM and the dose reconstruction 
rule (42 CFR Part 82) were inappropriately linked through their 
implicit use of common criteria for determining the feasibility of dose 
reconstructions. EEOICPA required HHS to establish, by regulation, 
methods for arriving at reasonable estimates' of radiation doses 
incurred by individuals (42 U.S.C. 7384n(d)). As discussed above, 
EEOICPA requires HHS to determine that it is not ``feasible'' to 
estimate with ``sufficient accuracy'' the radiation dose that a class 
received, for HHS to add a class of employees to the Cohort (42 U.S.C. 
7384q(b)(1)). The commenters believe the use of different terms in 
these two sections of EEOICPA (reasonable estimates of doses versus 
doses that are not feasible to estimate with sufficient accuracy) 
signals different intentions of Congress for determining the 
feasibility of dose reconstruction as it arises through the dose 
reconstruction program versus through a petition for adding a class to 
the Cohort. Accordingly, the commenters recommend that HHS establish 
different criteria for these two situations.
    The statutory provisions concerning the development of dose 
reconstruction methods (42 U.S.C. 7384n(d)) are concerned with how dose 
reconstructions are to be done, not a determination as to whether or 
not they can be done. It is implicit, nonetheless, that these dose 
reconstructions must be ``feasible to estimate with sufficient 
accuracy.'' It appears to HHS that the use of this phrase under 
provisions for considering the addition of classes of employees to the 
Cohort, and the omission of this phrase under provisions concerning 
dose reconstruction, simply reflects the fact that these two separate 
provisions of EEOICPA address different but complementary 
circumstances.
    An advocacy group and several labor organizations questioned 
whether or not an estimate of the maximum radiation dose produced by a 
dose reconstruction would be represented by a single value (point 
estimate) or by a distribution of values (that take uncertainty into 
account).
    When NIOSH is limited to estimating maximum doses in a dose 
reconstruction based on source term and process information, the dose 
reconstruction is likely to rely substantially on one or more worst-
case

[[Page 30770]]

assumptions that contribute to defining the level or levels of exposure 
and the characteristics of the exposure. It is unknown, however, how 
often such dose reconstructions would produce a point estimate of dose, 
versus a distribution of dose values that estimates dose. There are 
various circumstances that could result in the estimation of a 
distribution of dose values, such as when factors affecting the dose 
estimate have known and documented variability and/or uncertainties. 
NIOSH might use a distribution of values, for example, to characterize 
the particulate sizes of a radioactive material that has been ground or 
cut, when this factor had been studied and documented at comparable 
operations. In such a case, the distribution of values for particulate 
size would result in a distribution of dose values rather than a 
single, point estimate of dose.
    One advocacy group and labor organization requested the rule or 
guidelines define ``plausible circumstances,'' asserting that use of 
this term was simply substituting for the term ``sufficient accuracy.'' 
In context, HHS uses the term as follows: ``Radiation doses can be 
estimated with sufficient accuracy if NIOSH has established that it has 
access to sufficient information to estimate the maximum radiation dose 
that could have been incurred in plausible circumstances * * *'' 
(emphasis added). 42 CFR 83.13(c)(1)(i).
    In this case, ``plausible circumstances'' is not substituting for 
``sufficient accuracy'' as suggested, since the operative concept here 
is the ability to estimate the maximum radiation dose. The 
identification of plausible circumstances qualifies how such doses 
would be estimated. It means that NIOSH is not required to utilize 
unlikely, unreasonable, or illogical scenarios to estimate radiation 
doses. Furthermore, it is not reasonable to construct a ``litmus test'' 
for defining plausibility. It involves expert judgment, which will be 
applied by NIOSH and the Board in determining what are plausible 
circumstances consistent with the known information relevant to the 
evaluation of the petition. Dose reconstruction routinely uses expert 
judgment to address unknown and uncertain information. The important 
matter with respect to such judgments is that the NIOSH dose 
reconstruction program provides the benefit of the doubt to the 
claimant in identifying plausible scenarios, to ensure that dose 
reconstructions do not underestimate doses.
    One advocacy group and one labor organization also recommended that 
NIOSH consider applying a statistical concept such as ``the size of the 
standard error'' in guidelines for defining sufficient accuracy. The 
general idea of this comment is that NIOSH would define quantitatively 
the degree to which the range and likelihood of all possible dose 
estimates supported by the facts could diverge from the central 
tendency of these estimates.
    There is not a good scientific or logical basis for establishing a 
statistical measure of precision, which is not equivalent to accuracy, 
as a requirement for NIOSH dose reconstructions under EEOICPA. Any 
claimant for whom a less precise but more accurate estimate would 
support compensation might challenge such a requirement as arbitrary. 
For example, NIOSH might estimate that an employee incurred a radiation 
dose to the prostate of between 20 and 100 rem, with a central tendency 
of 60 rem. This dose distribution is not as precise as an estimate of 
between 50 and 70 rem, for example, but it could be more accurate to 
the degree that it appropriately accounts for the variability and 
uncertainty in the available data and hence better characterizes what 
we know and do not know about the level of dose received by the 
employee.
    HHS interprets ``sufficient accuracy'' in practical terms as 
sufficiently accurate to assure the fair adjudication of claims. NIOSH 
dose reconstructions provide this assurance by using methods that build 
on the factual and scientific bases using two principal measures that 
are designed to overestimate every employee's dose.
    First, as discussed above, the expert judgments (assumptions) used 
in NIOSH dose reconstructions give claimants the benefit of the doubt, 
when possible. When information is missing or questionable, the 
claimant is generally favored by NIOSH assuming the occurrence of the 
more harmful of plausible exposure scenarios.
    Second, NIOSH accounts quantitatively for the factual and 
scientific uncertainties involved in each dose reconstruction and 
includes this measure of uncertainty in the probability of causation 
calculation performed by DOL. In practical terms, this favors the 
claimant because, pursuant to 42 U.S.C. 7384n(c)(3)(A), DOL calculates 
the probability of causation at the upper 99 percent credibility limit; 
in other words, any uncertainty in the dose used to adjudicate the 
claim will contribute to DOL overestimating the likelihood that the 
employee's cancer was caused by radiation.
    These two measures taken together, claimant-favorable assumptions 
and the estimation of probability of causation at the upper 99 percent 
credibility limit, produce a doubly upper-bounded estimate of the 
employee's radiation dose. By these measures, whenever it is feasible 
for NIOSH to estimate radiation doses for a cancer claimant, NIOSH is 
almost certain to be overestimating the actual radiation doses.

D. Health Endangerment

    In addition to the condition that HHS find that it is not feasible 
to estimate the radiation doses of a class of employees with sufficient 
accuracy, a second requirement of EEOICPA for adding a class to the 
Cohort is that HHS find that there is ``a reasonable likelihood that 
such radiation dose may have endangered the health of members of the 
class.'' Under section 83.13(b)(3) of the NPRM, HHS proposed a standard 
based on the duration of employment within the employment conditions 
under which radiation doses cannot be estimated. As a default, this 
standard would be 250 work days, the same standard required by EEOICPA 
for employees of the gaseous diffusion plants included in the Cohort by 
Congress. 42 U.S.C. 7384l(14)(A). In addition, for classes of employees 
that may have been exposed to radiation during discrete incidents that 
were likely to have involved exceptionally high level exposures, such 
as nuclear criticality incidents, HHS provided that an employee's 
presence with potential exposure during the discrete incident, rather 
than a quantified duration of potential exposure, would satisfy the 
health endangerment criterion.
    HHS received relatively few comments concerning the health 
endangerment provisions of the rule and these were generally 
supportive. A few commenters recommended changes.
    An advocacy group and a labor organization recommended that 
employees should be able to accumulate the 250 work days required to 
qualify as members of a class added to the Cohort on the basis of their 
employment at multiple facilities, if the class includes employment at 
the multiple facilities. The central concern behind this comment is 
that some nuclear weapons workers are likely to have been employed at 
more than one facility, potentially conducting similar work (such as 
construction or maintenance) and incurring similar exposures for which 
dose reconstruction might not be feasible. The commenters are aware 
that DOL qualifies employees of the gaseous

[[Page 30771]]

diffusion plants to be included in the Cohort by aggregating their 
employment across all three of the plants, and hence believe classes 
added to the Cohort should be treated similarly.
    DOL is interpreting a section of EEOICPA that establishes a single, 
multi-facility class (42 U.S.C. 7384l(14)(A)), while HHS is 
interpreting a different section of EEOICPA (42 U.S.C. 7483q), which 
does not allow HHS to define a class as a group of employees from 
multiple facilities. However, HHS agrees with the principle of 
aggregating employment within separate classes of the Cohort for the 
purpose of determining health endangerment. There is no compelling 
health reason to distinguish between employment within one class of the 
Cohort and employment distributed among several classes of the Cohort, 
nor to distinguish whether such classes were employed at the same 
facility or at separate facilities. In any case, the employee would 
have accumulated 250 work days of employment involving exposure to 
radiation that either cannot be estimated by dose reconstruction under 
the provisions of this rule or for which Congress determined there was 
not a need for dose reconstruction when Congress included the various 
groups of employees in the Cohort.
    Accordingly, HHS has added a provision to the rule to implement 
this principle of aggregating employment. Whenever HHS adds a class of 
employees to the Cohort for which the 250 work days requirement is 
applicable, HHS will define class eligibility such that DOL can 
aggregate the work days of an employee from among all other classes in 
the Cohort for which the employee meets all of the other requirements 
for membership, except for the work days requirement. For this purpose, 
section 83.13(c)(3)(ii) of the rule includes the following additional 
text (in italics):

    (ii) For health endangerment not established on the basis of a 
discrete incident, as described under paragraph (b)(3)(i) of this 
section, NIOSH will specify a minimum duration of employment to 
satisfy the health endangerment criterion as having been employed 
for a number of work days aggregating at least 250 work days within 
the parameters established for the class or in combination with work 
days within the parameters established for one or more other classes 
of employees in the Cohort.

    An advocacy group and two labor organizations recommended that the 
rule allow for the health endangerment test to be met in fewer than 250 
work days for work operations lasting fewer than 250 days. The 
commenters indicated that certain short-term operations may have 
involved high level exposures. The comments also reflected the 
assumption that high level exposures could have occurred through the 
omission of radiation protection controls, versus their failure, only 
the latter of which was identified in the NPRM.
    HHS has not established a separate criterion that would waive the 
250 work days employment requirement for any short-term operation, 
since exceptionally high level exposures are not inherent to such 
operations. Section 83.13(c)(3)(i) of the HHS rule already provides for 
waiving the 250 work days employment requirement whenever classes of 
employees may have been exposed to radiation during discrete incidents 
likely to have involved exceptionally high level exposures, including 
any such incidents that may have occurred during projects of short 
duration. HHS has revised the text of this section to allow for the 
possibility that exceptionally high exposures could result from 
circumstances involving the omission of radiation protection controls, 
as well as their failure. With respect to this change, however, HHS 
advises potential petitioners that the omission of radiation protection 
controls, in and of itself, is not substantial evidence that 
exceptionally high level radiation exposures were likely. The provision 
of the rule allowing HHS to waive the 250 work days requirement is 
intended to address exposure scenarios distinctly more certain and 
severe than would be represented by exposure conditions generally at 
the gaseous diffusion plants, for which Congress established the 
precedent of setting an employment duration requirement at 250 work 
days.
    An advocacy group recommended HHS incorporate into the rule a text 
excerpt of the NPRM preamble that explained that HHS will use the 250 
work days employment requirement ``only when it lacks sufficient basis 
to establish a lower minimum standard.''
    HHS has not incorporated this text into the rule for two reasons. 
First, the term ``only'' may be misleading. HHS has no basis to predict 
that the 250 work days employment requirement would be waived for the 
majority of classes of employees that may be added to the Cohort. 
Moreover, the text is not appropriate for the rule, since it could be 
interpreted to require HHS to demonstrate that it lacks sufficient 
basis to waive the 250 work days requirement, versus demonstrating that 
there is sufficient basis to waive the requirement. This would amount 
to requiring HHS to ``prove the negative,'' that it lacks certain 
information.
    One labor organization commented that EEOICPA provides no basis for 
considering the effects of radiation in isolation when considering 
health endangerment.
    EEOICPA specifically requires that HHS consider whether ``* * * 
such radiation dose may have endangered the health of members of the 
class'' (emphasis added) 42 U.S.C. 7384q(b)(2). This might allow HHS to 
take into account a synergistic or risk-potentiating relationship 
between a chemical and a radiation exposure, if such a relationship 
were known. Otherwise, EEOICPA does not authorize HHS to consider 
health risks other than exposure to radiation.
    Two individuals commented that HHS should use epidemiological data 
to compare the cancer risks of classes of employees petitioning for 
addition to the Cohort with those of the groups included in the Cohort 
by statute. The commenters recommended that classes with cancer risks 
that are roughly comparable be added to the Cohort.
    HHS cannot add classes to the Cohort on the basis of health 
endangerment alone. As discussed above, pursuant to 42 U.S.C. 
7384q(b)(1), HHS must also find that dose reconstruction is not 
feasible. Moreover, as discussed in the second NPRM in response to this 
comment, there is no practical and scientifically defensible method for 
making such epidemiological comparisons for a variety of reasons, 
including limitations concerning timeliness, statistical power, and 
other matters (68 FR 11297).
    One labor organization asserted that Congress intended for HHS to 
use the same criteria for considering whether to add classes of 
employees to the Cohort as were used by Congress itself to include 
groups in the Cohort by statute.
    As discussed above, Congress specified in EEOICPA, 42 U.S.C. 
7384q(b), the criteria that it intended HHS to use.

E. Eligibility To Petition

    Section 83.7 of the NPRM specified parties that would be eligible 
to submit a petition on behalf of a class of employees. This included: 
``(c) One or more individuals or entities authorized in writing by one 
or more DOE, DOE contractor or subcontractor, or AWE employees, who 
would be included in the proposed class of employees, or their 
survivors.''
    HHS received conflicting comments concerning this provision. One 
labor organization recommended that HHS narrow the above provision 
specifically, and implied HHS would have to narrow another provision of 
Sec.  83.7 that would

[[Page 30772]]

allow employees and survivors to petition (paragraph (a)), ``to 
recognize the exclusive right of a labor union to represent the 
collective interests of employees in represented bargaining units who 
might petition for inclusion in the SEC.'' The commenter asserted: 
``Any NIOSH procedures inconsistent with this bedrock principle are 
incompatible with the National Labor Relations Act.'' The commenter 
further speculated that NIOSH would conserve resources by limiting the 
right to petition to the certified labor organization whenever the 
class includes members of an existing bargaining unit of a labor 
organization. The commenter explained that such a limitation ``will 
avoid the potential problem of several competing representatives filing 
overlapping or inconsistent petitions on behalf of common employees.''
    Two other labor organizations (one being a local unit of the 
commenter discussed above) and three advocacy groups expressed 
unqualified support for the eligibility requirements proposed in the 
NPRM and specifically opposed the recommendations and rationale of the 
commenter discussed above. One of these commenters asserted that the 
National Labor Relations Act (NLRA) provision regarding the exclusive 
right of a labor union to represent collective interests of employees 
in union-represented bargaining units does not apply to petitions for 
Cohort status under the EEOICPA. Some members of this group of 
commenters further argued that the limitation proposed by the first 
commenter above would be unworkable given the large number of unions 
representing employees at a single site.
    On its face, the NLRA, which in pertinent part at 29 U.S.C. 159(a) 
establishes the exclusive right of a labor union to represent employees 
in union-represented bargaining units for the purpose of ``collective 
bargaining in respect to rates of pay, wages, hours of employment, or 
other conditions of employment,'' does not apply to petitions for 
Cohort status under EEOICPA, as these do not involve ``collective 
bargaining in respect to rates of pay, wages, hours of employment, or 
other conditions of employment.'' None of the items potentially 
addressed by collective bargaining are determined by HHS in considering 
a petition to add a class of employees to the Cohort.
    HHS discussed the issue of potentially overlapping petitions, which 
concerned the first commenter above, in the first NPRM (67 FR 42966). 
This situation is unavoidable and HHS does not expect it to present 
major difficulties. HHS will consider concurrent petitions jointly, to 
the extent that they identify a class in common. With respect to the 
commenter's concern about potential conflicts between petitions, 
decisions by HHS on petitions will not govern decisions on subsequent 
petitions for the same class, or any part thereof, so long as 
substantial new information, germane to the criteria for adding a class 
to the Cohort, is provided by a subsequent petition.
    For the reasons discussed above, HHS has retained in the rule the 
relevant provisions of Sec.  83.7 from the NPRM, without change.
    HHS revised Sec.  83.7 to limit the number of petitioners that can 
submit a single petition to a maximum of three individuals and/or 
organizations. This limitation, which limits the number of petitioners 
but does not limit the number of members of a class of employees, is 
intended to facilitate the timely consideration of petitions by NIOSH, 
the Board, and the Secretary, since each petitioner for a petition has 
procedural rights under the rule that, if applicable to a large number 
of petitioners, could prolong the consideration of a petition 
substantially. HHS has also added a definition of the term 
``petitioner'' under Sec.  83.5(j) of the rule to reflect this change.

F. Petition Requirements

    Section 83.9 of the NPRM specifies informational requirements that 
must be fulfilled by petitioners in order for HHS to consider the 
petition. An advocacy group and two labor organizations commented 
generally that they support the reduced requirements of this second 
NPRM, compared to the first NPRM. Commenters had several specific 
recommendations.
    Subsection (b) requires claimants to petition when NIOSH has found 
that it cannot complete their dose reconstructions. The information to 
be provided by the petitioner in such cases is minimal, in effect 
simply notifying NIOSH formally that the claimant wishes to petition. 
Nonetheless, one labor organization recommended against this 
requirement, asserting that it is unnecessarily burdensome. The 
organization recommended that HHS automatically consider the addition 
of a class in these cases.
    HHS interprets EEOICPA, 42 U.S.C. 7384q(a)(3), to require the 
submission of a petition to initiate consideration for adding a class 
of employees to the Cohort. As specified under the dose reconstruction 
rule (42 CFR 82.12), NIOSH will encourage and assist these claimants to 
file a petition and has minimized the requirements for their petitions.
    Subsection (c)(1)(i) specifies that petitioners, other than the 
claimant-petitioners covered under subsection (b), must propose a 
definition of the class of employees for whom the petition would apply, 
including identifying, among other items: ``The DOE or AWE facility at 
which the class worked* * *'' (emphasis added). Three advocacy groups 
and three unions commented on this provision.
    The commenters recommended that petitions be allowed to cover 
multiple facilities. Commenters explained that certain occupational 
groups, such as construction and maintenance workers, had work tasks 
that spanned separate sites, or had occupational histories that 
commonly involved work at more than one site, and that there may be 
similar deficiencies in radiation monitoring for these particular 
occupational groups across such sites. Furthermore, in response to the 
finding of HHS in the NPRM stating that EEOICPA does not allow for 
classes to be defined to encompass employees at more than one facility 
(68 FR 11298-11299), some of the commenters asserted that HHS is not 
properly interpreting the statute. Specifically, the commenters assert 
that it is proper in this case to interpret ``the singular [facility] 
to include the plural [facilities].''
    The very first section of the United States Code, 1 U.S.C. 1, says: 
``In determining the meaning of any act of Congress, unless the context 
indicates otherwise--words importing the singular include and apply to 
several persons, parties, or things * * *'' (emphasis added). In the 
case of the statutory language used by Congress in the section of 
EEOICPA describing the procedure for designating additional members of 
the Cohort (42 U.S.C. 7384q), the context indicates Congress did not 
define a class as a group of employees from multiple facilities. In 
particular, the context of the reference to a ``class of employees at 
any Department of Energy facility who likely were exposed to radiation 
at that facility'' in 42 U.S.C. 7384(q)(a)(1) cannot be interpreted as 
a class covering more than one facility (emphasis added). HHS therefore 
believes that the concept of considering and adding multi-facility 
classes was not anticipated nor provided for in EEOICPA.
    As a result, HHS has not revised this section, nor the definition 
of the class under 83.5, to allow for classes spanning employment at 
multiple facilities. This limitation would not, however, prevent a 
petitioner from

[[Page 30773]]

submitting petitions separately for employees at each facility at which 
a group was employed, defining individual, facility-specific classes. 
Furthermore, changes in this rule eliminate the potential value of 
defining classes to include employment at multiple facilities. Under 
this rule (83.13(c)(3)(ii)), a claimant will be able to qualify as a 
member of a class added to the Cohort by HHS by combining the duration 
of his or her period of employment within the class with other periods 
of employment among other classes in the Cohort. Hence, for example, if 
classes of construction workers involved in certain operations were 
separately added to the Cohort from Hanford and from Los Alamos, then a 
construction worker who was employed for 100 work days in the specified 
operations at Hanford and for 150 work days in the specified operations 
at Los Alamos would meet a 250 work days employment requirement that 
might be established for such classes and he or she would qualify as a 
member of the Cohort.
    Subsection 83.9(c)(2) specified various options available to 
petitioners to support a petitioner's belief that records and 
information available are inadequate to estimate the radiation doses 
incurred by members of the proposed class of employees with sufficient 
accuracy. Two advocacy groups and two labor organizations recommended 
changes to paragraph (iv) to allow petitioners to use in support the 
report of any government agency, rather than only reports by agencies 
that conduct scientific work. The commenters suggested any government 
agency should be considered a potentially credible source of 
information. The commenters also recommended against requiring that 
such reports specifically address the need for any dosimetry 
information identified in the report, with respect to dose 
reconstruction. The Board provided a similar recommendation (discussed 
in the following section).
    HHS agrees that this provision should be clarified and improved, 
consistent with these comments. The paragraph now reads as follows:

    (iv) A scientific or technical report, published or issued by an 
agency of the Executive branch of government, the General Accounting 
Office, the Nuclear Regulatory Commission, or the Defense Nuclear 
Facilities Safety Board, or published in a peer-reviewed journal, 
that identifies dosimetry and related information that are 
unavailable (due to either a lack of monitoring or the destruction 
or loss of records) for estimating the radiation doses of employees 
covered by the petition.

    Subsection 83.9(c)(3) of the NPRM specified evidence that would be 
required only when a petition is based on an exposure incident (versus 
routine operations) and NIOSH is unable to obtain records or 
confirmation of the occurrence of such an incident from sources 
independent of the petitioner(s). One option specified for such 
evidence was confirmation by affidavit from two employees who witnessed 
the incident.
    One labor organization commented that a total of two witnesses 
should be sufficient and that secondhand accounts should be sufficient 
when eyewitnesses are deceased. The Board made similar recommendations 
(discussed in the following section).
    HHS has revised this subsection in response to the comments from 
the public and the Board. HHS has omitted the requirement for a 
specific number of witnesses, and has provided that the witnesses can 
be or include individuals who were informed by eyewitnesses, when the 
eyewitnesses are deceased, are incapable of providing an affidavit for 
reasons of poor health or impairment, or could not be located. HHS has 
also clarified that the provision of affidavits, in and of itself, 
would not constitute adequate evidence to verify the occurrence of an 
exposure incident. As with any other evidence used to evaluate 
petitions, NIOSH would have to consider the credibility and adequacy of 
the evidence provided in the affidavits.
    One labor organization commented that the NPRM required petitioners 
to know the source terms (the identities and quantities of the 
radioactive materials) to which employees were exposed.
    Neither the NPRM nor the final rule includes such a requirement.
    HHS has added a new Sec.  83.9(c)(5) necessary to provide that 
NIOSH would only be required to reconsider its initial evaluation or 
any subsequent evaluations concerning the addition of a particular 
class of employees to the Cohort (a class that has already been 
considered by NIOSH as the result of one or more previously submitted 
petitions) when a new petition for such a class provides substantially 
new information regarding the feasibility of estimating radiation doses 
with sufficient accuracy. This change will ensure that the Board and 
HHS can consider in a timely fashion the addition to the Cohort of as 
many classes as possible. The change preserves the ability of NIOSH, 
the Board, and HHS to reconsider the addition of a class when 
petitioners identify information not considered by NIOSH that might 
lead NIOSH and/or the Board to new findings and recommendations 
concerning a class previously considered.

G. Administrative Review of Decisions To Not Evaluate a Petition

    Section 83.11 of the NPRM proposed procedures by which NIOSH would 
assist petitioners on petitions that NIOSH finds do not meet the 
relevant requirements for a petition. A petition that fails to meet 
such requirements despite such assistance would not be further 
considered by HHS. HHS solicited comments from the public as to whether 
HHS should offer the petitioner an administrative review of such final 
decisions.
    Two advocacy groups and three labor organizations recommended the 
rule include the option of an administrative review. The commenters 
recommended that HHS specify the procedure for such reviews and that 
they be conducted independently. One commenter recommended that such 
reviews be conducted by NIOSH internally.
    In response to the public comments, HHS has included an option for 
prospective petitioners to request an administrative review. Paragraphs 
(b) through (e) of section 83.11 have been revised and added for this 
purpose. The review would be conducted by three HHS personnel, 
appointed by the Director of NIOSH, who were not involved in the 
initial consideration of the petition. The rule provides for a simple 
and timely process, with minimal requirements imposed on the 
petitioner. When appropriate, NIOSH would notify a petitioner of the 
right to seek an administrative review and of the associated 
procedures.

H. Decisions by the Secretary

    Section 83.16 of the NPRM described procedures by which the 
Secretary would decide the outcome of a petition.
    An advocacy group, four labor organizations, and some Members of 
Congress requested additional detail or provided other comment on these 
procedures. The advocacy group recommended the Secretary delegate his 
authority to the Director of NIOSH and questioned the extent of the 
discretion of the Secretary and the ``weight'' that would be assigned 
to the advice of the Board. A labor organization recommended the rule 
limit the circumstances under which the Secretary may reject a 
recommendation of the Board to add a class to the Cohort, and should 
require explanation of such decisions. Another labor organization 
asserted that the rule does not specify the criteria by which the 
Secretary will make decisions. Several commenters

[[Page 30774]]

recommended the rule require the Secretary to make decisions within 21 
days of receiving recommendations from NIOSH and the Board.
    The advocacy group, a labor union, and some Members of Congress 
also sought additional information about the procedure for 
administrative review of proposed decisions. The advocacy group and a 
labor organization specifically questioned whether such reviews would 
include the opportunity for oral presentations by petitioners and 
experts, and the availability of the administrative record of the NIOSH 
evaluation(s).
    HHS has specified procedures under Sec.  83.16 in greater detail in 
response to these comments. The procedures now specify that the 
Director of NIOSH will propose decisions on behalf of HHS. The 
authority to issue final decisions, however, has not been delegated to 
the Director of NIOSH. As discussed in the preamble of the NPRM, the 
Secretary may consider such a delegation on the basis of experience.
    The criteria for making proposed and final decisions were implicit 
in the NPRM but have been specified explicitly in the rule; these are 
the criteria to be applied by NIOSH in evaluating a petition under 
Sec.  83.13(c), implementing the two criteria specified in EEOICPA (42 
U.S.C. 7384q(b)(1) and (2)).
    HHS has revised the procedures for issuing proposed decisions to 
clarify that NIOSH would issue multiple proposed decisions in response 
to a single petition, when NIOSH determines that the petition 
encompasses more than one class of employees. As defined under Sec.  
83.5(c), a class of employees means, for the purposes of this rule, a 
group of employees who work or worked at the same DOE facility or AWE 
facility, and for whom the availability of information and recorded 
data on radiation exposures is comparable with respect to the 
informational needs of dose reconstructions conducted under 42 CFR Part 
82. Based upon NIOSH's evaluation of a petition, NIOSH may find that 
records are sufficient to conduct dose reconstructions for part of a 
proposed class, as defined by the petitioner, and insufficient to 
conduct dose reconstructions for another part of the proposed class. In 
such a case, NIOSH would define two or more separate classes of 
employees, distinguished by the difference in the sufficiency of the 
information available to conduct dose reconstructions.
    Related to this clarification, HHS has also revised the procedures 
to authorize petitioners to contest only those proposed decisions that 
would deny the addition of a class to the Cohort and to contest a 
health endangerment determination under Sec.  83.13(c)(3)(ii) for a 
decision that would add a class to the Cohort. This limitation will 
expedite the process of completing the consideration by HHS of classes 
that NIOSH has proposed adding to the Cohort by omitting a 30-day 
period, specified under the NPRM, during which HHS would have been 
required to await a challenge. It also will ensure that consideration 
by HHS of such classes would not have to further await, beyond the 30-
day period, the outcome of a challenge in which a petitioner asserts 
that the proposed scope of the class is overly restrictive. This 
limitation will not prevent a petitioner from contesting any proposed 
decision or aspect of a proposed decision regarding his or her petition 
that would deny the addition to the Cohort of individuals covered by 
the petition or a resultant NIOSH proposed decision.
    The section newly specifies the independence with which proposed 
decisions will be reviewed in response to challenges and provides 
clarification concerning the requirements of such challenges and the 
nature of such reviews. These will be records-based reviews conducted 
by a panel of three HHS personnel, appointed by the Secretary, rather 
than hearings involving witnesses and presided over by an 
administrative law judge. The reviews will not involve oral 
presentations or the introduction of new information that had not 
previously been presented or submitted to NIOSH or the Board prior to 
the Board completing its report of recommendations to the Secretary 
under Sec.  83.15. Petitioners will have received all NIOSH evaluations 
concerning their petitions, and will have access to the administrative 
record for such evaluations, all publicly available information 
considered by the Board, as well as to the final report of the Board; 
petitioners will not have access to information protected by the 
Privacy Act and information classified for purposes of national 
security. Complete instructions for contesting proposed decisions will 
be provided to each petitioner.
    The rule does not specify any particular weight that HHS will 
accord the advice of the Board in making proposed and final decisions. 
The Board recommendations are advisory. HHS would not prejudge such 
advice and will consider it according to its merits. Section 83.16 
specifies the sources and scope of information that HHS will consider 
in making its decisions, and provides that HHS will explain the basis 
for the decisions.
    The rule does not require that HHS make final decisions within 21 
days or any specified period. Decisions will be made as expeditiously 
as possible, but HHS is providing petitioners 30 days to contest 
proposed decisions and such challenges would then have to be 
considered. The volume and scope of petitions, factors not controlled 
by HHS and impossible to predict, also might affect the speed of such 
decisions.

I. Cancelling or Modifying a Final Decision

    One labor organization commented on the provisions under Sec.  
83.18 of the NPRM allowing the Secretary to cancel or modify a class 
that the Secretary had added to the Cohort. The commenter recommended 
such a decision by the Secretary be applied prospectively, for the 
adjudication of future claims; in other words, such a decision should 
not affect claimants who have already been compensated as a member of 
the Cohort, by potentially requiring the cessation of medical benefits 
or the return of the lump sum cash benefit, pending the results of a 
re-adjudication of the claim.
    Since DOL makes final compensation eligibility determinations for 
claimants, DOL will determine the application of such decisions by HHS 
to claims that DOL has already decided and claimants who have already 
received compensation.

J. Definitions of Terms Used in the Rule

    Section 83.5 provided definitions of terms used in the NPRM.
    Three advocacy groups and four labor organizations commented on 
several of the definitions. The Board also commented on definitions.
    The advocacy groups and two labor organizations recommended that 
the definition for a ``class of employees'' (Sec.  83.5(c)) in the NPRM 
be revised to allow for a class that would span multiple facilities. 
One advocacy group and one labor organization also recommended that 
this definition be revised to define a class in terms of information 
that is not available.
    The multi-facility issue is fully discussed above, under the 
section addressing comments on petition requirements. HHS does not 
interpret EEOICPA to allow for petitioners to define multi-facility 
classes of employees. Hence, HHS has not changed the definition as 
recommended by the commenters. This limitation would not, however, 
prevent a petitioner from submitting petitions separately for employees 
at each facility at which a group was employed,

[[Page 30775]]

defining individual, facility-specific classes. Furthermore, as 
discussed above under the section on health endangerment, changes in 
this rule eliminate any potential value of defining classes to include 
employment at multiple facilities.
    The terminology of the definition in the NPRM, in specifying that a 
class is defined in part by ``the availability of information,'' was 
appropriate and has not been changed in the final rule. The term 
``availability'' covers the possibility that information is available 
or is not available, with respect to the informational needs of dose 
reconstructions conducted under 42 CFR Part 82. Both of these 
possibilities need to be covered, since HHS might define classes of 
employees for whom information is sufficient for the needs of dose 
reconstructions and other classes for whom information is insufficient, 
as provided under this part.
    The NPRM did not include a definition of the term ``facility,'' 
which is used in the rule. Two advocacy groups and three labor 
organizations recommended the rule include a definition of facility, 
and that the definition be defined as broadly as possible. Some 
specific suggestions for wording were provided.
    HHS has not included a definition of the term ``facility'' in the 
rule since ``atomic weapons employer facility'' and ``Department of 
Energy facility'' are already defined in EEOICPA (42 U.S.C. 7384l(5) 
and (12)). These statutory definitions are complex. As a necessary 
consequence, DOE facility or AWE facility definitions must be 
considered on a case-by-case basis. To provide guidance on the types of 
facilities that would fall within the statutory definitions, and in 
particular, whether the term ``facility'' is limited to a single 
building or can also include multiple buildings, HHS has included a 
footnote to Sec.  83.9(c)(1)(i) in the final rule which provides:

    Depending on the factual circumstances present, a facility that 
meets the definition of an AWE facility or DOE facility covered 
under EEOICPA (42 U.S.C. 7384l(5) and (12)) could, among other 
possibilities, constitute a single building or structure, including 
the grounds upon which it is located, or a site encompassing 
numerous buildings or structures, including the grounds upon which 
it is located.

    While a petition for a class of employees must be limited to one 
facility, a facility can constitute a site encompassing numerous 
buildings or structure, including the grounds upon which it is located. 
This has no effect, however, on the prospects for a class being added 
to the Cohort or the prospects for an individual employee being 
included as a member of a class added to the Cohort. These depend on 
the criteria specified in this rule, regardless of the scope of the 
petition. As discussed above, the latter also can depend on whether an 
employee meets a 250 work days employment criterion, when applicable, 
but Sec.  83.13(c)(3)(ii) of the rule allows this criterion to be met 
through employment within the parameters of separate classes included 
in the Cohort.
    HHS received two comments on the definition of ``specified 
cancers'' (Sec.  83.5(k)) provided in the NPRM. An advocacy group 
recommended the definition be amended to allow for other cancers 
specified by DOL. A labor organization recommended that the definition 
include rectal cancers, which have been determined by DOL, after 
consultation with the National Cancer Institute, to be a subset of 
cancer of the colon for the purposes of compensation for members of the 
Cohort.
    The statutory definition of ``specified cancer'' can be found in 
EEOICPA at 42 U.S.C. 7384l(17). This definition cannot be changed by 
HHS; it can only be changed by Congress. The definition of ``specified 
cancer'' in the NPRM and in this final rule at Sec.  83.5(m)(6) 
explains, however, that the specified cancers identified in the 
definition mean the physiological condition or conditions that are 
recognized by the National Cancer Institute, the scientific body with 
which DOL consults if there are questions regarding the proposed 
classification of a particular cancer.
    HHS has added a definition of petitioner under Sec.  83.5(j). The 
definition limits the number of petitioners that can submit a single 
petition to a maximum of three individuals and/or organizations. This 
limitation, which limits the number of petitioners but does not limit 
the number of members of a class of employees, is intended to 
facilitate the timely consideration of petitions by NIOSH, the Board, 
and the Secretary, since each petitioner for a petition has procedural 
rights under the rule that, if applicable to a large number of 
petitioners, could prolong the consideration of a petition 
substantially. HHS has also revised Sec.  83.7 of the rule to reflect 
this change.

K. Miscellaneous Comments

    The rule provides for petitions in two distinct circumstances. One 
circumstance is when NIOSH has attempted to conduct a dose 
reconstruction for a cancer claimant, under 42 CFR Part 82, and finds 
that the dose reconstruction cannot be completed, because there is 
insufficient information to estimate the radiation doses of the 
claimant with sufficient accuracy. The second circumstance includes all 
other possibilities. For example, a petition may be submitted 
representing a class of employees whose members have yet to file claims 
under EEOICPA, or even have yet to be diagnosed with cancer.
    An advocacy group recommended that the rule explain these two 
circumstances that have been provided for under the rule. The commenter 
recommended specifically that the rule clarify that petitioners or 
potential class members are not required, as a prerequisite for 
petitioning, already to have incurred a cancer or to have filed a claim 
for a cancer.
    HHS agrees with the comment and has added explanation to the 
overview of the rule under Sec.  83.6 to summarize the two distinct 
circumstances for petitions.
    A labor organization commented that the rule is unduly vague about 
the types of information used to evaluate petitions, citing Sec.  
83.14(a)(8) of the NPRM, which reads: ``Other sources.''
    Section 83.13(a) provides a list of seven specific sources prior to 
the provision of concern to the commenter. It may not be possible for 
HHS to specify every possible source of information that might assist 
NIOSH in evaluating a petition. The purpose of specifying the limited 
list is to give the public a sense of the range of sources that might 
provide useful information. The purpose of including a non-specified 
``other'' category is to clearly communicate that NIOSH will not be 
limited to using the sources it has identified in the rule.

L. Non-Regulatory Comment: Dose Reconstructions for Cohort Members With 
Non-Specified Cancers

    Two advocacy groups questioned how NIOSH would handle dose 
reconstructions for individuals in the Cohort who have a cancer that is 
not one of the specified cancers or for individuals not included in the 
Cohort because they do not meet the health endangerment criterion of 
having been employed for 250 work days, when this criterion is 
applicable. In both situations, part or all of an employee's work 
experience may include potential radiation exposures that cannot be 
estimated. For the latter situation, one of the commenters suggested a 
scheme for assigning radiation doses to some cases.
    Under current dose reconstruction procedures, NIOSH would estimate 
all of the radiation doses of such employees that can be estimated. 
Some of these employees may have sufficient radiation

[[Page 30776]]

doses that can be estimated to support compensation without taking into 
account any potential radiation exposures that cannot be estimated. 
NIOSH may be able to estimate all radiation doses of certain employees, 
depending on the type of cancer they incurred. NIOSH may also be able 
to estimate radiation doses for some current members of the Cohort, who 
were included in the Cohort by statute but have a cancer that is not 
one of the specified cancers for which an individual can be compensated 
as a member of the Cohort. However, NIOSH is not authorized under 
EEOICPA to administratively assign radiation doses to employees for 
whom radiation doses cannot be estimated using methods of dose 
reconstruction. For any claimant referred to NIOSH who is a member of 
the Cohort and has a cancer not defined as a ``specified cancer'' under 
EEOICPA (and so is not eligible for compensation under EEOICPA without 
a dose reconstruction), NIOSH will continue to attempt to complete a 
dose reconstruction, using whatever information is available about that 
member's entire work history.

M. Non-Regulatory Comment: Reporting Estimated Completion Dates for 
Petition Evaluations

    One advocacy group and two labor organizations suggested that NIOSH 
report to Congress an estimated completion date for petitions whose 
evaluations by NIOSH will not be completed within 180 days.
    An automatic reporting procedure would divert HHS resources from 
reviewing Cohort petitions and completing dose reconstructions. 
Moreover, a ``one-size-fits-all'' reporting procedure of the type 
proposed would be inappropriate, considering the wide variability that 
is likely in the scope and volume of petitions, and in the duration of 
Board evaluations and proceedings involving the petitioner(s) 
associated with each petition.
    Two advocacy groups and two labor organizations recommended that 
NIOSH provide grants to fund health physicists and other experts to 
assist petitioners, as well as training workshops to address the 
informational requirements of a petition.
    Petitioners should not need the assistance of health physicists to 
address the requirements for a petition under Sec.  83.9. Most 
petitioners should find the petition instructions and petition form 
provided by NIOSH will be sufficient guidance. NIOSH, in coordination 
with the DOL/DOE resource centers, will assist petitioners on an 
individual basis as well. Section 83.11 of the rule commits NIOSH to 
providing further assistance to petitioners whose petitions have not 
met the basic requirements for evaluation.

N. Non-Regulatory Comment: Reporting on the Rate of Success of 
Petitions and Claimants

    Two individual commenters recommended HHS report on the success 
rate of petitions for the addition of classes of employees to the 
Cohort. The commenters also recommended that DOL report on the success 
rates of cancer claimants seeking compensation under EEOICPA, providing 
individual rates by class of employees in the Cohort and a separate 
rate for claimants who are not members of the Cohort.
    NIOSH provides extensive public information through its OCAS 
internet homepage (www.cdc.gov/niosh/ocas) on the status of its dose 
reconstruction activities and plans to be informative concerning 
petitions as well. The homepage will provide information on the status 
and the outcomes of petitions. The commenters should contact DOL if 
they wish to recommend specific types of reports on claims adjudication 
outcomes that might be useful to the public.

O. Non-Regulatory Comment: Recommendations To Add Specific Classes to 
the Cohort

    Three labor organizations and one individual commented that various 
employee groups might or should qualify to become members of the 
Cohort.
    NIOSH will send notices including this final rule and related 
information to all individuals or organizations who have indicated to 
NIOSH their intent to petition.

P. Non-Regulatory Comment: Completion of Dose Reconstructions for 
Mallinckrodt Chemical Company Employees

    One individual reports that NIOSH has access to complete dosimetry 
data on employees of Mallinckrodt Chemical Company and that minimal 
dose reconstruction is required for these workers. On this basis, the 
commenter recommends that NIOSH be required to complete these dose 
reconstructions within 180 days.
    The commenter assumes that if extensive radiation monitoring 
information is available, then dose reconstructions require ``minimal'' 
work. This is generally true for claims for which the monitoring data 
alone, prior to dose reconstruction, indicate high level exposures. In 
such cases, NIOSH would only conduct dose reconstruction to the extent 
sufficient to document dose levels that meet the threshold for 
compensation. In most settings, however, the majority of workers are 
unlikely to have records indicating high level radiation exposures. For 
these workers, NIOSH needs to carefully evaluate the adequacy of 
monitoring and monitoring records and to account for any deficiencies 
that might otherwise lead NIOSH to underestimate radiation doses.
    The full process for dose reconstructions is outlined in 42 CFR 
Part 82 and described in greater detail in technical documents 
available from NIOSH. These procedures were designed to be as efficient 
as possible.

Q. Non-Regulatory Comment: Inclusion of Transcripts of Board Meetings 
in the Administrative Record of the Rulemaking

    One advocacy group recommended that HHS include the transcripts of 
Board meetings for March 7, 14, and 28, 2003, and May 1, 2003 in the 
administrative record of this rulemaking. These Board meetings included 
discussions and decisions by the Board concerning its advice on this 
rulemaking, as well as public comment on issues considered by the 
Board.
    HHS has included the transcripts of the referenced Board meetings 
in the NIOSH docket for this rule.

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

    HHS requested the Board to provide advice concerning these 
procedures for making additions to the Cohort. As discussed above, the 
Board has an integral role in the evaluation of petitions to add 
classes of employees to the Cohort.
    The Board reviewed issues related to the Cohort during its meeting 
on May 2-3, 2002, and reviewed the initial NPRM, which was published on 
June 25, 2002, during its meetings on July 1-2, August 14-15, and 
August 22, 2002. After making substantial changes based on public 
comment and Board recommendations, NIOSH issued a second NPRM on March 
7, 2003. The Board reviewed the second NPRM during meetings on March 7, 
14, and 28, 2003, and May 1, 2003. The members also considered public 
comments on the two NPRMs provided during meetings of the Board and at 
four regional meetings held in July and August 2002. In addition, NIOSH 
staff members gave formal presentations on the two NPRMs and related 
issues during the Board meetings. The transcripts and minutes of these 
meetings are available to the

[[Page 30777]]

public and are included in the NIOSH docket for this rule.
    All of the Board members participated in the review of the second 
NPRM and concurred in establishing the Board findings and 
recommendations, with the exception of an abstention by one Board 
member concerning one finding and recommendation. The Board provided 
several recommendations on substantial issues addressed in the NPRM, as 
well as recommendations for clarifying specific sections of the NPRM. 
The recommendations, which are available to the public from the NIOSH 
docket for this rule, are summarized below, together with responses by 
HHS to the recommendations.

A. Removing Cancer-Specific Provisions Concerning Determinations of the 
Feasibility of Dose Reconstruction

    The Board recommended that HHS remove provisions of the NPRM in 
section 83.13 that would allow HHS to limit the employees included in a 
class to be added to the Cohort to those who incur specific types of 
cancers. The Board acknowledged that it may be possible in certain 
cases to determine that radiation doses are limited to certain specific 
sites in the body, which would provide a scientific basis for excluding 
employees who incur certain other types of cancer from certain classes 
that HHS might add to the Cohort. This finding notwithstanding, the 
Board was concerned that provisions accounting for such a possibility 
might conflict with the intent of Congress and, furthermore, the Board 
was concerned about providing ``some level of equity'' between the 
definition of classes added to the Cohort by HHS and those already 
defined by Congress in EEOICPA, which are not limited by type of 
cancer.
    As discussed above in response to similar public comments, HHS has 
omitted all provisions for establishing cancer-specific classes from 
the final rule, in response to the recommendations of the Board and to 
public comments. HHS agrees with the Board that the perception of the 
public that such provisions would constitute unfair treatment under 
EEOICPA should be an overriding consideration for this decision.

B. Developing Guidelines Addressing the Feasibility of Estimating Doses 
With Sufficient Accuracy

    The Board recommended that NIOSH develop guidelines, within a 
reasonable time period after promulgation of the final rule, to provide 
additional clarification on how NIOSH would determine whether it is 
feasible to estimate doses with sufficient accuracy, as specified under 
Sec.  83.13(b) of the NPRM and Sec.  83.13(c) of the rule. The Board 
recommended that it have the opportunity to review such guidelines. The 
Board also recommended that HHS make changes to the dose reconstruction 
rule (42 CFR Part 82), if any are needed, to resolve any potential 
conflict between these two rules that could leave claimants unable to 
obtain either a dose reconstruction or status as a member of the 
Cohort.
    As discussed in response to public comments, NIOSH is issuing 
concurrently with this rule procedures to implement the guidelines 
specified under section 83.13 of this rule by which NIOSH will evaluate 
a petition, including the determination addressed in this 
recommendation by the Board. The Board will have the opportunity to 
provide recommendations to NIOSH on these procedures, although NIOSH 
will not delay its evaluation of petitions to obtain recommendations of 
the Board, or make revisions to the procedures. The rule provides under 
Sec.  83.15 for the Board to consider each evaluation of a petition 
NIOSH completes and to request NIOSH to conduct additional analyses. 
Therefore, the Board will always have the opportunity to discuss with 
NIOSH any concerns the Board might have with the procedures and methods 
of a NIOSH evaluation.
    As discussed in response to public comments, the dose 
reconstruction rule and this rule do not conflict with respect to 
determining the feasibility of dose reconstruction. No revision of the 
dose reconstruction rule is necessary for this purpose.
    The consistency between the two rules does not, however, guarantee 
that all claimants will either receive a dose reconstruction or be 
included as members of the Cohort, as expressed by the Board. It is 
possible for a claimant to be excluded from the Cohort on the basis 
that the employee was not employed for a minimum of 250 work days 
within the parameters of a class of employees. This is specified under 
EEOICPA (42 U.S.C. 7384l(14)(A)), which provides statutory requirements 
defining the groups from the gaseous diffusion plants that Congress 
included in the Cohort, and under Sec.  83.13(c)(3)(ii) of this rule, 
which addresses the statutory requirement for HHS to find that the 
health of members of a class may have been endangered, for such a class 
to be added to the Cohort.

C. Combining Employment Within Separate Cohort Classes for Meeting 
Health Endangerment Requirements

    The Board recommended that employees be credited for days of 
employment within separate classes added to the Cohort, if necessary, 
to meet a 250 work days employment requirement that might be applicable 
to qualify as a member of a class added to the Cohort. As discussed 
above in response to similar public comments, HHS agrees with the Board 
and has added a provision to the rule for this purpose. Section 
83.13(c)(3)(ii) provides that whenever HHS adds a class to the Cohort 
for which a 250 work days employment requirement is applicable, 
employees will be able to meet this requirement by combining their 
employment within the added class with employment within other classes 
in the Cohort.

D. Adding a Definition for the Term ``Facility''

    The Board recommended HHS add to the rule a definition for the term 
``facility'' to more clearly specify the limit of the scope of a 
petition. The Board further recommended that HHS define facility 
broadly to encompass entire nuclear weapons production sites, such as 
Los Alamos and Rocky Flats. The Board was particularly concerned that 
facility not be defined as limited to individual buildings, structures, 
etc., which the Board was concerned could cause difficulties in 
considering petitions that relate to operations spanning more than one 
building or other type of facility.
    As discussed above in response to similar public comments, HHS has 
included in the final rule a footnote to Sec.  83.9(c)(1)(i) that 
explains that an AWE facility or DOE facility covered under EEOICPA (42 
U.S.C. 7384l(5) and (12)) could constitute a single building or 
structure, including the grounds upon which it is located, or a site 
encompassing numerous buildings or structures, including the grounds 
upon which it is located.

E. Evidence Confirming the Occurrence of Unrecorded Exposure Incidents

    Under Sec.  83.9(c)(3), the NPRM provided that for petitions based 
on exposure incidents, versus routine operations, petitioners would be 
required to provide evidence confirming the occurrence of the incident 
in cases that cannot be confirmed independently by NIOSH. One of the 
options for such evidence was the provision of affidavits from two 
employees who witnessed the incident.

[[Page 30778]]

    The Board recommended that HHS clarify that affidavits from only 
two witnesses would be required, since the rule could be interpreted as 
requiring two witnesses in addition to the petitioner in a case in 
which the petitioner was also a witness. The Board further recommended 
that in cases in which eyewitnesses may no longer be living or might be 
difficult to locate, the rule should allow NIOSH to accept the accounts 
of other parties who were informed of the incident but were not 
witnesses to the incident.
    As discussed above in response to similar public comments, HHS has 
revised this section of the rule to omit the requirement for a specific 
number of witnesses, to make the accommodation recommended by the Board 
with respect to situations in which eyewitnesses are not available, and 
to clarify that the provision of one or more affidavits would not, in 
and of itself, be sufficient to confirm the occurrence of an incident; 
NIOSH would have to consider the adequacy and credibility of the 
evidence provided in the affidavits.

F. Reviews of Findings That a Petition Does Not Satisfy the 
Requirements for a Petition

    In the NPRM, HHS requested comment on whether or not the rule 
should provide an opportunity for petitioners to obtain a review of 
NIOSH findings that a petition does not meet the requirements specified 
under Sec.  83.9. The first NPRM had provided for the Board to conduct 
such reviews, but the Board objected to such a role, which it viewed as 
an administrative function.
    The Board was concerned about the lack of an administrative appeals 
process for such decisions and recommended HHS consider how such 
reviews could be conducted.
    As discussed above in response to public comments, HHS has added 
provisions to Sec.  83.11 to give petitioners the option of an 
administrative review of proposed NIOSH decisions.

G. Recommendations for Section 83.9

    The Board recommended revisions to clarify the descriptions of two 
types of reports that a petitioner could use to support a petitioner's 
belief that records and information available are inadequate to 
estimate the radiation doses incurred by members of a class of 
employees. The first type is an unpublished report by a health 
physicist or expert in dose reconstruction that might be commissioned 
by petitioners. The second is a scientific report published in a peer 
reviewed journal or issued by a government agency.
    HHS clarified these provisions consistently with the 
recommendations of the Board, with one exception. With respect to the 
first type of report described above, the revisions suggested by the 
Board would omit the requirement that the expert document his or her 
findings with respect to the limitations of records on radiation 
exposures. HHS has retained this requirement. HHS believes it is 
reasonable to require experts to support their assertions on factual 
matters with factual evidence.
    The Board also recommended HHS consider whether placement of 
subsection (c)(3) is appropriate within this section, since the 
subsection addresses information requirements that only come into 
effect for certain petitions, in cases in which NIOSH requires 
additional information. The Board was concerned that this might be 
confusing to petitioners.
    HHS has retained the placement of this subsection because it 
specifies informational requirements for a petition, even though they 
are conditional requirements. The introductory paragraph of the 
subsection has been revised to clarify that NIOSH would not require a 
petitioner to provide the information discussed in the subsection when 
the petition is submitted, but only upon request. In addition, 
petitioners will have information from NIOSH in addition to this rule, 
such as petition instructions and an optional petition form, to guide 
them through the petition process.

H. Recommendations for Section 83.13

    The Board recommended a revision of Sec.  83.13(b)(1)(iii) of the 
NPRM, which informed the public that NIOSH may often be able to 
estimate maximum radiation doses without personal dosimetry data and 
area monitoring data. The Board appeared to be concerned that readers 
might interpret the statement as being dismissive of the value of such 
information for dose reconstructions. HHS has revised this subsection 
(83.13(c)(1)(iv) of the final rule) to remedy this concern, as follows 
(in italics):

    (iv) In many circumstances, access to personal dosimetry data 
and area monitoring data is not necessary to estimate the maximum 
radiation doses that could have been incurred by any member of the 
class, although radiation doses can be estimated more precisely with 
such data.

I. Recommendations for the Preamble

    The Board also made several editorial recommendations for 
clarifying the preamble of the NPRM. The preamble to this final rule, 
however, does not include any of the text addressed by the Board's 
recommendations.

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 entitlements, 
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 rule 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 
establishes 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 thousands of 
dollars to as much as hundreds of thousands of dollars, depending on 
the availability of information and the scope of the petition.
    The rule 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 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 E.O. 12866. It has

[[Page 30779]]

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 Special 
Exposure Cohort rule 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 rule will not have a significant economic impact on a 
substantial number of small entities within the meaning of the RFA. The 
rule 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 Rule?

    The Paperwork Reduction Act is applicable to the data collection 
aspects of 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.
    NIOSH has obtained approval from OMB to collect data as specified 
under this rule under OMB Control No. 0920-0639.
    The rule requires classes of employees seeking to be added to the 
Special Exposure Cohort to submit written petitions for such 
consideration to NIOSH. HHS has specified the information that 
petitioners are required to include in their petitions. All petitioners 
will be required to include identifying and contact information. Other 
informational requirements will depend on the circumstances of the 
petition. Petitioners who are claimants for whom NIOSH has attempted to 
complete a dose reconstruction under 42 CFR Part 82 and has concluded 
that the dose reconstruction is not feasible are only required to 
acknowledge their intent to petition; no other information is required. 
All other petitioners will have to provide more extensive information 
that comprises the justification for their petition.
    NIOSH will make available to petitioners a petition form and 
instructions to assist petitioners. As appropriate, NIOSH will also 
provide an authorization form that would be required by individuals who 
seek to authorize others to serve as petitioners. The authorization 
form is mandatory but the petition form is not mandatory.
    The only cost to respondents is their time to complete and submit 
the petition.

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 rule prior to its taking 
effect. 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.

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 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 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 rule has been reviewed carefully to eliminate drafting 
errors and ambiguities.

G. 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.''

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

J. 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 [****INSERT DATE****] and 
assigned control number [****INSERT NUMBER****].

List of Subjects in 42 CFR Part 83

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

[[Page 30780]]

Text of the Rule

0
For the reasons discussed in the preamble, the Department of Health and 
Human Services amends 42 CFR Chapter I by adding 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 will DOL use the designations established under the 
procedures in this part?
Subpart B--Definitions
83.5 Definitions 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 If a petition satisfies all relevant requirements under Sec.  
83.9, does this mean the class will be added to the Cohort?
83.11 What happens to petitions that do not satisfy all relevant 
requirements under Sec. Sec.  83.7 through 83.9?
83.12 How will NIOSH notify petitioners, the Board, and the public 
of petitions that have been selected for evaluation?
83.13 How will NIOSH evaluate petitions, other than petitions by 
claimants covered under Sec.  83.14?
83.14 How will NIOSH evaluate a petition by a claimant whose dose 
reconstruction NIOSH could not complete under 42 CFR Part 82?
83.15 How will the Board consider and advise the Secretary on a 
petition?
83.16 How will the Secretary decide the outcome of a petition?
83.17 How will the Secretary report a final decision to add a class 
of employees to the Cohort and any action of Congress concerning the 
effect of the final decision?
83.18 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, 
as amended (``EEOICPA'' or ``the Act''), 42 U.S.C. 7384-7385, provides 
for the payment of compensation benefits to covered employees and, 
where applicable, survivors of such employees, of 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 compensable 
under 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 second method to establish that a cancer incurred 
by a covered worker is compensable under EEOICPA is to establish that 
the worker is a member of the Special Exposure Cohort (``the Cohort'') 
and suffered a specified cancer after beginning employment at a DOE 
facility or AWE facility. In Section 3621(14) of EEOICPA (42 U.S.C. 
7384l(14)) Congress included certain classes of employees in the 
Cohort. Section 3626 of the Act (42 U.S.C. 7384q) 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 authorizes the President to add classes of employees to the 
Cohort, while providing Congress with the opportunity to review and 
expedite or reverse these decisions. The President delegated his 
authority to the Secretary of HHS. This part specifies the procedures 
by which HHS will determine whether to add new classes of employees 
from DOE and AWE facilities to the Cohort. HHS will consider adding new 
classes of employees in response to petitions by, or on behalf of, such 
classes of employees. The procedures specify requirements for petitions 
and for their consideration. These requirements are intended to ensure 
that petitions are submitted by authorized parties, are justified, and 
receive uniform, fair, scientific consideration. The procedures are 
also designed to give petitioners and interested parties opportunity 
for appropriate involvement in the process, and to ensure that the 
process is timely and consistent with requirements specified in 
EEOICPA. The procedures are not intended to provide a second 
opportunity to qualify a claim for compensation, once HHS has completed 
the dose reconstruction and DOL has determined that the cancer subject 
to the claim was not ``at least as likely as not'' caused by the 
estimated radiation doses. DOL has established procedures separate from 
those covered by this part, under 20 CFR part 30, for cancer claimants 
who want to contest the factual determinations or how NIOSH conducted 
their dose reconstructions.


Sec.  83.2  How will DOL use the designations established under the 
procedures in this part?

    DOL will adjudicate compensation claims 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. Specifically, 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 on 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 part, a 
group of employees who work or worked at the same DOE facility or AWE 
facility, and for whom the availability of information and recorded 
data on radiation 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.

[[Page 30781]]

    (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, for the purposes of EEOICPA, an employee of DOE, a DOE 
contractor or subcontractor, or an Atomic Weapons Employer.
    (h) NIOSH is the National Institute for Occupational Safety and 
Health, Centers for Disease Control and Prevention, U.S. Department of 
Health and Human Services.
    (i) OCAS is the Office of Compensation Analysis and Support, 
National Institute for Occupational Safety and Health, Centers for 
Disease Control and Prevention, U.S. Department of Health and Human 
Services.
    (j) Petitioner means an individual or organization that submits a 
petition on behalf of a class of employees and qualifies as a 
petitioner under Sec.  83.7. A single petition shall only include up to 
three petitioners.
    (k) 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.
    (l) Secretary is the Secretary of Health and Human Services.
    (m) Specified cancer, as is defined in Section 3621(17) of EEOICPA 
(42 U.S.C. 7384l(17)) and the DOL regulation implementing EEOICPA (20 
CFR 30.5(dd)), means:
    (1) Leukemia (other than chronic lymphocytic leukemia) provided 
that onset of the disease was at least two years after initial 
occupational exposure;
    (2) Lung cancer (other than in situ lung cancer that is discovered 
during or after a post-mortem exam);
    (3) Bone cancer;
    (4) Renal cancers;
    (5) The following diseases, provided onset was at least 5 years 
after first exposure:
    (i) Multiple myeloma;
    (ii) Lymphomas (other than Hodgkin's disease);
    (iii) Primary cancer of the:
    (A) Thyroid;
    (B) Male or female breast;
    (C) Esophagus;
    (D) Stomach;
    (E) Pharynx;
    (F) Small intestine;
    (G) Pancreas;
    (H) Bile ducts;
    (I) Gall bladder;
    (J) Salivary gland;
    (K) Urinary bladder;
    (L) Brain;
    (M) Colon;
    (N) Ovary;
    (O) Liver (except if cirrhosis or hepatitis B is indicated).
    (6) The specified diseases designated in 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 or nomenclature.
    (n) Survivor means a surviving spouse, child, parent, grandchild 
and grandparent of a deceased covered employee as defined in EEOICPA.

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 NIOSH, the Board, and the Secretary will use 
to consider a petition, leading to the Secretary's final determination 
to accept or deny adding a class to the Cohort. The rule provides for 
petitions in two distinct circumstances. One circumstance is when NIOSH 
has attempted to conduct a dose reconstruction for a cancer claimant, 
under 42 CFR Part 82, and finds that the dose reconstruction cannot be 
completed, because there is insufficient information to estimate the 
radiation doses of the claimant with sufficient accuracy. The second 
circumstance includes all other possibilities. For example, a petition 
may be submitted representing a class of employees whose members have 
yet to file claims under EEOICPA, or even have yet to be diagnosed with 
cancer. As required by EEOICPA (42 U.S.C. 7384l(14)(c)(ii)), the 
procedures in this part include formal notice to Congress of any 
decision by the Secretary to add a class to the Cohort, and the 
opportunity for Congress to expedite or change the outcome of the 
decision within 180 days.


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

    A petitioner or petitioners for a petition must be one or more, up 
to a maximum of three, of the following:
    (a) One or more DOE, DOE contractor or subcontractor, or AWE 
employees, who would be included in the proposed class of employees, or 
their survivors; or
    (b) One or more labor organizations representing or formerly having 
represented DOE, DOE contractor or subcontractor, or AWE employees, who 
would be included in the proposed class of employees; or
    (c) One or more individuals or entities authorized in writing by 
one or more DOE, DOE contractor or subcontractor, or AWE employees, who 
would be included in the proposed class of employees, or their 
survivors.


Sec.  83.8  How is a petition submitted?

    The petitioner(s) must send a petition in writing to NIOSH. A 
petition must provide identifying and contact information on the 
petitioner(s) and information to justify the petition, as specified 
under Sec.  83.9. Detailed instructions for preparing and submitting a 
petition, including an optional petition form, are available from NIOSH 
through direct request (1-800-35-NIOSH) or on the Internet at 
www.cdc.gov/niosh/ocas.


Sec.  83.9  What information must a petition include?

    (a) All petitions must provide identifying and contact information 
on the petitioner(s). The information required to justify a petition 
differs, depending on the basis of the petition. If the petition is by 
a claimant in response to a finding by NIOSH that the dose 
reconstruction for the claimant cannot be completed, then the petition 
must provide only the justification specified under paragraph (b) of 
this section. All other petitions must provide only the information 
specified under paragraph (c) of this section. The informational 
requirements for petitions are also summarized in Table 1 at the end of 
this section.
    (b) The petition must notify NIOSH that the claimant is petitioning 
on the basis that NIOSH found, under 42 CFR 82.12, that the dose 
reconstruction for the claimant could not be completed due to 
insufficient records and information.
    (c) The petition must include the following:
    (1) A proposed class definition \1\ specifying:
---------------------------------------------------------------------------

    \1\ HHS will determine the final class definition(s) for each 
petition (see Sec.  83.16).

---------------------------------------------------------------------------

[[Page 30782]]

    (i) The DOE facility or AWE facility \2\ at which the class worked;
---------------------------------------------------------------------------

    \2\ Depending on the factual circumstances present, a facility 
that meets the definition of an AWE facility or DOE facility covered 
under EEOICPA (42 U.S.C. 7384l(5) and (12)) could, among other 
possibilities, constitute a single building or structure, including 
the grounds upon which it is located, or a site encompassing 
numerous buildings or structures, including the grounds upon which 
it is located.
---------------------------------------------------------------------------

    (ii) The location or locations at the facility covered by the 
petition (e.g., building, technical area);
    (iii) The job titles and/or job duties of the class members;
    (iv) The period of employment relevant to the petition;
    (v) Identification of any exposure incident that was unmonitored, 
unrecorded, or inadequately monitored or recorded, if such incident 
comprises the basis of the petition; and
    (2) A description of the petitioner's (petitioners'') basis for 
believing records and information available are inadequate to estimate 
the radiation doses incurred by members of the proposed class of 
employees with sufficient accuracy. This description must include one 
of the following elements:
    (i) Documentation or statements provided by affidavit indicating 
that radiation exposures and doses to members of the proposed class 
were not monitored, either through personal or area monitoring; or
    (ii) Documentation or statements provided by affidavit indicating 
that radiation monitoring records for members of the proposed class 
have been lost, falsified, or destroyed; or
    (iii) 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, as 
relevant to the petition. This report should specify the basis for 
believing these documented limitations might prevent the completion of 
dose reconstructions for members of the class under 42 CFR Part 82 and 
related NIOSH technical implementation guidelines; or
    (iv) A scientific or technical report, published or issued by a 
government agency of the Executive Branch of government or the General 
Accounting Office, the Nuclear Regulatory Commission, or the Defense 
Nuclear Facilities Safety Board, or published in a peer-reviewed 
journal, that identifies dosimetry and related information that are 
unavailable (due to either a lack of monitoring or the destruction or 
loss of records) for estimating the radiation doses of employees 
covered by the petition.
    (3) If the petition is based on an exposure incident as described 
under paragraph (c)(1)(v) of this section, the petitioner(s) might be 
required to provide evidence that the incident occurred, but only if 
NIOSH is unable to obtain records or confirmation of the occurrence of 
such an incident from sources independent of the petitioner(s). Such 
evidence would not be required at the time the petition is submitted 
and the petitioner(s) would be directly informed of the need for this 
supplemental information. In such cases, either of the following may 
qualify as evidence:
    (i) Medical evidence that one or more members of the class may have 
incurred a high level radiation dose from the incident, such as a 
depressed white blood cell count associated with radiation exposure or 
the application of chelation therapy; or
    (ii) NIOSH will consider evidence provided by affidavit from one or 
more employees who witnessed the incident. If the petitioner cannot 
provide such affidavits because such employees are deceased, prevented 
by reasons of poor health or impairment, or cannot be identified or 
located, then the requirement for evidence provided by affidavit can be 
met by providing such an affidavit from one or more individuals who did 
not witness the incident, provided the individual was directly informed 
by one or more employees who witnessed the incident.\3\
---------------------------------------------------------------------------

    \3\ An affidavit may be from a petitioner but HHS does not 
require that an affidavit be from a petitioner.
---------------------------------------------------------------------------

    (4) The provision of any evidence under this section or other 
provisions of this part, including one or more affidavits, would not, 
in and of itself, be sufficient to confirm the facts presented by that 
evidence. NIOSH will consider the adequacy and credibility of any 
evidence provided.
    (5) If, under Sec.  83.15(a), NIOSH has already issued a Federal 
Register notice scheduling a Board meeting to consider a petition 
concerning a class of employees, then any petitions for such a class of 
employees submitted following this notice must, under paragraph (c)(2) 
of this section, present substantially new information that has not 
already been considered by NIOSH. For this purpose, NIOSH would find 
that information has been already considered by NIOSH if it were 
included in the petition(s) that were already considered by NIOSH or if 
it were addressed either in the report(s) by NIOSH evaluating such a 
petition or petitions under Sec.  83.13(c) or in a proposed decision by 
NIOSH responding to such a petition or petitions under Sec.  83.16(a).

 Table 1 for Sec.   83.9: Summary of Informational Requirements for All
                                Petitions
   [Petitioner(s) must submit identifying and contact information and
                     either A. or B. of this table.]
------------------------------------------------------------------------
 
------------------------------------------------------------------------
A. The claimant's authorization of the   B. (1) A proposed class
 petition, based on NIOSH having found    definition identifying: (i)
 it could not complete a dose             Facility, (ii) relevant
 reconstrucitn for the claimant           locations at the facility;
 submitting the petition; or.             (iii) job titles/duties, (iv)
                                          period of employment, and if
                                          relevant, (v) exposure
                                          incident.
                                         (2) The basis for infeasibility
                                          of dose reconstruction;
                                          either: (i) lack of
                                          monitoring; or (ii)
                                          destruction, falsification, or
                                          loss of records; or (iii)
                                          expert report; or (iv)
                                          scientific or technical
                                          report.
------------------------------------------------------------------------

Sec.  83.10  If a petition satisfies all relevant requirements under 
Sec.  83.9, does this mean the class will be added to the Cohort?

    Satisfying the informational requirements for a petition does not 
mean the class will be added to the Cohort. It means the petition will 
receive a full evaluation by NIOSH, the Board, and HHS, as described 
under Sec. Sec.  83.13 through 83.16. The role of the petitioner(s) is 
to identify classes of employees that should be considered for addition 
to the Cohort.


Sec.  83.11  What happens to petitions that do not satisfy all relevant 
requirements under Sec. Sec.  83.7 through 83.9?

    (a) NIOSH will notify the petitioner(s) of any requirements that 
are not met by the petition, assist the petitioner(s) with guidance in 
developing relevant information, and provide 30 calendar

[[Page 30783]]

days for the petitioner(s) to revise the petition accordingly.
    (b) After 30 calendar days from the date of notification under 
paragraph (a) of this section, NIOSH will notify any petitioner(s) 
whose petition remains unsatisfactory of the proposed finding of NIOSH 
that the petition fails to meet the specified requirements and the 
basis for this finding.
    (c) A petitioner may request in writing a review of a proposed 
finding within 30 calendar days of notification under paragraph (b) of 
this section. Petitioners must specify why the proposed finding should 
be reversed, based on the petition requirements and on the information 
that the petitioners had already submitted. The request may not include 
any new information or documentation that was not included in the 
completed petition. If the petitioner obtains new information within 
this 30 day period, the petitioner should provide it to NIOSH. NIOSH 
will consider this new information as a revision of the petition under 
paragraph (a) of this section.
    (d) Three HHS personnel, appointed by the Director of NIOSH, who 
were not involved in developing the proposed finding will complete 
reviews within 30 work days of the request for such a review. The 
Director of NIOSH will consider the results of the review and then make 
a final decision as to whether the petition satisfies the requirements 
for evaluation.
    (e) Proposed findings established by NIOSH under paragraph (b) of 
this section will become final decisions in 31 calendar days if not 
reviewed under paragraph (d) of this section.
    (f) Based on new information, NIOSH may, at its discretion, 
reconsider a decision not to select a petition for evaluation.


Sec.  83.12  How will NIOSH notify petitioners, the Board, and the 
public of petitions that have been selected for evaluation?

    (a) NIOSH will notify the petitioner(s) in writing that it has 
selected the petition for evaluation. NIOSH will also provide the 
petitioner(s) with information on the steps of the evaluation and other 
processes required pursuant to these procedures.
    (b) NIOSH will combine separate petitions and evaluate them as a 
single petition if, at this or at any point in the evaluation process 
under Sec. Sec.  83.13 and 83.14, NIOSH finds such petitions represent 
the same class of employees.
    (c) NIOSH will present petitions selected for evaluation to the 
Board with plans specific to evaluating each petition. Each evaluation 
plan will include the following elements:
    (1) An initial proposed definition for the class being evaluated, 
subject to revision as warranted by the evaluation conducted under 
Sec.  83.13 or Sec.  83.14; and
    (2) A list 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 the petition and evaluation plan to the Board.
    (e) NIOSH will publish a notice in the Federal Register notifying 
the public of its decision to evaluate a petition.


Sec.  83.13  How will NIOSH evaluate petitions, other than petitions by 
claimants covered under Sec.  83.14?

    (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 83.14, from the following potential 
sources, as necessary:
    (1) The petition or petitions submitted on behalf of the class;
    (2) DOE and AWE facility records and information;
    (3) Potential members of the class and their survivors;
    (4) Labor organizations 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 facility 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 DOE employees, DOE contractor or 
subcontractor employees, and/or AWE employees; and
    (8) Other sources.
    (b) The Director of OCAS may determine that records and/or 
information requested from DOE, an AWE, or another source to evaluate a 
petition is not, or will not be, available on a timely basis. Such a 
determination will be treated, for the purposes of the petition 
evaluation, as equivalent to a finding that the records and/or 
information requested are not available.
    (1) Before the Director of OCAS makes such a determination, the 
source(s) potentially in possession of such records and/or information 
will be allowed a reasonable amount of time, as determined by the 
Director of OCAS, to provide the records and/or information.
    (2) Such a determination may take into account the types and 
quantity of records and/or information requested from the source, as 
well as any other factors that might be relevant to the judgment under 
paragraph (b)(1) of this this section of the amount of time that is 
reasonable to provide the records and/or information, which would be 
decided on a case-by-case basis by the Director of OCAS.
    (c) NIOSH will evaluate records and information collected to make 
the following determinations:
    (1) Is it feasible to estimate the level of radiation doses of 
individual members of the class with sufficient accuracy? (i) Radiation 
doses can be estimated with sufficient accuracy if NIOSH has 
established that it has access to sufficient information to estimate 
the maximum radiation dose, for every type of cancer for which 
radiation doses are reconstructed, that could have been incurred in 
plausible circumstances by any member of the class, or if NIOSH has 
established that it has access to sufficient information to estimate 
the radiation doses of members of the class more precisely than an 
estimate of the maximum radiation dose. NIOSH must also determine that 
it has information regarding monitoring, source, source term, or 
process from the site where the employees worked to serve as the basis 
for a dose reconstruction. This basis requirement does not limit NIOSH 
to using only or primarily information from the site where the employee 
worked, but a dose reconstruction must, as a starting point, be based 
on some information from the site where the employee worked.
    (ii) In many circumstances, to establish a positive finding under 
paragraph (c)(1)(i) of this section would require, at a minimum, that 
NIOSH have access to reliable information on the identity or set of 
possible identities and maximum quantity of each radionuclide (the 
radioactive source material) to which members of the class were 
potentially exposed without adequate protection. Alternatively, if 
members of the class were potentially exposed without adequate 
protection to unmonitored radiation from radiation generating equipment 
(e.g., particle accelerator, industrial x-ray equipment), in many 
circumstances, NIOSH would require relevant equipment design and 
performance specifications or information on maximum emissions.
    (iii) In many circumstances, to establish a positive finding under 
paragraph (c)(1)(i) of this section would

[[Page 30784]]

also require information describing the process through which the 
radiation exposures of concern may have occurred and the physical 
environment in which the exposures may have occurred.
    (iv) In many circumstances, access to personal dosimetry data and 
area monitoring data is not necessary to estimate the maximum radiation 
doses that could have been incurred by any member of the class, 
although radiation doses can be estimated more precisely with such 
data.
    (2) How should the class be defined, consistent with the findings 
of the analysis discussed under paragraph (c)(1) of this section? NIOSH 
will define the following characteristics of a class, taking into 
account the class definition proposed by the petition and modified as 
necessary to reflect the results of the evaluation under paragraph 
(c)(1) of this section:
    (i) Any of the following employment parameters, as necessary to 
identify members included in the class: facility, job titles, duties, 
and/or specific work locations at the facility, the relevant time 
period, and any additional identifying characteristics of employment; 
and
    (ii) If applicable, the identification of an exposure incident, 
when unmonitored radiation exposure during such an incident comprises 
the basis of the petition or the class definition.
    (3) Is there a reasonable likelihood that such radiation dose may 
have endangered the health of members of the class? If it is not 
feasible to estimate with sufficient accuracy radiation doses for 
members of the class, as provided under paragraph (c)(1) of this 
section, then NIOSH must determine, as required by the statute, that 
``there is a reasonable likelihood that such radiation dose may have 
endangered the health of members of the class'' (42 U.S.C. 
7384q(b)(2)).
    (i) For classes of employees that may have been exposed to 
radiation during discrete incidents likely to have involved 
exceptionally high level exposures, such as nuclear criticality 
incidents or other events involving similarly high levels of exposures 
resulting from the failure of radiation protection controls, NIOSH will 
assume for the purposes of this section that any duration of 
unprotected exposure could cause a specified cancer, and hence may have 
endangered the health of members of the class. Presence with potential 
exposure during the discrete incident, rather than a quantified 
duration of potential exposure, will satisfy the health endangerment 
criterion.
    (ii) For health endangerment not established on the basis of a 
discrete incident, as described under paragraph (c)(3)(i) of this 
section, NIOSH will specify a minimum duration of employment to satisfy 
the health endangerment criterion as having been employed for a number 
of work days aggregating at least 250 work days within the parameters 
established for the class or in combination with work days within the 
parameters established for one or more other classes of employees in 
the Cohort.
    (d) 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, as necessary:
    (i) Any justification that may be needed for the inclusion of 
groups of employees who were not specified in the original petition(s);
    (ii) The identification of any groups of employees who were 
identified in the original petition(s) who should constitute a separate 
class of employees; or
    (iii) The merging of multiple petitions that represent a single 
class of employees;
    (3) The proposed class definition will address the following 
employment parameters:
    (i) The DOE facility or the 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, identification of an exposure incident, when 
potential radiation exposure during such an incident comprises the 
basis of the class definition;
    (v) If necessary, any other parameters that serve to define the 
membership of the class; and
    (vi) For a class for which it is not feasible to estimate radiation 
doses with sufficient accuracy, a minimum duration of employment within 
the parameters of the class for inclusion in the class, as defined 
under paragraph (c)(3) of this section;
    (4) A summary of the findings concerning the adequacy of existing 
records and information for reconstructing 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; and
    (5) For a class for which it is not feasible to estimate radiation 
doses with sufficient accuracy, a summary of the basis for establishing 
the duration of employment requirement with respect to health 
endangerment.


Sec.  83.14  How will NIOSH evaluate a petition by a claimant whose 
dose reconstruction NIOSH could not complete under 42 CFR Part 82?

    (a) NIOSH may establish two classes for evaluation, to permit the 
timely adjudication of the existing cancer claim:
    (1) A class of employees defined using the research and analyses 
already completed in attempting the dose reconstruction for the 
employee identified in the claimant's petition; and
    (2) A class of co-workers similar to the class defined under 
paragraph (a)(1) of this section, to be defined by NIOSH on the basis 
of further research and analyses, using the procedures under Sec.  
83.13.
    (b) NIOSH will determine the health endangerment criteria for 
adding the class under paragraph (a)(1) of this section to the Cohort, 
using the procedures under Sec.  83.13. NIOSH will report to the Board 
and to petitioner(s) the results of this determination, together with 
its finding under 42 CFR Part 82 that there was insufficient 
information to complete the dose reconstruction. HHS will consider this 
finding under 42 CFR Part 82 sufficient, without further consideration, 
to determine that it is not feasible to estimate the levels of 
radiation doses of individual members of the class with sufficient 
accuracy.
    (c) NIOSH will evaluate the petition as it may concern a class of 
co-workers, as described under paragraph (a)(2) of this section, 
according to the procedures under Sec.  83.13.


Sec.  83.15  How will the Board consider and advise the Secretary on a 
petition?

    (a) NIOSH will publish a notice in the Federal Register providing 
notice of a Board meeting at which a petition will be considered, and 
summarizing the petition to be considered by the Board at the meeting 
and the findings of NIOSH from evaluating the petition.
    (b) The Board will consider the petition and the NIOSH evaluation 
report at the meeting, to which the petitioner(s) will be invited to 
present views and information on the petition and the NIOSH evaluation 
findings. In

[[Page 30785]]

considering the petition, both NIOSH and the members of the Board will 
take all steps necessary to prevent the disclosure of information of a 
personal nature, concerning the petitioners or others, where disclosure 
would constitute a clearly unwarranted invasion of personal privacy.
    (c) In considering the petition, the Board may obtain and consider 
additional information not addressed in the petition or the initial 
NIOSH evaluation report.
    (d) NIOSH may decide to further evaluate a petition, upon the 
request of the Board. If NIOSH conducts further evaluation, it will 
report new findings to the Board and the petitioner(s).
    (e) Upon the completion of NIOSH evaluations and deliberations of 
the Board concerning a petition, the Board will develop and transmit to 
the Secretary a report containing its recommendations. The Board's 
report will include the following:
    (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 relevant criteria under Sec.  83.13(c) and findings and 
information upon which the recommendation is based, including NIOSH 
evaluation reports, information provided by the petitioners, any other 
information considered by the Board, and the deliberations of the 
Board.


Sec.  83.16  How will the Secretary decide the outcome(s) of a 
petition?

    (a) The Director of NIOSH will propose, and transmit to all 
affected petitioners, a decision to add or deny adding classes of 
employees to the Cohort, including an iteration of the relevant 
criteria, as specified under Sec.  83.13(c), and a summary of the 
information and findings on which the proposed decision is based. This 
proposed decision will take into consideration the evaluations of NIOSH 
and the report and recommendations of the Board, and may also take into 
consideration information presented or submitted to the Board and the 
deliberations of the Board. In the case of a petition that NIOSH has 
determined encompasses more than one class of employees, the Director 
of NIOSH will issue a separate proposed decision for each separate 
class of employees.
    (b) HHS will only allow the petitioner(s) to contest a proposed 
decision to deny adding a class to the Cohort or to contest a health 
endangerment determination under Sec.  83.13(c)(3)(ii). Such challenges 
must be submitted in writing within 30 calendar days and must include 
evidence that the proposed decision relies on a record of either 
substantial factual errors or substantial errors in the implementation 
of the procedures of this part. Challenges may not introduce new 
information or documentation concerning the petition or the NIOSH or 
Board evaluation(s) that was not submitted or presented by the 
petitioner(s) or others to NIOSH or to the Board prior to the Board's 
issuing its recommendations under Sec.  83.15.
    (c) A panel of three HHS personnel, independent of NIOSH and 
appointed by the Secretary, will conduct an administrative review based 
on a challenge submitted under paragraph (b) of this section and 
provide recommendations of the panel to the Secretary concerning its 
merits and the resolution of issues contested by the challenge. Reviews 
by the panel will consider, in addition to the views and information 
submitted by the petitioner(s) in the challenge, the proposed decision, 
the NIOSH evaluation report(s), and the report containing the 
recommendations of the Board issued prior to the proposed decision 
under Sec.  83.15. The reviews may also consider information presented 
or submitted to the Board and the deliberations of the Board prior to 
the issuance of the recommendations of the Board under Sec.  83.15. The 
panel shall consider whether HHS substantially complied with the 
procedures of this part, the factual accuracy of the information 
supporting the proposed decision, and the principal findings and 
recommendations of NIOSH and those of the Board issued under Sec.  
83.15.
    (d) The Secretary will make the final decision to add or deny 
adding a class to the Cohort, including the definition of the class, 
after considering information and recommendations provided to the 
Secretary by NIOSH, the Board, and from an HHS administrative review 
when such a review is conducted under paragraph (c) of this section. 
HHS will transmit a report of the decision to the petitioner(s), 
including an iteration of the relevant criteria, as specified under 
Sec.  83.13(c), and a summary of the information and findings on which 
the decision is based. HHS will also publish a notice summarizing the 
decision in the Federal Register.


Sec.  83.17  How will the Secretary report a final decision to add a 
class of employees to the Cohort and any action of Congress concerning 
the effect of the final decision?

    (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 findings upon which the 
designation was based.\4\
---------------------------------------------------------------------------

    \4\ See 42 U.S.C. 7384l(14)(C)(ii).
---------------------------------------------------------------------------

    (b) A designation of the Secretary will take effect 180 calendar 
days after the date on which the report of the Secretary is submitted 
to Congress, unless Congress takes an action that reverses or expedites 
the designation.
    (c) After either the expiration of the congressional review period 
or notification of final congressional action, whichever comes first, 
the Secretary will transmit to DOL and to the petitioner(s) a report 
providing 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.
    (d) The report specified under paragraph (c) of this section will 
be published on the Internet at www.cdc.gov/niosh/ocas and in the 
Federal Register.


Sec.  83.18  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 canceling 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 in this part 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;

[[Page 30786]]

    (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 requirements for analysis of a 
petition by NIOSH under Sec. Sec.  83.13(c)(1) and (2), and 83.13(c)(2) 
and (3);
    (3) A recommendation by the Board to the Secretary as to whether or 
not the Secretary should cancel or modify his final decision that added 
the class to the Cohort, based upon a review by the Board of the NIOSH 
analysis under paragraph (b)(2) of this section and any other relevant 
information considered by the Board;
    (4) An opportunity for members of the class to contest a proposed 
decision to cancel or modify the prior final decision that added the 
class to the Cohort, including a reasonable and timely effort by the 
Secretary to notify members of the class of this opportunity; and
    (5) Publication in the Federal Register of a final decision to 
cancel or modify the prior final decision that added the class to the 
Cohort.

    Dated: February 23, 2004.
Tommy G. Thompson,
Secretary, Department of Health and Human Services.
[FR Doc. 04-11930 Filed 5-27-04; 8:45 am]
BILLING CODE 4510-43-P