Authorizing Legislation 2

Friday,
May 28, 2004

Part IV

Department of
Health and Human
Services
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

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

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
Department of Health and
Human Services.
ACTION: Final rule.
AGENCY:

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 § 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

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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

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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.
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
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 § 83.5.

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

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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.
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
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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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

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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

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(www.cdc.gov/niosh/ocas), provide stepby-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 § 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

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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

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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

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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

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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 doserelated 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 § 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.

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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):

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.
Radiation doses can be estimated with
The NPRM and this final rule,
sufficient accuracy if NIOSH has established
however, do not reflect an assumption
that it has access to sufficient information to
that it will be feasible to estimate
estimate the maximum radiation dose, for
maximum doses or to more precisely
every type of cancer for which radiation
doses are reconstructed, that could have been estimate doses. The determination by
NIOSH, the Board, and the Secretary of
incurred in plausible circumstances by any
HHS as to whether dose reconstruction
member of the class, or if NIOSH has
established that it has access to sufficient
is feasible for a particular class of
information to estimate the radiation doses of employees is a central element of this
members of the class more precisely than an
rule.
estimate of the maximum radiation dose.
Related to this latter point, an
advocacy group and a labor organization
HHS has also supplemented the
questioned whether petitioning is
guidelines previously included in the
‘‘futile’’ under the provisions of this rule
rule regarding the feasibility of
concerning feasibility, because, in the
estimating the radiation dose of a class
view of the commenters, NIOSH ‘‘raised
of employees with sufficient accuracy.
the bar’’ for evaluating whether doses
A new § 83.13(c)(1)(iii) specifies the
can be estimated with sufficient
following additional guidelines:

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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.

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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 noncompensable 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

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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
§ 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
§ 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,

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30769

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

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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.

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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

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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

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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

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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.

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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 riskpotentiating 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 § 83.7 that would

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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 unionrepresented 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 unionrepresented 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

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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 § 83.7 from the NPRM,
without change.
HHS revised § 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 § 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

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minimized the requirements for their
petitions.
Subsection (c)(1)(i) specifies that
petitioners, other than the claimantpetitioners 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

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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.

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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 § 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

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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

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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
§ 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 § 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 § 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

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addition of a class to the Cohort and to
contest a health endangerment
determination under § 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
§ 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

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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 § 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’’
(§ 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,

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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 § 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

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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 § 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’’
(§ 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 § 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 § 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 § 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

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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 § 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 § 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 nonspecified ‘‘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

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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 § 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

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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,

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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

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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

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estimate doses with sufficient accuracy,
as specified under § 83.13(b) of the
NPRM and § 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 § 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 § 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.

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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
§ 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 § 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.

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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 § 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 § 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.

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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
§ 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

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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

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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-forprofit 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

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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

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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.

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Text of the Rule

Subpart A—Introduction

§ 83.0 Background information on the
For the reasons discussed in the
preamble, the Department of Health and procedures in this part.
The Energy Employees Occupational
Human Services amends 42 CFR Chapter
Illness
Compensation Program Act, as
I by adding Part 83 to read as follows:
amended (‘‘EEOICPA’’ or ‘‘the Act’’), 42
U.S.C. 7384–7385, provides for the
PART 83—PROCEDURES FOR
payment of compensation benefits to
DESIGNATING CLASSES OF
covered employees and, where
EMPLOYEES AS MEMBERS OF THE
SPECIAL EXPOSURE COHORT UNDER applicable, survivors of such employees,
of DOE, its predecessor agencies and
THE ENERGY EMPLOYEES
certain of its contractors and
OCCUPATIONAL ILLNESS
subcontractors. Among the types of
COMPENSATION PROGRAM ACT OF
illnesses for which compensation may
2000
be provided are cancers. There are two
Subpart A—Introduction
methods set forth in the statute for
claimants to establish that a cancer
Sec.
incurred by a covered worker is
83.0 Background information on the
compensable under EEOICPA. The first
procedures in this part.
is to establish that the cancer is at least
83.1 What is the purpose of the procedures
as likely as not related to covered
in this part?
employment at a DOE or Atomic
83.2 How will DOL use the designations
established under the procedures in this
Weapons Employer (‘‘AWE’’) facility
part?
pursuant to guidelines issued by the
Department of Health and Human
Subpart B—Definitions
Services (‘‘HHS’’), which are found at 42
83.5 Definitions of terms used in the
CFR part 81. The second method to
procedures in this part.
establish that a cancer incurred by a
Subpart C—Procedures for Adding Classes covered worker is compensable under
EEOICPA is to establish that the worker
of Employees to the Cohort
is a member of the Special Exposure
83.6 Overview of the procedures in this
Cohort (‘‘the Cohort’’) and suffered a
part.
83.7 Who can submit a petition on behalf of specified cancer after beginning
employment at a DOE facility or AWE
a class of employees?
facility. In Section 3621(14) of EEOICPA
83.8 How is a petition submitted?
(42 U.S.C. 7384l(14)) Congress included
83.9 What information must a petition
certain classes of employees in the
include?
Cohort. Section 3626 of the Act (42
83.10 If a petition satisfies all relevant
U.S.C. 7384q) authorizes the addition to
requirements under § 83.9, does this
the Cohort of other classes of
mean the class will be added to the
employees. This authority has been
Cohort?
83.11 What happens to petitions that do not delegated to the Secretary of HHS by
satisfy all relevant requirements under
Executive Order 13179.
■

§§ 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 § 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.

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§ 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

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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.
§ 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
§ 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.

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(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 § 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 radiofrequency 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;

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(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
§ 83.6
part.

Overview of the procedures in this

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.

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30781

§ 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.
§ 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 § 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.
§ 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 § 83.16).

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(i) The DOE facility or AWE facility 2
at which the class worked;
(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
(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 § 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 § 83.13(c) or in a
proposed decision by NIOSH
responding to such a petition or
petitions under § 83.16(a).

TABLE 1 FOR § 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 petition, based on NIOSH having
found it could not complete a dose reconstrucitn for the claimant
submitting the petition; or.

§ 83.10 If a petition satisfies all relevant
requirements under § 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
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

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B. (1) A proposed class definition identifying: (i) Facility, (ii) relevant locations at the facility; (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.

Board, and HHS, as described under
§§ 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.

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

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.

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

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(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

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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.
§ 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 §§ 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:

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(1) An initial proposed definition for
the class being evaluated, subject to
revision as warranted by the evaluation
conducted under § 83.13 or § 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.
§ 83.13 How will NIOSH evaluate petitions,
other than petitions by claimants covered
under § 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

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30783

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

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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.

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(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

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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.
§ 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
§ 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 § 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 § 83.13.
§ 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

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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
§ 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.
§ 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
§ 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

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endangerment determination under
§ 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 § 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 § 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 § 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 § 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 § 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.

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§ 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
(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.
§ 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;
4 See

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(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 §§ 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

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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

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(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

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