[Federal Register Volume 69, Number 104 (Friday, May 28, 2004)]
[Rules and Regulations]
[Pages 30764-30786]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11930]
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Part IV
Department of Health and Human Services
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42 CFR Part 83
Procedures for Designating Classes of Employees as Members of the
Special Exposure Cohort Under the Energy Employees Occupational Illness
Compensation Program Act of 2000; Final Rule
Federal Register / Vol. 69, No. 104 / Friday, May 28, 2004 / Rules
and Regulations
[[Page 30764]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 83
RIN 0920-AA07
Procedures for Designating Classes of Employees as Members of the
Special Exposure Cohort Under the Energy Employees Occupational Illness
Compensation Program Act of 2000; Final Rule
AGENCY: Department of Health and Human Services.
ACTION: Final rule.
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SUMMARY: This document describes how the Department of Health and Human
Services (``HHS'') will consider designating classes of employees to be
added to the Special Exposure Cohort under the Energy Employees
Occupational Illness Compensation Program Act of 2000 (``EEOICPA'').
Under EEOICPA, and Executive Order 13179, the Secretary of HHS is
authorized to make such designations, which take effect 180 days after
Congress is notified unless Congress provides otherwise. An individual
member (or the eligible survivors of a member) of a class of employees
added to the Special Exposure Cohort would be entitled to compensation
if the Department of Labor (``DOL'') finds that employee incurred a
specified cancer and the claim meets other requirements established
under EEOICPA.
DATES: Effective Date: This final rule is effective May 28, 2004.
Compliance Date: Affected parties are required to comply with the
information collection requirements in Sec. 82.9 effective May 28,
2004.
FOR FURTHER INFORMATION CONTACT: Larry Elliott, Director, Office of
Compensation Analysis and Support, National Institute for Occupational
Safety and Health, 4676 Columbia Parkway, MS-C-46, Cincinnati, OH
45226, Telephone 513-533-6800 (this is not a toll-free number).
Information requests can also be submitted by e-mail to [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
A. Statutory Authority
The Energy Employees Occupational Illness Compensation Program Act
(EEOICPA), 42 U.S.C. 7384-7385, established a compensation program to
provide a lump sum payment of $150,000 and prospective medical benefits
as compensation to covered employees suffering from designated
illnesses incurred as a result of their exposure to radiation,
beryllium, or silica while in the performance of duty for the
Department of Energy (``DOE'') and certain of its vendors, contractors
and subcontractors. This legislation also provided for lump sum
payments for certain survivors of these covered employees.
EEOICPA instructed the President to designate one or more Federal
Agencies to carry out the compensation program. Pursuant to this
statutory provision, on December 7, 2000, the President issued
Executive Order 13179 (``Providing Compensation to America's Nuclear
Weapons Workers''), which assigned primary responsibility for
administering the compensation program to the Department of Labor
(``DOL''). 65 FR 77487 (December 11, 2000). DOL published a final rule
governing DOL's administration of EEOICPA on December 26, 2002 (67 FR
78874).
Executive Order 13179 directed HHS to perform several technical and
policymaking roles in support of the DOL program:
(1) HHS was to develop procedures for considering petitions by
classes of employees at DOE and Atomic Weapons Employer (``AWE'')
facilities to be added to the Special Exposure Cohort established under
EEOICPA. These procedures are the subject of this rule. HHS is also to
apply these procedures in response to such petitions. Covered employees
included in the Special Exposure Cohort who have a specified cancer,
and eligible survivors of these employees, qualify for compensation
under EEOICPA.
(2) HHS was to develop guidelines, by regulation, to be used by DOL
to assess the likelihood that an employee with cancer developed that
cancer as a result of exposure to radiation in performing his or her
duty at a DOE facility or AWE facility. HHS published a final rule
establishing these ``Probability of Causation'' guidelines on May 2,
2002 (67 FR 22296) under 42 CFR Part 81.
(3) HHS was also to develop methods, by regulation, to estimate
radiation doses (``dose reconstruction'') for certain individuals with
cancer applying for benefits under the DOL program. HHS published a
final rule promulgating these methods under 42 CFR Part 82 on May 2,
2002 (67 FR 22314). HHS is applying these methods to conduct the
program of dose reconstruction required by EEOICPA.
(4) Finally, HHS is to provide the Advisory Board on Radiation and
Worker Health (``the Board'') with administrative and other necessary
support services. The Board, a federal advisory committee whose members
are appointed by the President, is advising HHS in implementing its
roles under EEOICPA described here.
42 U.S.C. 7384p requires HHS to implement its responsibilities with
the assistance of the National Institute for Occupational Safety and
Health (NIOSH), an Institute of the Centers for Disease Control and
Prevention, HHS.
B. What Is the Special Exposure Cohort?
The Special Exposure Cohort (``the Cohort'') is a category of
employees defined under 42 U.S.C. 7384l(14). In this definition,
Congress specified classes of employees to comprise the Cohort
initially, including DOE employees, DOE contractor or subcontractor
employees, who were (1) employed an aggregate of at least 250 work days
before February 1, 1992 at a gaseous diffusion plant in Paducah,
Kentucky, Portsmouth, Ohio, or Oak Ridge, Tennessee, and who were
monitored using dosimetry badges or worked in a job that had exposures
comparable to a job that is or was monitored using dosimetry badges; or
(2) employees of DOE or DOE contractors or subcontractors employed
before January 1, 1974 on Amchitka Island, Alaska and exposed to
ionizing radiation in the performance of duty related to the Long Shot,
Milrow, or Cannikin underground nuclear tests. As provided in 42 U.S.C.
7384l(9)(A), employees included in the Cohort who incur a specified
cancer \1\ qualify for compensation (see DOL regulations 20 CFR part 30
for details). Cancer claims submitted by these employees or their
survivors do not require DOL to evaluate the probability that the
cancer was caused by radiation doses incurred during the performance of
duty for nuclear weapons programs of DOE, as is required for other
cancer claims covered by EEOICPA.
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\1\ Specified cancers are a limited group of cancers that
EEOICPA specifies are compensable under provisions governing
compensation for members of the Cohort. Although the list of
specified cancers is determined by statute, the list can also be
found in this rule under Sec. 83.5.
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C. Purpose of the Rule
EEOICPA authorized the President to designate additional classes of
employees to be included in the Cohort, while providing Congress with
the opportunity to review these decisions and expedite or reverse them.
As noted previously, the President has delegated his authority in this
matter to the Secretary of HHS. The purpose of this rule is to
establish procedures by which the Secretary of HHS will determine
whether to add to the Cohort new classes of employees from DOE and AWE
facilities. The procedures are
[[Page 30765]]
intended to ensure that petitions for additions to the Cohort are given
uniform, fair, scientific consideration, that petitioners and
interested parties are provided the opportunity for appropriate
involvement in the process, and to comply with specific statutory
requirements of EEOICPA. The procedures also address, within their
relevant scope, the stated congressional purpose of the compensation
program to provide timely compensation to covered employees or their
survivors for covered illnesses incurred by such employees in the
performance of duty.
D. Statutory Requirements for Designating Classes of Employees as
Members of the Cohort
EEOICPA includes several requirements for these procedures. The
Board shall provide advice to the President (delegated by Executive
Order 13179 to the Secretary of HHS) concerning the designation of
additional classes as members of the Cohort. The Board's advice is to
be based on ``exposure assessments by radiation health professionals,
information provided by the Department of Energy, and such other
information as the Advisory Board considers appropriate.'' 42 U.S.C.
7384q. Section 7384q specifies that HHS obtain the advice of the Board
``after consideration of petitions by classes of employees * * * for
such advice.'' This section also mandates two broad criteria to govern
HHS decisions, which are to be made after receiving the advice of the
Board. Members of a class of employees at a DOE facility or AWE
facility may be treated as members of the Cohort for purposes of the
compensation program if HHS ``determines that: (1) It is not feasible
to estimate with sufficient accuracy the radiation dose that the class
received; and (2) there is a reasonable likelihood that such radiation
dose may have endangered the health of members of the class.'' Finally,
42 U.S.C. 7384l(14)(C)(ii) requires the Secretary to submit a report to
Congress for each class of employees the Secretary designates to be
added to the Cohort. The report must define the class of employees
covered by the designation and specify the criteria used to make the
designation. This section requires that the designation take effect 180
days after the date on which HHS submits the report to Congress
``unless Congress otherwise provides.''
E. Relationship of Procedures to an Existing Rule Promulgated by HHS To
Implement EEOICPA
These procedures complement the HHS final rule: ``Methods for
Radiation Dose Reconstruction Under the Energy Employees Occupational
Illness Compensation Program Act of 2000'' promulgated by HHS on May 2,
2002 at 42 CFR Part 82 (67 FR 22314).
42 CFR Part 82 provides the methods by which NIOSH is conducting
dose reconstructions to estimate the radiation doses incurred by
individual covered employees who have incurred cancer. These estimates
are required by EEOICPA for DOL to adjudicate a cancer claim for an
employee who is not a member of the Cohort or whose claim is not
covered by provisions of EEOICPA for compensating members of the
Cohort. The methods to arrive at these estimates, however, will be
directly considered by HHS in reviewing petitions to add classes of
employees to the Cohort. In particular, HHS will consider these methods
in determining for a petitioning class of employees, as required by
EEOICPA, whether ``it is not feasible to estimate with sufficient
accuracy the radiation dose that the class received.''
II. Summary of Public Comments
HHS published a first notice of proposed rulemaking (``NPRM'')
specifying procedures for adding classes of employees to the Cohort on
June 25, 2002 (67 FR 42962). Public and Board comments on this first
NPRM led HHS to make substantial changes in the proposal, which
resulted in the publication of a second NPRM on March 7, 2003 (68 FR
11294). HHS solicited public comments on this second NPRM from March 7,
2003 to May 6, 2003.\2\ During this period, comments were also
submitted by the Board.
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\2\ HHS extended the public comment period from 30 to 60 days at
the request of the Board and members of the public.
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HHS received comments on the second NPRM from 11 organizations and
19 individuals, including 14 Members of Congress. Organizations
commenting included six national or local labor organizations
representing DOE workers, the Health Physics Society, and four advocacy
groups. A summary of these comments and HHS responses is provided
below. These are organized by general topical area. The HHS responses
in this section also serve to explain changes made to the proposed rule
and to supplement explanations from both NPRMs concerning the intent of
the final rule.
A. Feasibility of Dose Reconstructions: Timeliness, Cost, and
Availability of Records
As discussed above, EEOICPA requires HHS to find that it is ``not
feasible to estimate with sufficient accuracy the radiation dose that
the class received'' as a condition for adding the class to the Cohort.
The NPRM proposed the criterion that this condition would be met if
NIOSH were not able to establish ``that it has access to sufficient
information to estimate the maximum radiation dose that could have been
incurred in plausible circumstances by any member of the class'' (68 FR
11308).
HHS received comments from several labor organizations, an advocacy
group, and Members of Congress recommending that the rule establish
additional criteria defining when dose reconstructions would not be
feasible. Some commenters recommended distinguishing this requirement
as separate and apart from the requirement for ``sufficient accuracy.''
The most common recommendation was for HHS to establish a time limit
for completing dose reconstructions, after which the dose
reconstruction would be determined to be not feasible. Commenters
recommended time limits ranging from 180 days to 24 months.
HHS does not agree that a regulatory time limit on dose
reconstructions would be appropriate in this rule, which establishes
procedures for determining whether to add a class of employees to the
Cohort. Some of the factors that could protract a dose reconstruction,
such as a poorly defined employment history or work history, would be
specific to the case of an individual employee, and would not be
germane to a class of employees.
HHS does not believe a time limit on the duration of a dose
reconstruction to be an appropriate addition to the dose reconstruction
rule, either. Such a limit would eliminate the flexibility to address
special circumstances and could effectively nullify the statutory
requirements for dose reconstruction and the determination of
probability of causation in their entirety by deeming all DOE and AWE
employees to be members of classes of employees for whom dose
reconstruction is not feasible.
In addition, a regulatory time limit could delay compensation for
claimants whose dose reconstructions might exceed a regulatory deadline
but would still be completed prior to the time at which a class of
employees could be added to the Cohort. As this rule describes,
Congress has 180 days to review any HHS decision to add a class to the
Cohort, before such a decision could become effective.
One of the most important factors presently affecting the
timeliness of dose reconstructions is the current
[[Page 30766]]
backlog of dose reconstructions, which is a result of the extensive
development requirements of the dose reconstruction program. NIOSH
began receiving cases requiring dose reconstructions in October of
2001, long before the dose reconstruction program could establish even
minimal capacity for completing dose reconstructions. HHS completed
final rules establishing the methods of dose reconstruction in May of
2002. NIOSH awarded a contract to build external capacity for
conducting dose reconstructions in September of 2002.
NIOSH and its contractor for dose reconstructions are now employing
more than 300 staff (including more than 100 health physicists) and are
working to complete tasks necessary to eliminate the backlog. These
tasks include the completion of ``site profiles,'' which summarize
site-specific exposure conditions, dosimetry, and other relevant
information. In parallel with this necessary developmental work, NIOSH
is completing dose reconstructions at an increasing pace for cases
involving sites for which NIOSH has already issued site profiles and
for which site profiles are not needed. It took NIOSH 26 months to
complete the first 1000 dose reconstructions. NIOSH completed the
second 1000 in 14 weeks. This rate is continuing to improve.
An advocacy group and some Members of Congress also recommended HHS
consider the cost of dose reconstructions as a criterion for
feasibility, to avoid incurring ``prohibitive expense'' in conducting a
dose reconstruction.
HHS has not included a cost criterion in the rule. The NIOSH dose
reconstruction program is designed with procedures specifically
intended to minimize the time and financial resources required for dose
reconstructions. Individual dose reconstructions are presently costing
an average of less than $10,000 each. A regulatory cost criterion would
require HHS to incur unproductive expenses and might delay the
consideration of petitions substantially, since HHS would have to
estimate dose reconstruction costs related to each Cohort petition.
Some Members of Congress also recommended that HHS consider the
deficiency or complete absence of records as a criterion for
feasibility.
HHS included such provisions in the NPRM and in the final rule, as
discussed in the following section discussing comments on ``sufficient
accuracy.'' NIOSH internal procedures for evaluating petitions,
available upon request from NIOSH (1-800-356-4674) or from the NIOSH
Web page (www.cdc.gov/niosh/ocas), provide step-by-step practical
information on how NIOSH will evaluate the availability of information
needed to estimate the radiation doses of a class of employees with
sufficient accuracy. These recommended internal procedures do not
create any substantive rights on the behalf of petitioners. Comments
may be provided at any time about these procedures to OCAS at
[email protected]. Any subsequent revision of the internal procedures will
be posted on the NIOSH Web site at www.cdc.gov/niosh/ocas. If there are
any substantial revisions to these procedures, NIOSH will publish a
Federal Register Notice including an indication that there have been
substantial revisions, a paragraph summarizing the changes, and that
the revised procedures can be found on the NIOSH Web site at
www.cdc.gov/niosh/ocas. Comments regarding these internal procedures or
any revisions thereto are invited.
In addition, HHS has added a provision to section 83.13(c)(1)(i) of
the rule, as part of the feasibility determination by NIOSH under this
section, to require that NIOSH determine whether it has information
regarding monitoring, source, source term, or process information from
the site where the employees worked to serve as the basis for a dose
reconstruction. EEOICPA requires that determinations of probability of
causation for claimants under EEOICPA be based on the radiation dose
received by the employee (or a group of employees performing similar
work) at the facility where the employee(s) worked. 42 U.S.C.
7384n(c)(3)(A). Consequently, for NIOSH to determine that dose
reconstruction is feasible, dose reconstruction must, as a starting
point, be based on some information from the site where the employee
worked. This basis requirement does not limit NIOSH to using only or
primarily information from the site where the employee worked, but it
requires the use of some information from the site.
HHS has also added a new Sec. 83.13(b) which authorizes the
Director of the Office of Compensation Analysis and Support (OCAS)
within NIOSH to determine that records and/or information requested
from DOE, an AWE, or another source to evaluate a petition is not, or
will not be, available on a timely basis. Such a determination will be
treated, for the purposes of the petition evaluation, as equivalent to
a finding that the records and/or information requested are not
available. This will facilitate the efforts of NIOSH to evaluate
petitions within a reasonable amount of time in relation to the records
and/or information required to evaluate the petition and any other
relevant factors.
Some Members of Congress also recommended that the rule clarify
that EEOICPA does not require a demonstration that no ``worst case
estimate'' can be reached for inclusion in the Cohort.
HHS has clearly and completely specified the statutory requirements
of EEOICPA relating to the addition of classes of employees to the
Cohort, under section I(D) above. The rule itself provides procedures
by which HHS will implement these statutory requirements. Related
specifically to the comment, to add a class of employees to the Cohort,
EEOICPA requires that HHS find that ``it is not feasible to estimate
with sufficient accuracy the radiation dose that the class received;* *
* ;'' 42 U.S.C. 7384q(b). Subsection 83.13(c)(1) of this rule specifies
clearly the approach HHS will use to evaluate feasibility. This
approach, as it relates to the statutory requirement regarding
feasibility, is discussed above, in sections B and C below, and in the
second NPRM (68 FR 11296). The ability to estimate the maximum
radiation dose received by members of a class is technically a critical
distinction between circumstances in which it is feasible to estimate
radiation doses through dose reconstruction and those in which it is
not feasible to do so.
B. Feasibility of Dose Reconstructions: Relevance of Type of Cancer to
Feasibility Determinations
The NPRM included provisions that would have allowed NIOSH to
define a class of employees that it would recommend be added to the
Cohort according to the specific cancers for which dose reconstruction
is not feasible and hence demonstrate a reasonable likelihood of a dose
that may have endangered the health of members of the class. Several
commenters questioned the scientific proposition that it could be
feasible to estimate radiation doses for individuals with certain
cancers, but not feasible to estimate doses for individuals with other
cancers. The statutory provisions of EEOICPA neither require nor
prohibit HHS from establishing cancer-specific classes.
The Board, which specifically reviewed this issue, recognized that
this situation ``may be scientifically and theoretically possible.''
Two theoretical examples of this situation, involving external
radiation exposures (originating from outside of the body), were
identified and considered during meetings of the Board and were not
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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 groups
of workers added to the Cohort ``would be eligible for compensation for
a fixed list of radiation related cancers,'' meaning the list of 22
``specified cancers'' established under EEOICPA and listed in section
83.5(m) of this rule. S10377, Congressional Record, October 12, 2000.
Many commenters also expressed the view that it would be unfair and
contrary to EEOICPA for HHS to exclude from classes of employees to be
added to the Cohort employees who incur certain specified cancers,
since all specified cancers are compensable for members of the classes
included in the Cohort by statute. The relevant portion of the
statutory provision of EEOICPA reads as follows: ``The term `covered
employee with cancer' means any of the following: [a]n individual with
a specified cancer who is a member of the Special Exposure Cohort, * *
*'' 42 U.S.C. 7384l(9)(A).
In addition, while the Board indicated that it might be
scientifically and theoretically possible for the situations addressed
by the NPRM to exist, the Board recommended against the establishment
of cancer-specific classes, as discussed below, stating that it was
concerned about ``providing some level of equity between the definition
of new SEC classes and those already defined in the legislation.''
The provisions of EEOICPA that directly govern which classes of
employees can be added to the Cohort are the feasibility and health
endangerment provisions addressed under the ``statutory requirements''
section above. These provisions can be interpreted in different ways to
either support or oppose the establishment of cancer-specific classes.
They neither require nor prohibit HHS from establishing cancer-specific
classes.
As discussed above, in support of cancer-specific classes, HHS has
identified possible situations in which the feasibility of estimating
doses would differ by type of cancer. In addition, the Health Physics
Society and a member of the Board identified possible situations in
which a determination of health endangerment might differ by type of
cancer.
In opposition to including provisions for cancer-specific classes,
one could interpret ``it is not feasible to estimate with sufficient
accuracy the radiation dose that the class received'' to mean: it is
not feasible to estimate with sufficient accuracy the radiation dose to
any cancer site rather than the dose relevant to the cancer incurred by
any particular employee. Similarly, health endangerment could be
interpreted to mean an employee having been put at risk of certain
types of cancers, regardless of whether the employee actually incurred
one of the cancers for which the employee was at risk. Such
interpretations would allow one to define a class without
qualification, even when it would be feasible to estimate radiation
doses for employees with all but one type of cancer, and even if most
types of cancers were unlikely to have been caused by the radiation
exposure of concern.
In light of the ambiguity of the statute, the limited practical
applications of the option to establish cancer-specific classes, the
nearly unanimous public opposition, and the opposition of the Board,
HHS has omitted from the final rule the provisions in the NPRM that
would have allowed the addition to the Cohort by HHS of cancer-specific
classes of employees. Furthermore, HHS has revised section 83.13(c)(1)
of the rule to state explicitly that NIOSH will make determinations of
feasibility based on whether or not NIOSH is able to reconstruct doses
for every type of cancer for which radiation doses are reconstructed.
The practical consequence of these changes is that HHS might
designate classes of employees to be added to the Cohort under this
rule despite the possibility that it might be feasible to estimate
radiation doses with sufficient accuracy for some members of the class;
specifically, that it might be feasible to estimate radiation doses
with sufficient accuracy for a member of the class who incurs one of a
subset cancer types for which there might be adequate dose-related
information, as discussed above.
C. Accuracy of Dose Reconstructions
HHS received various comments and recommendations that relate to
the determination as to whether it is feasible to estimate doses to
members of a class of employees with sufficient accuracy.
The most frequent of these comments requested HHS provide
additional detail, either in the rule or in guidelines, to define how
NIOSH would establish, under Sec. 83.13(c)(1), ``that it has access to
sufficient information to estimate the maximum radiation dose that
could have been incurred in plausible circumstances by any member of
the class* * *'' HHS was asked to provide the methods by which maximum
radiation doses would be estimated, and to define ``sufficient
information.'' The Board requested that NIOSH issue guidelines to
provide additional clarification concerning sufficient accuracy, after
promulgation of this final rule.
[[Page 30768]]
As discussed above, NIOSH is issuing internal procedures
concurrently with the promulgation of this rule that provide more
detailed procedures for how it will evaluate petitions. While these
procedures do not establish any substantive rights, they specify how
NIOSH will identify available information and the general methods for
determining whether such information will be sufficient to estimate
maximum radiation doses for employees in the class, when such estimates
are necessary. The internal procedures supplement the guidelines
already provided in this final rule under section 83.13(c)(1). The
internal procedures also provide limited generic information on how
maximum radiation doses can be estimated when necessary. More specific
detail outlining how available information would be used to conduct
dose reconstructions would be provided within each NIOSH evaluation of
a petition that finds that it is feasible to estimate radiation doses
with sufficient accuracy for the class.
One individual commented that the rule puts excessive emphasis on
estimating the maximum possible doses of radiation.
This emphasis was unintended. The proposed rule defined only the
limits of dose reconstruction. The public should realize, however, that
HHS may receive petitions for classes of employees for whom there is
sufficient information to conduct dose reconstructions that provide
more precise estimates than maximum doses, using, for example, personal
or area monitoring records. For these petitions, methods for estimating
maximum radiation doses would not be addressed in the NIOSH evaluation
because they would not be relevant, since more precise dose
reconstructions would be feasible. HHS has clarified the rule on this
point, adding the following provision (identified below in italics) to
section 83.13(c)(1):
Radiation doses can be estimated with sufficient accuracy if
NIOSH has established that it has access to sufficient information
to estimate the maximum radiation dose, for every type of cancer for
which radiation doses are reconstructed, that could have been
incurred in plausible circumstances by any member of the class, or
if NIOSH has established that it has access to sufficient
information to estimate the radiation doses of members of the class
more precisely than an estimate of the maximum radiation dose.
HHS has also supplemented the guidelines previously included in the
rule regarding the feasibility of estimating the radiation dose of a
class of employees with sufficient accuracy. A new Sec.
83.13(c)(1)(iii) specifies the following additional guidelines:
In many circumstances, to establish a positive finding under
paragraph (b)(1)(i) of this section would also require information
describing the process through which the radiation exposures of
concern may have occurred and the physical environment in which the
exposures may have occurred.
One labor organization interpreted the NPRM as indicating that
NIOSH would use analytic models, presumably to estimate maximum doses
when necessary, at the expense of the timely completion of dose
reconstructions.
The use of analytic models in such instances is efficient, not
delaying. Dose reconstructions that rely more extensively on analytic
exposure models can be completed far more quickly than dose
reconstructions that require the collection and evaluation of extensive
monitoring data, which may still involve the use of analytic exposure
models as well.
An individual commented that this rule should define how NIOSH
determines the reliability of dosimetry information for use in dose
reconstructions. The commenter correctly noted that the accuracy of
dosimetry results is affected by a variety of factors, some of which
the commenter enumerated. The commenter also asserted that it was a
``fatal flaw'' of the NPRM to assume that maximum doses can be
estimated 30 to 50 years after the fact.
The HHS dose reconstruction rule (42 CFR Part 82) and related dose
reconstruction guidelines specify how doses are reconstructed and
explain how NIOSH takes into account various factors that affect the
interpretation of dosimetry information, particularly the limitations
of dosimetry programs from the early decades of nuclear weapons
production. The types of studies the commenter cited, that have
evaluated the shortcomings of dosimetry programs, are used by NIOSH to
interpret the records of such dosimetry programs.
The NPRM and this final rule, however, do not reflect an assumption
that it will be feasible to estimate maximum doses or to more precisely
estimate doses. The determination by NIOSH, the Board, and the
Secretary of HHS as to whether dose reconstruction is feasible for a
particular class of employees is a central element of this rule.
Related to this latter point, an advocacy group and a labor
organization questioned whether petitioning is ``futile'' under the
provisions of this rule concerning feasibility, because, in the view of
the commenters, NIOSH ``raised the bar'' for evaluating whether doses
can be estimated with sufficient accuracy from the first NPRM to the
second NPRM, from when a dose reconstruction cannot be completed to
when maximum doses (nor more precise doses) cannot be estimated.
The provisions of the second NPRM discussed in the comment are no
more exclusive than those of the first NPRM, only more specific. The
specificity was requested by the Board and sought by other public
commenters as well.
There is, however, a substantial difference between the minimal
requirements for submitting a petition, when such a petition is not
based on NIOSH having already found that a claimant's dose
reconstruction cannot be completed, and the requirements for adding a
class of employees to the Cohort. Such petitions provide NIOSH with
basic information necessary to begin the determination process, but
NIOSH is likely to have more extensive access to information for dose
reconstructions than petitioners. NIOSH will consider all information
as necessary, not only information provided by the petitioner, to
determine whether or not the radiation doses of the class of employees
can be estimated with sufficient accuracy.
One labor organization commented that NIOSH had failed to address
limitations of the NPRM. In explanation, the commenter asserted that
the estimation of maximum doses would not be sufficient to estimate
lifetime exposure and would not be valid in circumstances involving a
mixture of radionuclides.
If NIOSH can estimate the maximum quantity of a radionuclide that
could have been inhaled, ingested, or absorbed by an employee, then the
maximum doses resulting from such internal exposure can be estimated
for the entire period between exposure and the occurrence of cancer, as
is necessary for NIOSH dose reconstructions.
With respect to mixtures of radionuclides, the critical issue is
the extent of information about the mixture (e.g., quantities and
identities). The involvement of multiple radionuclides is not
inherently an obstacle to dose reconstruction. On the other hand, in
situations involving exposure of a class of employees to a mixture of
radionuclides of uncertain identity and quantity, NIOSH may not be able
to estimate radiation doses and the class may be added to the Cohort,
as provided for under this rule.
Two labor organizations questioned how NIOSH could estimate
radiation doses for workers who move between buildings or facilities
and who may not, themselves, have any knowledge of radiation sources.
[[Page 30769]]
If doses can be estimated for employees who worked steadily within
a building or facility, then typically they could be estimated for
employees who were in the building or facility episodically. A major
difference in some such dose reconstructions, in cases in which the
worker was not monitored at some or any of the locations, would be the
need to allocate the worker's time among various locations. It is
relatively straightforward to do so, using assumptions that give the
benefit of the doubt to the worker when information concerning the
duration of the worker's activities at different locations is
insufficient.
An advocacy group, a labor organization, and some Members of
Congress asserted that the provision of the NPRM requiring that NIOSH
have sufficient information to be able to estimate maximum radiation
doses, at a minimum, is incompatible with a provision of the dose
reconstruction rule (42 CFR 82.10(k)(2)). Some of these commenters
interpret the provision of the dose reconstruction rule as limiting the
use of worst-case assumptions, which must be used in estimating maximum
radiation doses, to non-compensable cancer claims (i.e., claims for
which the probability of causation is below 50 percent). Furthermore,
the commenters conclude that this perceived incompatibility could
result in a situation in which NIOSH might find that it could not
complete a dose reconstruction for a claimant and yet NIOSH could find,
under this rule, that the claimants' doses can be estimated, preventing
HHS from adding a class of employees including the claimant to the
Cohort. For this reason, the commenters recommended that HHS amend the
dose reconstruction rule to be compatible with this rule.
The dose reconstruction rule (42 CFR Part 82) does not require any
revision with respect to this concern. It is not possible for NIOSH to
determine that it cannot complete a dose reconstruction for a claimant
under the dose reconstruction rule and simultaneously find the same
dose reconstruction to be feasible under this rule (42 CFR Part 83).
The dose reconstruction rule very specifically restricted the
condition on the use of worst-case assumptions to the case when they
are used as an efficiency measure to limit time-consuming and resource-
consuming additional research and analysis. This narrow restriction is
stated in the dose reconstruction rule as follows (emphasis added):
At any point during steps of dose reconstruction described
[above], NIOSH may determine that sufficient research and analysis
has been conducted to complete the dose reconstruction. Research and
analysis will be determined sufficient if one of the following three
conditions is met: * * * (2) Dose is determined using worst-case
assumptions related to radiation exposure and intake, to substitute
for further research and analysis; * * *
* * * Worst-case assumptions will be employed under condition 2
to limit further research and analysis only for claims for which it
is evident that further research and analysis will not produce a
compensable level of radiation dose (a dose producing a probability
of causation of 50% or greater), because using worst-case
assumptions it can be determined that the employee could not have
incurred a compensable level of radiation dose.'' 42 CFR Part
82.10(k)
In contrast, this Cohort rule implies the use of worst-case
assumptions for dose reconstructions in essentially the opposite
situation, to estimate maximum radiation doses in cases in which NIOSH
lacks extensive information that could be used to conduct ``further
research and analysis,'' rather than as an efficient substitute for
such further research and analysis.
The dose reconstruction rule does not assert or imply any
restriction in circumstances in which the total information available
is limited. In fact, the rule generally anticipates such circumstances
in describing the hierarchy of information that might be used in a dose
reconstruction, depending on availability. In the introductory section
of the rule, it describes the dose reconstruction practice of using
assumptions to substitute for a lack of data:
``For dose reconstructions conducted in occupational illness
compensation programs, this practice may include use of assumptions
that represent worst-case conditions.'' 42 CFR Part 82.2(a).
Furthermore, the Cohort rule provides that whenever NIOSH finds
under the dose reconstruction rule that it cannot complete a dose
reconstruction, this finding will suffice, without exception or further
consideration, to support a determination that it is not feasible to
estimate the radiation doses of individual members of the class with
sufficient accuracy. This was implicit in Sec. 83.14 of the NPRM but
has been made explicit, to eliminate any uncertainty in interpretation,
with the following inserted text (in italics):
(b) NIOSH will determine the health endangerment criteria for
adding the class under paragraph (a)(1) of this section to the
Cohort, using the procedures outlined under Sec. 83.13. NIOSH will
report to the Board the results of this determination, together with
its finding under 42 CFR Part 82 that there was insufficient
information to complete the dose reconstruction. HHS will consider
this finding under 42 CFR Part 82 sufficient, without further
consideration, to determine that it is not feasible to estimate the
levels of radiation doses of individual members of the class with
sufficient accuracy.
Two labor organizations asserted, in contrast with the comments
discussed immediately above, that the NPRM and the dose reconstruction
rule (42 CFR Part 82) were inappropriately linked through their
implicit use of common criteria for determining the feasibility of dose
reconstructions. EEOICPA required HHS to establish, by regulation,
methods for arriving at reasonable estimates' of radiation doses
incurred by individuals (42 U.S.C. 7384n(d)). As discussed above,
EEOICPA requires HHS to determine that it is not ``feasible'' to
estimate with ``sufficient accuracy'' the radiation dose that a class
received, for HHS to add a class of employees to the Cohort (42 U.S.C.
7384q(b)(1)). The commenters believe the use of different terms in
these two sections of EEOICPA (reasonable estimates of doses versus
doses that are not feasible to estimate with sufficient accuracy)
signals different intentions of Congress for determining the
feasibility of dose reconstruction as it arises through the dose
reconstruction program versus through a petition for adding a class to
the Cohort. Accordingly, the commenters recommend that HHS establish
different criteria for these two situations.
The statutory provisions concerning the development of dose
reconstruction methods (42 U.S.C. 7384n(d)) are concerned with how dose
reconstructions are to be done, not a determination as to whether or
not they can be done. It is implicit, nonetheless, that these dose
reconstructions must be ``feasible to estimate with sufficient
accuracy.'' It appears to HHS that the use of this phrase under
provisions for considering the addition of classes of employees to the
Cohort, and the omission of this phrase under provisions concerning
dose reconstruction, simply reflects the fact that these two separate
provisions of EEOICPA address different but complementary
circumstances.
An advocacy group and several labor organizations questioned
whether or not an estimate of the maximum radiation dose produced by a
dose reconstruction would be represented by a single value (point
estimate) or by a distribution of values (that take uncertainty into
account).
When NIOSH is limited to estimating maximum doses in a dose
reconstruction based on source term and process information, the dose
reconstruction is likely to rely substantially on one or more worst-
case
[[Page 30770]]
assumptions that contribute to defining the level or levels of exposure
and the characteristics of the exposure. It is unknown, however, how
often such dose reconstructions would produce a point estimate of dose,
versus a distribution of dose values that estimates dose. There are
various circumstances that could result in the estimation of a
distribution of dose values, such as when factors affecting the dose
estimate have known and documented variability and/or uncertainties.
NIOSH might use a distribution of values, for example, to characterize
the particulate sizes of a radioactive material that has been ground or
cut, when this factor had been studied and documented at comparable
operations. In such a case, the distribution of values for particulate
size would result in a distribution of dose values rather than a
single, point estimate of dose.
One advocacy group and labor organization requested the rule or
guidelines define ``plausible circumstances,'' asserting that use of
this term was simply substituting for the term ``sufficient accuracy.''
In context, HHS uses the term as follows: ``Radiation doses can be
estimated with sufficient accuracy if NIOSH has established that it has
access to sufficient information to estimate the maximum radiation dose
that could have been incurred in plausible circumstances * * *''
(emphasis added). 42 CFR 83.13(c)(1)(i).
In this case, ``plausible circumstances'' is not substituting for
``sufficient accuracy'' as suggested, since the operative concept here
is the ability to estimate the maximum radiation dose. The
identification of plausible circumstances qualifies how such doses
would be estimated. It means that NIOSH is not required to utilize
unlikely, unreasonable, or illogical scenarios to estimate radiation
doses. Furthermore, it is not reasonable to construct a ``litmus test''
for defining plausibility. It involves expert judgment, which will be
applied by NIOSH and the Board in determining what are plausible
circumstances consistent with the known information relevant to the
evaluation of the petition. Dose reconstruction routinely uses expert
judgment to address unknown and uncertain information. The important
matter with respect to such judgments is that the NIOSH dose
reconstruction program provides the benefit of the doubt to the
claimant in identifying plausible scenarios, to ensure that dose
reconstructions do not underestimate doses.
One advocacy group and one labor organization also recommended that
NIOSH consider applying a statistical concept such as ``the size of the
standard error'' in guidelines for defining sufficient accuracy. The
general idea of this comment is that NIOSH would define quantitatively
the degree to which the range and likelihood of all possible dose
estimates supported by the facts could diverge from the central
tendency of these estimates.
There is not a good scientific or logical basis for establishing a
statistical measure of precision, which is not equivalent to accuracy,
as a requirement for NIOSH dose reconstructions under EEOICPA. Any
claimant for whom a less precise but more accurate estimate would
support compensation might challenge such a requirement as arbitrary.
For example, NIOSH might estimate that an employee incurred a radiation
dose to the prostate of between 20 and 100 rem, with a central tendency
of 60 rem. This dose distribution is not as precise as an estimate of
between 50 and 70 rem, for example, but it could be more accurate to
the degree that it appropriately accounts for the variability and
uncertainty in the available data and hence better characterizes what
we know and do not know about the level of dose received by the
employee.
HHS interprets ``sufficient accuracy'' in practical terms as
sufficiently accurate to assure the fair adjudication of claims. NIOSH
dose reconstructions provide this assurance by using methods that build
on the factual and scientific bases using two principal measures that
are designed to overestimate every employee's dose.
First, as discussed above, the expert judgments (assumptions) used
in NIOSH dose reconstructions give claimants the benefit of the doubt,
when possible. When information is missing or questionable, the
claimant is generally favored by NIOSH assuming the occurrence of the
more harmful of plausible exposure scenarios.
Second, NIOSH accounts quantitatively for the factual and
scientific uncertainties involved in each dose reconstruction and
includes this measure of uncertainty in the probability of causation
calculation performed by DOL. In practical terms, this favors the
claimant because, pursuant to 42 U.S.C. 7384n(c)(3)(A), DOL calculates
the probability of causation at the upper 99 percent credibility limit;
in other words, any uncertainty in the dose used to adjudicate the
claim will contribute to DOL overestimating the likelihood that the
employee's cancer was caused by radiation.
These two measures taken together, claimant-favorable assumptions
and the estimation of probability of causation at the upper 99 percent
credibility limit, produce a doubly upper-bounded estimate of the
employee's radiation dose. By these measures, whenever it is feasible
for NIOSH to estimate radiation doses for a cancer claimant, NIOSH is
almost certain to be overestimating the actual radiation doses.
D. Health Endangerment
In addition to the condition that HHS find that it is not feasible
to estimate the radiation doses of a class of employees with sufficient
accuracy, a second requirement of EEOICPA for adding a class to the
Cohort is that HHS find that there is ``a reasonable likelihood that
such radiation dose may have endangered the health of members of the
class.'' Under section 83.13(b)(3) of the NPRM, HHS proposed a standard
based on the duration of employment within the employment conditions
under which radiation doses cannot be estimated. As a default, this
standard would be 250 work days, the same standard required by EEOICPA
for employees of the gaseous diffusion plants included in the Cohort by
Congress. 42 U.S.C. 7384l(14)(A). In addition, for classes of employees
that may have been exposed to radiation during discrete incidents that
were likely to have involved exceptionally high level exposures, such
as nuclear criticality incidents, HHS provided that an employee's
presence with potential exposure during the discrete incident, rather
than a quantified duration of potential exposure, would satisfy the
health endangerment criterion.
HHS received relatively few comments concerning the health
endangerment provisions of the rule and these were generally
supportive. A few commenters recommended changes.
An advocacy group and a labor organization recommended that
employees should be able to accumulate the 250 work days required to
qualify as members of a class added to the Cohort on the basis of their
employment at multiple facilities, if the class includes employment at
the multiple facilities. The central concern behind this comment is
that some nuclear weapons workers are likely to have been employed at
more than one facility, potentially conducting similar work (such as
construction or maintenance) and incurring similar exposures for which
dose reconstruction might not be feasible. The commenters are aware
that DOL qualifies employees of the gaseous
[[Page 30771]]
diffusion plants to be included in the Cohort by aggregating their
employment across all three of the plants, and hence believe classes
added to the Cohort should be treated similarly.
DOL is interpreting a section of EEOICPA that establishes a single,
multi-facility class (42 U.S.C. 7384l(14)(A)), while HHS is
interpreting a different section of EEOICPA (42 U.S.C. 7483q), which
does not allow HHS to define a class as a group of employees from
multiple facilities. However, HHS agrees with the principle of
aggregating employment within separate classes of the Cohort for the
purpose of determining health endangerment. There is no compelling
health reason to distinguish between employment within one class of the
Cohort and employment distributed among several classes of the Cohort,
nor to distinguish whether such classes were employed at the same
facility or at separate facilities. In any case, the employee would
have accumulated 250 work days of employment involving exposure to
radiation that either cannot be estimated by dose reconstruction under
the provisions of this rule or for which Congress determined there was
not a need for dose reconstruction when Congress included the various
groups of employees in the Cohort.
Accordingly, HHS has added a provision to the rule to implement
this principle of aggregating employment. Whenever HHS adds a class of
employees to the Cohort for which the 250 work days requirement is
applicable, HHS will define class eligibility such that DOL can
aggregate the work days of an employee from among all other classes in
the Cohort for which the employee meets all of the other requirements
for membership, except for the work days requirement. For this purpose,
section 83.13(c)(3)(ii) of the rule includes the following additional
text (in italics):
(ii) For health endangerment not established on the basis of a
discrete incident, as described under paragraph (b)(3)(i) of this
section, NIOSH will specify a minimum duration of employment to
satisfy the health endangerment criterion as having been employed
for a number of work days aggregating at least 250 work days within
the parameters established for the class or in combination with work
days within the parameters established for one or more other classes
of employees in the Cohort.
An advocacy group and two labor organizations recommended that the
rule allow for the health endangerment test to be met in fewer than 250
work days for work operations lasting fewer than 250 days. The
commenters indicated that certain short-term operations may have
involved high level exposures. The comments also reflected the
assumption that high level exposures could have occurred through the
omission of radiation protection controls, versus their failure, only
the latter of which was identified in the NPRM.
HHS has not established a separate criterion that would waive the
250 work days employment requirement for any short-term operation,
since exceptionally high level exposures are not inherent to such
operations. Section 83.13(c)(3)(i) of the HHS rule already provides for
waiving the 250 work days employment requirement whenever classes of
employees may have been exposed to radiation during discrete incidents
likely to have involved exceptionally high level exposures, including
any such incidents that may have occurred during projects of short
duration. HHS has revised the text of this section to allow for the
possibility that exceptionally high exposures could result from
circumstances involving the omission of radiation protection controls,
as well as their failure. With respect to this change, however, HHS
advises potential petitioners that the omission of radiation protection
controls, in and of itself, is not substantial evidence that
exceptionally high level radiation exposures were likely. The provision
of the rule allowing HHS to waive the 250 work days requirement is
intended to address exposure scenarios distinctly more certain and
severe than would be represented by exposure conditions generally at
the gaseous diffusion plants, for which Congress established the
precedent of setting an employment duration requirement at 250 work
days.
An advocacy group recommended HHS incorporate into the rule a text
excerpt of the NPRM preamble that explained that HHS will use the 250
work days employment requirement ``only when it lacks sufficient basis
to establish a lower minimum standard.''
HHS has not incorporated this text into the rule for two reasons.
First, the term ``only'' may be misleading. HHS has no basis to predict
that the 250 work days employment requirement would be waived for the
majority of classes of employees that may be added to the Cohort.
Moreover, the text is not appropriate for the rule, since it could be
interpreted to require HHS to demonstrate that it lacks sufficient
basis to waive the 250 work days requirement, versus demonstrating that
there is sufficient basis to waive the requirement. This would amount
to requiring HHS to ``prove the negative,'' that it lacks certain
information.
One labor organization commented that EEOICPA provides no basis for
considering the effects of radiation in isolation when considering
health endangerment.
EEOICPA specifically requires that HHS consider whether ``* * *
such radiation dose may have endangered the health of members of the
class'' (emphasis added) 42 U.S.C. 7384q(b)(2). This might allow HHS to
take into account a synergistic or risk-potentiating relationship
between a chemical and a radiation exposure, if such a relationship
were known. Otherwise, EEOICPA does not authorize HHS to consider
health risks other than exposure to radiation.
Two individuals commented that HHS should use epidemiological data
to compare the cancer risks of classes of employees petitioning for
addition to the Cohort with those of the groups included in the Cohort
by statute. The commenters recommended that classes with cancer risks
that are roughly comparable be added to the Cohort.
HHS cannot add classes to the Cohort on the basis of health
endangerment alone. As discussed above, pursuant to 42 U.S.C.
7384q(b)(1), HHS must also find that dose reconstruction is not
feasible. Moreover, as discussed in the second NPRM in response to this
comment, there is no practical and scientifically defensible method for
making such epidemiological comparisons for a variety of reasons,
including limitations concerning timeliness, statistical power, and
other matters (68 FR 11297).
One labor organization asserted that Congress intended for HHS to
use the same criteria for considering whether to add classes of
employees to the Cohort as were used by Congress itself to include
groups in the Cohort by statute.
As discussed above, Congress specified in EEOICPA, 42 U.S.C.
7384q(b), the criteria that it intended HHS to use.
E. Eligibility To Petition
Section 83.7 of the NPRM specified parties that would be eligible
to submit a petition on behalf of a class of employees. This included:
``(c) One or more individuals or entities authorized in writing by one
or more DOE, DOE contractor or subcontractor, or AWE employees, who
would be included in the proposed class of employees, or their
survivors.''
HHS received conflicting comments concerning this provision. One
labor organization recommended that HHS narrow the above provision
specifically, and implied HHS would have to narrow another provision of
Sec. 83.7 that would
[[Page 30772]]
allow employees and survivors to petition (paragraph (a)), ``to
recognize the exclusive right of a labor union to represent the
collective interests of employees in represented bargaining units who
might petition for inclusion in the SEC.'' The commenter asserted:
``Any NIOSH procedures inconsistent with this bedrock principle are
incompatible with the National Labor Relations Act.'' The commenter
further speculated that NIOSH would conserve resources by limiting the
right to petition to the certified labor organization whenever the
class includes members of an existing bargaining unit of a labor
organization. The commenter explained that such a limitation ``will
avoid the potential problem of several competing representatives filing
overlapping or inconsistent petitions on behalf of common employees.''
Two other labor organizations (one being a local unit of the
commenter discussed above) and three advocacy groups expressed
unqualified support for the eligibility requirements proposed in the
NPRM and specifically opposed the recommendations and rationale of the
commenter discussed above. One of these commenters asserted that the
National Labor Relations Act (NLRA) provision regarding the exclusive
right of a labor union to represent collective interests of employees
in union-represented bargaining units does not apply to petitions for
Cohort status under the EEOICPA. Some members of this group of
commenters further argued that the limitation proposed by the first
commenter above would be unworkable given the large number of unions
representing employees at a single site.
On its face, the NLRA, which in pertinent part at 29 U.S.C. 159(a)
establishes the exclusive right of a labor union to represent employees
in union-represented bargaining units for the purpose of ``collective
bargaining in respect to rates of pay, wages, hours of employment, or
other conditions of employment,'' does not apply to petitions for
Cohort status under EEOICPA, as these do not involve ``collective
bargaining in respect to rates of pay, wages, hours of employment, or
other conditions of employment.'' None of the items potentially
addressed by collective bargaining are determined by HHS in considering
a petition to add a class of employees to the Cohort.
HHS discussed the issue of potentially overlapping petitions, which
concerned the first commenter above, in the first NPRM (67 FR 42966).
This situation is unavoidable and HHS does not expect it to present
major difficulties. HHS will consider concurrent petitions jointly, to
the extent that they identify a class in common. With respect to the
commenter's concern about potential conflicts between petitions,
decisions by HHS on petitions will not govern decisions on subsequent
petitions for the same class, or any part thereof, so long as
substantial new information, germane to the criteria for adding a class
to the Cohort, is provided by a subsequent petition.
For the reasons discussed above, HHS has retained in the rule the
relevant provisions of Sec. 83.7 from the NPRM, without change.
HHS revised Sec. 83.7 to limit the number of petitioners that can
submit a single petition to a maximum of three individuals and/or
organizations. This limitation, which limits the number of petitioners
but does not limit the number of members of a class of employees, is
intended to facilitate the timely consideration of petitions by NIOSH,
the Board, and the Secretary, since each petitioner for a petition has
procedural rights under the rule that, if applicable to a large number
of petitioners, could prolong the consideration of a petition
substantially. HHS has also added a definition of the term
``petitioner'' under Sec. 83.5(j) of the rule to reflect this change.
F. Petition Requirements
Section 83.9 of the NPRM specifies informational requirements that
must be fulfilled by petitioners in order for HHS to consider the
petition. An advocacy group and two labor organizations commented
generally that they support the reduced requirements of this second
NPRM, compared to the first NPRM. Commenters had several specific
recommendations.
Subsection (b) requires claimants to petition when NIOSH has found
that it cannot complete their dose reconstructions. The information to
be provided by the petitioner in such cases is minimal, in effect
simply notifying NIOSH formally that the claimant wishes to petition.
Nonetheless, one labor organization recommended against this
requirement, asserting that it is unnecessarily burdensome. The
organization recommended that HHS automatically consider the addition
of a class in these cases.
HHS interprets EEOICPA, 42 U.S.C. 7384q(a)(3), to require the
submission of a petition to initiate consideration for adding a class
of employees to the Cohort. As specified under the dose reconstruction
rule (42 CFR 82.12), NIOSH will encourage and assist these claimants to
file a petition and has minimized the requirements for their petitions.
Subsection (c)(1)(i) specifies that petitioners, other than the
claimant-petitioners covered under subsection (b), must propose a
definition of the class of employees for whom the petition would apply,
including identifying, among other items: ``The DOE or AWE facility at
which the class worked* * *'' (emphasis added). Three advocacy groups
and three unions commented on this provision.
The commenters recommended that petitions be allowed to cover
multiple facilities. Commenters explained that certain occupational
groups, such as construction and maintenance workers, had work tasks
that spanned separate sites, or had occupational histories that
commonly involved work at more than one site, and that there may be
similar deficiencies in radiation monitoring for these particular
occupational groups across such sites. Furthermore, in response to the
finding of HHS in the NPRM stating that EEOICPA does not allow for
classes to be defined to encompass employees at more than one facility
(68 FR 11298-11299), some of the commenters asserted that HHS is not
properly interpreting the statute. Specifically, the commenters assert
that it is proper in this case to interpret ``the singular [facility]
to include the plural [facilities].''
The very first section of the United States Code, 1 U.S.C. 1, says:
``In determining the meaning of any act of Congress, unless the context
indicates otherwise--words importing the singular include and apply to
several persons, parties, or things * * *'' (emphasis added). In the
case of the statutory language used by Congress in the section of
EEOICPA describing the procedure for designating additional members of
the Cohort (42 U.S.C. 7384q), the context indicates Congress did not
define a class as a group of employees from multiple facilities. In
particular, the context of the reference to a ``class of employees at
any Department of Energy facility who likely were exposed to radiation
at that facility'' in 42 U.S.C. 7384(q)(a)(1) cannot be interpreted as
a class covering more than one facility (emphasis added). HHS therefore
believes that the concept of considering and adding multi-facility
classes was not anticipated nor provided for in EEOICPA.
As a result, HHS has not revised this section, nor the definition
of the class under 83.5, to allow for classes spanning employment at
multiple facilities. This limitation would not, however, prevent a
petitioner from
[[Page 30773]]
submitting petitions separately for employees at each facility at which
a group was employed, defining individual, facility-specific classes.
Furthermore, changes in this rule eliminate the potential value of
defining classes to include employment at multiple facilities. Under
this rule (83.13(c)(3)(ii)), a claimant will be able to qualify as a
member of a class added to the Cohort by HHS by combining the duration
of his or her period of employment within the class with other periods
of employment among other classes in the Cohort. Hence, for example, if
classes of construction workers involved in certain operations were
separately added to the Cohort from Hanford and from Los Alamos, then a
construction worker who was employed for 100 work days in the specified
operations at Hanford and for 150 work days in the specified operations
at Los Alamos would meet a 250 work days employment requirement that
might be established for such classes and he or she would qualify as a
member of the Cohort.
Subsection 83.9(c)(2) specified various options available to
petitioners to support a petitioner's belief that records and
information available are inadequate to estimate the radiation doses
incurred by members of the proposed class of employees with sufficient
accuracy. Two advocacy groups and two labor organizations recommended
changes to paragraph (iv) to allow petitioners to use in support the
report of any government agency, rather than only reports by agencies
that conduct scientific work. The commenters suggested any government
agency should be considered a potentially credible source of
information. The commenters also recommended against requiring that
such reports specifically address the need for any dosimetry
information identified in the report, with respect to dose
reconstruction. The Board provided a similar recommendation (discussed
in the following section).
HHS agrees that this provision should be clarified and improved,
consistent with these comments. The paragraph now reads as follows:
(iv) A scientific or technical report, published or issued by an
agency of the Executive branch of government, the General Accounting
Office, the Nuclear Regulatory Commission, or the Defense Nuclear
Facilities Safety Board, or published in a peer-reviewed journal,
that identifies dosimetry and related information that are
unavailable (due to either a lack of monitoring or the destruction
or loss of records) for estimating the radiation doses of employees
covered by the petition.
Subsection 83.9(c)(3) of the NPRM specified evidence that would be
required only when a petition is based on an exposure incident (versus
routine operations) and NIOSH is unable to obtain records or
confirmation of the occurrence of such an incident from sources
independent of the petitioner(s). One option specified for such
evidence was confirmation by affidavit from two employees who witnessed
the incident.
One labor organization commented that a total of two witnesses
should be sufficient and that secondhand accounts should be sufficient
when eyewitnesses are deceased. The Board made similar recommendations
(discussed in the following section).
HHS has revised this subsection in response to the comments from
the public and the Board. HHS has omitted the requirement for a
specific number of witnesses, and has provided that the witnesses can
be or include individuals who were informed by eyewitnesses, when the
eyewitnesses are deceased, are incapable of providing an affidavit for
reasons of poor health or impairment, or could not be located. HHS has
also clarified that the provision of affidavits, in and of itself,
would not constitute adequate evidence to verify the occurrence of an
exposure incident. As with any other evidence used to evaluate
petitions, NIOSH would have to consider the credibility and adequacy of
the evidence provided in the affidavits.
One labor organization commented that the NPRM required petitioners
to know the source terms (the identities and quantities of the
radioactive materials) to which employees were exposed.
Neither the NPRM nor the final rule includes such a requirement.
HHS has added a new Sec. 83.9(c)(5) necessary to provide that
NIOSH would only be required to reconsider its initial evaluation or
any subsequent evaluations concerning the addition of a particular
class of employees to the Cohort (a class that has already been
considered by NIOSH as the result of one or more previously submitted
petitions) when a new petition for such a class provides substantially
new information regarding the feasibility of estimating radiation doses
with sufficient accuracy. This change will ensure that the Board and
HHS can consider in a timely fashion the addition to the Cohort of as
many classes as possible. The change preserves the ability of NIOSH,
the Board, and HHS to reconsider the addition of a class when
petitioners identify information not considered by NIOSH that might
lead NIOSH and/or the Board to new findings and recommendations
concerning a class previously considered.
G. Administrative Review of Decisions To Not Evaluate a Petition
Section 83.11 of the NPRM proposed procedures by which NIOSH would
assist petitioners on petitions that NIOSH finds do not meet the
relevant requirements for a petition. A petition that fails to meet
such requirements despite such assistance would not be further
considered by HHS. HHS solicited comments from the public as to whether
HHS should offer the petitioner an administrative review of such final
decisions.
Two advocacy groups and three labor organizations recommended the
rule include the option of an administrative review. The commenters
recommended that HHS specify the procedure for such reviews and that
they be conducted independently. One commenter recommended that such
reviews be conducted by NIOSH internally.
In response to the public comments, HHS has included an option for
prospective petitioners to request an administrative review. Paragraphs
(b) through (e) of section 83.11 have been revised and added for this
purpose. The review would be conducted by three HHS personnel,
appointed by the Director of NIOSH, who were not involved in the
initial consideration of the petition. The rule provides for a simple
and timely process, with minimal requirements imposed on the
petitioner. When appropriate, NIOSH would notify a petitioner of the
right to seek an administrative review and of the associated
procedures.
H. Decisions by the Secretary
Section 83.16 of the NPRM described procedures by which the
Secretary would decide the outcome of a petition.
An advocacy group, four labor organizations, and some Members of
Congress requested additional detail or provided other comment on these
procedures. The advocacy group recommended the Secretary delegate his
authority to the Director of NIOSH and questioned the extent of the
discretion of the Secretary and the ``weight'' that would be assigned
to the advice of the Board. A labor organization recommended the rule
limit the circumstances under which the Secretary may reject a
recommendation of the Board to add a class to the Cohort, and should
require explanation of such decisions. Another labor organization
asserted that the rule does not specify the criteria by which the
Secretary will make decisions. Several commenters
[[Page 30774]]
recommended the rule require the Secretary to make decisions within 21
days of receiving recommendations from NIOSH and the Board.
The advocacy group, a labor union, and some Members of Congress
also sought additional information about the procedure for
administrative review of proposed decisions. The advocacy group and a
labor organization specifically questioned whether such reviews would
include the opportunity for oral presentations by petitioners and
experts, and the availability of the administrative record of the NIOSH
evaluation(s).
HHS has specified procedures under Sec. 83.16 in greater detail in
response to these comments. The procedures now specify that the
Director of NIOSH will propose decisions on behalf of HHS. The
authority to issue final decisions, however, has not been delegated to
the Director of NIOSH. As discussed in the preamble of the NPRM, the
Secretary may consider such a delegation on the basis of experience.
The criteria for making proposed and final decisions were implicit
in the NPRM but have been specified explicitly in the rule; these are
the criteria to be applied by NIOSH in evaluating a petition under
Sec. 83.13(c), implementing the two criteria specified in EEOICPA (42
U.S.C. 7384q(b)(1) and (2)).
HHS has revised the procedures for issuing proposed decisions to
clarify that NIOSH would issue multiple proposed decisions in response
to a single petition, when NIOSH determines that the petition
encompasses more than one class of employees. As defined under Sec.
83.5(c), a class of employees means, for the purposes of this rule, a
group of employees who work or worked at the same DOE facility or AWE
facility, and for whom the availability of information and recorded
data on radiation exposures is comparable with respect to the
informational needs of dose reconstructions conducted under 42 CFR Part
82. Based upon NIOSH's evaluation of a petition, NIOSH may find that
records are sufficient to conduct dose reconstructions for part of a
proposed class, as defined by the petitioner, and insufficient to
conduct dose reconstructions for another part of the proposed class. In
such a case, NIOSH would define two or more separate classes of
employees, distinguished by the difference in the sufficiency of the
information available to conduct dose reconstructions.
Related to this clarification, HHS has also revised the procedures
to authorize petitioners to contest only those proposed decisions that
would deny the addition of a class to the Cohort and to contest a
health endangerment determination under Sec. 83.13(c)(3)(ii) for a
decision that would add a class to the Cohort. This limitation will
expedite the process of completing the consideration by HHS of classes
that NIOSH has proposed adding to the Cohort by omitting a 30-day
period, specified under the NPRM, during which HHS would have been
required to await a challenge. It also will ensure that consideration
by HHS of such classes would not have to further await, beyond the 30-
day period, the outcome of a challenge in which a petitioner asserts
that the proposed scope of the class is overly restrictive. This
limitation will not prevent a petitioner from contesting any proposed
decision or aspect of a proposed decision regarding his or her petition
that would deny the addition to the Cohort of individuals covered by
the petition or a resultant NIOSH proposed decision.
The section newly specifies the independence with which proposed
decisions will be reviewed in response to challenges and provides
clarification concerning the requirements of such challenges and the
nature of such reviews. These will be records-based reviews conducted
by a panel of three HHS personnel, appointed by the Secretary, rather
than hearings involving witnesses and presided over by an
administrative law judge. The reviews will not involve oral
presentations or the introduction of new information that had not
previously been presented or submitted to NIOSH or the Board prior to
the Board completing its report of recommendations to the Secretary
under Sec. 83.15. Petitioners will have received all NIOSH evaluations
concerning their petitions, and will have access to the administrative
record for such evaluations, all publicly available information
considered by the Board, as well as to the final report of the Board;
petitioners will not have access to information protected by the
Privacy Act and information classified for purposes of national
security. Complete instructions for contesting proposed decisions will
be provided to each petitioner.
The rule does not specify any particular weight that HHS will
accord the advice of the Board in making proposed and final decisions.
The Board recommendations are advisory. HHS would not prejudge such
advice and will consider it according to its merits. Section 83.16
specifies the sources and scope of information that HHS will consider
in making its decisions, and provides that HHS will explain the basis
for the decisions.
The rule does not require that HHS make final decisions within 21
days or any specified period. Decisions will be made as expeditiously
as possible, but HHS is providing petitioners 30 days to contest
proposed decisions and such challenges would then have to be
considered. The volume and scope of petitions, factors not controlled
by HHS and impossible to predict, also might affect the speed of such
decisions.
I. Cancelling or Modifying a Final Decision
One labor organization commented on the provisions under Sec.
83.18 of the NPRM allowing the Secretary to cancel or modify a class
that the Secretary had added to the Cohort. The commenter recommended
such a decision by the Secretary be applied prospectively, for the
adjudication of future claims; in other words, such a decision should
not affect claimants who have already been compensated as a member of
the Cohort, by potentially requiring the cessation of medical benefits
or the return of the lump sum cash benefit, pending the results of a
re-adjudication of the claim.
Since DOL makes final compensation eligibility determinations for
claimants, DOL will determine the application of such decisions by HHS
to claims that DOL has already decided and claimants who have already
received compensation.
J. Definitions of Terms Used in the Rule
Section 83.5 provided definitions of terms used in the NPRM.
Three advocacy groups and four labor organizations commented on
several of the definitions. The Board also commented on definitions.
The advocacy groups and two labor organizations recommended that
the definition for a ``class of employees'' (Sec. 83.5(c)) in the NPRM
be revised to allow for a class that would span multiple facilities.
One advocacy group and one labor organization also recommended that
this definition be revised to define a class in terms of information
that is not available.
The multi-facility issue is fully discussed above, under the
section addressing comments on petition requirements. HHS does not
interpret EEOICPA to allow for petitioners to define multi-facility
classes of employees. Hence, HHS has not changed the definition as
recommended by the commenters. This limitation would not, however,
prevent a petitioner from submitting petitions separately for employees
at each facility at which a group was employed,
[[Page 30775]]
defining individual, facility-specific classes. Furthermore, as
discussed above under the section on health endangerment, changes in
this rule eliminate any potential value of defining classes to include
employment at multiple facilities.
The terminology of the definition in the NPRM, in specifying that a
class is defined in part by ``the availability of information,'' was
appropriate and has not been changed in the final rule. The term
``availability'' covers the possibility that information is available
or is not available, with respect to the informational needs of dose
reconstructions conducted under 42 CFR Part 82. Both of these
possibilities need to be covered, since HHS might define classes of
employees for whom information is sufficient for the needs of dose
reconstructions and other classes for whom information is insufficient,
as provided under this part.
The NPRM did not include a definition of the term ``facility,''
which is used in the rule. Two advocacy groups and three labor
organizations recommended the rule include a definition of facility,
and that the definition be defined as broadly as possible. Some
specific suggestions for wording were provided.
HHS has not included a definition of the term ``facility'' in the
rule since ``atomic weapons employer facility'' and ``Department of
Energy facility'' are already defined in EEOICPA (42 U.S.C. 7384l(5)
and (12)). These statutory definitions are complex. As a necessary
consequence, DOE facility or AWE facility definitions must be
considered on a case-by-case basis. To provide guidance on the types of
facilities that would fall within the statutory definitions, and in
particular, whether the term ``facility'' is limited to a single
building or can also include multiple buildings, HHS has included a
footnote to Sec. 83.9(c)(1)(i) in the final rule which provides:
Depending on the factual circumstances present, a facility that
meets the definition of an AWE facility or DOE facility covered
under EEOICPA (42 U.S.C. 7384l(5) and (12)) could, among other
possibilities, constitute a single building or structure, including
the grounds upon which it is located, or a site encompassing
numerous buildings or structures, including the grounds upon which
it is located.
While a petition for a class of employees must be limited to one
facility, a facility can constitute a site encompassing numerous
buildings or structure, including the grounds upon which it is located.
This has no effect, however, on the prospects for a class being added
to the Cohort or the prospects for an individual employee being
included as a member of a class added to the Cohort. These depend on
the criteria specified in this rule, regardless of the scope of the
petition. As discussed above, the latter also can depend on whether an
employee meets a 250 work days employment criterion, when applicable,
but Sec. 83.13(c)(3)(ii) of the rule allows this criterion to be met
through employment within the parameters of separate classes included
in the Cohort.
HHS received two comments on the definition of ``specified
cancers'' (Sec. 83.5(k)) provided in the NPRM. An advocacy group
recommended the definition be amended to allow for other cancers
specified by DOL. A labor organization recommended that the definition
include rectal cancers, which have been determined by DOL, after
consultation with the National Cancer Institute, to be a subset of
cancer of the colon for the purposes of compensation for members of the
Cohort.
The statutory definition of ``specified cancer'' can be found in
EEOICPA at 42 U.S.C. 7384l(17). This definition cannot be changed by
HHS; it can only be changed by Congress. The definition of ``specified
cancer'' in the NPRM and in this final rule at Sec. 83.5(m)(6)
explains, however, that the specified cancers identified in the
definition mean the physiological condition or conditions that are
recognized by the National Cancer Institute, the scientific body with
which DOL consults if there are questions regarding the proposed
classification of a particular cancer.
HHS has added a definition of petitioner under Sec. 83.5(j). The
definition limits the number of petitioners that can submit a single
petition to a maximum of three individuals and/or organizations. This
limitation, which limits the number of petitioners but does not limit
the number of members of a class of employees, is intended to
facilitate the timely consideration of petitions by NIOSH, the Board,
and the Secretary, since each petitioner for a petition has procedural
rights under the rule that, if applicable to a large number of
petitioners, could prolong the consideration of a petition
substantially. HHS has also revised Sec. 83.7 of the rule to reflect
this change.
K. Miscellaneous Comments
The rule provides for petitions in two distinct circumstances. One
circumstance is when NIOSH has attempted to conduct a dose
reconstruction for a cancer claimant, under 42 CFR Part 82, and finds
that the dose reconstruction cannot be completed, because there is
insufficient information to estimate the radiation doses of the
claimant with sufficient accuracy. The second circumstance includes all
other possibilities. For example, a petition may be submitted
representing a class of employees whose members have yet to file claims
under EEOICPA, or even have yet to be diagnosed with cancer.
An advocacy group recommended that the rule explain these two
circumstances that have been provided for under the rule. The commenter
recommended specifically that the rule clarify that petitioners or
potential class members are not required, as a prerequisite for
petitioning, already to have incurred a cancer or to have filed a claim
for a cancer.
HHS agrees with the comment and has added explanation to the
overview of the rule under Sec. 83.6 to summarize the two distinct
circumstances for petitions.
A labor organization commented that the rule is unduly vague about
the types of information used to evaluate petitions, citing Sec.
83.14(a)(8) of the NPRM, which reads: ``Other sources.''
Section 83.13(a) provides a list of seven specific sources prior to
the provision of concern to the commenter. It may not be possible for
HHS to specify every possible source of information that might assist
NIOSH in evaluating a petition. The purpose of specifying the limited
list is to give the public a sense of the range of sources that might
provide useful information. The purpose of including a non-specified
``other'' category is to clearly communicate that NIOSH will not be
limited to using the sources it has identified in the rule.
L. Non-Regulatory Comment: Dose Reconstructions for Cohort Members With
Non-Specified Cancers
Two advocacy groups questioned how NIOSH would handle dose
reconstructions for individuals in the Cohort who have a cancer that is
not one of the specified cancers or for individuals not included in the
Cohort because they do not meet the health endangerment criterion of
having been employed for 250 work days, when this criterion is
applicable. In both situations, part or all of an employee's work
experience may include potential radiation exposures that cannot be
estimated. For the latter situation, one of the commenters suggested a
scheme for assigning radiation doses to some cases.
Under current dose reconstruction procedures, NIOSH would estimate
all of the radiation doses of such employees that can be estimated.
Some of these employees may have sufficient radiation
[[Page 30776]]
doses that can be estimated to support compensation without taking into
account any potential radiation exposures that cannot be estimated.
NIOSH may be able to estimate all radiation doses of certain employees,
depending on the type of cancer they incurred. NIOSH may also be able
to estimate radiation doses for some current members of the Cohort, who
were included in the Cohort by statute but have a cancer that is not
one of the specified cancers for which an individual can be compensated
as a member of the Cohort. However, NIOSH is not authorized under
EEOICPA to administratively assign radiation doses to employees for
whom radiation doses cannot be estimated using methods of dose
reconstruction. For any claimant referred to NIOSH who is a member of
the Cohort and has a cancer not defined as a ``specified cancer'' under
EEOICPA (and so is not eligible for compensation under EEOICPA without
a dose reconstruction), NIOSH will continue to attempt to complete a
dose reconstruction, using whatever information is available about that
member's entire work history.
M. Non-Regulatory Comment: Reporting Estimated Completion Dates for
Petition Evaluations
One advocacy group and two labor organizations suggested that NIOSH
report to Congress an estimated completion date for petitions whose
evaluations by NIOSH will not be completed within 180 days.
An automatic reporting procedure would divert HHS resources from
reviewing Cohort petitions and completing dose reconstructions.
Moreover, a ``one-size-fits-all'' reporting procedure of the type
proposed would be inappropriate, considering the wide variability that
is likely in the scope and volume of petitions, and in the duration of
Board evaluations and proceedings involving the petitioner(s)
associated with each petition.
Two advocacy groups and two labor organizations recommended that
NIOSH provide grants to fund health physicists and other experts to
assist petitioners, as well as training workshops to address the
informational requirements of a petition.
Petitioners should not need the assistance of health physicists to
address the requirements for a petition under Sec. 83.9. Most
petitioners should find the petition instructions and petition form
provided by NIOSH will be sufficient guidance. NIOSH, in coordination
with the DOL/DOE resource centers, will assist petitioners on an
individual basis as well. Section 83.11 of the rule commits NIOSH to
providing further assistance to petitioners whose petitions have not
met the basic requirements for evaluation.
N. Non-Regulatory Comment: Reporting on the Rate of Success of
Petitions and Claimants
Two individual commenters recommended HHS report on the success
rate of petitions for the addition of classes of employees to the
Cohort. The commenters also recommended that DOL report on the success
rates of cancer claimants seeking compensation under EEOICPA, providing
individual rates by class of employees in the Cohort and a separate
rate for claimants who are not members of the Cohort.
NIOSH provides extensive public information through its OCAS
internet homepage (www.cdc.gov/niosh/ocas) on the status of its dose
reconstruction activities and plans to be informative concerning
petitions as well. The homepage will provide information on the status
and the outcomes of petitions. The commenters should contact DOL if
they wish to recommend specific types of reports on claims adjudication
outcomes that might be useful to the public.
O. Non-Regulatory Comment: Recommendations To Add Specific Classes to
the Cohort
Three labor organizations and one individual commented that various
employee groups might or should qualify to become members of the
Cohort.
NIOSH will send notices including this final rule and related
information to all individuals or organizations who have indicated to
NIOSH their intent to petition.
P. Non-Regulatory Comment: Completion of Dose Reconstructions for
Mallinckrodt Chemical Company Employees
One individual reports that NIOSH has access to complete dosimetry
data on employees of Mallinckrodt Chemical Company and that minimal
dose reconstruction is required for these workers. On this basis, the
commenter recommends that NIOSH be required to complete these dose
reconstructions within 180 days.
The commenter assumes that if extensive radiation monitoring
information is available, then dose reconstructions require ``minimal''
work. This is generally true for claims for which the monitoring data
alone, prior to dose reconstruction, indicate high level exposures. In
such cases, NIOSH would only conduct dose reconstruction to the extent
sufficient to document dose levels that meet the threshold for
compensation. In most settings, however, the majority of workers are
unlikely to have records indicating high level radiation exposures. For
these workers, NIOSH needs to carefully evaluate the adequacy of
monitoring and monitoring records and to account for any deficiencies
that might otherwise lead NIOSH to underestimate radiation doses.
The full process for dose reconstructions is outlined in 42 CFR
Part 82 and described in greater detail in technical documents
available from NIOSH. These procedures were designed to be as efficient
as possible.
Q. Non-Regulatory Comment: Inclusion of Transcripts of Board Meetings
in the Administrative Record of the Rulemaking
One advocacy group recommended that HHS include the transcripts of
Board meetings for March 7, 14, and 28, 2003, and May 1, 2003 in the
administrative record of this rulemaking. These Board meetings included
discussions and decisions by the Board concerning its advice on this
rulemaking, as well as public comment on issues considered by the
Board.
HHS has included the transcripts of the referenced Board meetings
in the NIOSH docket for this rule.
III. Recommendations of the Advisory Board on Radiation and Worker
Health
HHS requested the Board to provide advice concerning these
procedures for making additions to the Cohort. As discussed above, the
Board has an integral role in the evaluation of petitions to add
classes of employees to the Cohort.
The Board reviewed issues related to the Cohort during its meeting
on May 2-3, 2002, and reviewed the initial NPRM, which was published on
June 25, 2002, during its meetings on July 1-2, August 14-15, and
August 22, 2002. After making substantial changes based on public
comment and Board recommendations, NIOSH issued a second NPRM on March
7, 2003. The Board reviewed the second NPRM during meetings on March 7,
14, and 28, 2003, and May 1, 2003. The members also considered public
comments on the two NPRMs provided during meetings of the Board and at
four regional meetings held in July and August 2002. In addition, NIOSH
staff members gave formal presentations on the two NPRMs and related
issues during the Board meetings. The transcripts and minutes of these
meetings are available to the
[[Page 30777]]
public and are included in the NIOSH docket for this rule.
All of the Board members participated in the review of the second
NPRM and concurred in establishing the Board findings and
recommendations, with the exception of an abstention by one Board
member concerning one finding and recommendation. The Board provided
several recommendations on substantial issues addressed in the NPRM, as
well as recommendations for clarifying specific sections of the NPRM.
The recommendations, which are available to the public from the NIOSH
docket for this rule, are summarized below, together with responses by
HHS to the recommendations.
A. Removing Cancer-Specific Provisions Concerning Determinations of the
Feasibility of Dose Reconstruction
The Board recommended that HHS remove provisions of the NPRM in
section 83.13 that would allow HHS to limit the employees included in a
class to be added to the Cohort to those who incur specific types of
cancers. The Board acknowledged that it may be possible in certain
cases to determine that radiation doses are limited to certain specific
sites in the body, which would provide a scientific basis for excluding
employees who incur certain other types of cancer from certain classes
that HHS might add to the Cohort. This finding notwithstanding, the
Board was concerned that provisions accounting for such a possibility
might conflict with the intent of Congress and, furthermore, the Board
was concerned about providing ``some level of equity'' between the
definition of classes added to the Cohort by HHS and those already
defined by Congress in EEOICPA, which are not limited by type of
cancer.
As discussed above in response to similar public comments, HHS has
omitted all provisions for establishing cancer-specific classes from
the final rule, in response to the recommendations of the Board and to
public comments. HHS agrees with the Board that the perception of the
public that such provisions would constitute unfair treatment under
EEOICPA should be an overriding consideration for this decision.
B. Developing Guidelines Addressing the Feasibility of Estimating Doses
With Sufficient Accuracy
The Board recommended that NIOSH develop guidelines, within a
reasonable time period after promulgation of the final rule, to provide
additional clarification on how NIOSH would determine whether it is
feasible to estimate doses with sufficient accuracy, as specified under
Sec. 83.13(b) of the NPRM and Sec. 83.13(c) of the rule. The Board
recommended that it have the opportunity to review such guidelines. The
Board also recommended that HHS make changes to the dose reconstruction
rule (42 CFR Part 82), if any are needed, to resolve any potential
conflict between these two rules that could leave claimants unable to
obtain either a dose reconstruction or status as a member of the
Cohort.
As discussed in response to public comments, NIOSH is issuing
concurrently with this rule procedures to implement the guidelines
specified under section 83.13 of this rule by which NIOSH will evaluate
a petition, including the determination addressed in this
recommendation by the Board. The Board will have the opportunity to
provide recommendations to NIOSH on these procedures, although NIOSH
will not delay its evaluation of petitions to obtain recommendations of
the Board, or make revisions to the procedures. The rule provides under
Sec. 83.15 for the Board to consider each evaluation of a petition
NIOSH completes and to request NIOSH to conduct additional analyses.
Therefore, the Board will always have the opportunity to discuss with
NIOSH any concerns the Board might have with the procedures and methods
of a NIOSH evaluation.
As discussed in response to public comments, the dose
reconstruction rule and this rule do not conflict with respect to
determining the feasibility of dose reconstruction. No revision of the
dose reconstruction rule is necessary for this purpose.
The consistency between the two rules does not, however, guarantee
that all claimants will either receive a dose reconstruction or be
included as members of the Cohort, as expressed by the Board. It is
possible for a claimant to be excluded from the Cohort on the basis
that the employee was not employed for a minimum of 250 work days
within the parameters of a class of employees. This is specified under
EEOICPA (42 U.S.C. 7384l(14)(A)), which provides statutory requirements
defining the groups from the gaseous diffusion plants that Congress
included in the Cohort, and under Sec. 83.13(c)(3)(ii) of this rule,
which addresses the statutory requirement for HHS to find that the
health of members of a class may have been endangered, for such a class
to be added to the Cohort.
C. Combining Employment Within Separate Cohort Classes for Meeting
Health Endangerment Requirements
The Board recommended that employees be credited for days of
employment within separate classes added to the Cohort, if necessary,
to meet a 250 work days employment requirement that might be applicable
to qualify as a member of a class added to the Cohort. As discussed
above in response to similar public comments, HHS agrees with the Board
and has added a provision to the rule for this purpose. Section
83.13(c)(3)(ii) provides that whenever HHS adds a class to the Cohort
for which a 250 work days employment requirement is applicable,
employees will be able to meet this requirement by combining their
employment within the added class with employment within other classes
in the Cohort.
D. Adding a Definition for the Term ``Facility''
The Board recommended HHS add to the rule a definition for the term
``facility'' to more clearly specify the limit of the scope of a
petition. The Board further recommended that HHS define facility
broadly to encompass entire nuclear weapons production sites, such as
Los Alamos and Rocky Flats. The Board was particularly concerned that
facility not be defined as limited to individual buildings, structures,
etc., which the Board was concerned could cause difficulties in
considering petitions that relate to operations spanning more than one
building or other type of facility.
As discussed above in response to similar public comments, HHS has
included in the final rule a footnote to Sec. 83.9(c)(1)(i) that
explains that an AWE facility or DOE facility covered under EEOICPA (42
U.S.C. 7384l(5) and (12)) could constitute a single building or
structure, including the grounds upon which it is located, or a site
encompassing numerous buildings or structures, including the grounds
upon which it is located.
E. Evidence Confirming the Occurrence of Unrecorded Exposure Incidents
Under Sec. 83.9(c)(3), the NPRM provided that for petitions based
on exposure incidents, versus routine operations, petitioners would be
required to provide evidence confirming the occurrence of the incident
in cases that cannot be confirmed independently by NIOSH. One of the
options for such evidence was the provision of affidavits from two
employees who witnessed the incident.
[[Page 30778]]
The Board recommended that HHS clarify that affidavits from only
two witnesses would be required, since the rule could be interpreted as
requiring two witnesses in addition to the petitioner in a case in
which the petitioner was also a witness. The Board further recommended
that in cases in which eyewitnesses may no longer be living or might be
difficult to locate, the rule should allow NIOSH to accept the accounts
of other parties who were informed of the incident but were not
witnesses to the incident.
As discussed above in response to similar public comments, HHS has
revised this section of the rule to omit the requirement for a specific
number of witnesses, to make the accommodation recommended by the Board
with respect to situations in which eyewitnesses are not available, and
to clarify that the provision of one or more affidavits would not, in
and of itself, be sufficient to confirm the occurrence of an incident;
NIOSH would have to consider the adequacy and credibility of the
evidence provided in the affidavits.
F. Reviews of Findings That a Petition Does Not Satisfy the
Requirements for a Petition
In the NPRM, HHS requested comment on whether or not the rule
should provide an opportunity for petitioners to obtain a review of
NIOSH findings that a petition does not meet the requirements specified
under Sec. 83.9. The first NPRM had provided for the Board to conduct
such reviews, but the Board objected to such a role, which it viewed as
an administrative function.
The Board was concerned about the lack of an administrative appeals
process for such decisions and recommended HHS consider how such
reviews could be conducted.
As discussed above in response to public comments, HHS has added
provisions to Sec. 83.11 to give petitioners the option of an
administrative review of proposed NIOSH decisions.
G. Recommendations for Section 83.9
The Board recommended revisions to clarify the descriptions of two
types of reports that a petitioner could use to support a petitioner's
belief that records and information available are inadequate to
estimate the radiation doses incurred by members of a class of
employees. The first type is an unpublished report by a health
physicist or expert in dose reconstruction that might be commissioned
by petitioners. The second is a scientific report published in a peer
reviewed journal or issued by a government agency.
HHS clarified these provisions consistently with the
recommendations of the Board, with one exception. With respect to the
first type of report described above, the revisions suggested by the
Board would omit the requirement that the expert document his or her
findings with respect to the limitations of records on radiation
exposures. HHS has retained this requirement. HHS believes it is
reasonable to require experts to support their assertions on factual
matters with factual evidence.
The Board also recommended HHS consider whether placement of
subsection (c)(3) is appropriate within this section, since the
subsection addresses information requirements that only come into
effect for certain petitions, in cases in which NIOSH requires
additional information. The Board was concerned that this might be
confusing to petitioners.
HHS has retained the placement of this subsection because it
specifies informational requirements for a petition, even though they
are conditional requirements. The introductory paragraph of the
subsection has been revised to clarify that NIOSH would not require a
petitioner to provide the information discussed in the subsection when
the petition is submitted, but only upon request. In addition,
petitioners will have information from NIOSH in addition to this rule,
such as petition instructions and an optional petition form, to guide
them through the petition process.
H. Recommendations for Section 83.13
The Board recommended a revision of Sec. 83.13(b)(1)(iii) of the
NPRM, which informed the public that NIOSH may often be able to
estimate maximum radiation doses without personal dosimetry data and
area monitoring data. The Board appeared to be concerned that readers
might interpret the statement as being dismissive of the value of such
information for dose reconstructions. HHS has revised this subsection
(83.13(c)(1)(iv) of the final rule) to remedy this concern, as follows
(in italics):
(iv) In many circumstances, access to personal dosimetry data
and area monitoring data is not necessary to estimate the maximum
radiation doses that could have been incurred by any member of the
class, although radiation doses can be estimated more precisely with
such data.
I. Recommendations for the Preamble
The Board also made several editorial recommendations for
clarifying the preamble of the NPRM. The preamble to this final rule,
however, does not include any of the text addressed by the Board's
recommendations.
IV. Regulatory Assessment Requirements
A. Executive Order 12866
Under Executive Order (E.O.) 12866 (58 FR 51735, October 4, 1993),
the Agency must determine whether a regulatory action is
``significant'' and therefore subject to review by the Office of
Management and Budget (OMB) and the requirements of the executive
order. Under section 3(f), the order defines a ``significant regulatory
action'' as an action that is likely to result in a rule (1) Having an
annual effect on the economy of $100 million or more, or adversely and
materially affecting a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local, or tribal governments or communities (also referred to as
``economically significant''); (2) creating serious inconsistency or
otherwise interfering with an action taken or planned by another
agency; (3) materially altering the budgetary impacts of entitlements,
grants, user fees, or loan programs or the rights and obligations of
recipients thereof; or (4) raising novel legal or policy issues arising
out of legal mandates, the President's priorities, or the principles
set forth in this Executive Order.
This rule is being treated as a ``significant regulatory action''
within the meaning of the executive order because it meets the
criterion of Section 3(f)(4) in that it raises novel or legal policy
issues arising out of the legal mandate established by EEOICPA. It
establishes practical procedures, grounded in current science, by which
the Secretary of HHS can fairly consider petitions to add classes of
employees to the Cohort. The financial cost to the federal government
of responding to these petitions is likely to vary from thousands of
dollars to as much as hundreds of thousands of dollars, depending on
the availability of information and the scope of the petition.
The rule carefully explains the manner in which the procedures are
consistent with the mandate of 42 U.S.C. 7384q and implements the
detailed requirements of that section. The rule does not interfere with
State, local, and tribal governments in the exercise of their
governmental functions.
The rule is not considered economically significant, as defined in
section 3(f)(1) of the E.O. 12866. It has
[[Page 30779]]
a subordinate role in the adjudication of claims under EEOICPA, serving
as one element of an adjudication process administered by DOL under 20
CFR Parts 1 and 30. DOL has determined that its rule fulfills the
requirements of E.O. 12866 and provides estimates of the aggregate cost
of benefits and administrative expenses of implementing EEOICPA under
its rule (see 66 FR 28948, May 25, 2001). OMB has reviewed this Special
Exposure Cohort rule for consistency with the President's priorities
and the principles set forth in E.O. 12866.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq.,
requires each agency to consider the potential impact of its
regulations on small entities including small businesses, small
governmental units, and small not-for-profit organizations. We certify
that this rule will not have a significant economic impact on a
substantial number of small entities within the meaning of the RFA. The
rule affects only DOL, DOE, HHS, and certain individuals covered by
EEOICPA. Therefore, a regulatory flexibility analysis as provided for
under RFA is not required.
C. What Are the Paperwork and Other Information Collection Requirements
(Subject to the Paperwork Reduction Act) Imposed Under This Rule?
The Paperwork Reduction Act is applicable to the data collection
aspects of this rule. Under the Paperwork Reduction Act of 1995, a
Federal agency shall not conduct or sponsor a collection of information
from ten or more persons other than Federal employees unless the agency
has submitted a Standard Form 83, Clearance Request, and Notice of
Action, to the Director of the Office of Management and Budget (OMB),
and the Director has approved the proposed collection of information. A
person is not required to respond to a collection of information unless
it displays a currently valid OMB control number.
NIOSH has obtained approval from OMB to collect data as specified
under this rule under OMB Control No. 0920-0639.
The rule requires classes of employees seeking to be added to the
Special Exposure Cohort to submit written petitions for such
consideration to NIOSH. HHS has specified the information that
petitioners are required to include in their petitions. All petitioners
will be required to include identifying and contact information. Other
informational requirements will depend on the circumstances of the
petition. Petitioners who are claimants for whom NIOSH has attempted to
complete a dose reconstruction under 42 CFR Part 82 and has concluded
that the dose reconstruction is not feasible are only required to
acknowledge their intent to petition; no other information is required.
All other petitioners will have to provide more extensive information
that comprises the justification for their petition.
NIOSH will make available to petitioners a petition form and
instructions to assist petitioners. As appropriate, NIOSH will also
provide an authorization form that would be required by individuals who
seek to authorize others to serve as petitioners. The authorization
form is mandatory but the petition form is not mandatory.
The only cost to respondents is their time to complete and submit
the petition.
D. Small Business Regulatory Enforcement Fairness Act
As required by Congress under the Small Business Regulatory
Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), the Department
will report to Congress promulgation of this rule prior to its taking
effect. The report will state that the Department has concluded that
this rule is not a ``major rule'' because it is not likely to result in
an annual effect on the economy of $100 million or more. However, this
rule has a subordinate role in the adjudication of claims under
EEOICPA, serving as one element of an adjudication process administered
by DOL under 20 CFR Parts 1 and 30. DOL has determined that its rule is
a ``major rule'' because it will likely result in an annual effect on
the economy of $100 million or more.
E. Unfunded Mandates Reform Act of 1995
Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531
et seq.) directs agencies to assess the effects of Federal regulatory
actions on State, local, and tribal governments, and the private sector
``other than to the extent that such regulations incorporate
requirements specifically set forth in law.'' For purposes of the
Unfunded Mandates Reform Act, this rule does not include any Federal
mandate that may result in increased annual expenditures in excess of
$100 million by State, local or tribal governments in the aggregate, or
by the private sector.
F. Executive Order 12988 (Civil Justice)
This rule has been drafted and reviewed in accordance with
Executive Order 12988, Civil Justice Reform and will not unduly burden
the Federal court system. HHS adverse decisions may be reviewed in
United States District Courts pursuant to the Administrative Procedure
Act. HHS has attempted to minimize that burden by providing petitioners
an opportunity to seek administrative review of adverse decisions. HHS
has provided a clear legal standard it will apply in considering
petitions. This rule has been reviewed carefully to eliminate drafting
errors and ambiguities.
G. Executive Order 13132 (Federalism)
The Department has reviewed this rule in accordance with Executive
Order 13132 regarding federalism, and has determined that it does not
have ``federalism implications.'' The rule does not ``have substantial
direct effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
H. Executive Order 13045 (Protection of Children From Environmental,
Health Risks and Safety Risks)
In accordance with Executive Order 13045, HHS has evaluated the
environmental health and safety effects of this rule on children. HHS
has determined that the rule would have no effect on children.
I. Executive Order 13211 (Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use)
In accordance with Executive Order 13211, HHS has evaluated the
effects of this rule on energy supply, distribution or use, and has
determined that the rule will not have a significant adverse effect on
them.
J. Effective Date and Information Collection Approval
The Secretary has determined, pursuant to 5 U.S.C. 553(d)(3), that
there is good cause for this rule to be effective immediately to avoid
undue hardship on and facilitate payment to eligible claimants.
The Office of Management and Budget (OMB) approved these
information collection requirements on [****INSERT DATE****] and
assigned control number [****INSERT NUMBER****].
List of Subjects in 42 CFR Part 83
Government employees, Occupational safety and health, Nuclear
materials, Radiation protection, Radioactive materials, Workers'
compensation.
[[Page 30780]]
Text of the Rule
0
For the reasons discussed in the preamble, the Department of Health and
Human Services amends 42 CFR Chapter I by adding Part 83 to read as
follows:
PART 83--PROCEDURES FOR DESIGNATING CLASSES OF EMPLOYEES AS MEMBERS
OF THE SPECIAL EXPOSURE COHORT UNDER THE ENERGY EMPLOYEES
OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT OF 2000
Subpart A--Introduction
Sec.
83.0 Background information on the procedures in this part.
83.1 What is the purpose of the procedures in this part?
83.2 How will DOL use the designations established under the
procedures in this part?
Subpart B--Definitions
83.5 Definitions of terms used in the procedures in this part.
Subpart C--Procedures for Adding Classes of Employees to the Cohort
83.6 Overview of the procedures in this part.
83.7 Who can submit a petition on behalf of a class of employees?
83.8 How is a petition submitted?
83.9 What information must a petition include?
83.10 If a petition satisfies all relevant requirements under Sec.
83.9, does this mean the class will be added to the Cohort?
83.11 What happens to petitions that do not satisfy all relevant
requirements under Sec. Sec. 83.7 through 83.9?
83.12 How will NIOSH notify petitioners, the Board, and the public
of petitions that have been selected for evaluation?
83.13 How will NIOSH evaluate petitions, other than petitions by
claimants covered under Sec. 83.14?
83.14 How will NIOSH evaluate a petition by a claimant whose dose
reconstruction NIOSH could not complete under 42 CFR Part 82?
83.15 How will the Board consider and advise the Secretary on a
petition?
83.16 How will the Secretary decide the outcome of a petition?
83.17 How will the Secretary report a final decision to add a class
of employees to the Cohort and any action of Congress concerning the
effect of the final decision?
83.18 How can the Secretary cancel or modify a final decision to add
a class of employees to the Cohort?
Authority: 42 U.S.C. 7384q; E.O. 13179, 65 FR 77487, 3 CFR, 2000
Comp., p. 321.
Subpart A--Introduction
Sec. 83.0 Background information on the procedures in this part.
The Energy Employees Occupational Illness Compensation Program Act,
as amended (``EEOICPA'' or ``the Act''), 42 U.S.C. 7384-7385, provides
for the payment of compensation benefits to covered employees and,
where applicable, survivors of such employees, of DOE, its predecessor
agencies and certain of its contractors and subcontractors. Among the
types of illnesses for which compensation may be provided are cancers.
There are two methods set forth in the statute for claimants to
establish that a cancer incurred by a covered worker is compensable
under EEOICPA. The first is to establish that the cancer is at least as
likely as not related to covered employment at a DOE or Atomic Weapons
Employer (``AWE'') facility pursuant to guidelines issued by the
Department of Health and Human Services (``HHS''), which are found at
42 CFR part 81. The second method to establish that a cancer incurred
by a covered worker is compensable under EEOICPA is to establish that
the worker is a member of the Special Exposure Cohort (``the Cohort'')
and suffered a specified cancer after beginning employment at a DOE
facility or AWE facility. In Section 3621(14) of EEOICPA (42 U.S.C.
7384l(14)) Congress included certain classes of employees in the
Cohort. Section 3626 of the Act (42 U.S.C. 7384q) authorizes the
addition to the Cohort of other classes of employees. This authority
has been delegated to the Secretary of HHS by Executive Order 13179.
Sec. 83.1 What is the purpose of the procedures in this part?
EEOICPA authorizes the President to add classes of employees to the
Cohort, while providing Congress with the opportunity to review and
expedite or reverse these decisions. The President delegated his
authority to the Secretary of HHS. This part specifies the procedures
by which HHS will determine whether to add new classes of employees
from DOE and AWE facilities to the Cohort. HHS will consider adding new
classes of employees in response to petitions by, or on behalf of, such
classes of employees. The procedures specify requirements for petitions
and for their consideration. These requirements are intended to ensure
that petitions are submitted by authorized parties, are justified, and
receive uniform, fair, scientific consideration. The procedures are
also designed to give petitioners and interested parties opportunity
for appropriate involvement in the process, and to ensure that the
process is timely and consistent with requirements specified in
EEOICPA. The procedures are not intended to provide a second
opportunity to qualify a claim for compensation, once HHS has completed
the dose reconstruction and DOL has determined that the cancer subject
to the claim was not ``at least as likely as not'' caused by the
estimated radiation doses. DOL has established procedures separate from
those covered by this part, under 20 CFR part 30, for cancer claimants
who want to contest the factual determinations or how NIOSH conducted
their dose reconstructions.
Sec. 83.2 How will DOL use the designations established under the
procedures in this part?
DOL will adjudicate compensation claims for members of classes of
employees added to the Cohort according to the same general procedures
that apply to the statutorily defined classes of employees in the
Cohort. Specifically, DOL will determine whether the claim is for a
qualified member of the Cohort with a specified cancer, pursuant to the
procedures set forth in 20 CFR part 30.
Subpart B--Definitions
Sec. 83.5 Definitions of terms used in the procedures in this part.
(a) Advisory Board on Radiation and Worker Health (``the Board'')
is a federal advisory committee established under EEOICPA and appointed
by the President to advise HHS in implementing its responsibilities
under EEOICPA.
(b) Atomic Weapons Employer (``AWE'') is a statutory term of
EEOICPA which means any entity, other than the United States, that:
(1) Processed or produced, for use by the United States, material
that emitted radiation and was used in the production of an atomic
weapon, excluding uranium mining and milling: and,
(2) Is designated by the Secretary of Energy as an atomic weapons
employer for purposes of EEOICPA.
(c) Class of employees means, for the purposes of this part, a
group of employees who work or worked at the same DOE facility or AWE
facility, and for whom the availability of information and recorded
data on radiation exposures is comparable with respect to the
informational needs of dose reconstructions conducted under 42 CFR part
82.
(d) HHS is the U.S. Department of Health and Human Services.
[[Page 30781]]
(e) DOE is the U.S. Department of Energy, which includes
predecessor agencies of DOE, including the Manhattan Engineering
District.
(f) DOL is the U.S. Department of Labor.
(g) Employee, for the purposes of these procedures, means a person
who is or was, for the purposes of EEOICPA, an employee of DOE, a DOE
contractor or subcontractor, or an Atomic Weapons Employer.
(h) NIOSH is the National Institute for Occupational Safety and
Health, Centers for Disease Control and Prevention, U.S. Department of
Health and Human Services.
(i) OCAS is the Office of Compensation Analysis and Support,
National Institute for Occupational Safety and Health, Centers for
Disease Control and Prevention, U.S. Department of Health and Human
Services.
(j) Petitioner means an individual or organization that submits a
petition on behalf of a class of employees and qualifies as a
petitioner under Sec. 83.7. A single petition shall only include up to
three petitioners.
(k) Radiation means ionizing radiation, including alpha particles,
beta particles, gamma rays, x rays, neutrons, protons and other
particles capable of producing ions in the body. For the purposes of
the proposed procedures, radiation does not include sources of non-
ionizing radiation such as radio-frequency radiation, microwaves,
visible light, and infrared or ultraviolet light radiation.
(l) Secretary is the Secretary of Health and Human Services.
(m) Specified cancer, as is defined in Section 3621(17) of EEOICPA
(42 U.S.C. 7384l(17)) and the DOL regulation implementing EEOICPA (20
CFR 30.5(dd)), means:
(1) Leukemia (other than chronic lymphocytic leukemia) provided
that onset of the disease was at least two years after initial
occupational exposure;
(2) Lung cancer (other than in situ lung cancer that is discovered
during or after a post-mortem exam);
(3) Bone cancer;
(4) Renal cancers;
(5) The following diseases, provided onset was at least 5 years
after first exposure:
(i) Multiple myeloma;
(ii) Lymphomas (other than Hodgkin's disease);
(iii) Primary cancer of the:
(A) Thyroid;
(B) Male or female breast;
(C) Esophagus;
(D) Stomach;
(E) Pharynx;
(F) Small intestine;
(G) Pancreas;
(H) Bile ducts;
(I) Gall bladder;
(J) Salivary gland;
(K) Urinary bladder;
(L) Brain;
(M) Colon;
(N) Ovary;
(O) Liver (except if cirrhosis or hepatitis B is indicated).
(6) The specified diseases designated in this section mean the
physiological condition or conditions that are recognized by the
National Cancer Institute under those names or nomenclature, or under
any previously accepted or commonly used names or nomenclature.
(n) Survivor means a surviving spouse, child, parent, grandchild
and grandparent of a deceased covered employee as defined in EEOICPA.
Subpart C--Procedures for Adding Classes of Employees to the Cohort
Sec. 83.6 Overview of the procedures in this part.
The procedures in this part specify who may petition to add a class
of employees to the Cohort, the requirements for such a petition, how a
petition will be selected for evaluation by NIOSH and for the advice of
the Board, and the process NIOSH, the Board, and the Secretary will use
to consider a petition, leading to the Secretary's final determination
to accept or deny adding a class to the Cohort. The rule provides for
petitions in two distinct circumstances. One circumstance is when NIOSH
has attempted to conduct a dose reconstruction for a cancer claimant,
under 42 CFR Part 82, and finds that the dose reconstruction cannot be
completed, because there is insufficient information to estimate the
radiation doses of the claimant with sufficient accuracy. The second
circumstance includes all other possibilities. For example, a petition
may be submitted representing a class of employees whose members have
yet to file claims under EEOICPA, or even have yet to be diagnosed with
cancer. As required by EEOICPA (42 U.S.C. 7384l(14)(c)(ii)), the
procedures in this part include formal notice to Congress of any
decision by the Secretary to add a class to the Cohort, and the
opportunity for Congress to expedite or change the outcome of the
decision within 180 days.
Sec. 83.7 Who can submit a petition on behalf of a class of
employees?
A petitioner or petitioners for a petition must be one or more, up
to a maximum of three, of the following:
(a) One or more DOE, DOE contractor or subcontractor, or AWE
employees, who would be included in the proposed class of employees, or
their survivors; or
(b) One or more labor organizations representing or formerly having
represented DOE, DOE contractor or subcontractor, or AWE employees, who
would be included in the proposed class of employees; or
(c) One or more individuals or entities authorized in writing by
one or more DOE, DOE contractor or subcontractor, or AWE employees, who
would be included in the proposed class of employees, or their
survivors.
Sec. 83.8 How is a petition submitted?
The petitioner(s) must send a petition in writing to NIOSH. A
petition must provide identifying and contact information on the
petitioner(s) and information to justify the petition, as specified
under Sec. 83.9. Detailed instructions for preparing and submitting a
petition, including an optional petition form, are available from NIOSH
through direct request (1-800-35-NIOSH) or on the Internet at
www.cdc.gov/niosh/ocas.
Sec. 83.9 What information must a petition include?
(a) All petitions must provide identifying and contact information
on the petitioner(s). The information required to justify a petition
differs, depending on the basis of the petition. If the petition is by
a claimant in response to a finding by NIOSH that the dose
reconstruction for the claimant cannot be completed, then the petition
must provide only the justification specified under paragraph (b) of
this section. All other petitions must provide only the information
specified under paragraph (c) of this section. The informational
requirements for petitions are also summarized in Table 1 at the end of
this section.
(b) The petition must notify NIOSH that the claimant is petitioning
on the basis that NIOSH found, under 42 CFR 82.12, that the dose
reconstruction for the claimant could not be completed due to
insufficient records and information.
(c) The petition must include the following:
(1) A proposed class definition \1\ specifying:
---------------------------------------------------------------------------
\1\ HHS will determine the final class definition(s) for each
petition (see Sec. 83.16).
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[[Page 30782]]
(i) The DOE facility or AWE facility \2\ at which the class worked;
---------------------------------------------------------------------------
\2\ Depending on the factual circumstances present, a facility
that meets the definition of an AWE facility or DOE facility covered
under EEOICPA (42 U.S.C. 7384l(5) and (12)) could, among other
possibilities, constitute a single building or structure, including
the grounds upon which it is located, or a site encompassing
numerous buildings or structures, including the grounds upon which
it is located.
---------------------------------------------------------------------------
(ii) The location or locations at the facility covered by the
petition (e.g., building, technical area);
(iii) The job titles and/or job duties of the class members;
(iv) The period of employment relevant to the petition;
(v) Identification of any exposure incident that was unmonitored,
unrecorded, or inadequately monitored or recorded, if such incident
comprises the basis of the petition; and
(2) A description of the petitioner's (petitioners'') basis for
believing records and information available are inadequate to estimate
the radiation doses incurred by members of the proposed class of
employees with sufficient accuracy. This description must include one
of the following elements:
(i) Documentation or statements provided by affidavit indicating
that radiation exposures and doses to members of the proposed class
were not monitored, either through personal or area monitoring; or
(ii) Documentation or statements provided by affidavit indicating
that radiation monitoring records for members of the proposed class
have been lost, falsified, or destroyed; or
(iii) A report from a health physicist or other individual with
expertise in dose reconstruction documenting the limitations of
existing DOE or AWE records on radiation exposures at the facility, as
relevant to the petition. This report should specify the basis for
believing these documented limitations might prevent the completion of
dose reconstructions for members of the class under 42 CFR Part 82 and
related NIOSH technical implementation guidelines; or
(iv) A scientific or technical report, published or issued by a
government agency of the Executive Branch of government or the General
Accounting Office, the Nuclear Regulatory Commission, or the Defense
Nuclear Facilities Safety Board, or published in a peer-reviewed
journal, that identifies dosimetry and related information that are
unavailable (due to either a lack of monitoring or the destruction or
loss of records) for estimating the radiation doses of employees
covered by the petition.
(3) If the petition is based on an exposure incident as described
under paragraph (c)(1)(v) of this section, the petitioner(s) might be
required to provide evidence that the incident occurred, but only if
NIOSH is unable to obtain records or confirmation of the occurrence of
such an incident from sources independent of the petitioner(s). Such
evidence would not be required at the time the petition is submitted
and the petitioner(s) would be directly informed of the need for this
supplemental information. In such cases, either of the following may
qualify as evidence:
(i) Medical evidence that one or more members of the class may have
incurred a high level radiation dose from the incident, such as a
depressed white blood cell count associated with radiation exposure or
the application of chelation therapy; or
(ii) NIOSH will consider evidence provided by affidavit from one or
more employees who witnessed the incident. If the petitioner cannot
provide such affidavits because such employees are deceased, prevented
by reasons of poor health or impairment, or cannot be identified or
located, then the requirement for evidence provided by affidavit can be
met by providing such an affidavit from one or more individuals who did
not witness the incident, provided the individual was directly informed
by one or more employees who witnessed the incident.\3\
---------------------------------------------------------------------------
\3\ An affidavit may be from a petitioner but HHS does not
require that an affidavit be from a petitioner.
---------------------------------------------------------------------------
(4) The provision of any evidence under this section or other
provisions of this part, including one or more affidavits, would not,
in and of itself, be sufficient to confirm the facts presented by that
evidence. NIOSH will consider the adequacy and credibility of any
evidence provided.
(5) If, under Sec. 83.15(a), NIOSH has already issued a Federal
Register notice scheduling a Board meeting to consider a petition
concerning a class of employees, then any petitions for such a class of
employees submitted following this notice must, under paragraph (c)(2)
of this section, present substantially new information that has not
already been considered by NIOSH. For this purpose, NIOSH would find
that information has been already considered by NIOSH if it were
included in the petition(s) that were already considered by NIOSH or if
it were addressed either in the report(s) by NIOSH evaluating such a
petition or petitions under Sec. 83.13(c) or in a proposed decision by
NIOSH responding to such a petition or petitions under Sec. 83.16(a).
Table 1 for Sec. 83.9: Summary of Informational Requirements for All
Petitions
[Petitioner(s) must submit identifying and contact information and
either A. or B. of this table.]
------------------------------------------------------------------------
------------------------------------------------------------------------
A. The claimant's authorization of the B. (1) A proposed class
petition, based on NIOSH having found definition identifying: (i)
it could not complete a dose Facility, (ii) relevant
reconstrucitn for the claimant locations at the facility;
submitting the petition; or. (iii) job titles/duties, (iv)
period of employment, and if
relevant, (v) exposure
incident.
(2) The basis for infeasibility
of dose reconstruction;
either: (i) lack of
monitoring; or (ii)
destruction, falsification, or
loss of records; or (iii)
expert report; or (iv)
scientific or technical
report.
------------------------------------------------------------------------
Sec. 83.10 If a petition satisfies all relevant requirements under
Sec. 83.9, does this mean the class will be added to the Cohort?
Satisfying the informational requirements for a petition does not
mean the class will be added to the Cohort. It means the petition will
receive a full evaluation by NIOSH, the Board, and HHS, as described
under Sec. Sec. 83.13 through 83.16. The role of the petitioner(s) is
to identify classes of employees that should be considered for addition
to the Cohort.
Sec. 83.11 What happens to petitions that do not satisfy all relevant
requirements under Sec. Sec. 83.7 through 83.9?
(a) NIOSH will notify the petitioner(s) of any requirements that
are not met by the petition, assist the petitioner(s) with guidance in
developing relevant information, and provide 30 calendar
[[Page 30783]]
days for the petitioner(s) to revise the petition accordingly.
(b) After 30 calendar days from the date of notification under
paragraph (a) of this section, NIOSH will notify any petitioner(s)
whose petition remains unsatisfactory of the proposed finding of NIOSH
that the petition fails to meet the specified requirements and the
basis for this finding.
(c) A petitioner may request in writing a review of a proposed
finding within 30 calendar days of notification under paragraph (b) of
this section. Petitioners must specify why the proposed finding should
be reversed, based on the petition requirements and on the information
that the petitioners had already submitted. The request may not include
any new information or documentation that was not included in the
completed petition. If the petitioner obtains new information within
this 30 day period, the petitioner should provide it to NIOSH. NIOSH
will consider this new information as a revision of the petition under
paragraph (a) of this section.
(d) Three HHS personnel, appointed by the Director of NIOSH, who
were not involved in developing the proposed finding will complete
reviews within 30 work days of the request for such a review. The
Director of NIOSH will consider the results of the review and then make
a final decision as to whether the petition satisfies the requirements
for evaluation.
(e) Proposed findings established by NIOSH under paragraph (b) of
this section will become final decisions in 31 calendar days if not
reviewed under paragraph (d) of this section.
(f) Based on new information, NIOSH may, at its discretion,
reconsider a decision not to select a petition for evaluation.
Sec. 83.12 How will NIOSH notify petitioners, the Board, and the
public of petitions that have been selected for evaluation?
(a) NIOSH will notify the petitioner(s) in writing that it has
selected the petition for evaluation. NIOSH will also provide the
petitioner(s) with information on the steps of the evaluation and other
processes required pursuant to these procedures.
(b) NIOSH will combine separate petitions and evaluate them as a
single petition if, at this or at any point in the evaluation process
under Sec. Sec. 83.13 and 83.14, NIOSH finds such petitions represent
the same class of employees.
(c) NIOSH will present petitions selected for evaluation to the
Board with plans specific to evaluating each petition. Each evaluation
plan will include the following elements:
(1) An initial proposed definition for the class being evaluated,
subject to revision as warranted by the evaluation conducted under
Sec. 83.13 or Sec. 83.14; and
(2) A list of activities for evaluating the radiation exposure
potential of the class and the adequacy of existing records and
information needed to conduct dose reconstructions for all class
members under 42 CFR Part 82.
(d) NIOSH may initiate work to evaluate a petition immediately,
prior to presenting the petition and evaluation plan to the Board.
(e) NIOSH will publish a notice in the Federal Register notifying
the public of its decision to evaluate a petition.
Sec. 83.13 How will NIOSH evaluate petitions, other than petitions by
claimants covered under Sec. 83.14?
(a) NIOSH will collect information on the types and levels of
radiation exposures that potential members of the class may have
incurred, as specified under 42 CFR 83.14, from the following potential
sources, as necessary:
(1) The petition or petitions submitted on behalf of the class;
(2) DOE and AWE facility records and information;
(3) Potential members of the class and their survivors;
(4) Labor organizations who represent or represented employees at
the facility during the relevant period of employment;
(5) Managers, radiation safety officials, and other witnesses
present during the relevant period of employment at the DOE facility or
AWE facility;
(6) NIOSH records from epidemiological research on DOE populations
and records from dose reconstructions conducted under 42 CFR part 82;
(7) Records from research, dose reconstructions, medical screening
programs, and other related activities conducted to evaluate the health
and/or radiation exposures of DOE employees, DOE contractor or
subcontractor employees, and/or AWE employees; and
(8) Other sources.
(b) The Director of OCAS may determine that records and/or
information requested from DOE, an AWE, or another source to evaluate a
petition is not, or will not be, available on a timely basis. Such a
determination will be treated, for the purposes of the petition
evaluation, as equivalent to a finding that the records and/or
information requested are not available.
(1) Before the Director of OCAS makes such a determination, the
source(s) potentially in possession of such records and/or information
will be allowed a reasonable amount of time, as determined by the
Director of OCAS, to provide the records and/or information.
(2) Such a determination may take into account the types and
quantity of records and/or information requested from the source, as
well as any other factors that might be relevant to the judgment under
paragraph (b)(1) of this this section of the amount of time that is
reasonable to provide the records and/or information, which would be
decided on a case-by-case basis by the Director of OCAS.
(c) NIOSH will evaluate records and information collected to make
the following determinations:
(1) Is it feasible to estimate the level of radiation doses of
individual members of the class with sufficient accuracy? (i) Radiation
doses can be estimated with sufficient accuracy if NIOSH has
established that it has access to sufficient information to estimate
the maximum radiation dose, for every type of cancer for which
radiation doses are reconstructed, that could have been incurred in
plausible circumstances by any member of the class, or if NIOSH has
established that it has access to sufficient information to estimate
the radiation doses of members of the class more precisely than an
estimate of the maximum radiation dose. NIOSH must also determine that
it has information regarding monitoring, source, source term, or
process from the site where the employees worked to serve as the basis
for a dose reconstruction. This basis requirement does not limit NIOSH
to using only or primarily information from the site where the employee
worked, but a dose reconstruction must, as a starting point, be based
on some information from the site where the employee worked.
(ii) In many circumstances, to establish a positive finding under
paragraph (c)(1)(i) of this section would require, at a minimum, that
NIOSH have access to reliable information on the identity or set of
possible identities and maximum quantity of each radionuclide (the
radioactive source material) to which members of the class were
potentially exposed without adequate protection. Alternatively, if
members of the class were potentially exposed without adequate
protection to unmonitored radiation from radiation generating equipment
(e.g., particle accelerator, industrial x-ray equipment), in many
circumstances, NIOSH would require relevant equipment design and
performance specifications or information on maximum emissions.
(iii) In many circumstances, to establish a positive finding under
paragraph (c)(1)(i) of this section would
[[Page 30784]]
also require information describing the process through which the
radiation exposures of concern may have occurred and the physical
environment in which the exposures may have occurred.
(iv) In many circumstances, access to personal dosimetry data and
area monitoring data is not necessary to estimate the maximum radiation
doses that could have been incurred by any member of the class,
although radiation doses can be estimated more precisely with such
data.
(2) How should the class be defined, consistent with the findings
of the analysis discussed under paragraph (c)(1) of this section? NIOSH
will define the following characteristics of a class, taking into
account the class definition proposed by the petition and modified as
necessary to reflect the results of the evaluation under paragraph
(c)(1) of this section:
(i) Any of the following employment parameters, as necessary to
identify members included in the class: facility, job titles, duties,
and/or specific work locations at the facility, the relevant time
period, and any additional identifying characteristics of employment;
and
(ii) If applicable, the identification of an exposure incident,
when unmonitored radiation exposure during such an incident comprises
the basis of the petition or the class definition.
(3) Is there a reasonable likelihood that such radiation dose may
have endangered the health of members of the class? If it is not
feasible to estimate with sufficient accuracy radiation doses for
members of the class, as provided under paragraph (c)(1) of this
section, then NIOSH must determine, as required by the statute, that
``there is a reasonable likelihood that such radiation dose may have
endangered the health of members of the class'' (42 U.S.C.
7384q(b)(2)).
(i) For classes of employees that may have been exposed to
radiation during discrete incidents likely to have involved
exceptionally high level exposures, such as nuclear criticality
incidents or other events involving similarly high levels of exposures
resulting from the failure of radiation protection controls, NIOSH will
assume for the purposes of this section that any duration of
unprotected exposure could cause a specified cancer, and hence may have
endangered the health of members of the class. Presence with potential
exposure during the discrete incident, rather than a quantified
duration of potential exposure, will satisfy the health endangerment
criterion.
(ii) For health endangerment not established on the basis of a
discrete incident, as described under paragraph (c)(3)(i) of this
section, NIOSH will specify a minimum duration of employment to satisfy
the health endangerment criterion as having been employed for a number
of work days aggregating at least 250 work days within the parameters
established for the class or in combination with work days within the
parameters established for one or more other classes of employees in
the Cohort.
(d) NIOSH will submit a report of its evaluation findings to the
Board and to the petitioner(s). The report will include the following
elements:
(1) An identification of the relevant petitions;
(2) A proposed definition of the class or classes of employees to
which the evaluation applies, and a summary of the basis for this
definition, including, as necessary:
(i) Any justification that may be needed for the inclusion of
groups of employees who were not specified in the original petition(s);
(ii) The identification of any groups of employees who were
identified in the original petition(s) who should constitute a separate
class of employees; or
(iii) The merging of multiple petitions that represent a single
class of employees;
(3) The proposed class definition will address the following
employment parameters:
(i) The DOE facility or the AWE facility that employed the class;
(ii) The job titles and/or job duties and/or work locations of
class members;
(iii) The period of employment within which a class member must
have been employed at the facility under the job titles and/or
performing the job duties and/or working in the locations specified in
this class definition;
(iv) If applicable, identification of an exposure incident, when
potential radiation exposure during such an incident comprises the
basis of the class definition;
(v) If necessary, any other parameters that serve to define the
membership of the class; and
(vi) For a class for which it is not feasible to estimate radiation
doses with sufficient accuracy, a minimum duration of employment within
the parameters of the class for inclusion in the class, as defined
under paragraph (c)(3) of this section;
(4) A summary of the findings concerning the adequacy of existing
records and information for reconstructing doses for individual members
of the class under the methods of 42 CFR Part 82, and a description of
the evaluation methods and information upon which these findings are
based; and
(5) For a class for which it is not feasible to estimate radiation
doses with sufficient accuracy, a summary of the basis for establishing
the duration of employment requirement with respect to health
endangerment.
Sec. 83.14 How will NIOSH evaluate a petition by a claimant whose
dose reconstruction NIOSH could not complete under 42 CFR Part 82?
(a) NIOSH may establish two classes for evaluation, to permit the
timely adjudication of the existing cancer claim:
(1) A class of employees defined using the research and analyses
already completed in attempting the dose reconstruction for the
employee identified in the claimant's petition; and
(2) A class of co-workers similar to the class defined under
paragraph (a)(1) of this section, to be defined by NIOSH on the basis
of further research and analyses, using the procedures under Sec.
83.13.
(b) NIOSH will determine the health endangerment criteria for
adding the class under paragraph (a)(1) of this section to the Cohort,
using the procedures under Sec. 83.13. NIOSH will report to the Board
and to petitioner(s) the results of this determination, together with
its finding under 42 CFR Part 82 that there was insufficient
information to complete the dose reconstruction. HHS will consider this
finding under 42 CFR Part 82 sufficient, without further consideration,
to determine that it is not feasible to estimate the levels of
radiation doses of individual members of the class with sufficient
accuracy.
(c) NIOSH will evaluate the petition as it may concern a class of
co-workers, as described under paragraph (a)(2) of this section,
according to the procedures under Sec. 83.13.
Sec. 83.15 How will the Board consider and advise the Secretary on a
petition?
(a) NIOSH will publish a notice in the Federal Register providing
notice of a Board meeting at which a petition will be considered, and
summarizing the petition to be considered by the Board at the meeting
and the findings of NIOSH from evaluating the petition.
(b) The Board will consider the petition and the NIOSH evaluation
report at the meeting, to which the petitioner(s) will be invited to
present views and information on the petition and the NIOSH evaluation
findings. In
[[Page 30785]]
considering the petition, both NIOSH and the members of the Board will
take all steps necessary to prevent the disclosure of information of a
personal nature, concerning the petitioners or others, where disclosure
would constitute a clearly unwarranted invasion of personal privacy.
(c) In considering the petition, the Board may obtain and consider
additional information not addressed in the petition or the initial
NIOSH evaluation report.
(d) NIOSH may decide to further evaluate a petition, upon the
request of the Board. If NIOSH conducts further evaluation, it will
report new findings to the Board and the petitioner(s).
(e) Upon the completion of NIOSH evaluations and deliberations of
the Board concerning a petition, the Board will develop and transmit to
the Secretary a report containing its recommendations. The Board's
report will include the following:
(1) The identification and inclusion of the relevant petition(s);
(2) The definition of the class of employees covered by the
recommendation;
(3) A recommendation as to whether or not the Secretary should
designate the class as an addition to the Cohort;
(4) The relevant criteria under Sec. 83.13(c) and findings and
information upon which the recommendation is based, including NIOSH
evaluation reports, information provided by the petitioners, any other
information considered by the Board, and the deliberations of the
Board.
Sec. 83.16 How will the Secretary decide the outcome(s) of a
petition?
(a) The Director of NIOSH will propose, and transmit to all
affected petitioners, a decision to add or deny adding classes of
employees to the Cohort, including an iteration of the relevant
criteria, as specified under Sec. 83.13(c), and a summary of the
information and findings on which the proposed decision is based. This
proposed decision will take into consideration the evaluations of NIOSH
and the report and recommendations of the Board, and may also take into
consideration information presented or submitted to the Board and the
deliberations of the Board. In the case of a petition that NIOSH has
determined encompasses more than one class of employees, the Director
of NIOSH will issue a separate proposed decision for each separate
class of employees.
(b) HHS will only allow the petitioner(s) to contest a proposed
decision to deny adding a class to the Cohort or to contest a health
endangerment determination under Sec. 83.13(c)(3)(ii). Such challenges
must be submitted in writing within 30 calendar days and must include
evidence that the proposed decision relies on a record of either
substantial factual errors or substantial errors in the implementation
of the procedures of this part. Challenges may not introduce new
information or documentation concerning the petition or the NIOSH or
Board evaluation(s) that was not submitted or presented by the
petitioner(s) or others to NIOSH or to the Board prior to the Board's
issuing its recommendations under Sec. 83.15.
(c) A panel of three HHS personnel, independent of NIOSH and
appointed by the Secretary, will conduct an administrative review based
on a challenge submitted under paragraph (b) of this section and
provide recommendations of the panel to the Secretary concerning its
merits and the resolution of issues contested by the challenge. Reviews
by the panel will consider, in addition to the views and information
submitted by the petitioner(s) in the challenge, the proposed decision,
the NIOSH evaluation report(s), and the report containing the
recommendations of the Board issued prior to the proposed decision
under Sec. 83.15. The reviews may also consider information presented
or submitted to the Board and the deliberations of the Board prior to
the issuance of the recommendations of the Board under Sec. 83.15. The
panel shall consider whether HHS substantially complied with the
procedures of this part, the factual accuracy of the information
supporting the proposed decision, and the principal findings and
recommendations of NIOSH and those of the Board issued under Sec.
83.15.
(d) The Secretary will make the final decision to add or deny
adding a class to the Cohort, including the definition of the class,
after considering information and recommendations provided to the
Secretary by NIOSH, the Board, and from an HHS administrative review
when such a review is conducted under paragraph (c) of this section.
HHS will transmit a report of the decision to the petitioner(s),
including an iteration of the relevant criteria, as specified under
Sec. 83.13(c), and a summary of the information and findings on which
the decision is based. HHS will also publish a notice summarizing the
decision in the Federal Register.
Sec. 83.17 How will the Secretary report a final decision to add a
class of employees to the Cohort and any action of Congress concerning
the effect of the final decision?
(a) If the Secretary designates a class of employees to be added to
the Cohort, the Secretary will transmit to Congress a report providing
the designation, the definition of the class of employees covered by
the designation, and the criteria and findings upon which the
designation was based.\4\
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\4\ See 42 U.S.C. 7384l(14)(C)(ii).
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(b) A designation of the Secretary will take effect 180 calendar
days after the date on which the report of the Secretary is submitted
to Congress, unless Congress takes an action that reverses or expedites
the designation.
(c) After either the expiration of the congressional review period
or notification of final congressional action, whichever comes first,
the Secretary will transmit to DOL and to the petitioner(s) a report
providing the definition of the class and one of the following
outcomes:
(1) The addition of the class to the Cohort; or
(2) The result of any action by Congress to reverse or expedite the
decision of the Secretary to add the class to the Cohort.
(d) The report specified under paragraph (c) of this section will
be published on the Internet at www.cdc.gov/niosh/ocas and in the
Federal Register.
Sec. 83.18 How can the Secretary cancel or modify a final decision to
add a class of employees to the Cohort?
(a) The Secretary can cancel a final decision to add a class to the
Cohort, or can modify a final decision to reduce the scope of a class
added by the Secretary, if HHS obtains records relevant to radiation
exposures of members of the class that enable NIOSH to estimate the
radiation doses incurred by individual members of the class through
dose reconstructions conducted under the requirements of 42 CFR Part
82.
(b) Before canceling a final decision to add a class or modifying a
final decision to reduce the scope of a class, the Secretary intends to
follow evaluation procedures that are substantially similar to those
described in this part for adding a class of employees to the Cohort.
The procedures will include the following:
(1) Publication of a notice in the Federal Register informing the
public of the intent of the Secretary to review the final decision on
the basis of new information and describing procedures for this review;
[[Page 30786]]
(2) An analysis by NIOSH of the utility of the new information for
conducting dose reconstructions under 42 CFR Part 82; the analysis will
be performed consistently with the requirements for analysis of a
petition by NIOSH under Sec. Sec. 83.13(c)(1) and (2), and 83.13(c)(2)
and (3);
(3) A recommendation by the Board to the Secretary as to whether or
not the Secretary should cancel or modify his final decision that added
the class to the Cohort, based upon a review by the Board of the NIOSH
analysis under paragraph (b)(2) of this section and any other relevant
information considered by the Board;
(4) An opportunity for members of the class to contest a proposed
decision to cancel or modify the prior final decision that added the
class to the Cohort, including a reasonable and timely effort by the
Secretary to notify members of the class of this opportunity; and
(5) Publication in the Federal Register of a final decision to
cancel or modify the prior final decision that added the class to the
Cohort.
Dated: February 23, 2004.
Tommy G. Thompson,
Secretary, Department of Health and Human Services.
[FR Doc. 04-11930 Filed 5-27-04; 8:45 am]
BILLING CODE 4510-43-P