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/ 2002
/ June
/ Tuesday, June 25, 2002
[Federal Register: June 25, 2002 (Volume 67, Number 122)]
[Proposed Rules]
[Page 42961-42973]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jn02-24]
[[Page 42961]]
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Part VI
Department of Health and Human Services
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42 CFR Part 83
Procedures for Designating Classes of Employees as Members of the
Special Exposure Cohort Under the Energy Employees Occupational Illness
Compensation Program Act of 2000; Proposed Rule
[[Page 42962]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 83
RIN 0920-AA07
Procedures for Designating Classes of Employees as Members of the
Special Exposure Cohort Under the Energy Employees Occupational Illness
Compensation Program Act of 2000; Notice of Proposed Rulemaking
AGENCY: Department of Health and Human Services.
ACTION: Notice of Proposed Rulemaking.
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SUMMARY: This document describes how the Department of Health and Human
Services (``HHS'') proposes to consider designating additional classes
of employees to be added to the Special Exposure Cohort under the
Energy Employees Occupational Illness Compensation Program Act of 2000
(``EEOICPA''). Under EEOICPA, and Executive Order 13179, the Secretary
of HHS is authorized to make such designations, which take effect 180
days after Congress is notified unless Congress provides otherwise. An
individual member (or the survivors of a member) of a class of
employees added to the Special Exposure Cohort would be entitled to
compensation if the Department of Labor (``DOL'') finds that employee
incurred a specified cancer and the claim meets other requirements
established under EEOICPA.
DATES: HHS invites comments on this notice of proposed rulemaking from
interested parties. Comments must be received by August 26, 2002.
ADDRESSES: Address written comments on the notice of proposed
rulemaking to the NIOSH Docket Officer. Submit comments electronically
by e-mail to NIOCINDOCKET@CDC.GOV. See SUPPLEMENTARY INFORMATION for
file formats and other information about electronic filing.
Alternatively, submit printed comments to NIOSH Docket Office, Robert
A. Taft Laboratories, M/S C34, 4676 Columbia Parkway, Cincinnati, OH
45226.
FOR FURTHER INFORMATION CONTACT: Larry Elliott, Director, Office of
Compensation Analysis and Support, National Institute for Occupational
Safety and Health, 4676 Columbia Parkway, MS-R45, Cincinnati, OH 45226,
Telephone 513-841-4498 (this is not a toll-free number). Information
requests can also be submitted by e-mail to OCAS@CDC.GOV.
SUPPLEMENTARY INFORMATION:
I. Comments Invited
Interested persons or organizations are invited to participate in
this rulemaking by submitting written views, arguments,
recommendations, and data. Comments are invited on any topic related to
this proposal. Some specific topics for comment are identified under
section III, which summarizes the proposed procedures.
Comments should identify the author(s), return address, and phone
number, in case clarification is needed. Comments can be submitted by
e-mail to: NIOCINDOCKET@CDC.GOV. If submitting comments by e-mail, they
may be provided as e-mail text or as a Word or Word Perfect file
attachment. Printed comments can also be submitted to the address
above. All communications received on or before the closing date for
comments will be fully considered by the Secretary. An electronic
docket containing all comments submitted will be available online over
the Internet on the National Institute for Occupational Safety and
Health (``NIOSH'') homepage at http://www.cdc.gov/niosh.
II. Background
A. Statutory Authority
The Energy Employees Occupational Illness Compensation Program Act,
42 U.S.C. Secs. 7384-7385 [1994, supp. 2001]. EEOICPA established a
compensation program to provide a lump sum payment of $150,000 and
prospective medical benefits as compensation to covered employees
suffering from designated illnesses incurred as a result of their
exposure to radiation, beryllium, or silica while in the performance of
duty for the Department of Energy (``DOE'') and certain of its vendors,
contractors and subcontractors. This legislation also provided for
payment of compensation for certain survivors of these covered
employees.
EEOICPA instructed the President to designate one or more Federal
Agencies to carry out the compensation program. Pursuant to this
statutory provision, the President issued Executive Order 13179
(``Providing Compensation to America's Nuclear Weapons Workers'') which
assigned primary responsibility for administering the compensation
program to the Department of Labor (``DOL''). 65 FR 77487 (December 7,
2000). DOL published an interim final rule governing DOL's
administration of EEOICPA on May 25, 2001 (66 FR 28948).
The executive order directed the HHS to perform several technical
and policymaking roles in support of the DOL program:
(1) HHS is to develop procedures for considering petitions to be
added to the Special Exposure Cohort established under EEOICPA by
classes of employees at DOE and Atomic Weapons Employer (``AWE'')
facilities. HHS is also to apply these procedures in response to such
petitions. Covered employees (and certain eligible survivors) included
in the Special Exposure Cohort who have a specified cancer qualify for
compensation under EEOICPA. The procedures HHS is proposing to use for
considering Special Exposure Cohort petitions are the subject of this
notice of proposed rulemaking.
(2) HHS is to develop guidelines by regulation to be used by DOL to
assess the likelihood that an employee with cancer developed that
cancer as a result of exposure to radiation in performing his or her
duty at a DOE or AWE facility. HHS published a notice of proposed
rulemaking proposing these ``Probability of Causation'' guidelines on
October 5, 2001 (66 FR 50967) and published a final rule on May 2, 2002
(67 FR 22296).
(3) HHS is also to develop methods by regulation to estimate
radiation doses (``dose reconstruction'') for certain individuals with
cancer applying for benefits under the DOL program. HHS published an
interim final rule promulgating these methods under 42 CFR Part 82 on
October 5, 2001 (66 FR 50978) and published a final rule on May 2, 2002
(67 FR 22314). HHS is applying these methods to conduct the program of
dose reconstruction required by EEOICPA.
(4) Finally, HHS is to staff the Advisory Board on Radiation and
Worker Health and provide it with administrative and other necessary
support services. The Board, a federal advisory committee, will advise
HHS in implementing its roles under EEOICPA described here.
42 U.S.C. 7384p requires HHS to implement its responsibilities with
the assistance of the National Institute for Occupational Safety and
Health (NIOSH), an Institute of the Centers for Disease Control and
Prevention, HHS.
B. What Is the Special Exposure Cohort?
The Special Exposure Cohort (``the Cohort'') is a category of
employees defined under 42 U.S.C. 7384l(14). EEOICPA specifies which
employees comprise the Cohort initially, including employees of DOE,
DOE contractors or subcontractors, or AWEs who worked an aggregate of
at least 250 days before February 1, 1992 at a gaseous diffusion plant
in (1) Paducah, Kentucky, (2) Portsmouth, Ohio, or (3) Oak Ridge,
Tennessee and who were or could have
[[Page 42963]]
been monitored in those jobs using dosimetry badges; or (4) employees
of DOE or DOE contractors or subcontractors employed before January 1,
1974 on Amchitka Island, Alaska and exposed to ionizing radiation in
the performance of duty related to the Long Shot, Milrow, or Cannikin
underground nuclear tests. Employees included in the Cohort who incur a
specified cancer \1\ qualify for compensation (see DOL regulations 20
CFR 30 at 66 FR 28948 for details). Cancer claims submitted by these
employees or their survivors do not require DOL to evaluate the
probability that the cancer was caused by radiation doses incurred
during the performance of duty for nuclear weapons programs of DOE, as
is required for other cancer claims covered by EEOICPA.
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\1\ Specified cancers are a limited group of cancers that are
compensable under provisions governing compensation for members of
the Cohort. The list of specified cancers and the provisions
governing compensation for the Cohort can be found at 20 CFR Part
30. In addition, Pub. L. 107-20 added renal cancer to the list of
specified cancers, and Pub. L. 107-107 added leukemia, when initial
exposure is before age 21, to the list.
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C. Purpose of the Proposed Procedures
EEOICPA authorized the President to designate classes of employees
to be added to the Cohort, while providing Congress with the
opportunity to review these decisions and prevent their implementation.
As noted previously, the President has delegated his authority in this
matter to the Secretary of HHS. The purpose of this notice of proposed
rulemaking is to establish procedures by which the Secretary of HHS
will determine whether to add to the Cohort new classes of employees
from DOE and AWE facilities. The procedures are intended to ensure that
petitions for additions to the Cohort are given uniform, fair,
scientific consideration, that petitioners and interested parties are
provided opportunity for appropriate involvement in the process, and to
comply with specific statutory requirements of EEOICPA.
D. Statutory Requirements for Designating Classes of Employees as
Members of the Cohort
EEOICPA includes several requirements for these procedures. The
Advisory Board on Radiation and Worker Health (``the Board'') is
authorized to provide advice to the President (delegated to the
Secretary of HHS) concerning the designation of additional classes as
members of the Cohort. The Board's advice is to be based on ``exposure
assessments by radiation health professionals, information provided by
DOE, and other such information as the Board considers appropriate.''
42 U.S.C. 7384q. Section 7384q specifies that HHS obtain the advice of
the Board ``after consideration of petitions by classes of employees
for such advice.'' This section also mandates two broad criteria to
govern HHS decisions, which are to be made after receiving the advice
of the Board. Members of a class of employees at a DOE or AWE facility
may be treated as members of the Cohort for purposes of the
compensation program if HHS ``determines that: (1) It is not feasible
to estimate with sufficient accuracy the radiation dose that the class
received; and (2) there is a reasonable likelihood that such radiation
dose may have endangered the health of members of the class.'' Finally,
42 U.S.C. 7384l(14)(C) requires the Secretary to submit a report to
Congress for each class of employees the Secretary designates to be
added to the Cohort. The report must define the class of employees
covered by the designation and specify the criteria used to make the
designation. This section requires that the designation take effect 180
days after the date on which HHS submits the report to Congress unless
Congress takes action to reverse or expedite the designation.
E. Relationship of Proposed Procedures to Rules Proposed and
Promulgated by HHS To implement EEOICPA
These procedures complement the two HHS rules promulgated by HHS on
May 2, 2002, to implement EEOICPA for cancer claimants who are not
members of the Cohort. These are the final rule: ``Guidelines for
Determining the Probability of Causation Under the Energy Employees
Occupational Illness Compensation Program Act of 2000'' promulgated at
42 CFR Part 81 (67 FR 22296), and the final rule: ``Methods for
Radiation Dose Reconstruction Under the Energy Employees Occupational
Illness Compensation Program Act of 2000'' promulgated at 42 CFR Part
82 (67 FR 22314).
The final rule 42 CFR Part 82 provides the methods by which NIOSH
is conducting dose reconstructions to estimate the radiation doses
incurred by individual covered employees who have incurred cancer.
These estimates are required by EEOICPA to adjudicate a non-Cohort
cancer claim. The methods to arrive at these estimates, however, will
be directly considered by HHS in reviewing petitions to add classes of
employees to the Cohort. In particular, HHS will consider these methods
in determining for a petitioning class of employees, as required by
EEOICPA, whether ``it is not feasible to estimate with sufficient
accuracy the radiation dose that the [individual members of] the class
received.''
HHS is requiring a finding that NIOSH would be unable to complete
dose reconstructions for the individual members of a class of employees
to satisfy this first statutory requirement concerning ``sufficient
accuracy.'' In practical terms, if NIOSH can successfully reconstruct
the radiation doses of members of the class under the requirements of
42 CFR Part 82, then the doses of the class members can be estimated
with ``sufficient accuracy'' for DOL to adjudicate claims.
Commenters on 42 CFR Part 82 asked HHS to define the conditions
under which NIOSH would not have sufficient information to complete a
dose reconstruction, with the understanding that such conditions would
be relevant to petitions to add classes to the Cohort. As HHS explained
in response to the comments, these conditions will vary on a case-by-
case basis. In some cases, limited information about the radiation
source term (type and quantity of radioactive material) and the process
in which it was used, without any individual monitoring records, will
be sufficient to complete a dose reconstruction, particularly when the
potential level of radiation that was emitted is extremely low. In
these cases, NIOSH can make use of worst case assumptions to fully
account for the highest possible radiation doses that might have been
incurred.
Simplifying assumptions become more difficult to apply, however,
when the potential level of radiation exposure for an individual ranges
greatly, particularly when they range from low levels to potentially
compensable levels (levels that produce a probability of causation of
50% and above). In these circumstances, the ability of NIOSH to
complete a dose reconstruction depends on the extent and quality of
information available to substitute for monitoring data. This can be
defined on a case-by-case basis but not by using rigid criteria; the
potential circumstances are not readily foreseeable.
Some of the methods of dose reconstruction under 42 CFR Part 82
will also be applied in these procedures, to the limited extent
feasible, to make the second statutorily required determination as to
whether: ``there is reasonable likelihood that * * * radiation * * *
may have endangered the health of members of the class.'' Although dose
reconstructions would not be feasible for individual members of a
petitioning class of employees, the process of determining that dose
[[Page 42964]]
reconstructions are not feasible should provide information to
determine imprecisely the potential level of radiation to which the
class could have been exposed. For example, the most limited
information indicating the type, form, and quantities of radioactive
materials present or used in a work operation would provide a basis for
judging whether occupational exposures could have exceeded certain
specific levels, as discussed further below.
The HHS rule 42 CFR Part 81 establishes guidelines by which DOL
will estimate the probability that the cancer of an employee was caused
by ionizing radiation doses incurred by the employee in the performance
of duty for DOE nuclear weapons programs. The guidelines are based in
substantial part on scientific work of the National Cancer Institute,
which has developed an important scientific tool, the Interactive
RadioEpidemiological Program (IREP) for this purpose. IREP produces
statistical estimates of the probability that a specific cancer was
caused by specific amounts and types of ionizing radiation. NIOSH
worked with NCI on IREP and developed a special application of IREP
(``NIOSH-IREP'') to serve the needs of DOL in implementing EEOICPA for
cancer claimants who are not members of the Cohort.
NIOSH-IREP will be used by HHS in these procedures, in conjunction
with dose estimating methods, as discussed above, in making the
determination required by EEOICPA as to whether ``there is reasonable
likelihood that * * * radiation * * * may have endangered the health of
members of the class.'' In particular, NIOSH will use NIOSH-IREP to
determine whether a radiation exposure to a class of employees was
potentially high enough to cause any of the specified cancers for which
members of the class could be compensated under provisions of EEOICPA
and 20 CFR Part 30 concerning eligibility for compensation. Use of
NIOSH-IREP for this purpose will provide a feasible degree of
objectivity and consistency between the policies governing compensation
for claims under provisions for the Cohort and under provisions for all
other cancer claims. Additional detail on how HHS proposes using NIOSH-
IREP in evaluating Cohort petitions is provided under Section III of
this Supplementary Information and Section 83.12 of the procedures.
III. Summary of Proposed Rule
Congress, in enacting EEOICPA, created an Energy Employees
Occupational Illness Compensation Program to ensure an efficient,
uniform, and adequate compensation system for certain employees
involved in nuclear weapons production and related activities. Under
Executive Order 13179, the President assigned primary responsibility
for administering the program to DOL. The President assigned various
technical responsibilities for policymaking and assistance to HHS.
Included among these is the issuance and implementation of these
proposed procedures for designating classes of employees to be added to
the Cohort. This proposed rule includes procedures for the submission
of petitions to add classes of employees to the Cohort and procedures
by which HHS will consider such petitions and determine their outcome,
with the advice of the Advisory Board on Radiation and Worker Health
(``the Board'').
Subtitle A--Introduction
Section 83.0 and 83.1 briefly describe how this proposal relates to
DOL authorities under EEOICPA and report the assignment of
responsibility for this proposal to HHS. Section 83.1 also outlines the
purpose of the proposal and general principles guiding its development.
Section 83.2 describes the relevance of this proposal for cancer
claimants under EEOICPA. It explains the option of petitioning for a
Cohort designation by cancer claimants for whom NIOSH attempted and was
unable to complete dose reconstructions. The initial claims of these
individuals will be denied by DOL, because for individuals who are not
a member of the Cohort, DOL must determine the probability that their
cancers were caused by their radiation exposures. DOL's determination
relies upon NIOSH's ability to successfully produce radiation dose
estimates through its dose reconstruction program under EEOICPA.
Section 83.2 also explains that individuals who would be eligible to
file a claim but have yet to incur a cancer, ``potential claimants,''
can also submit petitions on behalf of a class of employees.
Section 83.3 summarizes the role of DOL in administering claims for
individuals who are members of classes of employees added to the Cohort
under this proposal. It identifies the principal criteria applied by
DOL in reviewing each claim, and provides a reference locating the
relevant regulatory requirements.
Subtitle B--Definitions
Section 83.5 defines the principal terms used in this proposal. It
includes terms specifically defined in EEOICPA that, for the
convenience of the reader of this proposal, are repeated in this
section.
An important statutory term requiring interpretation by HHS is
``endangered the health.'' This term is interpreted by HHS to mean
``there is a reasonable likelihood that the radiation dose may have
caused a specified cancer,'' since members of the Cohort cannot be
compensated as Cohort members for any adverse health effects other than
specified cancers. This definition and the related issue of
establishing a ``reasonable likelihood'' are addressed below in the
discussion of Section 83.12 under ``Procedures for Adding Classes of
Employees to the Cohort.'' HHS invites comment on this definition.
Subtitle C--Procedures for Adding Classes of Employees to the Cohort
Section 83.6 provides an overview of the procedures.
Section 83.7 describes the qualifications for a person submitting a
petition. A petition can be submitted by one or more DOE, DOE
contractor or subcontractor, or AWE employees, their survivors, or a
labor union representing the employees. Consideration was given to
allowing other potential representatives of classes of employees to
submit petitions, such as persons who have performed evaluations of
radiation exposures and radiation protection programs at DOE sites on a
contractual basis or in the course of research. These individuals may
have sufficient expertise to identify classes of employees that should
be added to the Cohort under this policy. However, HHS found it
reasonable to require that such experts work on behalf and with the
consent of one or more members of the class, who are the interested
parties. Hence, the consenting member(s) of the class can submit the
petition with the aid of the expert, who would assist the petitioners
to provide justification for the petition, as provided for under
Section 83.9. HHS invites public comment on these proposed
qualifications. In particular, HHS seeks suggestions about any
additional categories of individuals who might be authorized to submit
a petition on behalf of a class of employees.
Section 83.8 describes the procedure for submitting a petition.
Petitioners are required to complete a form made available by NIOSH,
which can be submitted in hard copy or electronically. The form is
intended to enable HHS to provide clear and consistent guidance to
petitioners efficiently, explaining the information required from the
petitioners for HHS to evaluate the petition.
[[Page 42965]]
Section 83.9 summarizes the informational requirements of a
petition. HHS requires a petitioner to establish a substantial basis
for petitioning to be part of the Cohort. The type of information
needed to establish a substantial basis differs, depending on the
circumstances of the proposed class. The information is described
generally in this section and specifically in the petition form to be
provided to potential petitioners by NIOSH.
If the proposed class includes one or more members who have already
submitted claims and for whom NIOSH was unable to complete a dose
reconstruction due to insufficient information, the informational
requirements of the petition are minimal. The petitioner need only
include a copy of NIOSH dose reconstruction report(s), together with
information required by HHS to administer the petition evaluation.
Petitions involving claims for which NIOSH has attempted
unsuccessfully to complete dose reconstructions provide a substantial
basis for HHS consideration. For this reason, HHS encourages potential
petitioners qualified to submit claims to DOL (i.e., covered employees
who have already incurred a cancer) to do so and allow NIOSH to attempt
to complete individual dose reconstructions prior to submitting
petitions.
If NIOSH has not yet determined whether or not it can complete dose
reconstructions for a class of employees, the petition must include
detailed information defining the proposed class of employees on whose
behalf the petition is being submitted, and information to justify the
petition. This information must include positive evidence that records
required to conduct dose reconstructions do not exist. NIOSH would
assist potential petitioners in requesting information from their
current or former employers on the availability of such records, if the
employer were unresponsive to such requests by the petitioner.
The information provided by the petitioner will help HHS and the
Board make the required determinations of: (1) Whether or not the class
was exposed to levels of radiation that may have endangered the health
of the class; and (2) whether records and information available are
adequate to estimate with sufficient accuracy the radiation doses
incurred by individual members of the proposed class.
HHS invites comments on the general scheme proposed here,
particularly the different requirements for potential petitioners
depending upon whether or not NIOSH has already determined it is not
possible to conduct dose reconstructions for members of the proposed
class. HHS also invites comments on the specific informational
requirements. Do they achieve a fair and reasonable balance between the
level of burden placed on potential petitioners and the information HHS
and the Board need to consider petitions fairly and efficiently? Are
there alternative approaches that HHS should consider?
Section 83.10 describes the roles and procedures of NIOSH, HHS, and
the Board in selecting petitions for evaluation and notifying the
petitioners of the resulting decision. NIOSH will select petitions for
evaluation that have met the requirements of this section. Petitioners
who have not met the informational requirements for a petition will be
notified of this finding in writing, after the opportunity to remedy
any omissions. The Board will have the opportunity to review the
petition and the finding of HHS and provide its recommendation before
HHS makes a final decision. HHS will then notify the petitioner of the
final decision to select or not select the petition for evaluation.
NIOSH will present to the board petitions that are selected
together with a plan for evaluating the petition. NIOSH will initiate
the evaluation as soon as possible, but will consider any advice of the
Board concerning the plan, when the Board gives such advice. The Board
will have already provided NIOSH advice on a generic approach to such
evaluations.
Section 83.11 describes procedures that apply when HHS decides not
to select a petition for evaluation. A cancer claim for a member of the
class of employees proposed by the petition would continue to be
adjudicated under provisions of 20 CFR Part 30 governing claims for
compensation not based upon the Cohort. Under these provisions, NIOSH
would attempt to conduct a dose reconstruction for the individual. HHS
will reverse its decision not to evaluate the petition if NIOSH finds
that dose reconstructions cannot be completed for members of the class
proposed by the petition. HHS may also reconsider its decision to not
select a petition at any time based on new information.
Section 83.12 describes how NIOSH will evaluate petitions to
support the Board in making recommendations and the Secretary in
deciding the outcome of the petition. The section specifies the
potential types of information, which are the same as those used for
dose reconstruction under 42 CFR Part 82, and specifies the potential
sources for this information. NIOSH will evaluate this information to
make two determinations required by EEOICPA: (1) Whether there was ``a
reasonable likelihood that such radiation dose may have endangered the
health of members of the class'' and (2) whether the level of radiation
exposures to individual members of the class can be estimated with
``sufficient accuracy''--in other words, using the methods of dose
reconstruction established under 42 CFR Part 82. If health was
endangered and the level of radiation exposures to individuals cannot
be estimated through dose reconstructions, these findings would provide
the basis for the Board to advise and HHS to decide that a class of
employees be added to the Cohort.
HHS interprets ``endangered the health'' to mean a finding that
there was a reasonable likelihood that such radiation dose may have
caused a specified cancer since, as explained above, EEOICPA restricts
compensation under provisions concerning the Cohort to those members of
the Cohort who have incurred a specified cancer. To determine whether
the potential level of radiation exposure is sufficient to produce ``a
reasonable likelihood'' of having caused a specified cancer, HHS will
apply an objective but necessarily less demanding standard than was
established under EEOICPA and applied under 42 CFR part 81 \2\, as
follows.
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\2\ Under EEOICPA and 42 CFR Part 81, the standard for ``at
least as likely as not'' is a 50% or greater probability at the
upper 99 percent credibility limit. This standard is designed to
provide a large margin of error in ensuring that an employee whose
cancer was likely to have been caused by radiation would not be
denied compensation under EEOICPA. For a full explanation of this
statistical concept and its use in NIOSH-IREP, see the explanation
in the preamble to 42 CFR Part 81 (66 FR 50967, 50968-9).
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NIOSH would use NIOSH-IREP, a software tool which was developed
under 42 CFR Part 81 for estimating the probability that specific
radiation doses caused a specific type of cancer in a specific
individual. Since use of NIOSH-IREP requires information about the type
of cancer, the attributes of the individual, and the circumstances of
the individual's exposure to radiation, information which may not be
known or applicable to a class of employees, NIOSH will apply
hypothetical values for these variables as necessary. The hypothetical
values will reasonably represent what is known about the class of
employees and its radiation exposure, while giving the benefit of the
doubt to the employees with respect to what may be unknown. However,
because the specified cancers differ according to the amount and type
of radiation dose that will result in a probability of causation of 50%
or higher calculated at the 99 percent credibility limit using NIOSH-
[[Page 42966]]
IREP, NIOSH will select the type of specified cancer that is most
readily caused by the radiation exposures to which the employees were
potentially exposed--the ``most radiogenic'' specified cancer.\3\ If
leukemia is the most radiogenic cancer caused by the radiation
exposures of concern to the class, however, NIOSH would select both
leukemia and the most radiogenic solid tumor cancer, to reasonably
account for the fact that leukemia is extremely radiogenic but also
rare (it may not occur at all in the employee class). NIOSH will then
use these variables and the selected type of cancer in NIOSH-IREP to
determine the level of radiation dose to which a member of the proposed
class of employees would have to have been exposed to reach a
probability of causation of 50 percent at the 99 percent credibility
limit.\4\ Using this level as the benchmark, NIOSH would determine
whether the actual level of radiation to which members of a class may
have been exposed could have reached or exceeded this benchmark, based
on the radiation source term (the type and quantity of radioactive
materials), the work processes, the radiation safety procedures, or
other relevant information. If so, the class would satisfy the
criterion for health endangerment.
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\3\ Despite selection of the most radiogenic cancer to calculate
probability of causation, once a class of employees has been added
to the Cohort, members would be eligible for compensation for
incurring any of the specified cancers, not only the cancer used for
this calculation.
\4\ In a case where NIOSH uses both leukemia and the most
radiogenic solid tumor cancer, NIOSH would average the two doses
resulting from the NIOSH-IREP analysis to produce a single dose
level to use as the benchmark discussed subsequently in this
paragraph.
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The practical result of this approach is to establish an objective
measure of health endangerment with minimal use of subjective expert
judgment. Subjective judgment will grant petitioning classes the
benefit of the doubt with respect to all assumptions about radiation
exposure levels and characteristics required to substitute for the lack
of dosimetry records and information from DOE or the AWEs. Given the
sparsity of records and information required to substantiate a SEC
petition, these assumptions should be relatively few and simple. They
should provide an easy basis for review by the Board and other experts.
By evaluating probability of causation using the most radiogenic
cancer, HHS similarly gives the petitioning class a substantial benefit
of the doubt with respect to the cancers that will actually be incurred
by members of the class. This reasonably minimizes the level of
radiation dose required to produce a probability of causation of 50
percent at the 99 percent credibility limit, and thereby helps ensure
HHS would approve a petition when there is a ``reasonable likelihood''
that the health of members of the class may have been endangered.
The entire approach presented above is intended to ensure HHS makes
determinations of health endangerment as fairly, transparently, and
consistently as possible, and compliant with the statutory requirement
that HHS establish a ``reasonable likelihood'' that the health of
members of the class may have been endangered. HHS invites comment on
its proposed interpretation of health endangerment and approach to
evaluate it.
Based on the findings of evaluations used to make the two
determinations discussed above, NIOSH may propose revisions, as
appropriate, to the proposed definition of the class of employees
covered by the petition. For example, NIOSH might find through such
evaluations that the definition of the class of employees should be
broadened to include additional workers not identified previously, or
that the individuals identified in several petitions should constitute
a single class of employees. NIOSH might also find that more than one
class of employees is proposed by the petition, for which the two
determinations discussed above differ.
The definition of the class will include a minimum duration of
employment for an individual to be included in the class. Members of
the gaseous diffusion plants included by statute in the Cohort must
have been employed at the plants for a minimum of 250 days, as provided
under EEOICPA. The same duration may be appropriate for other classes
of employees added to the Cohort. NIOSH will propose a minimum
duration, as appropriate, based on its findings concerning the
circumstances, types, and potential levels of radiation exposure to
each class of employees. In cases in which NIOSH cannot establish a
substantial basis for specifying a duration of employment, NIOSH will
use the 250 day duration of employment required for employees of the
gaseous diffusion plants.
With the completion of this evaluation, NIOSH will provide the
Board and the petitioners with an evaluation report summarizing its
methods and findings. The contents of the report are specified in this
section.
Section 83.13 describes how the Board will evaluate a petition. Its
evaluation will be conducted in one or more public meetings that will
be announced in the Federal Register, together with a summary of the
petition and the NIOSH evaluation report. The Board will review the
petition and the NIOSH report. In addition, the petitioner will have
the opportunity to address the Board regarding its petition and the
NIOSH evaluation report. If NIOSH subsequently conducts additional
evaluation in response to the review and recommendation of the Board,
NIOSH will provide a supplementary report to the petitioner(s) and the
Board for further deliberation. At the conclusion of the Board's
deliberation, the Board will prepare a report providing recommendations
to the Secretary on whether or not to add the proposed class of
employees to the Cohort, as well as on the definition of the class. The
report will include the criteria and information that provide the basis
for the Board's recommendations.
Section 83.14 describes how the Secretary will produce final
decisions on the outcome of petitions. The Secretary will issue
proposed decisions to the petitioner(s), including a definition of the
class or classes of employees effected and a summary of the criteria
and information supporting the decision. The petitioner(s) will have 30
days to challenge a proposed decision of the Secretary by requesting an
administrative review of the record. After 30 days or resolution of a
challenge, the Secretary will transmit a final decision to the
petitioner(s). At this time, the Secretary will also publish in the
Federal Register decisions to deny adding classes of employees to the
Cohort. Decisions to add a class of employees to the Cohort will not be
published in the Federal Register until expiration of the 180 day
congressional review period addressed in Sec. 83.15 and discussed
below.
Section 83.15 describes the role of Congress in designating
additional classes as members of the Cohort. As required by EEOICPA,
the Secretary will notify Congress by report of final decisions to add
classes of employees to the Cohort, including a definition of the class
and the criteria and information upon which the decision was based.
Congress will then have 180 days during which it may take an action to
reverse or expedite the designation. Without action by Congress, the
designation becomes effective automatically 180 days after the date
Congress received the report of the Secretary. Within 200 days, the
Secretary will transmit to DOL and publish in the Federal Register the
definition of the class covered by the
[[Page 42967]]
designation and the outcome of the designation, reflecting any action
taken by Congress.
Section 83.16 describes how the Secretary would cancel a final
decision to add a class to the Cohort or modify a final decision to
reduce the scope of a class the Secretary had added to the Cohort. The
addition of a class to the Cohort by the Secretary is premised on the
lack of sufficient records and information to enable NIOSH to complete
dose reconstructions for members of the class under 42 CFR Part 82. In
the event that HHS subsequently obtains sufficient records and
information for reconstructing the doses of some or all members of a
class the Secretary has added to the Cohort (e.g., records that were
deemed non-existent or missing at the time HHS decided to add the class
to the Cohort), the provisions of Section 16 are intended to reverse or
modify the decision. Covered employees who are no longer in the Cohort
may still seek compensation by establishing that their cancer was at
least as likely as not related to covered employment. Thus, their
claims seeking compensation for cancers would be evaluated by DOL and
forwarded to NIOSH for dose reconstructions under 42 CFR Part 82.
IV. Regulatory Assessment Requirements
A. Executive Order 12866
Under executive order (E.O.) 12866 (58 FR 51735, October 4, 1993),
the Agency must determine whether a regulatory action is
``significant'' and therefore subject to review by the Office of
Management and Budget (OMB) and the requirements of the Executive
Order. Under section 3(f), the order defines a ``significant regulatory
action'' as an action that is likely to result in a rule (1) Having an
annual effect on the economy of $100 million or more, or adversely and
materially affecting a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local, or tribal governments or communities (also referred to as
``economically significant''); (2) creating serious inconsistency or
otherwise interfering with an action taken or planned by another
agency; (3) materially altering the budgetary impacts of entitlement,
grants, user fees, or loan programs or the rights and obligations of
recipients thereof; or (4) raising novel legal or policy issues arising
out of legal mandates, the President's priorities, or the principles
set forth in this Executive Order. This notice of proposed rulemaking
is being treated as a ``significant regulatory action'' within the
meaning of the executive order because it meets the criterion of
Section 3(f)(4) in that it raises novel or legal policy issues arising
out of the legal mandate established by EEOICPA. It proposes to
establish practical procedures, grounded in current science, by which
the Secretary of HHS can fairly consider petitions to add classes of
employees to the Cohort. The financial cost to the federal government
of responding to these petitions is likely to vary from several
thousand dollars to as much as tens of thousands of dollars, depending
on the availability of information and scope of the petition.
The notice of proposed rulemaking carefully explains the manner in
which the procedures are consistent with the mandate of 42 U.S.C. 7384q
and implements the detailed requirements of that section. The proposal
does not interfere with State, local, and tribal governments in the
exercise of their governmental functions.
The proposal is not considered economically significant, as defined
in section 3(f)(1) of the E.O. 12866. It has a subordinate role in the
adjudication of claims under EEOICPA, serving as one element of an
adjudication process administered by DOL under 20 CFR Parts 1 and 30.
DOL has determined that its rule fulfills the requirements of E.O.
12866 and provides estimates of the aggregate cost of benefits and
administrative expenses of implementing EEOICPA under its rule (see 66
FR 28948, May 25, 2001). OMB has reviewed this proposal for consistency
with the President's priorities and the principles set forth in E.O.
12866.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq.,
requires each agency to consider the potential impact of its
regulations on small entities including small businesses, small
governmental units, and small not-for-profit organizations. We certify
that this proposed rule will not have a significant economic impact on
a substantial number of small entities within the meaning of the RFA.
This proposal affects only DOL, DOE, HHS, and certain individuals
covered by EEOICPA. Therefore, a regulatory flexibility analysis as
provided for under RFA is not required.
C. What Are the Paperwork and Other Information Collection Requirements
(Subject to the Paperwork Reduction Act) Imposed Under This Proposed
Rule, and How Are Comments Submitted?
Under the Paperwork Reduction Act of 1995, a Federal agency shall
not conduct or sponsor a collection of information from ten or more
persons other than Federal employees unless the agency has submitted a
Standard Form 83, Clearance Request, and Notice of Action, to the
Director of the Office of Management and Budget (OMB), and the Director
has approved the proposed collection of information. A person is not
required to respond to a collection of information unless it displays a
currently valid OMB control number. The Paperwork Reduction Act is
applicable to the data collection aspects of these proposed procedures.
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of projects. To
request more information on this project or to obtain a copy of the
data collection plans and instruments, call the CDC Reports Clearance
Officer at (404) 639-7090.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology.
Send comments to Anne O'Connor, CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS-D24, Atlanta, GA 30333. Written comments
should be received within 45 days of this notice.
Under the proposed rule, NIOSH will provide an ``SEC Petition
Form'' petitioners must use to submit a petition. The form and
accompanying instructions will assist the claimants in meeting the
informational requirements of these procedures for petitions to be
selected for evaluation by HHS and the Board. The completed form can be
submitted in hard copy or electronically over the internet.
[[Page 42968]]
There will be no cost to respondents for this data collection. This
is a new data collection. The estimated annual burden of this data
collection is described in the table below.
----------------------------------------------------------------------------------------------------------------
Avg. burden
Respondents Number of Number of per response Total hours
respondents responses (hrs.)
----------------------------------------------------------------------------------------------------------------
SEC Petition Form....................................... 90 1 68/60 103
----------------------------------------------------------------------------------------------------------------
D. Small Business Regulatory Enforcement Fairness Act
As required by Congress under the Small Business Regulatory
Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), the Department
will report to Congress promulgation of this proposed rule prior to its
effective date. The report will state that the Department has concluded
that this proposed rule is not a ``major rule'' because it is not
likely to result in an annual effect on the economy of $100 million or
more. However, this proposed rule has a subordinate role in the
adjudication of claims under EEOICPA, serving as one element of an
adjudication process administered by DOL under 20 CFR Parts 1 and 30.
DOL has determined that its rule is a ``major rule'' because it will
likely result in an annual effect on the economy of $100 million or
more.
E. Unfunded Mandates Reform Act of 1995
Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531
et seq.) directs agencies to assess the effects of Federal regulatory
actions on State, local, and tribal governments, and the private
sector, ``other than to the extent that such regulations incorporate
requirements specifically set forth in law.'' For purposes of the
Unfunded Mandates Reform Act, this proposed rule does not include any
Federal mandate that may result in increased annual expenditures in
excess of $100 million by State, local or tribal governments in the
aggregate, or by the private sector.
F. Executive Order 12988 (Civil Justice)
This proposed rule has been drafted and reviewed in accordance with
Executive Order 12988, Civil Justice Reform and will not unduly burden
the Federal court system. HHS adverse decisions may be reviewed in
United States District Courts pursuant to the Administrative Procedure
Act. HHS has attempted to minimize that burden by providing petitioners
an opportunity to seek administrative review of adverse decisions. HHS
has provided a clear legal standard it will apply in considering
petitions. This proposed rule has been reviewed carefully to eliminate
drafting errors and ambiguities.
G. Executive Order 13132 (Federalism)
The Department has reviewed this proposed rule in accordance with
Executive Order 13132 regarding federalism, and has determined that it
does not have ``federalism implications.'' The proposed rule does not
``have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government.''
H. Executive Order 13045 (Protection of Children From Environmental,
Health Risks and Safety Risks)
In accordance with Executive Order 13045, HHS has evaluated the
environmental health and safety effects of this proposed rule on
children. HHS has determined that the proposed rule would have no
effect on children.
I. Executive Order 13211 (Actions Concerning Regulations that
Significantly Affect Energy Supply, Distribution, or Use)
In accordance with Executive Order 13211, HHS has evaluated the
effects of this proposed rule on energy supply, distribution or use,
and has determined that the proposed rule will not have a significant
adverse effect on them.
List of Subjects in 42 CFR Part 83
Government employees, Occupational safety and health, Nuclear
materials, Radiation protection, Radioactive materials, Workers'
compensation.
Text of the Proposed Rule
For the reasons discussed in the preamble, the Department of Health
and Human Services proposes to amend 42 CFR to add Part 83 to read as
follows:
PART 83--PROCEDURES FOR DESIGNATING CLASSES OF EMPLOYEES AS MEMBERS
OF THE SPECIAL EXPOSURE COHORT UNDER THE ENERGY EMPLOYEES
OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT OF 2000
Subpart A--Introduction
Sec.
83.0 Background information on the procedures in this part.
83.1 What is the purpose of the procedures in this part?
83.2 How would cancer claimants be affected by the procedures in
this part?
83.3 How will DOL use the designations established under the
procedures in this part?
Subpart B--Definitions
83.5 Definition of terms used in the procedures in this part.
Subpart C--Procedures for Adding Classes of Employees to the Cohort
83.6 Overview of the procedures in this part.
83.7 Who can submit a petition on behalf of a class of employees?
83.8 How is a petition submitted?
83.9 What information must a petition include?
83.10 How will HHS select petitions for evaluation?
83.11 What happens to petitions that HHS does not select for
evaluation?
83.12 How will NIOSH evaluate a petition?
83.13 How will the Board evaluate a petition?
83.14 How will the Secretary decide the outcome of a petition?
83.15 What is the role of Congress in acting upon the final
decision of the Secretary to add a class of employees to the Cohort?
83.16 How can the Secretary cancel or modify a final decision to
add a class of employees to the Cohort?
Authority: 42 U.S.C. 7384q; E.O. 13179, 65 FR 77487, 3 CFR, 2000
Comp., p. 321.
Subpart A--Introduction
Sec. 83.0 Background information on the procedures in this part.
The Energy Employees Occupational Illness Compensation Program Act
(``EEOICPA''), 42 U.S.C. 7384-7385 [1994, supp. 2001], provides for the
payment of compensation benefits to
[[Page 42969]]
covered employees and, where applicable, survivors of such employees,
of the United States Department of Energy (``DOE''), its predecessor
agencies and certain of its contractors and subcontractors. Among the
types of illnesses for which compensation may be provided are cancers.
There are two methods set forth in the statute for claimants to
establish that a cancer incurred by a covered worker is covered by the
EEOICPA. The first is to establish that the cancer is at least as
likely as not related to covered employment at a DOE or Atomic Weapons
Employer (``AWE'') facility pursuant to guidelines issued by the
Department of Health and Human Services (``HHS''), which are found at
42 CFR Part 81. The other method to establish that a cancer incurred by
a covered worker is covered by EEOICPA is to establish that the worker
was a member of the Special Exposure Cohort (``Cohort'') who suffered a
specified cancer after beginning employment at a DOE or AWE facility.
Section 7384l(14) of the EEOICPA includes certain classes of employees
in the Cohort. Section 7384q of the Act authorizes the addition to the
Cohort of other classes of employees. This authority has been delegated
to the Secretary of HHS by Executive Order 13179.
Sec. 83.1 What is the purpose of the procedures in this part?
EEOICPA authorized the President to designate additional classes of
employees to be added to the Cohort, while providing Congress with the
opportunity to review and affect these decisions. The President has
delegated authority to consider and make such designations to the
Secretary. The purpose of this part is to specify the procedures by
which HHS determines whether to add new classes of employees from DOE
and AWE facilities to the Cohort. HHS will consider adding new classes
of employees only in response to petitions by or on behalf of such
classes of employees, as authorized under EEOICPA and described in
these procedures. The procedures are intended to ensure petitions for
additions to the Cohort are given uniform, fair, scientific
consideration, that petitioners and interested parties are provided
opportunity for appropriate involvement in the process, and that the
process is consistent with statutory requirements specified in EEOICPA.
Sec. 83.2 How would cancer claimants be affected by the procedures in
this part?
This part implements provisions of EEOICPA intended to serve
potential and current cancer claimants whose radiation doses (incurred
by a covered employee in the case of a survivor claimant) cannot be
estimated by the completion of a NIOSH dose reconstruction.
(a) A current cancer claimant can petition on behalf of a class of
employees to be added to the Cohort upon determination by NIOSH that it
cannot complete a dose reconstruction for the claimant. The initial
claim of the claimant must be denied by DOL, since compensation for a
cancer claim not based on the Cohort provision requires the completion
of NIOSH dose reconstruction. However, if a petition by the claimant is
successful, the claimant could reapply and obtain compensation as a
Cohort member (or survivor of a Cohort member), if the claim qualifies
under requirements governing compensation to members of the Cohort.
(b) A potential cancer claimant, a qualified DOE, DOE contractor or
subcontractor, or AWE employee who has not incurred cancer, can also
petition on behalf of a class of employees to be added to the Cohort. A
successful petition would entitle the claimant, upon incurring a
specified cancer, to submit a claim for compensation under provisions
of the Cohort.
Sec. 83.3 How will DOL use the designations established under the
procedures in this part?
DOL will adjudicate claims for compensation for members of classes
of employees added to the Cohort according to the same general
procedures that apply to the statutorily defined classes of employees
in the Cohort. In summary, this review by DOL will determine whether
the claim is for a qualified member of the Cohort with a specified
cancer, pursuant to the procedures set forth in 20 CFR Part 30.
Subpart B--Definitions
Sec. 83.5 Definitions of terms used in the procedures in this part
(a) Advisory Board for Radiation and Worker Health (``the Board'')
is a federal advisory committee established under EEOICPA and appointed
by the President to advise HHS in implementing its responsibilities
under EEOICPA.
(b) Atomic Weapons Employer (``AWE'') is a statutory term of
EEOICPA which means any entity, other than the United States, that:
(1) Processed or produced, for use by the United States, material
that emitted radiation and was used in the production of an atomic
weapon, excluding uranium mining and milling: and,
(2) Is designated by the Secretary of Energy as an atomic weapons
employer for purposes of EEOICPA.
(c) Class of employees means, for the purposes of this proposal, a
group of employees who work or worked at the same DOE or AWE facility,
who may have experienced similar types and levels of exposure to
radiation, and for whom the availability of information and recorded
data on such exposures is comparable with respect to the informational
needs of dose reconstructions conducted under 42 CFR Part 82.
(d) HHS is the U.S. Department of Health and Human Services
(e) DOE is the U.S. Department of Energy, which includes
predecessor agencies of DOE, including the Manhattan Engineering
District.
(f) DOL is the U.S. Department of Labor
(g) Employee, for the purposes of these procedures, means a person
who is or was an employee of DOE, a DOE contractor or subcontractor, or
an atomic weapons employer, as further defined in EEOICPA.
(h) Endangered the health is a statutory term from EEOICPA which
means, for the purposes of these procedures, ``there is reasonable
likelihood that the radiation dose may have caused a specified
cancer,'' determined according to these procedures using NIOSH-IREP.
(i) Interactive RadioEpidemiological Program (``IREP'') is a
computer software program that uses information on the dose-response
relationship and specified factors such as a claimant's radiation
exposure, gender, age at diagnosis, and age at exposure to calculate
the probability of causation for a given pattern and level of radiation
exposure.
(j) NIOSH is the National Institute for Occupational Safety and
Health, Centers for Disease Control and Prevention, U.S. Department of
Health and Human Services.
(k) Probability of causation means, for the purposes of these
procedures, the probability or likelihood that a cancer was caused by
radiation exposure incurred by a covered employee in the performance of
duty. In statistical terms, it is the cancer risk attributable to
radiation exposure divided by the sum of the baseline cancer risk (the
risk to the general population) plus the cancer risk attributable to
the radiation exposure. This concept is further explained under 42 CFR
Part 81, which provides guidelines by which DOL will determine
probability of causation under EEOICPA.
[[Page 42970]]
(l) Radiation means ionizing radiation, including alpha particles,
beta particles, gamma rays, x rays, neutrons, protons and other
particles capable of producing ions in the body. For the purposes of
the proposed procedures, radiation does not include sources of non-
ionizing radiation such as radio-frequency radiation, microwaves,
visible light, and infrared or ultraviolet light radiation.
(m) Secretary is the Secretary of the Department of Health and
Human Services.
(n) Specified cancer (as defined in section 4(b) of the Radiation
Exposure Compensation Act Amendments of 2000 (42 U.S.C. 2210 note) and
section 7384l(17) of EEOICPA means:
(1) Leukemia (other than chronic lymphocytic leukemia) if onset
occurred more than two years after first exposure;
(2) Primary or secondary lung cancer (other than in situ lung
cancer that is discovered during or after a post-mortem exam);
(3) The following diseases, provided onset was at least 5 years
after first exposure:
(i) Multiple myeloma;
(ii) Lymphomas (other than Hodgkin's disease);
(4) Primary cancer of the:
(i) Thyroid;
(ii) Male or female breast;
(iii) Esophagus;
(iv) Stomach;
(v) Pharynx;
(vi) Small intestine;
(vii) Pancreas;
(viii) Bile ducts;
(ix) Gall bladder;
(x) Salivary gland;
(xi) Urinary bladder;
(xii) Brain;
(xiii) Colon;
(xiv) Ovary;
(xv) Liver (except if cirrhosis or hepatitis B is indicated).
(5) Primary or secondary bone cancer.
(6) Primary or secondary renal cancers.
(o) The specified diseases designated in paragraph (n) of this
section mean the physiological condition or conditions that are
recognized by the National Cancer Institute under those names or
nomenclature, or under any previously accepted or commonly used names.
Subpart C--Procedures for Adding Classes of Employees to the Cohort
Sec. 83.6 Overview of the Procedures in this Part.
The procedures in this part specify who may petition to add a class
of employees to the Cohort, the requirements for such a petition, how a
petition will be selected for evaluation by NIOSH and for the advice of
the Board, and the process by which NIOSH, the Board, and the Secretary
will operate in considering a petition, leading to the Secretary's
final decision to accept or deny the petition. The petition
requirements differ for classes of employees including members who have
submitted cancer claims already, for whom NIOSH attempted and was
unable to complete individual dose reconstructions as specified under
42 CFR 82.12. As required by EEOICPA, the procedures include formal
notice to Congress of any decision by the Secretary to add a class to
the Cohort, and the opportunity for Congress to change the outcome of
the decision.
Sec. 83.7 Who can submit a petition on behalf of a class of employees?
Petitioners must be one of the following:
(a) One or more DOE, DOE contractor or subcontractor, or AWE
employees or their survivors (as defined under EEOICPA and 20 CFR Part
30); and/or
(b) A labor union representing or formerly having represented DOE,
DOE contractor or subcontractor, or AWE employees who would be included
in the proposed class of employees.
Sec. 83.8 How is a petition submitted?
(a) The petitioner(s) must send a completed ``SEC Petition Form''
to NIOSH/OCAS addressed as follows: SEC Petition, Office of
Compensation Analysis and Support, National Institute for Occupational
Safety and Health, 4676 Columbia Parkway, MS-R45, Cincinnati, OH 45226.
(b) The SEC petition form is available from NIOSH by calling the
NIOSH toll-free phone service at 1-800-35-NIOSH. The form is also
available from the NIOSH homepage at: www.cdc.gov/niosh. The form can
be completed and submitted electronically following instructions
provided on the NIOSH homepage.
Sec. 83.9 What information must a petition include?
The petition must include complete information according to the
instructions on the SEC petition form. As explained by these
instructions, in addition to identifying and contact information, the
petitioner(s) must provide the substantive information described under
paragraph (a) or (b) of this section before the petition is considered.
These informational requirements are also summarized in Table 1 of this
section.
(a) The petition must transmit a copy of a report produced by NIOSH
under 42 CFR 82.12 notifying the petitioner(s) that NIOSH attempted and
could not complete a dose reconstruction for the individual(s) due to
insufficient records and information; \1\ or, alternatively,
---------------------------------------------------------------------------
\1\ A Cohort petition by an individual for whom NIOSH was unable
to complete an individual dose reconstruction under 42 CFR Part 82
will be selected for evaluation without requiring further
information or documentation from the petitioner to justify
consideration of the petition. NIOSH will have already collected
related information from the claimant through a structured interview
during the dose reconstruction process. NIOSH will establish an
initial class definition based on records and information NIOSH
obtained during the attempted dose reconstruction, which NIOSH would
supplement with additional data collection, as necessary. HHS will
establish a final class definition with the advice of the Board.
---------------------------------------------------------------------------
(b) The petition must provide the following:
(1) A proposed class definition \2\ specifying:
(i) The DOE or AWE facility at which the class worked;
(ii) The job titles and/or job duties of the class members;
(iii) The period of employment relevant to the petition;
(iv) Identification of any exposure incident(s) that was
unmonitored, unrecorded, or inadequately monitored or recorded, if such
incident(s) comprises the basis of the petition; and
---------------------------------------------------------------------------
\2\ HHS will determine the final class definition for each
petition (see Sec. 83.14 of these procedures).
---------------------------------------------------------------------------
(2) A description of the petitioners' basis for believing the class
was exposed to levels of radiation at the facility that may have
``endangered the health of members of the class.'' \3\ An adequate
basis must include the following:
---------------------------------------------------------------------------
\3\ HHS interprets the statutory language ``endangered the
health'' [see 42 U.S.C. Sec. 7384q(b)(2)] to mean ``there is a
reasonable likelihood that the radiation dose may have caused a
specified cancer,'' since claimants cannot be compensated as members
of the Cohort for any adverse health effects other than certain
cancers under the relevant provisions of EEOICPA [see 42 U.S.C.
Sec. 7384l(9) and (17)].
---------------------------------------------------------------------------
(i) A description of short-term radiation-related health effects or
health care interventions that demonstrate special efforts to respond
to a hazardous radiation exposure, such as a depressed white blood cell
count associated with radiation exposure or the application of
chelation therapy among members of the class; and/or
(ii) The following two requirements:
(A) An identification of radioactive materials and emissions;
contaminated tools, equipment, or areas; and/or any other relevant
information suggesting the class was potentially exposed; and
(B) A description of shortcomings of radiation protection measures,
including the deficiencies of particular measures used or the omission
of measures that should have been used to
[[Page 42971]]
prevent hazardous radiation exposures at the facility; and
(3) A description of the petitioner's basis for believing records
and information available are inadequate to estimate the radiation
doses incurred by any members of the proposed class of employees. An
adequate basis must include at least one of the following elements:
(i) Documentation indicating the petitioner(s) sought records on
radiation exposures at the facility and relevant to the petition and
that DOE or the AWE responded indicating the records do not exist; or
(ii) A report from a health physicist or other individual with
expertise in dose reconstruction documenting the limitations of
existing DOE or AWE records on radiation exposures at the facility and
relevant to the petition and specifying the basis for finding these
documented limitations would prevent the completion of dose
reconstructions for individual members of the class under 42 CFR Part
82 and related NIOSH technical implementation guidelines.
Table 1.--Informational Requirements for Petitions
------------------------------------------------------------------------
Petitioner identifying and contact information and either (a) or (b):
-------------------------------------------------------------------------
(a) (b)
------------------------------------------------------------------------
Copy of NIOSH dose reconstruction (1) Proposed class definition
report indicating that NIOSH was identifying: (i) Facility,
unable to reconstruct the radiation (ii) Job titles/duties, (iii)
dose of a worker included in the Period of employment, and if
proposed class. relevant, (iv) Exposure
incident.
(2) Basis for health
endangerment; either: (i)
Health effects or health care
or (ii)(A) Identification of
potential exposures, and (B)
Shortcoming of radiation
protection.
(3) Basis for infeasibility of
dose reconstruction; either:
(i) Demonstrated lack of
records or (ii) Expert report.
------------------------------------------------------------------------
Sec. 83.10 How will HHS select petitions for evaluation?
(a) Where HHS finds the petition meets the requirements specified
in Secs. 83.7 through 83.9, HHS will transmit a written report
notifying the petitioner(s) that it has selected the petition for
evaluation. The HHS report will also provide the petitioner(s) with
information on the steps and expected duration of the evaluation and
deliberative processes required pursuant to these procedures.
(b) Where HHS finds the petition does not meet the requirements
specified in Secs. 83.7 through 83.9,
(1) HHS will notify the petitioner(s) of any requirements that are
not met by the petition, and provide 30 days for the petitioner(s) to
revise the petition accordingly.
(2) After 30 days, for petitions that continue to fail to meet one
or more requirements, HHS will transmit a written report notifying the
petitioner(s) of the recommended finding to not select the petition for
evaluation and the basis for this recommended finding. The report will
also inform the petitioner(s) that this recommended finding will be
reviewed by the Board.
(3) HHS will report the recommended finding and its basis to the
Board at its next meeting. HHS will consider the recommendations of the
Board before producing a final decision on whether or not to select the
petition for evaluation.
(4) HHS will report the final decision to the petitioner, including
the basis for the decision and the recommendation of the Board.
(c) NIOSH will present petitions selected for evaluation to the
Board with plans specific to evaluating each petition.\4\ Each specific
evaluation plan will be based on a general plan for evaluating
petitions which NIOSH will develop in consultation with the Board. Each
specific evaluation plan will include the following elements:
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\4\ NIOSH will combine separate petitions and evaluate them as a
single petition if, at this or any point in the evaluation process,
NIOSH finds such petitions represent the same class of employees.
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(1) An initial proposed definition for the class being evaluated,
subject to revision as warranted by evaluation conducted under
Sec. 83.12; and
(2) A schedule of activities for evaluating the radiation exposure
potential of the class and the adequacy of existing records and
information needed to conduct dose reconstructions for all class
members under 42 CFR Part 82.
(d) NIOSH may initiate work to evaluate a petition immediately,
prior to presenting selected petitions and associated evaluation plans
to the Board.
(e) NIOSH will publish a notice in the Federal Register notifying
the public of its plans to evaluate a petition and soliciting
information relevant to the evaluation.
Sec. 83.11 What happens to petitions that HHS does not select for
evaluation?
(a) Qualified cancer claims by members of the class of employees
proposed in the petition will be subject to NIOSH dose reconstructions
under 42 CFR part 82. \5\ If NIOSH is unable to complete such dose
reconstructions, a petitioner on behalf of the class can submit a new
petition on this basis, as provided under Sec. 83.9(a).
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\5\ Only claims which DOL determines involve a covered employee
who has cancer can be adjudicated by DOL to receive dose
reconstructions by NIOSH under the DOL and HHS rules cited.
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(b) Based on new information, HHS may, at its discretion,
reconsider a petition that was not selected for evaluation.
Sec. 83.12 How will NIOSH evaluate a petition?
(a) NIOSH will collect information on the types and levels of
radiation exposures that potential members of the class may have
incurred, as specified under 42 CFR 82.14, from the following potential
sources, as necessary:
(1) The petition or petitions submitted on behalf of the class;
(2) DOE;
(3) Potential members of the class and their survivors;
(4) Labor unions who represent or represented employees at the
facility during the relevant period of employment;
(5) Managers, radiation safety officials, and other witnesses
present during the relevant period of employment at the DOE or AWE
facility;
(6) NIOSH records from epidemiological research on DOE populations
and records from dose reconstructions conducted under 42 CFR Part 82;
(7) Records from research, dose reconstructions, medical screening
programs, and other related activities conducted to evaluate the health
and/or radiation exposures of employees of DOE, DOE contractors or
subcontractors, and the AWEs;
(8) Information obtained from any public meetings NIOSH convenes;
and
(9) Other sources.
[[Page 42972]]
(b) NIOSH will evaluate records and information collected to make
the following determinations:
(1) Is there a ``reasonable likelihood that such radiation dose may
have endangered the health of members of the class?'
(i) To make this determination, NIOSH will interpret the statutory
term ``endangered the health'' [see 42 U.S.C. 7384q(b)(2)] to mean
there is a reasonable likelihood that the radiation dose may have
caused a specified cancer, since the Cohort claims based on provisions
of the Act can only be approved for specified cancers under the
relevant provisions of EEOICPA, [see 42 U.S.C. 7384l(9) and (17)].
(ii) To determine whether radiation levels could have caused a
specified cancer, NIOSH will determine the minimum level of radiation
dose at which NIOSH-IREP will produce a probability of causation of 50%
at the upper 99 percent credibility limit for the most radiogenic \6\
specified cancer or cancers that could have resulted from the types of
radiation exposures potentially incurred by potential members of the
class. NIOSH will use reasonable values that confer the benefit of the
doubt to the class for demographic factors used by NIOSH-IREP cancer
models, such as gender and age at time of radiation exposure, except
when actual values are known for the class in general; when the actual
values are known, NIOSH will use these values to the extent possible.
Similarly, NIOSH will use reasonable values conferring the benefit of
the doubt to the class in selecting any radiation exposure parameters
that are unknown and that affect the probability of causation estimate.
Using this procedure to establish a minimum radiation dose level, NIOSH
will determine whether potential members of the class could have
incurred at least this threshold dose.
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\6\ The ``most radiogenic'' specified cancer will be the type of
specified cancer that is most readily caused by the radiation
exposures to which the employees were potentially exposed. In more
technical terms, it will be the type of specified cancer which
requires the lowest dose of the radiation types to which the
employees were potentially exposed to produce a probability of
causation of 50 percent at the upper 99 percent confidence limit
using NIOSH-IREP. In a case in which the most radiogenic specified
cancer is leukemia, NIOSH would select both leukemia and the most
radiogenic solid tumor cancer and apply them separately in the
NIOSH-IREP analysis discussed in this section, and then average the
two resulting threshold doses to establish the threshold dose to be
applied in evaluating health endangerment for the class.
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(2) Can the level of radiation exposures to individual members of
the class be estimated, using the methods of dose reconstruction
established under 42 CFR Part 82?
(3) How should the class be defined, to be consistent with the
findings of paragraphs (b)(1) and (2) of this section?
(c) NIOSH will submit a report of its evaluation findings to the
Board and to the petitioner(s). The report will include the following
elements:
(1) An identification of the relevant petitions;
(2) A proposed definition of the class or classes of employees to
which the evaluation applies, and a summary of the basis for this
definition, including any justification that may be needed for the
inclusion of individuals who were not identified in the original
petition(s), the identification of any individuals who were identified
in the original petition(s) who should constitute a separate class of
employees, and the merging of multiple petitions that represent a
single class of employees; the proposed class definition(s) will
address the following parameters:
(i) The DOE or AWE facility that employed the class;
(ii) The job titles and/or job duties and/or work locations of
class members;
(iii) The period of employment within which a class member must
have been employed at the facility under the job titles and/or
performing the job duties and/or working in the locations specified in
this class definition;
(iv) If applicable, an identification of an unmonitored or
unrecorded exposure incident or incidents, when such an incident(s)
comprises the basis of the petition; and
(v) A minimum duration of employment for inclusion in the class;
\7\ and
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\7\ NIOSH will define the minimum duration of employment as 250
days for classes for which NIOSH lacks a substantial basis to
support establishment of a different minimum duration.
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(vi) Any other parameters that serve to define the membership of
the class.
(3) a summary of the findings evaluating the potential for the
health of members of the class to have been endangered by radiation
exposures incurred in the performance of duty, and a description of the
evaluation methods and information upon which these findings are based;
and
(4) a summary of the findings evaluating the adequacy of existing
records and information to allow for the successful reconstruction of
doses for individual members of the class under the methods of 42 CFR
Part 82; and a description of the evaluation methods and information
upon which these findings are based.
Sec. 83.13 How will the Board evaluate a petition?
(a) NIOSH will publish a notice in the Federal Register in advance
of a Board meeting, summarizing the petition(s) to be considered by the
Board at the meeting and the findings of NIOSH from evaluating the
petition(s).
(b) The Board will review the petition(s) and the NIOSH evaluation
report at the meeting, at which the petitioner(s) will be invited to
present views and evidence regarding the petition(s) and the NIOSH
evaluation findings.
(c) NIOSH may decide to conduct additional evaluation addressing a
petition(s), upon the request of the Board. If NIOSH conducts further
evaluation, it will report new findings of this evaluation to the Board
and the petitioner(s).
(d) Upon the completion of NIOSH evaluation and deliberations of
the Board concerning a petition, the Board will develop and transmit to
the Secretary a consensus \8\ report containing its recommendations.
The Board's report will include the following:
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\8\ The term ``consensus'' as used with respect to the decisions
of federal advisory committees established under the Federal
Advisory Committee Act (FACA) does not necessarily mean
``unanimity.'' These committees have broad parameters under which
they can define the extent of agreement among members of the
committee that will constitute consensus and allow a decision to be
adopted as a decision of the committee.
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(1) The identification and inclusion of the relevant petition(s);
(2) The definition of the class of employees covered by the
recommendation;
(3) A recommendation as to whether or not the Secretary should
designate the class as an addition to the Cohort;
(4) The criteria and information upon which the recommendation is
based, including NIOSH evaluation reports, information presented by
petitioners, and the deliberation of the Board.
Sec. 83.14 How will the Secretary decide the outcome of a petition?
(a) The Secretary will propose, and transmit to all affected
petitioners, a decision to add or deny adding classes of employees to
the Cohort.
(b) HHS will provide the petitioner(s) 30 days to contest the
proposed decision of the Secretary. If the petitioner submits to HHS a
challenge that includes substantial evidence that the proposed decision
relies on a record of either factual or procedural errors in the
implementation of these procedures, then HHS will consider the evidence
submitted by the petitioner prior to issuing a final decision.
Challenges to
[[Page 42973]]
decisions of the Secretary under these procedures must be submitted in
writing, with accompanying documentation supporting the assertions.
(c) HHS will issue a final decision on the designation and
definition of the class, and transmit a report of the decision and the
criteria and information upon which the decision is based to the
petitioner(s).
(d) HHS will publish in the Federal Register at this time decisions
to deny adding a class of employees to the Cohort, including a
definition of the class and a summary of the criteria and information
upon which the decision is based. HHS will not publish in the Federal
Register affirmative decisions to add a class to the Cohort until
expiration of the 180 day congressional review period, as specified
under Sec. 83.15.
(e) As a matter of discretion, the Secretary may consider other
factors or employ other procedures not set forth in this part when he
deems it necessary to do so to address the circumstances of a
particular petition.
Sec. 83.15 What is the role of Congress in acting upon the final
decision of the Secretary to add a class of employees to the Cohort?
(a) If the Secretary designates a class of employees to be added to
the Cohort, the Secretary will transmit to Congress a report providing
the designation, the definition of the class of employees covered by
the designation, and the criteria and information upon which the
designation was based. \9\
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\9\ See 42 U.S.C. 7384l(14)(C)(ii).
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(b) A designation of the Secretary will take effect 180 days after
the date on which the report of the Secretary is submitted to Congress,
unless Congress takes an action that reverse or expedite the
designation.
(c) Within 200 days after transmittal of the report to Congress,
the Secretary will transmit to DOL and publish in the Federal Register
the definition of the class and one of the following outcomes:
(1) The addition of the class to the Cohort; or
(2) The result of any action by Congress to reverse or expedite the
decision of the Secretary to add the class to the Cohort.
Sec. 83.16 How can the Secretary cancel or modify a final decision to
add a class of employees to the Cohort?
(a) The Secretary can cancel a final decision to add a class to the
Cohort, or can modify a final decision to reduce the scope of a class
added by the Secretary, if HHS obtains records relevant to radiation
exposures of members of the class that enable NIOSH to estimate the
radiation doses incurred by individual members of the class through
dose reconstructions conducted under the requirements of 42 CFR Part
82.
(b) Before cancelling a final decision to add a class or modifying
a final decision to reduce the scope of a class, the Secretary intends
to follow evaluation procedures that are substantially similar to those
described above for adding a class of employees to the Cohort. The
procedures will include the following:
(1) Publication of a notice in the Federal Register informing the
public of the intent of the Secretary to review the final decision on
the basis of new information and describing procedures for this review;
(2) An analysis by NIOSH of the utility of the new information for
conducting dose reconstructions under 42 CFR Part 82; the analysis will
be performed consistently with the analysis of a petition by NIOSH
under Secs. 83.12(b)(2), 83.12(b)(3), 83.12(c)(2), and 83.12(c)(4);
(3) A recommendation by the Board to the Secretary as to whether or
not the Secretary should cancel or modify its final decision that added
the class to the Cohort, based upon a review by the Board of the NIOSH
analysis and any other relevant information considered by the Board;
(4) Any additional procedures that the Secretary may deem
appropriate, as specified in the notification provided for under
paragraph (b)(1) of this section.
Dated: June 12, 2002.
Tommy G. Thompson,
Secretary, Department of Health and Human Services.
[FR Doc. 02-15824 Filed 6-20-02; 2:46 pm]
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