[Federal Register Volume 68, Number 45 (Friday, March 7, 2003)]
[Proposed Rules]
[Pages 11294-11310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: X03-10307]
[[Page 11293]]
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Part IV
Department of Health and Human Services
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42 CFR Part 83
Procedure 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;
Proposed Rule
Federal Register&thnsp;/&thnsp;Vol. 68, No. 45&thnsp;/&thnsp;Friday,
March 7, 2003&thnsp;/&thnsp;Proposed Rules
[[Page 11294]]
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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 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. HHS previously published
a proposal for these procedures on June 25, 2002 (67 FR 42962). Public
comment on the original proposal has led HHS to make substantial
changes to the procedures that require issuance of this second notice
of proposed rulemaking.
DATES: HHS invites comments on this notice of proposed rulemaking from
interested parties. Comments must be received by April 7, 2003.
ADDRESSES: Address written comments on the notice of proposed
rulemaking to the NIOSH Docket Officer 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, MS–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.
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 over the
Internet on the National Institute for Occupational Safety and Health
(“NIOSH”), Office of Compensation Analysis and Support Web
page at www.cdc.gov/niosh/ocas, or comments will be available in
writing by request.
II. Background
A. Statutory Authority
The Energy Employees Occupational Illness Compensation Program Act,
42 U.S.C. 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 a
final rule governing DOL's administration of EEOICPA on December 26,
2002 (67 FR 78874).
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 included in the
Special Exposure Cohort who have a specified cancer, and eligible
survivors of these employees, qualify for compensation under EEOICPA.
The procedures HHS is proposing to use for considering Special Exposure
Cohort petitions were initially proposed as a notice of proposed
rulemaking on June 25, 2002 (67 FR 42962) under 42 CFR Part 83 and are
the subject of this second 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 final rule establishing
these “Probability of Causation” guidelines on May 2, 2002
(67 FR 22296) under 42 CFR Part 81.
(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 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 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 which employees comprise the Cohort
initially, including employees of DOE,
[[Page 11295]]
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 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 (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&thnsp;\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\&thnsp;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 can be found in this
rule under section 83.5.
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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 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 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 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
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 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 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 otherwise provides.”
E. Relationship of Proposed Procedures to 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).
The 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 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 [individual members of] the class
received.”
III. Summary of Public Comments
On June 25, 2002, HHS promulgated a notice of proposed rulemaking
specifying procedures for adding classes of employees to the Cohort (42
CFR part 83; see 67 FR 42962). Public comments were solicited from June
25, 2002 to August 26, 2002. During this period, comments were also
submitted by the Advisory Board on Radiation and Worker Health.
HHS received comments from nine organizations and 36 individuals.
Organizations commenting included several labor organizations
representing DOE workers, the Defense Threat Reduction Agency (which
conducts radiation dose reconstructions for a compensation program
serving U.S. Atomic Veterans), the Health Physics Society, and two
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
original proposal and the intent of the new rule provisions.
A. Feasibility of Dose Reconstructions
As noted 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. HHS received comments from several labor organizations and an
advocacy group recommending that the rule establish one or more clear
tests defining when dose reconstructions would not be feasible, some
commenters distinguishing this requirement as separate and apart from
the requirement for “sufficient accuracy.” One specific
recommendation is that HHS establish a time limit for completing dose
reconstructions, the expiration of which would determine the dose
reconstruction to be not feasible. HHS has consistently heard concern
about the duration of processes for adjudicating cancer claims and its
impact on claimants in failing health and their families. These
concerns were
[[Page 11296]]
presented by DOE and AWE employees and their survivors during four
public meetings convened to present the proposed rule during the
comment period in July and August, 2002.
HHS has not established in the proposed rule a feasibility test as
to whether dose reconstructions for the class could be completed within
a time limit. The factors that might delay a dose reconstruction would
typically be specific to an individual employee, versus a class of
employees, since the informational demands of a dose reconstruction are
cancer specific and employee specific. HHS also notes that the
development of the NIOSH dose reconstruction program has delayed all
dose reconstructions required to date, but that this is an inevitable
consequence of establishing a technical program of this unprecedented
scale and complexity, and of DOE's development of a commensurately
large records identification and retrieval system to support the NIOSH
dose reconstruction program.
Nevertheless, the development of the most efficient processes
possible to assist DOL in achieving timely adjudication of cancer
claims is a high priority for HHS. For this purpose, NIOSH will
consider the establishment of a time limit or guidelines concerning the
duration of individual dose reconstructions conducted under 42 CFR part
82, once the dose reconstruction program reaches its full operating
capacity.
B. Accuracy of Dose Reconstructions
NIOSH received various comments and recommendations that relate to
the determination, discussed above, as to whether it is feasible to
estimate doses to members of a class of employees with
“sufficient accuracy.”
Four labor organizations, an advocacy group, and several
individuals questioned the ability of NIOSH to reconstruct doses with
sufficient accuracy when DOE records are incomplete, lacking personal
monitoring records, alleged to be fraudulent, limited to co-worker
data, or lacking energy-specific dosimetry.
Most of these limitations are standard for a radiation dose
reconstruction program. The purpose of dose reconstructions is
specifically to estimate doses when records are incomplete or otherwise
inadequate. EEOICPA explicitly recognizes this fact and requires that
dose reconstructions be performed under precisely such circumstances.
Moreover, as discussed in the first notice of proposed rulemaking,
sufficient accuracy of estimates for a compensation program, in
contrast to estimates used for epidemiological research, is defined by
the extent that it assures the fair adjudication of claims, rather than
any arbitrary degree of precision. Hence, for the purposes of a
compensation program, a dose estimate is sufficiently accurate if it is
reasonably certain to be at least as high as the highest dose that
could plausibly have been received.
The labor organizations and advocacy group commenting on this rule
also requested that HHS provide one or more clear tests for when a dose
estimate would be sufficiently accurate.
NIOSH has established the use of maximum doses based on worst-case
assumptions in its dose reconstruction program whenever sufficient
information is available to support this approach and the additional
information needed for a more precise estimate is unavailable.
Accordingly, the more limited the dose information available for a
claim, the more likely it is a dose reconstruction will overestimate
the level of radiation dose, and the greater the degree of
overestimation, to achieve the objective of minimizing the possibility
of ever underestimating the radiation doses used to adjudicate a claim.
This dose reconstruction approach allows HHS to establish a more
qualified standard for sufficient accuracy than provided under the
initial notice of proposed rulemaking. Under section 83.13 of the
current proposal, 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 by any member of the class, based on the information available
and using “worst-case” assumptions. As discussed above,
such a maximum dose estimate would be used in dose reconstructions, if
available information is inadequate to establish more precise
estimates. This standard for sufficient accuracy is supported in
comments on this rule by the Health Physics Society and the Defense
Threat Reduction Agency. HHS believes this represents a fair standard
for sufficient accuracy under EEOICPA, since it provides that dose
reconstructions will be restricted to claims for which information is
sufficient to prevent the underestimation of an employee's dose.
The proposed rule also specifies some general guidance for
potential petitioners to consider with respect to whether there is
sufficient information for NIOSH to estimate doses. In addition, NIOSH
will publicize summaries of specific circumstances in which NIOSH is
unable to complete dose reconstructions with sufficient accuracy, as
such cases arise through the NIOSH dose reconstruction program. These
findings will be made available to the public on the Internet at http:/
/www.cdc.gov/niosh/ocas or by request. Finally, NIOSH will work with
the Board to develop other generic guidance, to the extent additional
generic guidance is possible, concerning the feasibility of dose
reconstructions.
The Health Physics Society further recommended that determinations
of the feasibility of estimating doses with sufficient accuracy be
limited to relevant cancers. This comment reflects the fact that the
feasibility of a dose reconstruction can be specific to certain cancer
sites in the body and hence to the type of cancer an employee incurs.
For example, internal doses of radiation resulting from inhalation,
ingestion, or absorption of internal emitters, such as radon progeny or
uranium, only concentrate and significantly irradiate certain organs
and tissues. Hence, it may be appropriate to limit the finding that it
is not feasible to estimate radiation doses with sufficient accuracy to
certain tissue-specific cancer sites relevant to individuals with
specific types of cancers.
HHS has added provisions under sections 83.13 (b)(1)(iv),
83.13(b)(2)(iii), and 83.13(c)(4) of this rule to allow HHS to limit
the definition of a class to those individuals who incur one or more of
a limited set of types of cancers, when appropriate, as discussed
above. These provisions will allow HHS to adhere fully to the statutory
requirement that HHS find that “it is not feasible to estimate
with sufficient accuracy the radiation dose that the class
received.” It will mean that in certain cases, HHS might add to
the Cohort a class of employees whose membership is limited to
employees who have incurred a cancer from a set of one or more types of
cancers specified in the definition of the class established by HHS.
(The cancer type or types HHS would specify in such cases could include
one or more cancer types that are not included in the list of specified
cancers established under EEOICPA and defined in section 83.5(k) of
this rule,\2\ as well as one or
[[Page 11297]]
more cancers included in the list of specified cancers.) Co-workers of
the employees who do not incur any of the cancers included by HHS would
not be included as members of the class added to the Cohort. NIOSH
would conduct dose reconstructions for cancer claims covering these co-
workers.
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\2\&thnsp;Readers should note that while HHS could define a
class of employees by a type of cancer that is not in the list of
specified cancers, DOL can only award compensation to members of
such a class as a member of the Cohort if they incur one or more of
the specified cancers, as required by EEOICPA (42 U.S.C.
7384l(9)(A)). Hence, members included in the class because they have
a type of cancer that is not in the specified cancer list must also
have or develop a type of cancer that is in the specified cancer
list to receive compensation as a member of the Cohort.
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C. Health Endangerment
The four labor organizations and two advocacy groups commenting on
the rule, and one individual opposed the use of risk models (NIOSH-
IREP) to establish whether or not the health of a class of employees
petitioning to be added to the Cohort was endangered. The commenters
believe health physicists could not make reliable determinations as to
whether the dose to which a class may have been exposed could have
exceeded the dose benchmark that was to be established using risk
models. The commenters also questioned the procedure for using the risk
models, which they found insufficiently detailed, and were concerned
that use of risk models would set too stringent a standard for health
endangerment. In place of using risk models, the commenters recommended
either the use of physician opinion or the employment and monitoring
criteria that Congress specified to be used for the statutorily defined
members of the Cohort employed by the gaseous diffusion plants in
EEOICPA (see 42 U.S.C. 7384l(14)). Alternatively, several individual
commenters recommended use of epidemiological analyses, comparing the
health of employees at the sites included by Congress in the Cohort to
the health of groups of employees at other sites petitioning to be
added to the Cohort.
The current proposed standard to be used by NIOSH for establishing
sufficient accuracy in section 83.13 would allow HHS to omit the use of
risk models in establishing health endangerment. Under this standard,
when NIOSH is unable to estimate doses with sufficient accuracy, then,
by definition, NIOSH will not be able to estimate the maximum dose that
employees in the class might have incurred. Lacking a factual basis for
establishing such a cap or upper bound to the possible level of
radiation exposure, NIOSH cannot quantitatively evaluate health
endangerment. The procedure that remains in the rule for establishing
that health may have been endangered is described under section
83.13(b)(3). As recommended by several labor organizations, the
advocacy groups, and individual commenters, this procedure is similar
to the approach taken by Congress in 42 U.S.C. 7384l(14), but it allows
NIOSH greater flexibility to make use of detailed information that
might be available.
First, instead of using a general monitoring criterion to indicate
which employees had radiation exposure, NIOSH will specifically
identify, by job title and other employment parameters, employees with
potential exposure, as provided under section 83.13. This allows NIOSH
to specifically include within a class those employees with potential
for radiation exposure whose doses cannot be estimated with sufficient
accuracy.
Second, NIOSH might not universally apply the 250 day employment
criterion that Congress specified in 42 U.S.C.
§&thnsp;7384l(14)(A). NIOSH will use the 250 day employment
criterion only when it lacks sufficient basis to establish a lower
minimum duration.
Specifically, when the exposure of concern occurred during a
discrete incident 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, the proposed rule would allow NIOSH
to specify presence during the incident as sufficient employment
duration for including members in the class. In these cases, it would
be impossible to specify any duration of exposure that would delimit
the potential for health endangerment, and the 250 day default
criterion would be irrelevant.
HHS has not incorporated into the rule the recommendation of one
labor organization to establish health endangerment on the basis of a
physician's opinion. The commenter suggested this model would be
appropriate because it is used for making determinations in workers'
compensation programs. Physicians evaluate occupational causation and
degree of impairment for patients seeking workers' compensation, but
under this rule there is no patient to evaluate, only very limited
exposure information pertaining to a class of employees. A physician
could not judge health endangerment with respect to exposure to
ionizing radiation without dose information on the class of employees
and specification of the cancers incurred by the employees.
HHS also has not incorporated into the rule the recommendation to
base determinations of health endangerment on epidemiological
comparisons between the health of congressionally established classes
and future classes to be designated by the Secretary, or on the basis
of any other epidemiological comparisons.
Epidemiological comparisons would require health data that would
not be available in reasonable time. Moreover, there would be numerous
methodological difficulties in making such comparisons, as was
generally recognized by the commenters making this recommendation. For
example, comparisons would require populations of sufficient size for
analysis, whereas the size of classes of employees may often be too
small to permit valid analyses.
D. Timeliness of Dose Reconstructions and Petition Decisions
The four labor organizations, two advocacy groups, and several
individuals expressed concern about the time that may be required to
conduct a dose reconstruction and, if a dose reconstruction is not
feasible, the additional time required to add a class of employees to
the Cohort. They recommended NIOSH establish a time limit on its dose
reconstructions, the tolling of which would determine the dose
reconstruction to be infeasible, and they recommended time limits on
actions involved in considering a petition for adding a class to the
Cohort. Individual commenters were specifically concerned about the
time required to add a claimant with cancer to the Cohort, if NIOSH
determines that it cannot complete his dose reconstruction.
HHS agrees that it should achieve a reasonable balance between the
duration of effort to obtain data for a dose reconstruction and the
speed with which it can complete a dose reconstruction. The NIOSH dose
reconstruction rule (42 CFR part 82) and program incorporate efficiency
measures to address precisely this concern. Taking this a step further,
as discussed above, NIOSH will consider establishing a time limit or
time guidelines for the completion of a dose reconstruction.
In addition to these measures, section 83.14 has been added to the
proposed rule to expedite the consideration of petitions by claimants
for whom NIOSH has found it cannot complete dose reconstructions under
42 CFR part 82. The new section would allow NIOSH to establish for
evaluation a class of employees based only on the information obtained
during the attempt to conduct the dose reconstruction for the employee
covered by such a claim, so that adding the employee to the Cohort,
together with other employees who match the same essential
characteristics, could be considered by the Board and HHS without
delay. HHS would then, through collection and
[[Page 11298]]
analysis of additional information, separately evaluate the possibility
that there might be additional groups of employees whose circumstances
are similar and would hence constitute a broader class of employees at
the facility that should be added to the Cohort, under the procedures
specified in section 83.13. This system should effectively ensure that
classes of employees including a cancer claimant for whom NIOSH could
not complete a dose reconstruction are considered for addition to the
Cohort as quickly as possible.
HHS has not adopted the recommendation to apply regulatory time
limits to the evaluation of petitions, the tolling of which would,
without other consideration, result in the addition of such petitioning
classes to the Cohort. Such a policy would conflict with the
requirements under EEOICPA that Cohort additions be limited to classes
of employees for whom it is not feasible to estimate radiation doses
with sufficient accuracy and whose health may have been endangered by
radiation doses. It could also broadly undermine the intent under
EEOICPA to adjudicate cancer claims, whenever feasible, consistently
with the requirements cited above: on the basis of whether it is
“at least as likely as not” that such cancers were caused
by radiation doses incurred in the performance of duty for nuclear
weapons programs.
The establishment of regulatory time limits for petitions would be
imprudent as well, since HHS cannot control the scope or volume of
petitions it receives. A single petition could cover thousands of
employees involved in hundreds of different occupations and activities
over many years of operations at a facility. HHS could also receive
hundreds of petitions simultaneously. In either of these circumstances,
the resources of HHS and the Board to evaluate the petitions within a
fixed deadline could readily be overwhelmed. HHS would then be required
by regulation to add these classes of employees to the Cohort
automatically.
HHS also received recommendations from individuals, employees,
survivors, and a labor organization, to achieve timeliness by
streamlining processes as much as possible, and in particular, again,
for claimants for whom NIOSH has already established the infeasibility
of completing their dose reconstruction.
As discussed above, HHS has added special procedures to streamline
the petition decision process for claimants. In addition, based on a
recommendation by the Board, HHS has eliminated a requirement that the
Board review NIOSH decisions to deny evaluations of petitions that do
not meet minimal petition requirements. Under section 83.11 of the
rule, the Board now has the option, rather than the duty, to advise
NIOSH concerning such decisions.
One labor organization recommended against the use of notices in
the Federal Register to notify the public about relevant actions with
respect to a petition. The commenter expressed concern that such
notices would prolong the time required to consider petitions. An
advocacy group, however, specifically commended the use of such notices
and recommended another opportunity within the procedures to provide
such notice.
The notices proposed have been retained. These notices can be
issued by HHS without delaying the evaluation of petitions. The notices
serve the intended purpose of officially informing the public of HHS
actions of consequence. They also serve as a basis for further
disseminating this information through the NIOSH and other federal
agency communications, public media, and other information outlets
serving interested parties.
One labor organization recommended that the Board meet frequently
to minimize delays with respect to its role in advising the Secretary
on Cohort decisions.
HHS intends to convene the Board as frequently as necessary and
possible for this purpose.
E. Defining a “Class” and Its Membership
Several individual commenters questioned the meaning of a
“class” of employees. Relevant to this, one commenter
wanted to know what would happen if a class included some members for
whom dose reconstruction is feasible and others for whom it is not
feasible. Another commenter wanted to know whether a petition could
cover all the employees of an entire facility, as a single class.
Finally, the two advocacy groups recommended the definition of a class
allow for the possibility that a class of employees was employed at
multiple facilities. Such classes might include certain crews of
construction or maintenance workers that might have been assigned to
work at several facilities.
The concept of a class is defined generically in section 83.5 of
the rule. To summarize, a class is a group of employees whose members
must have two factors in common: they must have worked at the same
facility; and the availability of records and information must be
comparable with respect to the feasibility of estimating their
radiation doses with sufficient accuracy. Petitioners will be
encouraged to define a class as specifically as possible and
appropriate with respect to other parameters, such as dates of
employment, occupations, specific locations of work, specific
operations of concern, etc.
One result of the process of evaluating a petition will be to
establish the final definition of the class, which may differ from the
class definition as it was proposed initially by the petitioner(s). The
class might be redefined because the proposed definition mixed
employees whose doses can be estimated with others whose doses cannot
be estimated, as commented above. Classes will be very specifically
defined, as described under provisions of section 83.13, with respect
to a variety of employment parameters, such as dates of employment or
job titles, to precisely identify the group of employees included in
the decision by the Secretary to add or denying adding the class to the
Cohort.
It is allowable under section 83.9 of this proposed rule to submit
a petition defining the class as all the employees at the facility or
any subset thereof, insofar as the petition provides adequate
justification for being broadly inclusive. This section of the rule is
intended, however, to require as much specificity as is consistent with
the justification. It is in the interest of the petitioners to specify
the class as narrowly as warranted. In general, the broader the
petitioner(s) defines the class, the more time will be required to
evaluate the petition, since HHS will have to determine whether the
proposed class includes heterogeneous groups of employees with respect
to the requirements of this rule. For example, if a petition defines a
class as all employees who worked in a certain building without
specifying the relevant time period or relevant occupations, HHS would
have to determine whether all occupations were potentially exposed to
radiation doses that cannot be estimated. It is possible that
monitoring or records might be deficient only for employees working
during a certain period of time, or for certain occupations employed in
the building.
By defining the class more broadly than warranted, the
petitioner(s) also risks HHS's determining against the petition in its
entirety, despite the possibility that some subgroups covered by the
class definition might qualify. HHS will be diligent in evaluating
major subgroups of employees that HHS discerns under a broad class
definition, but the more broadly the class is
[[Page 11299]]
defined, the less likely HHS is to identify all possible subgroups.
HHS has not revised the definition of class to allow for a class of
employees defined as having been employed at multiple facilities, as
proposed by commenters. 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) does not allow HHS to define a
class as a group of employees from multiple facilities. Congress refers
to “facility” in the singular form in each place it is used
in this section (“class of employees at any Department of Energy
facility who likely were exposed to radiation at that facility”
in 42 U.S.C. 7384q(a)(1); “a Department of Energy facility or at
an atomic weapons employer facility” in 42 U.S.C. 7384q(b);
(emphasis added in both sections)). This limitation would not, however,
prevent a petitioner(s) from submitting petitions separately for
employees at each facility at which the class was employed, defining
separate, facility-specific classes.
F. Modifications and Cancellations of Cohort Additions
Two labor organizations, the two advocacy groups, and several
individuals commented on the provisions under section 83.18 of the
current proposal allowing the Secretary to cancel or modify a class
once it is established. The commenters recommended such a decision by
the Secretary should only apply prospectively, for the adjudication of
future claims. In other words, they recommended 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.
DOL will determine the relevance of such decisions by HHS with
respect to claims that DOL has already decided and claimants who have
already received compensation.
G. Submission of Petitions to the Board
The two advocacy groups and one labor organization recommended that
all petitions evaluated by NIOSH be submitted to the Board as well.
This comment appears to refer to the Board's recommendation that it not
have a role in deciding whether or not a petition meets the minimal
requirements to be evaluated by NIOSH, the Board, and HHS (see Board
recommendations in the following section). The Board considered its
role to be limited to the evaluation of qualified petitions and
recommended that NIOSH or HHS have the exclusive administrative role to
ensure that petitions meet basic requirements.
HHS has revised the rule consistently with the view of the Board.
Under section 83.12, the Board will receive all petitions that NIOSH
ultimately finds meet the requirements for evaluation. Under section
83.10, however, the Board will not review petitions that NIOSH finds do
not meet the requirements for evaluation. It should be noted that
before making such a final decision, NIOSH will first provide
petitioners with guidance and time to remedy petitions that initially
do not meet the requirements. In light of this provision, HHS seeks
comment on whether HHS should provide an option for petitioners to seek
an administrative review of adverse final decisions.
H. Petitions by Claimants
Several individuals recommended against requiring claimants to
petition when NIOSH has found that it cannot complete their dose
reconstructions. They suggested NIOSH should initiate action to
evaluate such classes automatically, upon establishing such a finding.
HHS interprets EEOICPA as requiring the submission of a petition to
initiate consideration for adding a class of employees to the Cohort.
However, as specified under the dose reconstruction rule (42 CFR part
82.12), NIOSH will encourage claimants in these circumstances to file a
petition. In addition, HHS has designed the requirements and procedures
to minimize the burden on these claimants as petitioners. As provided
under section 83.9, the claimant is required only to authorize a
petition. No other documentation or information is required.
I. Use of Information by the Board for Evaluating a Petition
Two labor organizations commented that the statute allows the Board
to provide advice concerning a petition using information other than
exposure assessments by radiation health professionals and information
from DOE. This provision of EEOICPA is specifically quoted under the
“statutory requirements. . .” sections of this
and the previous notices (see section II.D above).
The initial proposal did not limit the information the Board could
obtain and consider. However, in response to the comment, under section
83.15 of the current proposal, HHS has specifically authorized the
Board to obtain and consider such information as it considers
appropriate.
J. Use of Federal Register Notices by HHS in the Petition Process
Two advocacy groups recommended that HHS issue a Federal Register
notice, in addition to those already proposed, to inform the public
that HHS has sent a report to Congress designating a class for addition
to the Cohort, for review by Congress.
HHS omitted such a notice from the original proposal out of concern
that notifying the public of affirmative decisions prior to their
review by Congress might be confusing, particularly if Congress were to
reverse such a decision. It is probably more important, however, that
interested parties are informed to ensure they have the opportunity to
make their views known to Congress. Hence, HHS agrees with the
recommendation and has added such a notice.
K. Publicizing HHS Decisions
One labor organization recommended that HHS use other announcement
procedures, in addition to publication in the Federal Register, to
notify classes of their addition to the Cohort or of modifications of
an added class.
HHS intends to work with DOE, DOL, AWEs, public media, labor
organizations, and others to publicize decisions. Such activities,
however, do not require specification in the rule.
L. Transmission of Designations of New Classes to DOL
Two advocacy groups and one labor organization recommended that HHS
transmit designations adding classes to the Cohort to DOL on the first
business day following expiration of the 180 day congressional review
period.
HHS has committed in the current proposal to transmit designations
within five days of either expiration of the congressional review
period or final congressional action, whichever occurs first. The five
day period is a maximum, not a minimum, and allows for the potential
for delay in communications between Congress and HHS and for
administrative processes within HHS.
M. Eligible Petitioners
The initial proposal defined eligible petitioners to include
employees, survivors, and labor organizations. One individual
recommended adding to the list of eligible petitioners the [management]
staff of DOE field offices and sites, on the basis that they may have
expertise on employee classes with radiation exposure for whom dose
reconstructions may not be feasible. The two advocacy groups
recommended that non-union worker advocacy groups be added to the list.
[[Page 11300]]
In section 83.7(c) of the proposal, HHS has allowed for a worker or
survivor to authorize any individual or entity, such as a worker
advocacy group, to petition on behalf of a class. HHS has not
specifically added the management staff of DOE field offices and sites.
Employees of DOE sites and field offices with work experience at DOE
sites are generally included among those eligible to submit petitions
under section 83.7(a) (if they would themselves be included among the
proposed class of employees) and (c) (if, in the proper discharge of
their official duties, they are petitioning on behalf of other
employees who would be included in the proposed class).
One individual raised concerns about one of the introductory
sections of the rule (section 83.2), as it was initially proposed. The
commenter believed it could be interpreted to require employees or
survivors to submit a claim for compensation to DOL as a prerequisite
to petitioning for addition to the Cohort.
The text of concern, which was explanatory and not procedural, has
been deleted from the rule to streamline the rule as much as possible.
Employees and their survivors are not required to submit a claim as a
prerequisite to petitioning for a class. On the other hand, HHS and DOL
encourage any employee who has incurred a cancer and hence is eligible
to submit a claim to do so immediately. Medical benefits for a cancer
claim awarded under EEOICPA are established based on the date on which
the claim is submitted to DOL. Any medical costs for the cancer
incurred before the date the claim is submitted would not be covered.
For this reason, employees with cancer should submit claims to DOL
without delay.
N. Petition Informational Requirements
Labor organizations and the two advocacy groups submitted a variety
of comments concerning the informational requirements of a petition,
and recommended not requiring the use of a form for petitioning. In
general, these comments argued for less burden on petitioners.
Under section 83.9, HHS has reduced the informational requirements
substantially to comprise a minimal basis for justifying a petition.
HHS has eliminated the requirement that petitioners have sought records
from DOE or AWEs to demonstrate a basis for concern about the
feasibility of estimating radiation doses for the class. HHS recognizes
that such efforts could be of little practical value to the evaluation
of a petition. HHS has also eliminated the requirement that petitioners
demonstrate a basis for suspecting the health of the class may have
been endangered, since the basis for establishing health endangerment
under the proposal (a finding that doses cannot be estimated with
sufficient accuracy and a determination as to whether this finding
applies to radiation exposure during a discrete exposure incident or
during routine operations) does not require information available to
the petitioners.
The procedures continue to require petitioners to justify their
concern that it may not be feasible to estimate the radiation dose
incurred by employees of the class with sufficient accuracy. HHS has
attempted to specify clear and minimal requirements for this
justification. The procedures also may require petitioners to
substantiate the occurrence of discrete exposure incidents potentially
involving high level exposures, when such an incident comprises the
basis of the petition and if NIOSH is otherwise unable to verify the
occurrence of incident through other sources. The evidence that may be
required in these cases, however, is similar to informational
requirements that were included in the initial proposed rule.
Finally, HHS has made optional the use of a petition form for the
submission of petitions, although its use should assist, rather than
burden, petitioners.
O. Technical Assistance for Petitioners
One labor organization and the two advocacy groups recommended HHS
sponsor technical assistance or training for petitioners to address
informational requirements. The commenters suggested some petitioners
are unlikely to have sufficient expertise to address these requirements
without assistance.
Although NIOSH will provide guidance to petitioners, HHS does not
intend to sponsor independent technical experts to assist petitioners
in developing the basis for a petition. The purpose of a petition, as
discussed in the rule, is to identify classes of employees that should
be considered for addition to the Cohort. In other words, it is to
bring to the attention of the Board, NIOSH, and HHS, classes of
employees who were exposed to radiation at a DOE or AWE facility but
for whom there are reasonable grounds to suspect radiation doses cannot
be estimated with sufficient accuracy. If a petitioner lacks reasonable
grounds for identifying such a class, as defined in the rule, they
should not file a petition. In addition, in cases where members of the
class submit claims and NIOSH determines that it cannot complete dose
reconstructions for them, this finding can serve as the basis for a
Cohort petition.
P. Basis for Petitioning
One labor organization recommended that petitioners should be
permitted to petition on the basis of qualitative or quantitative
information, and any such information as the Board deems appropriate.
The commenter further recommended that the petitioner should not be
required to prove that doses cannot be estimated or that health was
endangered.
In this rule, HHS has identified minimal requirements for a
petition. A petition that does not meet these minimal requirements
would not present a substantial likelihood of identifying a class that
should be added to the Cohort, according to the statutory requirements
for making such additions.
Meeting these petition requirements does not prove, however, that
the statutory requirements will be met; the petitioner is not proving
that it is not feasible to estimate doses with sufficient accuracy and
that doses may have endangered the health of members of the class.
These statutory requirements will be determined in the course of
evaluating the petition.
The Board has had the opportunity to recommend alternatives to the
petition requirements in the initial proposal. The Board's
recommendations on requirements for petitions are reflected in the
current proposal without exception, as discussed in Section IV below.
The Board will have the opportunity again to recommend requirements
during the public comment period on this second notice. HHS will
consider any such alternatives for use in the final rule. In addition,
section 83.11(c) of the current proposal would allow the Board to
advise NIOSH concerning a petition after NIOSH has preliminarily found
the petition does not meet the requirements specified in the rule.
Q. Deciding Whether To Petition
Several individuals sought guidance concerning how one should
decide whether or not to petition to be added to the Cohort. One
commenter noted that he had a claim awaiting dose reconstruction and
wanted to know whether he should petition immediately or await the
outcome of the dose reconstruction. Another commenter noted more
generally that an employee may want to consider whether he has a better
chance of being compensated as a member of the Cohort or through dose
reconstruction. The commenter recommended that HHS provide in the
[[Page 11301]]
rule as much guidance as possible concerning these decisions.
The rule provides clear requirements explaining who is eligible to
petition and identifying the information required of the petitioners.
In terms of helping individuals decide whether to petition, as
discussed in the HHS rule on dose reconstruction (42 CFR part 82.12),
NIOSH will directly encourage any claimant for whom it cannot complete
a dose reconstruction to petition. As discussed above, HHS and DOL also
encourage any employee who has incurred a cancer to submit a claim to
DOL immediately, whether or not they submit a petition to HHS, since
medical benefits only cover medical costs incurred for the cancer
beginning on the date a claim is submitted. Otherwise, HHS generally
encourages petitions whenever there is justification, as specified in
the rule; in other words, whenever it is known that a class of
employees was exposed to radiation that was not monitored, either by
personal dosimetry such as radiation badges and biological tests, or by
monitoring of the area in which the class of employees worked.
Knowledge that the records of such monitoring were destroyed, lost, or
falsified would also justify submitting a petition. The rule also
specifies expert sources that may justify a petition.
Petitioners should understand, however, that having justification
to petition does not mean that the petition will be successful. For
example, in some cases NIOSH may be able to conduct dose
reconstructions even when no radiation monitoring information is
available, using knowledge of health physics and with sufficient
information on the radiation source, quantity, and the relevant work
processes that might involve radiation exposures.
It also may be useful for potential petitioners to understand how
HHS plans to prioritize petitions for evaluation. The highest priority
petitions will be those based on NIOSH finding that it is unable to
complete a dose reconstruction for a claimant. These petitions will be
evaluated first because in these cases, HHS already knows there is a
class of employees for whom dose reconstructions are infeasible and
among whom one or more individuals have incurred cancer, for which a
claimant is awaiting a decision on a claim. The second highest priority
will be petitions for a class of employees that does not include
current claimants awaiting dose reconstructions. The lowest priority
will be petitions including current claimants awaiting dose
reconstructions, since the dose reconstruction process will determine
whether or not it is feasible to estimate doses with sufficient
accuracy for these claimants. If NIOSH finds the dose reconstructions
cannot be completed for these claimants, then their petition process
will be expedited, as described above.
R. Use of Unspecified Procedures by HHS
One labor organization recommended that HHS strike provisions in
the initially proposed rule (section 83.14(e)) that would have allowed
the Secretary to make Cohort determinations based on factors and
procedures other than those specified in the rule.
HHS has omitted this provision from the current proposed rule. The
provision was intended to permit the Secretary flexibility in
responding to novel, unforseen issues that might arise in the course of
considering the addition of a particular class of employees. Upon
further consideration, HHS believes the specified procedures of this
rule will fully and expeditiously serve its purpose.
S. Decisionmaking Authority
HHS received several comments concerning its authority to determine
whether or not to add a class of employees to the Cohort. One labor
organization recommended HHS be required to comply with the
recommendation of the Board. Another labor organization and an advocacy
group recommended the Secretary delegate authority for such
determinations to the Director of NIOSH to expedite the determinations.
Section 3626 of EEOICPA (42 U.S.C. 7384q) specifically authorizes
the President (delegated to the Secretary of HHS) to determine whether
or not to add a class of employees to the Cohort and specifically
limits the role of the Board to providing advice related to such
determinations. Hence, this rule cannot make the recommendations of the
Board binding on the Secretary. Moreover, the Federal Advisory
Committee Act, under which the Board is established, specifies the
following: “Unless otherwise specifically provided by statute or
Presidential directive, advisory committees shall be utilized solely
for advisory functions. Determinations of action to be taken and policy
to be expressed with respect to matters upon which an advisory
committee reports or makes recommendations shall be made solely by the
President or an officer of the Federal Government.” (5 U.S.C.A.
App. 2 §&thnsp;9(b)).
The Secretary can delegate authority to the Director of NIOSH to
determine the designation of classes of employees. The Secretary may
consider such a delegation of authority for the designation of certain
classes of employees if, upon experience, the Secretary finds this is
likely to improve the effectiveness and efficiency of the program.
T. Regulatory Approach
HHS received several comments concerning the regulatory approach to
establishing these procedures. One labor organization and the two
advocacy groups recommended this rule be issued as an interim final
rule to allow HHS and petitioners to obtain experience with certain
elements of the rule before rulemaking is completed. Three other labor
organizations recommended that these procedures be issued as a general
statement of policy rather than a rule, asserting that more flexibility
is required in such procedures than could be encompassed in a rule. The
commenters did not specify, however, the provisions that require
greater flexibility.
As discussed below, HHS has determined that the rule, as initially
proposed, required changes that were not discussed in the initial
notice of proposed rulemaking and that could not reasonably have been
anticipated based on a reading of the initial notice. For this reason,
HHS is issuing this second notice of proposed rulemaking and obtaining
public comment on this revised proposal.
For the same reason, HHS does not find sufficient justification to
publish these procedures as an interim final rule with a request for
comments. If HHS were to issue the current proposal as an interim final
rule, the rule and determinations the Secretary would make under the
rule could be legally contested on the basis of HHS not having provided
sufficient notice and opportunity for public comment in advance of
issuing the rule. Such a contest could delay implementation of these
procedures more substantially than issuance of this second notice.
HHS considered the issuance of a statement of policy, versus a
rule, before issuing the initial proposed rule in June 2002. HHS found
then, and continues to find, that these procedures are regulatory in
nature, comprising requirements that are binding on petitioners and on
HHS.
U. Congressional Review Period
One individual commented that the 180 day congressional review
period should be eliminated or shortened to 60 days or less.
HHS must allow for the full 180 day review period as required by
law under
[[Page 11302]]
section 3621(14)(C)(ii) of EEOICPA (42 U.S.C. 7384l(14)(C)(ii)). Under
section 3621(14)(C)(ii), however, Congress can reduce this review
period to expedite the addition of a class to the Cohort. This is
acknowledged under section 83.17 of this rule.
V. Non-regulatory Comment: Dose Reconstructions for Cohort Members With
Non-Specified Cancers
HHS received several comments on matters extraneous to the rule,
but relevant to the Cohort.
The two advocacy groups and a labor organization questioned how
NIOSH would handle cancer claims for individuals in the Cohort who have
a cancer that is not one of the specified cancers.
DOL refers claims for individuals in the Cohort who have a cancer
that is not one of the specified cancers to NIOSH for dose
reconstruction. NIOSH will conduct these dose reconstructions if
sufficient information is available. The situation becomes complicated,
however, if the individual may have incurred radiation doses that NIOSH
cannot estimate, because the necessary information is not available.
This will be true for classes of employees added to the Cohort by the
Secretary.
NIOSH will develop dose reconstruction procedures with the advice
of the Board to address these circumstances. The procedures will have
to resolve the issue of whether or not to assign a radiation dose
covering a potential exposure that cannot be estimated with sufficient
accuracy, and if so, how to determine the characteristics and quantity
of dose to be assigned. This issue is further discussed under section
IV in response to a recommendation by the Board.
W. Non-Regulatory Comment: Giving Claimants the Benefit of the Doubt in
Dose Reconstructions
One labor organization commented that NIOSH dose reconstructions
should give the benefit of the doubt to the claimants when making
assumptions concerning potentially unknown factors, such as the
solubility of a radioactive material.
NIOSH gives the benefit of the doubt to claimants when making
assumptions concerning unknown factors, except when the claim involves
recorded doses sufficiently high to qualify for compensation without
full development of the dose estimate. The NIOSH implementation guides
for dose reconstructions, which are available from NIOSH, consistently
illustrate this policy.
X. Non-Regulatory Comment: Basis for Including Employees of the Gaseous
Diffusion Plants in the Cohort
Several individuals questioned the basis for the decision by
Congress to include employees of the gaseous diffusion plants in the
Cohort. The commenters believe the potential for health endangering
radiation exposure was as great or greater at other DOE facilities. For
this reason, the commenters indicated that Congress should have
included other DOE facilities in the Cohort.
This is a matter that was decided by Congress and is beyond the
control of HHS. Therefore, HHS has not responded to the comment.
Y. Non-Regulatory Comment: Basis for Limiting Cohort Provisions to the
22 Specified Cancers
Several individuals questioned the decision by Congress to limit
the diseases covered by EEOICPA for the compensation of employees as
members of the Cohort to 22 specified cancers. Commenters questioned
why other cancers are not included, as well as other illnesses such as
acute health effects from high levels of radiation and diseases related
to exposure to asbestos and heavy metals.
This is a matter that was decided by Congress and is beyond the
control of HHS. Therefore, HHS has not responded to the comment.
HHS notes that Congress also established Part D of EEOICPA to
assist DOE contractor employees in seeking compensation through the
appropriate state workers' compensation systems for occupational
illnesses related to toxic exposures at DOE facilities.
Z. Non-Regulatory Comment: Recommendations for Adding Specific Classes
to the Cohort
A labor organization, an advocacy group, and several individuals
recommended the addition of specific employee classes to the Cohort.
This rule must be promulgated through the issuance of a final rule
before petitions can be evaluated. NIOSH will notify individuals and
organizations who have indicated an interest in petitioning at that
time.
IV. Recommendations of the Advisory Board on Radiation and Worker
Health
HHS requested the Board to consider issues related to 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 public
meeting on May 2–3, and reviewed the initial notice of proposed
rulemaking during its public meetings on July 1–2, August
14–15, and August 22, 2002. In preparation for the July meeting,
the Board members individually reviewed the initial notice of proposed
rulemaking, which was published on June 25, 2002. The members also
considered public comments on these rules provided during public
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 proposed rule and related issues during the Board meetings. The
transcripts and minutes of these meetings are included in the NIOSH
docket for this rule and are available to the public.
All of the Board members participated in the review of these
guidelines and the members present at the August 22 meeting concurred
in establishing the Board findings and recommendations. The Board
provided recommendations on general issues related to the rule, as well
as recommendations for text and other changes to specific sections of
the rule. The recommendations, which are available to the public from
the NIOSH Docket, are summarized below, together with responses by HHS
to the recommendations.
A. Dose Reconstruction for Members of the Cohort
Claims for cancers that are not included among the specified
cancers cannot be compensated under provisions of EEOICPA covering
members of the Cohort. These claims will require a NIOSH dose
reconstruction and a probability of causation determination by DOL,
despite the fact that the employee is a member of the Cohort. The Board
recommended that NIOSH review the proposed rule to ensure it does not
preclude appropriate handling of these dose reconstructions. Relatedly,
the Board also recommended that NIOSH develop procedures [for dose
reconstructions] for claims for which the employee's dose history is
partially but not completely covered in the employment parameters that
define a Cohort class.
As discussed in response to similar public comments, this proposed
rule would not affect claims that require dose reconstructions. The
determination by the Secretary to add a class of employees to the
Cohort does, however, have implications for the conduct of dose
reconstructions for these members of the Cohort. When HHS adds members
to the Cohort, HHS will have determined that radiation doses for
[[Page 11303]]
those members cannot be estimated with sufficient accuracy. Hence,
NIOSH may not be able to complete dose reconstructions for these
members.
The ability of NIOSH to conduct such dose reconstructions may
depend on whether the claim is for an employee who had radiation
exposures that were not considered in designating his class of
employees as part of the Cohort. If the employee had sufficient
radiation exposure outside of his work experience as a member of the
Cohort to qualify for compensation, then his dose reconstruction could
be completed on the basis of this extraneous work history. In addition,
the ability to complete such dose reconstructions may depend on whether
NIOSH determines it could assign doses that cannot be estimated, and on
the procedures that would be established for such claims. NIOSH will
discuss with the Board this option to assign doses. Of particular
importance, NIOSH cannot establish a procedure that conflicts with
provisions of EEOICPA. EEOICPA strictly limits the list of specified
cancers that can presumptively qualify members of the Cohort for
compensation.
B. Procedures for Determining Health Endangerment
HHS initially proposed that health endangerment would be evaluated
using cancer risk models (NIOSH-IREP) to determine a level of dose that
would constitute health endangerment and then by determining,
subjectively if necessary, whether a class of employees could have
incurred such a dose level or higher. The Board considered these
procedures to be inadequately justified and potentially unfair. It
recommended, without specificity, that NIOSH consider other procedures.
HHS finds these comments from the Board and similar public comments
to be persuasive and is thus proposing substantially different
procedures for determining health endangerment that do not make use of
cancer risk models. Instead, HHS is proposing to define the class
members who have potential exposures that cannot be estimated with
sufficient accuracy and will use a duration of employment criterion.
The specific 250 day criterion applied by Congress in defining which
employees of the gaseous diffusion plants are included in the Cohort
under 42 U.S.C. 7384l(14) will serve as a default value, when a shorter
duration cannot be justified.
C. Dose Reconstructions Guidelines
The Board recommended HHS clarify in the preamble of this rule the
criteria for determining when it is not possible to complete an
individual dose reconstruction with sufficient accuracy. This would
assist potential petitioners to understand the criteria that will be
used to evaluate a petition. The Board also recommended NIOSH develop
guidelines outlining the criteria for determining that the available
data are not adequate for conducting dose reconstructions, and
recommended HHS consider the use of time limits. The Board recommended
the Board serve as a reviewer of these guidelines.
As discussed in response to similar comments from the public, HHS
has included in the proposed rule a criterion and guidance for how it
would determine under this rule that it is not feasible to estimate
radiation doses with sufficient accuracy. This guidance for the public
will be supplemented by NIOSH reports summarizing conditions in which
it finds it is unable to complete a dose reconstruction, as such cases
arise. In addition, NIOSH will consider the use of a time limit or time
guidelines for individual dose reconstructions under 42 CFR part 82,
once the program has reached full operating capacity.
NIOSH will also consult with the Board to supplement the criterion
and guidance provided in the rule in the form of dose reconstruction
guidelines. It is possible, however, that the basis for these
determinations will not be definable by additional, broadly applicable
criteria, beyond the criterion and guidance provided in the rule. If
so, case-specific summaries of circumstances when NIOSH could not
complete dose reconstructions, as discussed above, might provide the
best possible guidance on this issue.
D. Regulatory Approach
The Board recommended that HHS consider issuing these regulations
as an interim final rule rather than a final rule. The Board was
concerned that certain aspects of the final rule, if similar to the
rule initially proposed in June 2002, might prove through
implementation to require additional changes. If this were to occur,
consideration of petitions would be substantially delayed while HHS
conducted another rulemaking with a new proposal for notice and public
comment.
As discussed above in response to public comments, HHS has made
substantial changes to the proposed rule that require issuing another
notice of proposed rulemaking. In addition, as discussed previously,
HHS believes this is likely to be the most expeditious approach to
establishing procedures under which petitions can be considered.
E. Recommendations for Section 83.1 and 83.2
The Board recommended that HHS add text to this introductory
section of the rule to specify that NIOSH would take an active role in
identifying classes that should consider petitioning and in assisting
employees in such classes to petition.
The dose reconstruction rule (42 CFR part 82.12) specifies the
active role NIOSH will take to encourage and assist claimants to
petition for the addition of a class, on the basis that their dose
reconstructions could not be completed. In addition, this proposed rule
specifies the assistance NIOSH will provide to petitioners who have not
initially provided sufficient information for their petition.
HHS does not agree that the proposed rule should also include a
commitment for NIOSH to identify employees for whom it has not
conducted dose reconstructions, to encourage and assist them in
petitioning. However, if, in the course of its work in obtaining
information for dose reconstructions, NIOSH learns of other classes of
employees that have a basis for petitioning, NIOSH would attempt to
assist them.
The Board also recommended HHS revise section 83.1 or 83.2 to
clarify that the purpose of petitions is not to serve as an appeal for
claimants whose dose reconstructions did not lead to compensation. DOL
has established procedures under 20 CFR part 30 for claimants who want
to contest the factual determinations or how NIOSH conducted their dose
reconstructions.
HHS has added text to section 83.1 to make this clarification.
F. Recommendation for Section 83.5
The Board recommended the definition of “class” include
the stipulation that the members of a class have worked during a common
time period.
Section 83.13 allows NIOSH to define class membership in terms of
the time period as well as other potentially relevant employment
parameters. In contrast, the generic definition of class provided in
section 83.5 is intended to describe briefly only the invariable
characteristics of a class, to aid readers of the rule. Time period may
not always be a defining characteristic. It is possible there will be
classes comprising workers from several distinct time periods relating
to intermittent operations. Also, the time period could be irrelevant
if a class
[[Page 11304]]
comprised all individuals who performed a certain task or manned a
certain type of operation at a facility.
G. Recommendations for Section 83.9
The Board recommended HHS eliminate the proposed requirement that
petitioners obtain from DOE or an AWE a response to a request for
records, indicating that dosimetry records are unavailable pertaining
to radiation exposures incurred by employees. The Board noted that it
may not be possible for petitioners to obtain such a response from AWEs
and from DOE for certain DOE employees. The Board suggested HHS
consider requiring a “good faith effort” to obtain records
instead.
As discussed in response to this comment from the public, HHS
agrees and has eliminated this proposed requirement. HHS has decided
not to propose any requirement with respect to the procurement of
records, even for a good faith effort, since this would be burdensome
to petitioners and often without value to the evaluation of the
petition.
The Board also recommended that HHS add an element to this section
allowing petitioners to submit a government report or published
scientific report concerning a deficiency of dosimetry records as a
basis for petitioning. HHS agrees and has added this option.
H. Recommendation for Section 83.10
Section 83.10 of the initially proposed rule (now section 83.11)
included the Board in the process for selecting petitions for
evaluation. The Board would review each petition that HHS proposes to
deny an evaluation (because the petition does not meet requirements
specified in section 83.9) prior to HHS's making a decision.
The Board recommended HHS independently select petitions for
evaluation, without the involvement of the Board. The Board was
particularly concerned about its ability to handle this work load and
did not consider as crucial its judgment on the qualifications of a
petition to receive an evaluation.
HHS has revised the petition selection process in response to the
concerns of the Board. Accordingly, the Board will not review petitions
that NIOSH finds do not meet the requirements for a petition. This
change should also be considered in light of the clarified and
simplified petition requirements specified in this current proposal,
and the process by which NIOSH will assist petitioners whose
petitioners do not initially meet the requirements, before making a
final decision. HHS seeks comment, however, on whether petitioners
should have the option to seek an administrative review of adverse
final decisions.
I. Recommendation on Section 83.13
Section 83.13 of the initially proposed rule (now section 83.15)
specifies the process by which the Board will review petitions. This
section includes a provision for inviting petitioners to present
directly to the Board concerning their petition and NIOSH evaluation
findings addressing their petition.
The Board recommended changes to this section to emphasize that the
Board's role is advisory, not adjudicatory; and to clarify that the
recommendations of the Board are only part of the information to be
considered by the Secretary in making a decision with respect to a
petition.
HHS has revised section 83.15 and 83.16 to address the concerns of
the Board. As recommended by the Board, the term “evidence”
is omitted from section 83.15, and section 83.16 clearly specifies that
the Board recommendations are only part of the information to be
considered by the Secretary in reaching a decision.
J. Recommendation on Section 83.14
Section 83.14 of the initially proposed rule provided the Secretary
with flexibility to make use of unspecified procedures and information
to address novel, unforeseen circumstances in the evaluation of a
petition. The Board was concerned about the broad latitude that this
authority would provide the Secretary, and recommended that the rule
require that such unspecified procedures as might be applied under this
broad authority would not conflict with procedures specified in the
rule.
As discussed in response to similar public comments, HHS has
omitted from the current rule authority for the Secretary to make use
of unspecified procedures under this rule. Upon further consideration,
HHS believes the specified procedures of this rule will fully and
expeditiously serve its purpose.
V. Publication of a Second Notice of Proposed Rulemaking
HHS is publishing this second notice of proposed rulemaking to
provide opportunity for public comment on the changes to the initial
proposal discussed above. Some of these changes are substantial and
were not discussed as options in the initial notice, nor were they
otherwise foreseeable extensions, abbreviations, or variations of the
initial proposal. These substantial changes include: a more qualified
definition of sufficient accuracy; revised procedures for establishing
health endangerment, which eliminate the use of cancer risk models and
of subjective judgments to quantify potential radiation doses; the
potential for defining a class to be added to the Cohort by type of
cancer in addition to previously specified employment parameters; and
expedited procedures for evaluating petitions by claimants for whom
NIOSH lacked sufficient information to complete dose reconstructions.
VI. 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
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
[[Page 11305]]
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 §&thnsp;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.
The Centers for Disease Control and Prevention will publish a separate
notice in the Federal Register announcing its intent to collect this
data and seek OMB approval of the data collection instrument.
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 Rule
For the reasons discussed in the preamble, the Department of Health
and Human Services proposes to amend 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.
[[Page 11306]]
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
§&thnsp;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 §§&thnsp;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 §&thnsp;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 What is the role of Congress in acting upon the final
decision of the Secretary to add a class of employees to the Cohort?
83.18 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
§&thnsp;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 et seq., provides for the payment of compensation benefits to
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 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 or AWE facility. Section 3621(14) of
EEOICPA (42 U.S.C. 7384l(14)) includes 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.
§&thnsp;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 rule, under 20 CFR part 30, for cancer
claimants who want to contest the factual determinations or how NIOSH
conducted their dose reconstructions.
§&thnsp;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
§&thnsp;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 rule, a
group of employees who work or worked at the same DOE 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.
(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) 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.
(j) Secretary is the Secretary of Health and Human Services.
(k) Specified cancer as defined in §&thnsp;3621 of EEOICPA (42
U.S.C. 7384l(17)) and the DOL regulation implementing EEOICPA (20 CFR
30.5(dd)) means:
[[Page 11307]]
(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.
(l) 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
§&thnsp;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. Special procedures are
included for considering the addition of a class of employees to the
Cohort when NIOSH finds, through the process of attempting a dose
reconstruction for an employee under 42 CFR 82.12, that available
information is insufficient to complete the dose reconstruction. As
required by EEOICPA, 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.
§&thnsp;83.7 Who can submit a petition on behalf of a class of
employees?
A petitioner or petitioners must be one or more 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.
§&thnsp;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 §&thnsp;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.
§&thnsp;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&thnsp;\1\ specifying:
---------------------------------------------------------------------------
\1\&thnsp;HHS will determine the final class definition for each
petition (see §&thnsp;83.16 of these procedures).
---------------------------------------------------------------------------
(i) The DOE or AWE facility at which the class worked;
(ii) The location or locations at the facility covered by the
petition (e.g., building, technical area);
(iii) The job titles and/or job duties of the class members;
(iv) The period of employment relevant to the petition;
(v) Identification of any exposure incident that was unmonitored,
unrecorded, or inadequately monitored or recorded, if such incident
comprises the basis of the petition; and
(2) A description of the petitioner's (petitioners’) basis
for believing records and information available are inadequate to
estimate the radiation doses incurred by members of the proposed class
of employees with sufficient accuracy. This description must include
one of the following elements:
(i) Documentation or statements provided by affidavit indicating
that radiation exposures and doses to members of the proposed class
were not monitored, either through personal or area monitoring; or
(ii) Documentation or statements provided by affidavit indicating
that radiation monitoring records for members of the proposed class
have been lost, falsified, or destroyed; or
(iii) A report from a health physicist or other individual with
expertise in dose reconstruction documenting the limitations of
existing DOE or AWE records on radiation exposures at the facility, as
relevant to the petition, and specifying the basis for finding 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 report published by a scientific government agency or
published in a peer-reviewed scientific 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 and
also finds that such information might be essential to produce such
estimates.
(3) If the petition is based on an exposure incident as described
under paragraph (c)(1)(v) of this section, the petitioner(s) may be
required to provide evidence that the incident occurred, if
[[Page 11308]]
NIOSH is unable to obtain records or confirmation of the occurrence of
such an incident from sources independent of the petitioner(s). 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) Confirmation by affidavit from two employees who witnessed the
incident, providing this evidence is consistent with other information
available to HHS.
Table 1 for §&thnsp;83.9.—Summary of Informational
Requirements for 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) Proposed class
petition, based on NIOSH having found definition identifying: (i)
it could not complete a dose Facility, (ii) relevant
reconstruction 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) 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) published
scientific report.
------------------------------------------------------------------------
§&thnsp;83.10 If a petition satisfies all relevant requirements
under §&thnsp;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 §§&thnsp;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.
§&thnsp;83.11 What happens to petitions that do not satisfy all
relevant requirements under §§&thnsp;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 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 the petitioner(s) of
its decision to evaluate the petition, or its final decision that the
petition has failed to meet the requirements for evaluation and the
basis for this decision.
(c) Based on new information, NIOSH may, at its discretion,
reconsider a decision not to select a petition for evaluation.
§&thnsp;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,
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
§&thnsp;83.13; 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.
§&thnsp;83.13 How will NIOSH evaluate petitions, other than
petitions by claimants covered under §&thnsp;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 82.14, 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 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; and
(8) Other sources.
(b) 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 that could have been incurred in plausible
circumstances by any member of the class.
(ii) In general, to establish a positive finding under paragraph
(b)(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 radioisotope (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 general, NIOSH would
require relevant equipment design and performance specifications or
information on maximum emissions.
(iii) In general, access to personal dosimetry data and area
monitoring data are not necessary to estimate the maximum radiation
doses that could
[[Page 11309]]
have been incurred by any member of the class.
(iv) If NIOSH determines that it is not feasible to estimate
radiation doses with sufficient accuracy, NIOSH will also determine
whether such finding is limited to radiation doses incurred at certain
tissue-specific cancer sites, and hence limited to specific types of
cancers (whether or not such cancer(s) is a specified cancer under
§&thnsp;83.5(k)).
(2) How should the class be defined, consistent with the findings
of the analysis discussed under paragraph (b)(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
(b)(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 within the facility or site, the
relevant time period, and any additional identifying characteristics of
employment;
(ii) If applicable, the identification of a exposure incident, when
unmonitored radiation exposure during such an incident comprises the
basis of the petition or the class definition;
(iii) If applicable, the identification of a set of one or more
types of cancers to which NIOSH's finding that it was not feasible to
estimate radiation doses with sufficient accuracy is limited.
(3) If it is not feasible to estimate with sufficient accuracy
radiation doses for members of the class, as provided under paragraph
(b)(1) of this section, then NIOSH must also make the following
determination as required by statute [see 42 U.S.C. 7384q(b)(2)]: Is
there a “reasonable likelihood that such radiation dose may have
endangered the health of members of the class?''
(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 (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 employment
parameters established for the class.
(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, 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 employment parameters of the class for inclusion in the class, as
defined under §&thnsp;83.13(b)(3).
(4) The proposed class definition may also specify that members of
the class are limited to employees who incur a cancer from a set of one
or more types of cancers specified by NIOSH. This provision applies to
classes of employees for which the finding that it is not feasible to
estimate radiation doses with sufficient accuracy is limited to certain
tissue-specific cancer sites, relevant to individuals with specific
types of cancers.
(5) 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.
(6) 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.
§&thnsp;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 outlined under
§&thnsp;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 outlined under §&thnsp;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.
(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 §&thnsp;83.13.
§&thnsp;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.
(c) In considering the petition, the Board may obtain and consider
[[Page 11310]]
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 criteria 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.
§&thnsp;83.16 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. This decision will take into consideration the evaluations
of NIOSH and the recommendations of the Board, and may also take into
consideration information presented to the Board and its deliberations.
(b) HHS will provide the petitioner(s) 30 calendar days to contest
the proposed decision of the Secretary. If the petitioner(s) 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(s) prior to issuing a final
decision. Challenges to decisions of the Secretary under these
procedures must be submitted in writing, with accompanying
documentation supporting the assertions of the challenge.
(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). HHS will also publish notice of the decision in the
Federal Register, including a definition of the class and a summary of
the criteria and information upon which the decision is based.
§&thnsp;83.17 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.\2\
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\2\&thnsp;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) Within five work days of either expiration of the congressional
review period or final congressional action, whichever comes first, the
Secretary will transmit to DOL 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.
§&thnsp;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 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 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;
(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 §§&thnsp;83.13(b)(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 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) An opportunity for members of the class to contest a proposed
decision by the Secretary 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: March 5, 2003.
Tommy G. Thompson,
Secretary, Department of Health and Human Services.
[FR Doc. 03–5604 Filed 3–5–03; 12:38 pm]
BILLING CODE 4160–17–P