[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]]

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

Part IV





Department of Health and Human Services





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



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]]


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

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.

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

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \2\&thnsp;See 42 U.S.C. 7384l(14)(C)(ii).
---------------------------------------------------------------------------

    (b) A designation of the Secretary will take effect 180 calendar 
days after the date on which the report of the Secretary is submitted 
to Congress, unless Congress takes an action that reverses or expedites 
the designation.
    (c) 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