11294 Federal Register / Vol. 68, No. 45 / Friday, March 7, 2003 / Proposed Rules 

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, 

Federal Register / Vol. 68, No. 45 / Friday, March 7, 2003 / Proposed Rules 11295

1Specified 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.

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 1 qualify for 

compensation (see DOL regulations 20 

CFR part 30 for details). Cancer claims 

submitted by these employees or their 

survivors do not require DOL to 

evaluate the probability that the cancer 

was caused by radiation doses incurred 

during the performance of duty for 

nuclear weapons programs of DOE, as is 

required for other cancer claims covered 

by EEOICPA.

C. Purpose of the 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 

11296 Federal Register / Vol. 68, No. 45 / Friday, March 7, 2003 / Proposed Rules 

2Readers 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.

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 

Federal Register / Vol. 68, No. 45 / Friday, March 7, 2003 / Proposed Rules 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.

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. 

§ 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 

11298 Federal Register / Vol. 68, No. 45 / Friday, March 7, 2003 / Proposed Rules 

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 

Federal Register / Vol. 68, No. 45 / Friday, March 7, 2003 / Proposed Rules 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. 

11300 Federal Register / Vol. 68, No. 45 / Friday, March 7, 2003 / Proposed Rules 

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 

Federal Register / Vol. 68, No. 45 / Friday, March 7, 2003 / Proposed Rules 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 § 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 

11302 Federal Register / Vol. 68, No. 45 / Friday, March 7, 2003 / Proposed Rules 

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 

Federal Register / Vol. 68, No. 45 / Friday, March 7, 2003 / Proposed Rules 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 

11304 Federal Register / Vol. 68, No. 45 / Friday, March 7, 2003 / Proposed Rules 

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 

Federal Register / Vol. 68, No. 45 / Friday, March 7, 2003 / Proposed Rules 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 

§ 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-forprofit 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. 

11306 Federal Register / Vol. 68, No. 45 / Friday, March 7, 2003 / Proposed Rules 

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 § 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 

§§ 83.7 through 83.9? 

83.12 How will NIOSH notify petitioners, 

the Board, and the public of petitions 

that have been selected for evaluation? 

83.13 How will NIOSH evaluate petitions, 

other than petitions by claimants 

covered under § 83.14? 

83.14 How will NIOSH evaluate a petition 

by a claimant whose dose reconstruction 

NIOSH could not complete under 42 

CFR Part 82? 

83.15 How will the Board consider and 

advise the Secretary on a petition? 

83.16 How will the Secretary decide the 

outcome of a petition? 

83.17 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

§ 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.

§ 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.

§ 83.2 How will DOL use the designations 

established under the procedures in this 

part? 

DOL will adjudicate compensation 

claims for members of classes of 

employees added to the Cohort 

according to the same general 

procedures that apply to the statutorily 

defined classes of employees in the 

Cohort. Specifically, DOL will 

determine whether the claim is for a 

qualified member of the Cohort with a 

specified cancer, pursuant to the 

procedures set forth in 20 CFR Part 30.

Subpart B—Definitions

§ 83.5 Definitions of Terms Used in the 

Procedures in this part. 

(a) Advisory Board on Radiation and 

Worker Health (‘‘the Board’’) is a federal 

advisory committee established under 

EEOICPA and appointed by the 

President to advise HHS in 

implementing its responsibilities under 

EEOICPA. 

(b) Atomic Weapons Employer 

(‘‘AWE’’) is a statutory term of EEOICPA 

which means any entity, other than the 

United States, that:

(1) Processed or produced, for use by 

the United States, material that emitted 

radiation and was used in the 

production of an atomic weapon, 

excluding uranium mining and milling; 

and 

(2) Is designated by the Secretary of 

Energy as an atomic weapons employer 

for purposes of EEOICPA. 

(c) Class of employees means, for the 

purposes of this 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 radiofrequency 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 

§ 3621 of EEOICPA (42 U.S.C. 7384l(17)) 

and the DOL regulation implementing 

EEOICPA (20 CFR 30.5(dd)) means: 

Federal Register / Vol. 68, No. 45 / Friday, March 7, 2003 / Proposed Rules 11307

1HHS will determine the final class definition for 

each petition (see § 83.16 of these procedures).

(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

§ 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.

§ 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.

§ 83.8 How is a petition submitted? 

The petitioner(s) must send a petition 

in writing to NIOSH. A petition must 

provide identifying and contact 

information on the petitioner(s) and 

information to justify the petition, as 

specified under § 83.9. Detailed 

instructions for preparing and 

submitting a petition, including an 

optional petition form, are available 

from NIOSH through direct request (1–

800–35–NIOSH) or on the Internet at 

www.cdc.gov/niosh/ocas.

§ 83.9 What information must a petition 

include? 

(a) All petitions must provide 

identifying and contact information on 

the petitioner(s). The information 

required to justify a petition differs, 

depending on the basis of the petition. 

If the petition is by a claimant in 

response to a finding by NIOSH that the 

dose reconstruction for the claimant 

cannot be completed, then the petition 

must provide only the justification 

specified under paragraph (b) of this 

section. All other petitions must provide 

only the information specified under 

paragraph (c) of this section. The 

informational requirements for petitions 

are also summarized in Table 1 at the 

end of this section. 

(b) The petition must notify NIOSH 

that the claimant is petitioning on the 

basis that NIOSH found, under 42 CFR 

82.12, that the dose reconstruction for 

the claimant could not be completed 

due to insufficient records and 

information. 

(c) The petition must include the 

following: 

(1) A proposed class definition 1

specifying:

(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 

11308 Federal Register / Vol. 68, No. 45 / Friday, March 7, 2003 / Proposed Rules 

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 § 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 petition, based on NIOSH having 

found it could not complete a dose reconstruction for the claimant 

submitting the petition; or 

B. (1) Proposed class definition identifying: (i) Facility, (ii) relevant locations at the facility; (iii) job titles/duties, (iv) period of employment, 

and if relevant, (v) exposure incident. 

(2) 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. 

§ 83.10 If a petition satisfies all relevant 

requirements under § 83.9, does this mean 

the class will be added to the Cohort? 

Satisfying the informational 

requirements for a petition does not 

mean the class will be added to the 

Cohort. It means the petition will 

receive a full evaluation by NIOSH, the 

Board, and HHS, as described under 

§§ 83.13 through 83.16. The role of the 

petitioner(s) is to identify classes of 

employees that should be considered for 

addition to the Cohort.

§ 83.11 What happens to petitions that do 

not satisfy all relevant requirements under 

§§ 83.7 through 83.9? 

(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.

§ 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 § 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.

§ 83.13 How will NIOSH evaluate petitions, 

other than petitions by claimants covered 

under § 83.14? 

(a) NIOSH will collect information on 

the types and levels of radiation 

exposures that potential members of the 

class may have incurred, as specified 

under 42 CFR 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 

Federal Register / Vol. 68, No. 45 / Friday, March 7, 2003 / Proposed Rules 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 § 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 

§ 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.

§ 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 § 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 § 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 § 83.13.

§ 83.15 How will the Board consider and 

advise the Secretary on a petition? 

(a) NIOSH will publish a notice in the 

Federal Register providing notice of a 

Board meeting at which a petition will 

be considered, and summarizing the 

petition to be considered by the Board 

at the meeting and the findings of 

NIOSH from evaluating the petition. 

(b) The Board will consider the 

petition and the NIOSH evaluation 

report at the meeting, to which the 

petitioner(s) will be invited to present 

views and information on the petition 

and the NIOSH evaluation findings. 

(c) In considering the petition, the 

Board may obtain and consider 

11310 Federal Register / Vol. 68, No. 45 / Friday, March 7, 2003 / Proposed Rules 

2See 42 U.S.C. 7384l(14)(C)(ii).

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.

§ 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.

§ 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

(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.

§ 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 §§ 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