486 

§ 82.30 42 CFR Ch. I (10–1–07 Edition) 

Subpart E—Updating the Scientific 

Elements Underlying Dose Reconstructions 

§ 82.30 How will NIOSH inform the 

public of any plans to change scientific elements underlying the 

dose reconstruction process to 

maintain methods reasonably current with scientific progress? 

Periodically, NIOSH will publish a 

notice in the FEDERAL REGISTER notifying the public of plans to change scientific elements underlying the dose 

reconstruction process under EEOICPA 

to reflect scientific progress. Notice 

will include a summary of the planned 

changes and the expected completion 

date for such changes. 

§ 82.31 How can the public recommend 

changes to scientific elements underlying the dose reconstruction 

process? 

(a) At any time, the public can submit written recommendations to 

NIOSH for changes to scientific elements underlying the dose reconstruction process, based on relevant new research findings and technological advances. NIOSH will provide these recommendations to the Advisory Board 

on Radiation and Worker Health to be 

addressed at a public meeting of the 

Advisory Board, with notification provided to the source of the recommendations. Recommendations should be addressed to: Director, Office of Compensation Analysis and Support, National Institute for Occupational Safety and Health, 4676 Columbia Parkway, 

MS-R45, Cincinnati, Ohio 45226. 

(b) The public can also submit recommendations by e-mail. Instructions 

will be provided on the NIOSH Internet 

homepage at www.cdc.gov/niosh/ocas. 

§ 82.32 How will NIOSH make changes 

in scientific elements underlying 

the dose reconstruction process, 

based on scientific progress? 

NIOSH will present proposed changes 

to the Advisory Board on Radiation 

and Worker Health prior to implementation. These proposed changes will be 

summarized in a notice published in 

the FEDERAL REGISTER. The public will 

have the opportunity to comment on 

proposed changes at the meeting of the 

Advisory Board and/or in written comments submitted for this purpose. 

NIOSH will fully consider the comments of the Advisory Board and of the 

public before deciding upon any 

changes. 

§ 82.33 How will NIOSH inform the 

public of changes to the scientific 

elements underlying the dose reconstruction process? 

(a) NIOSH will publish a notice in the 

FEDERAL REGISTER informing the public of changes and the rationale for the 

changes. This notice will also provide a 

summary of the recommendations and 

comments received from the Advisory 

Board and the public, as well as responses to the comments. 

(b) NIOSH may take into account 

other factors and employ other procedures than those specified in this subpart, if circumstances arise that require NIOSH to implement a change 

more immediately than the procedures 

in this subpart allow. 

PART 83—PROCEDURES FOR DESIGNATING CLASSES OF EMPLOYEES AS MEMBERS OF THE SPECIAL 

EXPOSURE COHORT UNDER THE 

ENERGY EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION 

PROGRAM ACT OF 2000 

Subpart A—Introduction 

Sec. 

83.0 Background information on the procedures in this part. 

83.1 What is the purpose of the procedures 

in this part? 

83.2 How will DOL use the designations established under the procedures in this 

part? 

Subpart B—Definitions 

83.5 Definitions of terms used in the procedures in this part. 

Subpart C—Procedures for Adding Classes 

of Employees to the Cohort 

83.6 Overview of the procedures in this part. 

83.7 Who can submit a petition on behalf of 

a class of employees? 

83.8 How is a petition submitted? 

83.9 What information must a petition include? 

83.10 If a petition satisfies all relevant requirements under §83.9, does this mean 

the class will be added to the Cohort? 


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Public Health Service, HHS § 83.1 

83.11 What happens to petition submissions 

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 How will the Secretary report a final 

decision to add a class of employees to 

the Cohort and any action of Congress 

concerning the effect of the final decision? 

83.18 How can petitioners obtain an administrative review of a final decision by the 

Secretary? 

83.19 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. 

SOURCE: At 69 FR 30780, May 28, 2004, unless 

otherwise noted. 

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. 7384–7385, provides for the payment of compensation benefits to covered employees and, where applicable, 

survivors of such employees, of DOE, 

its predecessor agencies and certain of 

its contractors and subcontractors. 

Among the types of illnesses for which 

compensation may be provided are cancers. There are two methods set forth 

in the statute for claimants to establish that a cancer incurred by a covered worker is compensable under 

EEOICPA. The first is to establish that 

the cancer is at least as likely as not 

related to covered employment at a 

DOE or Atomic Weapons Employer 

(‘‘AWE’’) facility pursuant to guidelines issued by the Department of 

Health and Human Services (‘‘HHS’’), 

which are found at 42 CFR part 81. The 

second method to establish that a cancer incurred by a covered worker is 

compensable under EEOICPA is to establish that the worker is a member of 

the Special Exposure Cohort (‘‘the Cohort’’) and suffered a specified cancer 

after beginning employment at a DOE 

facility or AWE facility. In Section 

3621(14) of EEOICPA (42 U.S.C. 7384l(14)) 

Congress included certain classes of 

employees in the Cohort. Section 3626 

of the Act (42 U.S.C. 7384q) authorizes 

the addition to the Cohort of other 

classes of employees. This authority 

has been delegated to the Secretary of 

HHS by Executive Order 13179. 

§ 83.1 What is the purpose of the procedures in this part? 

EEOICPA authorizes the President to 

add classes of employees to the Cohort, 

while providing Congress with the opportunity to review and expedite or reverse these decisions. The President 

delegated his authority to the Secretary of HHS. This part specifies the 

procedures by which HHS will determine whether to add new classes of employees from DOE and AWE facilities 

to the Cohort. HHS will consider adding new classes of employees in response to petitions by, or on behalf of, 

such classes of employees. The procedures specify requirements for petitions and for their consideration. These 

requirements are intended to ensure 

that petitions are submitted by authorized parties, are justified, and receive 

uniform, fair, scientific consideration. 

The procedures are also designed to 

give petitioners and interested parties 

opportunity for appropriate involvement in the process, and to ensure that 

the process is timely and consistent 

with requirements specified in 

EEOICPA. The procedures are not intended to provide a second opportunity 

to qualify a claim for compensation, 

once HHS has completed the dose reconstruction and DOL has determined 

that the cancer subject to the claim 

was not ‘‘at least as likely as not’’ 

caused by the estimated radiation 

doses. DOL has established procedures 

separate from those covered by this 

part, under 20 CFR part 30, for cancer 

claimants who want to contest the factual determinations or how NIOSH 

conducted their dose reconstructions. 


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§ 83.2 42 CFR Ch. I (10–1–07 Edition) 

§ 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) Computation of Time Periods: In 

this Rule, all prescribed or allowed 

time periods will be counted as calendar days from the business day of receipt by the submitter(s), the petitioner(s), NIOSH, or HHS. Receipt by 

NIOSH, the submitter(s) or petitioner(s) will be either the business day 

of actual receipt or three (3) business 

days after initial proof of mailing, 

whichever time period is shorter. Business days are defined as Monday 

through Friday, 8 a.m. to 4:30 p.m. est 

and ‘‘legal holiday’’ will be used as defined by the FED. R. CIV. P. 6(a). 

(d) Class of employees means, for the 

purposes of this part, a group of employees who work or worked at the 

same DOE facility or AWE facility, and 

for whom the availability of information and recorded data on radiation exposures is comparable with respect to 

the informational needs of dose reconstructions conducted under 42 CFR 

part 82. 

(e) HHS is the U.S. Department of 

Health and Human Services. 

(f) DOE is the U.S. Department of Energy, which includes predecessor agencies of DOE, including the Manhattan 

Engineering District. 

(g) DOL is the U.S. Department of 

Labor. 

(h) 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. 

(i) NIOSH is the National Institute 

for Occupational Safety and Health, 

Centers for Disease Control and Prevention, U.S. Department of Health 

and Human Services. 

(j) OCAS is the Office of Compensation Analysis and Support, National 

Institute for Occupational Safety and 

Health, Centers for Disease Control and 

Prevention, U.S. Department of Health 

and Human Services. 

(k) Petitioner means an individual or 

organization that submits a petition on 

behalf of a class of employees and 

qualifies as a petitioner under §83.7. A 

single petition shall only include up to 

three petitioners. 

(l) Radiation means ionizing radiation, including alpha particles, beta 

particles, gamma rays, x rays, neutrons, protons and other particles capable of producing ions in the body. For 

the purposes of the proposed procedures, radiation does not include 

sources of non-ionizing radiation such 

as radio-frequency radiation, microwaves, visible light, and infrared or ultraviolet light radiation. 

(m) Secretary is the Secretary of 

Health and Human Services. 

(n) Specified cancer, as is defined in 

Section 3621(17) of EEOICPA (42 U.S.C. 

7384l(17)) and the DOL regulation implementing EEOICPA (20 CFR 30.5(dd)), 

means: 

(1) Leukemia (other than chronic 

lymphocytic leukemia) provided that 

onset of the disease was at least two 

years after initial occupational exposure; 


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Public Health Service, HHS § 83.8 

(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. 

(o) Survivor means a surviving 

spouse, child, parent, grandchild and 

grandparent of a deceased covered employee as defined in EEOICPA. 

[69 FR 30780, May 28, 2004, as amended at 70 

FR 75952, Dec. 22, 2005; 72 FR 37459, July, 10, 

2007] 

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. The rule provides 

for petitions in two distinct circumstances. One circumstance is when 

NIOSH has attempted to conduct a 

dose reconstruction for a cancer claimant, under 42 CFR part 82, and finds 

that the dose reconstruction cannot be 

completed, because there is insufficient 

information to estimate the radiation 

doses of the claimant with sufficient 

accuracy. The second circumstance includes all other possibilities. For example, a petition may be submitted 

representing a class of employees 

whose members have yet to file claims 

under EEOICPA, or even have yet to be 

diagnosed with cancer. As required by 

EEOICPA (42 U.S.C. 7384l(14)(c)(ii)), the 

procedures in this part include formal 

notice to Congress of any decision by 

the Secretary to add a class to the Cohort, and the opportunity for Congress 

to expedite or change the outcome of 

the decision within 180 days. 

§ 83.7 Who can submit a petition on behalf of a class of employees? 

A petitioner or petitioners for a petition must be one or more, up to a maximum of three, of the following: 

(a) One or more DOE, DOE contractor 

or subcontractor, or AWE employees, 

who would be included in the proposed 

class of employees, or their survivors; 

or 

(b) One or more labor organizations 

representing or formerly having represented DOE, DOE contractor or subcontractor, or AWE employees, who 

would be included in the proposed class 

of employees; or 

(c) One or more individuals or entities authorized in writing by one or 

more DOE, DOE contractor or subcontractor, or AWE employees, who would 

be included in the proposed class of employees, or their survivors. 

§ 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– 


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§ 83.9 42 CFR Ch. I (10–1–07 Edition) 

1 HHS will determine the final class definition(s) for each petition (see §83.16). 2 Depending on the factual circumstances 

present, a facility that meets the definition 

of an AWE facility or DOE facility covered 

under EEOICPA (42 U.S.C. 7384l(5) and (12)) 

could, among other possibilities, constitute a 

single building or structure, including the 

grounds upon which it is located, or a site 

encompassing numerous buildings or structures, including the grounds upon which it is 

located. 

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 definition1 specifying: 

(i) The DOE facility or AWE facility2

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. 

This report should specify the basis for 

believing these documented limitations 

might prevent the completion of dose 

reconstructions for members of the 

class under 42 CFR part 82 and related 

NIOSH technical implementation 

guidelines; or 

(iv) A scientific or technical report, 

published or issued by a government 

agency of the Executive Branch of government or the General Accounting Office, the Nuclear Regulatory Commission, or the Defense Nuclear Facilities 

Safety Board, or published in a peer-reviewed journal, that identifies dosimetry and related information that are 

unavailable (due to either a lack of 

monitoring or the destruction or loss 

of records) for estimating the radiation 

doses of employees covered by the petition. 

(3) If the petition is based on an exposure incident as described under paragraph (c)(1)(v) of this section, the petitioner(s) might be required to provide 

evidence that the incident occurred, 

but only if NIOSH is unable to obtain 

records or confirmation of the occurrence of such an incident from sources 

independent of the petitioner(s). Such 

evidence would not be required at the 

time the petition is submitted and the 


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Public Health Service, HHS § 83.10 

3 An affidavit may be from a petitioner but 

HHS does not require that an affidavit be 

from a petitioner. 

petitioner(s) would be directly informed of the need for this supplemental information. In such cases, either of the following may qualify as 

evidence: 

(i) Medical evidence that one or more 

members of the class may have incurred a high level radiation dose from 

the incident, such as a depressed white 

blood cell count associated with radiation exposure or the application of 

chelation therapy; or 

(ii) NIOSH will consider evidence provided by affidavit from one or more 

employees who witnessed the incident. 

If the petitioner cannot provide such 

affidavits because such employees are 

deceased, prevented by reasons of poor 

health or impairment, or cannot be 

identified or located, then the requirement for evidence provided by affidavit 

can be met by providing such an affidavit from one or more individuals who 

did not witness the incident, provided 

the individual was directly informed by 

one or more employees who witnessed 

the incident.3

(4) The provision of any evidence 

under this section or other provisions 

of this part, including one or more affidavits, would not, in and of itself, be 

sufficient to confirm the facts presented by that evidence. NIOSH will 

consider the adequacy and credibility 

of any evidence provided. 

(5) If, under §83.15(a), NIOSH has already issued a FEDERAL REGISTER notice scheduling a Board meeting to 

consider a petition concerning a class 

of employees, then any petitions for 

such a class of employees submitted 

following this notice must, under paragraph (c)(2) of this section, present substantially new information that has 

not already been considered by NIOSH. 

For this purpose, NIOSH would find 

that information has been already considered by NIOSH if it were included in 

the petition(s) that were already considered by NIOSH or if it were addressed either in the report(s) by 

NIOSH evaluating such a petition or 

petitions under §83.13(c) or in a proposed decision by NIOSH responding to 

such a petition or petitions under 

§83.16(a). 

TABLE 1 FOR § 83.9: SUMMARY OF INFORMATIONAL REQUIREMENTS FOR ALL PETITIONS

[Petitioner(s) must submit identifying and contact information and either A. or B. of this table.] 

A. The claimant’s authorization of the petition, 

based on NIOSH having found it could not 

complete a dose reconstrucitn for the claimant submitting the petition; or.

B. (1) A 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) The basis for infeasibility of dose reconstruction; either: (i) lack of monitoring; or (ii) 

destruction, falsification, or loss of records; 

or (iii) expert report; or (iv) scientific or technical report. 

§ 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. 


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§ 83.11 42 CFR Ch. I (10–1–07 Edition) 

§ 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 requirement that is 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 

any petitioner(s) whose petition remains unsatisfactory of the proposed 

finding of NIOSH that the petition fails 

to meet the specified requirements and 

the basis for this finding. 

(c) A petitioner may request in writing a review of a proposed finding within 30 calendar days of notification 

under paragraph (b) of this section. Petitioners must specify why the proposed finding should be reversed, based 

on the petition requirements and on 

the information that the petitioners 

had already submitted. The request 

may not include any new information 

or documentation that was not included in the completed petition. If the 

petitioner obtains new information 

within this 30-day period, the petitioner should provide it to NIOSH. 

NIOSH will consider this new information as a revision of the petition under 

paragraph (a) of this section. 

(d) Three HHS personnel, appointed 

by the Director of NIOSH, who were 

not involved in developing the proposed 

finding will complete reviews within 30 

work days of the request for such a review. The Director of NIOSH will consider the results of the review and then 

make a final decision as to whether the 

petition satisfies the requirements for 

a petition. 

(e) Proposed findings established by 

NIOSH under paragraph (b) of this section will become final decisions in 31 

calendar days if not reviewed under 

paragraph (d) of this section. 

(f) Based on new information, NIOSH 

may, at its discretion, reconsider a decision that a petition does not satisfy 

the requirements for a petition. 

(g) A petitioner whose petition has 

been found not to satisfy the requirements for a petition under either paragraph (d) or (e) of this section may submit to NIOSH a new petition for the 

identical class of employees at any 

time thereafter on the basis of new information not provided to NIOSH in 

the original petition. In such a case, 

the petitioner is required to fully readdress all the requirements of §§83.7– 

83.9 in the petition. 

[70 FR 75952, Dec. 22, 2005, as amended at 72 

FR 37459, July 10, 2007] 

§ 83.12 How will NIOSH notify petitioners, the Board, and the public 

of petitions that have been selected 

for evaluation? 

(a) NIOSH will notify the petitioner(s) in writing that it has selected 

the petition for evaluation. NIOSH will 

also provide the petitioner(s) with information on the steps of the evaluation and other processes required pursuant to these procedures. 

(b) NIOSH will combine separate petitions and evaluate them as a single 

petition if, at this or at any point in 

the evaluation process under §§83.13 

and 83.14, NIOSH finds such petitions 

represent the same class of employees. 

(c) NIOSH will present petitions selected for evaluation to the Board with 

plans specific to evaluating each petition. Each evaluation plan will include 

the following elements: 

(1) An initial proposed definition for 

the class being evaluated, subject to revision as warranted by the evaluation 

conducted under §83.13 or §83.14; and 

(2) A list of activities for evaluating 

the radiation exposure potential of the 

class and the adequacy of existing 

records and information needed to conduct dose reconstructions for all class 

members under 42 CFR part 82. 

(d) NIOSH may initiate work to 

evaluate a petition immediately, prior 

to presenting the petition and evaluation plan to the Board. 

(e) NIOSH will publish a notice in the 

FEDERAL REGISTER notifying the public 

of its decision to evaluate a petition. 

§ 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 


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Public Health Service, HHS § 83.13 

under 42 CFR 83.14, from the following 

potential sources, as necessary: 

(1) The petition or petitions submitted on behalf of the class; 

(2) DOE and AWE facility records and 

information; 

(3) Potential members of the class 

and their survivors; 

(4) Labor organizations who represent or represented employees at the 

facility during the relevant period of 

employment; 

(5) Managers, radiation safety officials, and other witnesses present during the relevant period of employment 

at the DOE facility or AWE facility; 

(6) NIOSH records from epidemiological research on DOE populations and 

records from dose reconstructions conducted under 42 CFR part 82; 

(7) Records from research, dose reconstructions, medical screening programs, and other related activities conducted to evaluate the health and/or 

radiation exposures of DOE employees, 

DOE contractor or subcontractor employees, and/or AWE employees; and 

(8) Other sources. 

(b) The Director of OCAS may determine that records and/or information 

requested from DOE, an AWE, or another source to evaluate a petition is 

not, or will not be, available on a timely basis. Such a determination will be 

treated, for the purposes of the petition 

evaluation, as equivalent to a finding 

that the records and/or information requested are not available. 

(1) Before the Director of OCAS 

makes such a determination, the 

source(s) potentially in possession of 

such records and/or information will be 

allowed a reasonable amount of time, 

as determined by the Director of OCAS, 

to provide the records and/or information. 

(2) Such a determination may take 

into account the types and quantity of 

records and/or information requested 

from the source, as well as any other 

factors that might be relevant to the 

judgment under paragraph (b)(1) of this 

this section of the amount of time that 

is reasonable to provide the records 

and/or information, which would be decided on a case-by-case basis by the Director of OCAS. 

(c) NIOSH will evaluate records and 

information collected to make the following determinations: 

(1) Is it feasible to estimate the level of 

radiation doses of individual members of 

the class with sufficient accuracy? (i) Radiation doses can be estimated with 

sufficient accuracy if NIOSH has established that it has access to sufficient 

information to estimate the maximum 

radiation dose, for every type of cancer 

for which radiation doses are reconstructed, that could have been incurred 

in plausible circumstances by any 

member of the class, or if NIOSH has 

established that it has access to sufficient information to estimate the radiation doses of members of the class 

more precisely than an estimate of the 

maximum radiation dose. NIOSH must 

also determine that it has information 

regarding monitoring, source, source 

term, or process from the site where 

the employees worked to serve as the 

basis for a dose reconstruction. This 

basis requirement does not limit 

NIOSH to using only or primarily information from the site where the employee worked, but a dose reconstruction must, as a starting point, be based 

on some information from the site 

where the employee worked. 

(ii) In many circumstances, to establish a positive finding under paragraph 

(c)(1)(i) of this section would require, 

at a minimum, that NIOSH have access 

to reliable information on the identity 

or set of possible identities and maximum quantity of each radionuclide 

(the radioactive source material) to 

which members of the class were potentially exposed without adequate protection. Alternatively, if members of 

the class were potentially exposed 

without adequate protection to 

unmonitored radiation from radiation 

generating equipment (e.g., particle accelerator, industrial x-ray equipment), 

in many circumstances, NIOSH would 

require relevant equipment design and 

performance specifications or information on maximum emissions. 

(iii) In many circumstances, to establish a positive finding under paragraph 

(c)(1)(i) of this section would also require information describing the process through which the radiation exposures of concern may have occurred 


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§ 83.13 42 CFR Ch. I (10–1–07 Edition) 

and the physical environment in which 

the exposures may have occurred. 

(iv) In many circumstances, access to 

personal dosimetry data and area monitoring data is not necessary to estimate the maximum radiation doses 

that could have been incurred by any 

member of the class, although radiation doses can be estimated more precisely with such data. 

(2) How should the class be defined, 

consistent with the findings of the analysis discussed under paragraph (c)(1) of 

this section? NIOSH will define the following characteristics of a class, taking into account the class definition 

proposed by the petition and modified 

as necessary to reflect the results of 

the evaluation under paragraph (c)(1) 

of this section: 

(i) Any of the following employment 

parameters, as necessary to identify 

members included in the class: facility, 

job titles, duties, and/or specific work 

locations at the facility, the relevant 

time period, and any additional identifying characteristics of employment; 

and 

(ii) If applicable, the identification of 

an exposure incident, when 

unmonitored radiation exposure during 

such an incident comprises the basis of 

the petition or the class definition. 

(3) Is there a reasonable likelihood that 

such radiation dose may have endangered 

the health of members of the class? If it is 

not feasible to estimate with sufficient 

accuracy radiation doses for members 

of the class, as provided under paragraph (c)(1) of this section, then NIOSH 

must determine, as required by the 

statute, that ‘‘there is a reasonable likelihood that such radiation dose may have 

endangered the health of members of the 

class’’ (42 U.S.C. 7384q(b)(2)). 

(i) For classes of employees that may 

have been exposed to radiation during 

discrete incidents likely to have involved exceptionally high level exposures, such as nuclear criticality incidents or other events involving similarly high levels of exposures resulting 

from the failure of radiation protection 

controls, NIOSH will assume for the 

purposes of this section that any duration of unprotected exposure could 

cause a specified cancer, and hence 

may have endangered the health of 

members of the class. Presence with 

potential exposure during the discrete 

incident, rather than a quantified duration of potential exposure, will satisfy 

the health endangerment criterion. 

(ii) For health endangerment not established on the basis of a discrete incident, as described under paragraph 

(c)(3)(i) of this section, NIOSH will 

specify a minimum duration of employment to satisfy the health 

endangerment criterion as having been 

employed for a number of work days 

aggregating at least 250 work days 

within the parameters established for 

the class or in combination with work 

days within the parameters established 

for one or more other classes of employees in the Cohort. 

(d) NIOSH will submit a report of its 

evaluation findings to the Board and to 

the petitioner(s). The report will include the following elements: 

(1) An identification of the relevant 

petitions; 

(2) A proposed definition of the class 

or classes of employees to which the 

evaluation applies, and a summary of 

the basis for this definition, including, 

as necessary: 

(i) Any justification that may be 

needed for the inclusion of groups of 

employees who were not specified in 

the original petition(s); 

(ii) The identification of any groups 

of employees who were identified in the 

original petition(s) who should constitute a separate class of employees; 

or 

(iii) The merging of multiple petitions that represent a single class of 

employees; 

(3) The proposed class definition will 

address the following employment parameters: 

(i) The DOE facility or the AWE facility that employed the class; 

(ii) The job titles and/or job duties 

and/or work locations of class members; 

(iii) The period of employment within which a class member must have 

been employed at the facility under the 

job titles and/or performing the job duties and/or working in the locations 

specified in this class definition; 

(iv) If applicable, identification of an 

exposure incident, when potential radiation exposure during such an incident 


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495 

Public Health Service, HHS § 83.15 

comprises the basis of the class definition; 

(v) If necessary, any other parameters that serve to define the membership of the class; and 

(vi) For a class for which it is not 

feasible to estimate radiation doses 

with sufficient accuracy, a minimum 

duration of employment within the parameters of the class for inclusion in 

the class, as defined under paragraph 

(c)(3) of this section; 

(4) A summary of the findings concerning the adequacy of existing 

records and information for reconstructing doses for individual members 

of the class under the methods of 42 

CFR part 82 specifying, for each class 

defined in the report, whether NIOSH 

finds that it is feasible to estimate the 

radiation doses of members of the class 

with sufficient accuracy, and a description of the evaluation methods and information upon which these findings 

are based; and 

(5) For a class for which it is not feasible to estimate radiation doses with 

sufficient accuracy, a summary of the 

basis for establishing the duration of 

employment requirement with respect 

to health endangerment. 

(e) The NIOSH report under paragraph (d) of this section shall be completed within 180 calendar days of the 

receipt of the petition by NIOSH. The 

procedure for computing this time period is specified in §83.5(c). In addition, 

the computing of 180 calendar days 

shall not include any days during 

which the petitioner may be revising 

the petition to remedy deficiencies 

identified by NIOSH under §83.11(a) or 

(b), nor shall it include any days during 

which the petitioner may request a review of a proposed finding under 

§83.11(c) or during the conduct of such 

a review under §83.11(d). 

[69 FR 30780, May 28, 2004, as amended at 72 

FR 37459, July 10, 2007] 

§ 83.14 How will NIOSH evaluate a petition by a claimant whose dose reconstruction NIOSH could not complete under 42 CFR part 82? 

(a) NIOSH may establish two classes 

for evaluation, to permit the timely 

adjudication of the existing cancer 

claim: 

(1) A class of employees defined using 

the research and analyses already completed in attempting the dose reconstruction for the employee identified in 

the claimant’s petition; and 

(2) A class of co-workers similar to 

the class defined under paragraph (a)(1) 

of this section, to be defined by NIOSH 

on the basis of further research and 

analyses, using the procedures under 

§83.13. 

(b) NIOSH will determine the health 

endangerment criteria for adding the 

class under paragraph (a)(1) of this section to the Cohort, using the procedures under §83.13. NIOSH will report 

to the Board and to petitioner(s) the 

results of this determination, together 

with its finding under 42 CFR part 82 

that there was insufficient information 

to complete the dose reconstruction. 

HHS will consider this finding under 42 

CFR part 82 sufficient, without further 

consideration, to determine that it is 

not feasible to estimate the levels of 

radiation doses of individual members 

of the class with sufficient accuracy. 

(c) NIOSH will evaluate the petition 

as it may concern a class of co-workers, as described under paragraph (a)(2) 

of this section, according to the procedures under §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. In 

considering the petition, both NIOSH 

and the members of the Board will take 

all steps necessary to prevent the disclosure of information of a personal nature, concerning the petitioners or others, where disclosure would constitute 

a clearly unwarranted invasion of personal privacy. 


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§ 83.16 42 CFR Ch. I (10–1–07 Edition) 

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

(c) In considering the petition, the 

Board may obtain and consider additional information not addressed in the 

petition or the initial NIOSH evaluation report. 

(d) NIOSH may decide to further 

evaluate a petition, upon the request of 

the Board. If NIOSH conducts further 

evaluation, it will report new findings 

to the Board and the petitioner(s). 

(e) Upon the completion of NIOSH 

evaluations and deliberations of the 

Board concerning a petition, the Board 

will develop and transmit to the Secretary a report containing its recommendations. The Board’s report will 

include the following: 

(1) The identification and inclusion 

of the relevant petition(s); 

(2) The definition of the class of employees covered by the recommendation; 

(3) A recommendation as to whether 

or not the Secretary should designate 

the class as an addition to the Cohort; 

(4) The relevant criteria under 

§83.13(c) and findings and information 

upon which the recommendation is 

based, including NIOSH evaluation reports, information provided by the petitioners, any other information considered by the Board, and the deliberations of the Board. 

§ 83.16 How will the Secretary decide 

the outcome(s) of a petition? 

(a) The Director of NIOSH will propose a decision to add or deny adding 

any class or classes of employees to the 

Cohort, including an iteration of the 

relevant criteria, as specified under 

§83.13(c), and a summary of the information and findings on which the proposed decision is based. This proposed 

decision will take into consideration 

the evaluations of NIOSH and the report and recommendations of the 

Board, and may also take into consideration information presented or submitted to the Board and the deliberations of the Board. In the case of a petition that NIOSH has determined encompasses more than one class of employees, the Director of NIOSH will 

issue a separate proposed decision for 

each separate class of employees. 

(b) The Secretary will make the final 

decision to add or deny adding a class 

to the Cohort, including the definition 

of the class, after considering information and recommendations provided to 

the Secretary by the Director of 

NIOSH and the Board. HHS will transmit a report of the decision to the petitioner(s), including an iteration of the 

relevant criteria, as specified under 

§83.13(c), and a summary of the information and findings on which the decision is based. HHS will also publish a 

notice summarizing the decision in the 

FEDERAL REGISTER. 

(c) If, under §83.15(e), the Board recommends that the Secretary designate 

a class covered by the petition as an 

addition to the Cohort, and if, under 

paragraph (b) of §83.16, the Secretary 

decides to deny adding the class, as defined by the Board, to the Cohort, then 

the Secretary will submit to Congress 

a determination that the statutory criteria specified under 42 U.S.C. 

7384q(b)(1) and (2) have not been met 

for adding the class to the Cohort. The 

Secretary will submit this determination to Congress within 30 calendar 

days following receipt by the Secretary 

of the recommendation of the Board. 

[70 FR 75953, Dec. 22, 2005] 

§ 83.17 How will the Secretary report a 

final decision to add a class of employees to the Cohort and any action of Congress concerning the effect of the final decision? 

(a) If the Secretary designates a class 

of employees to be added to the Cohort, 

the Secretary will transmit to Congress a report providing the designation, the definition of the class of employees covered by the designation, and 

the criteria and findings upon which 

the designation was based.4

(b) If, under §83.15(e), the Board recommends that the Secretary designate 

a class covered by the petition as an 

addition to the Cohort, and if, under 

paragraph (b) of §83.16, the Secretary 

decides to add a class to the Cohort 

that is inclusive of the class as defined 

by the Board, then the Secretary will 

transmit to Congress the report specified in paragraph (a) of this section 

within 30 calendar days following receipt by the Secretary of the recommendation of the Board. 


bajohnson on PROD1PC69 with CFR
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Public Health Service, HHS § 83.18 

5 Under 42 U.S.C. 7384q(c)(2)(C), if the Secretary does not submit within 30 days the determination required under paragraph (a) of 

§83.17 of this part, then on the following day, 

‘‘it shall be deemed’’ that the Secretary submitted the report specified under paragraph 

(b) of §83.17 of this part. 

(c) A designation of the Secretary 

will take effect 30 calendar days after 

the date on which the report of the 

Secretary under paragraph (a) of this 

section is submitted to Congress, or is 

deemed to have been submitted to Congress,5 unless Congress takes an action 

that reverses or expedites the designation. 

(d) After either the expiration of the 

congressional review period or notification of final congressional action, 

whichever comes first, the Secretary 

will transmit to DOL and to the petitioner(s) a report providing the definition of the class and one of the following outcomes: 

(1) The addition of the class to the 

Cohort; or 

(2) The result of any action by Congress to reverse or expedite the decision of the Secretary to add the class 

to the Cohort. 

(e) The report specified under paragraph (d) of this section will be published on the Internet at http:// 

www.cdc.gov/niosh/ocas and in the FEDERAL REGISTER. 

[69 FR 30780, May 28, 2004, as amended at 70 

FR 75953, Dec. 22, 2005] 

§ 83.18 How can petitioners obtain an 

administrative review of a final decision by the Secretary? 

(a) HHS will allow petitioners to contest only a final decision to deny adding a class to the Cohort or a health 

endangerment determination under 

§83.13(c)(3)(ii). Such challenges must be 

submitted in writing within 30 calendar 

days and must include evidence that 

the final decision relies on a record of 

either substantial factual errors or 

substantial errors in the implementation of the procedures of this part. 

Challenges may not introduce new information or documentation concerning the petition or the NIOSH or 

Board evaluation(s) that was not submitted or presented by the petitioner(s) or others to NIOSH or to the 

Board prior to the Board’s issuing its 

recommendations under §83.15. 

(b) A panel of three HHS personnel, 

independent of NIOSH and appointed 

by the Secretary, will conduct an administrative review based on a challenge submitted under paragraph (a) of 

this section and provide recommendations of the panel to the Secretary concerning the merits of the challenge and 

the resolution of issues contested by 

the challenge. Reviews by the panel 

will consider, in addition to the views 

and information submitted by the petitioner(s) in the challenge, the NIOSH 

evaluation report(s), the report containing the recommendations of the 

Board issued under §83.15, and recommendations of the Director of 

NIOSH to the Secretary. The reviews 

may also consider information presented or submitted to the Board and 

the deliberations of the Board prior to 

the issuance of the recommendations of 

the Board under §83.15. The panel shall 

consider whether HHS substantially 

complied with the procedures of this 

part, the factual accuracy of the information supporting the final decision, 

and the principal findings and recommendations of NIOSH and those of 

the Board issued under §83.15. 

(c) The Secretary will decide whether 

or not to revise a final decision contested by the petitioner(s) under this 

section after considering information 

and recommendations provided to the 

Secretary by the Director of NIOSH, 

the Board, and from the HHS administrative review conducted under paragraph (b) of this section. HHS will 

transmit a report of the decision to the 

petitioner(s). 

(d) If the Secretary decides under 

paragraph (c) of this section to change 

a designation under §83.17(a) of this 

part or a determination under §83.16(c) 

of this part, the Secretary will transmit to Congress a report providing 

such change to the designation or determination, including an iteration of 

the relevant criteria, as specified under 

§83.13(c), and a summary of the information and findings on which the decision is based. HHS will also publish a 

notice summarizing the decision in the 

FEDERAL REGISTER. 


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§ 83.19 42 CFR Ch. I (10–1–07 Edition) 

(e) A new designation of the Secretary under this section will take effect 30 calendar days after the date on 

which the report of the Secretary 

under paragraph (d) of this section is 

submitted to Congress, unless Congress 

takes an action that reverses or expedites the designation. Such new designations and related congressional actions will be further reported by the 

Secretary pursuant to paragraphs (d) 

and (e) of §83.17. 

[70 FR 75953, Dec. 22, 2005] 

§ 83.19 How can the Secretary cancel 

or modify a final decision to add a 

class of employees to the Cohort? 

(a) The Secretary can cancel a final 

decision to add a class to the Cohort, 

or can modify a final decision to reduce 

the scope of a class added by the Secretary, if HHS obtains records relevant 

to radiation exposures of members of 

the class that enable NIOSH to estimate the radiation doses incurred by 

individual members of the class 

through dose reconstructions conducted under the requirements of 42 

CFR part 82. 

(b) Before canceling a final decision 

to add a class or modifying a final decision to reduce the scope of a class, the 

Secretary intends to follow evaluation 

procedures that are substantially similar to those described in this part for 

adding a class of employees to the Cohort. The procedures will include the 

following: 

(1) Publication of a notice in the FEDERAL REGISTER informing the public of 

the intent of the Secretary to review 

the final decision on the basis of new 

information and describing procedures 

for this review; 

(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(c)(1) and (2), and 

83.13(c)(2) and (3); 

(3) A recommendation by the Board 

to the Secretary as to whether or not 

the Secretary should cancel or modify 

his final decision that added the class 

to the Cohort, based upon a review by 

the Board of the NIOSH analysis under 

paragraph (b)(2) of this section and any 

other relevant information considered 

by the Board; 

(4) An opportunity for members of 

the class to contest a proposed decision 

to cancel or modify the prior final decision that added the class to the Cohort, 

including a reasonable and timely effort by the Secretary to notify members of the class of this opportunity; 

and 

(5) Publication in the FEDERAL REGISTER of a final decision to cancel or 

modify the prior final decision that 

added the class to the Cohort. 

[69 FR 30780, May 28, 2004. Redesignated at 70 

FR 75953, Dec. 22, 2005] 

PART 84—APPROVAL OF 

RESPIRATORY PROTECTIVE DEVICES 

Subpart A—General Provisions 

Sec. 

84.1 Purpose. 

84.2 Definitions. 

84.3 Respirators for mine rescue or other 

emergency use in mines. 

Subpart B—Application for Approval 

84.10 Application procedures. 

84.11 Contents of application. 

84.12 Delivery of respirators and components by applicant; requirements. 

Subpart C—Fees 

84.20 Examination, inspection, and testing 

of complete respirator assemblies; fees. 

84.21 Examination, inspection, and testing 

of respirator components or subassemblies; fees. 

84.22 Unlisted fees; additional fees; payment 

by applicant prior to approval. 

Subpart D—Approval and Disapproval 

84.30 Certificates of approval; scope of approval. 

84.31 Certificates of approval; contents. 

84.32 Notice of disapproval. 

84.33 Approval labels and markings; approval of contents; use. 

84.34 Revocation of certificates of approval. 

84.35 Changes or modifications of approved 

respirators; issuance of modification of 

certificate of approval. 

84.36 Delivery of changed or modified approved respirator. 

Subpart E—Quality Control 

84.40 Quality control plans; filing requirements. 

84.41 Quality control plans; contents. 


bajohnson on PROD1PC69 with CFR