22314 Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 

APPENDIX A TO PART 81—GLOSSARY OF ICD–9 CODES AND THEIR CANCER DESCRIPTIONS 1—Continued 

ICD–9 code 

187 ......................................
 


188 ......................................
 


189 ......................................
 


190 ......................................
 


191 ......................................
 


192 ......................................
 


193 ......................................
 


194 ......................................
 


195 ......................................
 


196 ......................................
 


197 ......................................
 


198 ......................................
 


199 ......................................
 


200 ......................................
 


201 ......................................
 


202 ......................................
 


203 ......................................
 


204 ......................................
 


205 ......................................
 


206 ......................................
 


207 ......................................
 


208 ......................................
 


Cancer description 

Malignant neoplasm of penis and other male genital organs.



Malignant neoplasm of urinary bladder.



Malignant neoplasm of kidney and other unspecified urinary organs.



Malignant neoplasm of eye.



Malignant neoplasm of brain.



Malignant neoplasm of other and unspecified parts of nervous system.



Malignant neoplasm of thyroid gland.



Malignant neoplasm of other endocrine glands and related structures.



Malignant neoplasm of other and ill-defined sites.



Secondary and unspecified malignant neoplasm of the lymph nodes.



Secondary malignant neoplasm of the respiratory and digestive organs.



Secondary malignant neoplasm of other tissue and organs.



Malignant neoplasm without specification of site.



Lymphosarcoma and reticulosarcoma.



Hodgkin’s disease.



Other malignant neoplasms of lymphoid and histiocytic tissue.



Multiple myeloma and other immunoproliferative neoplasms.



Lymphoid leukemia



Myeloid leukemia.



Monocytic leukemia.



Other specified leukemia.



Leukemia of unspecified cell type.



1 The International Classification of Diseases Clinical Modification (9th Revision) Volume I&II. [1991] Department of Health and Human Services Publication No. (PHS) 91–1260, U.S. Government Printing Office, Washington, D.C. 

Dated: April 10, 2002. 

Tommy G. Thompson, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 02–10764 Filed 4–30–02; 8:45 am] 

BILLING CODE 4160–17–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 82 

RIN 0920–ZA00 

Methods for Radiation Dose 

Reconstruction Under the Energy 

Employees Occupational Illness 

Compensation Program Act of 2000; 

Final Rule 

AGENCY: Department of Health and



Human Services.



ACTION: Final rule.



SUMMARY: This rule implements select 

provisions of the Energy Employees 

Occupational Illness Compensation 

Program Act of 2000 (‘‘EEOICPA’’ or 

‘‘Act’’). The Act requires the 

promulgation of methods, in the form of 

regulations, for estimating the dose 

levels of ionizing radiation incurred by 

workers in the performance of duty for 

nuclear weapons production programs 

of the Department of Energy and its 

predecessor agencies. These ‘‘dose 

reconstruction’’ methods will be applied 

by the National Institute for 

Occupational Safety and Health, which 

is responsible for producing the 

radiation dose estimates that the U.S. 

Department of Labor will use in 

adjudicating certain cancer claims 

under the Act. 

DATES: Effective Date: This final rule is 

effective May 2, 2002. 

Compliance Dates: Affected parties 

are required to comply with the 

information collection requirements in 

§ 82.10 May 2, 2002. 

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 may also be submitted by email to OCAS@CDC.GOV. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Statutory Authority 

The Energy Employees Occupational 

Illness Compensation Program Act of 

2000 (‘‘EEOICPA’’), 42 U.S.C. 7384– 

7385 [1994, supp. 2001], established a 

compensation program to provide a 

lump sum payment of $150,000 and 

medical benefits as compensation to 

covered employees suffering from 

designated illnesses (i.e. cancer 

resulting from radiation exposure, 

chronic beryllium disease, or silicosis) 

incurred as a result of their exposures 

while in the performance of duty for the 

Department of Energy (‘‘DOE’’) and 

certain of its vendors, contractors, and 

subcontractors. This law also provided 

for payment of compensation to certain 

survivors of 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, 

titled 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 (Dec. 7, 2000). 

DOL published an interim final rule 

governing DOL’s administration of 

EEOICPA on May 25, 2001 (20 CFR 

parts 1 and 30). 

The executive order directed the 

Department of Health and Human 

Services (‘‘HHS’’) to perform several 

technical and policymaking roles in 

support of the DOL program: 

(1) HHS is to develop methods to 

estimate radiation doses (‘‘dose 

reconstruction’’) for certain individuals 

with cancer applying for benefits under 

the DOL program. These methods are 

the subject of this rule. HHS is also to 

apply these methods to conduct the 

program of dose reconstructions 

required by EEOICPA. This program is 

delegated to the National Institute for 

Occupational Safety and Health 

(‘‘NIOSH’’), an institute of the Centers 

for Disease Control and Prevention. 

(2) HHS is also to develop guidelines 

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 duties at a DOE facility or atomic 

Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 22315 

weapons facility. These guidelines were 

published as a notice of proposed 

rulemaking under 42 CFR Part 81 on 

October 5, 2001, and are being 

published as a final rule simultaneously 

with this rule in this issue of the 

Federal Register. 

(3) HHS is to staff the Advisory Board 

on Radiation and Worker Health and 

provide it with administrative and other 

necessary support services. The Board, 

a federal advisory committee, was 

appointed by the President in November 

2001. It first convened on January 22, 

2002, and is advising HHS in 

implementing its roles under EEOICPA 

described here. 

(4) Finally, HHS is to develop and 

apply procedures for considering 

petitions by classes of employees at 

DOE or Atomic Weapons Employer 

facilities seeking to be added to the 

Special Exposure Cohort established 

under EEOICPA. Employees included in 

the Special Exposure Cohort who have 

a specified cancer and meet other 

conditions, as defined by EEOICPA and 

DOL regulations (20 CFR 30), qualify for 

compensation under EEOICPA. 

Proposed HHS procedures for 

considering Special Exposure Cohort 

petitions will be published soon in the 

Federal Register. HHS will obtain 

public comment and a review by the 

Advisory Board on Radiation and 

Worker Health before these procedures 

are made final and implemented. 

As provided for under 42 U.S.C. 

7384p, HHS is implementing its 

responsibilities with the assistance of 

NIOSH. 

B. What Legal Requirements Are 

Specified by EEOICPA for Dose 

Reconstruction? 

EEOICPA requires that HHS establish, 

by regulation, methods for arriving at 

reasonable estimates of the radiation 

doses incurred by covered employees in 

connection with claims seeking 

compensation for cancer, other than as 

members of the Special Exposure 

Cohort. 42 U.S.C. 7384n(d). These 

methods will be applied to estimate 

radiation doses for the following 

covered employees: (1) An employee 

who was not monitored for exposure to 

radiation at a DOE or Atomic Weapons 

Employer facility; (2) an employee who 

was monitored inadequately for 

exposure to radiation at such a facility; 

or (3) an employee whose records of 

exposure to radiation at such facility are 

missing or incomplete. 

EEOICPA requires the Advisory Board 

on Radiation and Worker Health to 

independently review the methods 

established by this rule and to verify a 

reasonable sample of dose 

reconstructions established under these 

methods. The Advisory Board is a 

federal advisory committee established 

by the statute and appointed by the 

President which is advising HHS on its 

major responsibilities under EEOICPA. 

EEOICPA requires that DOE provide 

HHS with relevant information on 

worker radiation exposures necessary 

for dose reconstructions and requires 

DOE to inform covered employees with 

cancer of the results of their dose 

reconstructions. 42 U.S.C. 7384n(e) and 

7384q(c). NIOSH, which will be 

conducting the dose reconstructions, 

will inform covered employees and DOE 

of the results of these dose 

reconstructions. 

Subject to provisions of the Privacy 

Act (5 U.S.C. 552(a)), HHS will also 

make available to researchers and the 

general public information on the 

assumptions, methodology, and data 

used in estimating radiation doses. 42 

U.S.C. 7384n(e)(2). 

Finally, HHS notes that EEOICPA 

does not authorize the establishment of 

new radiation protection standards 

through the promulgation of these 

methods, and these methods do not 

constitute such new standards. 

C. What Is the Purpose of Dose 

Reconstruction? 

Dose reconstructions are used to 

estimate the radiation doses to which 

individual workers or groups of workers 

have been exposed, particularly when 

radiation monitoring is unavailable, 

incomplete, or of poor quality. 

Originally dose reconstructions were 

conducted for research on the health 

effects of exposure to radiation. In 

recent decades, dose reconstruction has 

become an integral component of 

radiation illness compensation 

programs in the United States and 

internationally. 

D. How Are Radiation Doses 

Reconstructed? 

The procedures and level of effort 

involved in dose reconstructions 

depend in part on the quantity and 

quality of available dose monitoring 

information, the conditions under 

which radiation exposure arose, and the 

forms of radiation to which the 

individual was exposed. If individuals 

for whom dose estimates are needed 

were monitored using present day 

technology and received only external 

radiation doses, dose reconstruction 

could be very simple. It might only 

require summing the radiation doses 

recorded from radiation badges and 

adding estimated potential ‘‘missed’’ 

doses resulting from the limits of 

detection of monitoring badges. 

Dose reconstruction can require 

extensive research and analysis. Such 

work is required if radiation doses were 

not monitored or there is uncertainty 

about the monitoring methods involved; 

if there was potential for internal doses 

through the ingestion, inhalation or 

absorption of radioactive materials; or if 

the processes and circumstances 

involved in the radiation exposures 

were complex. For the most complex 

dose reconstructions, research and 

analyses may include determining or 

assuming specific characteristics of the 

monitoring procedures; identifying 

events or processes that were 

unmonitored; identifying the types and 

quantities of radioactive materials 

involved; evaluating production 

processes and safety procedures 

employed; identifying the locations and 

activities of exposed persons; 

identifying comparable exposure 

circumstances for which data is 

available to make assumptions; and 

conducting a variety of complex 

analyses to interpret the data compiled 

or estimated. 

E. How Is Dose Reconstruction 

Conducted in a Compensation Program? 

An additional, critical factor affecting 

how doses are reconstructed is the 

amount of time available. For health 

research studies dose reconstructions 

may take from months to years to 

complete. In compensation programs, 

however, a balance must be struck 

between efficiency and precision. 

Section 7384d of EEOICPA specifically 

states that one of the purposes of the 

compensation program is to provide for 

‘‘timely’’ compensation. As applied 

under EEOICPA, dose reconstruction 

must rely on information that can be 

developed on a timely basis and on 

carefully developed assumptions. 

When conducting dose reconstruction 

for a compensation program, our 

primary concern will be to ensure the 

assumptions used to estimate doses are 

fair, consistent, and well grounded in 

the best available science. To address 

fairness, the Defense Threat Reduction 

Agency (‘‘DTRA’’), which conducts dose 

reconstructions for veterans and 

Department of Defense civilian 

personnel who participated in U.S. 

atmospheric nuclear testing and in the 

occupation forces of Hiroshima and 

Nagasaki, applies certain assumptions 

that err reasonably on the side of 

overestimating exposures ( see 32 CFR 

part 218). These assumptions substitute 

for more detailed information that 

would be time-consuming and costly to 

develop. HHS will take an approach 

similar to that of DTRA by using 

reasonable, fair, and scientifically based 

22316 Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 

assumptions as substitutes for 

additional research and analysis to 

achieve an efficient dose reconstruction 

process. 

F. How Will Dose Reconstruction 

Methods Under EEOICPA Differ From 

Dose Reconstruction for Veterans? 

The major differences for the HHS 

methods for dose reconstructions arise 

from characteristics that distinguish the 

radiation exposure experiences of 

nuclear weapons production workers 

from those of veterans. Whereas 

veterans were primarily exposed to 

external sources of radiation over brief 

periods in acute doses, employees 

covered by EEOICPA frequently may 

have received both acute and chronic 

exposures to internal and external 

radiation over periods as long as three 

to four decades. Further, nuclear 

weapons production employees 

experienced more diverse exposures 

and circumstances of exposure, on an 

individual basis and as a group than did 

veterans. As a result, many HHS dose 

reconstructions will be more complex 

than those conducted by DTRA, making 

it necessary that HHS place a high 

premium on any efficiencies that can be 

achieved. 

Addressing the need for efficiency, 

HHS is establishing a dose 

reconstruction process that limits the 

work performed in cases where it is 

evident the outcome of the 

compensation claim will be unaffected. 

HHS will rely on less detailed or precise 

estimates for claims for which 

compensation would clearly be due 

based on the more limited dose 

reconstruction, and for claims for which 

additional work clearly would not result 

in compensation. In the former case, if 

it is evident from limited dose 

reconstruction that the estimated 

cumulative dose is sufficient to qualify 

the claimant for compensation, no 

additional work will be performed. In 

the latter case, limited dose 

reconstructions will be conducted only 

for claims for which it is evident that 

further research and dose reconstruction 

will not produce a compensable level of 

radiation dose, because the use of worstcase assumptions does not produce a 

compensable level of radiation dose. In 

these latter cases, the decisive factors 

that result in NIOSH deciding to limit 

the dose reconstruction process will be 

clearly explained in the draft of the dose 

reconstruction results reported to the 

claimant under § 82.25, and in the dose 

reconstruction results reported to the 

claimant under § 82.26. 

A second important aspect of the HHS 

dose reconstruction process is that it 

will involve interaction with the 

covered employee or survivor. NIOSH 

will use information provided by the 

claimant to evaluate the completeness 

and adequacy of dose information 

available, to locate additional exposure 

or dose-related information, and to 

estimate unmonitored doses. 

G. How Will HHS Incorporate Scientific 

Methods Established by the Radiation 

Safety Scientific Community in Internal 

Dose Estimation Under EEOICPA? 

The methods for calculating internal 

dose under this rule use current models 

published by the International 

Commission on Radiological Protection 

(ICRP). Specifically, at this time NIOSH 

will use the new ICRP respiratory tract 

model for assessing doses due to 

inhalation of radioactive particles. 1 In 

addition, NIOSH will use the new 

biokinetic models for the radionuclides 

contained in publications 56,2 67 3 and 

69 4 in place of those described in 

previous ICRP publications. These 

models currently provide the most 

widely accepted methods for 

mathematically describing the uptake, 

transport and retention of radionuclides 

in the body. 

H. What Elements Underlying the Dose 

Reconstruction Process Are Expected To 

Change With Scientific Progress? 

ICRP periodically updates the models 

used to evaluate internal doses, based 

on new research on the metabolic 

properties of radioactive materials 

(radionuclides). These ICRP updates 

reflect the current state of scientific 

knowledge on the uptake, transport, and 

retention of radionuclides in the human 

body. 

In addition, technological advances in 

the areas of retrospective detection of 

radiation exposure or radiation 

exposure and dose biomarkers 

(detectable changes in human tissues 

and/or physiologic processes resulting 

from radiation exposure) may make it 

1 International Commission on Radiological 

Protection (ICRP). 1994. Human Respiratory Model 

for Radiological Protection. ICRP Publicatiaon 66, 

Annals of the ICRP 24(1–4). Elsevier Scientific Ltd., 

Oxford. 

2 International Commission on Radological 

Protection (ICRP). 1989. Age Dependent Doses to 

Members of the Public from Intakes of 

Radionuclides: Part 1. ICRP Publication 56, Annals 

of the ICRP 20(2). Pergamon Press, Oxford. 

3 International Commission on Radiological 

Protection (ICRP). 1993. Age Dependent Doses to 

Members of the Public from Intakes of 

Radionuclides: Part 2 ICRP Publication 67, Annals 

of the ICRP 23(2⁄3). Pergamon Press, Oxford. 

4 International Commission on Radiological 

Protection (ICRP). 1995. Age Dependent Doses to 

Members of the Public from Intakes of 

Radionuclides: Part 3: Ingestion Dose Coefficients. 

ICRP Publication 69, Annals of the ICRP 25(1). 

Elsevier Scientific Ltd., Oxford. 

possible to add new analyses to the dose 

reconstruction process in the future. 

As described in §§ 82.30–82.33 of the 

rule, NIOSH will address the need to 

update the scientific elements 

underlying dose reconstructions in a 

process that involves review by the 

Advisory Board on Radiation and 

Worker Health and permits and 

facilitates input from the public. 

II. Summary of Public Comments 

On October 5, 2001, HHS 

promulgated an interim final rule 

issuing methods for conducting dose 

reconstructions under EEOICPA (42 

CFR part 82; see 66 FR 50978). Public 

comments were solicited initially from 

October 5, 2001 to November 5, 2001. 

The public comment period was 

reopened subsequently from January 17, 

2002, to January 23, 2002; from January 

17, 2002, to February 6, 2002, for 

comments from the Advisory Board on 

Radiation and Worker Health; and from 

February 14, 2002, to March 1, 2002. 

HHS received comments from 13 

organizations and 23 individuals. 

Organizations commenting included 

several labor unions representing DOE 

workers, a community based 

organization, an administrative office of 

the University of California, several 

DOE contractors, and several federal 

agencies. A summary of these comments 

and HHS responses is provided below. 

These are organized by general topical 

area. 

A. Purpose of the Rule 

HHS received various comments 

regarding the purpose of the rule. 

Several comments concerned the 

general issue of whether or not the rule 

includes sufficient technical detail. 

Several commenters recommended HHS 

specify the detailed assumptions and 

technical methods that might be used in 

a dose reconstruction. Another 

commenter supported retaining the 

general level of detail included in the 

interim rule. One commenter 

recommended the comment period on 

the rule remain open until the public 

has had opportunity to review the dose 

reconstruction technical procedures 

discussed in the interim final rule. 

The approach of this rule is to 

establish the principles, general 

procedures, and general criteria by 

which the NIOSH dose reconstruction 

program will operate. Very specific 

details about the technical procedures 

that may be involved in a dose 

reconstruction are established in NIOSH 

implementation guides and will be 

available for public review as discussed 

in this rule. These detailed technical 

procedures were presented in draft form 

Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 22317 

to the Advisory Board on Radiation and 

Worker Health on January 24 and 

February 13, 2002. Further detail will be 

established as standard operating 

procedures as procedural issues arise in 

performing dose reconstructions. 

This approach to regulation is 

necessary because the level of possible 

detail is far too great to encompass in a 

reasonably comprehensible regulation. 

Many specific circumstances that might 

arise in dose reconstructions either 

cannot be anticipated with reasonable 

certainty or cannot be identified and 

addressed without causing a great delay 

in the initiation of the dose 

reconstruction program, seriously 

harming claimants already awaiting 

decisions on compensation. This 

approach is appropriate because the 

public is provided a clear explanation of 

the general approach of the dose 

reconstruction procedures and the 

principles and criteria that will guide 

implementation of these procedures. 

And the public will have the 

opportunity to review the procedures 

set forth in the NIOSH implementation 

guides as they are developed and at any 

time thereafter. 

Several commenters requested HHS 

define what constitutes a ‘‘reasonable 

estimate’’ of the radiation doses 

incurred by an employee. EEOICPA 

requires the dose reconstruction 

program to arrive at ‘‘reasonable 

estimates’’ of these doses (42 U.S.C. 

7384n(d)). 

HHS interprets this term to mean 

estimates calculated using a substantial 

basis of fact and the application of 

science-based, logical assumptions to 

supplement or interpret the factual 

basis. As discussed in the interim final 

rule, assumptions applied by NIOSH 

will give the benefit of the doubt to 

claimants in cases of scientific or factual 

uncertainty or unknowns. 

One commenter noted that the single 

purpose of dose reconstructions under 

EEOICPA is to support compensation 

decisions by DOL and recommended 

HHS clarify the limitations of the dose 

reconstruction findings arising from this 

circumstance. 

As discussed above and in the interim 

final rule, NIOSH is applying methods 

designed to support compensation 

decisions by DOL that are fair and as 

timely as possible. As a consequence, 

many of the NIOSH dose reconstruction 

results are likely to differ substantially 

from those that would be produced 

under a scientific research protocol, 

when the principal object is to produce 

maximally complete and precise 

estimates. Under the methods 

promulgated in this rule and consistent 

with the intent of Congress, NIOSH will 

give the benefit of the doubt to 

claimants when there is uncertainty or 

unknowns concerning radiation 

exposures. This will tend to 

overestimate radiation doses for 

employees, except for those employees 

for whom immediately available records 

reveal doses sufficiently high to produce 

a compensable level of probability of 

causation. For these employees whose 

dose levels can be immediately 

determined to be compensable, NIOSH 

will tend to underestimate their total 

cumulative doses by abbreviating the 

dose reconstruction process. Further 

dose reconstruction for these latter 

claimants, however, would be 

unnecessary and harmful. It would 

prolong the adjudication process 

without benefit to the claimant (since 

the abbreviated dose reconstruction has 

already estimated a compensable level 

of radiation dose), and at the cost of 

unnecessarily delaying dose 

reconstructions for other claimants. 

For the reasons discussed above, a 

dose reconstruction conducted by 

NIOSH will not always produce 

complete or best estimates of the actual 

doses received by an individual. HHS 

does not believe that the dose 

reconstruction results should be used 

for any purpose other than the 

probability of causation calculations 

required under EEOICPA. 

B. Claimant Involvement 

HHS received various comments 

concerning the involvement of 

claimants in the dose reconstruction 

process and other related claims 

processes. 

Several commenters recommended 

that the claimant not be burdened with 

collecting the records needed for the 

dose reconstruction. Another 

commenter recommended that the 

claimant have an opportunity to 

contribute information for the dose 

reconstruction. 

The former comments appear to stem 

from a misunderstanding of the role of 

claimant interviews in the dose 

reconstruction process. As outlined in 

the interim final rule and this final rule, 

DOE will provide the records needed for 

dose reconstruction directly to NIOSH 

in response to requests by NIOSH. The 

claimant is generally not burdened with 

collecting dosimetry and related data. 

The purpose of the claimant interview 

is to capture any information or records 

available to the claimant that might not 

be initially identified by or available 

from DOE or AWEs; as well as 

information that would help NIOSH 

interpret DOE records, such as 

information on radiation dosimetry 

badge practices or placement of 

radiation area monitors or particulars of 

work practices; or information that 

might be missing from DOE records, 

such as radiation monitoring results, 

information connecting an employee 

with a radiation contamination incident, 

or medical records indicating the 

employee received medical treatment 

resulting from radiation exposure. 

The contribution of information from 

claimants (and also coworkers when the 

claimant is a survivor of a covered 

employee) is entirely voluntary. It is 

intended to improve, when possible and 

necessary, the dose reconstruction 

record that can be established using 

DOE records and the records and results 

of research conducted at DOE or AWE 

facilities or research evaluating the 

health of DOE or AWE employees. 

One commenter requested 

clarification of the interview options in 

cases when the claimant is a survivor. 

As noted above, when the claimant is 

a survivor, NIOSH will interview the 

claimant and will also attempt to 

interview one or more co-workers of the 

employee. HHS recognizes that 

survivors frequently will not know 

much, if anything, about working 

conditions, work procedures, or 

dosimetry practices at DOE facilities, 

even when the survivor is the spouse of 

an employee. Interviews with coworkers are intended to supplement 

information available from the survivor. 

One commenter recommended that 

when the federal compensation program 

of EEOICPA, administered by DOL, 

denies a cancer claim and the employee 

involved in the claim had a combination 

of radiation and chemical exposures, the 

federal government should itself submit 

a compensation claim on behalf of the 

claimant to the workers’ compensation 

program in the state with jurisdiction. 

The commenter’s intent is to reduce the 

burden on the claimant who has already 

filed for compensation once, under the 

federal EEOICPA compensation 

program. 

The federal government does not have 

legal authority to file compensation 

claims with state workers’ 

compensation programs on behalf of 

nuclear weapons employees. On the 

other hand, the federal government has 

established a program to assist DOE 

contractor employees in obtaining 

compensation from state workers’ 

compensation programs for any 

illnesses that may have been caused by 

toxic exposures at DOE facilities, 

including cancers potentially caused by 

a combination of radiation and chemical 

exposures or either of these types of 

exposures individually. The DOE Office 

of Worker Advocacy is authorized to 

conduct this program under Part D of 

22318 Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 

EEOICPA. The program includes the 

establishment of physicians panels, 

appointed by HHS, to evaluate the 

work-relatedness of such illnesses and 

the establishment of agreements 

between DOE and individual states to 

facilitate the consideration of these 

compensation claims. 

The public should note, however, that 

claimants under the federal EEOICPA 

compensation program are eligible to 

seek compensation from state workers’ 

compensation programs regardless of 

the outcome of their federal claim. A 

decision by DOL to compensate a 

claimant under the federal program 

provides no guarantee, in and of itself, 

that a state compensation program will 

also compensate the claimant. These 

programs are legally and 

administratively independent, apart 

from any agreements that might be 

entered into by DOE and individual 

state workers’ compensation programs. 

One commenter recommended 

NIOSH re-analyze completed dose 

reconstructions without a request by the 

claimant when NIOSH obtains new data 

or information that could substantially 

change the findings of the completed 

dose reconstruction. This comment is 

relevant to two foreseeable 

circumstances: (1) When NIOSH 

discovers records or information on 

previously unidentified or possibly 

underestimated radiation exposures at 

DOE or AWE facilities; and (2) when 

NIOSH modifies the scientific elements 

underlying dose reconstructions, such 

as the biokinetic models used to 

estimate internal radiation doses. 

HHS agrees with the comment and 

has added provisions under § 82.27 of 

this rule to authorize NIOSH to review 

completed dose reconstructions on its 

own initiative, upon obtaining new 

information or changing scientific 

elements underlying dose 

reconstructions. HHS has targeted the 

added provisions to circumstances in 

which use of the new information or 

scientific element could increase the 

levels of radiation doses previously 

estimated, since the purpose of these 

provisions is to provide new 

information to DOL on claims that were 

denied based on outdated information. 

One commenter recommended that 

the federal government provide 

claimants with resources to obtain 

independent reviews of NIOSH dose 

reconstructions. 

HHS will not fund claimants to obtain 

independent reviews of dose 

reconstructions. EEOICPA already 

provides for an independent review of 

the NIOSH dose reconstruction program 

by the Advisory Board on Radiation and 

Worker Health, funded by HHS. This 

review will be periodic and include a 

sample of completed dose 

reconstructions. NIOSH will also 

establish several levels of quality 

assurance procedures integral to the 

dose reconstruction process. The 

proposal for HHS to fund further 

independent reviews is largely 

duplicative of these current efforts and 

hence, unlikely to benefit claimants or 

further improve the NIOSH dose 

reconstruction program. 

C. Basics of Dose Reconstruction 

HHS received several comments 

addressing provisions on the basic 

approach of dose reconstructions 

described under § 82.2 of the interim 

final rule. 

Several commenters were uncertain 

how to interpret the ‘‘hierarchy of 

methods’’ described under this section. 

The commenters were concerned that 

NIOSH might exclusively analyze 

monitoring data on individual workers, 

when such data are available, without 

taking under consideration other 

relevant data, such as area monitoring, 

information on monitoring practices and 

technology, or information on 

unrecorded exposures or missing 

records. 

It is first important to note, this 

section provides only a general outline 

on the basic approach of dose 

reconstructions. It is intended to 

introduce readers to the elementary 

concepts of dose reconstruction, which 

is why it is included in the 

‘‘Introduction’’ subpart of the rule. 

Section 82.10 and following sections 

provide detail on the specific 

procedures NIOSH must follow in 

conducting a dose reconstruction. 

Second, the hierarchical use of dose 

reconstruction methods discussed in 

this section implicitly requires the 

consideration of data from various 

sources. The provision of this section 

which gives highest priority to 

individual monitoring data begins with 

the conditional statement: ‘‘If found to 

be complete and adequate, individual 

worker monitoring data...are given the 

highest priority in assessing exposure.’’ 

To evaluate whether individual 

monitoring data are complete and 

adequate, NIOSH may have to examine 

and consider the full scope of sources 

and types of data available and relevant, 

as described under the detailed 

procedural sections of the rule 

beginning with § 82.10. NIOSH will 

have to examine other sources and types 

of data to properly interpret primary 

data, even when they are complete and 

adequate, as explained in § 82.2. 

One commenter recommended HHS 

explain in detail in this section how 

NIOSH would evaluate data adequacy. 

As discussed above, this section is 

introductory and general. Section 82.15 

of the rule explains in some detail how 

NIOSH will evaluate the completeness 

and adequacy of individual monitoring 

data. NIOSH has prepared 

implementation guides that provide 

additional detail, and will be preparing 

standard operating procedures as 

needed to address issues that arise as 

NIOSH conducts dose reconstructions. 

The implementation guides will be 

available to the public from the NIOSH 

addresses provided above and the 

standard operating procedures will also 

be made available as they are 

established. 

Several commenters requested HHS 

clarify the meaning of the expression 

used in this section: ‘‘reasonable and 

scientific assumptions.’’ This section 

explains that dose reconstructions use 

such assumptions in establishing 

default values to supplement existing 

data on workplace radiation exposures. 

This expression is intended to mean 

assumptions that follow logically from 

scientific experience and a factual basis. 

For example, dosimetrists assume that a 

process operating at different times or in 

different places but involving the same 

source term used under comparable 

conditions, controls, and practices will 

produce comparable radiation exposure 

levels and characteristics. 

One commenter suggested a 

substantive edit to the last sentence 

under § 82.2(a), which provides an 

example of a situation in which a dose 

reconstruction would employ a worst 

case assumption to substitute for lack of 

information on the solubility of an 

inhaled material. The commenter 

recommended that HHS clarify in this 

example that the worst case assumption 

would be reasonable. HHS has clarified 

this sentence accordingly. The sentence 

now reads: ‘‘For example, if the 

solubility classification of an inhaled 

material cannot be determined, the dose 

reconstruction would use the 

classification that results in the largest 

dose to the organ or tissue relevant to 

the cancer and that is possible given 

existing knowledge of the material and 

process.’’ 

D. Who Receives Dose Reconstructions? 

HHS received various comments 

concerning who is eligible for dose 

reconstructions and the circumstances 

under which NIOSH would conduct a 

dose reconstruction. 

Several commenters suggested there 

may be covered employees who require 

dose reconstructions who do not fit 

Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 22319 

within the three statutorily-prescribed 

groups specified under section 

7384n(d)(1) of EEOICPA and reiterated 

under § 82.3 of this rule to be eligible for 

dose reconstructions. The commenters 

recommended the rule should include 

all individuals filing compensation 

claims for cancer under EEOICPA. 

EEOICPA covers two groups of claims 

seeking compensation for cancer: claims 

seeking compensation under provisions 

of the Special Exposure Cohort and all 

others. Claims seeking compensation in 

the former group do not require dose 

reconstructions for DOL to adjudicate 

and hence DOL will not refer these 

claims to NIOSH for a dose 

reconstruction. Thus, the HHS rule 

should not be broadened to include all 

claims seeking compensation. 

Several other commenters stated that 

EEOICPA did not require dose 

reconstructions for employees who were 

monitored and for whom DOE has 

complete dose records. One commenter 

indicated that DOL should be able to 

use the dose of record from DOE instead 

of obtaining a dose reconstruction from 

NIOSH when the dose of record is 

sufficiently high to qualify the claimant 

for compensation. 

NIOSH is implicitly required by 

EEOICPA to evaluate the dose of record 

of every eligible claim, since without 

such an evaluation it could not be 

determined whether the monitoring data 

for the individual are complete and 

adequate. Moreover, the data provided 

in the dose of record from DOE are not 

in a form that can be used by DOL to 

calculate probability of causation. 

Nonetheless, HHS agrees that when the 

dose of record is itself very high, NIOSH 

should not expend resources on a dose 

reconstruction needlessly or cause 

unnecessary delay in DOL’s 

adjudication of the claim. For this 

reason, the rule includes efficiency 

measures under § 82.10 to limit the 

extent of the dose reconstruction 

depending on the circumstances. In the 

example given by the commenter, if the 

dose of record was evidently high 

enough to qualify the claimant for 

compensation, NIOSH would greatly 

abbreviate its effort, so that the claimant 

is not unnecessarily delayed in awaiting 

DOL to determine probability of 

causation and complete adjudication of 

the claim. 

One commenter questioned whether 

the definition of a ‘‘covered employee’’ 

under § 82.5 is sufficiently inclusive. 

HHS specified more narrowly than 

EEOICPA that a covered employee, for 

the purposes of the HHS rules, is a DOE 

or AWE employee for whom DOL has 

requested HHS to perform a dose 

reconstruction. 

This distinction results practically 

from the separate responsibilities of 

DOL and HHS in implementing 

EEOICPA. DOL is solely responsible for 

initially reviewing each claim, 

evaluating whether the claim represents 

a covered employee with a covered 

illness, and determining whether or not 

the claim requires a dose reconstruction. 

The only claims DOL will forward to 

HHS for dose reconstructions are those 

for a cancer not covered by provisions 

of the Special Exposure Cohort. Hence, 

HHS retains its proposed definition in 

this rule to be clear that NIOSH will 

only conduct dose reconstructions 

under EEOICPA for the subset of claims 

submitted by DOL to HHS for dose 

reconstructions. This is intended to 

avoid the possible confusion and delay 

that would arise if claimants were to 

directly submit to NIOSH requests for 

dose reconstructions. 

One commenter recommended a 

change to the definition given in this 

rule for Atomic Weapons Employer 

(AWE). The commenter recommended 

the definition include entities that 

‘‘handled’’ material that emitted 

radiation and include entities that 

processed, produced, or handled 

radiation-emitting equipment as well as 

material. 

The definition for AWE in the rule 

was established by Congress in 

EEOICPA. For a conclusive 

interpretation, the commenter should 

contact DOE, which is the only federal 

agency authorized to designate AWEs. 

One commenter recommended that 

HHS explain which employees at DOE 

or AWE facilities are not covered by 

EEOICPA and hence not eligible for 

dose reconstructions. The commenter 

specified Department of Defense 

employees as an example. 

As explained above, HHS does not 

determine whether an individual is a 

covered employee under EEOICPA. This 

is a responsibility of DOL. Potential 

claimants for individuals who worked at 

DOE or AWE facilities should consult 

with DOL to determine whether the 

individual might be a covered 

employee. 

E. Establishing a Time Limit for Dose 

Reconstructions 

One commenter recommended HHS 

consider establishing a time limit for 

dose reconstructions. 

HHS is especially interested in 

ensuring that dose reconstructions are 

conducted on a timely basis, to allow 

the timely adjudication of claims by 

DOL. To this end, NIOSH is establishing 

performance standards for dose 

reconstructions that include time 

criteria for completion of dose 

reconstructions and for critical 

intermediate steps. And NIOSH is 

establishing capacity to conduct a high 

volume of dose reconstructions. 

It would not be in the interests of 

claimants, however, to establish rigid 

time requirements for dose 

reconstructions. A variety of parameters 

will affect the speed with which a dose 

reconstruction can be completed; these 

are not controlled or determined by 

NIOSH. For example: the first dose 

reconstructions conducted for 

employees at a particular facility or 

operation within a facility are likely to 

take longer than subsequent dose 

reconstructions, since a substantial 

factual basis relevant to the subsequent 

dose reconstructions will be established 

by the initial dose reconstructions; some 

facilities will have better organized and 

more accessible records than other 

facilities, making dose reconstruction 

more efficient; individual claims will 

require dose reconstructions that differ 

in complexity, depending on the 

employment history, the adequacy and 

completeness of the records available, 

and the radiation dose levels indicated 

by the records initially available; and 

the overall dose reconstruction program 

will become more efficient over time, as 

experience and data accrue to NIOSH, 

reducing the data collection phase of 

subsequent dose reconstructions. 

F. Use of Records and Information 

HHS received a variety of comments 

concerning the use of records and 

information for dose reconstructions. 

Several commenters disagreed with 

HHS in requiring under § 82.10(e) that 

for NIOSH to use information provided 

by the claimant, the information must 

be supported by ‘‘substantial evidence,’’ 

and not be ‘‘refuted by other evidence.’’ 

The commenters interpret the 

substantial evidence provision as 

placing the burden of proof on the 

claimant. They interpret the refutation 

provision as unfairly favoring 

information from DOE over information 

from the claimant. 

The provision concerning substantial 

evidence, when considered completely, 

should not place an unreasonable 

burden of proof on the claimant. The 

provision explains a variety of 

parameters that NIOSH will evaluate in 

determining whether information 

provided by the claimant is supported 

by substantial evidence. NIOSH, rather 

than the claimant, has the burden of 

conducting this evaluation, and most of 

the parameters relate to information 

held by NIOSH, rather than supplied by 

the claimant. The claimant may be 

requested to provide medical records, if 

relevant. Likewise, the claimant may be 

22320 Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 

able to identify coworkers who could 

confirm certain information provided by 

the claimant. 

The commenter did not indicate that 

any of the parameters NIOSH will 

consider, in evaluating information 

provided by the claimant, are 

unreasonable or unfair. Moreover, it 

would be irresponsible for NIOSH to 

make use of information provided by 

the claimant without considering its 

validity. In many cases, claimants and 

coworkers will be recalling procedures 

and conditions and incidents that 

occurred decades earlier. 

Similarly, HHS finds it reasonable to 

omit the use of information provided by 

a claimant that is refuted by other, more 

persuasive evidence available to NIOSH. 

If, for example, NIOSH establishes the 

period when a certain process was 

undertaken at a facility, based on a 

complete administrative record 

(purchase orders, shipment logs, 

production figures, etc.), this record 

might refute a claimant’s recollection 

that a different process operated during 

this period. 

This provision does not, as suggested 

by the commenter, unfairly favor DOE 

information over that of the claimant. 

The dose reconstruction program 

established under this rule includes 

major elements to evaluate the adequacy 

and completeness of DOE or AWE 

records. A key purpose of NIOSH 

interviewing claimants and co-workers 

and making use of records from research 

and other sources, is specifically to 

support such an evaluation. 

Several commenters recommended 

NIOSH determine the availability of 

records from DOE facilities 

independently of DOE, versus relying 

on certifications by DOE as provided for 

under § 82.10(h). 

As discussed in the rule, NIOSH will 

be determining the availability of 

records from a variety of sources, 

including NIOSH-conducted and 

NIOSH-funded research, other 

researchers with experience at DOE 

facilities, and interviews with claimants 

and coworkers. Nonetheless, the DOE 

certifications are an important measure 

to assist NIOSH in ensuring it has 

employed as complete a record as 

possible in each dose reconstruction. 

Several commenters recommended 

NIOSH should be required to make use 

of data from NIOSH records in a dose 

reconstruction, versus having the option 

to do so, as provided for under § 82.10 

(a). 

NIOSH should not be compelled to 

make use of records from sources other 

than DOE in all dose reconstructions. 

There will be many dose 

reconstructions for which the records 

provided by DOE will be preferable for 

use in the dose reconstruction. NIOSH 

must have the discretion to use records 

from whichever source will support the 

completion of the highest quality dose 

reconstructions and timely dose 

reconstructions under efficiency 

measures, when applied. 

One commenter interpreted the text of 

§ 82.10(a) to limit the relevant types of 

information NIOSH would seek from 

DOE. The commenter recommended 

that this text be expanded to explicitly 

include all types of records, such as 

information on contamination incidents 

and work restrictions. 

HHS provides substantial detail under 

§ 82.14 on the types of data NIOSH will 

use, as necessary, in dose 

reconstructions. The text addressed by 

the commenter is intended to be general 

and inclusive. 

G. Claimant and Coworker Interviews 

HHS received several comments 

concerning the claimant and coworker 

interviews covered under § 82.10 of the 

rule. 

One commenter sought clarification 

about whom would be interviewed 

when the claimant is a survivor. 

When the claimant is a survivor, the 

claimant and one or more coworkers of 

the deceased employee may be 

interviewed, as necessary and possible. 

The interviews of coworkers are 

intended to substitute for information 

that would have been available from the 

employee. 

One commenter recommended that 

the claimant have multiple rounds of 

the closing interview, if the claimant 

provides additional information at these 

interviews that might be incorporated 

into the dose reconstruction. 

NIOSH will continue the closing 

interview until it is complete. The use 

of the term ‘‘interview’’ (singular) in this 

rule, for both the initial and closing 

interviews, is intended to cover as many 

interview sessions as required. NIOSH 

anticipates that the initial interviews 

will often be conducted over more than 

one session, allowing the claimant or 

coworker to recall information or, in the 

case of ill and aged individuals, to rest 

and recover between sessions. When 

claimants provide new information or 

notify NIOSH of the intent to obtain 

new information in closing interviews, 

these too will require multiple sessions 

to conclude. 

One commenter noted that the 

interviews will not meet the therapeutic 

or social counseling needs the claimant 

might require as a cancer patient. 

HHS agrees with the commenter. The 

interviewers will be sensitive to the 

perspectives of claimants but they will 

not be trained as counselors or 

therapists. This is outside the scope of 

these interviews. 

H. Evaluating Exposure Characteristics 

HHS received one comment regarding 

§ 82.10(i), which describes generally 

that NIOSH will characterize internal 

and external exposure environments for 

parameters known to influence dose, as 

necessary, in conducting the dose 

reconstruction. A parameter for external 

dose is the non-uniformity and 

geometry of the radiation exposure, 

which relates to the fact that the 

location of a radiation source in relation 

to the worker can affect the level of 

exposure recorded by their radiation 

monitoring badge. The commenter asks 

how NIOSH will assess this factor. 

NIOSH will use process information 

available from DOE, an AWE, and/or the 

claimant or coworkers to locate the 

worker in relation to the radiation 

source. NIOSH will use this 

information, along with conversion 

factors published by the ICRP and the 

International Commission on Radiation 

Units and Measurements, to calculate 

the level of radiation dose received 

based on the level recorded by the 

radiation badge. More details on this 

procedure will be provided in the 

NIOSH Implementation Guide for 

External Dose Reconstruction under 

EEOICPA, which will be available 

through the internet or direct addresses 

for NIOSH provided above. 

I. Use of ICRP Models 

HHS received various comments 

concerning the use of ICRP models for 

calculating internal radiation doses. 

Most of the comments concerned 

differences between the use of the 

current ICRP models under this rule and 

the use of older ICRP models applied in 

DOE and other U.S. radiation protection 

programs. Commenters indicated that 

some of the older ICRP models produce 

higher dose estimates than current 

models, whereas other older ICRP 

models produce lower dose estimates 

than the current models. One 

commenter asserted these differences 

extend from one to two orders of 

magnitude ( i.e., a difference of 10—100 

times). Several commenters 

recommended that NIOSH use the dose 

of record, calculated using the older 

ICRP models, when these would 

produce a higher dose estimate. Another 

commenter recommended that NIOSH 

not diverge from the models used by 

DOE for radiation protection programs. 

Finally, one commenter recommended 

that NIOSH explain to claimants the 

difference between the doses estimated 

by NIOSH and the doses of record. 

Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 22321 

As explained in the interim final rule 

and above, NIOSH is using current ICRP 

models because they represent 

improvements in the science of internal 

and external radiation dosimetry 

compared to older ICRP models. It is 

true that in some cases the current 

models will reduce the dose calculated 

and in other cases they will increase the 

dose calculated, but the differences 

should typically be far less than stated 

by the commenter. In any event, the 

estimates are more accurate when based 

on the current ICRP models. 

Moreover, it is not possible for NIOSH 

to use the dose of record from DOE, nor 

will it generally be possible to even 

compare the dose of record with the 

dose estimates produced by NIOSH. In 

general, the dose of record is not organspecific, is not reported for the different 

forms of radiation required as an input 

for NIOSH-IREP, and applies to different 

time periods than the period from first 

exposure to the diagnosis of cancer, 

including 50 year committed doses, 

which are not useful for purposes of 

calculating probability of causation. 

These differences will be explained to 

the claimant in the final dose 

reconstruction report and during their 

closing interview. 

Several commenters recommended 

that NIOSH not rely exclusively on ICRP 

models, but allow the use of individualspecific models when available data are 

adequate. 

In rare individual cases the ICRP 

models will not be applicable, such as 

for workers with chronic emphysema, or 

who have undergone chelation therapy, 

or had their thyroids removed. Singular 

exposures might also fall outside the 

scope of ICRP models, such as a worker 

that inhaled metal tritides. In these 

cases, NIOSH will have to use alternate 

models or modify existing models. In all 

other cases, NIOSH will consistently 

apply the ICRP models, which are 

widely accepted and extensively peerreviewed. 

One commenter questioned how 

NIOSH will handle cases for which the 

cancer is in a tissue not covered by 

existing ICRP models. 

In these cases, NIOSH will use the 

ICRP model that best approximates the 

model needed, while giving the benefit 

of the doubt to the claimant. For 

internal exposures, NIOSH will select 

the highest dose estimate from among 

the modeled organs or tissues that do 

not concentrate the radionuclide. This 

provision has been added to the rule 

under § 82.18(b). 

One commenter questioned whether 

NIOSH intends to use original urine and 

fecal data and lung count data to 

recalculate the employee’s dose. 

As outlined in this rule, NIOSH will 

be using original source data from DOE. 

These procedures are explained in 

detail in the NIOSH implementation 

guides for dose reconstruction, available 

from NIOSH through the internet or 

directly from the addresses provided 

above. 

One commenter recommended against 

using the ICRP weighting factors 

provided in Table 1 of § 82.10(j) of the 

interim rule, which can differ from the 

weighting factors used by DOE in its 

radiation protection program. Another 

commenter suggested NIOSH obtain a 

peer-review of these weighting factors. 

And a third suggested HHS remove 

Table 1 from the rule, since this would 

lock HHS into using these current ICRP 

weighting factors, some of which could 

change in future ICRP udpates. 

As discussed above with respect to 

use of ICRP models, NIOSH is using 

current ICRP weighting factors because 

they represent the best, thoroughly peerreviewed, science. HHS agrees with the 

recommendation to remove Table 1, so 

that NIOSH can use new weighting 

factors at such time as ICRP updates 

them, without requiring HHS to repromulgate a section of this rule. This 

is consistent with the overall 

construction of this rule, which allows 

NIOSH to update underlying scientific 

elements through a public process that 

does not require rulemaking. 

J. Use of Efficiency Measures 

HHS received several comments 

addressing the use of efficiency 

measures under § 82.10k this rule to 

enable NIOSH to complete dose 

reconstructions efficiently and on a 

timely basis for claimants. These 

measures are discussed in the summary 

of rule below. 

One commenter recommended against 

use of these measures out of concern 

that resulting dose reconstructions 

might provide the basis for appeals by 

claimants whose claims are denied. The 

same commenter was also concerned 

these dose reconstructions might cause 

difficulties if they were used as 

evidence in litigation between private 

parties. 

It is highly likely some denied 

claimants will contest the results of 

their dose reconstructions, regardless of 

whether or not their doses were 

reconstructed using efficiency measures. 

DOL has established an administrative 

process for claimants to object to 

recommended decisions under 20 CFR 

Part 30. The public should recognize, 

however, that the use of efficiency 

measures in these cases means the claim 

has been adjudicated using dose levels 

estimated on a worst-case basis. In other 

words, the claim has been assigned dose 

estimates that are likely to be 

substantially higher than the doses 

actually incurred by the covered 

employee. This same understanding, 

which will be clearly explained in the 

NIOSH dose reconstruction report for 

these claims, will be important to any 

litigation that might arise between 

private parties. HHS does not believe 

that the dose reconstruction results 

should be used for any purpose other 

than the probability of causation 

calculations required under EEOICPA. 

Several commenters recommended 

against NIOSH considering the level of 

probability of causation associated with 

dose information on claims, a 

recommendation which, if accepted, 

would effectively preclude NIOSH from 

applying any efficiency measures. One 

commenter indicated that consideration 

of probability of causation by NIOSH 

would detract from the credibility of 

NIOSH dose reconstructions. A second 

commenter reasoned it would be 

presumptive for NIOSH to evaluate 

probability of causation, when this is 

the role of DOL later in the adjudication 

process. 

NIOSH will not consider probability 

of causation on a routine basis, only for 

claims that evidently involve very high 

or low doses, as explained in the 

interim rule and this final rule. As HHS 

has explained above, without the use of 

efficiency measures HHS cannot 

complete dose reconstructions on a 

timely basis, which would harm all 

claimants, whether or not their claims 

are accepted. Furthermore, for the 

claims in which efficiency measures 

will be applied, it would be 

disingenuous to suggest NIOSH does not 

recognize the implications for 

probability of causation of the high or 

low doses that are evident. 

One commenter requested HHS define 

the meaning of the phrase under 

82.10(k): ‘‘extremely unlikely to 

produce a compensable level of 

radiation dose.’’ This phrase is used in 

the provision allowing the use of worstcase assumptions as an efficiency 

measure only for claims involving 

uncompensably low doses of radiation. 

Dose estimates sufficiently high to 

qualify a claimant for compensation 

definitively cannot be based on worst 

case assumptions employed as an 

efficiency measure to abbreviate 

research and analysis. Consequently, 

HHS has changed this phrase to be 

definitive. This provision now reads: 

‘‘Worst-case assumptions will be 

employed * * * to limit further 

research and analysis only for claims for 

which it is evident that further research 

and analysis will not produce a 

22322 Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 

compensable level of radiation dose (a 

dose producing a probability of 

causation of 50% or greater), because 

using worst-case assumptions it can be 

determined that the employee could not 

have incurred a compensable level of 

radiation dose.’’ 

K. Types of Information To Be Used 

HHS received various comments 

addressing the types of information to 

be used by NIOSH in dose 

reconstructions. These comments 

primarily address provisions under 

§ 82.14 of the interim rule and this final 

rule. 

Several commenters recommended 

NIOSH include additional items under 

several of the types of information listed 

in § 82.14. One of the commenters 

suggested NIOSH add an ‘‘other’’ option 

for each type of information, rather than 

specify each possibility. 

HHS has added an appropriate option 

for other, unspecified examples of 

information that NIOSH might use, 

where needed. This will avoid the risk 

of omitting a type of information that 

has not been considered but might be 

relevant. 

One commenter questioned how 

NIOSH would determine the radiation 

type using the summary radiation 

records produced by DOE. 

NIOSH is obtaining and using primary 

data on radiation sources, exposures, 

and doses, rather than the summarized 

data reported to employees. In cases in 

which NIOSH cannot identify the type 

of radiation, NIOSH will assume the 

radiation is of a type consistent with 

existing information and which results 

in a higher probability of causation, 

compared to the alternatives. 

One commenter recommended that 

NIOSH not assume that neutron 

exposures are chronic doses and that 

photon exposures are acute doses. 

The methods under this rule do not 

include any presumption of chronic or 

acute doses based on the radiation type. 

Doses will be characterized as chronic 

or acute based on the information 

available. If, however, NIOSH does not 

have information that distinguishes 

between chronic and acute doses, 

NIOSH will assume the type of dose that 

would result in a higher probability of 

causation. 

Several commenters recommended 

against HHS including medical 

screening x rays administered to nuclear 

weapons employees as a condition of 

employment. Similar comments were 

received on the HHS probability of 

causation notice of proposed 

rulemaking (42 CFR Part 81), as well. 

Commenters argue that the benefit of 

these exposures justifies their attendant 

risks, and therefore they should not 

contribute to the acceptance of a claim 

for compensation. 

HHS will not exclude radiation 

exposures resulting from these medical 

screening x rays. The important factor in 

this decision is that the exposures were 

incurred ‘‘in the performance of duty,’’ 

as specified by EEOICPA. The 

employees were required to receive 

these x ray screenings and hence were 

exposed to radiation in the performance 

of duty. 

One commenter questioned how 

NIOSH would account for the doses 

associated with x ray administrations 

that were unsuccessful and thus had to 

be repeated, resulting in multiple doses. 

Similarly, the commenter asked whether 

individual factors affecting the x-ray 

dose would be taken into account, such 

as the weight of the employee. 

The rate of repeat exposures 

associated with unsuccessful 

administrations has been evaluated in 

the scientific literature. NIOSH will 

account for these rates in the 

uncertainty distribution for the medical 

x-ray dose. Generally, NIOSH will also 

use this approach to account for 

variation in individual factors affecting 

radiation dose. NIOSH will make use of 

information on individual factors when 

available and feasible, but expects such 

circumstances will be unusual. 

One commenter suggested HHS 

consider including the doses from 

diagnostic x rays that employees 

received in the treatment of workrelated injuries. 

EEOICPA authorizes HHS to account 

only for radiation exposures incurred by 

an employee in the performance of duty. 

The intent of Congress was to provide 

compensation for cancers arising from 

the unique radiation exposures incurred 

by covered employees in the 

performance of duty for U.S. nuclear 

weapons programs. Radiation exposures 

associated with medical treatment of 

work injuries are not incurred in the 

performance of duty and are not unique 

to the experience of nuclear weapons 

employees. 

Several commenters recommended 

NIOSH include radiation exposures to 

medical staff serving DOE or AWE 

facilities. 

NIOSH will include all radiation 

exposures incurred by covered 

employees in the performance of duty. 

Several commenters recommended 

NIOSH estimate non-covered radiation 

doses from community and personal 

exposures (e.g., sun, radon, diagnostic 

and therapeutic exposures in medical 

care). The commenters intended that 

DOL would adjust (reduce) probability 

of causation calculations to account for 

these non-covered exposures. 

The risks associated with these 

community and non-occupational 

exposures are already accounted for in 

the risk models DOL will use to 

calculate probability of causation. These 

are inherent in the background rates for 

cancer. DOL will not have access to 

personal data or related adjustment 

factors for the risk models that would be 

required to account for individual 

variation with respect to these nonoccupational radiation exposures. 

One commenter indicated that some 

of the information, particularly process 

information, that may be required by 

NIOSH for dose reconstructions will 

require substantial labor for DOE and its 

contractors to provide. The commenter 

indicated that DOE has not funded its 

contractors to provide this information 

and, hence, questions whether such 

information will be made available. 

HHS is aware that this program will 

make substantial informational 

demands on DOE and consequently on 

DOE contractors. NIOSH has experience 

obtaining information of types specified 

in the rule from DOE contractors for 

health studies on DOE populations. 

HHS, DOE, and DOE contractors are 

currently working together to collect 

records presently needed for dose 

reconstructions and to improve record 

and information collection procedures 

for dose reconstructions. The goal of the 

agencies is to establish procedures that 

are practical and efficient while 

ensuring NIOSH can complete high 

quality dose reconstructions on a timely 

basis. 

L. Evaluating the Completeness and 

Adequacy of Records 

HHS received several comments 

regarding the procedures by which 

NIOSH is evaluating the completeness 

and adequacy of records available for a 

dose reconstruction, under provisions of 

§ 82.15. 

One commenter recommended the 

rule address the problem of incomplete 

dose records. 

This is one of the principal reasons 

for conducting a dose reconstruction. 

The interim final rule and this final rule 

directly address this issue under 

§ 82.15. NIOSH is determining when 

dose records are incomplete through 

comparisons between records available 

from DOE or the AWE and information 

provided by the claimant, coworkers, 

and the variety of other sources 

available. Sections 82.2, 82.10, 82.16, 

and 82.17 generally address how NIOSH 

will conduct dose reconstructions 

making use of limited records and 

information. 

Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 22323 

Several commenters questioned how 

NIOSH would weigh potentially 

conflicting evidence from different 

sources. 

NIOSH will conduct these evaluations 

on a case-by-case basis, evaluating the 

weight of the evidence from different 

sources. The NIOSH evaluation will be 

fully documented in the NIOSH dose 

reconstruction report provided to the 

claimant, DOL, and DOE. There are no 

strict criteria to be applied to this 

purpose. As § 82.10(e) states, NIOSH 

will accept claimant information 

supported by substantial evidence, 

unless ‘‘refuted’’ by other evidence, 

which in the case of conflicting 

evidence places the burden on other 

sources to refute the claimant’s 

information. 

For example, a claimant might assert 

involvement in a contamination 

incident that cannot be confirmed by 

DOE records addressing the incident. 

NIOSH might accept this assertion if it 

is consistent with work history 

information, claimant provided details 

about the incident, co-worker 

recollections, or other investigations of 

the incident (e.g., during research). 

Evidence that certain DOE records are 

incomplete or inaccurate is likely to 

weigh against reliance on such records. 

As NIOSH develops approaches to 

address conflicting evidence in dose 

reconstructions, NIOSH will document 

those that can be incorporated into 

standard operating procedures. NIOSH 

will make these available to the public 

through the NIOSH addresses provided 

above. 

One commenter raised concerns about 

possible recall difficulties and bias of 

employees with respect to past exposure 

incidents and conditions. 

It is well recognized from health, 

behavioral, and social research that 

there are substantial limitations and 

variation in the ability of people to 

accurately recall past events, and that 

these limitations generally increase with 

the time elapsed since the past event. 

However, all of the sources of 

information available to NIOSH in 

conducting dose reconstructions 

potentially involve substantial 

limitations. To conduct dose 

reconstructions, NIOSH will apply 

procedures available to it to mitigate 

these limitations to the extent possible. 

To improve the recall of employees, 

NIOSH will inform the employee of 

information available from employment 

and dosimetry records. NIOSH will also 

compare information obtained from the 

employee with other sources of 

information, such as coworkers or DOE 

records. 

One commenter recommended that 

the rule require concurrence with 

NIOSH by DOE and its contractors when 

NIOSH finds that individual monitoring 

data from DOE records are either 

incomplete or inadequate. The 

commenter was concerned that the 

complex information available from 

DOE might be misinterpreted by NIOSH. 

Under EEOICPA, NIOSH alone is 

authorized to determine which data to 

use in a dose reconstruction and how to 

interpret them. NIOSH will work closely 

with DOE and its contractors, however, 

to obtain the most useful and complete 

data available, which will ensure dose 

reconstructions are of the highest 

possible quality. 

M. Remedying Limitations of Monitoring 

and Missed Dose 

HHS received various comments 

regarding how NIOSH would remedy 

limitations of monitoring and missed 

dose, including unmonitored doses. 

These comments relate to provisions of 

the interim final rule and this final rule 

under §§ 82.16–82.18. 

Several commenters recommended 

NIOSH use coworker external 

monitoring data for a similarly exposed 

worker whose records omit such 

information. One of the commenters 

recommended that NIOSH preferentially 

use coworker data over data from area 

monitoring. 

The interim final rule and this final 

rule provide for NIOSH to use coworker 

data under §§ 82.16 and 82.17. Use of 

coworker data depends on its 

availability and the extent to which 

coworkers shared similar exposures. 

Nonetheless, NIOSH will review area 

monitoring data to evaluate the 

adequacy of the personal dosimetry. 

Several commenters recommended 

NIOSH consider all relevant data, not 

only air sampling results, to estimate 

internal doses when biomonitoring data 

are unavailable. Another commenter 

indicated concern about the quality of 

early biomonitoring data. 

HHS agrees with the comments and 

recognizes the limitations of early 

biomonitoring data, which can be 

addressed. HHS has revised § 82.18 to 

reflect the intent of NIOSH to consider 

all sources of relevant data to interpret 

or substitute for biomonitoring data. 

Several commenters advised 

concerning § 82.16 that NIOSH cannot 

estimate missed dose by summing 

potential doses using the limit of 

detection of monitoring equipment. 

Missed dose is a term applied to the 

dose that is potentially undetected 

because of the detection limits of 

monitoring technology and procedures. 

Indeed, as indicated in this section, 

NIOSH will not sum potential doses to 

estimate missed dose; only to estimate 

the upper limit of missed dose. Missed 

dose will be evaluated statistically using 

standard dose reconstruction 

procedures, as detailed in the NIOSH 

implementation guide for reconstructing 

external doses. 

The commenters also remarked that 

NIOSH should consider the reason for 

missing records and generally the 

problem of noncompliance with official 

DOE procedures. 

These issues are important but 

separate, concerning the completeness 

and adequacy of records, and are 

addressed under § 82.15. 

One commenter indicated concern 

that NIOSH might indiscriminately 

assign missed doses to employees, even 

if their work did not require them to 

enter areas of potential radiation 

exposure. Similarly, the commenter was 

concerned that NIOSH might not 

understand that certain employees were 

not monitored because they did not 

have potential radiation exposure. 

NIOSH is experienced in dose 

reconstruction and fully understands 

the variety of conditions of work at DOE 

and other nuclear weapons production 

facilities. NIOSH will evaluate the 

potential for radiation exposure in the 

work activities and locations of the 

employee and will not indiscriminately 

estimate missed dose for periods when 

monitored workers lack detected 

exposures, or indiscriminately estimate 

doses for unmonitored workers. Dose 

reconstructions will be based on the 

conditions and radiation levels of the 

areas in which the individual worked. 

One commenter recommended HHS 

identify radioactive contamination 

surveys as a source of information that 

may be used to supplement or substitute 

for individual monitoring data, under 

§ 82.17. 

HHS has revised this section of the 

rule to explicitly include these surveys, 

as intended. 

N. Accounting for Uncertainty 

HHS received several comments 

concerning issues of statistical 

uncertainty and its ramifications for the 

dose reconstructions. 

Several commenters recommended 

NIOSH characterize uncertainty over the 

entire period of interest rather than 

estimating uncertainty parameters for 

each annual dose estimate. They 

reasoned that this would reduce 

uncertainty. 

NIOSH–IREP requires annual dose 

estimates with individual uncertainty 

parameters to calculate probability of 

causation. Since NIOSH–IREP uses 

22324 Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 

Monte-Carlo techniques to combine 

uncertainties, the propagated 

uncertainty based on annual 

uncertainties will be less than if the 

annual uncertainties were simply 

added. This issue will be addressed in 

detail in the NIOSH implementation 

guides. 

Several commenters indicated the 

dose reconstructions would be unfairly 

biased in favor of internally exposed 

workers. The commenters assumed 

there would be more uncertainty 

associated with internal doses. 

The extent and characteristics of 

uncertainty will differ on a case-by-case 

basis, depending on the completeness 

and adequacy of records and 

monitoring. Uncertainty will not always 

be greater for internal dose estimates. It 

is true, however, that a substantial 

degree of uncertainty is inherent to 

internal dose calculations. This is a 

scientific limitation without any 

remedy. 

Several commenters questioned at 

what point uncertainty associated with 

a dose reconstruction would be too great 

to be considered ‘‘reasonable.’’ 

EEOICPA requires ‘‘reasonable 

estimates’’ of radiation doses. 42 U.S.C. 

7384n(d)(1). 

As explained above, HHS interprets 

this term to mean estimates calculated 

using a substantial basis of fact and the 

application of science-based, logical 

assumptions to supplement or interpret 

the factual basis. Claimants will in no 

case be harmed by any level of 

uncertainty involved in their claims, 

since assumptions applied by NIOSH 

will consistently give the benefit of the 

doubt to claimants. Hence, the level of 

uncertainty is not an issue whenever 

there is a sufficient factual basis to 

establish the radiation source type and 

quantity and a basic understanding of 

the process in which the employee 

worked. This information can provide 

the basis for a reasonable estimate. 

When this basic information is lacking, 

however, then NIOSH may not be able 

to establish reasonable estimates. As 

discussed below, when NIOSH lacks 

sufficient information to complete dose 

reconstructions, claimants will be 

informed of procedures for petitioning 

HHS under the proposed Special 

Exposure Cohort procedures, which will 

be published soon in the Federal 

Register. 

O. Completing and Reporting Dose 

Reconstructions 

HHS received several comments 

concerning the procedures by which 

NIOSH completes and reports dose 

reconstructions. These address §§ 82.25 

and 82.26 of the interim final rule and 

this final rule. 

One commenter recommended HHS 

establish a procedure for claimants who 

refuse to certify that they have 

completed providing information for the 

dose reconstruction, by refusing to sign 

the form OCAS–1. NIOSH requires this 

certification to close the record and 

conclude the dose reconstruction. 

The interim final rule and this final 

rule include a provision under 

§ 82.10(n) to address these 

circumstances. Claimants will have at 

least 60 days to sign OCAS–1. After the 

60 days and after notifying the claimant 

or the authorized representative, NIOSH 

will administratively close the dose 

reconstruction for a claimant who, 

without good cause as described below, 

steadfastly refuses to sign OCAS–1. This 

provision will not be applied, however, 

while a claimant is attempting to obtain 

additional information relevant to the 

claim, notified NIOSH of this fact, and 

clearly specified the information being 

sought. 

One commenter recommended that 

NIOSH clarify that internal doses will 

only be estimated for the primary cancer 

sites covered in the claim. 

HHS agrees with this comment and 

has clarified the relevant provision 

under § 82.26(b)(2). 

Several commenters recommended 

NIOSH not report separate doses for 

different radiation types, dose patterns, 

and other parameters, because these 

specifics may not be meaningful to 

claimants. 

NIOSH must provide this detailed 

information to DOL to calculate 

probability of causation. HHS believes 

this information will also be meaningful 

to claimants, since it is the precise basis 

for their probability of causation 

determination by DOL. NIOSH will 

explain this information to the claimant 

in the final dose reconstruction report 

and the closing interview, as provided 

for under §§ 82.10 and 82.26 of the 

interim final rule and this final rule. 

One commenter requested that HHS 

define the term: ‘‘as necessary,’’ used 

under § 82.26(b)(3) with respect to 

specifying uncertainty distributions 

associated with each dose estimated. 

The term is used in this provision 

because uncertainty distributions will 

not be applied to all doses estimated. 

Doses estimated using worst-case 

assumptions will not involve 

uncertainty. 

Several commenters questioned the 

basis for NIOSH notifying claimants of 

the results of its dose reconstructions on 

behalf of DOE, as indicated in the 

interim final rule. EEOICPA includes a 

requirement that DOE inform employees 

of the results of dose reconstructions 

under EEOICPA. 42 U.S.C. 7384n(e) 

HHS has proposed to DOE that it 

would inform claimants of dose 

reconstruction results on behalf of DOE 

to avoid duplication of effort and an 

unnecessary expenditure of federal 

resources. This arrangement can be 

established by agreement between the 

two federal agencies and would fulfill 

the statutory requirement. DOE may 

decide, however, to reserve this 

authority to itself and inform its 

employees independently of NIOSH. 

HHS has omitted the term ‘‘on behalf of 

DOE’’ in this final rule to allow DOE to 

reserve this authority to itself. 

P. Reviews of Dose Reconstructions or 

Dose Reconstruction Methods 

HHS received several comments 

concerning the review of NIOSH dose 

reconstructions. 

One commenter recommended HHS 

describe the review process at NIOSH, 

as provided for under § 82.27, in greater 

detail. 

The rule includes additional 

provisions describing that reviews can 

be initiated by NIOSH as well, as 

discussed above. HHS has also added 

provisions to this section to clarify that 

NIOSH will report on the review to the 

claimant, DOL, and DOE, describing the 

basis for the review, the methods 

applied and the results. However, HHS 

has not specified the details of review 

processes. These are likely to vary 

substantially, depending on the basis for 

the review and the issues that must be 

addressed. Review processes are likely 

to vary from simple, in which a NIOSH 

staff person or contractor makes 

identified technical or factual 

corrections, to extensive, requiring 

previously uninvolved NIOSH 

employees, contractor staff, or 

independent experts to collect 

additional data and re-conduct elements 

of a dose reconstruction. Standard 

operating procedures for different types 

of reviews will be established as 

needed, and made available to the 

public. In every case, however, it will be 

in the agency’s interest to conduct an 

appropriate and credible review, since 

the review will be examined by DOL in 

order to exercise its discretion 

concerning whether the claim should be 

reopened. 

One commenter requested 

clarification of the review rights of DOL 

with respect to NIOSH dose 

reconstructions. Specifically, the 

commenter appeared to seek further 

explanation of the provision under 

§ 82.27(a) of the interim final rule and 

this final rule, which reads as follows: 

‘‘(2) although the methodology 

Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 22325 

established by HHS under this Part is 

binding on DOL, DOL may determine 

that arguments concerning the 

application [emphasis added] of this 

methodology should be considered by 

NIOSH.’’ 

This provision sets forth DOL’s 

regulatory description of the scope of 

the review performed by DOL in 

considering objections to recommended 

decisions. Further clarification of that 

provision should come from DOL. 

One commenter recommended that 

NIOSH provide the draft dose 

reconstruction report to DOE for its 

review, prior to concluding the dose 

reconstruction. The commenter 

indicated that the familiarity of DOE 

with its own records makes it uniquely 

able to review the use of its data in the 

dose reconstruction. 

Under EEOICPA, Congress and the 

President specifically intended that the 

role of DOE in dose reconstructions be 

limited to providing records and 

information, and that an agency in a 

separate federal department conduct the 

dose reconstructions. The intent was to 

ensure that the agency conducting the 

dose reconstructions would have no 

actual or perceived interest in their 

outcomes. HHS has not authorized DOE 

to review NIOSH dose reconstructions 

because such a measure would conflict 

with this intent. The public should also 

be assured that NIOSH, which has the 

lead federal role in health research on 

DOE employees, is highly expert on 

DOE operations, records, and dosimetry 

practices. 

One commenter recommended this 

rule specify the percentage of NIOSH 

dose reconstructions to be reviewed by 

the Advisory Board on Radiation and 

Worker Health. A second commenter 

recommended this rule specify the 

procedures to be applied by the Board 

in their review. 

As described above under the 

discussion of statutory provisions 

related to this rule, EEOICPA requires 

the Board to conduct an independent 

review of a sample of NIOSH dose 

reconstructions. 42 U.S.C. 7384n(d). 

Since this review is specified to be 

independent, the Board, rather than 

HHS, must determine the procedures for 

the Board’s review of NIOSH dose 

reconstructions. Moreover, this level of 

autonomy is important for the 

credibility of the review. 

One commenter recommended 

NIOSH obtain peer review of the 

detailed dose reconstruction methods 

used under this rule but not specified in 

this rule. These methods are described 

in the NIOSH implementation guides for 

dose reconstructions and will be further 

specified as NIOSH develops standard 

operating procedures, as needed. 

NIOSH is obtaining peer review of 

specific implementation procedures for 

dose reconstructions by the Advisory 

Board on Radiation and Worker Health, 

which is authorized under EEOICPA to 

review these methods. 42 U.S.C. 

7384n(d). In addition, NIOSH will 

obtain reviews from independent 

subject matter experts as necessary, and 

may also seek reviews periodically by 

other standing scientific bodies, such as 

the National Academy of Science. 

Q. When Information Is Inadequate To 

Complete a Dose Reconstruction 

HHS received several comments 

concerning NIOSH actions when it 

cannot complete a dose reconstruction 

due to inadequate data, as provided for 

under § 82.12 of this rule. 

Several commenters requested HHS to 

define the circumstances under which 

information would be inadequate to 

complete a dose reconstruction. One of 

the commenters recommended HHS 

establish a ‘‘checklist’’ of potential 

informational sources that would serve 

as standardized criteria for determining 

whether information is adequate to 

complete a dose reconstruction. 

HHS does not expect this situation to 

arise frequently. In some cases, limited 

information about the radiation source 

term (type and quantity of radioactive 

material) and the process in which it 

was used, without any individual 

monitoring records, will be sufficient to 

complete a dose reconstruction, 

particularly when the potential level of 

radiation that was emitted is extremely 

low. In these cases, NIOSH can make 

use of worst case assumptions to fully 

account for the highest possible 

radiation doses that might have been 

incurred. 

Simplifying assumptions become 

more difficult to apply, however, when 

the potential level of radiation exposure 

for an individual ranges greatly, 

particularly when they range from low 

levels to potentially compensable levels 

(levels that produce a probability of 

causation of 50% and above). In these 

circumstances, the ability of NIOSH to 

complete the dose reconstruction 

depends on the extent and quality of 

information available to substitute for 

monitoring data. This can be readily 

defined on a case-by-case basis but not 

using rigid criteria; the potential 

circumstances are not readily 

foreseeable. As explained in the interim 

final rule and in this final rule, when 

NIOSH cannot complete a dose 

reconstruction, the basis for this result 

will be clearly explained in a report to 

the claimant, DOL, and DOE. 

When NIOSH cannot complete a dose 

reconstruction, one commenter 

recommended HHS automatically 

provide any necessary forms required by 

the claimant to file a petition for 

addition of a class of employees to the 

Special Exposure Cohort. A second 

commenter recommended HHS file the 

petition on behalf of the employee. 

HHS agrees with the proposal to 

supply the claimant with information 

needed to file a petition with HHS, and 

has included this as a new provision in 

the final rule. HHS will not, however, 

file a petition to HHS on behalf of the 

claimant. EEOICPA requires that a 

petition be filed by a class of employees. 

42 U.S.C. 7384q. 

R. Definitions of Terms 

One commenter recommended HHS 

provide a more specific definition in the 

rule for the term ‘‘uncertainty 

distribution.’’ 

This definition is intended to be 

general. Various forms of uncertainty 

distributions are relevant to the 

definition, including unique, 

unspecifiable forms derived from Monte 

Carlo simulations. 

S. Special Exposure Cohort 

HHS received several comments that 

provide recommendations, criteria, or 

concerns related to adding members to 

the Special Exposure Cohort established 

under EEOICPA. These comments fall 

outside the scope of this rule and 

address related but separate procedures 

to be established by HHS. 

As discussed above, HHS is proposing 

procedures by which it will consider 

petitions by classes of employees at 

DOE or AWE facilities to be added to 

the cohort, with the advice of the 

Advisory Board on Radiation and 

Worker Health. These procedures will 

be published soon in the Federal 

Register. The proposed HHS procedures 

and their accompanying explanation 

will address the comments received and 

directly solicit additional public 

comments, which HHS will fully 

consider in establishing final 

procedures. 

III. Review and Recommendations of 

the Advisory Board on Radiation and 

Worker Health 

HHS requested the Advisory Board on 

Radiation and Worker Health to review 

these HHS methods of dose 

reconstruction. The Board reviewed the 

methods during public meetings on 

January 22–23 and February 13–14, 

2002. In preparation for the meetings, 

the Board members individually 

reviewed the interim final rule as well 

as the HHS notice of proposed 

22326 Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 

rulemaking proposing guidelines for 

determining probability of causation (42 

CFR Part 81), which will be applied by 

DOL using the radiation doses estimated 

under these methods. The members also 

reviewed public comments on these 

rules. In addition, NIOSH staff members 

gave formal presentations on the HHS 

rules, implementation procedures, 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 

they unanimously concurred in 

establishing the Board findings and 

recommendations. The Board provided 

general findings addressing the general 

questions for public comment HHS 

identified in the notice for proposed 

rulemaking. The Board also provided 

recommendations addressing details of 

the rule. The findings and 

recommendations are provided below, 

together with responses by HHS to the 

recommendations: 

A. General Comments of the Board 

Responding to HHS Questions 

‘‘Interim proposed rule 42 CFR, part 

82, makes appropriate use of current 

science in reconstruction of radiation 

dose scenarios to the extent practicable. 

The Board recognizes that if the efficient 

and expeditious consideration of claims 

is to be made, absolute precision is not 

possible. The methods proposed are 

intended to result in dose estimates 

favorable to the claimants and are 

appropriate to the occupational illness 

compensation program envisioned by 

the Energy Employees Occupational 

Illness Compensation Program Act 

(EEOICPA). 

The process for involving the 

claimant is fair and provides multiple 

opportunities for interaction with the 

involved agencies. Indeed, in cases 

where acceptably dependable personal 

exposure data do not exist, NIOSH will 

utilize other sources of information as 

the basis for dose reconstruction. This 

approach unavoidably introduces 

additional uncertainty into the 

calculation of dose. However, we view 

the proposed methods as being 

appropriate for the available 

information. There will be 

circumstances where NIOSH will not be 

able to estimate the dose with sufficient 

accuracy. Those circumstances need to 

be clarified in the implementation of the 

regulation and in the Board’s review of 

NIOSH’s dose reconstruction work. 

Groups whose exposure cannot be 

estimated with sufficient accuracy may 

be candidates for the Special Exposure 

Cohort.’’ 

B. Specific Comments and 

Recommendations of the Board: 

Board Comment #1: ‘‘The Advisory 

Board recommends that Section K of 

Part III, ‘background’ concerning 

changes to scientific elements 

underlying the dose reconstruction 

process be moved to the main body of 

the Rule so as to formalize the updating 

process including the role of the 

Advisory Board. The rule does an 

admirable job of providing an objective 

process for conducting dose 

reconstruction. However, the 

assessment of the adequacy of the 

exposure information will involve 

professional judgment, and thus, some 

subjectivity. The Board plays an 

important role through its review of 

such decisions on dose reconstructions, 

and that role needs to be included in the 

main body of the Rule. Although this 

role is included in the Preamble 

‘Background’ (Section III, Subsection K) 

of 42 CFR Part 82, making it part of the 

rule itself would formalize the change 

process, significantly strengthening 

assurance that review by the Advisory 

Board of proposed changes will occur.’’ 

HHS Response: HHS accepts this 

recommendation by the Board. 

Accordingly, as discussed above in 

response to public comments on peerreview, HHS has moved provisions for 

peer-review involving the Board from 

the preamble of the notice of proposed 

rulemaking into the body of the rule 

itself. These provisions can be found at 

42 CFR 82.30–82.33 (Subpart E). 

Board Comment #2: ‘‘The Advisory 

Board requests that the term ‘validated’, 

as used in Section 82.10(j), be either 

defined or clarified.’’ 

HHS Response: HHS has clarified this 

section by eliminating any reference to 

validation, which has a specific 

meaning in scientific work which was 

not intended. The point of the text, 

which is now revised, was to indicate 

that NIOSH would determine that these 

data are assigned correctly and 

complete, before developing the 

exposure matrix discussed under the 

provision. 

Board Comment #3: ‘‘The Advisory 

Board recommends that NIOSH clarify 

82.10(m), (n), and (o) in regards to the 

steps and timeline required for the 

claimants, or authorized representatives 

of the claimants, to provide information 

to NIOSH and to sign or submit form 

OCAS–1. NIOSH should ensure that the 

claimants, or authorized representatives 

of the claimants, have adequate time to 

obtain and submit additional 

information to NIOSH.’’ 

HHS Response: HHS has revised 

§§ 82.10(l), (m), and (n) to clarify the 

procedure and time for the claimants or 

their authorized representatives to 

provide final information and sign and 

submit form OCAS–1, permitting 

NIOSH to complete the dose 

reconstruction. The new provisions 

clarify that NIOSH may allow claimants 

time to obtain and provide NIOSH with 

additional relevant information, after 

NIOSH has provided to the claimant 

OCAS–1, and before the 60 day deadline 

to submit OCAS–1 is applied. The 

public should also note that claimants 

will not receive OCAS–1 for signature 

before they have completed their initial 

interview session or sessions, received a 

summary of their initial interview for 

their review and revisions, and received 

for review a draft dose reconstruction 

report. 

Board Comment #4: ‘‘The Advisory 

Board recommends that § 82.18, 

concerning the use of ICRP models, be 

clarified so as to clearly indicate that 

NIOSH intends to use current ICRP 

models.’’ 

HHS Response: HHS has clarified its 

intent to use current ICRP models in the 

text of this section, consistent with 

discussion of this provision in the 

preamble of the interim final rule and 

this final rule. 

Board Comment #5: ‘‘The Advisory 

Board recommends that the last 

sentence in § 82.28 (b), be clarified in 

regards to the coverage of the Privacy 

Act.’’ 

HHS Response: The Board was 

concerned that the rule does not clearly 

indicate that certain researchers who 

follow specific procedures under the 

Privacy Act to protect confidential 

information may have access to names 

of claimants, covered employees, and 

other confidential information. HHS has 

clarified the text of this provision 

accordingly. 

IV. Summary of the Rule 

Congress, in enacting EEOICPA, 

created a new Energy Employees 

Occupational Illness Compensation 

Program to ensure an efficient, uniform, 

and adequate compensation system for 

certain employees. Under Executive 

Order 13179, the President assigned 

primary responsibility for administering 

the program to DOL. The President 

assigned various technical 

responsibilities for policymaking and 

assistance to HHS. Included among 

these is promulgation of this rule to 

establish methods NIOSH will apply to 

conduct dose reconstructions for 

covered employees seeking 

compensation for cancer, other than as 

members of the Special Exposure Cohort 

Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 22327 

seeking compensation for a specified 

cancer. NIOSH dose reconstructions 

will be used by DOL to estimate the 

probability that the cancers of these 

covered employees were related to 

radiation exposures at covered facilities. 

Introduction 

Sections 82.0 and 82.1 briefly 

describe how these regulations relate to 

DOL authorities under EEOICPA and 

the assignment of authority for these 

regulations to HHS. In § 82.2, HHS 

provides a general introduction to dose 

reconstruction and describes the 

hierarchy of information to be relied 

upon for dose reconstructions. This 

hierarchy gives preference to individual 

radiation monitoring data, if complete 

and adequate, and provides for use of 

information on the workplace 

environment and radiation exposures 

for interpretation and as a secondary 

source of data, and provides for use of 

reasonable and scientific assumptions in 

lieu of certain data when the workplace 

environment cannot be fully 

characterized. HHS believes this 

approach would give due weight to the 

potentially most precise data, but would 

take into account the limitations of such 

data and its availability. 

Section 82.3 summarizes the specific 

provisions of EEOICPA directing HHS 

in the development of this regulation 

and NIOSH in the conduct of dose 

reconstructions under this regulation. 

Section 82.4 describes how DOL will 

use the results of NIOSH dose 

reconstructions for the adjudication of 

claims. 

Definitions 

Section 82.5 defines the principal 

terms used in this part. It includes terms 

specifically defined in EEOICPA that, 

for the convenience of the reader of this 

part, are repeated in this section. It 

clarifies the definition of radiation. 

Section 3621(16) of EEOICPA defines 

radiation as ionizing radiation in the 

form of alpha or beta particles, neutrons, 

gamma rays, or accelerated ions or 

subatomic particles from accelerator 

machines. The rule elaborates upon this 

definition, specifically including x rays, 

protons and other particles capable of 

producing ions in the body, which are 

components of ionizing radiation 

exposures experienced by nuclear 

weapons production workers. In 

addition, for clarity the definition in 

this rule explicitly excludes nonionizing forms of radiation, such as 

radio-frequency radiation and 

microwaves. 

The definition of EEOICPA has been 

revised to reflect the codification of the 

Act in the United States Code. 

Dose Reconstruction Process 

Section 82.10 provides an overview of 

the major elements of the dose 

reconstruction process that NIOSH will 

implement under EEOICPA. It describes 

the steps in the process, the sources and 

types of information that will be 

collected and analyzed, the role of the 

claimants in developing a factual basis 

for dose reconstruction, the types of 

analyses, and criteria that will direct 

NIOSH to ensure dose reconstructions 

produce reasonable dose estimates and 

serve claimants efficiently. 

NIOSH will obtain available 

monitoring data and information on the 

workplace environment and practices 

from DOE and other sources. NIOSH 

will interview the claimant to obtain 

information and to report to the 

claimant on dose reconstruction results 

and the methods and data used to 

produce the results. NIOSH will take 

measures to produce results as 

efficiently as possible, so that 

adjudication of the claim by DOL can be 

resumed and completed in a timely 

fashion. These measures include 

limiting the dose reconstruction process 

to use less detailed or precise estimates 

for claims for which it is evident that 

further research and analysis will not 

affect the outcome of the claim. 

For example, under these regulations, 

if it is evident from the record of 

external radiation dose alone that an 

employee incurred a sufficiently high 

level of dose to have the claim accepted 

by DOL for compensation (a dose that 

would result in a probability of 

causation of 50% or higher), NIOSH 

would conclude the process without 

continuing with time consuming 

research and analysis to estimate 

internal dose. Instead, NIOSH would 

immediately report the limited dose 

estimate, based on external dose only, to 

the claimant and DOL, along with an 

explanation of the reason for limiting 

the dose reconstruction process. 

Similarly, if, for example, records and 

information establish that an employee 

incurred radiation doses evidently 

below a level that could result in 

compensation, NIOSH would substitute 

worst-case assumptions for additional 

research and analysis, to complete and 

report on the dose reconstruction 

without delay. 

This approach will provide more 

timely compensation for claims for 

which it is evident the claimant will 

qualify for compensation, and more 

timely results and adjudication for 

claims for which it is evident further 

research and analysis will not produce 

a compensable level of radiation dose. 

Section 82.10(j) has been revised, as 

indicated above in the discussion of 

public comments, to remove Table 1— 

Radiation Weighting Factors from the 

rule. Instead, this section simply 

indicates NIOSH will use current ICRP 

weighting factors. Inclusion of this table 

in the rule would require HHS to repromulgate this section of the rule and 

the table as these weighting factors are 

updated by ICRP. 

Sections 82.10(l), (m), and (n) have 

been revised, as indicated above in the 

discussion of recommendations by the 

Advisory Board on Radiation and 

Worker Health, to clarify the 

opportunity for the claimant to provide 

additional information to NIOSH after 

NIOSH has provided the claimant with 

a draft dose reconstruction report. The 

revisions also clarify the application of 

a 60 day deadline for the claimant to 

certify that they have completed 

providing information, such that NIOSH 

can conclude the dose reconstruction. 

Section 82.11 defines the subset of 

claimants under EEOICPA for whom 

NIOSH will conduct dose 

reconstructions. NIOSH will attempt to 

conduct dose reconstructions for all 

claims forwarded to NIOSH from DOL. 

This includes all covered employees 

seeking compensation for cancer, other 

than as members of the Special 

Exposure Cohort seeking compensation 

for a specified cancer, as determined by 

DOL. 

Section 82.12 describes NIOSH 

procedures for notifying any claimants 

for whom a dose reconstruction cannot 

be completed because of insufficient 

information to reasonably estimate the 

dose potentially incurred by the covered 

employee. NIOSH will notify the 

claimant and DOL that a dose 

reconstruction cannot be completed and 

describe the basis for this finding. In 

these cases, the claimant would have 

the opportunity to seek administrative 

review of this result after DOL produces 

a recommended decision to deny the 

claim, based on the report from NIOSH 

that there is insufficient evidence to 

complete a dose reconstruction. For a 

claim in which the employee has a 

specified cancer, the claimant might 

still be eligible for compensation under 

EEOICPA. Classes of covered employees 

have the option to petition HHS to be 

added to the Special Exposure Cohort. 

NIOSH will provide claimants for whom 

it cannot complete a dose reconstruction 

any information and forms provided by 

HHS for classes of employees to petition 

HHS. HHS is establishing procedures to 

consider such petitions, as required 

under Section 7384q of EEOICPA and 

Section 2(b) of E.O. 13179. Proposed 

22328 Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 

procedures will be published soon in 

the Federal Register. 

Sections 82.13 and 82.14 describe in 

detail the sources and examples of the 

types of information NIOSH will use in 

dose reconstructions. DOE and 

claimants will be the primary sources of 

information. Information types include: 

subject and employment information, 

worker monitoring data, monitoring 

program data, workplace monitoring 

data, workplace characterization data, 

and process descriptions for each work 

location. The actual use of this wide 

range of information will be determined 

for each claim individually, based on 

the types of information available and 

necessary. HHS has revised these 

sections in response to public comments 

discussed above to ensure the types of 

information that might be used in dose 

reconstructions under this rule include 

any possibilities HHS has not specified. 

Sections 82.15–82.17 describe how 

NIOSH will evaluate the completeness 

and adequacy of monitoring data and 

how NIOSH would remedy limitations, 

applying the general approach described 

in § 82.2 and making use of the data 

sources and types described in §§ 82.13 

and 82.14. NIOSH will evaluate the 

completeness and adequacy of 

monitoring data by various means, such 

as evaluating associated information on 

the workplace environment and 

practices, evaluating the monitoring 

technology, and evaluating other 

sources of information. NIOSH will 

remedy data limitations using 

established dose reconstruction 

practices, such as interpolating from 

recorded doses to estimate unrecorded 

doses, and substituting monitoring data 

from comparably exposed workers. 

Sections 82.18–82.19 describe how 

NIOSH will address salient technical 

issues of calculating internal dose and 

taking into account uncertainty with 

respect to dose information. Internal 

dose is the radiation dose received by 

radioactive materials taken into the 

body, such as by inhalation or ingestion. 

It is important because it accumulates 

year after year, increasing the risk of 

certain cancers over time. NIOSH will 

use current ICRP models for calculating 

internal dose and accompany dose 

estimates with uncertainty distributions. 

DOL will use these distributions with 

appropriate statistical methods to take 

into account uncertainty about the dose 

when calculating probability of 

causation for a claim. 

As discussed in response to public 

comments above, HHS has added new 

language to § 82.18 to specify how 

NIOSH will select from among existing 

ICRP models to calculate internal dose 

for a cancer site that has not been 

addressed by ICRP. 

Reporting and Review of Dose 

Reconstruction Results 

Sections 82.25 and 82.26 describe in 

detail NIOSH procedures for reporting 

the results of dose reconstructions to 

claimants and DOL, specifying the 

timing, content, and form of the dose 

reconstruction reports. 

Section 82.27 describes how and 

when claimants can obtain reviews of 

NIOSH dose reconstructions. NIOSH 

will review dose reconstructions upon 

request by DOL under DOL procedures 

for claimants seeking review of dose 

reconstructions. These procedures also 

allow for DOL to request reviews of dose 

reconstruction upon its own initiative; 

for example, to request review of 

previously completed dose 

reconstructions to reflect updated 

scientific methods. 

As discussed above in response to 

public comments, HHS has revised this 

section to allow NIOSH to review 

completed dose reconstructions on its 

own initiative, in response to new 

information or scientific updates that 

could substantially increase the 

radiation doses NIOSH had estimated. 

HHS also revised this section to clarify 

that NIOSH will report to claimants, 

DOL, and DOE on NIOSH reviews of 

completed dose reconstructions 

conducted under this section. 

Updating the Scientific Elements 

Underlying Dose Reconstructions 

Section 82.30–82.33 describe the 

procedures NIOSH will follow to update 

the scientific elements underlying 

NIOSH dose reconstructions to maintain 

a dose reconstruction program that is 

reasonably current with progress in 

science. An example of such an update 

would be the incorporation of a newly 

published ICRP model for estimating 

internal dose. Updates may also be 

recommended by the public at any time. 

The Advisory Board on Radiation and 

Worker Health will consider all 

proposals for updates in its public 

meetings, and the public will have an 

opportunity to comment on the 

proposals. To facilitate public 

participation, NIOSH will periodically 

publish a notice in the Federal Register 

informing the public of proposed 

updates, as well as notifying the public 

of proposed updates to be considered at 

upcoming meetings of the Advisory 

Board. NIOSH will also publish a notice 

in the Federal Register notifying the 

public of the completion of updates. In 

the notice, NIOSH will address relevant 

public comments and recommendations 

from the Advisory Board. 

V. Significant Regulatory Action 

(Executive Order 12866) 

This rule is being treated as a 

‘‘significant regulatory action’’ within 

the meaning of Executive Order (E.O.) 

12866 because it raises novel or legal 

policy issues arising out of the legal 

mandate established by EEOICPA. The 

rule is designed to establish practical 

methods, grounded in current science, 

to fairly and efficiently assist claimants 

and support DOL in the adjudication of 

applicable claims seeking compensation 

for cancer under EEOICPA. NIOSH will 

apply the methods to produce 

reasonable, scientifically supported 

estimates of the radiation doses incurred 

by covered employees subject to the 

claims, as permitted by available data 

and information. The financial cost to 

the federal government of producing 

these estimates is expected to be several 

thousand dollars per claim, on average. 

The rule carefully explains the 

manner in which the regulatory action 

is consistent with the mandate for this 

action under section 3623(d) of 

EEOICPA and implements the detailed 

requirements concerning this action 

under this section of EEOICPA. The rule 

does not interfere with State, local, and 

tribal governments in the exercise of 

their governmental functions. 

The rule is not considered 

economically significant, as defined in 

section 3(f)(1) of the Executive Order 

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 Executive Order 12866 

and provides estimates of the aggregate 

cost of benefits and administrative 

expenses of implementing EEOICPA 

under its rule (see FR 28948, May 25, 

2001). OMB has reviewed this rule for 

consistency with the President’s 

priorities and the principles set forth in 

E.O. 12866. 

VI. 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 

rule will not have a significant 

economic impact on a substantial 

number of small entities within the 

meaning of the RFA. This rule affects 

only DOL, DOE, HHS, and some 

individuals filing compensation claims 

under EEOICPA. Therefore, a regulatory 

Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 22329 

flexibility analysis as provided for 

under RFA is not required. 

VII. What Are the Paperwork and 

Other Information Collection 

Requirements (Subject to the 

Paperwork Reduction Act) Imposed 

Under This Rule? 

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 this rule. 

NIOSH has obtained clearance from 

OMB to collect data under EEOICPA. 

In performance of its dose 

reconstruction responsibilities under 

the Act, NIOSH will interview claimants 

individually and provide them with the 

opportunity, through a structured 

interview, to assist NIOSH in 

documenting the work history of the 

employee (characterizing the actual 

work tasks performed), identifying 

incidents that may have resulted in 

undocumented radiation exposures, 

characterizing radiation protection and 

monitoring practices, and identifying 

co-workers, radiation protection 

management and staff, line managers, 

and other witnesses, if NIOSH 

determines this is necessary, to confirm 

undocumented information. In this 

process, NIOSH will use a computer 

assisted telephone interview (CATI) 

system, which will allow interviews to 

be conducted more efficiently and 

quickly than would be the case with a 

paper-based interview instrument. 

NIOSH will use the data collected in 

this process to complete an individual 

dose reconstruction that accounts for 

radiation dose, including unmonitored 

or inadequately monitored dose, 

incurred by the employee in the 

performance of duty for DOE nuclear 

weapons production programs. After 

dose reconstruction, NIOSH will 

provide a draft of the dose 

reconstruction report to the claimant 

and perform a brief follow-up interview 

with the claimant to explain the results 

and to allow the claimant to confirm or 

question the record NIOSH has 

compiled. This will also be the final 

opportunity for the claimant to 

supplement the dose reconstruction 

record. 

At the conclusion of the dose 

reconstruction process, the claimant 

will be requested to submit to NIOSH a 

form (OCAS–1) to confirm that the 

claimant has completed providing 

information to NIOSH for the dose 

reconstruction. The form will notify the 

claimant that signing the form allows 

NIOSH to provide a final dose 

reconstruction report to DOL and closes 

the record on data to be used for the 

dose reconstruction. DOL will use data 

from the dose reconstruction report to 

determine the probability that the 

cancer(s) of the covered employee may 

have been caused by radiation doses 

incurred in the performance of duty at 

a DOE or AWE facility. 

There will be no cost to respondents 

for this data collection. 

VIII. 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 rule prior 

to its effective date. The report will state 

that the Department has concluded that 

this 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 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. 

IX. 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 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. 

X. Executive Order 12988 (Civil Justice) 

This rule has been drafted and 

reviewed in accordance with Executive 

Order 12988, Civil Justice Reform and 

will not unduly burden the Federal 

court system. Dose reconstruction may 

be an element in reviews of DOL 

adverse decisions in the United States 

District Courts pursuant to the 

Administrative Procedure Act. 

However, DOL has attempted to 

minimize that burden by providing 

claimants an opportunity to seek 

administrative review of adverse 

decisions, including those involving 

dose reconstruction. This rule provides 

a clear legal standard for HHS and DOL 

to apply regarding dose reconstruction. 

This rule has been reviewed carefully to 

eliminate drafting errors and 

ambiguities. 

XI. Executive Order 13132 (Federalism) 

The Department has reviewed this 

rule in accordance with Executive Order 

13132 regarding federalism, and has 

determined that it does not have 

‘‘federalism implications.’’ The 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.’’ 

XII. 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 rule on children. The agency has 

determined that the rule will not affect 

children. 

XIII. 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 rule on energy supply, distribution 

or use, and has determined that this rule 

is not likely to have a significant 

adverse effect on them. 

XIV. Effective Date and Information 

Collection Approval 

The Secretary has determined, 

pursuant to 5 U.S.C. 553(d)(3), that there 

is good cause for this rule to be effective 

immediately to avoid undue hardship 

on and facilitate payment to eligible 

claimants. 

The Office of Management and Budget 

(OMB) approved these information 

collection requirements on October 30, 

2001, and assigned control number 

0920–0530. 

List of Subjects in 42 CFR Part 82 

Cancer, Dose reconstruction, 

Government employees, Occupational 

safety and health, Nuclear materials, 

22330 Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 

Radiation protection, Radioactive 

materials, Workers’ compensation. 

Text of the Rule 

For the reasons discussed in the 

preamble, the Department of Health and 

Human Services revises 42 CFR part 82 

to read as follows: 

PART 82—METHODS FOR 

CONDUCTING DOSE 

RECONSTRUCTION UNDER THE 

ENERGY EMPLOYEES 

OCCUPATIONAL ILLNESS 

COMPENSATION PROGRAM ACT OF 

2000 

Subpart A—Introduction 

Sec. 

82.0 Background Information on this part. 

82.1 What is the purpose of this part? 

82.2		 What are the basics of dose 

reconstruction? 

82.3		 What are the requirements for dose 

reconstruction under EEOICPA? 

82.4		 How will DOL use the results of the 

NIOSH dose reconstructions? 

Subpart B—Definitions 

82.5 Definition of terms used in this part. 

Subpart C—Dose Reconstruction Process 

82.10		 Overview of the dose reconstruction 

process. 

82.11		 For which claims under EEOICPA 

will NIOSH conduct a dose 

reconstruction? 

82.12		 Will it be possible to conduct dose 

reconstructions for all claims? 

82.13		 What sources of information may be 

used for dose reconstructions? 

82.14		 What types of information could be 

used in dose reconstructions? 

82.15		 How will NIOSH evaluate the 

completeness and adequacy of 

individual monitoring data? 

82.16		 How will NIOSH add to monitoring 

data to remedy limitations of individual 

monitoring and missed dose? 

82.17		 What types of information could be 

used to supplement or substitute for 

individual monitoring data? 

82.18		 How will NIOSH calculate internal 

dose to the primary cancer site(s)? 

82.19		 How will NIOSH address uncertainty 

about dose levels? 

Subpart D—Reporting and Review of Dose 

Reconstruction Results 

82.25		 When will NIOSH report dose 

reconstruction results, and to whom? 

82.26		 How will NIOSH report dose 

reconstruction results? 

82.27		 How can claimants obtain reviews of 

their NIOSH dose reconstruction results 

by NIOSH? 

82.28		 Who can review NIOSH dose 

reconstruction files on individual 

claimants? 

Subpart E—Updating 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? 

82.31		 How can the public recommend 

changes to scientific elements 

underlying the dose reconstruction 

process? 

82.32		 How will NIOSH make changes in 

scientific elements underlying the dose 

reconstruction process, based on 

scientific progress? 

82.33		 How will NIOSH inform the public of 

changes to the scientific elements 

underlying the dose reconstruction 

process? 

Authority: 42 U.S.C. 7384n(d) and (e); E.O. 

13179, 65 FR 77487, 3 CFR, 2000 Comp., p. 

321. 

Subpart A—Introduction 

§ 82.0 Background information on this 

part. 

The Energy Employees Occupational 

Illness Compensation Program Act 

(EEOICPA), 42 U.S.C. 7384–7385 [1994, 

supp. 2001], provides for the payment of 

compensation benefits to 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 

categories of covered employees with 

cancer under EEOICPA for whom 

compensation may be provided. The 

regulations that follow under this part 

apply only to the category of employees 

described under paragraph (a) of this 

section. 

(a) One category is employees with 

cancer for whom a dose reconstruction 

must be conducted, as required under 

20 CFR 30.115. 

(b) The second category is members of 

the Special Exposure Cohort seeking 

compensation for a specified cancer, as 

defined under EEOICPA. The U.S. 

Department of Labor (DOL) which has 

primary authority for implementing 

EEOICPA, has promulgated regulations 

at 20 CFR 30.210 and 30.213 that 

identify current members of the Special 

Exposure Cohort and requirements for 

compensation. Pursuant to section 3626 

of EEOICPA, the Secretary of HHS is 

authorized to add additional classes of 

employees to the Special Exposure 

Cohort. 

§ 82.1 What is the purpose of this part? 

The purpose of this part is to provide 

methods for determining a reasonable 

estimate of the radiation dose received 

by a covered employee with cancer 

under EEOICPA, through the 

completion of a dose reconstruction. 

These methods will be applied by the 

National Institute for Occupational 

Safety and Health (NIOSH) in a dose 

reconstruction program serving 

claimants under EEOICPA, as identified 

under § 82.0. 

§ 82.2 What are the basics of dose 

reconstruction? 

The basic principle of dose 

reconstruction is to characterize the 

radiation environments to which 

workers were exposed and to then place 

each worker in time and space within 

this exposure environment. Then 

methods are applied to translate 

exposure to radiation into quantified 

radiation doses at the specific organs or 

tissues relevant to the types of cancer 

occurring among the workers. A 

hierarchy of methods is used in a dose 

reconstruction, depending on the nature 

of the exposure conditions and the type, 

quality, and completeness of data 

available to characterize the 

environment. 

(a) If found to be complete and 

adequate, individual worker monitoring 

data, such as dosimeter readings and 

bioassay sample results, are given the 

highest priority in assessing exposure. 

These monitoring data are interpreted 

using additional data characterizing the 

workplace radiation exposures. If 

radiation exposures in the workplace 

environment cannot be fully 

characterized based on available data, 

default values based on reasonable and 

scientific assumptions may be used as 

substitutes. For dose reconstructions 

conducted in occupational illness 

compensation programs, this practice 

may include use of assumptions that 

represent the worst case conditions. For 

example, if the solubility classification 

of an inhaled material can not be 

determined, the dose reconstruction 

would use the classification that results 

in the largest dose to the organ or tissue 

relevant to the cancer and that is 

possible given existing knowledge of the 

material and process. 

(b) If individual monitoring data are 

not available or adequate, dose 

reconstructions may use monitoring 

results for groups of workers with 

comparable activities and relationships 

to the radiation environment. 

Alternatively, workplace area 

monitoring data may be used to estimate 

the dose. As with individual worker 

monitoring data, workplace exposure 

characteristics are used in combination 

with workplace monitoring data to 

estimate dose. 

(c) If neither adequate worker nor 

workplace monitoring data are 

available, the dose reconstruction may 

rely substantially on process description 

information to analytically develop an 

exposure model. For internal exposures, 

Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 22331 

this model includes such factors as the 

quantity and composition of the 

radioactive substance (the source term), 

the chemical form, particle size 

distribution, the level of containment, 

and the likelihood of dispersion. 

§ 82.3 What Are the Requirements for 

Dose Reconstruction Under EEOICPA? 

(a) Dose reconstructions are to be 

conducted for the following covered 

employees with cancer seeking 

compensation under EEOICPA: An 

employee who was not monitored for 

exposure to radiation at DOE or Atomic 

Weapons Employer (AWE) facilities; an 

employee who was monitored 

inadequately for exposure to radiation at 

such facilities; or an employee whose 

records of exposure to radiation at such 

facility are missing or incomplete. 

Technical limitations of radiation 

monitoring technology and procedures 

will require HHS to evaluate each 

employee’s recorded dose. In most, if 

not all cases, monitoring limitations will 

result in possibly undetected or 

unrecorded doses, which are estimated 

using commonly practiced dose 

reconstruction methods and would have 

to be added to the dose record. 

(b) Section 7384(n)(e) of EEOICPA 

requires the reporting of radiation dose 

information resulting from dose 

reconstructions to the covered 

employees for whom claims are being 

adjudicated. DOE is specifically charged 

with this responsibility but the 

Department of Health and Human 

Services (HHS), which will be 

producing the dose reconstruction 

information, will report its findings 

directly to the claimant, as well as to 

DOL and DOE. HHS will also make 

available to researchers and the general 

public information on the assumptions, 

methodology, and data used in 

estimating radiation doses, as required 

by EEOICPA. 

§ 82.4 How Will DOL Use the Results of the 

NIOSH Dose Reconstructions? 

Under 42 CFR part 81, DOL will apply 

dose reconstruction results together 

with information on cancer diagnosis 

and other personal information 

provided to DOL by the claimant to 

calculate an estimated probability of 

causation. This estimate is the 

probability that the cancer of the 

covered employee was caused by 

radiation exposure at a covered facility 

of DOE or an Atomic Weapons 

Employer (AWE). 

Subpart B—Definitions 

§ 82.5 Definition of terms used in this part. 

(a) Atomic weapons employer (AWE) 

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. 

(b) Bioassay means the determination 

of the kinds, quantities, or 

concentrations, and in some cases, 

locations of radioactive material in the 

human body, whether by direct 

measurement or by analysis, and 

evaluation of radioactive material 

excreted or eliminated by the body. 

(c) Claimant means the individual 

who has filed with the Department of 

Labor for compensation under 

EEOICPA. 

(d) Covered employee means, for the 

purposes of this part, an individual who 

is or was an employee of DOE, a DOE 

contractor or subcontractor, or an 

atomic weapons employer, and for 

whom DOL has requested HHS to 

perform a dose reconstruction. 

(e) Covered facility means any 

building, structure, or premises, 

including the grounds upon which such 

building, structure, or premise is 

located: 

(1) In which operations are, or have 

been, conducted by, or on behalf of, the 

DOE (except for buildings, structures, 

premises, grounds, or operations 

covered by Executive Order 12344, 

dated February 1, 1982, pertaining to 

the Naval Nuclear Propulsion Program); 

and, 

(2) With regard to which the DOE has 

or had: 

(i) A proprietary interest; or, 

(ii) Entered into a contract with an 

entity to provide management and 

operation, management and integration, 

environmental remediation services, 

construction, or maintenance services; 

or 

(3) A facility owned by an entity 

designated by the Secretary of Energy as 

an atomic weapons employer for 

purposes of EEOICPA that is or was 

used to process or produce, for use by 

the United States, material that emitted 

radiation and was used in the 

production of an atomic weapon, 

excluding uranium mining or milling. 

(f) DOE means the U.S. Department of 

Energy, and includes predecessor 

agencies of DOE, including the 

Manhattan Engineering District. 

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

Labor. 

(h) EEOICPA means the Energy 

Employees Occupational Illness 

Compensation Program Act of 2000, 42 

U.S.C. 7384–7385 [1994, supp. 2001]. 

(i) Equivalent dose is the absorbed 

dose in a tissue multiplied by a 

radiation weighting factor to account for 

differences in the effectiveness of the 

radiation in inducing cancer. 

(j) External dose means that portion of 

the equivalent dose that is received from 

radiation sources outside of the body. 

(k) Internal dose means that portion of 

the equivalent dose that is received from 

radioactive materials taken into the 

body. 

(l) NIOSH means the National 

Institute for Occupational Safety and 

Health, Centers for Disease Control and 

Prevention, U.S. Department of Health 

and Human Services. 

(m) Primary cancer means a cancer 

defined by the original body site at 

which the cancer was incurred, prior to 

any spread (metastasis) resulting in 

tumors at other sites in the body. 

(n) Probability of causation means the 

probability or likelihood that a cancer 

was caused by radiation exposure 

incurred by a covered employee in the 

performance of duty. In statistical terms, 

it is the cancer risk attributable to 

radiation exposure divided by the sum 

of the baseline cancer risk (the risk to 

the general population) plus the cancer 

risk attributable to the radiation 

exposure. This concept is further 

explained under 42 CFR part 81, which 

provides guidelines by which DOL will 

determine probability of causation 

under EEOICPA. 

(o) 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 

purposes of this rule, radiation does not 

include sources of non-ionizing 

radiation such as radio-frequency 

radiation, microwaves, visible light, and 

infrared or ultraviolet light radiation. 

(p) Specified cancer is a term defined 

in Section 3621(17) of EEOICPA and 20 

CFR 30.5(dd) that specifies types of 

cancer that, pursuant to 20 CFR part 30, 

may qualify a member of the Special 

Exposure Cohort for compensation. It 

includes leukemia (other than chronic 

lymphocytic leukemia), multiple 

myeloma, non-Hodgkin’s lymphoma, 

and cancers of the lung (other than 

carcinoma in situ diagnosed at autopsy), 

thyroid, male breast, female breast, 

esophagus, stomach, pharynx, small 

intestine, pancreas, bile ducts, gall 

bladder, salivary gland, urinary bladder, 

brain, colon, ovary, liver (not associated 

22332 Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 

with cirrhosis or hepatitis), and bone. 

Pursuant to section 2403 of Public Law 

107–20, this definition will include 

renal cancer effective October 1, 2001. 

(q) Uncertainty distribution is a 

statistical term meaning a range of 

discrete or continuous values arrayed 

around a central estimate, where each 

value is assigned a probability of being 

correct. 

(r) Worst-case assumption is a term 

used to describe a type of assumption 

used in certain instances for certain 

dose reconstructions conducted under 

this rule. It assigns the highest 

reasonably possible value, based on 

reliable science, documented 

experience, and relevant data, to a 

radiation dose of a covered employee. 

Subpart C—Dose Reconstruction 

Process 

§ 82.10 Overview of the dose 

reconstruction process. 

(a) Upon receipt of a claims package 

from the Department of Labor, as 

provided under 20 CFR part 30, NIOSH 

will request from DOE records on 

radiation dose monitoring and radiation 

exposures associated with the 

employment history of the covered 

employee. Additionally, NIOSH may 

compile data, and information from 

NIOSH records that may contribute to 

the dose reconstruction. For each dose 

reconstruction, NIOSH will include 

records relevant to internal and external 

exposures to ionizing radiation, 

including exposures from medical 

screening x rays that were required as a 

condition of employment. 

(b) NIOSH will evaluate the initial 

radiation exposure record compiled to: 

Reconcile the exposure record with the 

reported employment history, as 

necessary; complete preliminary 

calculations of dose, based upon this 

initial record, and prepare to consult 

with the claimant. Any discrepancies in 

the employment history information 

will be reconciled with the assistance of 

DOE, as necessary. 

(c) NIOSH will interview the 

claimant. The interview may be 

conducted in one or more sessions. The 

purpose of the interview is to: 

(1) Explain the dose reconstruction 

process; 

(2) Confirm elements of the 

employment history transmitted to 

NIOSH by DOL; 

(3) Identify any relevant information 

on employment history that may have 

been omitted; 

(4) Confirm or supplement monitoring 

information included in the initial 

radiation exposure record; 

(5) Develop detailed information on 

work tasks, production processes, 

radiologic protection and monitoring 

practices, and incidents that may have 

resulted in undocumented radiation 

exposures, as necessary; 

(6) Identify co-workers and other 

witnesses with information relevant to 

the radiation exposures of the covered 

worker to supplement or confirm 

information on work experiences, as 

necessary. 

(d) NIOSH will provide a report to the 

claimant summarizing the findings of 

the interview, titled: ‘‘NIOSH Claimant 

Interview under EEOICPA.’’ The report 

will also notify the claimant of the 

opportunity to contact NIOSH if 

necessary, by a specified date, to make 

any written corrections or additions to 

information provided by the claimant 

during the interview process. 

(e) Information provided by the 

claimant will be accepted and used for 

dose reconstruction, providing it is 

reasonable, supported by substantial 

evidence, and is not refuted by other 

evidence. In assessing whether the 

information provided by the claimant is 

supported by substantial evidence, 

NIOSH will consider: 

(1) Consistency of the information 

with other information in the possession 

of NIOSH, from radiation safety 

programs, research, medical screening 

programs, labor union documents, 

worksite investigations, dose 

reconstructions conducted by NIOSH 

under EEOICPA, or other reports 

relating to the circumstances at issue; 

(2) Consistency of the information 

with medical records provided by the 

claimant; 

(3) Consistency of the information 

with practices or exposures 

demonstrated by the dose 

reconstruction record developed for the 

claimant; and, 

(4) Confirmation of information by coworkers or other witnesses. 

(f) NIOSH will seek to confirm 

information provided by the claimant 

through review of available records and 

records requested from DOE. 

(g) As necessary, NIOSH will request 

additional records from DOE to 

characterize processes and tasks 

potentially involving radiation exposure 

for which dose and exposure monitoring 

data is incomplete or insufficient for 

dose reconstruction. 

(h) NIOSH will review the adequacy 

of monitoring data and completeness of 

records provided by DOE. NIOSH will 

request certification from DOE that 

record searches requested by NIOSH 

have been completed. 

(i) As necessary, NIOSH will 

characterize the internal and external 

exposure environments for parameters 

known to influence the dose. For 

internal exposures, examples of these 

parameters include the mode of intake, 

the composition of the source term (i.e., 

the radionuclide type and quantity), the 

particle size distribution and the 

absorption type. When it is not possible 

to characterize these parameters, NIOSH 

may use default values, when they can 

be established reasonably, fairly, and 

based on relevant science. For external 

exposures, the radiation type (gamma, xray, neutron, beta, or other charged 

particle) and radiation energy spectrum 

will be evaluated. When possible, the 

effect of non-uniformity and geometry of 

the radiation exposure will be assessed. 

(j) For individual monitoring records 

that are incomplete, NIOSH may assign 

doses using techniques discussed in 

§ 82.16. Once the resulting data set is 

complete, NIOSH will construct an 

occupational exposure matrix, using the 

general hierarchical approach discussed 

in § 82.2. This matrix will contain the 

estimated annual equivalent dose(s) to 

the relevant organ(s) or tissue(s), for the 

period from the initial date of potential 

exposure at a covered facility until the 

date the cancer was diagnosed. The 

equivalent dose(s) will be calculated 

using the current, standard radiation 

weighting factors from the International 

Commission on Radiological 

Protection. 1 

(k) At any point during steps of dose 

reconstruction described in paragraphs 

(f) through (j) of this section, NIOSH 

may determine that sufficient research 

and analysis has been conducted to 

complete the dose reconstruction. 

Research and analysis will be 

determined sufficient if one of the 

following three conditions is met: 

(1) From acquired experience, it is 

evident the estimated cumulative dose 

is sufficient to qualify the claimant for 

compensation (i.e., the dose produces a 

probability of causation of 50% or 

greater); 

(2) Dose is determined using worstcase assumptions related to radiation 

exposure and intake, to substitute for 

further research and analyses; or, 

(3) Research and analysis indicated 

under steps described in paragraphs (f)– 

(j) of this section have been completed. 

Worst-case assumptions will be 

employed under condition 2 to limit 

further research and analysis only for 

claims for which it is evident that 

further research and analysis will not 

produce a compensable level of 

radiation dose (a dose producing a 

probability of causation of 50% or 

1 The current weighting factors of the 

International Commission on Radiological 

Protection are provided in ICRP 60: ‘‘1990 

Recommendations of the International Commission 

on Radiological Protection.’’ Ann. ICRP 21 (1–3):6. 

Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 22333 

greater), because using worst-case 

assumptions it can be determined that 

the employee could not have incurred a 

compensable level of radiation dose. For 

all claims in which worst-case 

assumptions are employed under 

condition 2, the reasoning that resulted 

in the determination to limit further 

research and analysis will be clearly 

described in the draft of the dose 

reconstruction results reported to the 

claimant under § 82.25 and in the dose 

reconstruction results reported to the 

claimant under § 82.26. 

(l) After providing the claimant with 

a copy of a draft of the dose 

reconstruction report to be provided to 

DOL, NIOSH will conduct a closing 

interview with the claimant to review 

the dose reconstruction results and the 

basis upon which the results were 

calculated. This will be the final 

opportunity during the dose 

reconstruction process for the claimant 

to provide additional relevant 

information that may affect the dose 

reconstruction. The closing interview 

may require multiple sessions, if the 

claimant requires time to obtain and 

provide additional information, and to 

allow NIOSH time to integrate the new 

information into a new draft of the dose 

reconstruction report. NIOSH will 

determine whether to grant requests for 

time to provide additional information, 

based on whether the requests are 

reasonable and the claimant is actively 

seeking the information specified. 

(m) Subject to any additional 

information provided by the claimant 

and revision of the draft dose 

reconstruction report under § 82.10(l), 

the claimant is required to return form 

OCAS–1 to NIOSH, certifying that the 

claimant has completed providing 

information and that the record for dose 

reconstruction should be closed. Upon 

receipt of the form, NIOSH will forward 

a final dose reconstruction report to 

DOL, DOE, and to the claimant. 

(n) NIOSH will not forward the dose 

reconstruction report to DOL for 

adjudication without receipt of form 

OCAS–1 signed by the claimant or a 

representative of the claimant 

authorized pursuant to 20 CFR 30.600. 

If the claimant or the authorized 

representative of the claimant fails to 

sign and return form OCAS–1 within 60 

days, or 60 days following the 

claimant’s final provision of additional 

information and receipt of a revised 

draft dose reconstruction report under 

§ 82.10 (l), whichever occurs last, after 

notifying the claimant or the authorized 

representative, NIOSH may 

administratively close the dose 

reconstruction and notify DOL of this 

action. Upon receiving this notification 

by NIOSH, DOL may administratively 

close the claim. 

(o) Once actions under § 82.10 (m) are 

completed, the record for dose 

reconstruction shall be closed unless 

reopened at the request of DOL under 20 

CFR part 30. 

§ 82.11 For which claims under EEOICPA 

will NIOSH conduct a dose reconstruction? 

NIOSH will conduct a dose 

reconstruction for each claim 

determined by DOL to be a claim for a 

covered employee with cancer under 

DOL regulations at 20 CFR 30.210(b), 

subject to the limitation and exception 

noted in § 82.12. Claims for covered 

employees who are members of the 

Special Exposure Cohort seeking 

compensation for a specified cancer, as 

determined by DOL under 20 CFR 

30.210(a), do not require and will not 

receive a dose reconstruction under this 

rule. 

§ 82.12 Will it be possible to conduct dose 

reconstructions for all claims? 

It is uncertain whether adequate 

information of the types outlined under 

§ 82.14 will be available to complete a 

dose reconstruction for every claim 

eligible under § 82.11. 

(a) NIOSH will notify in writing any 

claimants for whom a dose 

reconstruction cannot be completed 

once that determination is made, as well 

as in the closing interview provided for 

under § 82.10(l). 

(b) Notification will describe the basis 

for finding a dose reconstruction cannot 

be completed, including the following: 

(1) A summary of the information 

obtained from DOE and other sources; 

and, (2) a summary of necessary 

information found to be unavailable 

from DOE and other sources. 

(c) NIOSH will notify DOL and DOE 

when it is unable to complete a dose 

reconstruction for the claimant. This 

will result in DOL producing a 

recommended decision to deny the 

claim, since DOL cannot determine 

probability of causation without a dose 

estimate produced by NIOSH under this 

rule. 

(d) A claimant for whom a dose 

reconstruction cannot be completed, as 

indicated under this section, may have 

recourse to seek compensation under 

provisions of the Special Exposure 

Cohort (see 20 CFR part 30). Pursuant to 

section 7384q of EEOICPA, the 

Secretary of HHS is authorized to add 

classes of employees to the Special 

Exposure Cohort. NIOSH will provide 

the claimant with any information and 

forms that HHS provides to classes of 

employees seeking to petition to be 

added to the Special Exposure Cohort. 

§ 82.13 What sources of information may 

be used for dose reconstructions? 

NIOSH will use the following sources 

of information for dose reconstructions, 

as necessary: 

(a) DOE and its contractors, including 

Atomic Weapons Employers and the 

former worker medical screening 

program; 

(b) NIOSH and other records from 

health research on DOE worker 

populations; 

(c) Interviews and records provided 

by claimants; 

(d) Co-workers of covered employees, 

or others with information relevant to 

the covered employee’s exposure, that 

the claimant identified during the initial 

interview with NIOSH; 

(e) Labor union records from unions 

representing employees at covered 

facilities of DOE or AWEs; and, 

(f) Any other relevant information. 

§ 82.14 What types of information could be 

used in dose reconstructions? 

NIOSH will obtain the types of 

information described in this section for 

dose reconstructions, as necessary and 

available: 

(a) Subject and employment 

information, including: 

(1) Gender; 

(2) Date of birth; and, 

(3) DOE and/or AWE employment 

history, including: job title held by year, 

and work location(s): including site 

names(s), building numbers(s), technical 

area(s), and duration of relevant 

employment or tasks. 

(b) Worker monitoring data, 

including: 

(1) External dosimetry data, including 

external dosimeter readings (film badge, 

TLD, neutron dosimeters); and, 

(2) Pocket ionization chamber data. 

(c) Internal dosimetry data, including: 

(1) Urinalysis results; 

(2) Fecal sample results; 

(3) In Vivo measurement results; 

(4) Incident investigation reports; 

(5) Breath radon and/or thoron 

results; 

(6) Nasal smear results; 

(7) External contamination 

measurements; and 

(8) Other measurement results 

applicable to internal dosimetry. 

(d) Monitoring program data, 

including: 

(1) Analytical methods used for 

bioassay analyses; 

(2) Performance characteristics of 

dosimeters for different radiation types; 

(3) Historical detection limits for 

bioassay samples and dosimeter badges; 

(4) Bioassay sample and dosimeter 

collection/exchange frequencies; 

(5) Documentation of record keeping 

practices used to record data and/or 

administratively assign dose; and, 

22334 Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 

(6) Other information to characterize 

the monitoring program procedures and 

evaluate monitoring results. 

(e) Workplace monitoring data, 

including: 

(1) Surface contamination surveys; 

(2) General area air sampling results; 

(3) Breathing zone air sampling 

results; 

(4) Radon and/or thoron monitoring 

results; 

(5) Area radiation survey 

measurements (beta, gamma and 

neutron); and, 

(6) Fixed location dosimeter results 

(beta, gamma and neutron); and, 

(7) Other workplace monitoring 

results. 

(f) Workplace characterization data, 

including: 

(1) Information on the external 

exposure environment, including: 

radiation type (gamma, x-ray, proton, 

neutron, beta, other charged particle); 

radiation energy spectrum; uniformity 

of exposure (whole body vs partial body 

exposure); irradiation geometry; 

(2) Information on work-required 

medical screening x rays; and, 

(3) Other information useful for 

characterizing workplace radiation 

exposures. 

(g) Information characterizing internal 

exposures, including: 

(1) Radionuclide(s) and associated 

chemical forms; 

(2) Results of particle size distribution 

studies; 

(3) Respiratory protection practices; 

and 

(4) Other information useful for 

characterizing internal exposures. 

(h) Process descriptions for each work 

location, including: 

(1) General description of the process; 

(2) Characterization of the source term 

(i.e., the radionuclide and its quantity); 

(3) Extent of encapsulation; 

(4) Methods of containment; 

(5) Other information to assess 

potential for irradiation by source or 

airborne dispersion radioactive material. 

§ 82.15 How will NIOSH evaluate the 

completeness and adequacy of individual 

monitoring data? 

(a) NIOSH will evaluate the 

completeness and adequacy of an 

individual’s monitoring data provided 

by DOE through one or more possible 

measures including, but not limited to: 

(1) Comparisons with information 

provided by claimants, co-workers, and 

other witnesses; 

(2) Comparisons with available 

information on area monitoring, 

production processes, and radiologic 

protection programs; 

(3) Comparisons with information 

documented in the records of unions 

representing covered employees; 

(4) Comparisons with data available 

on co-workers; and 

(5) Reviews of DOE contractor record 

systems. 

(b) NIOSH will evaluate the 

instruments and procedures used to 

collect individual monitoring data to 

determine whether they adequately 

characterized the radiation 

environments in which the covered 

employee worked, (adequately for the 

purpose of dose reconstruction,) based 

on present-day scientific understanding. 

For external dosimeter measurements, 

this includes an evaluation of the 

dosimeter response to the radiation 

types (gamma, x-ray, neutron, beta, or 

other charged particle) and the 

associated energy spectrum. For internal 

exposure, the methods used to analyze 

bioassay samples will be reviewed to 

determine their ability to detect the 

radionuclides present in the work 

environment. An analysis of the 

monitoring or exchange frequencies for 

the monitoring programs will also be 

conducted to determine the potential for 

undetected dose. 

§ 82.16 How will NIOSH add to monitoring 

data to remedy limitations of individual 

monitoring and missed dose? 

(a) For external dosimeter results that 

are incomplete due to historical record 

keeping practices, NIOSH will use 

commonly practiced techniques, such as 

those described in the NIOSH Research 

Issues Workshop,2 to estimate the 

missing component of dose and to add 

this to the total dose estimate. For 

monitoring periods where external 

dosimetry data are missing from the 

records, NIOSH will estimate a 

claimant’s dose based on interpolation, 

using available monitoring results from 

other time periods close to the period in 

question, or based on monitoring data 

on other workers engaged in similar 

tasks. 

(b) NIOSH will review historical 

bioassay sample detection limits and 

monitoring frequencies to determine, 

when possible, the minimum detectable 

dose for routine internal dose 

monitoring programs. This ‘‘missed 

dose’’ will establish the upper limit of 

internal dose that a worker could have 

received for periods when bioassay 

sample analysis results were below the 

detection limit. Using ICRP biokinetic 

models, NIOSH will estimate the 

2 NIOSH [1995]. NIOSH research issues 

workshop: epidemiologic use of nondetectable 

values in radiation exposure measurements. 

Cincinnati, OH: U.S. Department of Health and 

Human Services, Public Health Service, Centers for 

Disease Control and Prevention, National Institute 

for Occupational Safety and Health, DHHS (NIOSH) 

Publication No. 224647 (NTIS—PB 95189601). 

internal dose and include an associated 

uncertainty distribution. 

§ 82.17 What types of information could be 

used to supplement or substitute for 

individual monitoring data? 

Three types of information could be 

used: 

(a) Monitoring data from co-workers, 

if NIOSH determines they had a 

common relationship to the radiation 

environment; or, 

(b) A quantitative characterization of 

the radiation environment in which the 

covered employee worked, based on an 

analysis of historical workplace 

monitoring information such as area 

dosimeter readings, general area 

radiation and radioactive contamination 

survey results, air sampling data; or, 

(c) A quantitative characterization of 

the radiation environment in which the 

employee worked, based on analysis of 

data describing processes involving 

radioactive materials, the source 

materials, occupational tasks and 

locations, and radiation safety practices. 

§ 82.18 How will NIOSH calculate internal 

dose to the primary cancer site(s)? 

(a) The calculation of dose from 

ingested, inhaled or absorbed 

radioactivity involves the determination 

of the types and quantities of 

radionuclides that entered the body. 

NIOSH will use the results of all 

available bioassay monitoring 

information as appropriate, based on 

assessment of the technical 

characteristics of the monitoring 

program. If bioassay monitoring data are 

unavailable or inadequate, the dose 

reconstruction will rely on the results of 

air sampling measurements, radiation 

sources, work processes and practices, 

and incidents involving radiation 

contamination, as necessary. 

(b) NIOSH will calculate the dose to 

the organ or tissue of concern using the 

appropriate current metabolic models 

published by ICRP. Using data available 

to NIOSH, the models will be based on 

exposure conditions representative of 

the work environment. When NIOSH 

cannot establish exposure conditions 

with sufficient specificity, the dose 

calculation will assume exposure 

conditions that maximize the dose to 

the organ under consideration. When 

the cancer covered by a claim is in a 

tissue not covered by existing ICRP 

models, NIOSH will use the ICRP model 

that best approximates the model 

needed, while giving the benefit of the 

doubt to the claimant. For internal 

exposures, NIOSH will select the 

highest dose estimate from among the 

modeled organs or tissues that do not 

concentrate the radionuclide. 

Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 22335 

(c) Internal doses will be calculated 

for each year of exposure from the date 

of initial exposure to the date of cancer 

diagnosis. 

§ 82.19 How will NIOSH address 

uncertainty about dose levels? 

The estimate of each annual dose will 

be characterized with a probability 

distribution that accounts for the 

uncertainty of the estimate. This 

information will be used by DOL in the 

calculation of probability of causation, 

under HHS guidelines for calculating 

probability of causation estimates at 42 

CFR 81. In this way, claimants will 

receive the benefit of the doubt in cases 

in which the actual dose may have 

exceeded the best estimate calculated by 

NIOSH. 

Subpart D—Reporting and Review of 

Dose Reconstruction Results 

§ 82.25 When will NIOSH report dose 

reconstruction results, and to whom? 

NIOSH will report dose 

reconstruction results to DOL and to the 

claimant, as provided for under § 82.10. 

Draft results will be reported to the 

claimant upon tentative completion of 

the dose reconstruction. Final results 

will be reported to the claimant, DOL 

and DOE after NIOSH receives 

certification from the claimant that the 

claimant has completed providing 

information to NIOSH for the dose 

reconstruction (Form OCAS–1). 

§ 82.26 How will NIOSH report dose 

reconstruction results? 

(a) NIOSH will provide dose 

reconstruction results to the claimant, 

DOL, and DOE in a report: ‘‘NIOSH 

Report of Dose Reconstruction under 

EEOICPA.’’ The report itself will not 

provide information on probability of 

causation, which DOL must calculate to 

determine a recommended decision on 

the claim. 

(b) The report will include the 

following information, as relevant: 

(1) Annual dose estimates (or a 

fraction thereof) related to covered 

employment for each year from the date 

of initial radiation exposure at a covered 

facility to the date of cancer diagnosis; 

(2) Separate dose estimates for acute 

and chronic exposures, different types 

of ionizing radiation, and internal and 

external doses, providing internal dose 

information only for the organ or tissue 

relevant to the primary cancer site(s) 

established in the claim; 

(3) Uncertainty distributions 

associated with each dose estimated, as 

necessary; 

(4) Explanation of each type of dose 

estimate included in terms of its 

relevance for estimating probability of 

causation; 

(5) Identification of any information 

provided by the claimant relevant to 

dose estimation that NIOSH decided to 

omit from the basis for dose 

reconstruction, justification for the 

decision, and if possible, a quantitative 

estimate of the effect of the omission on 

the dose reconstruction results; and 

(6) A summary and explanation of 

information and methods applied to 

produce the dose reconstruction 

estimates, including any factual findings 

and the evidence upon which those 

findings are based. 

(c) As provided under § 82.10(l), 

NIOSH staff will conduct a closing 

interview with claimants to explain the 

dose reconstruction report. 

§ 82.27 How can claimants obtain reviews 

of their NIOSH dose reconstruction results 

by NIOSH? 

(a) Claimants can seek reviews of their 

dose reconstruction through the 

processes established by DOL under 20 

CFR 30. DOL will request NIOSH to 

review dose reconstructions under the 

following conditions, as provided under 

20 CFR 30.318: 

(1) DOL may determine that factual 

findings of the dose reconstruction do 

not appear to be supported by 

substantial evidence; or, 

(2) Although the methodology 

established by HHS under this Part is 

binding on DOL, DOL may determine 

that arguments concerning the 

application of this methodology should 

be considered by NIOSH. 

(b) NIOSH may review completed 

dose reconstructions on its own 

initiative and with the assistance of 

DOL to identify denied claims when 

either of the following circumstances 

arise: 

(1) NIOSH obtains records or 

information on radiation exposures of 

DOE or AWE employees that could 

substantially increase the level of 

radiation doses estimated in the 

completed dose reconstructions; or 

(2) NIOSH changes a scientific 

element underlying dose 

reconstructions according to the 

provisions of Subpart E of this rule and 

the change could substantially increase 

the level of radiation doses estimated in 

the completed dose reconstructions. 

(c) When NIOSH completes the 

review of a dose reconstruction, NIOSH 

will provide a report describing the 

basis for the review, the methods 

employed in the review, and the review 

findings to the claimant, DOL, and DOE. 

§ 82.28 Who can review NIOSH dose 

reconstruction files on individual 

claimants? 

(a) Claimants and DOL will be 

provided individual dose reconstruction 

files, upon request. Claimants should 

note, however, that a complete summary 

of the data and methods used in a dose 

reconstruction will be included in the 

‘‘NIOSH Report of Dose Reconstruction 

under EEOICPA’’. 

(b) Researchers and the public will be 

provided limited access to NIOSH dose 

reconstruction files, subject to 

provisions and restrictions of the 

Privacy Act for the protection of 

confidential information on individuals. 

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 

22336 Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 

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. 

Dated: April 10, 2002. 

Tommy G. Thompson, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 02–10763 Filed 5–1–02; 8:45 am] 

BILLING CODE 4160–17–P