November 23, 2005 

Mr. David Staudt 

Centers for Disease Control and Prevention 

Acquisition and Assistance Field Branch 

Post Office Box 18070 

626 Cochrans Mill Road – B-140 

Pittsburgh, PA 15236-0295 

Re: Contract 200-2004-03805, Task 5, Subtask 1, Review of NIOSH/ORAU Special 

Exposure Cohort Evaluation Procedures 

Dear Mr. Staudt: 

SC&A is pleased to submit our draft report, Review of NIOSH/ORAU Special Exposure Cohort 

Evaluation Procedures. This review, prepared pursuant to the Subtask 1 of Task Order No. 5 of 

the subject contract, is focused on OCAS-PR-004, Internal Procedures for Evaluation of Special 

Exposure Cohort Petitions, dated September 23, 2004. 

If you have any questions regarding this report, please feel free to contact me. 

Sincerely, 

John Mauro, PhD, CHP 

Project Manager 

cc:	 P. Ziemer, PhD, Board Chairperson 

Advisory Board Members 

L. Wade, PhD, NIOSH 

L. Elliott, NIOSH 

J. Neton, PhD, NIOSH 

S. Hinnefeld, NIOSH 

L. Homoki-Titus, NIOSH 

A. Brand, NIOSH 

J. Broehm, NIOSH 

L. Shields, NIOSH 

A. Makhijani, PhD, SC&A 

H. Behling, SC&A 

M. Thorne, SC&A 

H. Chmelynski, SC&A 

J. Fitzgerald, Saliant 

J. Lipsztein, SC&A 

K. Robertson-DeMers, CHP, Saliant 

S. Ostrow, PhD, SC&A 

K. Behling. SC&A 

Project File (ANIOS/005) 
 

 

 

Draft 

ADVISORY BOARD ON 

RADIATION AND WORKER HEALTH 

National Institute of Occupational Safety and Health 

REVIEW OF NIOSH/ORAU 

SPECIAL EXPOSURE COHORT 

EVALUATION PROCEDURES 

Contract No. 200-2004-03805 

Task 5: Subtask 1 

SCA-TR-TASK5-0001 

Prepared by 

S. Cohen & Associates 

6858 Old Dominion Drive, Suite 301 

McLean, Virginia 22101 

November 23, 2005 

Disclaimer 

This document is made available in accordance with the unanimous desire of the Advisory Board on Radiation and 

Worker Health (ABRWH) to maintain all possible openness in its deliberations. However, the ABRWH and its 

contractor, SC&A, caution the reader that at the time of its release, this report is pre-decisional and has not been 

reviewed by the Board for factual accuracy or applicability within the requirements of 42 CFR 82. This implies that 

once reviewed by the ABRWH, the Board’s position may differ from the report’s conclusions. Thus, the reader 

should be cautioned that this report is for information only and that premature interpretations regarding its 

conclusions are unwarranted. 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

2 of 35 

S. COHEN & ASSOCIATES: 

Technical Support for the Advisory Board on 

Document No. 

SCA-TR-TASK5-0001 

Radiation & Worker Health Review of 

NIOSH Dose Reconstruction Program 

Effective Date: 

Draft - November 23, 2005 

Revision No. 

0 (Draft) 

REVIEW OF NIOSH/ORAU SPECIAL EXPOSURE 

COHORT EVALUATION PROCEDURES Page 2 of 35 

Task Manager: _________________ Date:____________ 

 Arjun Makhijani 

Supersedes: 

N/A 

Project Manager:_______________ Date:____________ 

 John Mauro 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

3 of 35 

TABLE OF CONTENTS 

Acronyms and Abbreviations ..........................................................................................................4 

1.0 Executive Summary .............................................................................................................5 

1.1 Principal Strengths ...................................................................................................5 

1.2 Principal Findings ....................................................................................................6 

1.3 Suggestions for Improvement ..................................................................................8 

2.0 Introduction........................................................................................................................11 

2.1 Statement of Purpose and Scope of the Review ....................................................12 

2.2 SC&A’s Approach to Reviewing Documents .......................................................12 

2.3 Structure and Organization of the Report ..............................................................13 

3.0 Special Exposure Cohort Petition Forms A and B.............................................................14 

3.1 SEC Petition Form A (OMB Number: 0920-0639) ..............................................14 

3.2 SEC Petition Form B and Instructions (OMB Number: 0920-0639) ...................14 

3.2.1 Miscellaneous Comments on Form B........................................................15 

4.0 Internal Procedures for the Evaluation of Special Exposure Cohort Petitions 

(OCAS-PR-004) - Strengths ..............................................................................................16 

4.1 Procedural Strengths ..............................................................................................16 

4.2 Examples, Notes, and Discussions.........................................................................17 

4.3 Completed Dose Reconstructions ..........................................................................17 

4.4 Partial Reconstructions ..........................................................................................18 

4.5 Data Lists ...............................................................................................................18
 

4.6 Report Format ........................................................................................................18 

5.0 Internal Procedures for the Evaluation of Special Exposure Cohort Petitions 

(OCAS-PR-004) - Findings ...............................................................................................19 

5.1 Issue 1: Maximum Dose Estimates in Plausible Circumstances ..........................21 

5.2 Issue 2: Relation of 42 CFR 83 to 42 CFR 82 ......................................................22 

5.3 Issue 3: Adequacy of Data for Maximum Dose Reconstruction ..........................24 

5.4 Issue 4: Co-Worker Data ......................................................................................25 

5.5 Issue 5: Use of Completed Dose Reconstructions ................................................26 

5.6 Issue 6: Incidents...................................................................................................27 

5.7 Issue 7: Survivor Petitioners .................................................................................28 

5.8 Issue 8: Interviews with Petitioners ......................................................................28 

5.9 Issue 9: Data from Other Sites ..............................................................................28 

5.10 Issue 10: Use of OCAS-IG-001 and OCAS-IG-002 in 42 CFR 83 ......................29 

5.10.1 External Dose Guidelines OCAS-IG-001 ..................................................30 

5.10.2 Internal Dose Guidelines OCAS-IG-002 ...................................................31 

5.11 Issue 11: SEC Petition Evaluation Plan ................................................................32 

5.12 Issue 12: Definition of the Class under 42 CFR 83.14 .........................................32 

5.13 Issue 13: Site-Specific Data ..................................................................................32 

5.14 Miscellaneous Comments on OCAS-PR-004 ........................................................33 

References......................................................................................................................................34 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

4 of 35 

ACRONYMS AND ABBREVIATIONS 

ABRWH Advisory Board on Radiation and Worker Health 

(also referred to as Advisory Board or Board) 

AWE Atomic Weapons Employer 

CFR Code of Federal Regulations 

DOE U.S. Department of Energy 

DOL U.S. Department of Labor 

EEOICPA Energy Employees Occupational Illness Compensation Program Act 

HHS U.S. Department of Health and Human Services 

IAAP Iowa Army Ammunition Plant 

LOD Limits of Detection 

MAC Maximum Allowable Concentrations 

NIOSH National Institute for Occupational Safety and Health 

OCAS Office of Compensation and Analysis Support 

ORAU Oak Ridge Associated Universities 

POC Probability of Causation 

SC&A S. Cohen and Associates 

SEC Special Exposure Cohort 

TBD Technical Basis Document 

TIB Technical Information Bulletin 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

5 of 35 

1.0 EXECUTIVE SUMMARY 

The Energy Employees Occupational Illness Compensation Program Act (EEOICPA) provides 

for the U.S. Department of Health and Human Services (HHS) to add certain classes of U.S. 

Department of Energy (DOE), Atomic Weapons Employer (AWE), contractor, or subcontractor 

employees to the Special Exposure Cohort (SEC) under specified conditions. The rules, 

described in Title 42, Part 83, of the Code of Federal Regulations (42 CFR 83), relate to the 

process for filing petitions for additions to the Special Exposure Cohort and the ways in which 

National Institute of Occupational Safety and Health (NIOSH) and its contractors would evaluate 

the petitions. 

This report is a review of NIOSH procedures and guidelines to implement 42 CFR 83. SC&A 

prepared this review pursuant to a decision by the Advisory Board on Radiation and Worker 

Health (hereafter referred to as the Board) to review NIOSH procedures and guidelines for 

evaluating SEC petitions. The main procedures for implementing 42 CFR 83 are set forth in 

Internal Procedures for the Evaluation of Special Exposure Cohort Petitions, OCAS-PR-004, 

Rev. 0, dated September 23, 2004 (referred to hereafter as NIOSH SEC procedures or as 

OCAS-PR-004). This review is focused on OCAS-PR-004. It also covers the forms that 

petitioners must file (Forms A and B), and the instructions for filling out Form B. Finally, this 

review also addresses a few aspects of OCAS-IG-001 and OCAS-IG -002 to the extent that they 

affect the determination of the feasibility of dose reconstruction with sufficient accuracy as 

required under 42 CFR 83. 

1.1 Principal Strengths 

• 	 OCAS-PR-004 provides a logical step-by-step procedure for following 42 CFR 83 and 

preparing the various documents and findings required under the rule. 

• 	 The NIOSH procedures provide for assistance to petitioners in completing petitions and 

providing additional information in order to facilitate the qualification of the petition for 

evaluation. 

• 	 The NIOSH procedures provide for splitting up the class into subclasses when NIOSH 

determines that it is not possible to do dose reconstructions for one or more sub-groups of 

the class, but that it is possible to do dose reconstructions for others. 

• 	 OCAS-PR-004 contains several hypothetical, qualitative examples that help clarify the 

directions given in the guidelines. The examples are rather schematic and simple, and 

would be expected to be helpful in very straightforward cases. 

• 	 The NIOSH procedures rely on completed and in-process dose reconstructions that are 

relevant to the class in its petition evaluation. 

• 	 The NIOSH SEC procedures make provision for dose reconstruction for non-SEC 

cancers in cases where the petition is granted in view of the fact that dose reconstruction 

for some cancers may still be possible. 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

6 of 35 

• 	 Appendix B to OCAS-PR-004, Rev. 0, provides a useful summary of the DOE request 

for monitoring and related records that is indicative of the type of information that would 

be considered in evaluating the feasibility of dose reconstruction. 

• 	 Appendix C provides a helpful evaluation report template comprising an evaluation 

summary, class definition proposed by the petitioners and petition basis, description of 

the data collection effort and its results, summary of radiological operations relevant to 

the initial class, evaluation of the feasibility of dose reconstruction, summary of 

feasibility findings, evaluation of health endangerment, and definition of the class or 

classes established on the basis of the analyses. 

1.2 Principal Findings 

SC&A has arrived at the findings below in light of the requirements of 42 CFR 83 for petition 

evaluation. Specifically, they are focused on the requirement that NIOSH demonstrate the 

feasibility of reconstructing doses with sufficient accuracy for all 22 SEC cancers and all 

members of the proposed class in the meaning of the term “sufficient accuracy” as defined in 

42 CFR 83. As a general matter, SC&A notes that the requirements for assessing whether there 

are sufficient data to estimate “maximum radiation dose” that could have been incurred “in 

plausible circumstances by any member” (42 CFR 83.13(c)(1)) of the entire class of workers in a 

manner that is fair, uniform, and scientifically sound poses special challenges. Some of these 

challenges have been illustrated by the evaluations of the SEC petitions for IAAP and for the 

1949–1957 period for Mallinckrodt. Those cases show the importance of using (1) complete or 

partial dose reconstructions that, together, would be representative of all members of the class, 

and all periods, processes, and radionuclides covered by the job types in question to illustrate 

NIOSH’s ability to reconstruct doses with sufficient accuracy, and (2) data that have been 

sufficiently validated and shown to have the integrity needed to support the claims of ability to 

reconstruct maximum doses. The use of other documentation and data, such as site profiles and 

workbooks, should also be subjected to sufficient checks to ensure that there are no essential 

problems that would prevent dose reconstruction with sufficient accuracy for the members of the 

proposed class. 

As a preface to these findings, SC&A would like to emphasize that we recognize that the final 

decision regarding whether a given petition meets the SEC acceptance criteria pertaining to the 

plausibility of performing a dose reconstruction for a given class of workers and the health 

endangerment provisions of the rule will include “judgment calls” that are specific to each 

petition. The findings below represent an attempt to assist NIOSH and the Board in developing 

guidelines that will help to ensure that these judgments explicitly address the full range of 

pertinent issues and are made in a scientifically valid, claimant-favorable, and consistent manner. 

Finding 1: The NIOSH procedures need to provide more complete guidance to the Office of 

Compensation Analysis and Support (OCAS) staff and its contractors regarding acceptable 

methods for estimating the maximum dose for the class. Without guidelines to address the 

problem of constraining maximum dose estimation methods, it will be difficult to arrive at a 

result that simultaneously fulfills the criteria of scientific soundness and claimant favorability, 

and uniform and fair consideration for all members of the class, as required by 42 CFR 83. 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

7 of 35 

Finding 2: NIOSH needs to provide a practical way to distinguish between the definition and 

use of “maximum radiation dose” under 42 CFR 83, and the definition and use of “highest 

reasonable possible value” of dose using “worst-case assumptions” used only to deny 

compensation under 42 CFR 82.10(k)(2) and (k)(3) using the definition in 42 CFR 82.5(r). The 

latter kind of dose estimate is used only for denial on the grounds that a higher dose estimate is 

not scientifically credible. This is expressed in the regulation by the statement that “[d]oses 

estimated using worst-case assumptions will not involve uncertainty” (42 CFR 82, paragraph O, 

pg. 22324). The main implication is that the dose estimate using worst-case assumptions under 

42 CFR 82 should be greater than the maximum dose in plausible circumstances under 42 CFR 

83. Yet, there is no constraint in the procedures that this inequality should apply. 

Finding 3: NIOSH SEC procedures contain no guidelines for judging when data are or are not 

adequate for maximum dose estimates in plausible circumstances. For instance, they do not 

require creation of radionuclide lists applicable to different members of the class. Nor do they 

provide guidance on other critical issues, such as evaluation of data integrity or data needed to 

conclude that doses for unmonitored workers are (or are not) bounded by those for monitored 

workers. 

Finding 4: NIOSH SEC procedures do not set forth specific guidelines for co-worker data that 

would ensure that the estimated doses bound those for all members of the class when individual 

monitoring data are not available. The examples provided are insufficient to ensure uniform and 

fair consideration in complex circumstances, such as when job types are not easily comparable. 

Just as examples are provided for the use of co-worker data for reconstructing doses for 

unmonitored or inadequately monitored workers, examples should be provided describing when 

it is not possible to reconstruct doses using co-worker data. 

Finding 5: The procedures propose to use completed dose reconstructions, which is a strength, 

but do not require a them to be internally checked as representative of a class of workers. The 

procedures should provide guidelines that help to ensure that the cases are representative of 

members of the class or time periods under consideration in the SEC petition, so that the 

ensemble of dose reconstructions used enables a judgment about dose reconstruction feasibility 

under 42 CFR 83. 

Finding 6: The discussion of the term “incident” in the NIOSH procedures follows 42 CFR 83. 

However, it is not sufficiently developed to ensure that workers with less than 250 days 

employment, and who may have worked in conditions of failure of radiological controls or 

experienced a serious incident, other than one similar to a criticality accident, receive 

comparable consideration in regard to a health endangerment as those who have 250 or more 

days of employment. 

Finding 7: NIOSH guidelines do not address how issues of job types and incidents for proposed 

SEC classes that have very large proportions of survivor claimants might be addressed, 

particularly for petitions involving the early years (~first two decades after the start of the 

Manhattan Project). In this respect, survivor claimants who decide to become petitioners may 

find it considerably more difficult to provide the required information. The procedures make no 

special allowance for NIOSH assistance in such cases. 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

8 of 35 

Finding 8: NIOSH SEC procedures provide for interviews with petitioners, but do not require 

that even one such interview be conducted. This could result in missed information or 

misinterpretation of the intent of the petitioners. It may also contribute to reduced confidence in 

case NIOSH rejects a petition. 

Finding 9: NIOSH procedures do not provide guidelines for the selection of facilities or 

processes from other sites that could be used in SEC petition evaluations. This increases the risk 

of scientific misjudgments and inconsistencies. 

Finding 10: NIOSH procedures do not contain any specific guidelines that may be needed to 

supplement OCAS-IG-001 and OCAS-IG-002, the guidelines for external and internal dose 

reconstruction, respectively, devised for use in individual dose reconstruction. Such 

supplementary guidelines are needed in several areas, some of which are identified in this 

review. Of particular concern is guidance for performing plausible maximum radiation doses for 

a class of workers. 

Finding 11: NIOSH procedures provide no significant discussion of the contents of the 

evaluation plan that is to be presented to the Board under 42 CFR 83.12(c). 

Finding 12: NIOSH procedures are not detailed enough about how the breadth of a class added 

under 42 CFR 83.14 (when Form A is filed) would be determined. 

Finding 13: Part 83.13 requires that a dose reconstruction is considered feasible only if it is 

“based on some information from the site where the employee worked.” The procedures need to 

present guidance or examples of what constitutes “some information,” and how marginal 

information is to be distinguished from data that could be considered to be at least a partial basis 

for dose estimation. Our review of several dose reconstructions under 42 CFR 82 where the 

claimant was compensated found that NIOSH used bounding analyses that made no use of sitespecific information other than, for example, the fact that uranium was handled at the site of 

interest, and it was also handled at the site(s) from which the surrogate data were used for dose 

reconstruction. It is questionable whether this approach, if used as a basis for determining that a 

dose reconstruction is feasible, meets the intent of Part 83.13 for use of site-specific data. 

1.3 Suggestions for Improvement 

Some of the following suggestions for improvement, such as use of dose reconstruction reviews 

and site profile reviews, derive from the fact that certain procedures and guidelines may have 

been difficult or impossible to put in place at the time OCAS-PR-004 was published (September 

2004). Such suggestions should not be viewed as resulting from deficiencies, but rather as 

updates of the procedures that are needed. 

(1) The procedures should be updated to reflect the experience of the Iowa Army 

Ammunition Plant SEC evaluation, keeping the potential for similar cases in view. 

Specifically, the procedures should include explicit constraints on plausible 

circumstances used to make maximum dose estimates to ensure that the results are fair to 
 

 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

9 of 35 

and uniform for all members of the proposed class, even when they are based on 

assumptions not related to working conditions at the plant. 

(2) The procedures should include examples of cases where NIOSH found that it was not 

possible to perform dose reconstruction, and incorporate the rationale used in these 

determinations into guidelines that can be used to determine when a dose reconstruction 

cannot be performed. 

(3) The procedures should address timeliness issues; i.e., guidance that addresses conditions 

where it does not appear plausible to reconstruct doses in a timely manner. The 

timeliness guideline should be linked to technical feasibility. If the petition evaluation 

determines that a set of technical methods exists to reconstruct doses with sufficient 

accuracy, the evaluation should also address whether the methods can be applied to the 

claimants who are members of the proposed class within a reasonable time frame. 

(4) NIOSH SEC procedures should explicitly constrain maximum doses under 42 CFR 83 to 

be less than highest reasonable dose using worst-case assumptions under 42 CFR 82 in 

those cases where a petition is denied. In some cases where NIOSH’s worst-case 

assumptions are not related to facilities or radionuclide lists that are similar to the site or 

facilities under consideration, this might require NIOSH to revisit the worst-case 

assumptions it is using under 42 CFR 82. One example may be NIOSH’s use of the 

Hanford radionuclide lists as worst-case assumptions for Mallinckrodt workers compared 

to the approaches developed during the Site Profile Review process (ORAUT-OTIB0002, 2004; SC&A 2005a; SC&A 2005b). In other words, the following inequality 

should be made a part of the procedures for transition between 42 CFR 83 and 42 CFR 82 

in cases where NIOSH proposes to deny the petition on grounds of feasibility of dose 

reconstruction: 

D82worstcase ≥ D83max 

where D82worstcase is the highest reasonable value of dose using worstcase assumptions under 42 CFR 82, and 

D83max is the maximum dose in plausible circumstances using the 

methods proposed in a 42 CFR 83 petition evaluation that 

recommends a denial of the petition. 

(5) NIOSH procedures should explicitly require that the data and other information used for 

evaluating petitions be appropriately verified, by sampling for instance, and checked for 

correctness, as applied to a given class of workers, and that the completed dose and 

partial dose reconstructions used for determining feasibility of dose reconstruction with 

sufficient accuracy should cover or bound all job types and periods for all members of the 

proposed class. 

(6) NIOSH procedures should require at least one interview with one petitioner as part of the 

evaluation process. One or more interviews may be conducted under current procedures, 

but they are optional. At least one interview is needed to ensure a thorough evaluation 

process and to increase petitioner confidence in case the SEC petition is denied. 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 10 of 35 

(7) A more inclusive statement of health endangerment in cases where a member of the 

proposed class has worked for less than 250 days is needed. Specifically, while the 

current guidelines regarding high-exposure incidents provide adequate guidance for 

extreme conditions, there are other conditions involving failure of radiological controls 

that could result in health endangerment as defined, for instance, by a probability of 

causation of 50% or more that may be unfairly excluded under the current procedure. 

(8) NIOSH should make explicit provisions to provide additional assistance to survivors who 

wish to become petitioners in completing Form B, especially for the early periods, since 

many or most employees may no longer be available to provide assistance and expertise 

to survivors in such cases. 

(9) NIOSH should supplement the guidelines in OCAS-IG-001 and OCAS-IG-002 to address 

the specific requirements of SEC petition evaluations in regard to maximum dose 

estimates in plausible circumstances. 

(10) NIOSH procedures should be updated to include detailed guidelines for determining 

members of the class in cases where Form A is filed (i.e., where NIOSH has determined 

it cannot complete a dose reconstruction). 

(11) The NIOSH SEC petition evaluation plan that it is required to present to the Board should 

include the documentary basis for the evaluation, dose reconstruction that it might use in 

the process, and other details that it has decided on at the initial stage. As NIOSH adds 

documentation, dose reconstructions, analyses of data, and other elements to its petition 

evaluation process, it should inform the Board in a prompt manner, and make the 

documents and analyses available to the Board. Such a process would facilitate timely 

Board consideration of SEC petition evaluations when they are completed. 
 

 

 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 11 of 35 

2.0 INTRODUCTION 

The Energy Employees Occupational Illness Compensation Program Act (EEOICPA) provides 

for the U.S. Department of Health and Human Services (HHS) to add certain classes of U.S. 

Department of Energy (DOE), Atomic Weapons Employer (AWE), contractor, or subcontractor 

employees to the Special Exposure Cohort (SEC) under specified conditions. HHS has set forth 

the regulations for designating these classes in Title 42, Part 83 of the Code of Federal 

Regulations (42 CFR 83, Procedures for Designating Classes of Employees as Members of the 

Special Exposure Cohort Under the Energy Employees Occupational Illness Compensation 

Program Act of 2000, May 28, 2004). The rules described in 42 CFR 83 include a process for 

employees, survivors, or certain of their representatives to file petitions for inclusion in the SEC, 

as well as a process by which the National Institute of Occupational Safety and Health (NIOSH) 

and its contractors would evaluate the petitions that are being developed for the addition of 

employees of other DOE facilities and AWEs to the SEC. This report is a review of NIOSH 

procedures and guidelines to implement 42 CFR 83. SC&A prepared this report pursuant to a 

decision by the Advisory Board on Radiation and Worker Health (the Board) to review NIOSH 

procedures and guidelines for evaluating SEC petitions. The main procedures for implementing 

42 CFR 83 are set forth in Internal Procedures for the Evaluation of Special Exposure Cohort 

Petitions, OCAS-PR-004, dated September 23, 2004 (referred to hereafter as SEC procedures or 

as OCAS-PR-004). 

Addition to the SEC depends on two criteria under 42 CFR 83: 

HHS determines that (1) it is not feasible to estimate with sufficient accuracy the 

radiation dose that the class received; and (2) there is a reasonable likelihood 

that such radiation dose may have endangered the health of members of the class. 

Claimants choosing to petition for addition to the SEC must submit a petition to the U.S. 

Department of Labor (DOL). 42 CFR 83 divides petitions into the following two main 

categories: 

(1) Petitions under 42 CFR 83.9(b) in which NIOSH has already determined that a dose 

reconstruction cannot be completed under 42 CFR 82: These petitioners only need to 

cite NIOSH’s finding that a dose reconstruction is not possible. Petitioners are not 

required to provide any additional information other than basic identification information. 

(2) Petitions for all cases where NIOSH has not made a finding that dose reconstruction 

cannot be completed: The requirements for specification of the class and other 

information to be included in the petition are set forth in 42 CFR 83.9(c). The 

requirements in 42 CFR 83 for the content of petitions have the stated intention “to 

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

uniform, fair, scientific consideration.” While EEOICPA itself specifies inability to do 

dose reconstruction with “sufficient accuracy” as the criterion for addition to an SEC, 

42 CFR 83 specifies the overarching criterion for this as maximum dose estimation in 

“plausible circumstances.” This is specified in 42 CFR 83.13(c)(1)(i) as follows: 
 

 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 12 of 35 

Radiation doses can be estimated with sufficient accuracy if NIOSH has 

established that it has access to sufficient information to estimate the 

maximum radiation dose, for every type of cancer for which radiation 

doses are reconstructed, that could have been incurred in plausible 

circumstances by any member of the class, or if NIOSH has established 

that it has access to sufficient information to estimate the radiation doses 

of members of the class more precisely than an estimate of the maximum 

radiation dose. (42 CFR 83.13(c)(1)(i)) 

2.1 Statement of Purpose and Scope of the Review 

SC&A reviewed selected NIOSH documents to evaluate their consistency with 42 CFR 83, and 

with the dose reconstruction procedures in 42 CFR 82 and related guidelines in so far as they 

apply to 42 CFR 83. Specifically, minimum dose reconstruction guidelines in 42 CFR 82 are not 

relevant. Efficiency procedures for maximum dose specifically designed to shorten the dose 

reconstruction effort are also not relevant. The procedures and guidelines that SC&A reviewed 

are as follows: 

(1) SEC Petition Forms A and B. 

(2) SEC Petition Form B Instructions. 

(3) Internal Procedures for the Evaluation of Special Exposure Cohort Petitions, OCAS-PR004, September 23, 2004. 

(4) Office of Compensation Analysis and Support (OCAS) and Oak Ridge Associated 

Universities (ORAU) procedures guidelines for dose reconstruction. This portion of the 

review relied largely on work already completed by SC&A under Task 3. 

The last item in the above list has largely been covered in SC&A’s review of guidelines and 

procedures under Task 3 (SC&A 2005d) submitted to the Board in January 2005. Under the 

current task, SC&A incorporates by reference those parts, if any, of the Task 3 review that are 

relevant to SEC petition evaluations. 

2.2 SC&A’s Approach to Reviewing Documents 

The SC&A review of the procedures and other documents focuses on the extent to which they 

are suitable for allowing NIOSH to have a sufficient and scientifically sound basis in data and 

analytical approach to evaluate petitions so that they “receive uniform, fair, and scientific 

consideration,” as required by 42 CFR 83.1. So far as ability to reconstruct doses is concerned, 

SC&A’s review of procedures and guidelines focuses on the 42 CFR Part 83 definition of 

“sufficient accuracy;” that is, on maximum dose estimates under “plausible circumstances” or 

dose estimates more precise than the maximum. 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 13 of 35 

2.3 Structure and Organization of the Report 

• 	 Section 1 is the Executive Summary 

• 	 Section 2 is the Introduction 

• 	 Section 3 covers the SEC Petition Forms A and B, and SEC Petition Form B Instructions 

• 	 Section 4 reviews the strengths of OCAS-PR-004 

• 	 Section 5 discusses SC&A Findings relating to OCAS-PR-004 and specific issues in 

NIOSH dose reconstruction guidelines OCAS-IG-001 and OCAS-IG-002 as they relate to 

SEC petition evaluation 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 14 of 35 

3.0 SPECIAL EXPOSURE COHORT PETITION FORMS A AND B 

3.1 SEC Petition Form A (OMB Number: 0920-0639) 

Form A is for claimants who have been informed by NIOSH that it cannot reconstruct a 

claimant’s dose. In effect, Form A allows the claimant to become a petitioner as well. This 

enables the claimant to receive compensation, because NIOSH cannot reconstruct the 

employee’s dose. At the same time, it allows NIOSH to proceed with defining a class of 

employees that would fit the same criteria for identification. 

SC&A finds the procedure specified in Form A appropriate for claimants whose doses NIOSH 

has found it cannot reconstruct. Under 42 CFR 83.14, NIOSH constructs the class corresponding 

to these cases using criteria specified in 42 CFR 82.13. The review of OCAS-PR-004 in 

Section 5 of this report covers the question of the guidelines in relation to the definition of the 

Class for those cases where the petitioner has filed Form A. 

NIOSH procedures provide for addition of an entire class to the SEC in such cases, using the 

rules under 42 CFR83.13. However, the NIOSH SEC procedures do not provide detailed 

guidelines on how this might be done, leading to a risk of inconsistency across petitions. 

3.2 SEC Petition Form B and Instructions (OMB Number: 0920-0639) 

Form B is more elaborate than Form A, because it is for use by petitioners who are expected to 

provide some basis regarding the infeasibility of dose reconstruction with sufficient accuracy for 

the proposed class. Petitioners can be claimants, but they do not have to be. There is provision 

in 42 CFR 83 for representatives of claimants to be petitioners. Form B makes provisions for 

petitioners to supply information regarding radiation dose records, working conditions, incidents, 

and other issues relating to the feasibility of dose reconstruction. Affidavits by employees or 

former employees, as well as expert reports by health physicists, can be filed together with the 

form. The provisions of Form B, therefore, correspond to 42 CFR 83.9(c), which specifies the 

documentation and information that should accompany the petition. 

NIOSH has also published line-by-line instructions for completing Form B. These instructions 

are useful and can be expected to assist petitioners in filling out the form. 

There are no regulatory issues relating to Form B and the accompanying instructions. Since 

survivors may take the assistance of representatives of labor organizations or of health physicist 

experts in preparing the petition, and since representatives of labor organizations can themselves 

be petitioners, the problem of uniform and fair consideration appears to be considerably less 

difficult than the corresponding problem in interviews, which SC&A discussed in its Task 3 

report (SC&A 2005d, Section 5). Finally, NIOSH also makes provisions for assisting petitioners 

to provide missing documentation after it receives the petition. This is part of NIOSH’s 

procedure for deciding which petitions it is going to take up for evaluation. 

Despite these features of Form B and the accompanying instructions and NIOSH process, the 

hurdles are higher for survivor petitioners who want to file Form B than they are for employee 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 15 of 35 

petitioners. One large area of difference is that survivor petitioners cannot be expected to know 

about incidents. Secrecy and work culture often led to employees not discussing details of their 

work with family members. It was often a requirement of the classification status of the work to 

keep the nature of the work secret. Under the circumstances, employee petitioners would be far 

more likely to remember incidents in which high exposures could have occurred. The issue of 

incidents is even more important in case of SEC petitions than it is for dose reconstructions for 

the following reasons: 

• 	 SEC petitions involve situations where petitioners believe that records are incomplete, 

non-existent, or deficient in some other fundamental way so as to prevent dose 

reconstruction. 

• 	 A finding of health endangerment can occur without a 250-day minimum work time if the 

class was exposed to an incident with sufficiently high radiation levels or failure of 

radiation controls. 

NIOSH does provide assistance to petitioners in completing the forms and enhancing the 

information provided. However, the application process should specifically assist survivors who 

wish to become petitioners in regard to matters such as job types, exposure periods, and 

incidents. This would help to reduce any inequities between petitioners who are survivors and 

petitioners who are former workers. 

3.2.1 Miscellaneous Comments on Form B 

(1) The words "An authorization," which appear at the bottom of page 1, do not appear to be 

connected to any other words. 

(2) In the black IMPORTANT section at the top of Page 2 of 10, the definition of “Class” 

should include the time period. 

(3) C.7b, Dates of Employment, and C7d, Work Site Location, on page 2, are redundant to 

information requested in Section E. 

(4) Reference is made on page 6 and in Section F (p. 8) to the General Accounting Office. 

The name of this office has been changed to the Government Accountability Office. 

(5) Section F does not provide for explanations of suggested evidence about cases where 

monitors were not functional or were inadequately calibrated to the point that dose 

reconstruction might be significantly affected or compromised. 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 16 of 35 

4.0 INTERNAL PROCEDURES FOR THE EVALUATION OF SPECIAL 

EXPOSURE COHORT PETITIONS (OCAS-PR-004) - STRENGTHS 

SC&A reviewed the NIOSH procedures (OCAS-PR-004, Rev. 0, September 23, 2004) to 

evaluate compliance with the provisions of 42 CFR 83, primarily those related to dose 

reconstruction, rather than to administrative or procedural matters, undertaken by NIOSH, its 

contractors, or other offices under HHS. The document contains a careful, logical, step-by-step 

procedure for meeting the requirements of 42 CFR 83. 

4.1 Procedural Strengths 

The guidelines contain a step-by-step procedure for determining whether NIOSH can perform 

dose reconstructions for the entire class of employees that are the subject of the petition. The 

step-by-step format of the NIOSH guidelines is seen in several subsections of Section 6, which 

contain directions of the form, “If ... go to step ....” The evaluator can follow the instructions 

from subsection to subsection until the appropriate methodology for the petition being reviewed 

is fully executed. 

The procedure also provides for splitting up the class into subclasses when NIOSH determines 

that it is not possible to do dose reconstructions for one or more sub-groups of the class, but that 

it is possible to do dose reconstructions for others. This division of claimants addresses the 

directions of 42 CFR 83.13(2)(d)(2)(ii), which require “the identification of any group of 

employees who were identified in the original petition(s) who should constitute a separate class 

of employees.” Two examples of defining sub-groups where dose reconstruction may be 

feasible are taken from Section 6: 

If one or more dose reconstructions have been completed or initiated and they 

demonstrate feasibility only for a subgroup of the petitioning class of employees, 

as appropriate under 6.3.2, define the two separate classes of employees 

accordingly (one class of employees for which dose reconstruction is feasible, and 

one class for which feasibility must still be determined). Go to step 6.3.9 for the 

class for which dose reconstruction is feasible and go to step 6.3.4 for the class 

for which the feasibility of dose reconstruction must still be determined. 

(§6.3.3.2)

 If the personnel and/or area monitoring data are available and adequate to 

conduct dose reconstructions only for a subgroup of the class of employees 

considered in this step, as appropriate under 6.3.2, define two separate classes of 

employees accordingly (one class of employees for which dose reconstruction is 

feasible, and one class for which it is not). Go to step 6.3.9 for the class for which 

dose reconstruction is feasible and go to step 6.3.5 for the class for which 

personnel and/or area monitoring data are not available and adequate. 

(§6.3.4.2) 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 17 of 35 

4.2 Examples, Notes, and Discussions 

The NIOSH guidelines contain several hypothetical, qualitative examples in Sections 6.3 

(Evaluate a petition qualifying for evaluation under §83.13) and 6.4 (Evaluate the petition 

qualifying for evaluation under §83.14, for a claimant for whom OCAS was unable to complete a 

dose reconstruction). These examples are set off from the main text by boxes and help clarify 

the procedures. An illustration is taken from Section 6.4.4: 

Example: OCAS found that it could not complete a dose reconstruction for 

employee John Q. Public. Mr. Public was exposed to radiation during an 

incident, for which there any no monitoring data and inadequate source term and 

process data.... (§6.4.4) 

Several helpful notes also appear at the beginning of major sections to inform the reader of the 

purpose of a particular section. For example, the note in Section 6.1 begins as follows: 

Note: The steps and procedures under 6.0 are intended to provide guidance for 

determining whether a petition meets the requirements specified under 42 CFR 

Part 83 to qualify for evaluation by NIOSH, the Advisory Board on Radiation and 

Worker Health (“the Board”), and the Secretary of HHS. (§6.1) 

The procedures also include boxed discussions to clarify certain points. The following is taken 

from a section dealing with evaluation of petitions against requirements of 42 CFR 83.9(c)(2) 

and (3): 

Discussion: “Adequacy” and “credibility” are not judgments subject to any rigid 

criteria; because each case is likely to be unique, “adequacy” and “credibility” 

will be determined on a case-by-case basis, based on a totality of the 

circumstances. (§6.1.5.1.1) 

4.3 Completed Dose Reconstructions 

The NIOSH procedures use completed dose reconstructions, when applicable, as part of the 

process of making judgments of feasibility of dose reconstruction for all or parts of the class. 

This practice should facilitate petition evaluations and promote review consistency. An 

illustration can be taken from the section presenting guidelines for evaluating petitions under 42 

CFR 83.13: 

Determine whether one or more dose reconstructions have been completed and/or 

initiated that demonstrate that dose reconstructions are feasible for the class of 

employees identified in the petition, or, if appropriate under 6.3.2, for a subgroup 

thereof, in light of the information provided in the petition concerning the 

feasibility of estimating radiation doses for the class of employees identified in the 

petition. (§6.3.3) 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 18 of 35 

4.4 Partial Reconstructions 

Section 6.3.10 contains the appropriate caution that a determination that NIOSH cannot 

reconstruct doses for all members of the class and the 22 cancers in the SEC list does not mean 

that NIOSH cannot reconstruct some doses for some cancers for some members of the class. 

NIOSH applies this caution specifically to non-SEC cancers. As such, it is a necessary (but not 

sufficient) part of the procedure that would enable next steps in regard to estimation of doses for 

non-SEC cancers. 

Include the following statement: “The determination by NIOSH that it cannot 

estimate radiation doses with sufficient accuracy for members of this class does 

NOT necessarily mean that NIOSH cannot estimate ANY radiation doses with 

sufficient accuracy for ALL members of this class.” In a case in which a member 

of this class incurred a cancer not included among the 22 specified cancers 

covered by EEOICPA and hence requires a dose reconstruction (or would 

otherwise be left without a remedy), it is possible that NIOSH could reconstruct 

some or all of the radiation doses relevant to the individual’s cancer in 

conformance with 42 CFR Part 82. (§6.3.10.2(5)) 

4.5 Data Lists 

Appendix B to OCAS-PR-004 provides a useful summary of the DOE request for monitoring 

and related records that is indicative of the type of information that would be considered in 

evaluating the feasibility of dose reconstruction. 

4.6 Report Format 

Appendix C provides a helpful evaluation report template comprising an evaluation summary, 

class definition proposed by the petitioners and petition basis, description of the data collection 

effort and its results, summary of radiological operations relevant to the initial class, evaluation 

of the feasibility of dose reconstruction, summary of feasibility findings, evaluation of health 

endangerment, and definition of the class or classes established on the basis of the analyses. 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 19 of 35 

5.0 INTERNAL PROCEDURES FOR THE EVALUATION OF SPECIAL 

EXPOSURE COHORT PETITIONS (OCAS-PR-004) - FINDINGS 

In evaluating the NIOSH SEC procedures, SC&A considered the implications of the individual 

dose reconstruction regulation, 42 CFR 82, the SEC regulation, 42 CFR 83, and their relationship 

to each other. This relationship is discussed in a general way in 42 CFR 83, and has significant 

implications for the petition evaluation guidelines that the NIOSH procedures should contain. 

Section I.C of the Final Rule to 42 CFR 83 identifies the “Purpose of the Rule,” and states the 

following: 

The purpose of this rule is to establish procedures by which the Secretary of HHS 

will determine whether to add to the cohort new classes of employees from DOE 

and AWE facilities. The procedures are intended to ensure that petitions for 

additions to the Cohort are given uniform, fair, scientific consideration, that 

petitions and interested parties are provided the opportunity for appropriate 

involvement in the process... 

42 CFR Part 82 provides the methods by which NIOSH is conducting dose 

reconstructions to estimate the radiation doses incurred by individual covered 

employees who have incurred cancer. These estimates are required by EEOICPA 

for DOL to adjudicate a cancer claim for an employee who is not a member of the 

Cohort or whose claim is not covered by provisions of EEOICPA for 

compensating members of the Cohort. The methods to arrive at these estimates, 

however, will be directly considered by HHS in reviewing petitions to add classes 

of employees to the Cohort. In particular, HHS will consider these methods in 

determining for a petitioning class of employees, as required by EEOICPA, 

whether ‘‘it is not feasible to estimate with sufficient accuracy the radiation dose 

that the class received.’’ [42 CFR 83, Section I.C, Federal Register, Vol. 69, No. 

104, May 28, 2004, pp. 30764-30765, Emphasis added.] 

Regulatory requirements for adding new classes to the cohort are defined in 42 CFR 

Part §83.13(c), which states how NIOSH will evaluate records and information to make critical 

determinations about the following question: 

Is it feasible to estimate the level of radiation doses of individual members of the 

class with sufficient accuracy? 

(i) Radiation doses can be estimated with sufficient accuracy if NIOSH has 

established that it has access to sufficient information to estimate the maximum 

radiation dose, for every type of cancer for which radiation doses are 

reconstructed, that could have been incurred in plausible circumstances by any 

member of the class, or if NIOSH has established that it has access to sufficient 

information to estimate the radiation doses of members of the class more 

precisely than an estimate of the maximum radiation dose. NIOSH must also 

determine that it has information regarding monitoring, source, source term, or 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 20 of 35 

process from the site where the employees worked to serve as the basis for a 

dose reconstruction. This basis requirement does not limit NIOSH to using 

only or primarily information from the site where the employee worked, but a 

dose reconstruction must, as a starting point, be based on some information 

from the site where the employee worked. 

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

(c)(1)(i) of this section would require, at a minimum, that NIOSH have access to 

reliable information on the identity or set of possible identities and maximum 

quantity of each radionuclide (the radioactive source material) to which members 

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

if members of the class were potentially exposed without adequate protection to 

unmonitored radiation from radiation generating equipment (e.g., particle 

accelerator, industrial x-ray equipment), in many circumstances, NIOSH would 

require relevant equipment design and performance specifications or information 

on maximum emissions. 

(iii) In many circumstances, to establish a positive finding under paragraph (c)(1)(i) of 

this section would also require information describing the process through which the 

radiation exposures of concern may have occurred and the physical environment in 

which the exposures may have occurred. [Emphases added.] 

SC&A interprets these statutory requirements to include the following: 

(1) Guidance and procedural documents currently employed to adjudicate claims under 

42 CFR 82 are potentially also applicable for the evaluation of SEC Petitions under 

42 CFR 83. 

(2) Denial of a Petition for SEC status requires that, at a minimum, “radiation doses can be 

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

sufficient information to estimate the maximum radiation dose, for every type of cancer 

... that could have been incurred in plausible circumstances by any member of the 

class.” [Emphasis added.] 

(3) Denial of a Petition also requires that NIOSH “... has [at least some] information 

regarding monitoring, source, source term, or process from the site where the 

employees worked.” [Emphasis added.] 

(4) Lastly, denial of a Petition requires “... that NIOSH have access to reliable information 

on the identity or set of possible identities and maximum quantity of each radionuclide 

(the radioactive source material) to which members of the class were potentially exposed 

without adequate protection.” [Emphasis added.] 

The findings below discuss various aspects of these requirements. As a general matter, SC&A 

notes that assessing whether there are sufficient data to estimate maximum doses for an entire 

class of workers in a manner that is fair, uniform, and scientifically sound poses special 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 21 of 35 

challenges. Some of these challenges have been illustrated by the evaluations of the SEC 

petitions for IAAP and for the 1949–1957 period for Mallinckrodt. Those cases show the 

importance of using (1) complete or partial dose reconstructions that, together, would be 

representative of all members of the class, and all periods, processes, and radionuclides covered 

by the job types in question to illustrate NIOSH’s ability to reconstruct doses with sufficient 

accuracy, and (2) data that have been sufficiently validated and shown to have the integrity 

needed to demonstrate the feasibility of dose reconstruction for a class of workers. The use of 

other documentation and data, such as site profiles and workbooks, should also be subjected to 

sufficient checks to ensure that there are no essential problems that would prevent dose 

reconstruction with sufficient accuracy for the members of the proposed class. 

5.1 Issue 1: Maximum Dose Estimates in Plausible Circumstances 

Requirements have been established in 42 CFR 83.13 for claims where NIOSH has not 

previously determined that it could not complete a dose reconstruction for a claimant under 

42 CFR 82 regulations. Section 83.13 asks: “How will NIOSH evaluate petitions, other than 

petitions by claimants covered under §83.14?” Section 83.13(c)(1) discusses the issue of 

feasibility by asking: “Is it feasible to estimate the level of radiation doses of individual 

members of the class with sufficient accuracy?” As noted above, 42 CFR 83.13(c)(1)(i) states the 

regulation’s requirements for estimating doses with “sufficient accuracy” in terms of maximum 

dose that could have been incurred in plausible circumstances by any member of the proposed 

SEC class. 

SC&A notes that OCAS-PR-004 and the general references in the guidelines to 42 CFR 82, 

OCAS-IG-001, and OCAS-IG-002 are not sufficient to provide adequate guidance to the OCAS 

staff and its contractors as to how much conservatism to employ in developing maximum dose 

estimates, or how such methods are to be constrained either between different petitions or for 

members of the class proposed in the petition. In a sense, this problem might be viewed as a lack 

of guidelines in the procedures for assessing when the method for maximum dose estimation can 

be considered to possess sufficient accuracy. Without explicit guidance on this point, different 

evaluators may employ different degrees of claimant-favorable conservatism in compensating for 

deficiencies in the data and reach different conclusions for the same or similar cases. This 

question becomes even sharper if NIOSH uses different methods for estimating maximum dose 

for members of the class in circumstances not relating to the nature of the work. 

The process for evaluating the IAAP SEC petition illustrates the potential problem. NIOSH 

prepared a TBD, which was used, in part, to recommend a denial of the IAAP SEC petition. The 

method resulted in a sudden decline in dose estimates in 1963 created by issues relating to the 

need to protect pre-1963 classified data. The reduction in the dose estimate did not relate to a 

change in working conditions in 1963, and derived principally from the change from a model 

based on classified data to one based on dose measurements. This made both the uniformity and 

fairness issues acute in the case of IAAP (SC&A 2005c). 

Further, the review of the methods proposed by NIOSH to estimate a maximum dose for IAAP 

workers prior to 1963 also raised the issue of whether there was a procedure to bound the 

maximum doses when the estimation procedures were not related to working conditions, but 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 22 of 35 

rather to the need to protect classified data. The proposed method to estimate maximum doses 

for the pre-1963 workers yielded values that were an order of magnitude higher than those 

estimated using measurements for the period covering 1963 until the close of production. 

Therefore the guidelines need to be more explicit regarding the methods for maximum dose 

estimation in “plausible circumstances,” with specific reference to the requirement of 

42 CFR 83.1 that SEC petitioners be given uniform and fair consideration. In summary, NIOSH 

SEC procedures do not address the problem of constraining maximum dose estimation methods 

in order to arrive at a result that simultaneously fulfills the criteria of scientific soundness, 

claimant favorability, and uniform and fair consideration for all members of the class. This gap 

also raises a question of uniformity of evaluation across petitions. 

5.2 Issue 2: Relation of 42 CFR 83 to 42 CFR 82 

The problem of uniform and fair consideration also relates to how maximum dose estimates are 

developed under 42 CFR 83 to justify denial of an SEC petition and the highest reasonable dose 

estimates using worst-case assumptions under 42 CFR 82 for the purpose of denying a claim. 

42 CFR 83 distinguishes the approach for developing maximum dose estimates under 42 CFR 83 

from the efficiency approach for maximum dose estimates that are used only for denial of claims 

under 42 CFR 82 as follows: 

The dose reconstruction rule very specifically restricted the condition on 

the use of worst-case assumptions to the case when they are used as an 

efficiency measure to limit time-consuming and resource-consuming 

additional research and analysis. This narrow restriction is stated in the 

dose reconstruction rule as follows (emphasis added): 

At any point during steps of dose reconstruction described 

[above], 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: * * * 

(2) Dose is determined using worst-case assumptions related to 

radiation exposure and intake, to substitute for further research 

and analysis; * * * 

* * * 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 greater), because using worstcase assumptions it can be determined that the employee could not 

have incurred a compensable level of radiation dose.’’ 42 CFR 

Part 82.10(k) (40 CFR 83) 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 23 of 35 

In contrast, this Cohort rule implies the use of worst-case assumptions for dose 

reconstructions in essentially the opposite situation, to estimate maximum 

radiation doses in cases in which NIOSH lacks extensive information that could 

be used to conduct ‘‘further research and analysis,’’ rather than as an efficient 

substitute for such further research and analysis. (42 CFR 83, pg. 30769} 

Maximum dose estimates methods developed under 42 CFR 83 are not “worst-case” estimates 

and may be used for compensation and denial (once an SEC petition is rejected on the basis of 

demonstration of the feasibility dose reconstruction with sufficient accuracy). One implication 

of the above contrast is that the dose estimate using worst-case assumptions under 42 CFR 82 

that is used for denial only should be greater than the maximum dose in plausible circumstances 

under 42 CFR 83. Yet, there is no constraint in the procedures that this inequality should apply. 

That this could be a problem in terms of fairness of compensation as indicated by the evaluation 

of the Mallinckrodt SEC petition for the group of employees who worked there from 1949 to 

1957. In attempting to define methods to estimate maximum doses in plausible circumstances 

for the class, NIOSH developed a method to compare a maximum dose that might have been 

incurred by a group of workers exposed to U-238, U-235, and the radionuclides in their decay 

chains (including Th-230, Ra-226, Pa-231, and Ac-227) with a maximum dose for a group of 

workers exposed mainly to Th-230, but not to significant amounts of Ra-226 or uranium isotopes 

(see attachments to SC&A 2005b, where the methods developed by NIOSH are reproduced). 

SC&A evaluated NIOSH’s suggested approaches and compared them with one maximum dose 

approach that had been used to deny Mallinckrodt claimants under 42 CFR 82, using worst-case 

assumptions. NIOSH used the radionuclide lists from Hanford for internal dose estimation, even 

though the list had little if any relation to the radionuclide list at Mallinckrodt. SC&A Site 

Profile reviews raised the possibility that the worst-case procedure used by NIOSH under 42 

CFR 82 would yield estimates less than those under maximum dose estimation procedures 

suggested by NIOSH under 42 CFR 83 (see SC&A 2005a, Finding 16; SC&A 2005b, 

Section 1.3 and attachments). 

In the absence of any constraints in the guidelines, a similar problem could arise in creating very 

high maximum dose estimates while recommending denial of SEC petitions. In case the petition 

is actually denied, the problem of a lack of a fair and uniform approach to compensating or 

denying claims could become acute. As in the case of changes in dose estimates between 

members of the class not related to working conditions, the lack of specificity in the SEC 

procedures regarding the transition between 42 CFR 83 and 42 CFR 82 dose reconstruction 

could lead to methods that lack sufficient accuracy to simultaneously meet the test of uniform, 

fair, and scientific consideration. 

It is important, therefore, for the SEC evaluation procedures to provide a specific guide as to the 

relationship of the worst-case assumptions used to deny claims under 42 CFR 82, and the 

constraints that might be applicable in determining maximum dose estimated in plausible 

circumstances under 42 CFR 83. SC&A suggests that the procedures specify that the following 

inequality should be maintained in the transition between 42 CFR 83 and 42 CFR 82: 
 

 

 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 24 of 35 

D82worstcase ≥ D83max 

where D82worstcase is the highest reasonable value of dose using worstcase assumptions under 42 CFR 82, and 

D83max is the maximum dose in plausible circumstances using the 

methods proposed in a 42 CFR 83 petition evaluation that 

recommends a denial of the petition. 

5.3 Issue 3: Adequacy of Data for Maximum Dose Reconstruction 

Additional guidance is needed regarding when data are or are not adequate for maximum dose 

estimates in plausible circumstances. For instance, no guidelines are provided regarding 

radionuclide lists and their connection to job types performed by members of the class. This was 

a major issue in the Mallinckrodt SEC Petition, 1949–1957. Guidelines or checklists for other 

critical issues would be useful in making the considerations of petitions fair, uniform, and 

scientifically sound, including the following: 

• 	 Investigation of data integrity questions, which were alleged in the context of the 

Mallinckrodt petition1
 

• 	 Validation of the data, as necessary, using appropriate sampling procedures 

• 	 Data needed to conclude whether unmonitored workers were at lower risk than monitored 

workers 

• 	 Guidelines for extrapolating backwards or forwards in time from a given set of data for a 

particular group of workers 

Development of specific guidelines is important for such issues. For instance, data falsification 

has been alleged in at least one SEC petition (Mallinckrodt). These issues may come up not only 

as part of allegations in SEC petitions, but also in the course of Site Profile reviews, or NIOSH’s 

own review of available data. Guidelines for evaluating data integrity issues might include the 

following: 

(1) Review of available documentation to examine whether there is any evidence that 

radiation doses in high-exposure areas were not recorded (due to workers not wearing 

their dosimeters, for instance), problems with instrumentation that might result in 

systematic underestimation of doses, the use of unwarranted adjustment factors prior to 

recording dose, and fabrication of data, such as entering zeros in dose records when the 

badges were not turned in or were not available. 

(2) Interviews with personnel, such as site experts, petitioners, members of the class, and coworkers of members of the class. 

1

 SC&A review of the documentation in the context of the series of reports on the Mallinckrodt Site Profile 

determined that there did not appear to be significant data integrity issues in terms of data falsification that would 

affect the feasibility of dose reconstruction. 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 25 of 35 

(3) Review of historical documentation and archives, Congressional hearings, and lawsuit 

documentation records (if any are available). 

The first two of these items should be a mandatory part of the procedure for SEC petition 

evaluation when (1) the petition alleges that data integrity problems exist, (2) NIOSH determines 

that such problems may exist, or (3) a Board review or a Board-commissioned review indicates 

that such problems may exist. 

Some of the gaps in the procedures are also discussed in the sections below on OCAS-IG-001 

and OCAS-IG-002, which are the guidelines for external and internal dose, respectively, referred 

to in the NIOSH SEC procedures. 

NIOSH SEC procedures provide no more than a general comment that site profiles “will provide 

an important resource of information to assist in evaluating feasibility (recognizing, however, 

that petitions may raise issues not yet identified through the site profile development process)” 

(§6.3.1(3)). There is no substantive guidance on the use of site profiles. SC&A recognizes that 

site profiles are not part of the regulations and that, in light of this, NIOSH may choose not to 

rely on the information contained in them. However, in cases where NIOSH does use the 

information, a more specific set of guidelines for the use of information in the site profiles that is 

relevant to SEC petition evaluations could provide for more uniform consideration of SEC 

petitions. They could also provide insights into whether and how the 42 CFR 83 dose estimation 

procedures are used in specific cases. This would ensure that problems of uniformity and 

fairness do not arise in the transition from a denial of an SEC petition, because maximum doses 

in plausible circumstances can be estimated, to actual dose reconstructions under 42 CFR 82. 

5.4 Issue 4: Co-Worker Data 

Section 6.3 of the NIOSH SEC procedures provides guidelines on how to comply with the 

requirements of 42 CFR 83.13 (i.e., where NIOSH has not already determined that it cannot 

complete a dose reconstruction for a particular claimant). The section includes examples where 

co-worker data could be used to conclude that NIOSH can do dose reconstruction for the 

petitioning class or some sub-groups of the class. However, the section lacks quantitative 

guidance on the procedure or set of steps that relate the co-worker data to the class or sub-group 

of employees in the SEC petition. Essential elements required for comparability of claimant and 

co-worker data, such as time periods worked and job-type details, are not specified. An 

illustration of what starts out as a helpful example, but does not provide sufficient guidance, may 

be found in Section 6.3.2 (“Procedures for determining the extent and specificity of evaluations 

supporting positive determinations”): 

Example 1: The petition asserts that personnel monitoring was not conducted for 

a group of maintenance workers when they were engaged in a particular 

operation. An examination of records shows that maintenance workers were not 

monitored while engaged in the particular operation but that another group of 

maintenance workers were monitored while engaged in the same operation 

involving comparable exposure conditions at another location at the facility. 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 26 of 35 

This information may be sufficient to determine that dose reconstruction is 

feasible for the group of maintenance workers covered by the petition, while 

engaged in the particular operation. It would not be necessary to evaluate the 

availability and adequacy of records concerning the work of the group of 

maintenance workers while engaged in other operations not addressed by the 

petition. (OCAS-PR-004, §6.3.2) 

Cases that are similar to the above straightforward example can, of course, be addressed by coworker data. More complex issues arise when a whole group of workers, such as support 

workers at Y-12, is unmonitored for certain time periods. In that case, the analysis is more 

difficult, because it must be shown that job descriptions of monitored workers exist that can be 

demonstrated to bound the doses of unmonitored workers. The procedures would benefit from 

additional examples of when it is not feasible to use co-worker data. SC&A believes that there 

may be conditions where it is not plausible to use co-worker data as the basis for determining 

that a dose reconstruction for a given class of workers can be performed. NIOSH should provide 

guidance for determining when these conditions exist, along with examples drawn from past 

dose reconstructions where this determination was made, if such dose reconstructions are 

available. 

5.5 Issue 5: Use of Completed Dose Reconstructions 

OCAS-PR-004 appropriately refers to completed dose reconstructions as one of the ways that 

can help to determine the feasibility of dose reconstruction under 42 CFR 83. Section 6.3.3 of 

the guidelines discusses use of existing dose reconstructions to inform the SEC feasibility 

assessment: 

Determine whether one or more dose reconstructions have been completed and/or 

initiated that demonstrate that dose reconstructions are feasible for the class of 

employees identified in the petition, or, if appropriate under 6.3.2, for a subgroup 

thereof, in light of the information provided in the petition concerning the 

feasibility of estimating radiation doses for the class of employees identified in the 

petition. (§6.3.3) 

However, it is not clear how the relationship of the dose reconstructions that are consulted to all 

members of the class or a clearly defined subgroup of the class is to be established. OCAS-PR004 has a number of gaps that could affect the accuracy of NIOSH conclusions regarding 

feasibility of reconstructing doses for all or parts of the petitioning class. Specifically, while 

OCAS-PR-004 makes provisions for relating NIOSH conclusions about feasibility of dose 

reconstruction for all or parts of the SEC petition class to the completed and/or initiated dose 

reconstructions, there are no specific guidelines for assessing “sufficient accuracy” as required 

by EEOICPA and 42 CFR 83. For example, the latter asks in §83.13(c)(1): “Is it feasible to 

estimate the level of radiation doses of individual members of the class with sufficient 

accuracy?” In particular, the NIOSH SEC procedures do not contain guidelines that would allow 

a test of whether the dose reconstructions that are examined are actually relevant to estimating 

maximum doses with plausible assumptions. These guidelines should be selected so that the 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 27 of 35 

completed and partial dose reconstructions that are used to evaluate petitions are representative 

of all members of the proposed class for all periods covered by the petition. SC&A suggests that 

the term “representative” in this context be defined to ensure that the methods used in the 

selected cases yield dose estimates that would cover or bound the values for all members of the 

class. 

In addition, the procedures should specify that the data and other information used for petition 

evaluation be checked for accuracy. Such validation should include verification against a sample 

of raw data, as necessary. 

5.6 Issue 6: Incidents 

The regulations discuss the case where claimant radiation exposure is asserted to have arisen 

from an “incident.” The regulation does not include “incident” in its definition section, but 

discusses exposure during incidents: 

For classes of employees that may have been exposed to radiation during discrete 

incidents likely to have involved exceptionally high level exposures ... resulting 

from the failure of radiation protection controls, NIOSH will assume for the 

purposes of this section that any duration of unprotected exposure could cause a 

specified cancer, and hence may have endangered the health of members of the 

class. [42 CFR 83.13(c)(3)(i)] 

OCAS-PR-004 echoes the regulation by stating the following: 

For classes of employees for which dose reconstruction is not feasible, evaluate 

health endangerment by examining whether the class of employees was exposed 

during a discrete incident likely to have involved exceptionally high level 

radiation exposures, comparable to the levels of exposure in nuclear criticality 

incidents. (§6.3.11) 

The procedures go on to say that “exceptionally high” levels of exposure during incidents 

“typically cause acute, radiation-related effects” (§6.3.11.3). However, they do not quantify the 

radiation level experienced in an incident. Acute health effects do not necessarily occur with an 

acute intake due to short-term breakdown of radiological controls or prolonged (days or more) 

breakdown. However, such an acute intake may well cause radiation doses to be more than 

enough to endanger health or even to cause POC > 50%. An example could be air concentration 

of uranium in the tens of thousands of times MAC for short periods (less than a day), as has 

occurred at the Fernald and Mallinckrodt plants. 

The discussion of the term “incident” in OCAS-PR-004 is not encompassing enough to cover 

significant cancer risk in periods of less than 250 days due to failure of radiation controls, 

accidents, or other similar causes. The quantitative aspects of that might be difficult to define, 

but NIOSH should at least develop guidelines for health endangerment over periods less than 

250 days that reflect the kinds of cancer risks that could be incurred. For instance, a dose 

threshold corresponding POC threshold of 50% or less for the most sensitive cancer(s) under 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 28 of 35 

plausible circumstances for members of the class who meet the 250-day employment criterion 

could be developed in order to assess health endangerment over shorter periods of time due to 

incidents or failure(s) of radiological controls. Viewed in this way, the existing guidance could 

well exclude some members of the proposed class whose health may have been endangered, but 

who do not meet the 250-day employment test. In so far as the guidelines relating to health 

endangerment are concerned, the current procedures appear to be inadequate to ensure uniform 

and fair consideration for members of the proposed class who worked for less than 250 days in 

the period covered by the petition. 

5.7 Issue 7: Survivor Petitioners 

NIOSH guidelines do not suggest how the problems of data, such as job types, incidents, and 

working conditions, are to be addressed in cases where the class is heavily composed of survivor 

claimants, who most likely are unable to provide any of the solicited details, or in the case of 

survivor petitioners. SC&A suggests that this could be a significant issue in some SEC petition 

evaluations. 

At some facilities, for instance at some AWEs, individual worker records do not exist. In these 

cases, it would be difficult to identify individual claimants with members of the class if that 

membership depends on job type. This problem could be especially acute in case of survivors 

who want to be petitioners and employee petitioners who cannot remember job types due to 

health problems or loss of memory. It would be desirable for the guidelines to be specific about 

how the lack of job-type data is to be addressed when defining an SEC class. 

5.8 Issue 8: Interviews with Petitioners 

OCAS-PR-004 makes provision for interviews with petitioners or their experts who may have 

helped to prepare the petition, but does not require that at least one thorough interview be 

conducted and documented on the substantive issues raised in the petition. This should be a 

requirement of the petition evaluation process if it appears that NIOSH believes that dose 

reconstruction with sufficient accuracy is possible. This is desirable both as a measure to ensure 

that petitioner input is taken into account and to improve petitioner confidence in the resulting 

NIOSH recommendation. 

5.9 Issue 9: Data from Other Sites 

42 CFR 83 allows NIOSH to use data from other sites to demonstrate the feasibility of 

reconstructing doses with sufficient accuracy, provided that some data from the facility in 

question is included: 

NIOSH must also determine that it has information regarding monitoring, source, 

source term, or process from the site where the employees worked to serve as the 

basis for a dose reconstruction. This basis requirement does not limit NIOSH to 

using only or primarily information from the site where the employee worked, but 

a dose reconstruction must, as a starting point, be based on some information 

from the site where the employee worked. [42 CFR 83.13(c)(1)(i)] 
 

 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 29 of 35 

OCAS-PR-004 does not provide significant guidance as to how the parallels between the facility 

for which the petition has been filed and that from which data is being used as a surrogate set are 

to be compared. There are no explicit constraints on time periods, processes, measurement 

methods, materials processed, or general conditions of work that are set forth to guide the 

process of selecting a surrogate site, facility, or process for use. This has been a significant issue 

in site profile development and review, and in other contexts. For instance, SC&A concluded 

that the use of October 1948 air concentration data from Simonds Saw and Steel for dose 

reconstruction at Bethlehem Steel was reasonable, but that the times spent at various 

workstations could not be so transferred (SC&A 2005e; ABRWH 2004, pp. 143-148). Similarly, 

the use of the neutron-to-photon ratio from the Pantex Plant might be suitable for use at the 

IAAP, but not for workers involved in reactor operations. 

While being too prescriptive on this account is likely to be counterproductive and unnecessarily 

restrictive, some guidance as to what constitutes an acceptable set of surrogate data and what 

constraints might rule out the use of data from other facilities would be useful. 

Related to this issue is the requirement in Part 83 that “a dose reconstruction must, as a starting 

point, be based on some information from the site where the employee worked.” NIOSH should 

provide guidance on what constitutes a minimum acceptable level of site-specific information 

required to meet this criterion. 

5.10 Issue 10: Use of OCAS-IG-001 and OCAS-IG-002 in 42 CFR 83 

The NIOSH SEC procedures refer the evaluator to the “implementation guidelines,” i.e., OCASIG-001 and OCAS-IG-002, to find an elaboration of “the technical issues involved in evaluating 

the availability and adequacy of records and information relevant to feasibility determinations ... 

for internal and external dose reconstructions” (§6.3.1(2)). The section later instructs the 

evaluator that “feasibility should be determined by evaluating the availability and adequacy of 

records and information in the order established by the hierarchy of dose reconstruction 

information specified under 42 CFR 82.2, addressing the informational sources, types, and the 

adequacy of information as specified under 42 CFR Part 82 and 83 and under the OCAS 

implementation guidelines for dose reconstruction” (§6.3.1.(3)). 

These references to procedures that were designed as guidelines for individual dose 

reconstruction under 42 CFR 82 are helpful and necessary, but they do not provide guidance 

regarding dose reconstruction that is essential in the context of SEC petition evaluation. OCASIG-001 and OCAS-IG-002 contain some gaps that need to be filled in for the specific purpose of 

assessing whether maximum dose reconstruction estimates in plausible circumstances can be 

made for all members of the class and for all cancers in the SEC list. 

OCAS-IG-001 has already been reviewed by SC&A, and the Board’s procedure for resolving the 

issues raised by SC&A’s review has been completed. The following examples illustrate some of 

the specific issues that can arise in the context of estimating maximum doses in plausible 

circumstances for a class or portion of a class of workers that are not covered in OCAS-IG-001 

and OCAS-IG-002. 
 

 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 30 of 35 

SC&A also notes that OCAS-IG-001 and OCAS-IG-002 do not discuss how the data gaps arising 

from problems of data integrity are to be addressed (as distinguished from missed doses related 

to limits of detection (LOD) values). The issue of data validation is also an important gap, as 

noted above. 

5.10.1 External Dose Guidelines OCAS-IG-001 

NIOSH guidance for evaluating SEC Petitions is provided in OCAS-PR-004, Internal 

Procedures for the Evaluation of Special Exposure Cohort Petitions; Rev. 0, September 23, 

2004. 

Section 6.3 of OCAS-PR-004 provides steps and procedures for OCAS to conduct its evaluation 

of regulatory criteria defined under §83.13. Specifically, Section 6.3.1 provides the following: 

Procedures for determining feasibility: (1) The principal guidelines for 

evaluating feasibility for petitions qualifying for evaluation under 6.3 are 

established under §83.13(c)(1). (2) The technical issues involved in evaluating 

the availability and adequacy of records and information relevant to feasibility 

determinations are addressed in the implementation guidelines for internal and 

external dose reconstructions. These dose reconstruction guidelines generally 

explain the types of information that can be used in dose reconstructions, and 

approaches to examine the availability and adequacy of information, as well as 

describing how such information should be used. These guidelines also provide 

general guidance concerning how maximum doses can be estimated when 

necessary, and the information essential to such estimates, under section 5.3 of 

the internal dose reconstruction guidelines and Sections 3.1.3, 3.1.4, 3.2.3, 3.3.3, 

and 3.3.4 of the external dose reconstruction guidelines. (Emphases added.) 

SC&A evaluation of the cited sections for use in the context of 42 CFR 83 indicates that each of 

these sections must be used with caution because it has gaps when applied to determining the 

feasibility of dose reconstruction for an entire class of workers over the history of nuclear 

weapons production and testing activities. 

Section 3.1.3 provides guidance for external photon dose reconstruction when personnel 

monitoring data, co-worker monitoring data, and area monitoring survey data are not available. 

When such data are not available, the guide recommends the use of source term information. As 

applied to a class of workers, as opposed to an individual claimant, this strategy for determining 

feasibility of dose reconstruction is questionable, because the complexity of the source term may 

preclude the performance of a scientifically valid maximum dose that can be applied to all 

members of a class. 

Section 3.1.4 provides guidance for photon dose reconstruction that is based on “control limits.” 

This guidance is questionable as applied to an SEC petition for a class of workers. For instance, 

the monitoring threshold of 100 mrem per year is a current value for members of the general 

public and not a regulatory threshold for required monitoring of facility workers. As another 

example, the OCAS-IG-001 guidance restricts the use of the “annual dose limit” to periods less 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 31 of 35 

than 1 year, which conflicts with the SEC employment requirement of at least 250 work days, as 

defined in 42 CFR 83.13 c(3)(ii). 

Section 3.2.3, dealing with neutron dose reconstruction, recommends using NCRP 38 (1971) 

methodologies, which is a point source equation and which NIOSH acknowledges has an order 

of magnitude uncertainty. It is unclear how such uncertainties may be magnified in the context 

of devising methods for an entire class of workers and whether the resultant dose estimates might 

still qualify as having the “sufficient accuracy” required under 42 CFR 83. Further, the shielding 

data in NRCP 38 appear to have limited value and/or applicability to the highly restricted 

condition of a single point source. 

Section 3.3.4 of OCAS-IG-001 briefly summarizes current DOE practices for controlling 

radiological contamination, and recommends the use of these limits for dose reconstruction. 

However, the use of current practices has limited validity for historical dose reconstruction. 

Further, the reference to the “three levels of radiological contamination postings/contamination 

control checkpoints” has a limited relationship to external dose rates. 

SC&A’s evaluation of the cited sections of OCAS-IG-001 indicates that it is unlikely that 

guidance currently provided will, by itself, yield dose estimates with sufficient accuracy, as 

mandated under §83.13. The use of external dose guidelines must be complemented by the use 

of completed or partial dose reconstructions that have been selected for relevance to the 

evaluation of the SEC petition, as discussed above. 

5.10.2 Internal Dose Guidelines OCAS-IG-002 

Guidelines for internal dose reconstruction in OCAS-PR-004 are limited to a reference to 

Section 5.3 of OCAS-IG-002 (Source Term Evaluation), which provides only a few brief 

statements, including the following: 

... without bioassay or air sample data, the last resort is to attempt a 

determination of the airborne concentrations ... in the individual’s breathing 

zone ... using source term evaluations. [Emphasis added.] 

Determination of internal doses that may result from the inhalation of airborne contaminant(s) 

requires the need to define critical parameters, including area ventilation rate/resuspension 

factors, chemical form/solubility of airborne contaminants, particle size, breathing rates, duration 

of exposure, etc. In brief, Section 5.3 addresses none of these issues and provides little guidance 

for deriving internal doses with “sufficient accuracy” from source term data that would satisfy 

the regulatory requirements of 42 CFR 83.13 for any member of the proposed class. 

Some issues relating to internal dose are particular to consideration of SEC petitions; for 

instance, when they involve defining plausible circumstances for maximum dose estimation. For 

instance, doses from large hot particles to the gastrointestinal tract may be important in some 

evaluations. This is not discussed in OCAS-IG-002 or in OCAS-PR-004. 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 32 of 35 

As another example, the importance of a complete radionuclide list and complete job types for 

the members of the class is often more critical for internal dose, since explicit monitoring is 

required to detect them and apply the appropriate dose conversion factors. In contrast, if the 

members of a class or sufficiently representative sub-groups of the class had adequate 

monitoring for photons, beta radiation, and neutrons, the specific radionuclide lists are not as 

crucial for external dose estimation. The importance of this issue was illustrated in the various 

approaches suggested by NIOSH for dose reconstruction for the 1949–1957 SEC class at 

Mallinckrodt. It is also a significant issue for some groups of workers at Y-12. While site 

profiles and individual dose reconstructions can be selective in the issues and radionuclides that 

they address at any particular time, with elaboration reserved for the future, such an option is not 

available for any significant length of time for SEC petition evaluations. In the absence of 

monitoring data for specific radionuclides, bounding approaches have to be developed. This 

poses considerable challenges as was demonstrated in the case of the development of methods 

for the 1949-1957 Mallinckrodt class (see Attachments to SC&A 2005b). 

In summary, as with the external dose guidelines, the internal dose guidelines in OCAS-IG-002 

must be complemented by the use of relevant completed or partial dose reconstructions in order 

to demonstrate the feasibility of dose estimation with sufficient accuracy for all members of the 

proposed SEC class. 

5.11 Issue 11: SEC Petition Evaluation Plan 

NIOSH is required to present its plan for evaluating an SEC petition to the Board once NIOSH 

has determined that a petition is qualified for evaluation (42 CFR 83.12(c)). The procedures 

state that the Board will be provided with such a plan, but do not contain any details of what 

would be provided. They also do not contain any provision for updating the information 

provided to the Board as NIOSH increases and/or changes the kinds of data, documents, and 

other information that it may bring to bear on the evaluation process. 

5.12 Issue 12: Definition of the Class under 42 CFR 83.14 

If NIOSH determines that it cannot do a dose reconstruction and requests a claimant to file 

Form A to initiate inclusion in a SEC, a corresponding class of petitioners must be defined, if 

that has not already been done. NIOSH proposes to use 42 CFR 83.13 to do this. However, the 

NIOSH SEC procedures provide no guidance or checklist to be followed in defining the class 

and reaching potential class members. 

5.13 Issue 13: Site-Specific Data 

42 CFR 83 requires that “a dose reconstruction must, as a starting point, be based on some 

information from the site where the employee worked” (42 CFR 83.13(c)(1)). This could be a 

potentially significant constraint, since it specifies that site-specific data should be the starting 

point, and that it should form part of the basis of the dose reconstruction methods proposed for 

members of the class. While the regulation allows NIOSH to use information from other sites 

liberally, the constraints in the rule would appear to require some elaboration in the NIOSH 

procedures. This is needed for some consistency across site profiles. 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 33 of 35 

5.14 Miscellaneous Comments on OCAS-PR-004 

(1) NIOSH states that it focuses its evaluation on the specific issues raised in the petition; 

this is appropriate for timeliness. But, if the petition is rejected for a technical (not 

procedural) reason, NIOSH is, in effect, certifying that it is able to do dose reconstruction 

for the entire class. Hence, an explicit process and checklist to ensure that the relevant 

aspects of dose reconstruction have been taken into account would be helpful. Such a 

checklist might be developed, at least in part, from the findings above and the suggestions 

for improvement provided in this review, as well as from that material already in OCASPR-004. 

(2) The phrase “at least one petitioner cannot be verified” is confusing. NIOSH might 

consider changing it to "one or more petitioners cannot be verified.” 

(3) Section 6.1.3.3 on page 5 refers to "processes" included in the class definition. However, 

"processes" are not mentioned in either 42 CFR 83.9 or the Petition Form B (though 

“process” is mentioned in 42 CFR 83.13(c)(1)(i)). This item would be clearer if the term 

“processes” were related to the term “job types.” 

(4) In Section 6.1.5.1.3 on page 9, General Accounting Office should be changed to 

Government Accountability Office.
 

(5) In Section 6.1.9 on page 10, the words "who were not involved in developing the 

proposed finding" should appear after "HHS personnel." 

(6) In Section 6.1.10 on page 10, 31 days should be changed to 30 days. 

(7) In Section 6.3.11.2 on page 19, the words "was likely" should be changed to "could 

possibly.” 

(8) In Section 6.4.4 on page 22, 6.2 should be changed to 6.3. 

(9) In Appendix B on pages 33 and 34, the calibration of monitors and the functionality of 

monitors, in so far as these aspects might affect the feasibility of dose reconstruction with 

sufficient accuracy, should be mentioned (see also a similar comment for Form B). 

(10) A separate line item in the summary sheet of the petition evaluation report for each class 

discussed in the report would be helpful. The current form is confusing when there are 

different actions for different classes discussed in the same evaluation report. 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 34 of 35 

REFERENCES 

42 CFR 82. Methods for Radiation Dose Reconstruction Under the Energy Employees 

Occupational Illness Compensation Program Act of 2000; Final Rule, Department of Health and 

Human Services, Federal Register, Vol. 67, No. 85, May 2, 2002, pp. 22314-22336. 

42 CFR 83. Procedures for Designating Classes of Employees as Members of the Special 

Exposure Cohort Under the Energy Employees Occupational Illness Compensation Program Act 

of 2000; Final Rule, Department of Health and Human Services, Federal Register, Vol. 69, No. 

104, May 28, 2004, pp. 30764-30786. 

ABRWH 2004. Transcript of the Twenty-seventh meeting of the Advisory Board on Radiation 

and Worker Health held at the Doubletree Club Hotel, Livermore, California, Second Day 

Transcript, December 14, 2004. 

NCRP 38 (1971). Protection Against Neutron Radiation, NCRP Publications, Bethesda, 

Maryland, 1971. 

OCAS-IG-001. External Dose Implementation Guideline, Rev. 01, National Institute of 

Occupational Safety and Health, Office of Compensation Analysis and Support, October 2002. 

OCAS-IG-002. Internal Dose Implementation Guideline, Rev. 0, National Institute of 

Occupational Safety and Health, Office of Compensation Analysis and Support, August 2002. 

OCAS-PR-004. Internal Procedures for the Evaluation of Special Exposure Cohort Petitions, 

OCAS-PR-004, Rev. 0, National Institute of Occupational Safety and Health, Office of 

Compensation Analysis and Support, 9/23/2004. 

ORAUT-OTIB-0002 2004. Maximum Internal Dose Estimates for Certain DOE Complex 

Claims, Oak Ridge Associated Universities, ORAUT-OTIB-0002, Rev. 01, January 10, 2004. 

ORAUT-OTIB-0004 2003. Technical Basis for Estimating the Maximum Plausible Dose to 

Workers at Atomic Weapons Employer Facilities, Oak Ridge Associated Universities, ORAUTOTIB-0004, Rev. 02, December 4, 2003. 

SC&A 2005. Supplemental Review of the NIOSH Site Profile for Mallinckrodt Chemical 

Company, St. Louis, Downtown Site, St. Louis MO, SCA-TR-TASK1-0002, S. Cohen & 

Associates, McLean, Virginia. April 18, 2005. 

SC&A 2005a. Second Supplemental Review of the NIOSH Site Profile for Mallinckrodt 

Chemical Company, St. Louis, Downtown Site, St. Louis MO, SCA-TR-TASK1-0002, S. Cohen 

& Associates, McLean, Virginia. July 1, 2005. 

SC&A 2005b. Third Supplemental Review of the NIOSH Site Profile for Mallinckrodt Chemical 

Company, St. Louis, Downtown Site, St. Louis MO, SCA-TR-TASK1-0002, S. Cohen & 

Associates, McLean, Virginia. August 16, 2005. 
 

Effective Date: 

November 23, 2005 

Revision No. 

 0 (Draft) 

Document No. 

SCA-TR-TASK5-0001 

Page No. 

 35 of 35 

SC&A 2005c. Review of NIOSH Site Profile for the Atomic Energy Operations at the Iowa Army 

Ammunition Plant (IAAP) Final Integrated Version, SCA-TR-TASK1-0009c, S. Cohen & 

Associates, McLean, Virginia. June 2005. 

SC&A 2005d. The Review of NIOSH/ORAUT Procedures and Methods Used for Dose 

Reconstruction, Report, SCA-TR-Task3-0001, S. Cohen & Associates, McLean, Virginia. 

SC&A 2005e. Review of NIOSH Site Profile for Bethlehem Steel Plant, Lackawanna, NY, SCATR-TASK1-0001, S. Cohen & Associates, McLean, Virginia. October 2004.