EEOICPA BULLETIN NO. 03-23

EEOICPA BULLETIN NO.03-23

Issue Date: May 2, 2003

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Effective Date: May 2, 2003

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Expiration Date: May 3, 2004

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Subject: Review of Dose Reconstruction in the Final Adjudication Branch Hearing Process

Background: 20 CFR 30.318(a) provides for the review by the Final Adjudication Branch (FAB) of any objections raised by the claimant related to the factual findings upon which NIOSH based its dose reconstruction. If these factual findings are not supported by substantial evidence, the case must be remanded to the district office for referral to NIOSH.

The first sentence of 20 CFR 30.318(b) provides that the methodology NIOSH uses in making radiation dose estimates, established by regulations issued by HHS at 42 CFR 82, is "binding on the FAB." Dose reconstruction is considered to be the "methodology" defined herein. Some of that "methodology" is dictated by 42 U.S.C. 7384n(c) and (d). For example, NIOSH dose reconstruction methods must "be based on the radiation dose received by the employee (or a group of employees performing similar work) . . . and the upper 99 percent confidence interval of the probability of causation in the radioepidemiological tables published under the . . . Orphan Drug Act." The Act also requires NIOSH to consider the type of cancer, past health-related activities (such as smoking), and information on the risk of developing a radiation-related cancer from workplace exposure.

The "methods" of dose reconstruction are set out in 42 CFR Part 82 and include: analyzing specific characteristics of the monitoring procedures in a given work setting; identifying events or processes that were unmonitored; identifying the types and quantities of radioactive materials involved; evaluating production processes and safety procedures; applying certain assumptions that err reasonably on the side of overestimating exposures while achieving efficiency; and using current models for calculating internal dose published by the International Commission on Radiological Protection (ICRP). The NIOSH "efficiency" process of using overestimates and underestimates in dose reconstruction is another example of a methodology. It is these "methods" that cannot be addressed by FAB.

A separate issue from methodology (discussed above) is addressed in the second sentence of 20 CFR 30.318(b), namely "application." This portion of the rule notes that a claimant may present arguments to the FAB that NIOSH made an error in applying the radiation dose estimate methods to his or her individual circumstances. The rule grants the FAB authority to address issues concerning application. Some examples of application include: did NIOSH identify all sources of exposure to the worker; were the air samples chosen to represent the air breathed by the worker appropriate; is the group of co-workers appropriate for determining exposure to the worker; and are appropriate assumptions made about the particular physical or chemical form of radioactive material that was used in the facility where the employee worked and its solubility class. Another application issue might involve the use of the "worst case" approach (which is a NIOSH method). The application aspect of this issue might be whether the "worst case" selected, i.e., the case that provides for the highest radiation dose, was indeed the worst case.

A meeting between DOL and NIOSH management was held in Cincinnati, OH, on November 13 – 14, 2002. The primary topic of discussion was the DOL – NIOSH approach to handling objections to recommended decisions that involve technical issues related to NIOSH dose reconstructions. The actions described below are the product of those deliberations and subsequent discussions between DOL and NIOSH.

Training for district office staff and FAB staff was provided by the DEEOIC Health Physicist as part of the NIOSH training conducted in the National and District Offices in January and the FAB training in February 2003.

Reference: Energy Employees Occupational Illness Compensation Program Act of 2000, 42 U.S.C. § 7384n(c) and (d); final rule 20 CFR § 30.318; and 42 CFR Part 82.

Purpose: To provide procedures for FAB review of claimant objections to NIOSH dose reconstruction decisions.

Applicability: FAB staff and DEEOIC Health Physicist.

Actions:

1. The DEEOIC Health Physicist serves as the central liaison between NIOSH and DOL on all dose reconstruction related issues. All objections that come to the Final Adjudication Branch (FAB), that are related to dose reconstruction, must be forwarded to the DEEOIC Health Physicist for review, except as noted in Item 2. This process of consulting the DEEOIC Health Physicist occurs for every case in which a claimant provides objections to matters involving dose reconstruction (at least initially, until further notice).

2. After a recommended decision has been issued, the claimant may submit written objections and request a review of the written record (RWR) or hearing. When a FAB representative reviews the objections to a dose reconstruction, he/she will note that the objection involves dose reconstruction. The Hearing Representative (HR)/CE will review the claimant’s objections and first determine whether the objections are solely related to factual findings, i.e., whether the facts upon which the dose reconstruction report was based were correct. This is the only determination the HR/CE may make on his/her own. If the HR/CE determines, after the hearing or the RWR, that the factual evidence reviewed by NIOSH was properly addressed, the HR/CE will accept NIOSH’s findings (no referral to the DEEOIC Health Physicist is necessary). If the HR/CE determines that there is substantial factual evidence that was not reviewed by NIOSH, he/she remands the case to the DO for referral to NIOSH for review (no referral to the DEEOIC Health Physicist is necessary). Hearing representatives will NOT determine on their own whether an objection addresses methodology or application. The DEEOIC Health Physicist will make this determination.

Once the HR/CE identifies a technical objection involving methodology or application, either before or after the hearing or through the RWR, he or she must send the technical objection and associated information to the DEEOIC Health Physicist. The DEEOIC Health Physicist reviews the objections and the case. He will then determine whether the objections raised are objections as to factual findings, application or methodology. As part of his review, he will refer pertinent parts of the case and the objections (in writing with specific questions) to NIOSH for their opinion on the objections. Any response from the NIOSH Office of Compensation Analysis and Support (OCAS) to the DEEOIC Health Physicist will be in writing and represent NIOSH’s overall opinion on the issues presented. NIOSH will be requested to respond to DOL’s inquiries within 30 days of the date they receive the inquiry.

The DEEOIC Health Physicist then forwards the case and his opinion (and NIOSH’s opinion, if any) to the FAB. The DEEOIC Health Physicist’s opinion and the NIOSH response will NOT be given to the claimants with the final decision (but would be available from the case file).

If none of the objections are deemed plausible by the DEEOIC Health Physicist, the hearing representative incorporates the DEEOIC Health Physicist’s findings on these technical issues into the final decision.

If there are any objections to dose reconstruction related to the factual findings the DEEOIC Health Physicist determines to be unsupported by substantial evidence or to an application of methodology issue that should be considered by NIOSH, he notifies the FAB hearing representative and the case is remanded to the district office with instructions to refer back to NIOSH. In most cases, NIOSH will perform a new dose reconstruction (based on the circumstances of the remand). Remanded cases will more than likely contain new facts that were not previously reviewed in the case by NIOSH.

When a particular objection is directed at NIOSH’s methodology, the hearing representative will state in the decision that, based on 20 CFR § 30.318(b), this issue cannot be addressed. However, the hearing representative will only make this statement if so advised by the DEEOIC Health Physicist.

The hearing representative includes a discussion in the remand order of the facts of the case. The hearing representative also includes a separate document for the claims examiner (CE) to forward to NIOSH. This document contains the list of questions to be addressed by NIOSH. The CE prepares a cover letter to forward the FAB questions to NIOSH.

No time frame is imposed on NIOSH regarding how long it will take to return remanded cases (given that a new dose reconstruction may be required).

The DEEOIC Health Physicist tracks trends with regard to the types of objections received, and notifies NIOSH of these trends as necessary. The trends provided to NIOSH include the type of issues raised, case numbers, names, SSN, etc.

Disposition: Retain until incorporated in the Federal (EEOICPA) Procedure Manual

PETER M. TURCIC

Director, Division of Energy Employees

Occupational Illness Compensation

Distribution List No. 1: Claims Examiners, Supervisory Claims Examiners, Technical Assistants, Customer Service Representatives, Fiscal Officers, FAB District Managers, Operation Chiefs, Hearing Representatives, District Office Mail & File Sections

Distribution List No. 4: FAB National Office & Regional FAB Units

Distribution List No. 6: Regional Directors, District Directors, Assistant District Directors, National Office Staff