Comments of the Government Accountability Project Page 4 of 8

GAP believes that it is important to look at all source of employment information and radiation
exposure date (source term, other employees exposure data, process information, bioassay
analysis methods and modifications, etc.) for a given facility to get the best understanding of
what actually occurred 10 to 60 years earlier. Information regarding radiation incidents,
occurrences, and other unusual situations should also be included in the claims packet. NIOSH
should include information regarding work restrictions, which would include programmatic
information on how work was restricted and what the restriction meant at a given facility, as well
as, data on individuals work restrictions. NIOSH should also include exposures to medical staff
from the medical screening process.

Section 82.10 also states that NIOSH “may compile data and information from NIOSH records
that contribute to the dose reconstruction.” GAP believes NIOSH must use all available data not
just what DOE provides or what they feel is sufficient. Other sections of the regulation seem to
suggest a broader vision of what data will be included (see 82.10 (e)) creating a significant
ambiguity in what to expect for the compilation of data.

Section 82.10(h) requires “certification from DOE that record searches have been completed”
for a claim to go forward. DOE field people have their pre-conceived ideas of what data NIOSH
will need and not need to do their job. It is critical that NIOSH and/or their contractors
understand initially what data is available, and not rely solely on DOE field office guidance.
NIOSH has great experience in this area, but also needs to have some kind of direct check or
review of this process. Furthermore, NIOSH should include stronger in this section to encourage
DOE to cooperate. Such language may state that “NIOSH will request that DOE provide all
applicable records or access to all records potentially related to radiation dose reconstruction in a
timely and efficient manner. If DOE fails to provide adequate documentation the dose
reconstruction process will proceed based on the assumption that the employee's evidence,
including testimony, is correct.”

Additionally, the provision in 82.10(e) that the evidence be "reasonably, supported by substantial
evidence and not refuted by other evidence" unfairly favors the evidence of the DOE and DOE's
contractors against the evidence of the claimant. The rule should state that when the evidence is
contradictory, but of equal weight, the benefit of the doubt-should go to the claimant. The clause
"not refuted by other evidence” should be stricken as all together.

2. Denial of Dose Reconstruction

Both Sections 82.12 and 82.10 provide, in one way or another, that if the evidence is non-
existent or insufficient (based on worst case assumptions) NIOSH can deny dose reconstruction
and/or send information to DOL denying claim. Although GAP understands NIOSH's desire to
expedite the process and filter out cases that are clearly ineligible, there are nonetheless several
problems with these provisions. First, DOL's initial screening procedure has already filtered out
frivolous claims. It is unnecessary for NIOSH's rule to provide for such extensive and
ambiguous denial authority. Second, the NIOSH rule does not clarify when exactly there is a
lack of "adequate information" or what "extremely unlikely to produce a compensable level of


Comments of the Government Accountability Project Page 7 of 8

H. Section 82.18 How will NIOSH calculate internal dose to the primary cancer site(s)?

Again, in determining the effect of internal dose in relationship to the primary cancer site NIOSH
should considered all of the relevant data. It would be inappropriate to use isolated bits of data
to determine a given dose and later justify that determination. Where bioassay data are
unavailable, NIOSH should not simply rely on air monitoring data when completing dose
reconstruction. Data regarding source term, process knowledge, external contamination levels,
etc., should be considered when available. Additionally, NIOSH should allow individual
specific models if available data supports — rather than just relying on ICRP data.

The phrase in Section 82.18(b) stating that “when NIOSH cannot establish exposure conditions
with sufficient specificity, the dose calculation will assume exposure condition that maximize the
dose to the organ under consideration" is ambiguous and could create potentially unfair results.
At what point does NIOSH decide that the dose determination cannot be completed? At what
point are the estimates too uncertain to complete a “reasonable estimate?”

Methods of interpreting data will be based on numerous assumptions, including protracted and
acute exposures, therefore exposures calculated for a given year are unlikely to represent reality.
Additionally, only having bioassay results every six months can make it very difficult to
determine annual doses. NIOSH should ascertain the exposure for the purpose of PC
determination to some date that is not necessarily 50 years old. This can be done without
estimating annual doses. The error associated with any given year's calculated dose will be
typically significantly higher than that associated with the overall assessment, and could be the
basis for significant disagreement in dose determinations. The resulting arguments will not serve
anyone and this extraneous and non-meaningful requirement should be eliminated.

I. Section 82.19 How will NIOSH address uncertainty about dose levels?

Annual uncertainty is not a useful concept for these historical internal dose assessments. Often
assumptions of chronic exposures are used to characterize’a series of acute intake. Relatively
small exposures in a given year may not be directly accounted for and early data is sometimes
over or underestimated to allow for a best fit to the data with simplifying assumptions. While the
concept of uncertainty is certainly important and the uncertainty of these assessments should be
characterized, it should be characterized over the period of interest. Typically the period of
interest should be at least 5 years but may be more than 20, 30 or 50 years in some cases.

This section must outline how the uncertainty in dose will be determined and define “reasonable
certainty” as outlined in the statute. This section should answer three fundamental questions
namely:

1. Which uncertainties will NIOSH will account for (i.e. uncertainties concerning
particle size, solubility, chemical yields, calibration error, biokentic models,
laboratory methods, failure to follow proper bioassay protocols, and failure to
monitor for specific isotopes)?


Comments of the Government Accountability Project Page 3 of 8

Section 82.2(c) states that “if neither adequate worker nor workplace monitoring data are
available, the dose reconstruction may rely substantially on process description information to
analytically develop an exposure model." GAP believes that it is also important to consider
process information and source term information as outlined in Section 82.2(a) and (b). There
are cases where monitoring is adequate for some internal exposures or external exposures but not
for both (i.e. the Paducah transuranics question). Additionally, understanding the process and
source term is important in order to realistically assess the data. For example, increasing and
then decreasing Pu results are assumed to be a chronic exposure, when in reality they represent
an acute exposure to Pu-238 oxide. The determination that the exposure is more likely acute
comes from Radiation Work Restriction documentation and incident/occurrence reports, as well
as knowledge of the actual composition of the source term. This could be completely
misinterpreted if that data was not reviewed along with the bioassay data for the individual.

Additionally, NIOSH does not specify when or how it decides that a reasonable estimate of dose
can not be made. The EEOIPCA states that NIOSH shall “establish by regulation methods for
arriving at reasonable estimates of the radiation doses received by an individual ....” GAP
believes that this phrase as used in the EEOICPA is of sufficient importance to require a clear
definition within the regulations.

B. Section 82.3 What are the requirements for dose reconstruction under the EEOICPA?

The proposed rule lists the three groups of individuals requiring dose reconstruction as stated in
Section 3623(d) of the EEOICPA. Although the EEOICPA lists only these three groups of
employees, GAP believes that it is important to remain open to employees which do not
necessarily fit within these specific groups. The rule should broadly define the statutory
provisions to potentially include all individuals who are filing for compensation for a radiation
related cancer.

C. Section 82.5 Definitions of Terms Used in this Rule.

The definition of "uncertainty distribution” is unclear. Specifically, the type of distribution is not
specified, nor a statement as to how NIOSH will determine the distribution around the central
estimate (see comment to Section 82.19 below).

D. Section 82.10 and 82.12 of the Dose Reconstruction Process

Sections 82.10 through 82.12 state the general procedure for dose reconstruction, as well as
determining what claims will receive dose reconstruction. GAP has several concerns about this
section which can be divided into two general themes, information and denial of dose
reconstruction.

1. Information


Comments of the Government Accountability Project Page 5 of 8

radiation dose" means. It is unfair that NIOSH is able to validate these denials based on such
flexible standards, while approvals have to adhere to such rigorous scientific review. Third,
these provision are inconsistent with Sections 82.16 and 82.17 remedying the lack of information
for claims. NIOSH does not state how these sections relate to one another and what claims will
be eligible for remedy while other claims are denied.

NIOSH should create a standardized process which all claims go through initially and if upon
completion of the initial review it is extremely likely that the claim will succeed or fail dose
reconstruction, only then NIOSH should have the authority to approve or deny the claim. Ifthe
evidence remains uncertain, then NIOSH should conduct further research. The initial review
should consist of the completion of a standardized form, listing all the sources of relevant
information (specified in section 82.14), whether that information exists, and what that
information says. The reviewer should fill out the form, contacting DOE and the claimant,
gathering the information and listing the information on the form. This form could be completed
in a short period of time, no more than 60 days. If the claim is initially denied, it would have to
be denied within this 60-day period, subject to and based upon the completion of the form. The
benefit of this form is two-fold: first, it standardizes the procedure for the initial denial or
approval of dose reconstruction, and second it allows for time constraints on the process.

3. Additional considerations

Under Section 82.10(i), NIOSH will assess the effect of non-uniformity and geometry for
external exposures. This could be a formidable task and needs further clarification.

Under Section 82.10(j), NOSH should use the word "assigned" or "ascribed" rather than the
word "imputed."

Imposing time limitations on dose reconstruction is difficult because of the complex nature of
does reconstruction. If NIOSH created a two-step dose reconstruction process there could be
two time limitations allowing for some flexibility and some reassurance for claimants. The
initial time limitation of 60 days for the initial review and a longer period of no more than 180
days or a year.

E. Section 82.14 What types of information could be used in dose reconstruction?

Section 82.14 lists all the relevant information to be used in dose reconstruction. Although we
addressed some concerns about information in the previous sections, it is important to include
the following pieces of information:

Blood results;

Reports documenting unusual circumstances and associated related data;
Information regarding in vivo detection limits;

Information regarding locations of air sampling heads for both workplace and BZA
samplers;

Redr


Comments of the Government Accountability Project Page 8 of 8

2. What is the acceptable standard error around the mean and how wide of an
uncertainty measure will NIOSH accept?

3. At what point is dose no longer reasonable because the error is so large relative to the
mean?

GAP believes that the answer to these questions are fundamental to the effectiveness of the
program and we do not want to leave it to a private contractor to determine the range of
uncertainty. These questions should be answer by regulation, a politically accountable
mechanism.

J. Section 82.26 How will NIOSH report dose reconstruction results?

Section 82.26(b)(2) states that a dose reconstruction report will include "separate dose estimates
for acute and chronic exposures..." As noted above, because of the need for simplifying
assumptions to assess historical bioassay data, the importance of providing separate realistic dose
estimates for acute and chronic exposures is negated and has little meaning in reality. In the end,
NIOSH should consider the total dose to a specified tissue for some relevant time period of time.
The importance of acute and chronic exposures is only meaningful in terms of modeling the data,
not in terms of reporting the actual truth, which is an unknown.

Additionally, the language of Section 82.26(b)(2) creates the impression that separate estimates
for each radiation type, and exposure pathway and exposure period are required. This distinction
is somewhat arbitrary. There is no reason as to why the dose from alphas plus x-rays cannot be
combined or why it would be necessary to report these separately, especially in the case of
internal dose.

Under Section 82.26(b)(3) it is unclear as to how the words "as necessary" will be interpreted in
association with determining when an uncertainty distribution must be performed for a given
dose estimate. This phrase needs additional clarification.

K. Additional Considerations

NIOSH's rule should provide for review of a certain percentage of cases by the Advisory Board
on Radiation and Worker Health.

In the event that a claim is denied dose reconstruction process due to lack of data, NOISH should
file the claim for Special Exposure Cohort status as a default rule. Such a rule will come at
minimal expense to NIOSH and will remedy the denial in the most equitable fashion.


Miller, Diane M.
——

From: frank morales [frankmorales@yahoo.com]

Sent: Monday, November 05, 2001 6:18 PM

To: NIOCINDOCKET@CDC.GOV .

Subject: Comments of the Government Accountability Project on the NIOSH Proposed Rule (42 CFR
Part 82)

fre] 7}
GAP's NIOSH

Comments.doc
Dear Mr. Elliot,

The Government Accountability Project respectfully
submits these attached comments on NIOSH's proposed
rule "Methods for Radiation Dose Reconstruction Under
the Energy Employees Occupational Illness Compensation
Program Act of 2000" (42 CFR Part 81). We are

thankful for this opportunity to comment and hope that
you will find our comments useful in the promulgation
and review of your final rule.

We will send you a hard through the mail, in addition
to this electronic copy. If you have any questions or
concerns feel free to contact us.

The Government Accountability Project
1612 K. Street, NW

Suite 400

Washington DC 20006

T: 202-408-0034

F: 202-408-9855

Sincerely,

Louis Clark
Executive Director

Do You Yahoo!?
Find a job, post your resume.
http://careers.yahoo.com


Comments of the Government Accountability Project Page 6 of 8

Information regarding particle sizes;

Airflow patterns in relation to locations (3D) of the sampling heads;

Information regarding facility specific interpretation of air monitoring data (i.e.
sample flow rate, filter type, filter size, collection efficiency, dustiness of
environment, frequency of filter change, filter analysis method(s), etc.); and

8. Information regarding physical forms (e.g., solid, particulate, solution, vapors, etc.)

nay

Additionally, there has been much debate on what historical detection limits might have been for
the early bioassay programs and how to determine such detection limits (examples: no
background recorded, no negative values recorded, no count times, no chemical recovery data
recorded, thus you can not calculate the detection limits) (see Section 82.14(d)(3)). There are
examples of procedures suggesting longer count times than were actually used. Resolving this
inconsistency can be a very complicated process and may result in necessitating the “selection”
of a “conservative” estimate of the detection limit.

F. Section 82.16 How will NIOSH add to monitoring data to remedy limitations of
individual monitoring and missing dose?

Section 82.16 states that "for monitoring periods where external dosimetry data are missing from
the records, NIOSH will estimate a claimant's dose based on interpolation..." The
determination of what constitutes a "missing" dose is a difficult and needs further explanation.
Also NIOSH should consider why the data is missing and if the individual was involved in any
kind of accident or special work which may have resulted in greater dose than would be assigned
if “normal tasks” were assumed.

NIOSH should also make sure that sample collection practices are examined and that actual
practices, not just those described in procedural documents, are considered while interpreting the
data. NIOSH should verify this data because employees reports at all DOE sites state that
“according to procedures we were supposed to do it one way but what really happened was
different.” (See DOE Portsmouth, K-25 and Paducah investigation reports)

The use of the words "missed dose," as used in Section 82.16(b) has many connotations and
should avoided. Also, for internal doses, in many cases, the minimum detectable dose cannot be
simply added for.the monitoring periods to determine an upper limit for an extended period. The
minimum detectable dose should be based on the actual data available. For example a
radionuclide exposure measured using urinalysis may have a MDD of 3 rem per quarter but that
does not necessarily mean that there would be an annual MDD of 12 rem.

G. Section 82.17 What types of information could be used to supplement or substitute for
individual monitoring data?

‘The words "and radioactivity" or "and radioactive contamination" should be inserted between
"radiation" and "survey" to read: "general area radiation and radioactive contamination survey
survey’ gs
results, air sampling data; or,... ."


COMMENTS OF
THE GOVERNMENT ACCOUNTABILITY PROJECT

ON
THE DEPARTMENT OF HEALTH AND HUMAN SERVICES' PROPOSED RULES

"GUIDELINES FOR DETERMINING THE PROBABILITY OF CAUSATION UNDER THE
ENERGY EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT
OF 2000"

(42 CFR Part 81)

AND

"METHODS FOR RADIATION DOSE RECONSTRUCTION UNDER THE ENERGY
EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT OF 2000"
(42 CFR Part 82)

OCTOBER 5, 2001

1 INTRODUCTION

A. Overview of the Government Accountability Project-- The Government Accountability
Project (GAP) is a non-profit law firm and public interest organization which represents the
interests of workers who have suffered retaliation for raising concerns about the workplace.
We advocate on behalf of groups of workers interested in the enforcement of safety and
health standards and specific acts of individual whistleblowing. GAP has a nearly thirty-year
history defending workers who raise health and safety concerns, either to an enforcement
agency or as part of filing a claim for compensation. GAP has developed a program to track,
educate and advocate on issues related to the implementation of the EEOICPA. GAP has
offices in Washington, D.C. and Seattle, WA.



Comments of the Government Accountability Project Page 2 of 8

B. Statement of Purpose-- The purpose of these comments is to address our concerns about
the National Institution of Occupational Safety and Health's (NIOSH) proposed regulations
on select provisions of the Energy Employees Occupational Illness Compensation Program
Act of 2000 (EEOICPA). The EEOICPA is an essential first step to ensuring that the men
and women who dedicated their lives to the defense of our nation during the Cold War are
adequately and equitably compensated for the injuries they suffered during their employment
in DOE facilities.

Section 3623 (c) of the EEOICPA requires the promulgation of guidelines for the purpose
of determining whether a cancer sustained in the performance of day "was at least as likely as
not related to employment." Specifically, the EEOICPA states that such guidelines must: (1)
"be based on the radiation dose received by the employee... at such facility and the upper 99
percent confidence interval of the probability of causation in the radioepidemiological tables
published under section 7(b) of the Orphan Drug Act," (2) incorporate specific methods of
dose reconstruction for employees who were not monitored, monitored inadequately, or
whose records are incomplete, and (3) "take into consideration the type of cancer, past health
related activities (such as smoking), information on the risk of developing radiation-related
cancer from the workplace exposure, and other relevant factors." Our comments focus solely
on NIOSH proposed 42 CFR Part 82 concerning the method of dose reconstruction.

Il. THE PROPOSED RULE "METHODS FOR RADIATION DOSE RECONSTRUCTION
UNDER THE ENERGY EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION
PROGRAM ACT OF 2000" (42 CFR PART 82)

A. Section 82.2 What are the basics of dose reconstruction?

Section 82.2 of the proposed rule states that "the basic principle of dose reconstruction is to
characterize the radiation environments to which workers were exposed and to then place each
worker in time and space within this exposure environment.” GAP supports NIOSH's approach
and believes this is a reasonable method, however, NIOSH's should be closely analyzed all of its
data in conjunction with the assessment of personal monitoring records, rather than analyzing
each piece of data separately.

Section 82.2(a) states that “if found to be complete and adequate individual worker monitoring
bioassay sample results, are given the highest priority in assessing exposure. NIOSH will
interpret this monitoring data using additional data characterizing the workplace radiation
exposures.” There is clear evidence from various studies of workplace monitoring as well as
congressional testimony that workers were inadequately monitored. The EEOICPA expresses
this concern by incorporating into Section 3623(d) requirements for the consideration of
inadequately monitored or record employees. GAP believes that all data should be considered
and weighted based on site or individual specific cases, rather than creating a hierarchical
method of data consideration.