Comments of PACE Local 5-4200 on HHS Special Cohort Rule Page 4 of 9
May 3, 2003
sufficient information to estimate the maximum radiation dose that could have been
incurred in plausible circumstances by any member of the class.”

First, the rule should define what the term “plausible circumstances” means. And
what it doesn’t mean. Simply saying that this term will be applied on a case-by-case
basis is not adequate. Substituting one vague term (“sufficient accuracy”) in the statute
with another vague term (“plausible circumstances”) in the rule, does not meet the
minimal requirements of a rule giving effect to a statute and offers no clear basis for
assuring NIOSH will achieve consistency from case-to-case.

Second, the rule should define what “sufficient information” means. (a) What is the
minimum amount and type of information needed to “cap the dose.” (b) Is there a
checklist or some other methods that can provide a basis for qualitative judgment that
there is not “sufficient data” to “cap the dose”? For example, if workers moved between
multiple process buildings, such as maintenance workers or security guards, and there is
no valid personal monitoring data, how will NIOSH know whether or not it can cap the
dose for this class of workers? (c) What methods will be allowed or disallowed in
determining whether NIOSH fairly “capped the dose,” (d) What test will be applied to
determine whether NIOSH improperly underestimated maximum potential dose? Simply
saying that NIOSH will decide these questions on a case-by-case basis is not adequate,
and offers no clear basis for assuring that NIOSH will achieve consistency from case-to-
case.

Third, we are concerned that claimants could fall into a regulatory void between
NIOSH's proposed Special Exposure Cohort rule and NIOSH's existing dose
reconstruction rule (42 CFR 82). Under the proposed rule, SEC petitions would be
dismissed if there is enough data for “to estimate maximum potential dose.” However,
these claims could also be dismissed under the dose reconstruction rule because “worst
case” estimates are only allowable at 42 CFR 82.10(k) as part of an “efficiency”
mechanism if the dose falls below the 50 percent probability of causation. What is not
clear is what happens to claimants where the worst case estimates exceed 50 percent
probability of causation? Do they fall into a void?

The Preamble to the dose reconstruction rule at 67 FR 22325 suggests that using
a worst case estimate will be “difficult” and “the ability of NIOSH to complete dose
reconstruction depends on extent and quality of information available to substitute for
monitoring data.” It states:

"Simplifying assumptions (e.g., worst case) become more difficult to apply,
however, when the potential level of radiation for individual ranges greatly,
particularly when they range from low levels to potentially compensable
levels... In these circumstances, the ability of NIOSH to complete dose
reconstruction depends on extent and quality of information available to
Substitute for monitoring data..."


Comments of PACE 5-4200 on HHS Special Cohort Rule Page 9 of 9
May 5, 2003

Or will there be an independent review within HHS? We recommend that an independent

review be provided. What rules of procedure will be used? Will such appeals allow for

oral presentations by petitioners? Will hearings allow for presentations by experts in

support of a petition? Will the entire administrative record involved in the NIOSH SEC

evaluation be made available to petitioners for use during the appeals process?

3) Notification — PACE Local 5-4200 applauds the addition of a notification in the
Federal Register immediately after the Secretary makes a determination to add a class
to the SEC and forwards such recommendation to Congress for its 180 day review.

Other issues

1) Time lines—We believe NIOSH should establish a time frame of 180 days to
complete a dose reconstruction, after which NIOSH should establish that “it is not
feasible to estimate dose with sufficient accuracy.”

NIOSH should establish a time frame for completing SEC petitions and sending
them to the Secretary within 180 days. If it cannot meet this time line, NIOSH should
provide written notice to Congressional Committees and the House and Senate
Members who have petitioners in their district or state with an estimate of when such
petitions will be completed.

2) Technical Assistance--NIOSH should provide small technical assistance grants
to assist petitioners in the development of SEC petitions. Grants would be used to hire
health physicists or other qualified professionals to assist in the development of a
technically sound petition. In addition, NIOSH should also hold several training
workshops to address the informational requirements of a petition.

3) Coordination Between SEC and Dose Reconstruction Rule — NIOSH should
have proposed necessary changes to its dose reconstruction rule at 42 CFR Part 82 in
conjunction with this rulemaking proceeding, rather than dealing with the two rules in a
piecemeal fashion. NIOSH should refrain from finalizing any adverse SEC determination
until it implements revisions to its dose reconstruction rule due to need to align
thresholds for eligibility in both rules.



Comments of PACE Local 5-4200 on HHS Special Cohort Rule Page 6 of 9
May 3, 2003
The legislative history explains that a "fixed list" of specified cancers would serve
as the basis for compensation for members of a Special Exposure Cohort, and not a
variable list drawn up on a case-by-case basis at the discretion of the agency. The
Congressional Record (Page 10377) for October 12, 2000 states (attached):

“There are a few groups of workers that we know, today, belong in this
category. They are specifically mentioned in the definition of Special
Exposure Cohort. For other workers to be placed in this special category, the
decision that it was infeasible to reconstruct their dose would have to be
made both by the President (or his designee) and by an independent
external advisory committee of radiation, health, and workplace safety
experts. We allow groups of workers to petition to be considered by the
advisory committee for inclusion in this group. Once a group of workers
was placed in the category [i.e., the Special Exposure Cohort], it would
be eligible for compensation for a fixed list of radiation-related
cancers." (Emphasis added)

NIOSH should delete the provisions authorizing it to select organ specific cancers
in §§83.13(b)(2), 83.13(b)(3) and 83.13(c)(4).

By saying it can identify which organs are at risk and which organs are not at risk

in an SEC, NIOSH has contradicted its own finding that it is infeasible to quantify cancer
risk when there is insufficient data to “cap the dose.”

NIOSH states in the Preamble to the §83.13 of the proposed rule at 68 FR 11297:

Lacking a factual basis for establishing such a cap or upper bound to the
possible level of radiation exposure, NIOSH cannot quantitatively evaluate
health endangerment.

By authorizing a process to determine which organs will be “endangered” from
tadiation exposure in a SEC, NIOSH has positioned itself at odds with its clearly stated
declaration (above) that “NIOSH cannot quantitatively evaluate health endangerment” for
those classes of workers where it admittedly lacks sufficient data to even come up with a
maximum potential dose.

The proposed rule also positions itself at odds with the previous recommendations
of the NIOSH Advisory Board to remove risk quantification from the SEC rule precisely
because it is impossible to assign risk where a maximum potential dose cannot even be
estimated. This double standard on the use of risk estimation should be rejected.

Congress resolved the question of scientific uncertainty in favor of claimants
precisely because risk cannot be quantified when exposures are not known and it is the
right thing to do for those put at risk. NIOSH should not be second guessing or
otherwise undermining this sound policy decision.


Comments of PACE Local 5-4200 on HHS Special Cohort Rule Page 5 of 9
May 3, 2003
As noted above, the Preamble is equivocal, at best, and there is no other explicit
support in 42 CFR 82 for the argument that worst case estimate could be used when P
of C >50%.

If NIOSH wants to introduce the use of “worst case” dose estimates to limit who
can be placed in new Special Exposure Cohorts, it should do so in an even-handed way.
Indeed, it would be contradictory (and unfair) for NIOSH to take the position that
claimants cannot be compensated if data only permits a worst-case dose estimate which
ends up above the 50 percent probability of causation threshold.

In sum, NIOSH should--coincident with the current SEC rulemaking--amend its
dose reconstruction rule to provide absolute clarity that worst case estimates will be used
to “complete” a dose reconstruction (if it wants to retain the “worst case” threshold for
determining an SEC).

Fourth, NIOSH must spell out how it will use a “maximum potential dose” in a
compensation case. Will NIOSH include this maximum potential dose as a point
estimate? Or is NIOSH going to use a “worst case” estimate as part of a dose distribution
where the maximum is at the upper tail end of a distribution where it will receive lesser
weight in a P of C determination. Clearly, using the worst case as a constant value would
generate a more claimant friendly outcome than including it in the tail of a distribution.

Fifth, in NPRM#2 NIOSH appears to have raised the bar for evaluating whether
doses can be estimated with “sufficient accuracy” to only those cases (or classes) for
whom NIOSH cannot “cap the dose.” NIOSH has not explained why it chose to raise the
bar on eligibility for SECs. Why did NIOSH raise the bar compared with NPRM #1? Will
this have the effect to limiting the number of classes added to the SEC, and was this
intentional?

2) Limiting the List of 22 Specified Cancers--In §83.12(b)(1)(iv), NIOSH says that
when it finds it is not feasible to estimate dose with sufficient accuracy, NIOSH will then
“determine” whether such finding “is limited to radiation doses incurred at certain tissue-
specific cancer sites.” Likewise, in §83.13(b)(2)(iii), NIOSH proposes to identify tissue
specific cancers for which it was not feasible to estimate dose with sufficient accuracy.
Further, in §83.13(c)(4), NIOSH may, in its report to the petitioner and Board, limit
specified cancers to “a set of one or more types of cancers specified by NIOSH.”

NIOSH's proposal to limit the number of specified cancers in a given Special
Exposure Cohort directly contradicts Congressional intent.

NIOSH has no legal authority to reduce or limit the 22 specified cancers
designated by EEOICPA for any members of any Special Exposure Cohort, including
both those designated by Congress or those designated by the Secretary of HHS
pursuant to EEOICPA §3626.


Comments of PACE Local 5-4200 on HHS Special Cohort Rule Page 8 of 9
May 3, 2003
4) May have endangered the health of the members of the class--In
§83.13(b)(3), the proposed rule, NIOSH establishes endangerment by two basic tests:

a) employment information that indicated the potential for radiation exposure
b) 250 days of employment, or less in the event of discrete exposure event(s).

This basic framework is a major improvement compared with the approach used
in NPRM#1 for determining “endangerment”. However, added refinements are needed.

Employment information— What employment information is needed to establish
potential for radiation exposure?

Duration of employment — NIOSH sets forth duration of employment as
exposure to “discrete events” (such as criticality), or in the absence of a “discrete event’,
having been employed for 250 work days within the employment parameters set forth for
the class.

First, the rule itself (and not just the Preamble) should provide added flexibility in
abbreviating the 250 days requirement when appropriate. Thus we recommend that the
rule explicitly state in §83.13(b)(3)(ii):

“NIOSH will use the 250 day employment criterion only when it lacks
sufficient basis to establish a lower minimum duration.”

Second, the 250 day employment requirement should allow for workers to
accumulate this time at multiple facilities, if their employment at one site totals less than
250 days, and the class includes employment at more than one facility.

Third, the rule should allow clarify that “discrete events” covered under
§83.13(b)(3)(i) could include short duration operations where radiation controls were
largely non-existent or doses cannot be estimated.

Section 83.16—How will the Secretary decide the outcome of a petition?
1) Timelines for Initial Secretarial Decision — The rule should stipulate that the

Secretary shall review recommended decisions from NIOSH and the Advisory Board and
issue a final written determination in not more than 21 days after receipt of such
materials from NIOSH and the Advisory Board. Inasmuch as all of the evaluations and
reviews have been undertaken by NIOSH staff, its contractors and the Advisory Board,
the Secretary's review appears to be more of a formality, unless there is an appeal
taken.

2) Type of Appeals, Hearings — The proposed rule does not indicate which Office
or branch of HHS will hear appeals of adverse determinations by the Secretary (or
his/her designee). Will the same individuals who rendered an adverse determination on
an SEC petition be the same individuals who evaluate the appeals of their initial finding?



Miller, Diane M.

From: Eric Parker [PARKEI|@doe-md.gov]
Sent: Wednesday, April 30, 2003 7:23 AM
To: NIOCINDOCKET@CDC.GOV
Subject: Comments on NIOSH SEC Rule
NIOSHSECCommer

tsMound_1.rtf (5...
Comments from PACE Local 5-4200, Miamisburg, Ohio

regarding the HHS Notice of Proposed Rulemaking
for Designating Classes of Employees as Members of the Special Exposure Cohort under the Energy Employees
Occupational Iliness Compensation Program Act of 2000 (42 CFR Part 83)

PACE Local 5-4200 is pleased to offer its comments the NIOSH Notice of Proposed Rulemaking Procedure for
Designating Classes of Employees as Members of the Special Exposure Cohort under EEOICPA.

Eric Parker
President, PACE Local 5-4200
937-865-3389


Comments of PACE Local 5-4200 on HHS Special Cohort Rule Page 7 of 9
May 3, 2003

At 68 FR 11296 NIOSH takes the position that there is adequate information
about “where the radioactive compounds concentrate and significantly irradiate certain
organs and tissues” that could allow NIOSH to estimate which cancers could be
excluded from a class where the dose cannot be “capped”. The proposed rule does not
define the term “significantly,” leaving completely open to speculation what risk level is
actually indicated.

The rule doesn’t explain whether NIOSH will adopt the Health Physics Society's
(HPS) recommendations for deciding which tissues would be deemed “significantly”
irradiated. HPS opines that 10 rem is the threshold level beneath which no adverse
health effects occur. HPS’s March 2001 position paper states: “there should be no
compensation for persons whose lifetimes doses are less than approximately 0.1 Sv (10
rem).” The scientific validity of the HPS contention that a threshold compensation model
should be adopted at the 10 rem level is completely at odds with the premises underlying
NIOSH IREP. Indeed, the NIOSH-IREP model compensates certain cancers below 5
rem exposure (e.g., leukemia). If the HPS recommended threshold is adopted, NIOSH
will be presented with highly visible inconsistencies in its application of the NIOSH-IREP
model on the one hand, and risk estimations used to include or exclude certain cancers
from SECs on the other hand.

3) Is it “feasible” to estimate dose?-- The proposed rule takes the position that
dose reconstruction is feasible "if HHS has access to sufficient information to estimate
the maximum radiation dose that could have been incurred in plausible circumstances by
any member of the class." This standard is inconsistent with clearly expressed
Congressional intent. The pertinent discussion in the legislative history (October 12,
2000 Congressional Record, $10377) states:

"There are several reasons why reconstructing a dose might be infeasib[le].
First, relevant records of dose may be lacking, or might not exist altogether.
Second, there might be a way to reconstruct the dose, but it would be
prohibitively expensive to do so. Finally, it might take so long to reconstruct
a dose for a group of workers that they will be all dead before we have an
answer that can be used to determine their eligibility."

This passage evidences a much broader test of feasibility than the one proposed
in the rule. Congress consciously used the word feasible in EEOICPA §3626 because it
was motivated by a concern that the dose reconstruction process could become so
complicated that the essential aim of the statute (i.e., timely compensation) would be
frustrated. The standard proposed in the rule will result in dose reconstructions being
attempted in many of the circumstances that Congress sought to exclude when crafting
the statute. The final rule should specify parameters related to time and cost to serve as
a means of considering the issues of excessive length of time and prohibitive cost in
dose reconstruction. This should include time limits on dose reconstruction.



Comments of PACE Local 5-4200 on HHS Special Cohort Rule Page 3 of 9
May 3, 2003
Section 83.9--What information must a petition include?

Section 83.9(c)(iv) only authorizes report(s) published by a “scientific”
government agency to meet the informational requirements regarding deficient
information in this subsection (emphasis added). The word “scientific” should be deleted
in §83.9(c)(iv), in order to allow government agency reports from any agency or branch
of government. For example, the U.S. General Accounting Office (GAO) is not a
“scientific” agency, but it has done extensive auditing on the inadequacy of DOE
dosimetry practices and provided this information to Congress. Likewise, Congress has
published reports (such as Committee reports and hearing records) which describe
inadequate radiation monitoring and/or destruction or dose records. Although these are
not “scientific” agencies, their reports are credible and should not be rejected when
evaluating an SEC petition.

Section 83.9(c)(iv) also contains a limitation that government agencies reports or
peer review articles of deficient radiation dosimetry programs must “also find that such
information might be essential to produce such estimates.” It is over-burdensome for a
petitioner to produce an article which finds that both radiation dosimetry is unavailable
and also make a finding that such information might be essential to produce such
estimates. Although such conclusions would be helpful, NIOSH has reduced the
universe of information commonly available to petitioners, such as the DOE Tiger Team
Reports, Occurrence Reports, Inspector General Reports, or Oversight and
Investigation Team Reports. These reports typically identify deficiencies in radiation
dosimetry, but may not make a formal finding that “such information might be essential
to produce such [dose] estimates;” indeed, that kind of conclusion depends upon
NIOSH using its professional judgment in consultation with the Advisory Board. We urge
the deletion of the requirement in §83.9(c)(iv) that the report must explicitly “find that
such information might be essential to produce such estimates.”

PACE Local 5-4200 supports the reduced information requirements for
submitting a SEC petition in this rule, compared with what had been proposed in NPRM
#1,

Section 83.11-What happens to petitions that do not satisfy all relevant

requirements under §§ 83.7 through 83.9?

The rule should provide an independent administrative appeals process within
HHS for petitioners after NIOSH makes a determination under §83.11(b) that the petition
has failed to meet the requirements for evaluation. Absent an administrative review
process, claimants will have no choice but to seek judicial review in federal court after
NIOSH renders a final agency action

Section 83.13-How will NIOSH evaluate petitions, other than petitions for
claimants covered under §83.14?

1) Definition and Application of the “Sufficient Accuracy” Test--
Section 83.13(b)(1)(i) states that NIOSH will determine that “radiation doses can
be estimated with sufficient accuracy if NIOSH has established that it has access to


Comments of PACE Local 5-4200 on HHS Special Cohort Rule Page 2 of 9
May 3, 2003
Number of Assessments > 250 rem: 25
Total 1522

The MJW report notes a lack of data to reliably reconstruct dose for a wide array
of less commonly used nuclides. “The nuclides used to varying degrees consisted of
actinium-227, protactinium-231, radium-226 and 228, thorium-228, 230 and 232 and
uranium-233, 234, 235 and 238. As detailed in the Phase | Final Report, the bioassay

information for these relatively minor players in the Mound facility operations was not
well documented and often was non-existent.” (Phase II Report, pp 3). Further, it will be

difficult, if not impossible, to estimate exposures to workers who were exposed in the
1990s to high fired oxides of plutonium, actinium-227 and stable metal tritites and for
which bio-assays were not conducted, or for which samples results were not deemed
valid (See: Levell v Monsanto). Subsequent bioassay resampling of Ac-227, for
example, resulted in minimum detectable levels so high, that it would have failed to
detect most uptakes that were <100 rem.

PACE Local 5-4200 believes that the absence of dose data will make it
impossible to estimate dose for certain groups of workers, and thus there may be
several classes of workers who are viable candidates for the Special Exposure Cohort
at the DOE’s Mound facility.

Section 83.5—Definitions

Section 83.5 should define “facility” as a term.

The definition of “facility” in this rule should include all buildings, structures,
premises, production processes, and the grounds upon which such buildings,
structures, premises and production processes are or were located at an Atomic
Weapons Employer facility or a Department of Energy facility.

The reason for making the definition of facility as broad and inclusive as possible
is that it will reduce the number of classes to be established for a given group of
workers. It makes more sense to group classes based on exposure histories within a
DOE site or an AWE site. Common exposure histories can crossover from process-to-
process, building-to-building and site-to-site. The law doesn't call for “facility cohorts,”
rather it calls for exposure cohorts. A narrowly defined facility (e.g., a production line)
would frustrate the establishment of exposure cohorts, or result in the unnecessary
proliferation of exposure cohorts. Instead, the classes should be defined by whether
there was insufficient data to estimate doses for employees who meet the employment
duration threshold.

Section 83.7--Who can submit a petition on behalf of a class of employees?
The proposed rule at §83.7 has come up with the right formula for assuring that

unions can file petitions, and that petitions by others are adequately authorized. NIOSH
should not tamper with this section in this rulemaking.


Comments of Eric Parker, President

PACE Local 5-4200, Miamisburg, Ohio

regarding the HHS Notice of Proposed Rulemaking
for Designating Classes of Employees as Members of the Special

Exposure Cohort under the Energy Employees Occupational Illness
Compensation Program Act of 2000 (42 CFR Part 83)

PACE Local 5-4200 is pleased to offer its comments the NIOSH Notice of
Proposed Rulemaking Procedure for Designating Classes of Employees as Members of
the Special Exposure Cohort under EEOICPA, published on March 7, 2003 (68 FR
11294-11310, hereinafter NPRM #2). PACE Local 5-4200 filed comments on August
23, 2002 with respect to the previous HHS Notice of Proposed Rulemaking related to
Special Exposure Cohorts (67 FR 42962-42973, published on June 25, 2002). Eric
Parker can be reached at 937-865-3389.

PACE Local 5-4200 has represented hourly workers for over 40 years at the US
Department of Energy's Mound site located in Miamisburg, Ohio. PACE Local 5-4200
(and it predecessor Oil, Chemical and Atomic Workers) represented production,
maintenance, environmental restoration and support service workers in support of the
many missions and subsequent decontamination/decommissioning at the site, including
Polonium-210 operations, Plutonium 238 Heat Source Project, the Reactor Waste
Decontamination Project, the Reactor Fuels Program, the Uranium-234 Program, and
the Neutron and Alpha Source Program, tritium operations, operations involving
insoluble high-fired oxides of plutonium and stabilized metal tritites (Class YY), the
Radium-Actinium Separation Program, the lonium (Th-230) Program, the Protactinium-
231 Program, the Thorium-232 Refining and Redrumming Program, the Cotter
Concentrate Program and non-nuclear components and explosives testing programs.

DOE contracted for an internal dose reconstruction at the Mound facility for
workers with at least 20 rem internal dose prior to 1989. Phase II results (MJW, June,
2002) identified significant uptakes. These results have not been widely communicated,
unfortunately, and nearly 60% of those with a dose >20 rem have not been notified by
DOE.

Number of Assessments < 20 rem: 751
Number of Assessments = 20 rem: 2
Number of Assessments > 20 but < 30 rem: 226
Number of Assessments > 30 but< 50 rem: 181
Number of Assessments > 50 but < 100 rem: 215
Number of Assessments > 100 but < 250 rem: 122