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July 1, 2002 NIOSH Advisory Board meeting in Denver (pp. 203-212). Unless the workers were
deemed to have been included in a “discrete event”, they would be disqualified as a class under
the 250 day employment rule, because the employment in firefighting and cleanup operations
took less than 250 work days.

The rule should be modified, as recommended above, to provide additional flexibility in
setting forth shorter durations of employment (outside of criticality or equivalent events).

SECTION 83.16-HOW WILL THE SECRETARY DECIDE THE OUTCOME OF A PETITION?

1) Secretarial Decision Criteria — Where the Secretary receives a NIOSH recommendation
in favor of granting a petition, and such recommendation is supported by the Advisory Board,
does the Secretary have the discretion to reverse such a finding in the absence of substantial
evidence to the contrary? What weight will HHS give to recommendations from the Advisory
Board, if these recommendations differ from the NIOSH recommendation? Can the Secretary
remand the NIOSH determination for further deliberations without making a finding?

2) 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 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.

3) Delegation of Authority Will Increase Efficiency--We restate our views that authority
for decision making on SEC petitions should be delegated by the Secretary to the Director of
NIOSH. The Preamble states that “the Secretary may delegate authority for making final SEC
determinations to the Director of NIOSH, if upon experience, the Secretary finds this is likely to
improve the effectiveness and efficiency of the program.“ This action would eliminate a time
consuming step in the process and increase the efficiency and effectiveness of the program.

4) 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? 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?

5) Notification - GAP applauds the addition of 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 RECOMMENDATIONS
NIOSH requested comment on how to address several issues related to an employee’s



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HHS Special Exposure Cohort Rule

demanded that labor unions be the exclusive entity entitled to petition for an SEC on behalf of
employees which they represent because the union is the “exclusive representative.” This
argument is bedrocked on a misreading of the National Labor Relations Act’s (NLRA’s)
definition of “exclusive representative.” The provision of the NLRA dealing with the ambit of
responsibilities of an “exclusive representative” is limited to representation on rates of pay,
wages, hours, and other conditions of employment. Section 9(a) of the National Labor Relations
Act, 29 USC §159(a), states:

Exclusive Representatives

“Representatives designated or selected for the purposes of collective bargaining
by the majority of employees shall be the exclusive representatives of all the
employees in such unit for purposes of collective bargaining in respects to rates of
pay, wages, hours of employment, or other conditions of employment.”

The matter of an individual or group filing for federal worker compensation benefits is
outside of the ambit for which unions are the “exclusive representative.” Unions are clearly well
positioned to file SEC petitions, but when it comes to worker compensation proceedings,
unionized workers have the freedom of choice to elect to be represented by their own legal
counsel, or by their union, or an advocacy group (such as injured workers unions), or a state
appointed advocate. NIOSH shouldn’t take away that freedom of choice.

If NIOSH were to adhere to narrow limits proposed by the PACE national union-namely
only a labor union representing its own members at a unionized site can file an SEC petition--
NIOSH will be needlessly enmeshed in making findings on whether one union improperly
included workers in a class who belonged to different union. NIOSH could be forced to deny
petitions where competing unions were claiming that they were the “exclusive” representative due
to jurisdictional disputes (a not uncommon occurrence at DOE facilities). Moreover, where
unions have failed to file SEC petitions, but a COSH group or an injured workers organization
(ie., Coalition for a Healthy Environment in Oak Ridge) did file a petition with authorization
from individuals encompassed within the proposed class, NIOSH would be required to dismiss
this petition. What happens if some of the affected employees in the class are bargaining unit
workers and others are non-bargaining unit employees? What happens if some members of the
class are in one bargaining unit, and other members of the class are in another bargaining unit?
Who should file? Must there be two petitions instead of one? This is more than a hypothetical. In
the case of workers at Rocky Flats who fought the plutonium fires, there are three separate groups
of unionized employees (firefighters, security guards and Steelworkers) plus salaried employees
that were potentially exposed to high-fired oxides of plutonium. Limiting petitions to the basis of
specific union membership is clearly impractical.

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.

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



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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 contradicts Congressional intent. Authority to limit cancers should be deleted from
§83.13 of the rule.

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.

The legislative history for EEOICPA delineates Congressional intent 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.)

By saying it can identify which organs are at risk and which organs are not at risk in an SEC.
NIOSH has contradicted its published declaration 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 significantly affected (e.g.,
“endangered”), the rule is at odds with this section of the Preamble. The proposed rule is also at
odds with a previous recommendation of the NIOSH Advisory Board to remove risk



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HHS Special Exposure Cohort Rule

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 sufficient
information to estimate the maximum radiation dose that could have been incurred in plausible
circumstances by any member of the class” (called a “worst case” or “capping the dose”).

First, 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 when 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.

GAP recommends that NIOSH develop guidelines which use statistical methods to define
“sufficient accuracy”. For example, if the standard error is many times the size of the mean (or
mode), there may be a basis for drawing conclusions about whether the estimate is sufficiently
accurate (assuming that even the upper 95% confidence interval of the dose estimate would not be
compensable). An example is the Bethlehem Steel site profile developed by NIOSH (posted at
www.cdc.gov/niosh/ocas) where the mode is 2 MAC and the upper confidence interval is 1000
MAC. Isa distribution with such a larger error around the mode “sufficiently accurate”? Or is the
range of error so large that the class properly belongs in an SEC?

Second, NIOSH should define in the rule 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
tule giving effect to a statute and offers no clear basis for assuring 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 “to
estimate maximum potential dose”, e.g. a “worst case”. However, these claims could also be
dismissed under the dose reconstruction rule (42 CFR 82.10(k)(3)) because “worst case”
estimates are only allowable at as part of an “efficiency” mechanism if the dose falls below the
50% probability of causation. 42 CFR 82.10(k)(3) states:

"Worst case assumptions will be employed under condition 2
[which allows completing a dose reconstruction with worst case
estimates] to limit further research and analysis only for claims
which it is evident that further research and analysis will not
produce a compensable level of radiation dose [a dose producing a



Comments of Government Accountability Project Page 5 of 15
HHS Special Exposure Cohort Rule

(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. 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 of dose records. Although these are not
“scientific” agencies, their reports are credible and should not be rejected when evaluating an
SEC petition. In fact “scientific” agencies, such as the Department of Energy (and its
predecessors), have issued reports declaring their contractor’s radiation measurement programs
credible, only to be contradicted by subsequent reviews by non-scientific agencies or declassified
documents. Recommendation: the word “scientific” should be removed as a limitation on the
source of government agency assessments that can be used by petitioners; rather, any authentic
government report should be allowable as a source of information.

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.”

Finally, GAP 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. While we expect NIOSH will act in good faith, people are occasionally fallible. An
independent review within HHS is a way to help conserve judicial resources and reduce the
agency’s burden on its legal department. The rule should specify with whom the request for an
appeal must be filed, the address, the procedural requirements, and the regulations that will
gover these appeals proceedings.

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--



Comments of Government Accountability Project Page 8 of 15
HHS Special Exposure Cohort Rule

Fourth, NIOSH must spell out how it will use a “maximum potential dose” in a
compensation case. The Health Physics Society, in their comments on the SEC Rule, recommends
that “[a] “maximum realistic” dose estimate should be estimated and used as a point estimate of
dose for the remainder of the probability of causation determination.” (HPS Comments, pp.10,
Section B3). Assuming that the “maximum realistic dose” is the same as the “maximum
potential” dose or a “worst case” estimate, 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. (A triangular mode distribution was compared with a single point estimate
to confirm this conclusion using NIOSH-IREP). Clearly, using the worst case as a point estimate
would generate a more claimant friendly outcome than including it in the tail of a distribution.

At the March 7 Advisory Board meeting, NIOSH’s health physics director (Jim Neton)
indicated that the maximum potential dose would not be used as a point estimate, rather it would
be used as part of a distribution:

Dr. Neton: I'd like to maybe clarify what Ted said. Not necessarily the maximum
dose, if we could develop some sort of distribution, but the maximum credible dose
would be used in the analysis. It would not always be the maximum dose.

Mr. Katz: But it could be.

Dr. Neton: It could be, sure.
Mr. Katz: Yes, which is—

Dr. Neton: But if one generated distribution, a theoretical distribution of doses, that
would be the sampling that would be done to that dose reconstruction. (Tr. p. 46)

NIOSH should clarify the rule to provide the “worst case” as a point estimate (e.g., input
the dose as a “constant value” in IREP). NIOSH needs to justify why it would not use the
maximum potential dose as a point estimate.

Fifth, NPRM #1 set the threshold for “sufficient accuracy” at the level at which a dose
could be “completed.” When “completing” a dose estimate, NIOSH is making a “reasonable
estimate of dose received.” In NPRM #1, when a reasonable estimate cannot be developed,
NIOSH concludes it cannot estimate dose with “sufficient accuracy.”

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.

NIOSH personnel have stated that they can “cap any dose,” which effectively pre-judges
any SEC petition. Indeed, NIOSH’s decision to raise the bar may have precluded virtually anyone
from ever qualifying for the SEC. Is this the intent of NIOSH? If so, NIOSH should explain its
view, so that claimants will understand the futility of petitioning for a Special Exposure Cohort.



Page 1 of 1

Miller, Diane M.

From: RickuDana@aol.com

Sent: Saturday, May 03, 2003 10:00 PM
To: NIOCINDocket@cdc.gov

Subject: GAP Comments on 42 CFR Part 83

Dear Sir or Madam:

]

Attached please find the Comments of Richard D. Miller, Policy Analyst on behalf of
the Government Accountability Project (GAP), concerning the HHS Notice of
Proposed Rulemaking for Designating Classes of Employees as Members of the
Special Exposure Cohort under EEOICPA, published in the Federal Register March
7, 2003, Vol. 68, No. 45, pp 11294-11310.

The comments are attached in a Word file "NIOSHCommentsNPRMJ#2". They are 15 pages total.

Please contact me if you have any questions or if you have any problems receiving or opening the attached
document.

Richard D. Miller
GAP
rickudana@aol.com
413-536-3858 (h)
413-536-9616 (fax)
413-531-5787 (cell)

5/8/2003



Comments of Government Accountability Project Page 11 of 15
HHS Special Exposure Cohort Rule

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.
NIOSH concedes, properly, that some amount of radiation that is inhaled or ingested will find its
way into every organ in some quantity (March 7, 2003 hearing transcript). Thus, every organ will
incur some unquantified risk from radiation dose, but the amount is unknown, because NIOSH
concedes that in these instances the dose cannot even be capped.

The rule doesn’t explain whether HPS’s recommendations will be adopted when it comes
to defining threshold exposure levels where certain 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.

Moreover, the record of the Advisory Board reveals that neither NIOSH staff, nor the
Advisory Board, has been able to identify a single theoretical example where dose cannot be
capped and yet it can identify the “significantly” affected organ(s). Indeed, in every case where
affected organs could be identified, NIOSH (or the Board) also found that a worst case estimate
could also be developed.

In sum, limiting the list of specified cancers is unworkable and at odds with NIOSH’s
previous finding that where a dose cannot be capped, health endangerment cannot be determined.
Congress did not want to limit the list of 22 cancers precisely because of this reason.

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, 810377) 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
tule. 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



Comments of Government Accountability Project Page 10 of 15
HHS Special Exposure Cohort Rule

quantification from the SEC rule precisely because it is impossible to assign risk where a
maximum potential dose cannot even be estimated. It is scientifically unsound to set up a process
where the HHS has already conceded that “NIOSH cannot quantitatively evaluate health
endangerment” for those classes of workers where it lacks sufficient data to estimate a maximum
potential dose.

Moreover, in limiting the list of cancers, the rule establishes “disease cohorts” rather than
“exposure cohorts” without any Congressional authority. Congress resolved the question of
scientific uncertainty with respect to covered cancers in favor of claimants precisely because risk
cannot be quantified when exposures are not known, and it is the ethical policy to follow when
the government puts workers at risk but failed to monitor them. NIOSH should not be second
guessing or otherwise undermining this sound Congressional policy decision.

Given NIOSH’s apparently heavy reliance upon the recommendations of the Health
Physics Society (HPS) staff for limiting the list of specified cancers for given classes, a critique of
this position is necessary.

First, HPS staff challenged the fundamental policy decision to create Special Exposure
Cohorts when EEOICPA was enacted in 2000. They lobbied Congress and the Administration
against SECs. This is documented in the HPS newsletter. Today, HPS is seeking to overturn
through rulemaking what they could not achieve in the legislative process. This is revealed, in
part, in the HPS staff comments, where they want to first establish the principle in the NIOSH
SEC rule that cancer types should defined on a case-by case basis for each SEC, and then they
want use this as the basis to re-examine whether all 22 cancers should apply to the statutory SECs
at the GDPs and Amchitka. (Of course, the latter objective cannot be controlled by NIOSH.).
HPS staff has been told, but has failed to accept, that Congress placed GDP workers in the SECs,
in part, to remedy the fact that these workers were placed in harm’s way by DOE and its
contractors, lied to about it by management, and not tested or adequately protected from exposure
to transuranics for over 40 years. These unethical actions were never criticized by the Health
Physics Society. No one to our knowledge had their health physics accreditation removed
because of professional malfeasance, despite the abundant evidence of such misconduct by health
physicists and others in the DOE complex.

The policy algorithm for SECs in EEOICPA is rooted in the Recommendation #2 of the
Final Report of the President’s Advisory Committee on Human Radiation Experiments. This
Recommendation states that when the government put individuals in harm’s way without their
knowledge and consent, and harm can be attributable to those actions, then compensation should
be paid. This ethics-based remedy may not suit HPS’s broader political agenda, but it is the
product of extensive deliberation by an expert committee. This algorithm was subsequently
adopted by DOE Secretary Richardson, DOE Assistant Secretary Michaels and a bi-partisan
group of House and Senate members in the enactment of EEOICPA.

Second, at 68 FR 11296, the rule tracks the HPS position that for certain emitters, 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



Comments of Government Accountability Project Page 7 of 15
HHS Special Exposure Cohort Rule

P of C >50% or greater], because using worst case assumptions it
can be determined that the employee could not have incurred a
compensable level of radiation dose. (Emphasis added)

What happens to claimants where the “worst case” estimates exceed 50% probability of
causation? Do they fall into a void?

According to the record of a discussion between NIOSH’s Ted Katz and Advisory Board
Member Mark Griffon at the March 7, 2003 Advisory Board meeting, staff believes that
maximum dose estimates would be used in determining claims under 42 CFR Part 82:

Mr. Griffon: And just to clarify that....if you can calculate a maximum dose, then those
maximum doses will be used in their determination of—

Mr. Katz: Yes.
Mr. Griffon: --probability of causation?

Mr. Katz: Then they {the claimant} would have dose reconstructions based on those
maximum doses versus something more accurate and lower. (See: transcript, pp. 45-46)

The contents of the rule at 42 CFR 82.10(k) and the representations of Mr. Katz do not
align. Furthermore, 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..."

As noted above, the Preamble is equivocal, at best, and there is no other explicit support in
42 CFR 82 for the argument that when data is limited, the worst case estimate would always be
even where the 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 %
probability of causation threshold.

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).


Comments of Government Accountability Project Page 3 of 15
HHS Special Exposure Cohort Rule

reason for NIOSH to impose a cramped reading of the law.

Recommendation: The NIOSH rule at §83.5(c) should be amended to allow for
employment in either “one or more DOE and/or AWE facilities” to be used in defining both a
“class”, and in accumulating days of potential radiation exposure to meet the 250 day
employment threshold under §83.13).

(b) a “class” is also defined in the proposed rule by the requirement that “availability of
information and recorded data is comparable with respect to the informational needs of dose
reconstructions conducted under 42 CFR Part 82.” It doesn’t make sense to require specific
“information and recorded data” be “available” for purposes of “class definition” The point of a
Special Exposure Cohort is that the information and recorded data needed for a dose
reconstruction is not available. This section must be redrafted to establish that the class is defined
by what information is NOT available.

2) Section 83.5 should define “facility” as a term.

Employees from two categories of facilities covered under EEOICPA can file petitions: an
Atomic Weapons Employer Facilities (as defined in EEOICPA §3621(5)) and a Department of
Energy facility (as defined in EEOICPA §3621(12)).

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.

3) Specified Cancer—

Section 83.5(k), the list of Specified Cancers, should be amended to provide at the end of
subsection 83.5(k)(6), the following phrase “or specified within Department of Labor policy or
procedures”. For example, DOL has included rectal cancer as a subset of colon cancer, and
cancer of the tonsils as a subset of pharynx cancer. It has also treated cancer of the bone cartilage
of the larynx as a subset of bone cancer. These policy determinations should be incorporated by
reference.

SECTION 83.7--WHO CAN SUBMIT A PETITION ON BEHALF OF A CLASS OF EMPLOYEES?
NIOSH has developed a well considered approach to who can file a petition, and assures
that petitioners are adequately authorized. One labor union (PACE) filed comments which



Comments of Government Accountability Project Page 14 of 15
HHS Special Exposure Cohort Rule

dose history that is partially but not completely covered in a SEC class. See: 68 FR 11302-03.

1) Assigning Dose—(a) For claimants who have both radiation exposures that can be
estimated and radiation doses that cannot be capped (but not included in an SEC due to
employment for less than 250 days), how should NIOSH assign the dose that cannot be
estimated? Options for the amount that would be “assigned” are not discussed in the Preamble.
EEOICPA §3626 provides guidance on assigning dose in this case. Where it is not feasible to
estimate dose with sufficient accuracy, the claimant, by default should be added to the SEC. (The
endangerment question is presumably mooted by the employment history.)

For individual claimants who received an unknowable dose as an SEC member, and also
received dose that can be estimated outside of the SEC, how will dose be assigned if the claimant
has a cancer which is not on the list of 22 “specified cancers”? Options were not described in the
Preamble. One option would be to assign dose to the organ with cancer where dose reconstruction
indicates that the P of C was at least 25% (at the 99% confidence interval). The amount to be
assigned from employment within the SEC should add dose to allow a P of C determination .
>50% for that organ. Given the uncertainties at hand, the challenge is to assure potentially valid
claims are not arbitrarily denied where it is not feasible to estimate a dose for an organ that is
known to have had some potential for meaningful amounts of radiation dose. This may require
further discussion in a workshop setting.

2) Time lines-- 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.

3) Technical Assistance--GAP urges NIOSH to provide small technical assistance grants to
assist 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. NIOSH should
also hold several training workshops to address the information requirements of a petition.

4) Harmonizing the SEC Rule with the Dose Reconstruction Rule —

HHS 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.

5) Administrative Record — GAP requests that the March 7, 14, 28 and May 1 transcripts of
the Advisory Board be incorporated in the Administrative Record for this rulemaking.

Attachment: Excerpt from October 12, 2000 Congressional Record dealing with Special
Exposure Cohorts by Jeff Bingaman (a lead sponsor with Senator Fred Thompson)



Comments of Government Accountability Project Page 2 of 15
HHS Special Exposure Cohort Rule

develop a specified cancer, they would be eligible to file for benefits if they meet the DOL
eligibility criteria.

SECTION 83.5—-DEFINITIONS
There are three (3) sets of comments on the “definitions” section of the rule:

1) Class of Employees--In §83.5(c), the proposed rule defines a “class of employees” as “a
group of employees who work or worked at the same DOE or AWE facility and for whom the
availability of information and recorded data is comparable with respect to the informational
needs of dose reconstructions conducted under 42 CFR Part 82.” (Emphasis added)

(a) the definition of “class of employees” should be modified so that employees who work
(or worked) at one or more DOE and/or AWE facility may be included in a “class of employees”
if they are similarly situated with respect to employment (time and place) and insufficient
radiation monitoring. Radiation technicians, “burn and turn” workers, and construction workers
are groups that could conceivably fall into a class of employees who were employed in multiple
facilities. NIOSH has an unquestionable legal right to interpret the term “facility” to allow more
than one facility in defining a class of employees, pursuant to §3626. Section 3626 states, in part:

" the members of a class of employees at a Department of Energy facility, or at
an atomic weapons employer facility, may be treated as members of the Special
Exposure Cohort for purposes of the compensation program..." (Emphasis added)

Whenever the interpretation of a legislative enactment becomes an issue in a case, the
courts will commonly resort to the Rules of Statutory Construction to determine the proper
application of the statutory language to the facts at hand.

In reviewing the question of whether the singular includes the plural, five different texts
dealing with the rules of statutory construction all make the same point: the singular includes the
plural (and none were found that contradict this principle). For example:

“The singular includes the plural, and the plural, the singular...”
“Most drafting texts advise drafters to use the singular when possible.” See: Reed
Dickerson, The Fundamentals of Legal Drafting, pp. 124-125.

Thus, unless the result of such an interpretation was to defeat clear legislative intent, the
rules of statutory construction allow the singular to include the plural. In this case, legislative
intent is enhanced, not defeated, by construing the term “facility” to include “facilities,” because
the object of the Special Exposure Cohorts is to define a class of employees where radiation doses
cannot be estimated, and this may include groups of workers employed in similar jobs at multiple
facilities with similar limitations on the quantity or quality of radiation exposure information.

The Department of Labor (DOL) allows the use of multiple facilities for members of the
SECs in its EEOICPA regulations at 20 CFR 30.214. DOL’s rules allow members of the class to
accumulate days of employment at multiple gaseous diffusion plants in up to 3 different states to
meet the 250 day threshold for members of that Special Exposure Cohort. There is no logical


Government Accountability Project
1612 K Street, NW, Suite 400, Washington, DC 20006,
202/408-0034
www.whistleblower.org

COMMENTS OF RICHARD D. MILLER, POLICY ANALYST
GOVERNMENT ACCOUNTABILITY PROJECT (GAP)
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 (EEOICPA)
FEDERAL REGISTER VOL. 68, NO. 45, PP. 11294-11310 (MARCH 7, 2003)

Outlined below are the Government Accountability Project’s (GAP’s) comments on the
HHS Notice of Proposed Rulemaking Procedure for Designating Classes of Employees as
Members of the Special Exposure Cohort under EEOICPA, 68 FR 11294-11310, published on
March 7, 2003 (hereinafter NPRM #2). GAP filed comments on the previous HHS Notice of
Proposed Rulemaking related to Special Exposure Cohorts, 67 FR 42962-42973, published on
June 25, 2002 (hereinafter NPRM#1). Contact: Richard Miller, Policy Analyst at 202/408-0034,
x.128 for additional information.

GAP is a non-profit, public-interest group based in Washington, DC which operates
programs to protect the rights of whistleblowers, advocates for worker health and safety, and
provide oversight of the DOE nuclear weapons complex. In addition, GAP provides policy
analysis and serves as an information dissemination hub for claimants, worker advocacy groups,
unions and media outlets concerned about the implementation of EEOICPA. GAP has
participated in all of the 14 NIOSH Advisory Board meetings held since its inception, including
the Advisory Board conference calls and meetings held to discuss this rules and previous rules.

Due to the complexity of this rule, GAP had requested a 30 day extension of the initial 30
day comment period under this rulemaking. The Advisory Board requested a 15 day extension of
the comment period. GAP thanks HHS for providing a 60 day comment period. GAP also made a
written request for a public hearing on this rule. Members of the NIOSH Advisory Board and
interested members of public also made requests on the formal record. No response was provided
by NIOSH or HHS to these requests. We are disappointed by the lack of a response.

SECTION 83.1-WHAT IS THE PURPOSE OF THE PROCEDURES IN THIS PART?

NIOSH should add a provision to explain that there are two types of Special Exposure
Cohort (“SEC”) petitions: (1) a petition for claimants where NIOSH has not been able to
complete a dose pursuant to 42 CFR Part 82.12 due to insufficient or inadequate data; and (2) a
petition for individuals or classes of employees, whether or not any of the members of the class
have been diagnosed with specified cancer, where it is not feasible to estimate dose with
sufficient accuracy. The rule should state that petitioners do not necessarily have to file a claim
with DOL to file a petition under option 2. However, if a member of an approved class does



Comments of Government Accountability Project Page 12 of 15
HHS Special Exposure Cohort Rule

rule will result in dose reconstructions being attempted in many of the circumstances that
Congress sought to exclude when crafting the statute. Thus, GAP urges that the rule incorporate
the legislative history cited in the previous paragraph. Thus, the SEC rule must define
“feasibility” to include length of time to reconstruct dose from date claim is received from the
DOL (we recommend 180 days) and prohibitive cost (cost to estimate dose exceeds benefits to be
paid to claimant(s)).

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. For
example, would a “discrete event” include AWE vendors where production operations (rolling of
uranium or thorium) from start to finish took several weeks or months, but didn’t take 250 work
days, and for which maximum potential exposures were unquantifiable? The 250 day limit would
be unfair to impose in this instance, because there were not 250 days in the discrete event.

Would those fighting a plutonium fire or conducting related rescue operations count as a
“discrete event,” even though the class of individuals involved in fighting the fire may not have
received the same dose as a person would have received in a criticality event, but nonetheless
received an unknowable potential uptake of high fired oxides of plutonium (which cannot be
monitored through bioassay)? This potential class was discussed by Dr. Robert Bistline at the

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Comments of Government Accountability Project

Page 15 of 15

EXCERPT FROM FLOOR STATEMENT OF SENATOR JEFF BINGAMAN

October 12, 2000

For radiation, the situation is more
complex, Radiation is proven to cause
cancer in high doses. But when you
look at a cancer tumor, you can’t tell
for sure whether it was caused by an
alpha particle of radiation from the
workplace, a molecule of a carcinogen
in something you ate, or even a stray
cosmic ray from outer space. But
scientists can make a good estimate of
the types of radiation doses that make it
more likely than not that your cancer was
caused by a workplace exposure.

The original legislative proposal passed
by the Senate put the Department of
Health and Human Services, HHS, in
charge of making the causal connection
between specific workplace exposures to
radiation and cancer. Within the HHS, it
was envisioned that the National Institute
for Occupational Safety and Health, or
NIOSH, take the lead for the tasks
assigned by this legislation.

This assignment followed a decision
made in DOE during the Bush
Administration, and ratified by the
National Defense Authorization Act for
Fiscal Year 1993, to give NIOSH the
lead in identifying levels of exposure at
DOE sites that present employees with
significant health risks. While in the
final legislative text, the President was
assigned these responsibilities, I think
it is clearly the intent of the Senate
proponents that he delegate these
authorities as laid out in the original
Senate amendment.

HHS was also given a Congressional
mandate, in the Orphan Drug Act, to
develop and publish

radioepidemiological tables that estimate
“the likelihood that persons who have or
have had any of the radiation related
cancers and who have received specific
doses prior to the onset of such disease
developed cancer as a result of those
doses.”” I would like to ask unanimous
consent that a more detailed discussion
of how the Senate proponents envision
these guidelines being used be included
as an exhibit at the end of my remarks.
(See Exhibit 2.)

Under guidelines that would be
developed and used under this
legislation, if your radiation dose was
high enough to make it at least as likely
as not that your cancer was DOE-work-
related, you would be eligible for

compensation for lost wages and medical
benefits.

‘The HHS-based method will work for
the many of the workers at DOE sites.
But it won’t work for a significant
minority who were exposed to radiation,
but for whom it would be infeasible to
reconstruct their dose.

There are several reasons why
reconstructing a dose might be this
infeasibility might exist. 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 all be
dead before we have an answer that can
be used to determine their eligibility.
One of the workers who testified at

my Los Alamos hearing might be an
example of a worker who could fall into
the cracks of a system that operated
solely on dose histories. He was a
supervisor at what was called the “hot
dump”’ at Los Alamos. All sorts of
radioactive materials were taken there

to be disposed of. It is hard to reconstruct
who handled what. And digging up the
dump to see what was there would not
only be very expensive, it would expose
new workers to radiation risks that could
be large.

‘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, it would be eligible for
compensation for a fixed list of radiation
related cancers.

The program in this amendment provides
for a lump-sum payment, combined

with ongoing medical coverage under
language identical to that used to provide
medical coverage under the Federal
Employee’s Compensation Act,

ot FECA, in section 8103 of title 5,

CONGRESSIONAL RECORD—SENATE $10377

United States Code. Since Congress has
consciously mirrored FECA for one
important part of this new program, I
hope that the Administration, in
implementing our legislation, looks to
FECA as a precedent for establishing
other parameters for this program.

The legislation before us also invites

the Administration to submit further
legislative proposals to help implement
this new program. In my view, it was
not a good policy call for Congress to
enact this program without more
direction on the details of how it should
operate, as was the case in the original
legislative proposal passed by the Senate.
I believe that the flexibility that the
Congress has provided to the Executive
Branch should be used to the fullest
extent by the President to put the
necessary implementing framework in
place by Executive Order. If there are
changes needed to the law that we have
passed, they should be sent up by the
President forthwith. But I do not have
much confidence that Congress will be
able to enact additional legislation on this
program before the deadline date of July
31, 2001.

We have a duty to take care of sick
workers from the nuclear weapons
complex today. It is a doable task, and
a good use of our national wealth at a
time of budget surpluses. I congratulate
my colleagues on having achieved a
successful result from our initial
partisan amendment.