17

18

August 20, 2002

Comments of the Government Accountability Project on the Department of Health and Human Services Proposed Rule “Procedures 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.

Section
83.12

(b)(1)

Section
83.13

NIOSH evaluates a peti
there is a “reasonable likelihood that such

radiation dose may have endangered the health collects on the types and levels of radi

of members of the class." To make this

reasonable likelihood that a potential radiation
dose may have caused a specified cancer (i.e.
iation dose which
ly of
causation of 50% at the upper 99 percent
credibility limit for the most radiogenic specified
cancer or cancer that could have resulted from
the type of radiation exposure).

This section describes how the Advisory Board
on Radiation and Worker Health (ABRWH) will
evaluate a petition.

NIOSH says that its estimate of potential dose
will depend on the information that NIOSH
n
exposures that potential members of the class

e if there is a may have incurred. The assumption that the

information will be available or to any degree
sufficient is presumptuous at best, and

intuitive when the basic
premise is that there is not enough information
to reconstruct dose. NIOSH has no proposed
methods for determining endangerment when
such information is not available. Moreover,
NIOSH has to spell out the degree to which it
will provide benefit of the doubt to the claimant.
‘What will NIOSH do when there is no credible
source term information for a class? Or
ity information? What do when
there are multiple potential radiation types?
How will NIOSH account for different biokinetic
models with different target organs that could
produce multiple primary cancers?

All petitions evaluated by NIOSH should be
submitted to ABRWH regardless of the
outcome. A positive des in by NIOSH should
not preclude the Board's review, because
NIOSH and the petitioners may disagree on the
class definition even though the petition was
granted in part.

Page.11 of 13

NIOSH's rule or procedures manual needs to
state how it will ascertain endangerment when
there is not enough information to formulate a
potential dose. See comment and
recommendation #5.

All petitions evaluated by NIOSH should be
submitted to ABRWH regardless of the
outcome.


August 20, 2002

Comments of the Government Accountability Project on the Department of Health and Human Services Proposed Rule “Procedures for Designating Classes of Employees as
Members of the Special Exposure Cohort under the Energy Employees Occupational I!Iness Compensation Program Act of 2000” 42 CFR Part 83.

Preamble The preamble to the rule states that "if NIOSH The Rule fails to set forth the criteria for what
Sec. Il. E can successfully reconstruct the radiation doses determines a “successful” vs. an “unsuccessful" "successful" and an "unsuccessful" dose
of members of the class under the requirements dose reconstruction. The concern is that NIOSH reconstruction so that claimants, contractors,

Preamble
Sec. LE

of 42 CFR Part 82 (emphasis added), then the
dose of the class members can be estimated
with ‘sufficient accuracy’ for DOL to adjudicate
claims."

NIOSH states that simplifying assumptions will
not always be easy to apply, especially when
potential levels of radiation exposure for an
individual ranges between low doses and those
that qualify for compensation. NIOSH will
evaluate each petition on "case-by-case basis
and not by using rigid criteria."

and its contractors will have broad latitude to
declare what constitutes a "successful" effort,
based on subjective judgments. Radiological
hazards, which are masked by the lack of

underlying data, could be assumed away in a

dose reconstruction, thus depriving claimants of

a chance to successfully petition for the SEC
There must be some line between the two, and
this should be defined on something other than
a case-by-case determination. There has to be
criteria less subjective than "NIOSH-will-know-
it-when-they-see-it.”

There should be an automatic presumption in
favor of the petitioner whenever there is
uncertainty in applying simplifying assumptions.
For example, if the solubility of the isotope is
unknown, NIOSH could choose "Y" class or a
mixture of 50% "W" class and 50% "Y" class.
The worst case (in terms of dose effect) should
be applied. The basis for assuming anything
other than the worst case (e.g., "Y" class)
should be spelled out and justified.

Page 2 of 13

NIOSH must define what it means by a

the Advisory Board, and the Congress will also
know one when they see it. NIOSH has used
very ambiguous language to define the term
“reasonable” estimate in 42 CFR Part 82.

NIOSH's rule or procedures manual must spell
out a policy that the petitioner will always
receive the benefit of the doubt when using
simplifying assumptions to calculate a potential
dose. NIOSH must spell out in its report on a
petition which simplifying assumptions it
selected, which it could have selected, and
reasoning must be provided whenever the
benefit of the doubt is not given to the
petitioners.


10

1

Rule: NIOSH is relying upon the use of the NIOSH-
Section IREP Model to calculate the SEC test for "may
83.5, have been endangered" based on potential
83.12 dose estimates.

Section This section states that "Petitioners must be
83.7 one of the following: (a) One or more DOE,

August 20, 2002

Comments of the Government Accountability Project on the Department of Health and Human Services Proposed Rule “Procedures 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.

DOE contractor or subcontractor, or AWE

IREP requires individual characteristics for
probability of causation calculations, but many
of these inputs will not be available for entire
classes of workers. Section 83.12((b)(ji) states
that NIOSH will use "reasonable values that
confer the benefit of the doubt to the class".
Absent better guidance, it is questionable
whether identical inputs would be used in two
identical circumstances. Many IREP
calculations are age sensitive. Data will be
scarce on age at exposure; will NIOSH use 20?
30? 40? Since ages within the class will vary,
how can an "average" ever give the whole class
the benefit of the doubt? Will NIOSH always
assume the gender or race most favorable to
the class when gender or race is unknown?
Cancer risks vary with latency; what latency
assumptions will be used? Biokinetic models do
not exist for many isotopes and chemical forms;
how will NIOSH select the most radiosensitive
location? Why not use leukemia as the most
tadiosensitive cancer in all externa! radiation
cases? IREP allows for multiple primary
cancers; will the probability of causation be
adjusted for exposures to multiple isotopes?

Worker advocacy organizations, if formally
authorized in writing by a member or members
of a potential class, should be able to submit

employees or their survivors; and/or (b) A labor petitions. Organizations such as Los Alamos
union representing or formerly having represent POWS, CHE (Oak Ridge), FACTS of

DOE, DOE contractor or subcontractor, or AWE Tonawanda are u

employees who would be included in the
proposed class of employees." The preamble

juely qualified to submit
petitions and are often composed of non-union
workers, and/or workers whose unions are not

NIOSH does not appear to have “road tested"
its proposed approach to calculating
endangerment using IREP to know what the
range is of potential radiation doses for setting a
threshold of “endangerment." The NIOSH rule
or policy manual must be far more prescriptive
in spelling out how it will address the range of
variables. Since cancer effects have been
observed at 10 rem and below, it would be
prudent to assure that this endangerment
threshold doesn't produce a contrary outcome.

The rule should be expanded to include other
types of petitioners in addition to DOE
contractor or AWE workers or their unions.
NIOSH should add established worker
advocacy groups, including injured worker
organizations and worker support groups to
apply on behalf of workers if they represent
potentially compensable workers, and have

states that other potential representatives were engaged in this issue. To eliminate the ability ofreceived written authorization to submit a

excluded because "HHS found it reasonable to

require that such experts work on behalf and
with the class, who are the interested parties.

organized groups of workers from submitting
petitions because they are not labor unions is
unfair.

Page7 of 13

petition on behalf of at least two members of a
potential class. Also the rule should provide
that attorneys working on behalf of an individual
or class of workers may submit a petition on
their behalf.


August 20, 2002

Comments of the Government Accountability Project on the Department of Health and Human Services Proposed Rule “Procedures 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.

83.2(a)

Proposed Section 83.2 states: (a) A current cancer Section 83.2(a), as proposed, sets forth a The NIOSH rule or policy manual should define

Rule, Sec. claimant can petition on behalf of a class of subjective standard for deciding whether or not the criteria--perhaps a checklist and/or metrics--
employees to be added to the Cohort upon it will determine that dose can be reconstructed. when NIOSH will establish that insufficient
determination by NIOSH that it cannot complete A "determination by NIOSH that it cannot information prevents it from completing a dose
a dose reconstruction for the claimant. complete a dose reconstruction for the reconstruction. A checklist should include

claimant" is inconsistent with the EEOICPA uncertainty on the various source terms, energy
Section 3626(b), which sets a higher standard: level, solubility, lack of a biokinetic model, lack
it is not feasible to estimate with sufficient of reliable monitoring technology, failure to use
accuracy the radiation dose the class received.” proper monitoring procedures, unmonitored

It is not acceptable to deny SEC petitions if dose, conflicting data, missing records,
NIOSH can assert, without defining its terms, | doctored records, adequacy of workplace

that it can "complete a dose reconstruction. The radiation protection, etc.

way this is worded, NIOSH can "complete" dose

reconstructions, which are inaccurate,

unreliable and miss significant amounts of

unmonitored dose.

Page 4 of 13


August 20, 2002

Comments of the Government Accountability Project on the Department of Health and Human Services Proposed Rule “Procedures 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.

Preamble NIOSH's proposed rule states that even where This is a counterintuitive approach to ascertain NIOSH must state what it will do when it cannot

E dose reconstructions are not feasible, “the
process of determining that dose
reconstruct
information to determine imprecisely the
potential level of radiation to which the class
could have been exposed.

endangerment. When NIOSH determines that estimate potential doses. GAP recommends
there is not enough data to reconstruct a dose that when NIOSH cannot estimate potential

ns are not feasible should provide to ascertain individual causation determinations, doses, NIOSH assign a dose that exceeds the

its rule assumes that there will nonetheless be threshold for the most radio-sensitive cancer to
sufficient "potential" dose data to establish meet the endangerment test. The NIOSH Rule
“endangerment” using IREP. NIOSH has not violate the EEOICPA
demonstrated this counterintuitive assumption petitions to be denied for lack of information to
to be true in all cases. There be situations estimate a "potential dose". Without a fall back
where NIOSH will not be able to determine the to determine endangerment in the absence of
potential level of radiation to which the class data, the Courts and Congress will readily see
was exposed and the rule does not state what this proposed rule as circular and self-defeating
NIOSH do in these situations. The rule's —_ reasoning.

lence implies that NIOSH has only one choice.

When it cannot estimate a potential dose, it wi
conclude that the class was not endangered.
This would be an unreasonable and illogical
conclusion. Additionally, it would be an
unlawful execution of the SEC provision, which
is to provide compensation to those claimants
who "may have been endangered" and for
whom “sufficient” dose data does not exist.
NIOSH should, if it sticks with the proposed
"endangerment" algorithm, create alternative
methods when it cannot estimate "potential
dose.

Page 3 of 13


9

August 20, 2002

Comments of the Government Accountability Project on the Department of Health and Human Services Proposed Rule “Procedures 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.

Rule
Section
83.5(b)

Section 83.5 Definition of "endangered health" The “may have been endangered” standard for The test for the statutory term "there is a

for purposes of these procedures means that
“there is a reasonable likelihood that the
tadiation dose may have caused a specified
cancer" determined according to these
procedures using NIOSH IREP.

the Gaseous Diffusion Plant workers in a reasonable likelihood that such radiation dose
Special Exposure Cohort is, in most may have endangered the health of the
circumstances, far more defensible. It members of the class" should be changed in the

eliminates inequity between the statutory SECs Rule to provide for employment duration-based
tests, such as the test as used for the SEC at
the Gaseous Diffusion Plants. However, when
require potential radiation doses of 40 rad (for there are short duration high-risk work
populations age 40 who develop a cancer 15 —_ environments, NIOSH will need to develop
years later). This is a very high threshold for alternative procedures for determining whether
endangerment, when cancers such as leukemia such workers may have been endangered. As
are compensable at much lower exposures. a legal matter, NIOSH IREP is not suggested in
NIOSH responds that Congress did not direct any statutory provision for determining whether
them to use the GDP (or any other time claimants should be included in an SEC. Thi
duration) criteria. Congress gave NIOSH wholly an invention created in this rule with no
guidance through its two examples (Amchitka is legislative history.

duration specific, as are GDPs). Congress did

not tell NIOSH not to use time duration.

Congress wanted to assure that the

endangerment test was rational enough to

include "at risk" workers and eliminate those

who had very short tenure (Pepsi delivery

persons) and those with little potential for

exposure (office workers removed from

buildings with radiation related jobs).

Page 6 of 13


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14

August 20, 2002

Comments of the Government Accountability Project on the Department of Health and Human Services Proposed Rule “Procedures 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.

Section
83.9(b)

This section applies to all individuals or groups Under 83.9(b)(3), petitioners must describe the The requirements of section 83.9(b)(1) and (2)
who do not or could not petition under section basis of their belief that the available data is

83.9(a). In summary, these workers must

insufficient to estimate the radiation doses with

submit a petition to the Secretary of Health and sufficient accuracy. First, NIOSH is imposing

Human Services with 1) a proposed class

period of employment, and if relevant, (iv)
exposure incidents; 2) the basis for health
endangerment:
care or (ii)(A) identification of potential
exposures and (B) shortcoming of radiation
protection; and 3) the basis for infeasibility of
dose reconstruction: either (i) demonstrated
lack of records or (ji) expert report.

provide sufficient information for NIOSH to
determine whether to evaluate the petition.
NIOSH will always have the discretion to deny a

It is apparent that the informational requirement
is solely to achieve NIOSH's goal of
health effects or health discouraging petitions under 83.9(b). Second,

the informational requirement of 83.9(b)
imposes an impossible informational
requirement for most AWE petitioners.
Pursuant to a DOE memorandum dated
February 27, 2002 to the DOL, DOE stated that
for certain AWE fa s, DOE has no records
to verify employment. Doe would not likely
have access to exposure records at these
AWEs. Third, DOE does not construe
EECOIPA 3623(e) to require them to request
records from the AWEs. Also, AWE's are not
covered under the Freedom of Information Act;
such a request for information will be futile.
Claimants will not even get an answer that "the
records do not exist". Fourth, petitioners for a
class will not be able to get class member
records from DOE due to Privacy Act
restrictions. Fifth, health physicists, absent
access to comprehensive data, will not be able
to offer an informed opinion on whether the
“documented limitations would prevent the
completion of dose reconstructions for
individual members of the class.”

Page 9 of 13

requirements of section 83.9(b)(3) should be
optional because they significantly increase the
burden on the claimant and in many cases will
be a futile endeavor. If a record request is
required there must be a limit on the time DOE
has to respond to a p



12

13

August 20, 2002

Comments of the Government Accountability Project on the Department of Health and Human Services Proposed Rule “Procedures 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.

Section
83.8

Section
83.9(a)

This se
a completed 'SEC Petition Form' to
NIOSH/OCAS...."

This section applies to a claimant who has
attempted and failed a dose reconstruction.
The petitioner need only transmit a copy of a

n states "the petitioner(s) must send The form was not published with the rule.

Comments cannot be provided.

The process under 83.9(a) is excessively time
consuming and the rule should seek to
eliminate delays. From the point the claim is

report produced by NIOSH under 42 CFR 82.12 filed with the DOL, NIOSH attempts dose

notifying the petitioner's that NIOSH attempted reconstru:

and could not complete a dose reconstruction

in, fails, DOL denies claim, the
petitioner files for SEC status, a positive

for the individuals due to insufficient records or determination goes to the ABRWH, and

information.

Secretary sends it to Congress for mandatory
180-day review, it appears that several years
will pass. Moreover, except for Congressional
review, there are no time limits at any phase of
this process. The Secretary for HHS should

NIOSH should provide the form for public
comment and review by the public and the
Advisory Board on Radiation and Worker Health
to assess the informational requirements,
clarity, and ensure the form is not unduly
burdensome.

Time limits need to be specified to accelerate
the process. Three recommendations follow: (1)
Streamline decision-making through the
delegation of authority to approve/deny petitions
to the Director of NIOSH (the Secretary can
delegate this authority to NIOSH); (2) A 20-day
timeline should be set from receipt of a
recommendation from NIOSH staff and ABRWH
for issuance of a final determination and
transmittal to Congress; (3) Set forth a
maximum 180-day period for reconstructing
radiation doses as an outer limit, after which

delegate final decision making to the Director of NIOSH should determine that it is not “feasible”

NIOSH under Section 83.14, with a mandatory
20-day turnaround after receipt of NIOSH staff
and ABRWH recommendation.

Page 8 of 13

to estimate dose. (Delay is a very real. The
Secretary's office has added months of delay in
issuing a draft SEC rule, and delayed issuance
of the report to Congress on atomic energy
weapons employer sites that was due back on
June 28, 2002, pursuant to Section 3151(b) of
the FY 2002 Defense Authorization Act.)



7

8

August 20, 2002

Comments of the Government Accountability Project on the Department of Health and Human Services Proposed Rule “Procedures 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.

Rule
Section
83.5(b)

Rule
Section
83.5(b)

Definition of “feasibility”

Section 83.5 Definition of "endangered the

The rule does not explain how NIOSH will
define the term "feasibility" for the purpose of
the rule, although the EEOICPA states that the
SEC will apply to employees for who "it is not
feasible to estimate with sufficient accuracy the
radiation dose that the class received."
(Emphasis added). The term “feasible” is of
equal importance to "sufficient accuracy" and
“endangered the health" to warrant an
explanation and definition.

NIOSH's definition proposes circular reasoning:

health" for purposes of these procedures means If the radiation dose is assumed to be an

that "there is a reasonable likelihood that the
radiation dose may have caused a specified
cancer" determined according to these
procedures using NIOSH IREP.

NIOSH rule should set forth a checklist of items
that should be used in determining "feasibility",
including time to recover data, cost to establish
data, difficulty in finding data, etc. For example,
NIOSH's letter responding to a claimant dated
April 25, 2002, gives an estimate of 90 to 180
days to complete dose reconstruction. NIOSH
could use the 180-day limit as criteria to
conclude that it is not “feasible” to estimate that
radiation dose.

NIOSH should use the approach Congress
applied to SEC's at the gaseous diffusion plants

unknown (and not knowable), then how can you (250 days and the individuals in class were

determine whether health was endangered
using potential radiation dose estimates to
define the degree of endangerment? If there is
not a good enough dose for estimating
likelihood of causation, how is it possible that
there is a good enough dose for deciding
whether someone was endangered?

Page 5 of 13

monitored for radiation or should have been
monitored) or, in cases were potential dose
cannot be estimated, NIOSH should assign a
dose that exceeds the threshold for the most
radio-sensitive cancer to meet the
endangerment test. Additional criteria will have
to be developed for acute exposures of a
shorter duration (e.g., fought fire with pyrophoric
radioactive materials) that can serve as a proxy
for endangerment.


GAP'S POINT-BY-POINT COMMENTS ON HHS'S PROPOSED RULE
“Procedures 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

26 st
g Ses

August 20, 2002

Sas

scegcayenoucnnerae

Se oe

aes SSUES US
CcOM- SECTION RULE OR PREAMBLE SECTION COMMENT OR QUESTION RECOMMENDED CHANGES
MENT # #
1 Preamble Background: Purpose of Proposed Procedures There are many areas in the proposed rule that NIOSH should issue an “Interim Final Rule" with
Sec. Il. C have yet to be spelled out. By their own commitment to issue a "Final Rule" rule within
admission, NIOSH cannot resolve many of the 6-12 months of publication of Interim Rule. This
questions concerning the proposed procedures will avoid delays while giving HHS more time to
u gains some experience with petitions, resolve significant issues and further consult
such as: (1) estimating potential dose, (2) using with Advisory Board. This is a legally
IREP for the determination of "endangerment", permissible route. The Administrative
(3) defining classes, and (4) estimating and Procedure Act, Title 5 Section 553
applying potential SEC doses when ("Rulemaking"), does not dictate what form a
reconstructing dose for non-SEC cancers (see rule must take subsequent to a notice of
item #20 below). Rather than issuing a “Final proposed rulemaking.
Rule,” HHS issue should an “Interim Final
Rule,” which would allow decisions on petitions
to proceed without impairing petitioners’ rights
as the rule becomes further refined. Issuing a
“work in progress” as a "Final Rule" is bad
policy. It will undermine public confidence, and
result in negative public reaction. There are
alternative choices available to HHS.
2 Preamble Summary of Proposed Rule: Procedures for These underlined terms are ambiguous, NIOSH should establish, through rule or

Sec. Ill, Adding Classes of Employees to the Cohort

Subtitle C states: "If the proposed class includes one or
more members who have already submitted
claims and for whom NIOSH was unable to
complete a dose reconstruction due to

subjective and not amenable to adjudication. —_ procedure, criteria (i.e. a checklist or metrics),
establishing a "bright line" test for when doses
cannot be "completed" due to “insufficient

information." Perhaps after NIOSH has done a

few petitions it will be able to propose such a

insufficient information, the informational
requirements of the petition are minimal."
(emphasis added).

bright line test, but this underscores the case for
an Interim Rule.


19

20

August 20, 2002

Comments of the Government Accountability Project on the Department of Health and Human Services Proposed Rule “Procedures 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.

Section
83.15

Comment
of NIOSH
official,
Ted Katz
at July 23,
2002,
NIOSH
Hearing
on SEC
Rule in
Amherst
New York,
transcript
at pp.14-
15

This section describes the role of Congress in What is the purpose of the extra 20-day period Designation of SEC should be transmitted to

acting upon the final decision of the Secretary after Congress's 180-day review has been DOL on the first business day after the 180-
to add a class of employees to the Cohort. The exhausted? Why isn't the Secretary's calendar day Congressional review period
section provides that the Secretary's designation transmitted to DOL immediately — expires.

designation of a class "will take effect 180 days after 180-day review is concluded? .

after the date on which the report of the -

Secretary is submitted to Congress" and that
“within 200 days after transmittal of the report to
Congress, the Secretary will transmit to DOL"
the designation.

Mr. Katz stated: "And the last point | just want to NIOSH's policy statement, which was not NIOSH must fill in this gap before it issues an
make is that the decisions to add a class to the proposed in its rule, blocks anyone in an SEC Interim or Final Rule. NIOSH need to explain
cohort are really, in a sense, grave decisions, _ class from seeking a dose reconstruction for —_ how it will address individuals who meet the
and we view them as grave decisions. They non-SEC cancers. This policy is unsupported in exposure and time periods for inclusion in a
have important consequences because if you EEOICPA. Classes are defined by time and SEC, but who have a non-SEC cancer. NIOSH
add a class to the cohort, members of that class exposure. People with a non-SEC cancer who need to assure that claimants can obtai
then can only be compensated for the 22 are covered in an SEC class should be able to dose reconstruction when there are radiation
cancers that are specified cancers as allowed _ file for a non-SEC cancer if they received other exposures that are not covered in the time
by EEOICPA, allowed by the law; and if you radiation exposures at a DOE/AWE facility. For frame of a special cohort. NIOSH needs to
have a different cancer you cannot be example, those who worked at a DOE site establish radiation dose estimates for the time
compensated under this program -- for within an SEC class (e.g., all who worked 1960- periods someone was employed in a SEC and
example, if you have prostate cancer or skin n dose outside files for a non-SEC cancer in another time
cancer. So when we make de ns to add a_—of an SEC class which can be e: ated (e.g., period. GAP recommends that the "potential"
class to the cohort it’s a grave decision. It's an 1971-1981) should be able to file a claim fora dose estimated for the SEC time period (if
important decision. it has real implications for _non-SEC cancer. NIOSH will need to assign a calculable) be added to the dose estimates for
some members of that class, in a jood, dose estimate (e.g., the potential radiation dose the non-SEC time periods. Likewise, the policy
because some members of a class are likely to used in determining “endangerment") for the needs to consider the opposite circumstance
have skin cancer or prostate cancer." 1960-1970 time period to tally a composite dosewhere there is not enough potential dose to
estimate for 1960-1981. This may require an _ include the class in the SEC (e.g., P of Cis
amendment to the dose reconstruction rule or 40%) but for certain subgroups, when added to
procedures manual. Further, NIOSH should —_ exposures incurred outside of the Special
consider the circumstance where petitioners for Cohort time periods, they would exceed the

‘ a proposed SEC would not have enough threshold for endangerment (>50%). NIOSH's
potential dose to meet the threshold for policy as elucidated on the record at the July
“endangerment,” but when combined with non- 23rd meeting in Amherst, New York must be
SEC exposures, some would qualify for revised and subject to notice and comment.

inclusion in an SEC.

Page-12 of 13


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15

16

August 20, 2002

Comments of the Government Accountability Project on the Department of Health and Human Services Proposed Rule “Procedures 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.

Section See Above
83.9(b)
Section Section 83.9(b) requires "the facility at which

the class worked" and "a description of the
petitioner's basis for bel ig the class was
(b)(2), and exposed to levels of radiation at the facility..."
83.12

O20

Petitioners will have a very difficult time meeting NIOSH should provide Technical Assistance

all the levels of proof necessary under
83.9(b)(1) when they worked on a “need to
know” basis and, for survivors, may not know
enough detailed information about the
conditions of the workplace. Moreover, health
physics is a highly specialized area of expertise
not available to most potential petitioners, yet
this knowledge base is required to establish a
credible peti

This definition precludes treating workers who
worked at multiple facilities as a single class.
This particularly affects construction workers
who moved from site to site. At Oak Ridge, for
example, there was a common pool of
construction workers that served Y-12, X-10
and K-25. By definition, these are multi-site
employees. Likewise security guards and
production workers floated between Y-12, K-25
and X-10.

Page. 10 of 13

Grants to organizations (or set up university
based providers) with health physics or
radiation dose reconstruction expertise who can
assist claimants in demonstrating the
shortcomings of radiation protection when
preparing petitions for special exposure cohorts.
DOE and DOE contractors should not be
funded by NIOSH to provide this service,
although DOE and its contractors are free to
assist petitioners.

NIOSH's rule needs to expand the definition of
a class to include multiple facilities when
workers moved from DOE site to DOE site.
NIOSH needs to modify this rule to allow multi-
facility petitions, which incorporates information
as workers moved from site to site, Thi
reasonable interpretation of the EEOICPA, even
though the Act did not expressly authorize
multi-facility petitions.



August 20, 2002

Comments of the Government Accountability Project on the Department of Health and Human Services Proposed Rule “Procedures 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.

21 Rule
Section
83.13,
83.14,
83.15

22 Rule:
Section
83.16

Federal Register notices are required when
petitions are sent to Advisory Board, when
petitions are denied, and when petitions are
approved after Congressional review.

Secretary can cancel or modify a final decision
to reduce scope of a class. Secretary must
notify public via Federal Register.

GAP supports notifications in the Federal Add one additional Federal Register notification
Register. NIOSH should use the Federal requested: when a petition that has been
Register in addition to other ways (press approved by Secretary of HHS (or designee) is

releases) to communicate with widely dispersed sent to Congress for 180-day review.
groups of potential SEC members. We request

one additional notification in the Federal

Register. When petitions, which are approved,

have been transmitted to Congress for review.

We also believe Petitions should be tracked on

the NIOSH Web page, so that its progress

through each stage can be followed by

claimants, the public and press.

If claims have been paid by DOL for members Rule should preclude any requirement for
of an SEC that has been approved by the claimants who have been awarded benefits to
Secretary of HHS after Congressional review, have to repay them if the Secretary reduces the
and the Secretary subsequently reduces the _ size of the class under Section 83.16. Further,
size of the class under Section 83.16 such that the Secretary should notify the petitioners and
some claimants would be disqualified who have issue a press release in the area where the
already been paid as members of the SEC, will facility was located, in addition to the placing a
these claimants have to repay their benefits? —_ notice in the Federal Register. We strongly
support the use of Federal Register notice.

Page 13 of 13