making its procedures timely. The maximum time allotted for the review
of a claim should be six months exclusive of Congressional review.

Finally, NIOSH has stated that it has no alternative to this process given the statutory
limitations it is operating under. The BCTD does not believe that NIOSH is so limited
under the Statute. NIOSH should rethink its attachment to the model (IREP) and
consider other options. On the one hand NIOSH says that it can perform dose
reconstructions because it has on hand and is fully informed about DOE’s existing
exposure information. On the other hand it says it does not know enough about DOE
exposures to determine in the absence of | conducting a dose reconstruction, whether there
is a case for SEC inclusion. As an alternative to this rule, the BCTD recommends that
NIOSH establish a standard for when SEC coverage is applicable, and apply that
standard in accordance with its knowledge of the strengths and limitations of DOE site
exposure records. One simple standard might be, “Any worker is included in the SEC
where exposure records are found to be deficient for at least xx (2.g., 30%) of the
duration of employment.”

Specific Concerns

Presentation of Statutory Requirements. NIOSH errs in two interpretations of
the statute:

a. In Background Section (D}—Statutory Requirements for Designating

Classes of Employees as Members of the Cohort, NIOSH misstates the
statute. The notice should be corrected to read: “The Board’s advice is to
be based on ‘exposure assessments by radiation health professionals,
information provided by DOE and such other information as the Board
considers appropriate.” This is a very significant distinction, because
“such other” would mean “other than exposure assessment by radiation
health professionals” which “other such” would mean “same as exposure
assessment by radiation health professionals.” This is more than a
semantic difference, because all the rest of the rule derives from this
interpretation. It is the BCTD position that Congress left for the Board
to define what is meant by “such other.”

One of the criterion for inclusion in the SEC as defined in the statute is
“Tt is not feasible (our emphasis) to estimate with sufficient accuracy the
dose that the class received. “ In Background Section (E) NIOSH has
chosen to interpret this to mean that “...if NIOSH can successfully
reconstruct the radiation doses of the members of the class....” then the
class does not qualify for SEC membership. In other words, NIOSH has
chosen to interpret “feasible” in the most narrow, technical or scientific
manner. Yet, “feasible” has many other meanings. It may be technically
possible to reconstruct a dose, but if it cannot be done in a timely manner,
or if costs are prohibitive, then it is not feasible. The BCTD Position is

BCTD Comments on NIOSH Proposed SEC Rule


3. NIOSH will apply its rules for radiation dose reconstruction and its guidelines
for causation, notwithstanding the potential for arbitrary actions under
these rules. The Notice acknowledges, in response to comments on
42CFR Part 82, that the conditions that NIOSH will apply for making a
dose determination will vary on a case-by-case basis. The absence of firm
guidelines is very troubling. Further, the rule for dose reconstruction is
designed to review risk for individual workers and not classes.
Consequently, the proposed SEC rule could lead to a determination in
which if NIOSH could perform a dose reconstruction on even only one
member of a class that has made a petition for inclusion in the SEC, it
could deny the petition for the class as a whole. This approach was not
the intent of Congress, because it changes the burden of proof from DOE
to show that records are complete and onto workers to show that they are
totally incomplete. In the case of both the Gaseous Diffusion Plants and
Amchitka, Congress concluded that the classes qualified [for SEC status
because records on some workers were incomplete, and therefore it was
not possible for a worker to show whether his or her records were
complete. NIOSH should revise the rule to read that unless DOE can
produce records sufficient for NIOSH to conduct individual dose
estimates _on all members of the class, the class shall be included in the
SEC. Moreover, NIOSH should develop and publish for comment more
detailed guidance on how these determinations will be reached.

4. Under the proposed rule since claimants will not be able to perform this
work themselves, they will be forced into NIOSH’s dose reconstruction
framework; that is, unless they allow NIOSH to try and fail to perform a
dose reconstruction, NIOSH will not consider the petition for SEC. This
means the following steps that will be faced by a petitioner:

Table 1: Time Line for SEC Claims Process

Step No. Procedure Duration
1 Filing of claim 1-3 month
2 DOL request for DOE employment records 3-6 months
3 Referral to NIOSH dose reconstruction 6-9 months
4 Review by dose reconstruction by DOL 1-3 months
5 Submission of SEC Petition 1-3 months
6 NIOSH review of petition 3 months
7 Board on Worker and Radiation Health review 3-6 months
8 Congressional review 6 months??

Total duration 24-40 months

In other words, under the proposed rule the government finds it reasonable
to expect claimants with cancer to wait roughly two to three years to have
their claims acted upon. This unconscionable delay in processing claims is
not acceptable. NIOSH should reconsider the rule in terms of the

BCTD Comments on NIOSH Proposed SEC Rule


that Congress had in mind a much broader interpretation of “feasible”
than NIOSH has included in its rule.

The Role of the Advisory Board

This rule limits the role of the Advisory Board to a post-hoc review of actions
taken by NIOSH on individual petitions. Yet, Congress clearly implied a more
proactive role for the Advisory Board, including determining the kind of
information that petitioners can rely on to make their case [See EEOICPA Section
3626 (a)(2)]. Therefore, before this rule is promulgated, NIOSH should go back
to the Advisory Board and ask it to define what type of information—both
quantitative and qualitative — can be used by petitioners to make their case. For
instance, we can envision a board saying that qualitative information on deficient
exposure monitoring could be acceptable. Under EEOICP, an affidavit from co-
workers is sufficient proof of employment where DOE cannot verify employment
from its records. Why could not affidavits from workers be used to determine
that exposure records are sufficiently deficient to warrant inclusion of a class in
the SEC?

NIOSH’s Singular View of the Process is Ill Advised.

NIOSH has concluded that the process for establishing additional members of the
SEC should follow a single procedure, in which petitioners in effect must prove
NIOSH dose reconstruction process wrong before NIOSH will accept their
petition. This singular approach is both impractical and ill advised. We note with
regret that in the year that has passed since EEOICP went into effect NIOSH has
managed to complete only seven (7) dose reconstructions; that is, NIOSH has
reviewed the exposure information on seven workers only. This is hardly
encouraging to those who believe that workers should be entitled to an expedited
hearing on their claims, given that these claims are for cancers, many of which
have poor outcomes. We also think that NIOSH has reasoned poorly when it
decided that only one approach is permissible. There are many different ways in
which determination of a petition can be made, and it seems that NIOSH has
selected the most cumbersome one as its sole approach.

NIOSH’s Assumption that Risk Can be Extrapolated is not Validated

NIOSH believes that if it can establish a dose reconstruction for one worker, then
it can extrapolate that finding to other workers similarly situated. Thus, a petition
for class may not be approved if as few as one dose reconstruction can be made
for members of that class. The amount of uncertainty that surrounds this belief
has not been determined. For instance, in CPWR-NIOSH T-BEAM projects
attempting to standardize exposure estimates for construction trades workers
doing similar tasks, the variability in exposures has been so great as to make a
prediction of exposure levels infeasible in many cases. It is likely that this will be

BCTD Comments on NIOSH Proposed SEC Rule


Miller, Diane M.

From: Pete Stafford [PStafford@CPWR.com]

Sent: Monday, August 26, 2002 11:49 AM

To: ‘NIOCINDOCKET@CDC.GOV' |
Ce: ‘delisbur@infi.net’; 'knutringen@msn.com'

Subject: BCTD Comments on SEC |
Importance: High

3CTD Comments on

SEC august 26...
<<BCTD Comments on SEC august 26 20021.doc>>



the case with radiation as well. Therefore, we don’t think the fact that a dose
reconstruction can be made for one worker should be used to evaluate a petition
for SEC coverage for a class of workers.

5. The Proposed Process Does Not Appear Timely

NIOSH proposes a process with many steps, but does not sufficiently place time
limits on each of them (paragraph 83.10(a)). As noted in table 1, we estimate that
the NIOSH part of the process (steps 3-7) will take 15-18 months, and it is
possible that a petition for a class could be dragged out indefinitely. As noted
above, the timeliness of dose reconstructions to date is not encouraging, and while
NIOSH has an explanation for why so few have been completed to date, claimants
are not getting satisfaction. Clearly, the procedures for reviewing a SEC petition
are much more complex than reviewing a claim from a single worker. We think
NOSH has a duty to impose deadlines upon itself in the review of SEC petitions,
which if not met, gives the petitioner a favorable decision. It seems that 30 days
is a reasonable time to perform the initial review.

Concern about the Basic Construct

The BCTD also questions whether this proposal is appropriately characterized as a rule
under the Administrative Procedures Act. The reason for this concern is the potential for
highly arbitrary actions under this proposal. NIOSH has stated that this proposal will be
interepreted on a case by case basis suggesting more that this is a general statement of
NIOSH policy and does not have the specificity for a rule. Further, the proposal as
presented has the potential of becoming “a house of cards,” with this rule being
dependent on another rule (for dose reconstruction) first failing. It would be appropriate
for NIOSH to revise the proposal by incorporating comments received, and then
reissuing the draft as a guidance document, rather than a rule. This will enable NIOSH to
be more flexible in their interpretation and action as the case issues develop.

BCTD Comments on NIOSH Proposed SEC Rule



August 26, 2002

NIOSH Docket Officer

NIOCINDOCKET@CDC.GOV

Re: Procedures for Designating Classes of Employees as Members of the Special
Exposure Cohort Under the Energy Employees Occupational Illness
Compensation Act of 2000; Notice of Proposed Rulemaking

Submitted by:

The Building and Construction Trades Department, AFL-CIO
815 - 16" Street, N.W.

Washington, DC 2006

Attention: Pete Stafford, Director, Safety and Health

Summary: The proposed rule does not appear helpful to potential claimants under this
program. This draft is at a stage of development where it should not be presented as a
rule. NIOSH should consider recasting it as a guidance document which could “evolve”
into a rule in the future.

The rule, as drafted, is convoluted and not easy to understand. It is also circular in its
reasoning. Under the proposed rule, the only way to qualify for inclusion in the SEC is to
prove that dose reconstruction cannot be done in accordance with the NIOSH rule for
dose reconstruction; the only way this can be proven is for NIOSH to be given the
opportunity to perform a dose reconstruction. Therefore, in order to succeed petitioners
must prove that a dose reconstruction cannot be done and they must be able to challenge
a dose reconstruction that has been done by NIOSH. There is no time limit on how long
NIOSH can take to conduct a dose reconstruction or to review a subsequent SEC petition.
Thus, it is likely that workers for whom NIOSH cannot perform a dose reconstruction
will have to wait at least two years for NIOSH to complete its work. This built in delay
is not acceptable under any circumstances, and is especially cruel given that these
claimants have cancer. The approach of this rule is not what Congress intended; it
creates an undue burden on workers to prove their case, and will not result in a timely
disposition of petitions.

Core BCTD Concerns

The core of BCTD’s concern rests with NIOSH’s interpretation of the EEOICP statute,
and the actions that follow from that interpretation, in which there is a strong likelihood
that (1) NIOSH has created an adversarial proceeding in which a class of workers without
resources is once again pitted against the Government with its unlimited resources, (2) it
has shifted the burden of proof from DOE to show that records are complete on to
workers to prove that records are totally incomplete, and (3) it has lost sense of the need
for timely disposition of these claims. This places an undue burden on workers which is
BCTD Comments on NIOSH Proposed SEC Rule



patently unfair. At its core, the NIOSH rule proposes the following steps, with BCTD
comments and proposed alternative approach:

1. NIOSH expects that petitions shall prove that (1) it is not feasible to
estimate with sufficient accuracy the radiation dose that the class received
using as the benchmark its own dose reconstruction model; and (2) that
there is reasonable likelihood that such radiation dose may have
endangered the health of members of the class. NIOSH offers some
assistance, but only if petitioners prove that they cannot get access to all
exposure information. The BCTD contends that Congress did not intend
that it was the duty of petitioners to provide proof of these conditions, but
rather to show that it was possible for these conditions to exist. Had it
been the Congressional intent that petitioners prove these conditions, it
would surely have included workers in Section 3625(b) which directs DOE
to provide such information, but only to DHHS and members and staff of
the Advisory Board. NIOSH should reconsider this interpretation, and
revise the rule to incorporate as the criterion for consideration of
petitions that petitioners shall show that there is a reasonable likelihood
that some exposure records may be incomplete.

2. Upon receipt of the petition, NIOSH will then evaluate (or challenge) the |
petition to determine whether it is sufficiently documented and justified to
be considered by the Advisory Board. To do this, NIOSH expects that the
petitioners will have conducted exposure assessments by radiation health
professionals that are in terms of scope and quality equivalent to what
NIOSH itself might have conducted. The NIOSH rule also limits the
burden of proof that it places upon petitioners to one test: SEC
membership qualifies only where a dose reconstruction cannot be
performed. Therefore, for all practical purposes, NIOSH requires
petitioners to prove that dose reconstructions cannot be performed on
members of the class before NIOSH will accept the petition. The BCTD
contends that it is unreasonable for NIOSH to expect that workers meet
this burden of proof. Workers are not radiation health professionals, and
in most cases will not have the resources to obtain such expertise, and
even if they did, such expertise is rarely available to workers. Further,
since the statute does not give workers access to all the needed
information held by DOE, it is unreasonable to expect that workers will be
able to obtain such information based on the history of obfuscation that
has characterized DOE's response to private requests for radiation
exposure data and information. NIOSH should revise the rule to read
that upon acceptance of the petition NIOSH will determine whether
there is sufficient exposure information available to make individual
dose estimates.

BCTD Comments on NIOSH Proposed SEC Rule