Tab B

42 CER. pt. 83



Federal Register/Vol

69, No. 104/Friday, May 28, 2004/Rules and Regulations

30783

days for the petitioner(s) to revise the
petition accordingly.

(b) After 30 calendar days from the
date of notification under paragraph (a)
of this section, NIOSH will notify any
petitioner(s) whose petition remains
unsatisfactory of the proposed finding of
NIOSH that the petition fails to meet the
specified requirements and the basis for
this finding.

(c) A petitioner may request in writing
a review of a proposed finding within
30 calendar days of notification under
paragraph (b) of this section. Petitioners
must specify why the proposed finding
should be reversed, based on the
petition requirements and on the
information that the petitioners had
already submitted. The request may not
include any new information or
documentation that was not included in
the completed petition. If the petitioner
obtains new information within this 30
day period, the petitioner should
provide it to NIOSH. NIOSH will
consider this new information as a
revision of the petition under paragraph
(a) of this section.

(d) Three HHS personnel, appointed
by the Director of NIOSH, who were not
involved in developing the proposed
finding will complete reviews within 30
work days of the request for such a
review. The Director of NIOSH will
consider the results of the review and
then make a final decision as to whether
the petition satisfies the requirements
for evaluation.

(e) Proposed findings established by
NIOSH under paragraph (b) of this
section will become final decisions in
31 calendar days if not reviewed under
paragraph (d) of this section.

(f)} Based on new information, NIOSH
may, at its discretion, reconsider a
decision not to select a petition for
evaluation.

§83.12 How will NIOSH notify petitioners,
the Board, and the public of petitions that
have been selected for evaluation?

(a) NIOSH will notify the petitioner(s)
in writing that it has selected the
petition for evaluation. NIOSH will also
provide the petitioner(s) with
information on the steps of the
evaluation and other processes required
pursuant to these procedures.

(b) NIOSH will combine separate
petitions and evaluate them as a single
petition if, at this or at any point in the
evaluation process under §§ 83.13 and
83.14, NIOSH finds such petitions
represent the same class of employees.

(c) NIOSH will present petitions
selected for evaluation to the Board with
plans specific to evaluating each
petition. Each evaluation plan will
include the following elements:

(1) An initial proposed definition for
the class being evaluated, subject to
revision as warranted by the evaluation
conducted under § 83.13 or § 83.14; and

(2) A list of activities for evaluating
the radiation exposure potential of the
class and the adequacy of existing
records and information needed to
conduct dose reconstructions for all
class members under 42 CFR Part 82.

(d) NIOSH may initiate work to
evaluate a petition immediately, prior to
presenting the petition and evaluation
plan to the Board.

(e) NIOSH will publish a notice in the
Federal Register notifying the public of
its decision to evaluate a petition.

§83.13 How will NIOSH evaluate petitions,
other than petitions by claimants covered
under § 83.14?

(a) NIOSH will collect information on
the types and levels of radiation
exposures that potential members of the
class may have incurred, as specified
under 42 CFR 83.14, from the following
potential sources, as necessary:

(1) The petition or petitions submitted
on behalf of the class;

(2) DOE and AWE facility records and
information;

(3) Potential members of the class and
their survivors;

(4) Labor organizations who represent
or represented employees at the facility
during the relevant period of
employment;

(5) Managers, radiation safety
officials, and other witnesses present
during the relevant period of
employment at the DOE facility or AWE
facility;

(6) NIOSH records from
epidemiological research on DOE
populations and records from dose
reconstructions conducted under 42
CFR part 82;

(7) Records from research, dose
reconstructions, medical screening
programs, and other related activities
conducted to evaluate the health and/or
radiation exposures of DOE employees,
DOE contractor or subcontractor
employees, and/or AWE employees; and

(8) Other sources.

(b) The Director of OCAS may
determine that records and/or
information requested from DOE, an
AWE, or another source to evaluate a
petition is not, or wil] not be, available
on a timely basis. Such a determination
will be treated, for the purposes of the
petition evaluation, as equivalent toa
finding that the records and/or
information requested are not available.

(1) Before the Director of OCAS makes
such a determination, the source(s)
potentially in possession of such
records and/or information will be

allowed a reasonable amount of time, as
determined by the Director of OCAS, to
provide the records and/or information.

(2) Such a determination may take
into account the types and quantity of
records and/or information requested
from the source, as well as any other
factors that might be relevant to the
judgment under paragraph (b)(1) of this
this section of the amount of time that
is reasonable to provide the records
and/or information, which would be
decided on a case-by-case basis by the
Director of OCAS.

(c) NIOSH will evaluate records and
information collected to make the
following determinations:

(1) Is it feasible to estimate the level
of radiation doses of individual
members of the class with sufficient
accuracy? (i) 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, for every type
of cancer for which radiation doses are
reconstructed, that could have been
incurred in plausible circumstances by
any member of the class, or if NIOSH
has established that it has access to
sufficient information to estimate the
radiation doses of members of the class
more precisely than an estimate of the
maximum radiation dose. NIOSH must
also determine that it has information
regarding monitoring, source, source
term, or process from the site where the
employees worked to serve as the basis
for a dose reconstruction. This basis
requirement does not limit NIOSH to
using only or primarily information
from the site where the employee
worked, but a dose reconstruction must,
as a starting point, be based on some
information from the site where the
employee worked.

(ii) In many circumstances, to
establish a positive finding under
paragraph (c)(1)(i) of this section would
require, at a minimum, that NIOSH have
access to reliable information on the
identity or set of possible identities and
maximum quantity of each radionuclide
(the radioactive source material) to _
which members of the class were
potentially exposed without adequate
protection. Alternatively, if members of
the class were potentially exposed
without adequate protection to
unmonitored radiation from radiation

generating equipment (e.g., particle

accelerator, industrial x-ray equipment),
in many circumstances, NIOSH would
require relevant equipment design and
performance specifications or
information on maximum emissions.
(iii) In many circumstances, to
establish a positive finding under
paragraph (c)(1)(i) of this section would



Federal Register / Vol.

69, No. 104/Friday, May 28, 2004/Rules and Regulations

30779

a subordinate role in the adjudication of
claims under EEOICPA, serving as one
element of an adjudication process
administered by DOL under 20 CFR
Parts 1 and 30. DOL has determined that
its rule fulfills the requirements of E.O.
12866 and provides estimates of the
aggregate cost of benefits and
administrative expenses of
implementing EEOICPA under its rule
(see 66 FR 28948, May 25, 2001). OMB
has reviewed this Special Exposure
Cohort rule for consistency with the
President’s priorities and the principles
set forth in E.O. 12866.

B, Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA),
5 U.S.C. 601 et seq., requires each
agency to consider the potential impact
of its regulations on small entities
including small businesses, small
governmental units, and small not-for- ,
profit organizations. We certify that this
rule will not have a significant
economic impact on a substantial
number of small entities within the
meaning of the RFA. The rule affects
only DOL, DOE, HHS, and certain
individuals covered by EEOICPA.
Therefore, a regulatory flexibility
analysis as provided for under RFA is
not required.

C. What Are the Paperwork and Other
Information Collection Requirements
(Subject to the Paperwork Reduction
Act) Imposed Under This Rule?

The Paperwork Reduction Act is
icable to the data collection aspects
of this rule. Under the Paperwork
Reduction Act of 1995, a Federal agency
shall not conduct or sponsor a
collection of information from ten or
more persons other than Federal
employees unless the agency has
submitted a Standard Form 83,
Clearance Request, and Notice of
Action, to the Director of the Office of
Management and Budget (OMB), and
the Director has approved the proposed
collection of information. A person is
not required to respond to a collection
of information unless it displays a
currently valid OMB control number. .

NIOSH has obtained approval from
OMB to collect data as specified under
this rule under OMB Control No. 0920-
0639.

The rule requires classes of employees
seeking to be added to the Special
Exposure Cohort to submit written
petitions for such consideration to
NIOSH. HHS has specified the
information that petitioners are required
to include in their petitions. All
petitioners will be required to include
identifying and contact information.
Other informational requirements will

depend on the circumstances of the
petition. Petitioners who are claimants
for Widm NIOSH has attempted to¥
complete a dose reconstruction under
42 CFR Part 82 and has concluded that
the dose reconstruction is not feasible
are only required to acknowledge their
intent to petition; no other information
is required. All other petitioners will
have to provide more extensive
information that comprises the
justification for their petition.

NIOSH will make available to
petitioners a petition form and
instructions to assist petitioners. As
appropriate, NIOSH will also provide an
authorization form that would be
iduals who seek to
to serve as petitioners.
The authorization form is mandatory
but the petition form is not mandatory.

The only cost to respondents is their
time to complete and submit the
petition.

D. Small Business Regulatory
Enforcement Fairness Act

As required by Congress under the
Small Business Regulatory Enforcement
Fairness Act of 1996 (5 U.S.C. 801 et
seq.), the Department will report to
Congress promulgation of this rule prior
to its taking effect. The report will state
that the Department has concluded that
rule is not a “major rule” because

it is not likely to result in an annual
effect on the economy of $100 million
or more. However, this rule has a
subordinate role in the adjudication of
claims under EEOICPA, serving as one
element of an adjudication process
administered by DOL under 20 CFR
Parts 1 and 30. DOL has determined that
its rule is a “major rule” because it will
likely result in an annual effect on the
economy of $100 million or more.

E. Unfunded Mandates Reform Act of
1995

Title II of the Unfunded Mandates
Reform Act of 1995 (2 U.S.C. 1531 et
seq.) directs agencies to assess the
effects of Federal regulatory actions on
State, local, and tribal governments, and
the private sector “other than to the
extent that such regulations incorporate
requirements specifically set forth in
law.” For purposes of the Unfunded
Mandates Reform Act, this rule does not
include any Federal mandate that may
result in increased annual expenditures
in excess of $100 million by State, local
or tribal governments in the aggregate,
or by the private sector.

F. Executive Order 12988 (Civil Justice)

This rule has been drafted and
reviewed in accordance with Executive
Order 12988, Civil Justice Reform and

will not unduly burden the Federal
court system. HHS adverse decisions
may be reviewed in United States
District Courts pursuant to the
Administrative Procedure Act. HHS has
attempted to minimize that burden by
providing petitioners an opportunity to
seek administrative review of adverse
decisions. HHS has provided a clear
legal standard it will apply in
considering petitions. This rule has
been reviewed carefully to eliminate
drafting errors and ambiguities.

G. Executive Order 13132 (Federalism)

The Department has reviewed this
tule in accordance with Executive Order
13132 regarding federalism, and has
determined that it does not have
“federalism implications.” The rule
does not “have substantial direct effects
on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government.”

H. Executive Order 13045 (Protection of
Children From Environmental, Health
Risks and Safety Risks)

In accordance with Executive Order
13045, HHS has evaluated the
environmental health and safety effects
of this rule on children. HHS has
determined that the rule would have no
effect on children.

I. Executive Order 13211 (Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use)

In accordance with Executive Order
13211, HHS has evaluated the effects of
this rule on energy supply, distribution
or use, and has determined that the rule
will not have a significant adverse effect
on them.

J. Effective Date and Information
Collection Approval

The Secretary has determined,
pursuant to 5 U.S.C. 553(d)(3), that there
is good cause for this rule to be effective
immediately to avoid undue hardship
on and facilitate payment to eligible
claimants.

The Office of Management and Budget
(OMB) approved these information
collection requirements on
{****INSERT DATE****] and assigned
contro] number |****INSERT
NUMBER****].

List of Subjects in 42 CFR Part 83

Government employees, Occupational
safety and health, Nuclear materials,
Radiation protection, Radioactive
materials, Workers’ compensation.



75950

Federal Register/Vol. 70,

No. Ioas Thursday, December 22, 2005/Rules and Regulations

Word Perfect file attachment.:Printed
comments can also be submitted to the
address above. All communications
received on or before the closing date
for comments will be fully considered
by the Secretary. An electronic docket
containing all comments submitted will
be available over the Internet on the
Web page of the National Institute for
Occupational Safety and Health
(“NIOSH”), Office of Compensation
Analysis and Support at hitp://
www.cde.gov/niosh/ocas, and comments
will be available in writing by request.

Il. Purpose of Rulemaking

On October 28, 2004, the President
signed the Ronald W. Reagan National
Defense Authorization Act for Fiscal
Year 2005, Public Law 108-375
(codified as amended in scattered
sections of 42 U.S.C.). Division C,
Subtitle E, of this Act includes _
amendments to the Energy Employees
Occupational Illness Compensation
Program Act (‘“EEOICPA”) 42 U.S.C.
7384-7385. Several of these
amendments, under section 3166 (b),
establish new statutory requirements
under 42 U.S.C. 7384q and
73841(14)(C)(ii), relevant to the
Department of Health and Human
Services (“HHS”) procedures
established under 42 CFR part 83:
“Procedures for Designating Classes of
Employees as Members of the Special
Exposure Cohort under the Energy,
Employees Occupational Illness
Compensation Program Act of 2000.””
These new requirements include the
following: (1) Following the receipt by
NIOSH ofa petition for designation as
members of the Cohort, NIOSH must
submit ‘a recommendation” on that,
petition, including all documentation,
to the Advisory Board on Radiation and
Worker Health (“the Board”) within 180
days; (2) following the receipt by the
Secretary of HHS (“‘the Secretary”) of a
recommendation by the Board that the
Secretary determine in the affirmative
that a class meets the statutory criteria
for addition to the Cohort, the Secretary
must submit to Congress a
determination as to whether or not the
class meets these statutory criteria
within 30 days; (3) if the Secretary does
not submit this determination to
Congress within 30 days, then it shal] be
deemed that the Secretary has submitted
a report to Congress on the 31st day that
designates, as an addition to the Cohort,
the class recommended by the Board for
addition to the Cohort and that provides
the criteria used to support the
designation; and (4) the period for
Congress to review a report submitted
by the Secretary to designate a class as

i i
an addition to the Cohort is teduced
from 180 days to 30 days. |

To implement these new

requirements, HHS must amend 42 CFR
part|83. Als discussed below} some of the
changes to the HHS rule are|necessary
legally for compliance with the new
requirements and other changes are
necessary, to make implementation of
the fequifements feasible. |

m1. Summary of the Rule Changes

HHS has made changes to four
sections of the Cohort rule to implement
the hew statutory requirements
summarized above. These changes are
described below in relation to the
relevant statutory requirement.

if
A, 190-Ddy Deadline for NIOSH
Recommendations

HHS has amended §§ 83.! 5 and 83.11
of the tule to enable NIOSH ito meet the
statutory Fequirement that NIOSH
submit tothe Board“a |
recommendation” on a petition within
180|days bf its receipt (see 42 U.S.C.
7384q(c)(1)). The change to § 83.5
provides A definition of a petition,
which was previously undefined in the
tule! to specify that only submissions by
qualified petitioners that meet the
informational and procedural
requirements of a petition under the
tule will be-considered to bé “petitions”
and!hence will be covered by the 180-
day/deadli ine. This provision is
necessary to clarify that the submission
of alpetition by an unqualified
petitiones or the submission ofan :
incgmplet e petition does not initiate the
180: day 1 quirement. NIOSH experience
with petitions demonstrates that it may
take months to assist and consult with
petitioners to help make incompletely
submitte petitions as complete and
accurate as possible. Starting the 180-
day|requirement after such preparatory
work of the petitioners will help
support the completion of the NIOSH
evaluation of the petition within 180-
day|deadfi ine. NIOSH will provide
written notification to the submitter
indicating the official date the
submissign qualified as a petition, thus
starting the 180-day deadline for
providing a recommendation to the
Board.

The changes to § 83.11 support the
distinction between an incomplete or”
non!-qualifying submission and a
petit ion, which is subject tothe 180-day
deadline, They include the substitution
of the term “submission” for “petition”
where appropriate. |

HHS has also amended paragraph (c)
of §{83.11 to reduce, from 30 to 7
calendar days, the time during which a
petitioner can request a review of a

proposed finding by NIOSH that the
petition fails to meet the specified
requirements. Seven days is sufficient
time for the petitioner to make such a
request and the 21 days potentially
saved by such a change are necessary to
support the completion of the NIOSH
evaluation of the petition within 180
days, should the review determine that
the petition satisfies the requirements of
a petition: Consistent with this change,
HHS has also amended paragraph (e) of
§ 83.11 to reduce, from 31 to 8 calendar
days, the time at which a proposed
finding by NIOSH under paragraph (b)
becomes final if no review is conducted.

B. 30-Day Deadline for Determinations
by HHS

HHS has amended §§ 83.16 and 83.17
and added a new § 83.18 of the rule to
enable HHS to meet the statutory
requirement that the Secretary submit to
Congress determinations as to whether
or not a class meets the statutory criteria
for addition to the Cohort within 30
days of the Secretary receiving a
recommendation by the Board to make
an affirmative determination in this
regard (see 42 U.S.C. 7384q(c)(2)(A)-
(B)). The changes to § 83.16 remove the
opportunity for petitioners to seek an
administrative review of proposed .
decisions by the Director of NIOSH.
This change is being made because it
would not be possible for the Director
of NIOSH to issue a proposed decision,
for petitioners to seek and HHS to
provide an administrative review of the
proposed decision, and for the Secretary
to issue a final decision, all within the
30-day congressional report deadline.

HHS has added provisions under a
new § 83.18 (the existing § 83.18 is
redesignated as § 83.19) to provide
petitioners with the opportunity to seek
administrative reviews of final decisions
by the Secretary, since petitioners will
no longer have the opportunity to seek
administrative reviews of proposed
decisions. This new administrative
review opportunity is essentially
identical to that provided previously
under § 83.16 for proposed decisions.

Under § 83.16(c) and § 83.17(b), HHS
has provided for the Secretary to submit
to Congress within 30 days the
determinations required under the
statutory 30-day deadline.

C. Computation of Time Periods

HHS has added a new paragraph (c)
“Computation of Time Periods” under
§ 83.5 to specify how HHS'and NIOSH
will count the time periods for the
various deadlines included in the rule.


(2) NIOSH did not identify any evidence from the petitioners or from other resources
that would establish that the class was exposed to radiation during a discrete
incident likely to have involved exceptionally high-level exposures, such as a
nuclear criticality incident, as defined under 42 C.F.R. § 83.13(c)(3)(i).

(3) The Board concurred with NIOSH’s finding that the health of the class may have
been endangered and defined the class according to the 250-workday requirement
specified under 42 C.F.R. § 83.13(c)(3)(ii).

Vv. — Effect and Effective Date of Designation

The Secretary submits this report on the designation of one additional class to the
SEC for review by Congress, pursuant to 42 U.S.C. §§ 7384/(14)(C)(ii) and
7384q(c)(2)(A), as amended by the Ronald W. Reagan National Defense
Authorization Act for Fiscal Year 2005, Pub. L. No. 108-375 (codified as amended in
scattered sections of 42 U.S.C.). Pursuant to 42 U.S.C. § 7384/(14)(C)(ii), as
amended by the Ronald W. Reagan National Defense Authorization Act for Fiscal
Year 2005, Pub. L. No. 108-375 (codified as amended in scattered sections of 42
U.S.C.), the designation in this report will become effective 30 days after the date of
this report’s submission to Congress “unless Congress otherwise provides.”

VI. Administrative Review of Designation

The health endangerment determination of the designation provided in this report
may be subject to an administrative review within HHS, pursuant to 42 C.F.R. §
83.18(a). On the basis of such a review, if the Secretary decides to expand the class
of employees covered by this designation, the Secretary would transmit a
supplementary report to Congress providing the expanded employee class definition
and the criteria and findings on which the decision was based.

HHS Special Exposure Cohort Designation:
Combustion Engineering



SEC-00099 12-14-07 Combustion Engineering

11.0 References

42 CFR. pt. 81, Guidelines for Determining the Probability of Causation Under the Energy
Employees Occupational Illness Compensation Program Act of 2000; Final Rule, Federal
Register/Vol. 67, No. 85/Thursday, p 22296; May 2, 2002; SRDB Ref ID: 19391

42 CFR. pt. 82, Methods for Radiation Dose Reconstruction Under the Energy Employees
Occupational Illness Compensation Program Act of 2000; Final Rule; May 2, 2002; SRDB Ref ID: ~
19392

42 C.F.R. pt. 83, Procedures for Designating Classes of Employees as Members of the Special
Exposure Cohort Under the Energy Employees Occupational Illness Compensation Program Act of
2000; Final Rule; May 28, 2004; SRDB Ref ID: 22001

42 U.S.C. §§ 7384-7385 [EEOICPA], Energy Employees Occupational Illness Compensation
Program Act of 2000; as amended; OCAS website

OCAS-PR-004, Internal Procedures for the Evaluation of Special Exposure Cohort Petitions, Rev. 0,
National Institute for Occupational Safety and Health (NIOSH); Cincinnati, Ohio; September 23,
2004

ORAUT-OTIB-0006, Dose Reconstruction from Occupationally Related Diagnostic X-Ray
Procedures, Rev. 3, PC-1, Oak Ridge Associated Universities Team (ORAUT), Oak Ridge,
Tennessee, December 21, 2005

ORAUT-TKBS-0017-1, Technical Basis Document for the Fernald Environmental Management
Project - Introduction, Rev. 1, Oak Ridge Associated Universities Team (ORAUT), Oak Ridge,
Tennessee, March 17, 2004; SRDB Ref ID: 19478

ORAUT-TKBS-0017-5, Technical Basis Document for the Fernald Environmental Management
Project - Occupational Internal Dose, Rev. 00, Oak Ridge Associated Universities Team (ORAUT),
Oak Ridge, Tennessee, May 28, 2004; SRDB Ref ID: 19485

CE, 1991, Memo from Jack C. Moulton, (CE Program Manager) to James W. Wagoner II (Acting
Chief, Off-Site Branch, Division of Eastern Programs, DOE Office of Environmental Restoration)
requesting FUSRAP designation for AEC-related areas of the Combustion Engineering site in
Windsor, Connecticut

CE, 1996, Response to DOE Questions, memo and enclosures from John F. Conant (Combustion
Engineering Senior Project Manager) to Mr. Albert S. Johnson (DOE FUSRAP Team); September 4,
1996; SRDB Ref ID: 6475, pdf pages 45-50

FUSRAP, 1994, Authority Determination —- Combustion Engineering Site, Windsor, Connecticut, U.S.

Department of Energy; Formerly Utilized Site Remedial Action Program (FUSRAP); June 20, 1994;
SRDB Ref ID: 6248 pdf pp. 147-149; CE Site Map, pdf page 19

19 of 20



SEC Petition Evaluation Report
Petition SEC-00099

Report Rev #_0 Report Submittal Date:_December 14, 2007
Subject Expert(s): Michael J. Domal, Michael S. Kubiak |
Site Expert(s): N/A :

——

SEC-00099 83.14 October 9, 2007 Combustion Engineering

[rroposed{GlassiDefinition|
All AWE employees who were monitored, or should have been monitored, for exposure to ionizing
radiation while working at the Combustion Engineering site in Windsor, Connecticut, for a number of
work days aggregating at least 250 work days from January 1, 1965 through December 31, 1972, or in
combination with work days within the parameters established for one or more other Classes of
employees in the SEC.

[”””—CC FS —*d
ESEG)Petitionyrrackingy} (SRM [MPetlionWhy pel MENNDOE/AWEIRScilityIName MN MNBP.StitionlStatas a

None
|

IRelatediE Valuation \Reportiln format ir Acc cr
200 nn DOE AW ER AcilityNs aa

None

ORAU Lead Technical Evaluator: Michael J. Domal | ORAU Review Completed By: Michael S. Kubiak

i

Peer Review Completed By: [Signature on file] 12/14/2007
LaVon B. Rutherford : Date
SEC Petition Evaluation Reviewed By: [Signature on file] » 12/17/2007
J. W. Neton | Date
]
SEC Evaluation Approved By: {Signature on file] : 12/17/2007

Larry Elliott H Date



I
|
|
|

18/83/2887 98:19 8606784338 , PAGE 02/87
i i
i :

Special Exposure Cohort Petition us! Department of Health and Human Services
under the Energy Employees Occupational | Centers for Dise4se Control and Prevention
Mnass Compensation Act National Institute for ipational Safety and Health

. | ” OMB Number, 0920-0638 | Expires: 05/31/2007
Special Exposure Cohort Petition — Form\|A : Page 2 of 2
=

| Putie Burden Statement
Public reporting burden for this collectioh of information is estimated to average 3 minutes per response,
including time for reviewing instructions! gathering the information needed, and completing the form. if you
have any comments regarding the burden estimate or any other aspect of this cree of information,

including suggestions for reducing this burden, send them to CDC Reports Clearance Officer, 1600 Clifton
Road, MS-E-11, Atianta GA, 30333; ATIN: PRA 0920-0639. Do not send the completed petition form to this
address, Completed petitions are to be Submitted to NIOSH at tne address provided in these instructions.
Persons are not required to respond to the information collected on this form unless it dI splays @ currently
valid OMB number, | | .

| Pri cy Act Advisement

In accordance with the Privacy Act of 1974, is amended (5 U.S.C. § 552a), you are hereby notified of the
following: ‘

The Energy Employees Occupational illness ompensation Program Act (42 U.S.C. §§| 7384-7385)
{EEOICPA) authorizes the President to designate additional classes of employees to bé included in the
Special Exposure Cohort (SEC). EEOICPA authorizes HHS to implement its responsibilities with the
assistarica of the National Institute for Occupational Safety (NIOSH), an Institute of the (Centers for Disease
Control and Prevention. Information obtained ! by NIOSH in connection with petitions forlincluding additional
classes of employees in the SEC will be used to evaluate the qetition’é ‘and report findings to the Advisory
Board on Radiation and Worker Health land HHS, i

Records containing identifiable information become part of an existing NIOSH system of records under the «
Privacy Act, 09-20-147 “Occupational Health Epidemiological Studies ‘and EEQICPA Phogram Records.
HHS/COC/NIOSH.” These records are treated in a confidential manner, unless otherwise compelled by law.
Disclosures that NIOSH may need to make for Ihe processing of your petition or other purposes are listed
below. | \

NIOSH may need to disclose personal identi jing information to: (a) the Department of Energy, other federal
agencies, other government or private enti S and to private sector employers to permit these entities to
retrieve records required by NIOSH: (b) identified witnesses as designated by NIOSH so that these
individuals can provide information to assist with the evaluation of SEC petitions; (c) contractors assisting
NIOSH; (d) collaborating researchers, under Certain limited circumstances to conduct further investigations;
(e) Federal, state and local agencies fot law enforcement purposes; and (f) a Member a Congress ora
Congressional staff member in response to a verified inquiry. a
| . :
This notice applies to all forms and informational requests that'you may receive from NIOSH in connection
with the evaluation of an SEC petition. | | j
Use of the NIOSH petition forms (A and 8) is voluntary but your provision of information required by thase
forms is mandatory for the consideration of a petition, as nei under 42 CFR Part 43. Petitions that fail to
provide required information may not be dered by HHS. i

|
|
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l
Name or Social Security Number of First TI wes we be



SEC-00099 12-14-07 Combustion Engineering

Table of Contents

Evaluation Report Summary: SEC-00099, Combustion Engineering ................eee | soeeseeseneeseeseeeees 3

1.0 — Purpose and ScOpe........scccccsecsecsssecsessessssesseseesessecsesssssesssssessecsseassessusesessesssussusesssesenesseeseeseeseenees 7
2.0 Introduction ..........ecsssseseeeecssssseeeecssssnneeeeseesssnnnseetecssssseee cevesessnssteensessvnseseslsseunsstevnesseeeee 7
3.0  NIOSH-Proposed Class Definition and Petition Basis..........c.cccsccssssscessssssssseeleccssssssemeecsecesssee 8
1

4.0 Radiological Operations Relevant to the Proposed Class . :

4.1 Operations Description

4.2 Radiation Exposure Potential from Operations.

4.3 Time Period Associated with Radiological Operations...

4.4 Site Locations Associated with Radiological Operations

4.5 Job Descriptions Affected by Radiological Operations ..
5.0 Summary of Available Monitoring Data for the Proposed Class.

5.1 Internal Personnel Monitoring Data

5.2 External Personnel Monitoring Data

5.3. Workplace Monitoring Data

5.4 Radiological Source Term Data
6.0 Feasibility of Dose Reconstruction for the Proposed Clas:

6.1 Feasibility of Estimating Internal Exposures

6.2 Feasibility of Estimating External Exposures .........0.ccccscceescceeeseseetesesteeseeteeeseeeeessteeeee LO
7.0 Summary of Feasibility Findings for Petition SEC-00099............cessesesseseseeeseeeeeeereeeseeneseees 16
8.0 Evaluation of Health Endangerment for Petition SEC-00099..........c.escecsessessessecsessessesenceneeneenee 17
9.0 | NIOSH-Proposed Class for Petition SEC-00099 ........:sceccsesssesseessesssesseesseesseessecsneesneessecsseesneeees 18
10.0 Evaluation of Second Similar Class ............cessesseesetesessssesesseesssesssssesseeasssseecssseseeessresseesessesseeee 18
11.0 References .......ceccccccecssecssesseesessecssessessecsuessscsseesseessesssscssscssessvsevesseeasesssussuecsuessuesnesssecssecsneesneettes 19

5 of 20


SEC-00099 12-14-07 Combustion Engineering

4.1 Operations Description

Combustion Engineering (CE) sent shipments of uranium to Fernald between 1965 and 1972 for use
in nuclear weapons production. It is because of these shipments that the CE site qualifies as an
Atomic Weapons Employer for these years. The Fernald site was a uranium processing facility
designed to provide high-purity uranium metal products in support of the nuclear weapons production
program (ORAUT-TKBS-0017-1). No documentation describing the Combustion Engineering
on-site operations related to uranium shipments to Fernald has been Jocated.

In addition to the AWE work described above, Combustion Engineering has a history of non-
weapons-related radiological activities. For example, during the 1950s and 1960s, the Combustion
Engineering site was used for nuclear research, fabrication of nuclear fuel from highly-enriched
uranium (HEU), and construction of naval reactor prototypes for the Atomic Energy Commission
(AEC). Combustion Engineering performed HEU fuel fabrication (using 5% to 93% U-235) from
1955 through 1967. Since the 1960s, the facility has been licensed by the Nuclear Regulatory
Commission (NRC) to fabricate low-enriched uranium assemblies for light-water moderated
commercial power reactors, and to conduct research and development using light-water fuel.

4.2 Radiation Exposure Potential from Operations

The potential for internal and external radiation dose from uranium compounds existed at the
Combustion Engineering site, based on weapons-related uranium shipments made between 1965 and
1972. NIOSH does not know either what activities were performed with uranium compounds or.the
processing involved in uranium shipping operations. NIOSH has located documentation regarding the
Combustion Engineering shipments to Fernald, including dates, quantities, weight, and enrichment
classification (NMMSS); however, NIOSH has no indication as to the completeness of the
documentation. The earliest shipment date listed is December 1967; NIOSH has been unable to verify
whether additional shipments of AEC-related uranium were or were not made from Combustion
Engineering. The documentation available to NIOSH does not describe the work processes or
exposure conditions associated with the Combustion Engineering handling of the AEC shipments.

9 of 20





30766 Federal Register/Vol]. 69, No. |104/Friday, May 28, 2004 /Rules and Regulations

backlog of dose reconstructions, which (www.cd¢.gov/niosh/ocas}, provide step- and/or information required to evaluate
is aresult of the extensive development __ by-step practical information on how the petition and any other relevant
requirements of the dose reconstruction NIOSH will evaluate the availability of factors.

program. NJOSH began rect gcases _ information needed to estimate the Some Members of Congress also

requiring dose reconstructions in
October of 2001, long before the dose
reconstruction program could establish
even minimal capacity for completing
dose reconstructions. HHS completed
final rules establishing the methods of
dose reconstruction in May of 2002.
NIOSH awarded a contract to build
external capacity for conducting dose
reconstructions in September of 2002.

NIOSH and its contractor for dose
reconstructions are now employing
more than 300 staff (including more
than 100 health physicists) and are
working to complete tasks necessary to
eliminate the backlog. These tasks
include the completion of “site
profiles,” which summarize site-specific
exposure conditions, dosimetry, an
other relevant information. In parallel
with this necessary developmental
work, NIOSH is completing dose
reconstructions at an increasing pace for
cases involving sites for which NIOSH
has already issued site profiles and for
which site profiles are not needed. It
took NIOSH 26 months to complete the
first 1000 ‘dose reconstructidns. NIOSH
completed the second 1000 in 14 weeks.
This rate is continuing to improve.

An advocacy group and some
Members of Congress also
recommended HHS consider the cost of
dose reconstructions as a criterion for
feasibility, to avoid incurring
“prohibitive expense” in conducting a
dose reconstruction.

HHS has not included a'cost criterion
in the rule. The NIOSH dose
reconstruction program is designed with
procedures specifically intended to
minimize the time and financial
resources required for dose
reconstructions. Individual dose
reconstructions are presently costing an
average of less than $10,000 each. A
regulatory cost criterion would require
HHS to incur unproductive expenses
and might delay the consideration of
petitions substantially, since HHS
would have to estimate dose
reconstruction costs related to each
Cohort petition.

‘Some Members of Congress also
recommended that HHS consider the
deficiency or complete absence of
records as a criterion for feasibility.

HHS included such provisions in the
NPRM and in the final rule, as
discussed in the following section
discussing comments on “sufficient
accuracy.” NIOSH internal procedures
for evaluating petitions, available upon
request from NIOSH (1-800-356-4674)
or from the NIOSH Web page

radiation|doses of a class of employees
with sufficient accuracy. These
recommehded internal procedures do
not creaté any substantive rights on the
behalf of petitioners. Comments may be
provided|at any time about these
procedures to OCAS at ocas@cdc.gov.
Any subsequent revision-of. the internal
procedures will be posted on the NIOSH
Web site ht www.cde.gov/niosh/ocas. If
there are any substantial revisions to
these probedures, NIOSH will publish a
Federal Register Notice including an
indication that there have been
substantial revisions, a paragraph
summariting the changes, and that the
revised procedures can be found on the
NIOSH Web site at www.cd¢.gov/niosh/
ocas. Comments regarding these internal
procedures or any revisions'thereto are
invited. }
In addition, HHS has added a
provision to section 83.13(c}(1)(i) of the
rule, as part of the feasibility
detérmination by NIOSH under this
section, tb require that NIOSH
determine whether it has information
regarding monitoring, source, source
term, or process information from the
site where the employees worked to
serve as the basis for a dose;
reconstruction. EEOICPA requires that
determindtions of probability of
causation for claimants under EEOICPA
be based on the radiation dose received
by the employee (or a group of
employees performing similar work) at
the facility where the employee(s)
worked. 2 U.S.C. 7384n(c)(3)(A).
Congequ mtly, for NIOSH to determine
that! dose|reconstruction is feasible, dose
reconstruction must, as a starting point,
be based bn some information from the
site wherb the employee worked. This
basis reqhhirement does not limit NIOSH
to using dnly or primarily information
from the site where the employee
worked, ut it requires the use of some
information from the site.
HHS at also added a new § 83.13(b)

which authorizes the Director of the
Office of Compensation Analysis and
Support (OCAS) within NIOSH to
determine that records and/or
information requested from DOE, an
AWE, or another source to evaluate a
petition is not, or will not.bé, available
on a timely basis. Such a determination
willbe trpated, for the purposes of the
petition evaluation, as equivalent toa
finding tHat the records and/or
informatipn requested are not available.
This will facilitate the efforts of NIOSH
to evaluate petitions within a reasonable
amount of time in relation to the records

‘

recommended that the rule.clarify that
EEOICPA does not require a
demonstration that no “worst case
estimate”-can be reached for inclusion
in the Cohort.

HHS has clearly and conipletely
specified the statutory requirements of
EEOICPA relating to the addition of
classes of employees to the Cohort,
under section I(D) above. The rule itself
provides procedures by which HHS will
implement these statutory requirements.
Related specifically to the comment, to
add a class of employees to the Cohort,
EEOICPA requires that HHS find that “it
is not feasible to estimate with sufficient
accuracy the radiation dose that the
class received;* * *;” 42 U.S.C.
7384q(b). Subsection 83.13(c)(1) of this
rule specifies clearly the approach HHS
will use to evaluate feasibility. This
approach, as it relates to the statutory
requirement regarding feasibility, is
discussed above, in sections B and C
below, and in the second NPRM (68 FR
11296). The ability to estimate the
maximum radiation dose received by
members of a class,is technicallya +.
critical distinction between . "
circumstances in which it is feasible to
estimate radiation doses through dose. .
reconstruction and those in which itis
not feasible todoso. =; wot oe

B, Feasibility of Dose Reconstructions:
Relevance of Type of Cancer to
Feasibility Determinations

The NPRM included provisions that
would have allowed NIOSH to define a
class of employees that it would
recommend be added to the Cohort
according to the specific cancers for
which dose reconstruction is not
feasible and hence demonstrate a
reasonable likelihood of a dose that may
have endangered the health of members
of the class. Several commenters
questioned the scientific proposition
that it could be feasible to estimate
radiation doses for individuals with
certain cancers, but not feasible to
estimate doses for individuals with
other cancers. The statutory provisions
of EEOICPA neither require nor prohibi
HHS from establishing cancer-specific
classes.

The Board, which specifically
reviewed this issue, recognized that this
situation “may be scientifically and
theoretically possible.” Two theoretical
examples of this situation, involving
external radiation exposures (originating
from outside of the body), were
identified and considered during
meetings of the Board and were not



30784

Federal Register / Vol.

|

i
, !
69, No. 104/Friday, May 28, 2004/Rules and Regulations *

also require information describing the
process through which the radiation
exposures of concern may have
occurred and the physical environment
in which the exposures may have
occurred.

(iv) In many circumstances, access to
personal dosimetry data and area
monitoring data is not necessary to
estimate the maximum radiation doses
that could have been incurred by any
member of the class, although radiation
doses can be estimated more precisely
with such data.

(2) How should the class be defined,
consistent with the findings of the
analysis discussed under paragraph
(c)(1) of this section? NIOSH will define
the following characteristics of a class,
taking into account the class definition
proposed by the petition and modified
as necessary to reflect the results of the
evaluation under paragraph (c)(1) of this
section:

(i) Any of the following employment.
parameters, as necessary to identify
members included in the class: facility,
job titles, duties, and/or specific work
locations at the facility, the relevant
time period, and any additional
identifying characteristics of
employment; and

(ii) If applicable, the identification of
an exposure incident, when
unmonitored radiation exposure during
such an incident comprises the basis of
the petition or the class definition.

(3) Is there a reasonable likelihood
that such radiation dose may have
endangered the health of members of

. the class? If it is not feasible to estimate
with sufficient accuracy radiation doses
for members of the class, as provided
under paragraph (c)(1) of this section,
then NIOSH must determine, as
required by the statute, that “there is a
reasonable likelihood that such
radiation dose may have endangered
the health of members of the class” (42
U.S.C. 7384q(b)(2)).

(i) For classes of employees that may
have been exposed to radiation during
discrete incidents likely to have
involved exceptionally high level
exposures, such as nuclear criticality
incidents or other events involving
similarly high levels of exposures
resulting from the failure of radiation
protection controls, NIOSH will assume
for the purposes of this section that any,
duration of unprotected exposure could
cause a specified cancer, and hence may
have endangered the health of members
of the class. Presence with potential
exposure during the discrete incident,
rather than a quantified duration of
potential exposure, will satisfy the
health endangerment criterion.

Ll i

(ii) For health endangerment not
established on the basis of aidiscrete
incident, as described under paragraph
()(3)H) of this section, NIOSH will
specify a minimum duration of
emploympnt to satisfy the health
endangerjent criterion as having been
employed for a number of work days
aggregating at least 250 work days
within the parameters established for
the Class or in combination with work
days within the parameters established
for one or more other classes of
employers inthe Cohort. {

NIOSH will submit a report of its
evalluation findings to the Board and to
the petitioner(s). The report will include
the following elements: i

(1) An identification of the relevant
peutons;

(2) A proposed definition of the class
or classes of employees to which the
evaluation applies, and a summary of
the basis for this definition, including,
as necess: ry:

(i) Any justification that thay be
needed for the inclusion of groups of
employees who were not specified in
the priginlal petition(s); q

(ii) The identification of any groups of
employees who were identified in the
original petition(s) who should

constitute a separate class of employees;

(ili) The merging of multiple petitions
that|represent a single class of
employees;

(3) The|proposed class definition will
addtess the following employment
pardmetets: |

(i) The DOE facility or the AWE
facility thet employed the class;

(ii) The job titles and/or job duties
and/or work locations of class members;

period of employment within
th a dlass member must/have been
employed at the facility under the job
titles and/or performing theljob dutiés
and/or working in the locations
specified|in this class definition;

(i¥) If applicable, identification of an
exposure |incident, when potential
radiation lexposure during such an
incident comprises the basis of the class
definition; |
(w) If necessary, any other|parameters
that! serve to define the menibership of
the class;|and
(vi) For a class for which itis not
feasible to estimate radiation doses with
sulin accuracy, aminimum
duration of employment within the
par te of the class for inclusion in

i
the Class,|as defined under paragraph
(c)(3) of this section; |

(4) A summary of the findings
concerning the adequacy of existing
records ahd information for}
reconstructing doses for individual

members of the class under the methods
of 42 CFR Part 82, and a description of
the evaluation methods and information
upon which these findings‘are based;
and

(5) Fora class for which it is not
feasible to estimate radiation doses with
sufficient accuracy, a summary of the
basis for establishing the duration of
employment requirement with respect
to health endangerment.

§83.14 How will NIOSH evaluate a petition
by a claimant whose dose reconstruction
NIOSH could not complete under 42 CFR
Part 82?

(a) NIOSH may establish two classes
for evaluation, to permit the timely
adjudication of the existing cancer
claim:

(1) A class of employees defined using
the research and analyses already
completed in attempting the dose
reconstruction for the employee
identified in the-claimant’s petition; and

(2) A class of co-workers similar to the
class defined under paragraph (a)(1) of
this section, to be defined by NIOSH on
the basis of further research and
analyses, using the Procedures under
§ 83.13.

(b) NIOSH will determind the health .
endangerment criteria for adding the
class under paragraph (a)(1) of this
section ‘to the Cohort, using the
procedures under § 83.13. NIOSH will'
report to the Board and to petitioner(s)'
the results of this determination,
together with its finding under 42 CFR
Part 82 that there was insufficient
information to complete the dose
reconstruction. HHS will consider this
finding under 42 CFR Part 82 sufficient,
without further consideration, to
determine that it is not feasible to
estimate the levels of radiation doses of
individual members of the‘class with
sufficient accuracy.

(c) NIOSH will evaluate the petition
as it may concern a class of co-workers,
as described under paragraph (a)(2) of
this section, according to the procedures
under § 83.13.

§83.15 How will the Board consider and
advise the Secretary on a petition?

(a) NIOSH will publish a notice in the
Federal Register providing notice of a
Board meeting at which a petition will
be considered, and summarizing the
petition to be considered by the Board
at the meeting and the findings of
NIOSH from evaluating the petition.

(b) The Board will consider the
petition and the NIOSH evaluation
report at the meeting, to which the
petitioner(s) will be invited to present
views and information on the petition
and the NIOSH evaluation findings. In



SEC-00099

12-14-07 Combustion Engineering

|
9.0 NIOSH-Proposed Class for Petition SEC-00099

ord .
The evaluation defines a single class of employees for which NIOSH cannot estimate radiation doses

with sufficient accuracy. This class! incl
have been monitored, for exposure to io
site in Windsor, Connecticut, for a rumb
January 1, 1965 through December 81, |]
established for one or more other classes
10.0 Evaluation of second

In accordance with § 83.14(a), NIOSH
similar to the class defined in Section 9.
be feasible, but for whom additional res
addressed in a separate SEC evaluation,

time, NIOSH has not identified a second
site for whom dose reconstruction may n

udes all AWE employees who were monitored, or should
izing radiation while working at the Combustion Engineering
er of work days aggregating at least 250 work days from ~
972, or in combination with work days within the parameters
of employees in the SEC.

Ee Class

ay establish a second class of coworkers at the facility,

|, for whom NIOSH believes that dose reconstruction may not
arch and analyses are required. Such a class would be
lso as not to delay consideration of the current claim. At this
similar class of employees at the Combustion Engineering

ot be feasible.

18 of 20



THE SECRETARY OF HEALTH AND HUMAN SERVICES
WASHINGTON, D.C. 20201

MAR - 3 2008

The Honorable Richard Cheney
President of the United States Senate
Washington, D.C. 20510

Dear Mr. President:

Pursuant to the Energy Employees Occupational Illness Compensation Program Act of
2000 and 42 C.F.R. § 83.14, the Centers for Disease Control and Prevention’s (CDC) National
Institute for Occupational Safety and Health (NIOSH) initiated a petition for a class of workers
from the Combustion Engineering facility to be added to the Special Exposure Cohort (SEC).

On January 9, 2008, NIOSH presented its findings on the petition evaluation to the
Advisory Board on Radiation and Worker Health (Board). The Board considered the petition,
and on February 1, 2008, I received the Board’s recommendation concerning this petition. I
have also received the deliberations, findings, and recommendations of the Director of NIOSH
and the Director of CDC. I have designated the following class for addition to the SEC:

Atomic Weapons Employer (AWE) employees who worked at the Combustion
Engineering site in Windsor, Connecticut, from January 1, 1965, through
December 31, 1972, for a number of work days aggregating at least 250 work
days or in combination with work days within the parameters established for one
or more other classes of employees in the Special Exposure Cohort.

The criteria and findings upon which this designation is based are provided in the enclosed
report.

Please call me if you have any further questions regarding this matter.

Sincerely,

Michael O. Leavitt

Enclosure



Tab E

Board Recommendation Letter to Secretary Leavitt



SEC-00099

Combustion Engineering

FUSRAP, 1999, Characterization Repo
Volume I; U.S. Army Corps of Engineer

Action Program; October, 1999; SRDB
|

HASL, 1964, Combustion Engineering, Inc., Nuclear Di

and Fire Protection Survey; H. Glatberd

Division, Health and Safety Laboratory;
Office; March 10, 1964; SRDB RefiD:

License, 1965, Special Nuclear Material
Division; U.S. Atomic Energy Commissi

NMMSS, Nuclear Material Managemen,
Engineering LEU Shipments to Fernald,
SRDB

Quarterly, 1960, Quarterly Report: D he I.
Contract AT(30-1)-2379; U.S. Atomic E

Request, 1967, Request. for Authorid
H. Noyes (Manager, National Lead Com
Cincinnati Area Office); 1967; SRDB Re

12-14-07 |

't for Buildings 3 and 3A at the Combustion Engineering Site,
is, New England District; Formerly Utilized Sites Remedial
ef ID: 6475, Page 102

vision; Windsor, Connecticut: Health, Safety
an and A. A. Weintraub; Health Protection Engineering
U.S. Atomic Energy Commission; New York Operations

4815

License for Combustion Engineering, Inc., Nuclear
ion; August 9, 1965; SRDB Ref ID: 6537

and Safeguards System (NMMSS) Extract of Combustion
U.S. Department of Energy; SRDB Ref ID: Not currently in

evelopment& Testing of Homogenous Ceramic Fuels;
nergy Commission; December, 1960: SRDB Ref ID: 31925

to Remove Depleted Uranium from Inventory, memo from J.

pany of Ohio) td C. L. Karl (Area Manager; USAEC,
f ID: 29932

i
20 of 20 |



‘

The Honorable Michael O. Leavitt

January 30, 2008

e NIOSH deterinined that health may have been endangered for these Combustion
Engineering facility workers. The-Board concurs with this determination.

Enclosed is supporting documentation from the recent Advisory Board Meeting held in Las Vegas,
Nevada where this.class of the special exposure cohort was discussed. If'any of these items are

unavailable at this time, they will follo’

P.
C

Enc.

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Si

shortly.

incerely,

LEO

‘aul L. Ziemer, Ph:D.

haitman



Federal Register/Vol.

69, No. 104/Friday, May 28, 2004/Rules and Regulations

30777

public and are included in the NIOSH
docket for this rule. .

All of the Board members participated
in the review of the second NPRM and
concurred in establishing the Board
findings and recommendations, with the
exception of an abstention by one Board
member concerning one finding and
recommendation. The Board provided
several recommendations on substantial
issues addressed in the NPRM, as well
as recommendations for clarifying
specific sections of the NPRM. The
recommendations, which are available
to the public from the NIOSH docket for
this rule, are summarized below,
together with responses by HHS to the
recommendations.

A. Removing Cancer-Specific Provisions
Concerning Determinations of the
Feasibility of Dose Reconstruction

The Board recommended that HHS
remove provisions of the NPRM in
section 83.13 that would allow HHS to
limit the employees included in a class
to be added to the Cohort to those who
incur specific types of cancers. The
Board acknowledged that it may be
possible in certain cases to determine
that radiation doses are limited to
certain specific sites in the body, which
would provide a scientific basis for
excluding employees who incur certain
other types of cancer from certain
classes that HHS might add to the
Cohort. This finding notwithstanding,
the Board was concerned that
provisions accounting for such a
possibility might conflict with the intent
of Congress and, furthermore, the Board
was concerned about providing “some
level of equity” between the definition
of classes added to the Cohort by HHS
and those already defined by Congress
in EEOICPA, which are not limited by
type of cancer.

As discussed above in response to
similar public comments, HHS has
omitted all provisions for establishing
cancer-specific classes from the final
rule, in response to the
recommendations of the Board and to
public comments. HHS agrees with the
Board that the perception of the public
that such provisions would constitute
unfair treatment under EEOICPA should
be an overriding consideration for this
decision.

B. Developing Guidelines Addressing
the Feasibility of Estimating Doses With
Sufficient Accuracy

The Board recommended that NIOSH
develop guidelines, within a reasonable
lime period after promulgation of the
final rule, to provide additional
clarification on how NIOSH would
determine whether it is feasible to

estimate doses with sufficient accuracy,
as specified under § 83.13(b) of the:
NPRM and § 83.13(c) of the rule. The
Board recommended that it have the
opportunity to review such guidelines.
The Board also recommended that HHS
make changes to the dose reconstruction
tule (42 CFR Part 82), if any are needed,
to resolve any potential conflict between
these two rules that could leave
claimants unable to obtain either a dose
reconstruction or status as a member of
the Cohort.

As discussed in response to public
comments, NIOSH is issuing
concurrently with this rule procedures
to implement the guidelines specified
under section 83.13 of this rule by
which NIOSH will evaluate a petition,
including the determination addressed
in this recommendation by the Board.
The Board will have the opportunity to
provide recommendations to NIOSH on
these procedures, although NIOSH will
not delay its evaluation of petitions to
obtain recommendations of the Board,
or make revisions to the procedures.
The rule provides under § 83.15 for the
Board to consider each evaluation of a
petition NIOSH completes and to
request NIOSH to conduct additional
analyses. Therefore, the Board will
always have the opportunity to discuss
with NIOSH any concerns the Board
might have with the procedures and
methods of a NIOSH evaluation.

As discussed in response to public
comments, the dose reconstruction rule
and this rule do not conflict with
respect to determining the feasibility of
dose reconstruction. No revision of the
dose reconstruction rule is necessary for
this purpose.

The consistency between the two
rules does not, however, guarantee that
all claimants will either receive a dose
reconstruction or be included as
members of the Cohort, as expressed by
the Board. It is possible for a claimant
to be excluded from the Cohort on the
basis that the employee was not
employed for a minimum of 250 work
days within the parameters of a class of
employees. This is specified under
EEOICPA (42 U.S.C. 73841(14)(A)),
which provides statutory requirements
defining the groups from the gaseous
diffusion plants that Congress included
in the Cohort, and under § 83.13(c)(3)(ii)
of this rule, which addresses the
statutory requirement for HHS to find
that the health of members of a class
may have been endangered. for such a
class to be added to the Cohort.

C. Combining Employment Within
Separate Cohort Classes for Meeting
Health Endangerment Requirements

The Board recommended that
employees be credited for days of
employment within separate classes
added to the Cohort, if necessary, to
meet a 250 work days employment
requirement that might be applicable to
qualify as a member of a class added to
the Cohort. As discussed above in
response to similar public comments,
HHS agrees with the Board and has
added a provision to the rule for this
purpose. Section 83.13(c)(3){ii) provides
that whenever HHS adds a class to the
Cohort for which a 250 work days
employment requirement is applicable,
employees will be able to meet this
requirement by combining their
employment within the added class
with employment within other classes
in the Cohort.

D. Adding a Definition for the Term
“Facility”

The Board recommended HHS add to
the rule a definition for the term
“facility” to more clearly specify the
limit of the scope of a petition. The
Board further recommended that HHS
define facility broadly to encompass
entire nuclear weapons production
sites, such as Los Alamos and Rocky
Flats. The Board was particularly
concerned that facility not be defined as
limited to individual buildings, ‘
structures, etc., which the Board was’
concerned could cause difficulties in
considering petitions that relate to
operations spanning more than one
building or other type of facility.

As discussed above in response to
similar public comments, HHS has
included in the final rule a footnote to
§ 83.9(c)(1)(i) that explains that an AWE
facility or DOE facility covered under
EEOICPA (42 U.S.C. 73841(5) and (12))
could constitute‘a single building or
structure, including the grounds upon
which it is located, or a site
encompassing numerous buildings or
structures, including the grounds upon
which it is located.

E, Evidence Confirming the Occurrence
of Unrecorded Exposure Incidents

Under § 83.9(c)(3), the NPRM
provided that for petitions based on
exposure incidents, versus routine
operations, petitioners would be
required to provide evidence confirming
the occurrence of the incident in cases
that cannot be confirmed independently
by NIOSH. One of the options for such
evidence was the provision of affidavits
from two employees who witnessed the
incident.


— Friday, ‘
QD May 28, 2004
Z
3
“) ~
ors
Part IV

Department of
Health and Human
Services

42 CFR Part 83

Procedures for Designating Classes of
Employees as Members of the Special
Exposure Cohort Under. the Energy
Employees Occupational Illness
Compensation Program Act of 2000; Final
Rule

Hederal Reg



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30769

If doses can be estimated for
employees who worked steadily within
a building or facility, then typically they
could be estimated for employees who
were in the building or facility
episodically. A major difference in some
such dose reconstructions, in cases in
which the worker was not monitored at
some or any of the locations, would be
the need to allocate the worker's time
among various locations. It is relatively
straightforward to do so, using
assumptions that give the benefit of the
doubt to the worker when information
concerning the duration of the worker's
activities at different locations is
insufficient.

‘An advocacy group, a labor
organization, and some Members of
Congress asserted that the provision of
the NPRM requiring that NIOSH have
sufficient information to be able to
estimate maximum radiation doses, at a
minimum, is incompatible with a
provision of the dose reconstruction
tule (42 CFR 82.10(k)(2)). Some of these
commenters interpret the provision of
the dose reconstruction rule as limiting
the use of worst-case assumptions,
which must be used in estimating
maximum radiation doses, to non-
compensable cancer claims (i.e., claims
for which the probability of causation is
below 50 percent). Furthermore, the
commenters conclude that this
perceived incompatibility could result
in a situation in which NIOSH might
find that it could not complete a dose
reconstruction for a claimant and yet
NIOSH could find, under this rule, that
the claimants’ doses can be estimated,
preventing HHS from adding a class of
employees including the claimant to the
Cohort. For this reason, the commenters
recommended that HHS amend the dose
reconstruction rule to be compatible
with this rule.

The dose reconstruction rule (42 CFR
Part 82) does not require any revision
with respect to this concern. It is not
possible for NIOSH to determine that it
cannot complete a dose reconstruction
for a claimant under the dose .
reconstruction rule and simultaneously
find the same dose reconstruction to be
feasible under this rule (42 CFR Part 83).

The dose reconstruction rule very
specifically restricted the condition on
the use of worst-case assumptions to the
case when they are used as an efficiency
measure to limit time-consuming and
resource-consuming additional research
and analysis. This narrow restriction is
stated in the dose reconstruction rule as
follows (emphasis added):

At any point during steps of dose
reconstruction described [above], NIOSH
may determine that sufficient research and
analysis has been conducted to complete the

dose reconstruction. Research and analysis
will be determined sufficient if one of the
following three conditions is met: *”.t~¥ (2)
Dose is determined using worst-case
assumptions related to radiation exposure
and intake, to substitute for further research
and analysis;* * *

* * * Worst-case assumptions will be
employed under condition 2 to limit further
research and analysis only for claims for
which it is evident that further research and.
analysis will not produce a compensable
level of radiation dose (a dose producing a
probability of causation of 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.” 42 CFR Part 82.10(k}

In contrast, this Cohort rule implies
the use of worst-case assumptions for
dose reconstructions in essentially the
opposite situation, to estimate
maximum radiation doses in cases in
which NIOSH lacks extensive
information that could be used to
conduct “further research and analysis,”
rather than as an efficient substitute for
such further research and analysis.

The dose reconstruction rule does not
assert or imply any restriction in
circumstances in which the total
information available is limited. In fact,
the rule generally anticipates such
circumstances in describing the
hierarchy of information that might be
used in a dose reconstruction,
depending on availability. In the
introductory section of the rule, it
describes the dose reconstruction
practice of using assumptions to
substitute for a lack of data:

“For dose reconstructions conducted in
occupational illness compensation programs,
this practice may include use of assumptions
that represent worst-case conditions.”’ 42
CFR Part 82.2(a).

Furthermore, the Cohort rule provides
that whenever NIOSH finds under the
dose reconstruction rule that it cannot
complete a dose reconstruction, this
finding will suffice, without exception
or further consideration, to support a
determination that it is not feasible to
estimate the radiation doses of
individual members of the class with
sufficient accuracy. This was implicit in
§ 83.14 of the NPRM but has been made
explicit, to eliminate any uncertainty in
interpretation, with the following
inserted text (in italics):

(b) NIOSH will determine the health
endangerment criteria for adding the class
under paragraph (a)(1) of this section to the
Cohort. using the procedures outlined under
§ 83.13. NIOSH will report to the Board the
results of this determination, together with
its finding under 42 CFR Part 82 that there
was insufficient information to complete the
dose reconstruction. HHS will consider this
finding under 42 CFR Part 82 sufficient,

without further consideration, to determine
that it is not feasible to estimate the levels
of radiation doses of individual members of
the class with sufficient accuracy.

Two labor organizations asserted, in
contrast with the comments discussed
immediately above, that the NPRM and
the dose reconstruction rule (42 CFR
Part 82) were inappropriately linked
through their implicit use of common
criteria for determining the feasibility of
dose reconstructions. EEOICPA required
HHS to establish, by regulation,
methods for arriving at reasonable
estimates’ of radiation doses incurred by
individuals (42 U.S.C. 7384n(d)). As
discussed above, EEOICPA requires
HHS to determine that it is not
“feasible” to estimate with “sufficient
accuracy” the radiation dose that a class
received, for HHS to add a class of
employees to the Cohort (42 U.S.C.
7384q(b)(1)). The commenters believe
the use of different terms in these two
sections of EEOICPA (reasonable
estimates of doses versus doses that are
not feasible to estimate with sufficient
accuracy) signals different intentions of
Congress for determining the feasibility
of dose reconstruction as it arises
through the dose reconstruction
program versus through a petition for
adding a class to the Cohort.
Accordingly, the commenters
recommend that-HHS establish different
criteria for these two situations.

The statutory provisions concerning
the development of dose reconstruction
methods (42 U.S.C. 7384n(d)) are
concerned with how dose
reconstructions are to be done, not a
determination as to whether or not they
can be done. It is implicit, nonetheless,
that these dose reconstructions must be
“feasible to estimate with sufficient
accuracy.” It appears to HHS that the
use of this phrase under provisions for
considering the addition of classes of
employees to the Cohort, and the
omission of this phrase under
provisions concerning dose
reconstruction, simply reflects the fact
that these two separate provisions of
EEOICPA address different but
complementary circumstances.

‘An advocacy group and several labor
organizations questioned whether or not
an estimate of the maximum radiation
dose produced by a dose reconstruction
would be represented by a single value
(point estimate) or by a distribution of
values (that take uncertainty into
account).

When NIOSH is limited to estimating
maximum doses in a dose
reconstruction based on source term and
process information, the dose
reconstruction is likely to rely
substantially on one or more worst-case



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30765

intended to ensure that petitions for
additions to the Cohort are given
uniform, fair, scientific consideration,
that petitioners and interested parties
are provided the opportunity for
appropriate involvement in the process,
and to comply with specific statutory
requirements of EEOICPA. The
procedures also address, within their
relevant scope, the stated congressional
purpose of the compensation program to
provide timely compensation to covered
employees or their survivors for covered
illnesses incurred by such employees in
the performance of duty.

D. Statutory Requirements for
Designating Classes of Employees as
Members of the Cohort

EEOICPA includes several
requirements for these procedures. The
Board shall provide advice to the
President (delegated by Executive Order
13179 to the Secretary of HHS)
concerning the designation of additional
classes as members of the Cohort. The
Board’s advice is to be based on
“exposure assessments by radiation
health professionals, information
provided by the Department of Energy,
and such other information as the
Advisory Board considers appropriate.”
42 U.S.C. 7384q. Section 7384q specifies
that HHS obtain the advice of the Board
“after consideration of petitions by
classes of employees * * * for such
advice.” This section also mandates two
broad criteria to govern HHS decisions,
which are to be made after receiving the
advice of the Board. Members of a class
of employees at a DOE facility or AWE
facility may be treated as members of
the Cohort for purposes of the
compensation program if HHS
“determines that: (1) It is not feasible to
estimate with sufficient accuracy the
radiation dose that the class received;
and (2) there is a reasonable likelihood
that such radiation dose may have
endangered the health of members of
the class.” Finally, 42 U.S.C.
73841(14)(C)(ii) requires the Secretary to
submit a report to Congress for each
“class of employees the Secretary
designates to be added to the Cohort.
The report must define the class of
employees covered by the designation
and specify the criteria used to make the
designation. This section requires that
the designation take effect 180 days after
the date on which HHS submits the
report to Congress “unless Congress
otherwise provides.”

E. Relationship of Procedures to an
Existing Rule Promulgated by HHS To
Implement EEOICPA

These procedures complement the
HHS final rule: ‘Methods for Radiation

Dose Reconstruction Under the Energy
Employees Occupational Illness _,
Compeniation Program Act of 2000" .
promulgated by HHS on May 2, 2002 at
42 CFR Part 82 (67 FR 22314).

42 CFR Part 82 provides the methods
by which NIOSH is conducting dose
reconstructions to estimate the radiation
doses incurred by individual covered
employees who have incurred cancer.
These estimates are required by
EEOICPA for DOL to adjudicate a cancer
claim for an employee who is not a
member of the Cohort or whose claim is
not covered by provisions of EEOICPA
for compensating members of the
Cohort. The methods to arrive at these
estimates, however, will be directly
considered by HHS in reviewing
petitions to add classes of employees to
the Cohort. In particular, HHS will
consider these methods in determining
for a petitioning class of employees, as
required by EEOICPA, whether “it is not
feasible to estimate with sufficient
accuracy the radiation dose that the
class received.”

II. Summary of Public Comments

HHS published a first notice of
proposed rulemaking (“NPRM”)
specifying procedures for adding classes
of employees to the Cohort on June 25,
2002 (67 FR 42962). Public and Board
comments on this first NPRM led HHS
to make substantial changes in the
proposal, which resulted in the
publication of a second.NPRM on March
7, 2003 (68 FR 11294). HHS solicited
public comments on this second NPRM
from March 7, 2003 to May 6, 2003.2
During this period, comments were also
submitted by the Board.

HHS received comments on the
second NPRM from 11 organizations
and 19 individuals, including 14
Members of Congress. Organizations
commenting included six national or
local labor organizations representing
DOE workers, the Health Physics
Society, and four advocacy groups. A
summary of these comments and HHS
responses is provided below. These are
organized by general topical area. The
HHS responses in this section also serve
to explain changes made to the
proposed rule and to supplement
explanations from both NPRMs
concerning the intent of the final rule.

A. Feasibility of Dose Reconstructions:
Timeliness, Cost, and Availability of
Records

As discussed above, EEOICPA
requires HHS to find that it is ‘not

2 HS extended the public comment period from
30 to 60 days at the request of the Board and
members of the public.

feasible to estimate with sufficient
accuracy the radiation dose that the
class received” as a condition for adding
the class to the Cohort. The NPRM.
proposed the criterion that this
condition would be met if NIOSH were
not able to establish “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” (68 FR 11308).

HHS received comments from several.
labor organizations, an advocacy group,
and Members of Congress
recommending that the rule establish
additional criteria defining when dose
reconstructions would not be feasible.
Some commenters recommended
distinguishing this requirement as
separate and apart from the requirement
for “sufficient accuracy.” The most
common recommendation was for HHS
to establish a time limit for completing
dose reconstructions, after which the
dose reconstruction would be
determined to be not feasible.
Commenters recommended time limits
ranging from 180 days to 24 months.

HHS does not agree that a regulatory
time limit on dose reconstructions
would be appropriate in this rule, which
establishes procedures for determining
whether to add a class of employees to
the Cohort. Some of the factors that
could protract a dose reconstruction,
such as a poorly defined employment
history or work history, would be
specific to the case of an individual
employee, and would not be germane to
a class of employees.

HHS does not believe a time limit on
the duration of a dose reconstruction to
be an appropriate addition to the dose
reconstruction rule, either. Such a limit
would eliminate the flexibility to
address special circumstances and
could effectively nullify the statutory
requirements for dose reconstruction
and the determination of probability of
causation in their entirety by deeming
all DOE and AWE employees to be
members of classes of employees for
whom dose reconstruction is not
feasible.

In addition, a regulatory time limit
could delay compensation for claimants
whose dose reconstructions might
exceed a regulatory deadline but would
still be completed prior to the time at
which a class of employees could be
added to the Cohort. As this rule
describes, Congress has 180 days to
review any HHS decision to add a class
to the Cohort, before such a decision
could become effective.

One of the most important factors
presently affecting the timeliness of
dose reconstructions is the current



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The Board recommended that HHS
clarify that affidavits from only two
witnesses would be required, since the
rule could be interpreted as requiring
two witnesses in addition to the
petitioner in a case in which the
petitioner was also a witness. The Board
further recommended that in cases in
which eyewitnesses may no longer be
living or might be difficult to locate, the
rule should allow NIOSH to accept the
accounts of other parties who were
informed of the incident but were not
witnesses to the incident.

As discussed above in response to
similar public comments, HHS has
revised this section of the rule to omit
the requirement for a specific number of
witnesses, to make the accommodation
recommended by the Board with respect
to situations in which eyewitnesses are
not available, and to clarify that the
provision of one or more affidavits
would not, in and of itself, be sufficient
to confirm the occurrence of an
incident; NIOSH would have to
consider the adequacy and credibility of
the evidence provided in the affidavits.

F. Reviews of Findings That a Petition
Does Not Satisfy the Requirements for a
Petition’;

In the NPRM, HHS requested
comment on whether or not.the rule

* should provide an opportunity for

petitioners to obtain a review of NIOSH
findings that a petition does not meet .
the requirements specified under § 83.9.
The first NPRM had provided for the
Board to conduct such reviews, but the
Board objected to such a role, which it’
viewed as an administrative function.

The Board was concerned about the
lack of an administrative appeals
process for such decisions and
recommended HHS consider how such
reviews could be conducted.

As discussed above in response to
public comments, HHS has added
provisions to § 83.11 to give petitioners
the option of an administrative review
of proposed NIOSH decisions.

G. Recommendations for Section 83.9

The Board recommended revisions to
clarify the descriptions of two types of
reports that a petitioner could use to
support a petitioner’s belief that records
and information available are
inadequate to estimate the radiation
doses incurred by members of a class of
employees. The first type is an
unpublished report by a health physicist
or expert in dose reconstruction that
might be commissioned by petitioners.
The second is a scientific report
published in a peer reviewed journal or
issued by a government agency.

HHS clbrified these provisions
consistently with the recommendations
of the Board, with one exception. With
respect td the first type of report
describe | above, the revisions suggested
by the Board would omit the
requirement that the expert document
his or her findings with respect to the
limitations of records on radiation
exposures. HHS has retained this
requirembnt. HHS believes it is

‘reasonable to require experts to support

their assertions on factual matters with
factual evidence.

The Board also recommended HHS
consider whether placement of
subsection (c)(3) is appropriate within
this section, since the subsection
addresses information requirements that
only come into effect for certain
petitions, in cases in which NIOSH
requires Additional information. The
Board was concerned that this might be
confusing to petitioners.

HHS has retained the placement of
this:subséction because it specifies
informational requirements for a
petition, even though they are
conditional requirements. The
introductory paragraph of the
subsection has been revisedito clarify
that NIOSH would not requite a
petitionei to provide the information *
discusse in the subsection when the
petition is submitted, but only upon
request. In addition, petitioners will -
have information from NIOSH in
addition ‘0 this rule, such as petition
instructions and an optional petition
form, to guide them through the petition

process. |

i. Reco mendations for Séction 83.13

The Board recommended a revision of
§ 83,13(b](1)(iii) of the NPRM, which
infcrmed]|the public that NIOSH may
often be able to estimate maximum
radiation doses without personal
dosimetry data and area monitoring
data. The|Board appeared to be
concerned that readers might interpret
the state! ent as being dismissive of the
value of such information for dose
reconstructions. HHS has revised this
subgection (83.13(c)(1)(iv) of the final
tule) to remedy this concern, as follows
(in italics):

(iv) In many circumstances, access to
personal dosimetry data and area monitoring
data'is not|necessary to estimate the
maximum radiation doses that could have
been incurred by any member of the class,
although radiation doses can be estimated
more preety with such data,

I. Recommendations for the Preamble

The Board also made several editorial
recommendations for clarifying the
preamble|of the NPRM. The preamble to

this final rule, however, does not
include any of the text addressed by the
Board’s recommendations.

IV. Regulatory Assessment
Requirements

A, Executive Order 12866 ©

Under Executive Order (E.0.) 12866
(58 FR 51735, October 4, 1993), the
Agency must determine whether a
regulatory action is “significant” and
therefore subject to review by the Office
of Management and Budget (OMB) and
the requirements of the executive order.
Under section 3(f), the order'defines a
“significant regulatory action” as an
action that is likely to result in a rule
(1) Having an annual effect on the
economy of $100 million or more, or
adversely and materially affecting a
sector of the economy, productivity,
competition, jobs, the environment,
public health or safety, or State, local,
or tribal governments or communities
(also referred to as “economically
significant”); (2) creating serious
inconsistency or otherwise interfering
with an action taken or planned by
another agency; (3) materially altering
the budgetary impacts of entitlements,
grants, user fees, or loan programs or the
rights and obligations of recipients .
thereof; or (4) raising novel legal or
policy issues ng out of legal
mandates, the President's priorities, or ‘
the principles set forth in this Executive
Order.

This rule is being treated asa -
“significant regulatory action” within
the meaning of the executive order
because it meets the criterion of Section
3(f)(4) in that it raises novel-or legal
policy issues arising out of the legal
mandate established by EEOICPA. It
establishes practical procedures,
grounded in current science, by which
the Secretary of HHS can fairly consider
petitions to add classes of employees to
the Cohort. The financial cost to the
federal government of responding to
these petitions is likely to vary from
thousands of dollars to as much as
hundreds of thousands of dollars,
depending on the availability of
information and the scope of the
petition.

The rule carefully explains the
manner in which the procedures are
consistent with the mandate of 42
U.S.C. 7384q and implements the
detailed requirements of that section.
The rule does not interfere with State,
local, and tribal governments in the
exercise of their governmental
functions.

The rule is not considered
economically significant, as defined in
section 3(f)(1) of the E.O. 12866. It has



IV. Designation Findings

Feasibility of Estimating Radiation Doses with Sufficient Accuracy

The Secretary established the feasibility determination for the class of employees
covered by this report based upon the findings summarized below.

(1) NIOSH has not found information on the analytical methodology or the work
activities for the proposed class. In addition, NIOSH does not have access to
sufficient personnel monitoring data, area monitoring data, or source term data to
estimate internal exposures for the proposed class.

(2) NIOSH could not determine which individuals should have been monitored for
external exposure or the magnitude of this potentially unmonitored dose.
Therefore, NIOSH does not have access to adequate information to estimate with
sufficient accuracy the external occupational exposures for the proposed class.

(3) Pursuant to 42 C.F.R. § 83.13(c)(1), NIOSH determined that there is insufficient
information to either: (1) estimate the maximum radiation dose, for every type of
cancer for which radiation doses are reconstructed, that could have been incurred
under plausible circumstances by any member of the class; or (2) estimate the
radiation doses of members of the class more precisely than a maximum dose
estimate.

(4) The Board concurred with the NIOSH evaluation and recommended the proposed
class for addition to the SEC.

(5) Although NIOSH found that it is not possible to completely reconstruct radiation
doses for these employees, NIOSH determined that it is possible to reconstruct
occupational medical dose. Therefore, individuals with non-presumptive cancers
may be considered for partial dose reconstructions.

Health Endangerment

The Secretary established the health endangerment determination for the class of
employees covered by this report based upon the findings summarized below.

(1) Pursuant to 42 C.F.R. § 83.13(c)(3), NIOSH established that there is a reasonable
likelihood that such radiation doses may have endangered the health of members
of the class. Pursuant to 42 C.F.R. §.83.13(c)(3)(ii), NIOSH specified a minimum
duration of employment to satisfy this health endangerment criterion as “having
been employed for a number of work days aggregating at least 250 work days
within the parameters established for this class or in combination with work days
within the parameters (excluding aggregate work day requirements) established
for one or more other classes of employees in the Cohort.”

HHS Special Exposure Cohort Designation:
Combustion Engineering



CHAIRMAN:

Paul L. Ziemer, Ph.D.
Lafayette, Indiana

MEMBERS:

Josie Beach
Richland, Washington

Bradley P. Clawson
Rexburg, Idaho

Michael H. Gibson
Franklin, Ohio

Mark A. Griffon
‘Salem, New Hampshire

James E. Lockey, M.D.
Cincinnati, Ohio

James M. Melius, M.D., Ph.D.
Albany, New York

Wanda |. Munn
Richland, Washington

John W. Poston, Sr., Ph.D.
College Station, Texas.

Robert W. Presley
Clinton, Tennessee

Genevieve S. Roessier, Ph.D.
Elysian, Minnesota

Phillip Schofield
Bosque Farm, New Mexico

STAFF.
EXECUTIVE SECRETARY:

Lewis V. Wade, Ph.D
Washington, DC

COMMITTEE MANAGEMENT :

Zaida Burgos
Atlanta, Georgia

ADVISORY BOARD ON RADIATION AND WORKER HEALTH
4676 Columbia Parkway, MS: C-46

Cincinnati, Ohio 45226
(513) 533-6825,

January 30, 2008

The Honorable Michael O. Leavitt
Secretary of Health and Human Services
Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, DC 20201

Dear Mr. Secretary:

The Advisory Board on Radiation and Worker Health (The Board) has
evaluated SEC Petition-00099 concerning workers at the Combustion
Engineering facility in Windsor, Connecticut under the statutory
requirements established by EEOICPA and incorporated into 42 CFR Sec.
83.13 and 83.14. The Board respectfully recommends Special Exposure
Cohort (SEC) status be accorded to all Atomic Weapons Employees
(AWE) who worked at the Combustion Engineering site in Windsor,
Connecticut from January 1, 1965 through December 31, 1972 for a
number of work days aggregating at least 250 work days, or in
combination with work days within the parameters established for one or
more other classes of employees in the SEC. The Board notes that
although NIOSH found that they were unable to completely reconstruct
radiation doses for these employees, NIOSH believes that they are able to
reconstruct external doses from medical exposures for workers at the
facility.

This recommendation is based on the following factors:

2 People working at the Combustion Engineering facility during this
time period worked on research and production activities related to
nuclear fuel and nuclear weapons production.

The NIOSH review of the available monitoring data as well as the
available source term and other information found that they lacked
adequate information necessary to conduct accurate individual dose
reconstructions for internal doses and external doses (other than
medical) at the Combustion Engineering facility during the time
period in question.


SEC-00099 12-14-07 Combustion Engineering

SEC Petition Evaluation Report for SEC-00099

1.0 Purpose and Scope

ATTRIBUTION AND ANNOTATION: This is a single-author document. All conclusions drawn from
the data presented in this evaluation were made by the Oak Ridge Associated Universities (ORAU)
Team Lead Technical Evaluator: Michael Domal, MJW Corporation, Inc. These conclusions were
peer-reviewed by the individuals listed on the cover page. The rationales for all conclusions in this
document are explained in the associated text.

This report evaluates the feasibility of reconstructing doses for employees who worked at a specific
facility during a specified time. It provides information and analysis germane to considering a petition
for adding a class of employees to the Congressionally-created SEC.

This report does not make any determinations concerning the feasibility of dose reconstruction that
necessarily apply to any individual energy employee who might require a dose reconstruction from
NIOSH, with the exception of the employee whose dose reconstruction could not be completed, and
whose claim consequently led to this petition evaluation. The finding in this report is not the final
determination as to whether or not the proposed class will be added to the SEC. This report:will be
considered by the Advisory Board on Radiation and Worker Health (the Board) and by the Secretary
of Health and Human Services (HHS). The Secretary of HHS will make the final decision concerning
whether to add one or more classes to the SEC in response to the petition addressed by this report.

This evaluation, in which NIOSH provides its findings both on the feasibility of estimating radiation
doses of members of this class with sufficient accuracy and on health endangerment, was conducted in
accordance with the requirements of EEOICPA and 42 C.F.R. § 83.14.

2.0 Introduction

Both EEOICPA and 42 C.F.R. pt. 83 require NIOSH to evaluate qualified petitions requesting the
Department of Health and Human Services to add a class of employees to the SEC. The evaluation is
intended to provide a fair, science-based determination of whether it is feasible to estimate, with
sufficient accuracy, the radiation doses of the proposed class of employees through NIOSH dose
reconstructions.

NIOSH is required to document its evaluation in a report, and to do so, relies upon both its own dose
reconstruction expertise as well as technical support from its contractor, Oak Ridge Associated
Universities. Once completed, NIOSH provides the report to both the petitioners and the Advisory
Board on Radiation and Worker Health. The Board will consider the NIOSH evaluation report,
together with the petition, comments of the petitioner(s) and such other information as the Board

' NIOSH dose reconstructions under EEOICPA are performed using the methods promulgated under 42 C.F.R. pt. 82 and
the detailed implementation guidelines available at http://www.cdc.gov/niosh/ocas.

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Federal Register / Vol

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30775

defining individual, facility-specific
classes. Furthermore, as discussed
above under the section on health
endangerment, changes in this rule
eliminate any potential value of
defining classes to include employment
at multiple facilities.

The terminology of the definition in
the NPRM, in specifying that a class is
defined in part by “the availability of
information,” was appropriate and has
not been changed in the final rule. The
term “availability” covers the
possibility that information is available
or is not available, with respect to the
informational needs of dose
reconstructions conducted under 42
CFR Part 82. Both of these possibilities
need to be covered, since HHS might
define classes of employees for whom
information is sufficient for the needs of
dose reconstructions and other classes
for whom information is insufficient, as
provided under this part.

The NPRM did not include a
definition of the term “facility,” which
is used in the rule. Two advocacy
groups and three labor organizations
recommended the rule include a
definition of facility, and that the
definition be defined as broadly as
possible. Some specific suggestions for
wording were provided.

HHS has not included a definition of
the term “facility” in the rule since
“atomic weapons employer facility” and
“Department of Energy facility” are
already defined in EEOICPA (42 U.S.C.
73841(5) and (12)). These statutory
definitions are complex. As a necessary
consequence, DOE facility or AWE
facility definitions must be considered
on a case-by-case basis. To provide
guidance on the types of facilities that
would fall within the statutory
definitions, and in particular, whether
the term “facility” is limited to a single
building or can also include multiple
buildings, HHS has included a footnote
to § 83.9(c)(1)(i) in the final rule which
provides:

Depending on the factual circumstances
present, a facility that meets the definition of
an AWE facility or DOE facility covered
under EEOICPA (42 U.S.C. 73841(5) and (12))

-could, among other possibilities, constitute a
single building or structure, including the
grounds upon which it is located, or a site
encompassing numerous buildings or
structures, including the grounds upon
which it is located.

While a petition for a class of
employees must be limited to one
facility, a facility can constitute a site
encompassing numerous buildings or
structure, including the grounds upon
which it is located. This has no effect,
however, on the prospects for a class
being added to the Cohort or the

prospects for an individual employee
being included as a member of a class.
addéd ‘to the Cohort. These deperid on
the criteria specified in this rule,
regardless of the scope of the petition.
As discussed above, the latter also can
depend on whether an employee meets
a 250 work days employment criterion,
when applicable, but § 83.13(c)(3)(ii) of
the rule allows this criterion to be met
through employment within the
parameters of separate classes included
in the Cohort.

HHS received two comments on the
definition of “specified cancers”

(§ 83.5(k)) provided in the NPRM. An
advocacy group recommended the
definition be amended to allow for other
cancers specified by DOL. A labor
organization recommended that the
definition include rectal cancers, which
have been determined by DOL, after
consultation with the National Cancer
Institute, to be a subset of cancer of the
colon for the purposes of compensation
for members of the Cohort.

The statutory definition of “specified
cancer” can be found in EEOICPA at 42
U.S.C. 73841(17). This definition cannot
be changed by HHS; it can only be
changed by Congress. The definition of
“specified cancer” in the NPRM and in
this final rule at § 83.5(m)(6) explains,
however, that the specified cancers
identified in the definition mean the
physiological condition or conditions
that are recognized by the National
Cancer Institute, the scientific body
with which DOL consults if there are
questions regarding the proposed
classification of a particular cancer.

HHS has added a definition of
petitioner under § 83.5(j). The definition
limits the number of petitioners that can
submit a single petition toa maximum
of three individuals and/or
organizations. This limitation, which
limits the number of petitioners but
does not limit the number of members
of a class of employees, is intended to
facilitate the timely consideration of
petitions by NIOSH, the Board, and the
Secretary, since each petitioner for a
petition has procedural rights under the
rule that, if applicable to a large number
of petitioners, could prolong the
consideration of a petition substantially.
HHS has also revised § 83.7 of the rule
to reflect this change.

K. Miscellaneous Comments

The rule provides for petitions in two
distinct circumstances. One
circumstance is when NIOSH has
attempted to conduct a dose
reconstruction for a cancer claimant,
under 42 CFR Part 82, and finds that the
dose reconstruction cannot be
completed, because there is insufficient

information to estimate the radiation
doses of the claimant with sufficient
accuracy. The second circumstance
includes all other possibilities. For
example, a petition may be submitted
representing a class of employees whose
members have yet to file claims under
EEOICPA, or even have yet to be
diagnosed with cancer.

An advocacy group recommended
that the rule explain these two
circumstances that have been provided
for under the rule. The commenter
recommended specifically that the rule
clarify that petitioners or potential class
members are not required, as a
prerequisite for petitioning, already to
have incurred a cancer or to have filed
acclaim for a cancer.

HHS agrees with the comment and
has added explanation to the overview
of the rule under § 83.6 to summarize
the two distinct circumstances for
petitions.

A labor organization commented that
the rule is unduly vague about the types
of information used to evaluate
petitions, citing § 83.14(a)(8) of the
NPRM, which reads: ‘‘Other sources.”

Section 83.13(a) provides a list of
seven specific sources prior to the
provision of concern to the commenter.
It may not be possible for HHS to
specify every possible source of
information that might assist NIOSH in
evaluating a petition. The purpose of
specifying the limited list is to give the
public a sense of the range of sources
that might provide useful information.
The purpose of including a non-
specified “other” category is to clearly
communicate that NIOSH will not be
limited to using the sources it has
identified in the rule.

L. Non-Regulatory Comment: Dose
Reconstructions for Cohort Members
With Non-Specified Cancers

Two advocacy groups questioned how
NIOSH would handle dose
reconstructions for individuals in the
Cohort who have a cancer that is not
one of the specified cancers or for
individuals not included in the Cohort
because they do not meet the health
endangerment criterion of having been
employed for 250 work days, when this
criterion is applicable. In both
situations, part or all of an employce’s
work experience may include potential
radiation exposures that cannot be
estimated. For the latter situation, one of
the commenters suggested a scheme for
assigning radiation doses to some cases.

Under current dose reconstruction
procedures, NIOSH would estimate all
of the radiation doses of such employees
that can be estimated. Some of these:
employees may have sufficient radiation



SEC-00099

12-14-07 Combustion Engineering

5.1 Internal Personnel Monito

ring Data

Only one of the approximately 30 NIOSH claimants has records of internal monitoring during the
1965 to 1972 time frame; these consist of two uranium urinalysis results. Three other claimants have
bioassay records (lung counts or chest counts); however, none of their measurements are before 1982.

Due to the lack of source term and materi
AWE and commercial operations, and tht
claimants, it is not possible to use th
period 1965 through 1972.

|
;
NIOSH also attempted to locate othér i
breathing zone results, and nasal swabs,
records describing urinalysis practices.
practices in 1964 that consisted of gener:
workers; however, NIOSH has located n

sampled by Combustion Engineering. A

al type information for pre-1973 Combustion Engineering

© lack of internal monitoring results for the majority of the
ese four in vivo results to bound doses for all workers for the

wn

mal monitoring records, including fecal monitoring,

but none was found. NIOSH also could not locate any

me report (HASL, 1964) cited workplace monitoring
1 air sampling and breathing zone air sampling for groups of
air sampling results. Ventilation effluents were also

erage and high values were given in the 1964 report, but no

individual data or sampling analysis |descriptions were provided (HASL, 1964). No similar reports

could be found for the time period 1965-1972.
|

5.2

External Personnel Mohito ‘ing Data

‘External monitoring data-were found for four claimants for the period 1965‘through' 1972. None of *

the other 25 claimants.had dosimetry rec
of the‘claimants had only summary data
appears that film badges were used. ,Rec
i
Area monitoring and radiological culvey:
any radiological incident or personnel con
5.3. Workplace Monitoring|/Dat
No workplace monitoring records were fc
air sampling, area air samples, area radiat
reports. No such records were found for

5.4 Radiological Source Term |

NIOSH has been unable to locate dodund

rds of any kind. Of the four with external dose records, two
n an annual basis or longer, and two had monthly results. It
rds included whole-body, skin, and some neutron doses.

i
were sought but not found. NIOSH was unable to locate
tamination records.

2

und. Types of records that NIOSH sought include general :
‘ion monitoring, iradiological-surveys, and annual radiological
the time period 1965-1972.

Data

ntation on the work processes associated with the uranium

shipments to Fernald, and has located onl

limited data on the materials involved in the shipments, as

presented in Table 4-1. Some historical information pertaining to the non-weapons-related
radiological work may be useful in races both the types of activities that occurred during the time

period under evaluation, and some of the

nown radionuclides. According to a 1999 FUSRAP

Characterization Report, as many as 20 out of 100 Combustion Engineering contracts with the AEC
from 1955 through 1965 specified the use of HEU and other special nuclear material (FUSRAP,
1999). A 1965 special nuclear materials license was located indicating the presence of U-235 at

various levels of enrichment (License,

|

1965). A 1960 Quarterly Progress Report describes the

14 of 20 |



|

| |
for, or the magnitude of any potentially unmonitored internal doses. It is also not possible to

reasonably bound potential internal loses. Based on the:lack of relevant data, NIOSH is unable to
estimate with sufficient accuracy the potential internal exposures at the Combustion Engineering site

during the period from January 1, 1965 ough December 31, 1972.

SEC-00099 12-14-07 | Combustion Engineering

i
6.2 Feasibility of Bstimating xternal Exposures

As indicated in Section 5.0, NIOSH does not have access to sufficient personnel monitoring data, area
monitoring data, or source term data to dstimate external occupational exposures at Combustion
Engineering for the period January 1, 1965 through December 31, 1972. Of the approximately 30
claimants, four individuals had limited dosimetry records. Dose records results were given for

shallow dose and deep dose. One neutr
could be found for any of the other emp!
monitoring practices, work activities, or
data were available. It is not known wh:

of their potentially-unmonitored external

to estimate with sufficient accuracy the
Engineering site during the period from

NIOSH considers the adequate recdnstru
be feasible by using claimant-favorable
complex-wide Technical Information Bi
Diagnostic X-Ray Procedures (ORAUT,

7.0 Sum

mary of Feasibilit
|

y Findings for Petition SEC-00099

n result was also given. No other external monitoring data
loyees. No information could be found regarding personnel
[possible source terms. No survey records or area monitoring
ich individuals should have been monitored, or the magnitude
dose. Based on the lack of relevant data, NIOSH is unable
potential total external exposures at the Combustion’

January 1, 1965 through December 31, 1972.

ction of medical dose for Combustion Engineering likely to

assumptions as. well as the applicable protocols in the ,

ulletin Dose Reconstruction from Occupationally Related, ;
+OTIB-0006). ;

‘

This report evaluates the feasibility, for | imating the dose, with sufficient accuracy, for all AWE

employees at the Combustion Enginee:

ring site from January 1, 1965 through December 31, 1972.

:

NIOSH has determined that it lacks sufficient dosimetry data, workplace monitoring data, and source

term data to reconstruct the total interna
Consequently, NIOSH finds that it jis noi
doses resulting from exposures receive

=f

| and external exposures at the facility during this time period.
it feasible to estimate with sufficient accuracy the radiation

by members of this class of emp

loyees.
i .

NIOSH has documented herein that it cannot complete the dose reconstruction related to this petition.

The basis of this finding is specified in
access to sufficient information to éstimt
member of the class or to estimate such

estimate.

this report, which demonstrates that NIOSH does not have
ate either the maximum radiation dose incurred by any
radiation doses more precisely than a maximum dose

16 of 20



SEC-00099 12-14-07 Combustion Engineering

Members of this class at the Combustion Engineering site may have received internal and external
radiation exposures from covered AEC work and commercial activities at the plant. This work would
involve any AWE covered or commercial activities associated with uranium that was on site and
subsequently shipped to Fernald and research involving radioactive material. NIOSH lacks sufficient
information, which includes dosimetry data, workplace monitoring data, and source term data that
would allow it to estimate the potential internal and external exposures to the proposed class.

Occupational medical exposures may be reasonably estimated by using claimant-favorable
assumptions as well as the applicable protocols in the complex-wide Technical Information Bulletin
Dose Reconstruction from Occupationally Related Diagnostic X-Ray Procedures (ORAUT-OTIB-
0006).

8.0 Evaluation of Health Endangerment for Petition SEC-00099

The health endangerment determination for the class of employees covered by this evaluation report is
governed by EEOICPA and 42 C.F.R. § 83.14(c) and § 83.13(c)(3). Pursuant to these requirements, if
it is not feasible to estimate with sufficient accuracy radiation doses for members of the class, NIOSH
must determine that there is a reasonable likelihood that such radiation doses may have endangered
the health of members of the class. The regulations require NIOSH to assume that any duration of
unprotected exposure may have endangered the health of members of a class when ‘it has been
established that the class may have been exposed to radiation during a discrete incident likely to have
involved levels of exposure similarly high to those occurring during nuclear criticality incidents. If -
the occurrence of such an exceptionally high-level exposure has not been established, then NIOSH is
required to specify that health was endangered for those workers who were employed for a number of
work days aggregating at least 250 work days within the parameters established for the class or in
combination with work days within the parameters established for one or more other classes of
employees in the SEC. .

NIOSH has determined that members of the class were not exposed to radiation during a discrete
incident likely to have involved levels of exposure similarly high to those occurring during nuclear
criticality incidents. However, the evidence reviewed in this evaluation indicates that some workers in
the class may have accumulated chronic radiation exposures through intakes of radionuclides and
from direct exposure to radioactive materials. Consequently, NIOSH is specifying that health was
endangered for those workers covered by this evaluation who were employed for a number of work
days aggregating at least 250 work days within the parameters established for this class or in
combination with work days within the parameters established for one or more other classes of
employees in the SEC.

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30772

Federal Register/Vol. 69, No. 104/Friday, May 28, 2004/Rules and Regulations

allow employees and survivors to
petition (paragraph (a)), “to recognize
the exclusive right of a labor union to
represent the collective interests of
employees in represented bargaining
units who might petition for inclusion
in the SEC.” The commenter asserted:
“Any NIOSH procedures inconsistent
with this bedrock principle are
incompatible with the National Labor
Relations Act.” The commenter further
speculated that NIOSH would conserve
resources by limiting the right to
petition to the certified labor
organization whenever the class
includes members of an existing
bargaining unit of a labor organization.
The commenter explained that such a
limitation ‘will avoid the potential
problem of several competing
representatives filing overlapping or
inconsistent petitions on behalf of
common employees.”

Two other labor organizations (one
being a local unit of the commenter
discussed above) and three advocacy
groups expressed unqualified support
for the eligibility requirements proposed
in the NPRM and specifically opposed
the recommendations and rationale of
the commenter discussed above. One of
these commenters asserted that the
National Labor Relations Act (NLRA)
provision regarding the exchisive right

* ofa labor union to represent collective
interests of employees in union-
representéd bargaining units ‘does not
apply to petitions for Cohort status
under the EEOICPA. Some members of
this group of commenters further argued
that the limitation proposed by the first
commenter above would be unworkable
given the large number of unions
representing employees at a single site.

On its face, the NLRA, which in
pertinent part at 29 U.S.C. 159(a)
establishes the exclusive right of a labor
union to represent employees in union-
represented bargaining units for the
purpose of “collective bargaining in
respect to rates of pay, wages, hours of
employment, or other conditions of
employment,” does not apply to
petitions for Cohort status under
EEOICPA, as these do not involve
“collective bargaining in respect to rates
of pay, wages, hours of employment, or
other conditions of employment.” None
of the items potentially addressed by
collective bargaining are determined by
HHS in considering a petition to add a
class of employees to the Cohort.

HHS discussed the issue of
potentially overlapping petitions, which
concerned the first commenter above, in
the first NPRM (67 FR 42966). This
situation is unavoidable and HHS does
not expect it to present major
difficulties. HHS will consider

concurrent petitions jointly; to the
extent that they identify a class in
common.|With respect to the
commenter’s concern about potential
conflicts between petitions, \decisions by
HHS on petitions will not govern
decisions’ on subsequent petitions for
the Same class, or any part thereof, so
long as substantial new information,
germane to the criteria for adding a class
to the Cohort, is provided by a

subsequeht petition. 1

For thelreasons discussed above, HHS
has retained in the rule the relevant
provisions of § 83.7 from the NPRM,
without change.

HHS revised § 83,7 to limit the
number of petitioners that can submit a
single petition to a maximum of three
individuals and/or organizations. This
limitation, which limits the'number of
petitioners but does not limit the
number of members of a class of
employegs, is intended to facilitate the
timely consideration of petitions by
NIOSH, the Board, and the Secretary,
since each petitioner for a petition has
procedural rights under the rule that, if
applicable to a large number of
petitionets, could prolong the
consider tion of a petition substantially.
HHS has also added a definition of the
term ‘petitioner’ under § 83.5(j) of the
rulé to reflect this change. '

F, Petition Requirements

Section 83.9 of the NPRM specifies °
informational requirements that must be
fulfilled by petitioners in order for HHS
to consider the petition. An advocacy
group and two labor organizations
commented generally that they support
the reduced requirements of this second
NPRM, cbmpared to the first NPRM.
Commenters had several specific
recommendations.

Subsection (b) requires claimants to
petition when NIOSH has found that it
cannot complete their dose
reconstructions. The information to be
provided by the petitioner in such cases
is minimal, in effect simply notifying
NIOSH formally that the claimant
wishes tg petition. Nonetheless, one
labor organization recommended against
this requirement, asserting that it is
unneces arily burdensome! The
organization recommended that HHS
automatically consider the addition of a
clags in these cases.

HHS interprets EEOICPA, 42 U.S.C.
7384q(a)(3), to require the submission of
a petition to initiate consideration for
adding a|class of employees to the
Cohort. As specified under the dose
reconstruction rule (42 CFR 82.12),
NIQSH will encourage and assist these
claimants to file a petition and has

| i

minimized the requirements for their
petitions.

Subsection (c)(1)(i) specifies that
petitioners, other than the claimant-
petitioners covered under subsection
(b), must propose a definition of the
class of employees for whom the
petition would apply, including
identifying, among other items: “The
DOE-or AWE facility at which the class
worked* * *” (emphasis added). Three
advocacy groups and three unions
commented on this provision.

The commenters recommended that
petitions be allowed to cover multiple
facilities. Commenters explained that
certain occupational groups, such as
construction and maintenance workers,
had work tasks that spanned separate
sites, or had occupational histories that
commonly involved work at more than
one site, and that there may be similar
deficiencies in radiation monitoring for
these particular occupational groups
across such sites. Furthermore, in
response to the finding of HHS in the
NPRM stating that EEOICPA does not
allow for classes to be defined to
encompass employees at more than one
facility (68 FR 11298-11299), some of
the commenters asserted that HHS is not
properly interpreting the statute. |,
Specifically, the commenters assert that
it is proper in this case to interpret ‘‘the
singular [facility]-to include the plural
[facilities].”

The very first section of the United
States Code, 1 U.S.C. 1, says:,“‘In
determining the meaning of any act of
Congress, unless the context indicates
otherwise—words importing the
singular include and apply to several
persons, parties, or things * * *”
(emphasis added). In the case of the
statutory language used by Congress in
the section of EEOICPA describing the
procedure for designating additional
members of the Cohort (42 U.S.C.
7384q), the context indicates Congress
did not define a class as a group of
employees from multiple facilities. In
particular, the context of the reference
to a “class of employees at any
Department of Energy facility who likely
were exposed to radiation.at that
facility” in 42 U.S.C. 7384(q)(a)(1)
cannot be interpreted as a class covering
more than one facility (emphasis
added). HHS therefore believes that the
concept of considering and adding
multi-facility classes was not
anticipated nor provided for in
EEOICPA.

As a result, HHS has not revised this
section, nor the definition of the class
under 83.5, to allow for classes
spanning employment at multiple
facilities. This limitation would not,
however, prevent a petitioner from



THE SECRETARY OF HEALTH AND HUMAN SERVICES
WASHINGTON, 0.C. 20201

MAR - 3 2008

The Honorable Nancy Pelosi
Speaker of the House of Representatives
Washington, D.C. 20515

Dear Madam Speaker:

Pursuant to the Energy Employees Occupational Illness Compensation Program Act of
2000 and 42 C.F.R. § 83.14, the Centers for Disease Control and Prevention’s (CDC) National
Institute for Occupational Safety and Health (NIOSH) initiated a petition for a class of workers
from the Combustion Engineering facility to be added to the Special Exposure Cohort (SEC).

On January 9, 2008, NIOSH presented its findings on the petition evaluation to the
Advisory Board on Radiation and Worker Health (Board). The Board considered the petition,
and on February 1, 2008, I received the Board’s recommendation concerning this petition. I
have also received the deliberations, findings, and recommendations of the Director of NIOSH
and the Director of CDC. I have designated the following class for addition to the SEC:

Atomic Weapons Employer (AWE) employees who worked at the Combustion
Engineering site in Windsor, Connecticut, from January 1, 1965, through
December 31, 1972, for a number of work days aggregating at least 250 work
days or in combination with work days within the parameters established for one
or more other classes of employees in the Special Exposure Cohort.

The criteria and findings upon which this designation is based are provided in the enclosed
Teport.

Please call me if you have any further questions regarding this matter.

Sincerely,

Michael O. Leavitt

Enclosure


THE SECRETARY OF HEALTH AND HUMAN SERVICES
WASHINGTON, D.C. 20201

MAR - 3 2008

The Honorable Mitch McConnell
Minority Leader

United States Senate
Washington, D.C. 20510

Dear Senator McConnell:

Pursuant to the Energy Employees Occupational IIIness Compensation Program Act of
2000 and 42 C.F.R. § 83.14, the Centers for Disease Control and Prevention’s (CDC) National
Institute for Occupational Safety and Health (NIOSH) initiated a petition for a class of workers
from the Combustion Engineering facility to be added to the Special Exposure Cohort (SEC).

On January 9, 2008, NIOSH presented its findings on the petition evaluation to the
Advisory Board on Radiation and Worker Health (Board). The Board considered the petition,
and on February 1, 2008,, I received the Board’s recommendation concerning this petition. I
have also received the deliberations, findings, and recommendations of the Director of NIOSH
and the Director of CDC. I have designated the following class for addition to the SEC:

Atomic Weapons Employer (AWE) employees who worked at the Combustion
Engineering site in Windsor, Connecticut, from January 1, 1965, through
December 31, 1972, for a number of work days aggregating at least 250 work
days or in combination with work days within the parameters established for one
or more other classes of employees in the Special Exposure Cohort.

The criteria and findings upon which this designation is based are provided in the enclosed
report.

Please call me if you have any further questions regarding this matter.

Sincerely,

Michael O. Leavitt

Enclosure



(2) NIOSH did not identify any evidence from the petitioners or from other resources
that would establish that the class was exposed to radiation during a discrete
incident likely to have involved exceptionally high-level exposures, such as a
nuclear criticality incident, as defined under 42 C.F.R. § 83.13(c)(3)(i).

(3) The Board concurred with NIOSH’s finding that the health of the class may have
been endangered and defined the class according to the 250-workday requirement
specified under 42 C.F.R. § 83.13(c)(3)(ii).

Vv. Effect and Effective Date of Designation

The Secretary submits this report on the designation of one additional class to the
SEC for review by Congress, pursuant to 42 U.S.C. §§ 7384/(14)(C)(ii) and
7384q(c)(2)(A), as amended by the Ronald W. Reagan National Defense
Authorization Act for Fiscal Year 2005, Pub. L. No. 108-375 (codified as amended in
scattered sections of 42 U.S.C.). Pursuant to 42 U.S.C. § 7384/(14)(C)(ii), as
amended by the Ronald W. Reagan National Defense Authorization Act for Fiscal
Year 2005, Pub. L. No. 108-375 (codified as amended in scattered sections of 42
U.S.C.), the designation in this report will become effective 30 days after the date of
this report’s submission to Congress “unless Congress otherwise provides.”

VI. Administrative Review of Designation

The health endangerment determination of the designation provided in this report
may be subject to an administrative review within HHS, pursuant to 42 C.F.R. §
83.18(a). On the basis of such a review, if the Secretary decides to expand the class
of employees covered by this designation, the Secretary would transmit a
supplementary report to Congress providing the expanded employee class definition
and the criteria and findings on which the decision was based.

HHS Special Exposure Cohort Designation:
Combustion Engineering



THE SECRETARY OF HEALTH AND HUMAN SERVICES
WASHINGTON, D.C. 20201

MAR - 3 2008

The Honorable John A. Boehner
Minority Leader

United States House of Representatives
Washington, D.C. 20515

Dear Congressman Boehner:

Pursuant to the Energy Employees Occupational Illness Compensation Program Act of
2000 and 42 C.F.R. § 83.14, the Centers for Disease Control and Prevention’s (CDC) National
Institute for Occupational Safety and Health (NIOSH) initiated a petition for a class of workers
from the Combustion Engineering facility to be added to the Special Exposure Cohort (SEC).

On January 9, 2008, NIOSH presented its findings on the petition evaluation to the
Advisory Board on Radiation and Worker Health (Board). The Board considered the petition,
and on February 1, 2008, I received the Board’s recommendation concerning this petition. I
have also received the deliberations, findings, and recommendations of the Director of NIOSH
and the Director of CDC. [ have designated the following class for addition to the SEC:

Atomic Weapons Employer (AWE) employees who worked at the Combustion
Engineering site in Windsor, Connecticut, from January 1, 1965, through
December 31, 1972, for a number of work days aggregating at least 250 work
days or in combination with work days within the parameters established for one
or more other classes of employees in the Special Exposure Cohort.

The criteria and findings upon which this designation is based are provided in the enclosed ,
report.

Please call me if you have any further questions regarding this matter.

Sincerely,

Enclosure



Federal Register / Vol.

69, No. 104/Friday, May 28, 2004/Rules and Regulations

30767

contested by members of the Board (see
Transcript of the Advisory Board on
Radiation and Worker Health, March 7,
2003, page 17; Transcript of the
Advisory Board on Radiation and
Worker Health, March 28, 2003, pages
46-48).

On the other hand, some members of
the Board did contest the proposition
that it could be feasible to estimate
radiation doses from internal exposures
(originating from radioactive materials
that are taken into the body) for certain
cancer sites and not others. This
discussion clarified that all tissues and
organs could be irradiated to some
degree in cases involving internal
exposures (see Transcript of the
Advisory Board on Radiation and
Worker Health, March 7, pages 36-37;
Transcript of the Advisory Board on
Radiation and Worker Health, March 31,
2003, pages 42-66). Asa result, a
scientific finding concerning the
feasibility of estimating doses in cases
involving internal exposures would
have to apply to all cancers. This
reduces the practical applicability of a
policy for establishing cancer-specific
classes on the basis of the feasibility of
dose reconstruction, since additions to
the Cohort are likely to involve internal
radiation exposures.

A second scientific issue related to
the issue of adding cancer-specific
classes to the Cohort but not related to
the HHS proposal, is whether or not
certain cancers should be excluded from
a class because the radiation exposure of
concern is unlikely to have caused those
cancers. The Health Physics Society
advocated such a policy, providing an
example of situations in which one
might reasonably conclude the
probability of causation would be very
low for certain cancers. An advocacy
group and several labor organizations
recommended against such a policy.
HHS did not propose and has not
established such a policy, which relates
to health endangerment rather than the
feasibility of dose reconstruction.

The most prevalent comment HHS
received on this rule did not concern
the scientific justification for
establishing cancer-specific classes, but
argued that such a policy conflicted
with EEOICPA and with congressional
intent. These commenters included the
14 Members of Congress, advocacy
groups, and labor organizations.
Although the courts generally give little
weight to statements by individual
legislators when determining
congressional intent, many of these
commenters referenced an October 12,
2000 statement by Senator Jeff
Bingaman to the full Senate. In this
statement, Senator Bingaman said that

groups of workers added to the Cohort
“would be eligible for compensation for
a fixed list’of radiation félatéd cancers,”
meaning the list of 22 “specified
cancers” established under EEOICPA
and listed in section 83.5{m) of this rule.
$10377, Congressional Record, October
12, 2000.

Many commenters also expressed the
view that it would be unfair and
contrary to EEOQICPA for HHS to
exclude from classes of employees to be
added to the Cohort employees who
incur certain specified cancers, since all
specified cancers are compensable for
members of the classes included in the
Cohort by statute. The relevant portion
of the statutory provision of EEOICPA
reads as follows: ‘The term ‘covered
employee with cancer’ means any of the
following: [a]n individual with a
specified cancer who is a member of the
Special Exposure Cohort, * * *” 42
U.S.C. 73841(9)(A).

In addition, while the Board indicated
that it might be scientifically and

theoretically possible for the situations -

addressed by the NPRM to exist, the
Board recommended against the
establishment of cancer-specific classes,
as discussed below, stating that it was
concerned about “‘providing some level
of equity between the definition of new
SEC classes and those already defined
in the legislation.”

The provisions of EEOICPA that
directly govern which classes of
employees can be added to the Cohort
are the feasibility and health
endangerment provisions addressed
under the “statutory requirements”
section above. These provisions can be
interpreted in different ways to either
support or oppose the establishment of
cancer-specific classes. They neither
require nor prohibit HHS from
establishing cancer-specific classes.

As discussed above, in support of
cancer-specific classes, HHS has
identified possible situations in which
the feasibility of estimating doses would
differ by type of cancer. In addition, the
Health Physics Society and a member of
the Board identified possible situations
in which a determination of health
endangerment might differ by type of
cancer.

In opposition to including provisions
for cancer-specific classes, one could
interpret “‘it is not feasible to estimate
with sufficient accuracy the radiation
dose that the class received" to mean: it
is not feasible to estimate with sufficient
accuracy the radiation dose to any
cancer site rather than the dose relevant
to the cancer incurred by any particular
employee. Similarly, health
endangerment could be interpreted to
mean an employce having been put at

risk of certain types of cancers,
regardless of whether the employee
actually incurred one of the cancers for
which the employee was at risk. Such
interpretations would allow one to
define a class without qualification,
even when it would be feasible to
estimate radiation doses for employees
with all but one type of cancer, and
even if most types of cancers were
unlikely to have been caused by the
radiation exposure of concern.

In light of the ambiguity of the statute,
the limited practical applications of the
option to establish cancer-specific
classes, the nearly unanimous public
opposition, and the opposition of the
Board, HHS has omitted from the final
rule the provisions in the NPRM that
would have allowed the addition to the
Cohort by HHS of cancer-specific
classes of employees. Furthermore, HHS
has revised section 83.13(c)(1) of the
rule to state explicitly that NIOSH will
make determinations of feasibility based
on whether or not NIOSH is able to
reconstruct doses for every type of
cancer for which radiation doses are
reconstructed.

The practical consequence of these
changes is that HHS might designate
classes of employces to be added to the
Cohort under this rule despite the
possibility that it might be feasible to
estimate radiation doses with sufficient
accuracy for some members of the class;
specifically, that it might be feasible to
estimate radiation doses with sufficient
accuracy for a member of the class who
incurs one of a subset cancer types for
which there might be adequate dose-
related information, as discussed above.

C. Accuracy of Dose Reconstructions

HHS received various comments and
recommendations that relate to the
determination as to whether it is
feasible to estimate doses to members of
a class of employees with sufficient
accuracy.

The most frequent of these comments
requested HHS provide additional
detail, either in the rule or in guidelines,
to define how NIOSH would establish,
under § 83.13(c)(1), “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* * *" HHS was asked to provide
the methods by which maximum
radiation doses would be estimated, and
to define “sufficient information.” The
Board requested that NIOSH issue
guidelines to provide additional
clarification concerning sufficient
accuracy, after promulgation of this
final rule.



oan,

TM~
f }

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

National Institute for

Occupational Safety and Health
Centers for Disease Control

and Prevention (CDC)
200 Independence Avenue, SW
Washington, DC 20201

DATE:
TO: The Secretary
Through: DS
Cos
ES :
CDC
FROM: Director

National Institute for Occupational Safety and Health

SUBJECT: Designating Certain Employees of the Combustion Engineering site in Windsor,
Connecticut, as Members of the Special Exposure Cohort under the Energy
Employees.Occupational IlIness Compensation Program Act of 2000 42 U.S.C. §
7384q -- ACTION

Action Required: Submit Report to Congress by March 3, 2008
ISSUE

Attached for your approval and signature is a proposed designation to add certain employees
from Combustion Engineering as members of the SEC Special Exposure Cohort under
EEOICPA (Tab A).

DISCUSSION

Energy Employees Occupational Illness Compensation Program Act (EEOICPA) established an
SEC, a designation applied to certain classes of employees who worked at U.S. nuclear weapons
production facilities of the Department of Energy (DOE) or Atomic Weapons Employers
(AWEs). EEOICPA confers upon SEC designees a presumption of causation regarding the
relation of their cancers to their employment ata DOE or AWE facility. This presumption
allows them to obtain federal compensation under EEOICPA if they incur at least one of a list of
“specified cancers” that, under EEOICPA, are presumptively linked with occupational exposures
to radiation at DOE and AWE facilities. EEOICPA initially included four classes of employees
in the SEC and provided that the President could designate additional classes as members of the
SEC if certain statutory conditions are met. The authority to designate additional members was
delegated by the President to the Secretary of the Department of Health and Human Services
(HHS), who promulgated procedures for doing so (42 C.F.R. pt. 83, Tab B). Since these
procedures were promulgated, Congress has amended EEOICPA to mandate that HHS report to



75952

Federal Register/Vol. 70,

| ‘
No.|245/Thursday, December 22, 2005/Rules and Regulations

B. Regulatory Flexibility Act

The Regulatory Flexibility Act
(“RFA”), 5 U.S.C. 601 et. seq., requires
each agency to consider the potential
impact of its regulations on small
entities, including small businesses,
small governmental units, and small
not-for-profit organizations. HHS
certifies that this rule will not have a
significant economic impact on a
substantial number of small entities
within the meaning of the RFA. The rule
affects only HHS, DOL, the Department
of Energy, and certain individuals
covered by EEOICPA. Therefore, a
regulatory flexibility analysis as
provided for under RFA is not required.

C. What Are the Paperwork and Other
Information Collection Requirements
(Subject to the Paperwork Reduction
Act) Imposed Under This Rule?

The Paperwork Reduction Act
(“PRA”) 44 U.S.C. 3501 et. seq., requires
an agency to invite public comment on
and to obtain OMB approval of any
regulation that requires ten or more
people to report information to the
agency or to keep certain records. This
tule, which makes limited changes to 42
CFR part 83, does not contain any
information collection requirements.
Thus, HHS has determined that the PRA
does not apply to this rule. ,

D. Small Business Regulatory
Enforcement Fairness Act

As required by Congress under the
Small Business Regulatory Enforcement
Fairness Act of 1996 (5 U.S.C. 801 et.
seq.), HHS will report to Congress
promulgation of this rule prior to its
taking effect. The report will state that
HHS has concluded that this rule is not
a “major rule” because it is not likely
to result in an annual effect on the
economy of $100 million or more.
However, this rule has a subordinate
role in the adjudication of claims under
EEOICPA, serving as one element of an
adjudication process administered by
DOL under 20 CFR parts 1 and 30. DOL
has determined that its rule is a “major
rule”. because it will likely result in an
annual effect‘on the economy of $100
million or more.

E. Unfunded Mandates Reform Act of
1995 4

Title II of the Unfunded Mandates
Reform Act of 1995 (2 U.S.C. 1531 et.
seq.) directs agencies to assess the
effects of federal regulatory actions on
State, local, and tribal governments, and
the private sector “other than to the
extent that such regulations incorporate
requirements specifically set forth in
law.” For purposes of the Unfunded
Mandates Reform Act, this rule does not

include any federal mandat¢ that may
res ulti in increased annual expenditures
in ekcess of $100 million by; State, local
or tribal governments in thejaggregate,

or by the private sector. |
P. Executive Order 12988 (Civil Justice)

i
This rule has been drafted and
reviewed in accordance with Executive
Order 12988 on Civil Justice Reform and
will not unduly burden the federal court
system. HHS adverse decisions may be
reviewed|in United States District
Courts pursuant to the APA! HHS has
atteinpted to minimize that burden by
providing petitioners an opportunity to
seek administrative review of adverse
decisions, HHS has provided a clear
legal standard it will apply in

considering petitions. This rule has
been reviewed carefully to eliminate
drafting errors and ambiguities.

G. Brecut ‘ive Order 13132 (Federalism )

HHS has reviewed this miei in
accordance with Executive Order 13132
regarding federalism, and has
det rmined that it does not have

“federalism implications.” The rule
does not /‘have substantial direct effects
on the States, on the relationship
between the National Government and
the States, or on the'di tribution of
power and responsibilities 4 among the
various levels of government.”

H. Executive Order 13045 (Protection of
Children|From Environmental, Health
Risks and Safety Risks) |

In accordance with Executive Order
13045, HHS has evaluated the
environnjental health and safety effects
of this rule on children. HHS has
determinbd that the rule would have no
effet on children. \

I Ekecut ive Order 13211 (Actions
Cortcerning Regulations That

Sigh hifcantly Affect Energy Supply,
Distribution, or Use) |

Ih accordance with Executive Order
13211, HHS has evaluated the effects of
this rule pn energy supply, distribution
or use, and has determined that the rule
will not _ a significant adverse effect

on them. {
y. Effect re Date |

‘The Secretary has determined,
purpuant to 5 U.S.C. 553(d)(3), that there
is good cause for this rule to be effective
immediately to eliminate legal
inconsistencies between new statutory
requirements under 42 U.S.C. 7384] and
7384q and regulatory requirements
under 42 CFR part 83 and to make the
implementation of the new statutory

requirements feasible. |

|
'
i
|
i

List of Subjects in 42 CFR Part 83

Government employees, Occupational
safety and health, Nuclear materials,
Radiation protection, Radioactive
materials, Workers’ compensation.

Text of the Rule '

au For the reasons discussed in the

preamble, HHS amends 42. CFR part 83
to read as follows:

PART 83—[AMENDED]

@ 1-2. The authority citation for part 83
continues to read as follows:

Authority: 42 U.S.C, 7384q; E.O. 13179, 65
FR 77487, 3 CFR, 2000 Comp./p. 321.

Subpart B—Definitions '

m 3. Amend § 83.5 by redesignating
paragraphs (j) through (n) as (1) through
(p), respectively and by redesignating
paragraphs (c) through (i) as (d) through
(j), respectively, and by adding new
paragraphs (c) and (k) to read as follows:

§83.5 Definition of terms used in the
procedures in this part.
ee ee ee

(c) Computation of Time Periods: In
this Rule, all prescribed or‘allowed time
periods will be counted as calendar
days from the business day of receipt by
the submitter(s), the petitioner(s),
NIOSH, or HHS. Receipt by NIOSH, the:
submitter(s) or petitioner(s) will be «
either the business day of actual receipt
or three (3) business days after initial
proof of mailing, whichever time period
is shorter. Business days are defined as
Monday through Friday, 8 a.m. to 4:30
p.m. est and “legal holiday” will be
used as defined by the FED. R. CIV. P.
6(a).

i

(k) Petition means a submission under
§ 83.8 of this part that meets all the
requirements of §§ 83.7-83.9 of this part
and has incorporated any revisions
made by the petitioner under §§ 83.7~
83.9 or § 83.11 of this part.
to
Subpart C—Procedures for Adding
Classes of Employees to the Cohort

i 4. Revise § 83.11 to read as follows:

§83.11 What happens to petition
submissions that do not satisfy all relevant
requirements under §§ 83.7 through 83.9?

(a) NIOSH will notify the petitioner(s)
of any requirement that is not met by
the submission, assist the petitioner(s).
with guidance in developing relevant
information, and provide 30 calendar
days for the petitioner(s) to revise the
submission accordingly.



I. Designation

I, Michael O. Leavitt, Secretary of Health and Human Services (Secretary), designate
the class of employees defined in Section II of this report for addition to the Special
Exposure Cohort (SEC), as authorized under the Energy Employees Occupational
Illness Compensation Program Act of 2000 (E ), 42 U.S.C. § 7384q. -

MAR - 3 2008

Date Michael O. Leavitt

Il. | Employee Class Definition

Atomic Weapons Employer (AWE) employees who worked at the
Combustion Engineering site in Windsor, Connecticut, from January 1,
1965, through December 31, 1972, for a number of work days aggregating
at least 250 work days or in combination with work days within the
parameters established for one or more other classes of employees in the
Special Exposure Cohort.

III. Designation Criteria and Recommendations

Pursuant to 42 U.S.C. § 73844, for the class defined in Section II of this report, the
Secretary has determined, and the Advisory Board on Radiation and Worker Health
(Board) has recommended, that
(1) it is not feasible to estimate with sufficient accuracy the radiation dose that the
class received; and
(2) there is a reasonable likelihood that such radiation dose may have endangered
the health of members of the class.

The SEC final rule states in 42 C.F.R. § 83.13(c)(1) that it is feasible in two situations
to estimate the radiation dose that the class received with sufficient accuracy. First,
the rule states that radiation doses may be estimated with sufficient accuracy if
NIOSH has established that it has access to sufficient information to estimate the
maximum radiation dose for every type of cancer for which radiation doses are
reconstructed that could have been incurred under plausible circumstances by any
member of the class. Alternatively, radiation doses may be estimated with sufficient
accuracy if NIOSH has established that it has access to sufficient information to
estimate the radiation doses of members of the class more precisely than 4 maximum
dose estimate.

The Board, pursuant to 42 U.S.C. § 7384q, advised the Secretary to designate the
class as an addition to the SEC in a letter received by the Secretary on February |,
2008.

HHS Special Exposure Cohort Designation:
Combustion Engineering



HHS Designation of Additional Members of the

Special Exposure Cohort
under the
Energy Employees Occupational [Illness Compensation Program Act of 2000

Designating a Class of Employees from

Combustion Engineering
Windsor, Connecticut

HHS Special Exposure Cohort Designation:
Combustion Engineering



SEC-00099

12-14-07

Combustion Engineering

4-1

4-1
4-2

'

: Combustion Engineering Site

: Uranium Shipments from Comb

ap.

usti

Figure

Tables

yn Engineering to Fernald Feed Center.

: Known AEC- and Non-AEC-Rélated Work Locations and Operations

6 of 20



30786 Federal Register/Vol. 69, No. 104/Friday, May 28, 2004/Rules and Regulations

(2) An analysis by NIOSH of the Cohbrt, based upon a review by the (5) Publication in the Federal Register
utility of the new information for Board of the NIOSH analysis under ofa final decision to cancel’ or modify
conducting dose reconstructions under _ paragraph (b)(2) of this section and any the prior final decision'that ‘added the
42 CFR Part 82; the analysis will be other relevant information considered class to the Cohort. "
performed consistently with the by the Board; ( Dated: Feb 23,2004
requirements for analysis of a petition (4) An opportunity for members of the lated: February 23, 2004. :
by NIOSH under §§ 83.13(c)(1) and (2), _class to contest a proposed decision to Tommy G. Thompson, i
and 83.13(c)(2) and (3); candel or modify the prior final decision Secretary, Department of Health and Human

(3) A recommendation by the Board to that|added the class to the Cohort, Services. .
the Secretary as to whether or not the including|a reasonable and timely effort [FR Doc. 04-11930 Filed 5~27~04; 8:45 am]
Secretary should cancel or modify his _by the Se¢retary to notify members of —_ gua cove 4510-40-P

final decision that added the class to the the class of this opportunity} and :



30774

Federal Register / Vol.

69, No.

04/Friday, May 28, 2004/Rules. and Regulations

recommended the rule réquire the
Secretary to make decisions within 21
days of receiving recommendations
from NIOSH and the Board.

The advocacy group, a labor union,
and some Members of Congress also
sought additional information about the
procedure for administrative review of
proposed decisions. The advocacy
group and a labor organization
specifically questioned whether such ,
reviews would include the opportunity
for oral presentations by petitioners and
experts, and the availability of the
administrative record of the NIOSH
evaluation(s).

HHS has specified procedures under
§ 83.16 in greater detail in response to
these comments. The procedures now
specify that the Director of NIOSH will
propose decisions on behalf of HHS.
The authority to issue final decisions,
however, has not been delegated to the
Director of NIOSH. As discussed in the
preamble of the NPRM, the Secretary
may consider such a delegation on the
basis of experience.

The criteria for making proposed and
final decisions were implicit in the
NPRM but have been specified
explicitly in the rule; these are the
criteria to be applied by NIOSH in’
evaluating a petition under § 83.13(c),
implementing the two.criteria specified
in EEOICPA (42.U.S.C. 7384q(b)(1) and.
(2)).

HHS has revised,the procedures for
issuing proposed decisions to clarify
that NIOSH would issue multiple
proposed decisions in response to a
single petition, when NIOSH determines
that the petition encompasses more than
one class of employees. As defined
under § 83.5(c), a class of employees
means, for the purposes of this rule, a
group of employees who work‘or
worked at the same DOE facility or AWE
facility, and for whom the availability of
information and recorded data on
radiation exposures is comparable with
respect to the informational needs of
dose reconstructions conducted under
42 CFR Part 82. Based upon NIOSH’s
evaluation of a petition, NIOSH may
find that records are sufficient to
conduct dose reconstructions for part of
a proposed class, as defined by the
petitioner, and insufficient to conduct
dose reconstructions for another part of
the proposed class. In such a case,
NIOSH would define two or more
separate classes of erployees,
distinguished by the difference in the
sufficiency of the information available
to conduct dose reconstructions.

Related to this clarification, HHS has
also revised the procedures to authorize
petitioners to contest only those
proposed decisions that would deny the

7 :
addition of.a class to the Cohort and to
contest a health endangerment
determination under § 83.13(c)(3){ii) for
a decision that would add a class to the
Cohort. This limitation will expedite the
process of completing the consideration
by HHS of classes that NIOSH has
proposed| adding to the Cohort by
omitting a 30-day period, specified
under thé NPRM, during which HHS
would have been required to await a
challengd, It also will ensure that
considerdtion by HHS of such classes
would nat have to further await, beyond
the 30-day period, the outcome of a
challenge in which a petitioner asserts
that the proposed scope of the class is
overly restrictive. This limitation will
not prevent a petitioner from contesting
any proppsed decision or aspect of a
proposed! decision regarding his or her
petition that would deny the addition to
the {Coho of individuals covered by the
petition or a resultant NIOSH proposed
decision ||
The sec
indepen
decision:
to challe:

tion newly specifies the
lence with which proposed
will be reviewed in response
ges and provides clarification
concerning the requirements of such
challenges and the nature of such
réviews. [hese will be records-based -
reviews fended by a panel of three
HHS personnel, appointed by the
Secretary, rather than hearings
involving witnesses and presided over
by an administrative law judge. The
reviews will not involve oral
presentations or the introduction of new
information that had not previously
been presented or submitted to NIOSH
or the Board prior to the Board
completing its report of
recommendations to the Secretary under
§ 83.15. Petitioners will have received
all NIOSH evaluations concerning their
petitions, and will have access to the
administrative record for such
evaluatidns, all publicly available
informatjon considered by the Board, as
well as td the final report of the Board;
petitioners will not have access to
informat on protected by the Privacy
Act and information classified for
purposes of national security. Complete
instructipns for contesting proposed
decisions will be provided to each
petitioner. !
[he rule does not specify any
particular weight that HHS will accord
the advige of the Board in making
proposed and final decisions. The Board
recommendations are advisory. HHS
woild nbt prejudge such advice and
will consider it according to its merits.
Sedtion 83.16 specifies the'sources and
scope of information that HHS will
consider, in making its decisions, and

provides that HHS will explain the basis
for the decisions.

The rule does not require that HHS
make final decisions within 21 days or
any specified period. Decisions will be
made as expeditiously as possible, but
HHS is providing petitioners 30 days to
contest proposed decisions and such
challenges would then have to be
considered. The volume and scope of
petitions, factors not controlled by HHS
and impossible to predict, also might
affect the speed of such decisions.

I. Cancelling or Modifying a Final
Decision

One labor organization commented on

_the provisions under § 83.18 of the

NPRM allowing the Secretary to cancel
or modify a class that the Secretary had
added to the Cohort. The commenter
recommended such a decision by the
Secretary be applied prospectively, for
the adjudication of future claims; in
other words, such a decision should not
affect claimants who have already been
compensated as a member of the Cohort,
by potentially requiring the cessation of
medical benefits or the return of the
lump sum cash benefit, pending the
results of a re-adjudication of the claim:
Since DOL makes final compensation
eligibility determinations for claimants,
DOL will determine the application of _
such decisions by HHS to claims that
DOL has already decided and claimants
who have already received '
compensation. .

J. Definitions of Terms Used in the Rule

Section 83.5 provided definitions of
terms used in the NPRM.

Three advocacy groups and four labor
organizations commented on several of
the definitions. The Board’ also
commented on definitions.

The advocacy groups and two labor
organizations recommended that the
definition for.a “class of employees”

(§ 83.5(c)) in the NPRM be revised to
allow for a class that would span
multiple facilities. One advocacy group
and one labor organization also
recommended that this definition be
revised to define a class in terms of
information that is not available.

The multi-facility issue is fully
discussed above, under the section
addressing comments on petition
requirements. HHS does not interpret
EEOICPA to allow for petitioners to
define multi-facility classes of
employees. Hence, HHS has not
changed the definition as recommended
by the commenters. This limitation
would not, however, prevent a
petitioner from submitting petitions
separately for employees at each facility
at which’a group was employed,



Federal Register / Vo]. 70, No. 245/Thursday, December 22, 2005/Rules and Regulations

75953

(b) After 30 calendar days from the
date of notification under paragraph (a)
of this section, NIOSH will notify any
petitioner(s) whose submission remains
unsatisfactory of the proposed finding of
NIOSH that the submission fails to meet
the specified requirements and the basis
for this finding.

(c) A petitioner may request in writing
a review of a proposed finding within 7
calendar days of notification under
paragraph (b) of this scction. Petitioners
must specify why the proposed finding
should be reversed, based on the
petition requirements and on the
information that the petitioners had
already submitted. The request may not
include any new information or
documentation that was not included in
the completed submission. If the
petitioner obtains new information
within this 7 day period, the petitioner
should provide it to NIOSH. NIOSH will
consider this new information as a
revision of the submission under
paragraph (a) of this section-

(d) Three HHS personnel, appointed
by the Director of NIOSH, who were not
involved in developing the proposed
finding will complete reviews within 30
work days of the request for such a
review. The Director of NIOSH will
consider the results of the review and
then make a final decision as to whether
the submission satisfies the
requirements fora petition.

fe) Proposed findings established by
NIOSH under paragraph (b) of this
section will become final decisions in 8
calendar days if not reviewed under
paragraph (d) of this section.

(f) Based on new information, NIOSH
may, at its discretion, reconsider a
decision that a submission does not
satisfy the requirements for a petition.
m5. Revise § 83.16 to read as follows:

§83.16 How will the Secretary decide the
outcome(s) of a petition?

(a) The Director of NIOSH will
propose a decision to add or deny
adding any class or classes of employees
to the Cohort, including an iteration of
the relevant criteria, as specified under
§ 83.13(c), and a summary of the
information and findings on which the
proposed decision is based. This
proposed decision will take into
consideration the evaluations of NIOSH
and the report and recommendations of
the Board, and may also take into
consideration information presented or
submitted to the Board and the
deliberations of the Board. In the case of
a petition that NIOSH has determined
encompasses more than one class of
employees, the Director of NIOSH will
issue a separate proposed decision for
each separate class of employees.

(b) The Secretary will make the final
decision to add or deny adding a class
to the Cohdit; including the definition
of the class, after considering
information and recommendations
provided to the Secretary by the
Director of NIOSH and the Board. HHS
will transmit a report of the decision to
the petitioners), including an iteration
of the relevant criteria, as specified
under § 83.13(c), and a summary of the
information and findings on which the
decision is based. HHS will also publish
a notice summarizing the decision in
the Federal Register.

(c) If, under § 83.15(e), the Board
recommends that the Secretary
designate a class covered by the petition
as an addition to the Cohort, and if,
under paragraph (b) of § 83.16, the
Secretary decides to deny adding the
class, as defined by the Board, to the
Cohort, then the Secretary will submit
to Congress a determination that the
statutory criteria specified under 42
U.S.C. 7384q(b)(1) and (2) have not been
met for adding the class to the Cohort.
The Secretary will submit this
determination to Congress within 30
calendar days following receipt by the
Secretary of the recommendation of the
Board. +
m6. Amend § 83.17 by redesignating
paragraphs (b), (c), and (d), as (c), (d),
and (¢), respectively, and by adding new
paragraph (b), and revising newly
redesignated paragraphs (c) and (e) to
read as follows:

§83.17 How will the Secretary report a
final decision to add a class of employees
to the Cohort and any action of Congress
concerning the effect of the final decision?

(b) If, under § 83.15(e), the Board
recommends that the Secretary
designate a class covered by the petition
as an addition to the Cohort, and if,
under paragraph (b) of § 83.16, the
Secretary decides to add a class to the
Cohort that is inclusive of the class as
defined by the Board, then the Secretary
will transmit to Congress the report
specified in paragraph (a) of this section
within 30 calendar days following
receipt by the Secretary of the
recommendation of the Board.

(c) A designation of the Secretary will
take effect 30 calendar days after the
date on which the report of the
Secretary under paragraph (a) of this
section is submitted to Congress, or is
deeined to have been submitted to
Congress.$ unless Congress takes an

“Und
does not
required onder paragraph (a) of § 83.17 of t
then on the following day, “it shall be deemed” that

action that reverses or expedites the
designation.

(e} The report shecified under
paragraph (d) of this section will be
published on the Internet at http://
www.cdc.gov/niosh/ocas and in the
Federal Register.

§83.18 [Redesignated as § 83.19]

m 7. Redesignate § 83.18 as § 83.19.

@ 8. Add a new § 83.18 to read as
follows: |

§83.18 How can petitioners obtain an
administrative review of a final decision by
the Secretary?

(a) HHS will allow petitioners to
contest only a final decision to deny
adding a class to the Cohort or a health
endangerment determination under
§ 83.13(c)(3)(ii). Such challenges must
be submitted in writing within 30
calendar days and must include
evidence that the!final decision relies on
a record of either substantial factual
errors or substantial errors in the
implementation of the procedures of
this part. Challenges may not introduce
new information or documentation
concerning the petition or the NIOSH or
Board evaluation(s) that was not
submitted or presented by the
petitioner(s) or others to NIOSH or to
the Board prior té the Board’s issuing its
recommendations under § 83.15.

(b) A panel of three HHS personnel,
independent of NIOSH and appointed
by the Secretary, will conduct an
administrative review based on a
challenge submitted under paragraph (a)
of this section and provide
recommendations of the panel to the
Secretary concerning the merits of the
challenge and thé resolution of issues
contested by the challenge. Reviews by
the panel will consider, in addition to
the views and information submitted by
the petitioner(s) in the challenge, the
NIOSH evaluation report(s), the report
containing the recommendations of the
Board issued under § 83.15, and
recommendations of the Director of
NIOSH to the Secretary. The reviews
may also consider information
presented or submitted to the Board and
the deliberations of the Board prior to
the issuance of the recommendations of
the Board under § 83.15. The panel shall
consider whether HHS substantially
complied with the procedures of this
part, the factual accuracy of the
information supporting the final
decision, and the principal findings and
recommendations of NIOSH and those
of the Board issued under § 83.15.

the Secretary submitted the report specified under
paragraph (b) of § 83.17 of this part


Federal Register / Vol.

69, No. 104/Friday, May 28, 2004/Rules and Regulations

30773

submitting petitions separately for
employees at each facility at which a
group was employed, defining
individual, facility-specific classes.
Furthermore, changes in this rule
eliminate the potential value of defining
classes to include employment at
multiple facilities. Under this rule
(83.13(c)(3)(ii)), a claimant will be able
to qualify as a member of a class added
to the Cohort by HHS by combining the
duration of his or her period of
employment within the class with other
periods of employment among other
classes in the Cohort. Hence, for
example, if classes of construction
workers involved in certain operations
were separately added to the Cohort
from Hanford and from Los Alamos,
then a construction worker who was
employed for 100 work days in the
specified operations at Hanford and for
150 work days in the specified
operations at Los Alamos would meet a
250 work days employment requirement
that might be established for such
classes and he or she would qualify as

a member of the Cohort.

Subsection 83.9(c)(2) specified
various options available to petitioners
to’ support a petitioner's belief that
records and information available are
inadequate to estimate the radiation
doses incurred by members of the
proposed class of employees with
sufficient accuracy. Two advocacy
groups and two labor organizations
recommended changes to paragraph (iv)
to allow petitioners to use in support
the report of any government agency,
rather than only reports by agencies that
conduct scientific work. The
commenters suggested any government
agency should be considered a
potentially credible source of
information. The commenters also
recommended against requiring that
such reports specifically address the
need for any dosimetry information
identified in the report, with respect to
dose reconstruction. The Board
provided a similar recommendation
(discussed in the following section).

HHS agrees that this provision should
be clarified and improved, consistent
with these comments. The paragraph
now reads as follows:

liv) A scientific or technical report,
published or issued by an agency of the
Executive branch of government, the General
Accounting Office, the Nuclear Regulatory
Commission, or the Defense Nuclear
Facilities Safety Board, or published in a
peer-reviewed journal; that identifies
dosimetry and related information that are
unavailable (due to either a lack of
monitoring or the destruction or loss of
records) for estimating the radiation doses of
employees covered by the petition.

Subsection 83.9(c)(3) of the NPRM
specified evidence that would be |,
requited only when a petition is based
on an exposure incident (versus routine
operations) and NIOSH is unable to
obtain records or confirmation of the
occurrence of such an incident from
sources independent of the petitioner(s).
One option specified for such evidence
was confirmation by affidavit from two
employees who witnessed the incident.

ine labor organization commented
that a total of two witnesses should be
sufficient and that secondhand accounts
should be sufficient when eyewitnesses
are deceased. The Board made similar
recommendations (discussed in the

following section)

HHS has revised this subsection in
response to the comments from the
public and the Board. HHS has omitted
the requirement for a specific number of
witnesses, and has provided that the
witnesses can be or include individuals
who were informed by eyewitnesses,
when the eyewitnesses are deceased, are
incapable of providing an affidavit for
reasons of poor health or impairment, or
could not be located. HHS has also
clarified that the provision of affidavits,
in and of itself, would not constitute
adequate evidence to verify the
occurrence of an exposure incident. As
with any other evidence used to
evaluate petitions, NIOSH would have
to consider the credibility and adequacy
of the evidence provided in the
affidavits.

One labor organization commented
that the NPRM required petitioners to
know the source terms (the identities
and quantities of the radioactive
materials) to which employees were
exposed.

either the NPRM nor the final rule
includes such a requirement.

HHS has added a new § 83.9(c)(5)
necessary to provide that NIOSH would
only be required to reconsider its initial
evaluation or any subsequent
evaluations concerning the addition of a
particular class of employees to the
Cohort (a class that has already been
considered by NIOSH as the result of
one or more previously submitted
petitions) when a new petition for such
a class provides substantially new
information regarding the feasibility of
estimating radiation doses with
sufficient accuracy. This change will
ensure that the Board and HHS can
consider in a timely fashion the
addition to the Cohort of as many
classes as possible. The change
preserves the ability of NIOSH, the
Board, and HHS to reconsider the
addition of a class when petitioners
identify information not considered by
NIOSH that might lead NIOSH and/or

the Board to new findings and
recommendations concerning a class
previously considered.

G. Administrative Review of Decisions
To Not Evaluate a Petition

Section 83.11 of the NPRM proposed
procedures by which NIOSH would
assist petitioners on petitions that
NIOSH finds do not meet the relevant
requirements for a petition. A petition
that fails to meet such requirements
despite such assistance would not be
further considered by HHS. HHS
solicited comments from the public as
to whether HHS should offer the
petitioner an administrative review of
such final decisions.

Two advocacy groups and three labor
organizations recommended the rule
include the option of an administrative
review. The commenters recommended
that HHS specify the procedure for such
reviews and that they be conducted
independently. One commenter
recommended that such reviews be
conducted by NIOSH internally.

In response to the public comments,
HHS has included an option for
prospective petitioners to request an
administrative review. Paragraphs (b)
through (c) of section 83.11 have been
revised and added for this purpose. The
review would be conducted by three
HHS personnel, appointed by the
Director of NIOSH, who were not
involved in the initial consideration of
the petition. The rule provides for a
simple and timely process, with
minimal requirements imposed on the
petitioner. When appropriate, NIOSH
would notify a petitioner of the right to
seek an administrative review and of the
associated procedures.

H. Decisions by the Secretary

Section 83.16 of the NPRM described
procedures by which the Secretary
would decide the outcome of a petition.

An advocacy group, four labor
organizations, and some Members of
Congress requested additional detail] or
provided other comment on these
procedures. The advocacy group
recommended the Secretary delegate his
authority to the Director of NIOSH and
questioned the extent of the discretion
of the Secretary and the “weight” that
would be assigned to the advice of the
Board. A labor organization
recommended the rule limit the
circumstances under which the
Secretary may reject a recommendation
of the Board to add a class to the Cohort,
and should require explanation of such
decisions. Another labor organization
asserted that the rule does not specify
the criteria by which the Secretary will
make decisions. Several commenters

«


SEC-00099 12-14-07 Combustion Engineering

4.5 Job Descriptions Affected by Radiological Operations

No documentation on the job descriptions or operations associated with uranium shipments to Fernald
has been located. Due to the lack of information regarding worker job descriptions, and lack of
knowledge concerning worker movements within the Combustion Engineering site, NIOSH is unable
to rely solely on worker job descriptions to determine the potential for AWE radiological exposure.

5.0 Summary of Available Monitoring Data for the Proposed Class

The primary data used for determining internal exposures are derived from personal monitoring data,
such as urinalyses, fecal samples, and whole-body counting results. If these are unavailable, the air
monitoring data from breathing zone and general area monitoring are used to estimate the potential
internal exposure. If personal monitoring and breathing zone area monitoring are unavailable, internal
exposures can sometimes be estimated using more general area monitoring, process information, and
information characterizing and quantifying the source term.

This same hierarchy is used for determining the external exposures to the cancer site. Personal
monitoring data from film badges or thermoluminescent dosimeters (TLDs) are the primary data used
to determine such external exposures. If there are no personal monitoring data, exposure rate surveys,

’ process knowledge, and source term modeling can sometimes be used to reconstruct the potential
exposure.

A more detailed discussion of the information required for dose reconstruction can be found in
OCAS-IG-001, External Dose Reconstruction Implementation Guideline, and OCAS-IG-002, Internal
Dose Reconstruction Implementation Guideline. These documents are available at:
http://www.cdc.gov/niosh/ocas/ocasdose.html.

NIOSH has searched the Site Research Database (SRDB), the claimant data stored in its NIOSH
OCAS Claims Tracking System (NOCTS), and documents available on the Internet. NIOSH has also
completed data capture efforts with the successor company, Asea Brown Boveri, and with both state
and federal regulators. There are approximately 30 claimants in the NOCTS database who worked for
Combustion Engineering during the 1965-72 timeframe. Of these claimants, only one had internal
monitoring data for this time period, which consisted of two bioassay results. Four claimants had
limited external dose records during this time period. The available bioassay results were for natural
uranium and were less than the detection limits for urinalysis at the Fernald Site for this time period
(ORAUT-TKBS-0017-5). The highest recorded external cumulative whole-body dose for a claimant
for the period 1965-72 was approximately 5 rem.

There were no workplace monitoring records, area monitoring, or air sampling data found for the time
period 1965-72. No documentation on the work activities or processes associated with the uranium
shipments to Fernald has been located. Although other sites supplied uranium to the Fernald site,
there is no way to determine if their work activities were similar to Combustion Engineering given the
limited Combustion Engineering data currently available. Based on available information, NIOSH
can make no reasonable assumptions regarding the possible source term during Combustion
Engineering’s AWE operational period.

13 of 20



THE SECRETARY OF HEALTH AND HUMAN SERVICES
WASHINGTON, D.C. 20201

MAR - 3 2008

The. Honorable Harry Reid
Majority Leader

United States Senate
Washington, D.C. 20510

Dear Senator Reid:

Pursuant to the Energy Employees Occupational Illness Compensation Program Act of
2000 and 42 C.F.R. § 83.14, the Centers for Disease Control and Prevention’s (CDC) National
Institute for Occupational Safety and Health (NIOSH) initiated a petition for a class of workers
from the Combustion Engineering facility to be added to the Special Exposure Cohort (SEC).

On January 9, 2008, NIOSH presented its findings on the petition evaluation to the
Advisory Board on Radiation and Worker Health (Board). The Board considered the petition,
and on February 1, 2008, I received the Board’s recommendation concerning this petition. I
have also received the deliberations, findings, and recommendations of the Director of NIOSH
and the Director of CDC. I have designated the following class for addition to the SEC:

Atomic Weapons Employer (AWE) employees who worked at the Combustion
Engineering site in Windsor, Connecticut, from January 1, 1965, through
December 31, 1972, for a number of work days aggregating at least 250 work
days or in combination with work days within the parameters established for one
or more other classes of employees in the Special Exposure Cohort.

The criteria and findings upon which this designation is based are provided in the enclosed
report. .

Please call me if you have any further questions regarding this matter.

Sincerely,

Michael O. Leavitt

Enclosure



30764

Federal Register/Vol.

69, ‘No.

104/Friday, May 28, 2004/Rules and Regulations

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

42 CFR Part 83
RIN 0920-AA07

Procedures for Designating Classes of
Employees as Members of the Special
Exposure Cohort Under the Energy
Employees Occupational IlIness
Compensation Program Act of 2000;
Final Rule

AGENCY: Department of Health and
Human Services.
ACTION: Final rule.

summary: This document describes how
the Department of Health and Human
Services (“HHS”) will consider
designating classes of employees to be
added to the Special Exposure Cohort
under the Energy Employees
Occupational Illness Compensation
Program Act of 2000 (“EEOICPA”).
Under EEOICPA, and Executive Order
13179, the Secretary of HHS is
authorized to make such designations,
which take effect 180 days after
Congress is notified unless Congress
provides otherwise. An individual
member (or the eligible survivors of a

member) ofa élass of employees added *.

to the Special Exposure Cohort would
be entitled ‘to compensation if the
Department of Labor (“DOL”) finds that
employee incurred a specified cancer
and the claim meets other requirements
established under EEOICPA.

bates: Effective Date: This final rule is
effective May 28, 2004.

Compliance Date: Affected parties are
required to comply with the information
collection requirements in § 82.9
effective May 28, 2004.

FOR FURTHER INFORMATION CONTACT:
Larry Elliott, Director, Office of
Compensation Analysis and Support,
National Institute for Occupational
Safety and Health, 4676 Columbia
Parkway, MS-C-46, Cincinnati, OH
45226, Telephone 513-533-6800 (this is
not a toll-free number). Information
requests can also be submitted by e-mail
to OCAS@CDC.GOV.

SUPPLEMENTARY INFORMATION:

I. Background

A. Statutory Authority

The Energy Employees Occupational
Iness Compensation Program Act
(EEOICPA), 42 U.S.C. 7384-7385,
established a compensation program to
provide a lump sum payment of
$150,000 and prospective medical
benefits as compensation to covered
employees suffering from designated
illnesses incurred as a result of their

i
exposure to radiation, beryllium, or
silica while in the performance of duty
for the Department of Energy (“DOE”)
and certajn of its vendors, contractors
and subcpntractors. This legislation also
provided|for lump sum payments for
certain survivors of these covered
employees. '
EOICPA instructed the President to
designate one or more Federal Agencies
to carry out the compensation program.
Pursuant/to this statutory provision, on
December 7, 2000, the President issued
Executive Order 13179 (Providing
Compensation to America’s Nuclear
Weapons Workers”), which'assigned
primary esponsibility for administering
the compensation program to the
Department of Labor (“DOL”). 65 FR
77487 (December 11, 2000). DOL
published a final rule governing DOL’s
administration of EEOICPA on
December 26, 2002 (67 FR 78874).

Executive Order 13179 directed HHS
to perform séveral technical and
policymaking roles in support of the
DOL program:

(1) HH$ was to develop procedures
for considering petitions by classes of
employe¢s at DOE and Atomic Weapons
Employer (“AWE”) facilities to be
added to the Special Exposure Cohort
established under EEOICPA. These
procedur s are the subject of this rule.
HHS is also to apply these procedures
in response to such petitions. Covered
employeds included in the Special
Exposure Cohort who have a specified
cancer, and eligible survivors of these
employe¢s, qualify for compensation
under EEDICPA.

(2) HH$ was to develop guidelines, by
regulation, to be used by DOL to assess
the likelihood that an employee with
cancer developed that cancer as a result
of exposure to radiation in performing
his or her duty at a DOE facility or AWE
facility. HHS published a final rule
establishing these “Probability of
Causation” guidelines on May 2, 2002
(67 FR 22296) under 42 CFR Part 81.

(3) HH$ was also to develop methods,
by regulation, to estimate radiation
dosés (“dose reconstruction”’) for certain
individuals with cancer applying for
benefits under the DOL program. HHS
published a final rule promulgating
these methods under 42 CFR Part 82 on
May 2, 2002 (67 FR 22314). HHS is
applying these methods to conduct the
program of dose reconstruction required
by EEOICPA.

(4) Finally, HHS is to provide the
Advisory Board on Radiation and
Worker Health (“the Board”) with
administiative and other necessary
support services. The Board, a federal
advisory tommittee whose members are
appointed by the President, is advising

HHS in implementing its roles under
EEOICPA described here.

42 U.S.C. 7384p requires HHS to
implement its responsibilities with the
assistance of the National Institute for
Occupational Safety and Health
(NIOSH), an Institute of the Centers for
Disease Control and Prevention, HHS.

B. What Is the Special Exposure Cohort?

The Special Exposure Cohort (“the
Cohort”) is a category of employees
defined under 42 U.S.C. 73841(14). In
this definition, Congress specified
classes of employees to comprise the
Cohort initially, including DOE
employees, DOE contractor or
subcontractor employees, who were (1)
employed an aggregate of at-least 250
work days before February 1, 1992 ata
gaseous diffusion plant in Paducah,
Kentucky, Portsmouth, Ohio, or Oak
Ridge, Tennessee, and who were
monitored using dosimetry badges or
worked in a job that had exposures
comparable to a job that is or was ~
monitored using dosimetry badges; or
(2) employees of DOE or DOE
contractors or subcontractors employed
before January 1, 1974 on Amchitka
Island, Alaska and exposed to ionizing
radiation in the performance of duty »
related to the Long Shot, Milrow, or’.
Cannikin underground nuclear tests. As
provided in 42 U.S.C. 73841(9)(A),
employees included in the Cohort who”
incur a specified‘cancer? qualify for
compensation (see DOL regulations 20
CFR part 30 for details). Cancer claims
submitted by these employees or their
survivors do not require DOL to
evaluate the probability that the cancer
was caused by radiation doses incurred
during the performance of duity for
nuclear weapons programs of DOE, as is
required for other cancer claims covered
by EEOICPA.

C. Purpose of the Rule

EEOICPA authorized the President to
designate additional classes of
employees to be included in the Cohort,
while providing Congress with the
opportunity to review these decisions
and expedite or reverse them. As noted
previously, the President has delegated
his authority in this matter to the
Secretary of HHS. The purpose of this
tule is to establish procedures by which
the Secretary of HHS will determine
whether to add to the Cohort new
classes of employees from DOE and
AWE facilities. The procedures are

Specified cancers are a limited group of cancers
that EEOICPA specifies are compensable under
provisions governing compensation for members of
the Cohort. Although the list of specified cancers
is determined by statute, the list ean also be found
in this rule under § 83.5.



SEC-00099

12-14-07

Combustion Engineering

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4 of 20



SEC-00099 12-14-07 Combustion Engineering

4.4 Site Locations Associated with Radiological Operations

Locations on the Combustion Engineering site that are known to have been used for AWE work
included Buildings 1-6, the Prototype Reactor, the Waste Storage Area, the Drum Burial Site, and the
Creekbed (FUSRAP, 1994). Commercial nuclear work was also conducted in all of these areas, with
the exception of Building 3 where fuel fabrication involving highly-enriched uranium was performed
for the AEC. A Combustion Engineering site map is shown in Figure 4-1 (CE, 1996, pdf page 61).
Table 4-2 summarizes the information available to NIOSH regarding AEC-related work locations and
their operations (CE, 1991; CE, 1996; FUSRAP, 1994). There was on-going work being performed in
other buildings from 1965 to 1972; however, Combustion Engineering did not seek FUSRAP
designation for these buildings (CE, 1991). Therefore, NIOSH concludes that these buildings hosted
non-AEC activities.

Table 4-2: Known AEC- and Non-AEC-Related Work Locations and Operations

Building Number/Facility Activities
1 AEC contract activities and commercial activities
2 AEC contract activities and commercial activities
3 Used exclusively for AEC fuel fabrication and enrichment
4 AEC contract activities and commercial activities
5 AEC fuel manufacturing, radioactive material storage, and commercial
work
6 Liquid waste dilutions and pumping from Buildings 3 and 5
Waste Storage Area Stored barrels and equipment from both AEC and non-AEC sources
Drum Burial Site Onsite burial
(located next to Waste Storage area)
Prototype Reactor Building prow Bower tt for AEC projects; transferred in 1971 to GE (Knolls
Building 17 Commercial fuel fabrication (FUSRAP, 1994, pdf page 19)
All other buildings Unknown commercial activities or administrative support

Because NIOSH lacks any information regarding on-site operations, NIOSH has no insight into
Combustion Engineering control of radioactive materials being transported between work areas.
Without such information, given the proximity of AWE and non-AWE work on site, and NIOSH’s
inability to rule out cross-contamination of work areas, NIOSH is unable to limit the SEC class based
on work location within the Combustion Engineering site. Consequently, all Combustion Engineering
areas are included in the proposed SEC class.

11 of 20


Federal Register/Vol. 69, No. 104/Friday, May 28, 2004/Rules and Regulations

30781

(e) DOE is the U.S. Department of
Energy, which includes predecessor
agencies of DOE, including the
Manhattan Engineering District

(f) DOL is the U.S. Department of
Labor.

(g) Employee, for the purposes of
these procedures, means a person who
is or was, for the purposes of EEOICPA,
an employee of DOE, a DOE contractor
or subcontractor, or an Atomic Weapons
Employer.

(h) NIOSH is the National Institute for
Occupational Safety and Health, Centers
for Disease Control and Prevention, U.S.
Department of Health and Human
Services.

(i) OCAS is the Office of
Compensation Analysis and Support,
National Institute for Occupational
Safety and Health, Centers for Disease
Control and Prevention, U.S.
Department of Health and Human
Services.

(j) Petitioner means an individual or
organization that submits a petition on
behalf of a class of employees and
qualifies as a petitioner under § 83.7. A
single petition shall only include up to
three petitioners.

(k) Radiation means ionizing
radiation, including alpha particles, beta
particles, gamma rays, x rays, neutrons,
protons and other particles capable of
producing ions in the body. For the
purposes of the proposed procedures,
radiation does not include sources of
non-ionizing radiation such as radio-
frequency radiation, microwaves, visible
light, and infrared or ultraviolet light
radiation.

(1) Secretary is the Secretary of Health
and Human Services.

(m) Specified cancer, as is defined in
Section 3621(17) of EEOICPA (42 U.S.C.
73841(17)) and the DOL regulation
implementing EEOICPA (20 CFR
30.5(dd)), means:

(1) Leukemia (other than chronic
lymphocytic leukemia) provided that
onset of the disease was at least two
years after initial occupational
exposure;

(2) Lung cancer (other than in situ
lung cancer that is discovered during or
after a post-mortem exam);

(3) Bone cancer;

(4) Renal cancers;

(5) The following diseases, provided
onset was at least 5 years after first
exposure:

(i) Multiple myeloma;

(ii) Lymphomas (other than Hodgkin's
disease);

(iii) Primary cancer of the:

(A) Thyroid;

(B) Male or female breast;

(C) Esophagus;

(D) Stomach;

(E) Pharynx;

(F) Small intestine;

(G) Pancreas;

(H) Bile ducts;

(I) Gall bladder;

(J) Salivary gland;

(K) Urinary bladder;

(L) Brain;

(M) Colon;

(N) Ovary;

(O) Liver (except if cirrhosis or
hepatitis B is indicated).

(6) The specified diseases designated
in this section mean the physiological
condition or conditions that are
recognized by the National Cancer
Institute under those names or
nomenclature, or under any previously
accepted or commonly used names or
nomenclature.

(n) Survivor means a surviving
spouse, child, parent, grandchild and
grandparent of a deceased covered
employee as defined in EEOICPA.

Subpart C—Procedures for Adding
Classes of Employees to the Cohort

§83.6 Overview of the procedures in this
part.

The procedures in this part specify
who may petition to add a class of
employees to the Cohort, the
requirements for such a petition, how a
petition will be selected for evaluation
by NIOSH and for the advice of the
Board, and the process NIOSH, the
Board, and the Secretary will use to
consider a petition, leading to the
Secretary's final determination to accept
or deny adding a class to the Cohort.
The rule provides for petitions in two
distinct circumstances. One
circumstance is when NIOSH has
attempted to conduct a dose
reconstruction for a cancer claimant,
under 42 CFR Part 82, and finds that the
dose reconstruction cannot be
completed, because there is insufficient
information to estimate the radiation
doses of the claimant with sufficient
accuracy. The second circumstance
includes all other possibilities. For
example, a petition may be submitted
representing a class of employees whose
members have yet to file claims under
EEOICPA, or even have yet to be
diagnosed with cancer. As required by
EEOICPA (42 U.S.C. 73841(14)(c)(ii)),
the procedures in this part include
formal notice to Congress of any
decision by the Secretary to add a class
to the Cohort, and the opportunity for
Congress to expedite or change the
outcome of the decision within 180
days.

§83.7 Who can submit a petition on behalf
of aclass of employees?

A petitioner or petitioners for a
petition must be one or more, up toa
maximum of three, of the following:

(a) One or more DOE, DOE contractor
or subcontractor, or AWE employees,
who would be included in the proposed
class of employees, or their survivors; or

(b) One or more labor organizations
representing or formerly having
represented DOE, DOE contractor or
subcontractor, or AWE employees, who
would be included in the proposed class
of employees; or

(c) One or more individuals or entities
authorized in writing by one or more
DOE, DOE contractor or subcontractor,
or AWE employees, who would be
included in the proposed class of
employees, or their survivors.

§83.8 Howis a petition submitted?

The petitioner(s) must send a petition
in writing to NIOSH. A petition must
provide identifying and contact
information on the petitioner(s) and
information to justify the petition, as
specified under § 83.9. Detailed
instructions for preparing and
submitting a petition, including an
optional petition form, are available.
from NIOSH through direct request (1-
800-35-NIOSH) or on the Internet at

* www.cde.gov/niosh/ocas.

§83.9 What information must a petition
include?

(a) All petitions must provide
identifying and contact information on
the petitioner(s). The information
required to justify a petition differs,
depending on the basis of the petition.
If the petition is by a claimant in
response to a finding by NIOSH that the
dose reconstruction for the claimant
cannot be completed, then the petition
must provide only the justification
specified under paragraph (b) of this
section. All other petitions must provide
only the information specified under
paragraph (c) of this section. The
informational requirements for petitions
are also summarized in Table 1 at the
end of this section.

(b) The petition must notify NIOSH
that the claimant is petitioning on the
basis that NIOSH found, under 42 CFR
82.12, that the dose reconstruction for
the claimant could not be completed
due to insufficient records and
information.

(c) The petition must include the
following:

(1) A proposed class definition?
specifying:

‘HHS will determine the final class definition(s)
for each petition (see § 83.16).


|
30782 Federal Register/Vol. 69, No. 104/Friday, May 28, 2004/Rules and Regulations
(i) The DOE facility or AWE facility? _ reconstruttions for members of the class _ employees who witnessed the incident.
at which the class worked; under 42 CFR Part 82 and related If the petitioner cannot provide such
(ii) The location or locations at the NIOSH technical implementation affidavits because such employees are
facility covered by the petition (e.g., guidelines; or j deceased, prevented by reasons of poor
building, technical area); (iy) A s¢ientific or technical report, health or impairment, or cannot be

(iii) The job titles and/or job duties of
the class members;

(iv) The period of employment
relevant to the petition;

(v) Identification of any exposure
incident that was unmonitored,
unrecorded, or inadequately monitored
or recorded, if such incident comprises
the basis of the petition; and

(2) A description of the petitioner's
(petitioners”) basis for believing records
and information available are
inadequate to estimate the radiation
doses incurred by members of the
proposed class of employees with
sufficient accuracy. This description
must include one of the following
elements:

(i) Documentation or statements
provided by affidavit indicating that
Tadiation exposures and doses to
members of the proposed class were not
monitored, either through personal or
area monitoring; or

(ii) Documentation or statements
provided by affidavit indicating that
radiation monitoring records for
members of the proposed class have
been lost, falsified, or destroyed; or

(iii) A report from a health physicist
or other individival with expertise in
dose reconstruction documenting the*
limitations of existing DOE or AWE
records on radiation exposures at the
facility, as relevant to the petition. This
report should specify the basis for
believing these documented limitations
might prevent the completion of dose

published or issued by a government
agericy of|the Executive Branch of
government or the General Accounting
Offiée, thé Nuclear Regulatory
Commission, or the Defense Nuclear
Facilities Safety Board, or published in
a peer-reviewed journal, that identifies
dosimetry and related information that
are unavailable (due to either a lack of
monitoring or the destruction or loss of
records) for estimating the radiation
dosés of employees covered by the
petition.

(3) If the petition is based on an
exposure incident as described under
paragraph (c)(1)(v) of this section, the
petitioner(s) might be required to
provide evidence that the incident
occurred but only if NIOSH is unable
to obtain records or confirmation of the
occurrence of such an incident from
sources independent of the petitioner(s).
Such evidence would not bé required at
the time the petition is submitted and
the petitioner(s) would be directly
informed of the need for thig
supplemental information. In such
cases, either of the following may
qualify as evidence: ‘,

(i) Medical evidence that one or more
members of the class may have incurred ”
a high level radiation dose from the
incident, such as a depressed white
blood cell count associated with
radiation exposure or the application of
chelation therapy; or

(ii) NIOSH will consider evidence
provided by affidavit from one or more

identified or located, then the
requirement for evidence ptovided by
affidavit can be met by providing such
an affidavit from one or more
individuals who did not witness the
incident, provided the individual was
directly informed by one or more
employees who witnessed the incident.

(4) The provision of any evidence
under this section or other provisions of
this part, including one or more
affidavits, would not, in and of itself, be
sufficient to confirm the facts presented
by that evidence. NIOSH will consider
the adequacy and credibility of any
evidence provided. . .

(5) If, under § 83.15(a), NIOSH has.
already issued a Federal Register notice
scheduling a Board meeting to consider
a petition concerning a class of
employees, then any petitions for sich
a class of employees submitted
following this notice must, "under
paragraph (c)(2) of this section, present
substantially new information that has
not already been considered by'NIOSH.’
For this purpose, NIOSH would find
that information has been already
considered by NIOSH if it were
included in the petition(s) that were
already considered by NIOSH or if it
were addressed either in the report(s) by
NIOSH evaluating such a petition or
petitions under § 83.13(c) or ina
proposed decision by NIOSH
responding to such a petition or
petitions under § 83.16(a).

TABLE 1 FOR § 83.9: SUMMARY OF INFORMATIONAL: REQUIREMENTS FOR ALL PETITIONS
[Petitioner(s) must submit identifying and contact information and either A. or B. ofthis table]

T
A. The claimant's authorization of the petition, based on NIOSH having
found it could not complete a dose reconstrucitn for t

submitting the petition; or.

B. (1) A proposed class
je claimant

(2) The basis for
monitoring; or (i)

cations at the facility; (
and if relevant, (v) exposure incident.

feasibility of dose reconstruction; either: (i) lack of
destruction, falsification, or loss of records; or (ii)
expert report; or (iv) scientific or technical report.

definition identifying: (i) Facility, (ji) relevant lo-
ii) job titles/duties, (iv) period of employment,

§83.10 Ifa petition satisfies all relevant
requirements under § 83.9, does this mean
the class will be added to the Cohort?

Satisfying the informational
requirements for a petition does not
mean the class will be added to the
Cohort. It means the petition will
receive a full evaluation by NIOSH, the

2 Depending on the factual circumstances present,
a facility that meets the definition of an AWE
facility or DOE facility covered under EEOICPA (42
U.S.C. 73841(5) and (12)) could, among other
possibilities, constitute a single building or

Boatd, and HHS, as described under

§§ 83.13 through 83.16. Thelrole of the
petitioners) is to identify classes of
employees that should be considered for
addition to the Cohort.

structure, influding the grounds upon which it is
located, or alsite encompassing numerous buildings
or strictures, including the grounds upon which it
is located.

1"
§83.11 What happens to petitions that do
not satisty.all relevant requirements under
§§ 83.7 through 83.97 ,

(a) NIOSH will notify the petitioner(s)
of any requirements that are not met by
the petition, assist the petitioner(s) with
guidance in developing relevant
information, and provide 30 calendar

3 An affidavit may be from a petitioner but HHS
does not require that an affidavit be from a
petitioner.



Tab D

NIOSH SEC Evaluation Report



30770

Federal Register/Vol.

69, |No.

104/Friday, May 28, 2004/Rules and Regulations

assumptions that contribute to defining
the level or levels of exposure and the
characteristics of the exposure. It is
unknown, however, how often such
dose reconstructions would produce a
point estimate of dose, versus a
distribution of dose values that
estimates dose. There are various
circumstances that could result in the
estimation of a distribution of dose
values, such as when factors affecting
the dose estimate have known and
documented variability and/or
uncertainties, NIOSH might use a
distribution of values, for example, to
characterize the particulate sizes ofa
radioactive material that has been
ground or cut, when this factor had been
studied and documented at comparable
operations. In such a case, the
distribution of values for particulate size
would result in a distribution of dose
values rather than a single, point
estimate of dose.
_ One advocacy group and labor
‘organization requested the rule or
guidelines define “plausible
circumstances,” asserting that use of
this term was simply substituting for the
term "sufficient accuracy.” In context,
‘HHS uses'the term as follows:,
“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 * * *” (emphasis
added). 42 CFR 83.13(c)(1)(i).

In this case, “plausible
circumstances” is not substituting for
“sufficient accuracy” as suggested, since
the operative concept here is the ability
to estimate the maximum radiation
dose. The identification of plausible
circumstances qualifies how such doses
would be estimated. It means that
NIOSH is not required to utilize
unlikely, unreasonable, or illogical
scenarios to estimate radiation doses.
Furthermore, it is not reasonable to
construct a “litmus test” for defining
plausibility. It involves expert
judgment, which will be applied by
NIOSH and the Board in determining
what are plausible circumstances
consistent with the known information
relevant to the evaluation of the
petition. Dose reconstruction routinely
‘uses expert judgment to address
unknown and uncertain information.
The important matter with respect to
such judgments is that the NIOSH dose
reconstruction:program provides the
benefit of the doubt to the claimant in
identifying plausible scenarios, to
ensure that dose reconstructions do not
underestimate doses.

T

One advocacy group and one labor
organization also recommended that
NIOSH consider applying a'statistical
contept such as “the size of the
standard error” in guidelines for
defining sufficient accuracy. The
general idea of this comment is that
NIOSH would define quantitatively the
degree to|which the range and
likelihood of all possible dose estimates
supported by the facts could diverge
from the ¢entral tendency of these
estimates, !

There ii

not'a good scientific or
logical basis for establishing a statistical
measure of precision, which is not
equivalent to accuracy, as a requirement
for NIOSH dose reconstructions under
EEOICPA, Any claimant for'whom a less
precise but more accurate estimate
would support compensation might
challenge such a requirement as
arbitrary.|For example, NIOSH might
estimate that an employee incurred a
radiation |dose to the prostate of between
20 and 100 rem, with a central tendency
of 60 rem, This dose distribution is not
as precis¢ as an estimate of between 50
and|70 rem, for example, but it could be
more accurate to the degree that it
appropriately accounts for the
variability and uncertainty in the
available (data and hence better
chatacterizes. what we know and do not
know abdut the level of dose received
by the employee., :

HHS interprets “sufficient accuracy”
in practical terms as sufficiently
accurate to assure the fair adjudication
of claims, NIOSH dose reconstructions
provide this assurance by using
methods that build on the factual and
scientific bases using two principal
megsures)that are designed to
overestimate every employee's dose.

First, as discussed above, the expert
judgments (assumptions) used in
NIOSH dose reconstructions give
claimants the benefit of the doubt, when
possible. When information'is missing
or questionable, the claimant is
generally favored by NIOSH assuming
the occurrence of the more harmful of
plausible|exposure scenarios.

Second, NIOSH accounts;
quahtitatively for the factual and
scientific uncertainties involved in each
dose reconstruction and includes this
measure of uncertainty in the
probability of causation calculation
performed by DOL. In practical terms,
this|favors the claimant because,
pursuant to 42 U.S.C. 7384n(c)(3)(A),
DOL, calculates the probability of
causation at the upper 99 percent
credibility limit; in other words, any
uncertainty in the dose used to
adjudicate the claim will contribute to
DOL overestimating the likelihood that

the employee’s cancer was caused by
radiation. 4

These two measures taken together,
claimant-favorable assumptions and the
estimation of probability of causation at
the upper 99 percent credibility limit,
produce a doubly upper-bounded
estimate of the employee's radiation
dose. By these measures, whenever it is
feasible for NIOSH to estimate radiation
dosés for a cancer claimant, NIOSH is
almost certain to be overestimating the
actual radiation doses.

D. Health Endangerment

In addition to the condition that HHS
find that it is not feasible to estimate the
radiation doses of a class of employees
with sufficient accuracy, a second
requirement of EEOICPA for adding a
class to the Cohort is that HHS find that
there is “a reasonable likelihood that
such radiation dose may have
endangered the health of members of
the class.” Under section 83.13(b)(3) of
the NPRM, HHS proposed a standard
based on the duration of employment
within the employment conditions
under which radiation doses cannot be
estimated. As a default, this standard
would,be 250 work days, the same
standard required by EEOICPA for ,
employees of the gaseous diffusion
plants included in the Cohort by’
Congress. 42 U.S.C.'73841(14)(A). In
addition, for classes of employees that
may have been exposed to radiation
during discrete incidents that were
likely to have involved exceptionally
high level exposures, suchas nuclear
criticality incidents, HHS provided that
an employee's presence with potential
exposure during the discrete incident,
rather than a quantified duration of
potential exposure, would satisfy the
health endangerment criterion.

HHS received relatively few
comments concerning the health
endangerment provisions of the rule and
these were generally supportive. A few
commenters recommended changes.

‘An advocacy group and labor
organization recommended that
employees should be able to accumulate
the 250 work days required to qualify as
members of a class added to the Cohort
on the basis of their employment at
multiple facilities, if the class includes
employment at the multiple facilities.
The central concern behind this
comment is that some nuclear weapons
workers are likely to have been
employed at more than one facility,
potentially conducting similar work
(such as construction or maintenance)
and incurring similar exposures for
which dose reconstruction might not be
feasible. The commenters are aware that
DOL qualifies employees of the gaseous

i



|
SEC-00099 12-14-07 Combustion Engineering

i
Evaluation Report Summary: SEC-00099, Combustion Engineering

This evaluation report by the National Institute for Occupational Safety and Health (NIOSH)
addresses a class of employees proposed for addition to the Special Exposure Cohort (SEC) per the
Energy Employees Occupational Illness Compensation Program Act of 2000, as amended, 42 U.S.C.
§ 7384 et seq. (EEOICPA) and 42 C.F.R. pt. 83, Procedures for Designating Classes of Employees
as Members of the Special Exposure Cohort Under the Energy Employees Occupational Illness
Compensation Program Act of 2000. ;

NIOSH-Proposed Class Definition

The NIOSH-proposed class includes all Atomic Weapons Employer (AWE) employees who were
monitored, or should have been monitored, for exposure to ionizing radiation while working at the
Combustion Engineering site in Windsor, Connecticut, for a number of work days aggregating at least
250 work days from January 1, 1965 through December 31, 1972, or in combination with work days
within the parameters established for one or more other classes of employees in the SEC.

Feasibility of Dose Reconstruction

Per EEOICPA and 42 C.F.R. § 83.14(b), NIOSH has established that it does not have'sufficient
information to complete dose reconstructions for individual members of the class with sufficient
accuracy. NIOSH lacks sufficient dosimetry data, workplace monitoring data, and source term data,

making reconstruction of total internal and external doses infeasible. \-
i

|

Health Endangerment Determination

The NIOSH evaluation did not identify evidence supplied by the petitioners or from other sources that
would establish the class was exposed to radiation during a discrete incident likely to have involved
exceptionally high-level exposures, such as nuclear criticality incidents or other events involving
similarly high levels of exposures. However, the evidence reviewed in this evaluation indicates that
some workers in the class may have accumulated chronic radiation exposures through intakes of
uranium and direct exposure to radioactive materials. Therefore, 42 C.F.R. § 83.13(c)(3)(ii) requires
NIOSH to specify that health may have been endangered for those workers covered by this evaluation
who were employed for a number of work days aggregating at least 250 work days within the
parameters established for this class or in combination with work days within the parameters
established for one or more other classes of employees in the SEC.

i

3 of 20

$$.



SEC-00099 i

12-14-07 |

“Combustion Engineering

°
Science Applications *
International Corporation

COMBUSTION ENGINEERING
WINDSOR, CONNECTICUT

seg ie [ee ioe

: Combustion Engineering Site Map



Page 5 — The Secretary

7 Attachments:
Tab A — Designation of a Class of Employees from Combustion Engineering

Tab B - 42 C.F.R. pt. 83

Tab C — Combustion Engineering SEC Petition

Tab D —- NIOSH SEC Petition Evaluation Report, SEC-00099
Tab E - Board Recommendation Letter to Secretary Leavitt
Tab F - Transcripts of relevant Board discussions


Federal Register/Vol. 70,

pind!

No. 245/Thursday, December 22, 2005/Rules and Regulations

75951

IV. Regulatory Procedures

HHS follows the Administrative
Procedure Act ('PA”) rulemaking
procedures specified in 5 U.S.C. 553 for
the development of its regulations. In
most circumstances, the APA requires a
public notice and comment period and
consideration of the submitted
comments prior to promulgation of a
final rule having the effect of law.
However, the APA provides for
exceptions to its notice-and-comment
procedures when an agency finds that
there is good cause for dispensing with
such procedures on the basis that they
are impracticable, unnecessary, or
contrary to the public interest. In the
case of this interim final rule, HHS has
determined that under 5 U.S.C.
553(b)(B), good cause exists for waiving
the notice and comment procedures. For
these same reasons, HHS has also
determined that good cause exists under
5 U.S.C. 553(d)(3) for these interim rules
to become effective immediately.

A number of courts have considered
the circumstances under which an
agency can conclude that good cause
exists for issuing regulations without
prior notice and comment. In American
Transfer & Storage Co., et al. v.
Interstate Commerce Commissian, 719
F.2d 1283, 1295 (5th Cir. 1983), the
Fifth Circuit described the
impracticability test as requiring
“analysis in practical terms of the
particular statutory-agency setting and
the reasons why agency action could not
await notice and comment.” Similarly,
the Seventh Circuit noted that the
“legislative history of the
impracticability standard reveals that
Congress intended this exemption to
operate when the regular course of
rulemaking procedure would interfere
with the agency’s ability to perform its
functions with the time constraints
imposed by Congress.” United States
Steel Corporation v. United States
Environmental Protection Agency, 605
F.2d 283, 287 (7th Cir. 1979).

Precisely such an “analysis in
practical terms” demonstrates that in
this case, HHS cannot await the process
of notice and comment to implement
the changes to 42 CFR part 83 set forth
here on an interim final basis. As
discussed above, the amendments to
EEOICPA addressed by this rulemaking
directly. conflict, legaliy and practically,
with the existing provisions of the
existing provisions of the HHS rule. The
potential consequences of these
conflicts are that HHS would have to
violate the legal requirements of its rule
to uphold the statutory requirements of
the EEOICPA amendments

Specifically, under the new 30-day
statutory deadline for producing HHS
detetminatiéns on petitions that the
Board recommends receive affirmative
determinations (42 U.S.C.
7384q(c)(2)(A)), HHS would not be able
to produce a proposed decision, provide
petitioners with the opportunity to
contest the proposed decision, and
provide an administrative review of
such a challenge prior to issuing a final
decision with respect to the
determination, as previously provided
for under § 83.16(a)-(c) of the rule.
Similarly, the reduction in the
statutorily-set congressional review
period for designations by the Secretary
of additions to the Cohort, from 180
days to 30 days (42 U.S.C.
73841(14)(C)(ii)), conflicts with
§ 83.17(b) of the rule, which mandates a
period of 180 days before a designation
by the Secretary would become
effective.

If HHS were to issue a notice of
proposed rulemaking proposing changes
to the Cohort procedures, HHS would
have to violate either the new statutory
requirements or its Cohort regulations
for each Cohort petition that is
considered, until a final regulation
could be issued. Hence, HHS believes
good cause exists to waive the notice
and comment procedures under the
APA for the promulgation of this
interim final rule.

Although HHS is adopting this rule
on an interim final basis, it requests
public comment on this rule. After full
consideration of public comments, HHS
will publish a final rule with any
necessary changes. HHS expects to issue
a final rule within six months of the
publication of this interim final rule.

V. Regulatory Assessment
Requiremenis

A. Executive Order 12866

Under Executive Order 12866 (58 FR
51735, October 4, 1993), the agency
must determine whether a regulatory
action is “‘significant” and therefore
subject to review by the Office of
Management and Budget (OMB) and the
requirements of the executive order.
Under section 3(f), the order defines a

“significant regulatory action” as an

action that is likely to result in a rule
(1) Having an annual effect on the
economy of $100 million or more, or
adversely and materially affecting a
sector of the economy, productivity,
competition, jobs, the environment,
public health or safety, or State, local,
or tribal governments or communities
{also referred to as “economically
significant”); (2) creating serious
inconsistency or otherwise interfering

_with an action taken or planned by

another agency; (3) materially altering
the budgetary impacts of entitlements,
grants, user fees, or loan programs or the
rights and obligations of recipients
thereof; or (4) raising novel legal or
policy issues arising out of legal
mandates, the President's priorities, or
the principles set forth in the executive
order.

This rule is being treated as a
“significant regulatory action” within
the meaning of the executive order
because it meets the criterion of Section
3(f)(4) in that it raises novel or legal
policy issues arising out of the legal
mandate established by EEOICPA. It
amends current procedures by which
the Secretary considers petitions to add
classes of employees to the Cohort to
comport with new statutory deadlines
(see 42 U.S.C. 7384q(c)(2)(A) and 42
U.S.C. 73841(14)(C)(ii)). The amendment
also includes the provision of the
opportunity for certain affected parties
to obtain administrative reviews of final
agency actions, versus proposed agency
actions. The revisions do not, however,
affect the financial cost to the Federal
Government of responding to these
petitions nor the scientific and policy
bases for making decisions on such
petitions. :

The rule carefully explains the
manner in which the procedures are
consistent with the mandates of 42
U.S.C. 7384q and 73841(14)(C)(ii) and
implements the detailed requirements of
these sections. The rule does not
interfere with State, local, and tribal
governments in the exercise of their
governmental functions.

The rule is not considered
economically significant, as defined in
§ 3(f)(1) of the Executive Order 12866.
As discussed above, it does not affect
the financial cost to the Federal
Government of responding to these
petitions nor the scientific and policy
bases for making decisions on such
petitions. Furthermore, it has a
subordinate role in the adjudication of
claims under EEOICPA, serving as one
element of an adjudication process
administered by the Department of
Labor (“OL”) under 20 CFR parts 1 and
30. DOL has determined that its rule
fulfills the requirements of Executive
Order 12866 and provides estimates of
the aggregate cost of benefits and
administrative expenses of
implementing EEOICPA under its rule
(see 70 FR 33590, June 8, 2005). OMB
has reviewed this rule for consistency
with the President's priorities and the
principles set forth in Executive Order
12866.



Federal Register/Vol. 70,

No. 245/Thursday, December 22, 2005/Rules and Regulations

75949

benefits must complete Part A of the
Certification of Traumatic Injury
Protection Form and sign the form.

(ii) Ifa member is unable to do so,
anyone acting on the member's behalf
may request a Certification of Traumatic
Injury. Protection Form from the
uniformed service. However, the
Certification of Traumatic Injury
Protection Form must be signed by the
member, the member's guardian, or the
member's attorney-in-fact.

(iii) Ifa member suffered a scheduled
loss as a direct result of the traumatic
injury, survived seven full days from the
date of the traumatic event, and then
died before the maximum benefit for
which the service member qualifies is
paid the beneficiary or beneficiaries of
the member’s Servicemembers’ Group
Life Insurance policy should complete a
Certification of Traumatic Injury
Protection Form

(2) Ifa member seeks traumatic injury
protection benefits for a scheduled loss
occurring after submission of a
completed Certification of Traumatic
Injury Protection Form for a different
scheduled loss, the member must
submit a completed Certification of
Traumatic Injury Protection Form for
the new scheduled loss and for each
scheduled loss that occurs thereafter.
For example, if a member seeks
traumatic injury protection benefits for
a scheduled loss due to coma from
traumatic injury and/or the inability to
carry out activities of daily living due to
traumatic brain injury
(§ 9.20(e)(7)(xxxvii)), or the inability to
carry out activities of daily living due to
loss directly resulting from a traumatic
injury other than an injury to the brain
(§ 9.20(c)(7)(xliv)), a completed
Certification of Traumatic Injury
Protection Form must be submitted for
each increment of time for which TSGLI
is payable. Also, for example, if a
service member suffers a scheduled loss
due to a coma, a completed Certification
of Traumatic Injury Protection Form
should be filed after the 15th
consecutive day that the member is in
the coma, for which $25,000 is payable.
If the member remains in a coma for
another 15 days, another completed
Certification of Traumatic Injury
Protection Form should be submitted
and another $25,000 will be paid.

(h) How does a member or beneficiary
appeal an adverse eligibility
determination? (1) Notice of a decision
regarding a member's eligibility for
traumatic injury protection benefits will
include an explanation of the procedure
for obtaining review of the decision. An
appeal of an eligibility determination,
such as whether the loss occurred
within 365 days of the traumatic injury,

whether the injury was self-inflicted or
whether a loss of hearing was total and
perrfianent, must be in writing. An
appeal must be submitted by a member
or a member's legal representative or by
the beneficiary or the beneficiary’s legal
representative, within one year of the
date of a denial of eligibility, to the
office of the uniformed service
identified in the decision regarding the
member's eligibility for the benefit.

(2) An appeal regarding whether a
member was insured under
Servicemembers’ Group Life Insurance
when the traumatic injury was
sustained must be in writing. An appeal
must be submitted by a member or a
member's legal representative or by the
beneficiary or the beneficiary's legal
representative within one year of the
date of a denial of eligibility to the
Office of Servicemembers’ Group Life
Insurance.

(3) Nothing in this section precludes
a member from pursuing legal remedies
under 38 U.S.C. 1975 and 38 CFR 9.13.

(i) Who will be paid the traumatic
injury protection benefit? The injured
member who suffered a scheduled loss
will be paid the traumatic injury
protection benefit in accordance with
title 38 U.S.C. 1980A except under the
following circumstances:

(1) Ifa member is legally
incapacitated, the member's guardian or
attorney-in-fact will be paid the benefit
on behalf of the member.

(2) Ifa member dies before payment
is made, the beneficiary or beneficiaries
who will be paid the benefit will be
determined in accordance with 38
U.S.C. 1970{a).

[Authority: 38 U.S.C. 501(a) and 1980A)

IFR Doc. 05-24390 Filed 12-20-05; 10:53
am]
BILLING CODE 8320-01-P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

42 CFR Part 83
RIN 0920-AA13

Procedures for Designating Classes of
Employees as Members of the Special
Exposure Cohort Under the Energy
Employees Occupational liness
Compensation Program Act of 2000;
Amendments; Interim Final Rule With
Request for Comments

AGENCY: Department of Health and
Human Services.

ACTION: Interim final rule with request
for comments.

SUMMARY: The Department of Health and
Human Services (“HHS”) is amending

its procedures to consider designating
classes of employees to be added to the
Special Exposure Cohort under the
Energy Employees Occupational Illness
Compensation Program Act of 2000
(“EEOICPA"), 42 U.S.C. 7384-7385.
HHS must change these procedures to
implement amendments to EEOICPA
enacted on October 28, 2004, as part of
the Ronald W. Reagan National Defense
Authorization Act for Fiscal Year 2005,
Public Law 108-375 (codified as
amended in scattered sections of 42
US.C,).

DATES: Effective Date: This interim final
tule is effective December 22, 2005.

Comments: The Department invites
written comments on the interim final
rule from interested parties. Comments
on the rule must be received by
February 21, 2006.

ADDRESSES: Address written comments
on the interim final rule to the National
Institute for Occupational Safety and
Health (“NIOSH”) Docket Officer
electronically by e-mail to
NIOCINDOCKET@cdc.gov. See
SUPPLEMENTARY INFORMATION for file
formats and other information about
electronic filing. Alternatively, submit
printed comments to NIOSH Docket
Office, Robert A. Taft Laboratories, MS-
C34, 4676 Columbia Parkway,
Cincinnati, OH 45226.

FOR FURTHER INFORMATION CONTACT:
Larry Elliott, Director, Office of
Compensation Analysis and Support,
National Institute for Occupational
Safety and Health, 4676 Columbia
Parkway, MS-C--46, Cincinnati, OH
45226, Telephone 513-533-6800 (this is
not a toll free number). Information
requests can also be submitted by e-mail
to OCAS@cdc.gov.

SUPPLEMENTARY INFORMATION:
I. Comments Invited

Interested persons or organizations
are invited to participate in this
rulemaking by submitting written views,
arguments, recommendations, and data.
Comments are invited on any topic
related to the changes in the Special
Exposure Cohort (“the Cohort") rule (42
CFR part 83) effectuated by this
rulemaking. Comments concerning any
other provisions of the Cohort rule,
unchanged and unaffected by this
rulemaking, will not be considered.

Comments should identify the
author(s), return address, and phone
number, in case clarification is needed.
Comments can be submitted by e-mail
to: NIOCINDOCKET@cdc.gov.
Comments submitted by e-mail may be
provided as e-mail text or as a Word or


SEC-00099 12-14-07 Combustion Engineering

development and testing of homogeneous ceramic fuels (Quarterly, 1960). A 1967 memo describes
the shipment of scrap depleted uranium (Request, 1967). The 1999 Characterization Report focused
on three uranium isotopes of concern (U-234, U-235, and U-238), and also indicated the presence of
Co-60, which may have been associated with Combustion Engineering research and development
(FUSRAP, 1999).

Many projects took place at the Combustion Engineering site during the 1965-72 timeframe and for
many years thereafter. However, given the limited data currently available, NIOSH can make no
assumptions about quantities of particular isotopes or source materials that may have been used on site
during the AWE operational period.

6.0 Feasibility of Dose Reconstruction for the Proposed Class

42 C.F.R. § 83.14(b) states that HHS will consider a NIOSH determination that there was insufficient
information to complete a dose reconstruction, as indicated in this present case, to be sufficient,
without further consideration, to conclude that it is not feasible to estimate the levels of radiation
doses of individual members of the class with sufficient accuracy.

In the case of a petition submitted to NIOSH under 42 C.F.R. § 83.9(b), NIOSH has already
determined that a dose reconstruction cannot be completed for an employee at the DOE or AWE
facility. This determination by NIOSH provides the basis for the petition by the affected claimant.
Per § 83.14(a), the NIOSH-proposed class defines those employees who, based on completed
research, are similarly affected and for whom, as a class, dose reconstruction is similarly not feasible.

In accordance with § 83.14(a), NIOSH may establish a second class of co-workers at the facility for
whom NIOSH believes that dose reconstruction is similarly infeasible, but for whom additional
research and analysis is required. If so identified, NIOSH would address this second class in a
separate SEC evaluation rather than delay consideration of the claim currently under evaluation (see
Section 10). This would allow NIOSH, the Board, and HHS to complete, without delay, their
consideration of the class that includes a claimant for whom NIOSH has already determined a dose
reconstruction cannot be completed, and whose only possible remedy under EEOICPA is the addition
of a class of employees to the SEC.

This section of the report summarizes research findings by which NIOSH determined that it lacked
sufficient information to complete the relevant dose reconstruction and on which basis it has defined
the class of employees for which dose reconstruction is not feasible. NIOSH’s determination relies on
the same statutory and regulatory criteria that govern consideration of all SEC petitions.

6.1 Feasibility of Estimating Internal Exposures

As indicated in Section 5.0, NIOSH does not have access to sufficient personnel monitoring data, area
monitoring data, or source term data to estimate internal exposures at Combustion Engineering for the
period January 1, 1965 through December 31, 1972. The two available urinalysis results were for
natural uranium. No information exists on the analytical methodology. There were no lung counts or
fecal analyses results. Furthermore, neither the work activities nor the source terms are known.
Therefore, is not possible to determine which radionuclides employees should have been monitored

15 of 20


Tab A

Designation of a Class of Employees to the Special Exposure Cohort



SEC-00099 | 12-14-07 Combustion Engineering

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2 of 20



SEC-00099

12-14-07 Combustion Engineering

considers appropriate, to make recommendations to the Secretary of HHS on whether or not to add

one or more classes of employees to'the

of the Board, the Director of NIOSH wil
HHS will make the final decision, taking!
and the proposed decision issued by NIO}

may seek a review of certain types of fin

3.0 NIOSH-Proposed Class

The NIOSH-proposed class includes all
monitored, for exposure to ionizing radia
Windsor, Connecticut, for a numberiof w
1965 through December 31, 1972, or in

EC. Once NIOSH has received and considered the advice
propose a decision on behalf of HHS. The Secretary of
into account the NIOSH evaluation, the advice of the Board,

SH. As part of this final decision process, the petitioner(s)

| decisions issued by the Secretary of HHS.

Definition and Petition Basis

.WE employees who were monitored, or should have been
ion while working at the Combustion Engineering site in
tk days aggregating at least 250 work days from January 1,
mbination with work days within the parameters

established for one or more other classes of employees in the SEC. During this period, employees at
this facility were involved with research activities, uranium processes, and shipments of uranium to

the Fernald Site.

The evaluation responds to Petition SEC:

whose dose reconstruction could not be f
related information.. This claimant was emp!

Engineering site from 1968 through 1972,

reconstruction for an EEOICPA claimant,
‘to 42 C.F.R. § 83.9(b). |
24 |

(00099, which was submitted by an EEOICPA claimant
mpleted by NIOSH due to a lack of sufficient dosimetry-
loyed as a Test Project Engineer at the Combustion :

. NIOSH’s determination that it is unable to complete a dose
is a qualified basis for submitting an SEC petition pursuant

|

4.0 Radiological Operations Relevant to the Proposed Class

The following subsections summarize the

radiological operations at the Combustion Engineering site

from January 1, 1965 through December 31, 1972 and the information available to NIOSH to

characterize particular processes and radii
has attempted to gather process and source
quantities of radionuclides of concern, ani
radiation exposures of concern may have
have occurred. The information included
of the available information. |

? See 42 C.F-R. pt. 83 for a full description of the
available at http://www.cdc.gov/niosh/ocas. |

oactive source materials. Using available sources, NIOSH
e descriptions, information regarding the identity and
information describing processes through which the
loccurred and the physical environment in which they may
within this evaluation report is meant only to be a summary

procedures summarized here. Additional intemal procedures are
i

8o0f20 |



I. Designation

I, Michael O. Leavitt, Secretary of Health and Human Services (Secretary), designate
the class of employees defined in Section II of this report for addition to the Special

. Exposure Cohort (SEC), as authorized under the Energy Employees Occupational
Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. § 7384q.

Date Michael O. Leavitt

II. | Employee Class Definition

Atomic Weapons Employer (AWE) employees who worked at the
Combustion Engineering site in Windsor, Connecticut, from January 1,
1965, through December 31, 1972, for a number of work days aggregating
at least 250 work days or in combination with work days within the
parameters established for one or more other classes of employees in the
Special Exposure Cohort.

III. Designation Criteria and Recommendations

Pursuant to 42 U.S.C. § 73844, for the class defined in Section II of this report, the
Secretary has determined, and the Advisory Board on Radiation and Worker Health
(Board) has recommended, that
(1) it is not feasible to estimate with sufficient accuracy the radiation dose that the
class received; and
(2) there is a reasonable likelihood that such radiation dose may have endangered
the health of members of the class.

The SEC final rule states in 42 C.F.R. § 83.13(c)(1) that it is feasible in two situations
to estimate the radiation dose that the class received with sufficient accuracy. First,
the rule states that radiation doses may be estimated with sufficient accuracy if
NIOSH has established that it has access to sufficient information to estimate the
maximum radiation dose for every type of cancer for which radiation doses are
reconstructed that could have been incurred under plausible circumstances by any
member of the class. Alternatively, radiation doses may be estimated with sufficient
accuracy if NIOSH has established that it has access to sufficient information to
estimate the radiation doses of members of the class more precisely than a maximum
dose estimate.

The Board, pursuant to 42 U.S.C. § 7384q, advised the Secretary to designate the
class as an addition to the SEC in a letter received by the Secretary on February |,
2008.

HHS Special Exposure Cohort Designation:
Combustion Engineering



Page 3 - The Secretary

reasonable likelihood that such radiation doses may have endangered the health of members of
the class. The regulations require NIOSH to assume that any duration of unprotected exposure
may have endangered the health of members of a class when it has been established that the class
may have been exposed to radiation during a discrete incident likely to have involved levels of
exposure similarly high to those occurring during nuclear criticality incidents. If the occurrence
of such an exceptionally high-level exposure has not been established, then NIOSH is required to
specify that health was endangered for those workers who were employed for a number of work
days aggregating at least 250 work days within the parameters established for the class or in
combination with work days within the parameters established for one or more other classes of
employees in the SEC. NIOSH has determined that members of the class were not exposed to
radiation during a discrete incident likely to have involved levels of exposure similarly high to
those occurring during nuclear criticality incidents. However, the evidence NIOSH reviewed
indicates that some workers in the class may have accumulated chronic radiation exposures
through intakes of radionuclides. In summary, NIOSH determined that it is not feasible to
estimate with sufficient accuracy the radiation dose and that the health of the proposed class of
employees may have been endangered.

Although NIOSH found that it is not possible to completely reconstruct radiation doses for these
employees, NIOSH determined that it is possible to reconstruct occupational medical dose.
NIOSH intends to use any available, reliable data that may be included in an individual’s file
(and that can be interpreted using existing NIOSH dose reconstruction processes or procedures)
to support a partial dose reconstruction for non-presumptive cancers and/or cases that have less
than 250 work days of employment.

After consideration of the NIOSH presentation, the Board voted to advise the Secretary to add
the class. The Board vote was unanimous (12-0). The Board letter to the Secretary, received on
February 1, 2008, is Tab E; the transcript of the Board discussion is Tab F.

The petitioner may seek an administrative review of certain HHS decisions, either a class denial
or a 250-workday health endangerment requirement, as specified in the HHS SEC procedures
(42 C.F.R. § 83.18(a), Tab B).

RECOMMENDATIONS

Based upon the foregoing, the Director of NIOSH and the Director of CDC recommend that the
Secretary approve and sign the attached designation to add to the SEC certain employees from
Combustion Engineering.

Disapproved Date MAR - 3 2008

K.

hn Howard, M.D.



30780

Federal Register/Vol.

69, Ino. 104/Friday, May 28, 2004/Rules and Regulations

Text of the Rule .

m For the reasons discussed in the
preamble, the Department of Health and
Human Services amends 42 CFR Chapter
I by adding Part 83 to read as follows:

PART 83—PROCEDURES FOR
DESIGNATING CLASSES OF
EMPLOYEES AS MEMBERS OF THE
SPECIAL EXPOSURE COHORT UNDER
THE ENERGY EMPLOYEES
OCCUPATIONAL ILLNESS
COMPENSATION PROGRAM ACT OF
2000

Subpart A—introduction

Sec.

83,0 Background information on the
procedures in this part.

83.1 What is the purpose of the procedures
in this part?

83.2 How will DOL use the designations
established under the procedures in this
part?

Subpart B—Definitions

83.5 Definitions of terms used in the
procedures in this part.

Subpart C—Procedures for Adding Classes
of Employees tothe Cohort ||. .

83.6 Overview of the procedures i in this
part. '

83.7 Who can submit a petition on behalf of
‘aiclass of employees? *  *

83.8: How is a petition submitted?

83.9: What information must a petition
‘include?

83.10 Ifa petition satisfies all relevant
requirements under § 83.9, does this
mean the class will be added to the
Cohort?

83.11 What happens to petitions that do not
satisfy all relevant requirements under
§§ 83.7 through 83.9?

83.12 How will NIOSH notify petitioners,
the Board, and the public of petitions
that have been selected for evaluation?

83.13 How wil] NIOSH evaluate petitions,
other than petitions by claimants
covered under § 83.14?

83.14 How will NIOSH evaluate a petition
by a claimant whose dose réconstruction
NIOSH could not complete under 42
CFR Part 82?

83.15 How will the Board consider and
advise the Secretary on a petition?

83.16 How will the Secretary decide the
‘outcome of a petition?

83.17 How will the Secretary report a final
decision to add a class of employees to
the Cohort and any action of Congress
concerning the effect of the final
decision?

83.18 . How can the Secretary cancel or
modify a final decision to add a class of
employees to the Cohort?

Authority: 42 U.S.C. 7384q; E.O. 13179, 65
FR 77487, 3 CFR, 2000 Comp., p: 321.

Subpart Introduction

§830 Background information on the
procedures in this part.

The Energy Employees Occupational
Ninéss Compensation Program Act, as
amended (“EEOICPA” or “the Act”), 42
U.SIC. 7384-7385, provides! for the
payment bf compensation benefits to
covered: employees and, where
applicable, survivors of such employees,
of DOE, its predecessor agencies and
certain of its contractors and
subcontr ctors. Among the types of

illngsses for which compensation may
be provided are cancers. There are two
methods et forth in the statute for
claimants to establish that a cancer
incurred by a covered worktr is
conipensable under EEOICRA. The first
is to estal lish that the cancer is at least
as likely as not related to covered
employment at a DOE or Atomic
Weapons| Employer (“AWE}) facility
pursuant Ito guidelines issued by the
Departm nt of Health and Human
Services (“HHS”), which are found at 42
CFR part81. The second method to
establish that a cancer incutred by a
covpred worker is compensable under
EEGICPA is to establish that the worker
is almember of the Special Exposure
Cohprt (‘the Cohort”) and suffered a
spetified|cancer after beginning.
employment at a DOE facility.or AWE «
facility. In Section 3621(14) of EEOICPA
(42|U.S.G, 73841(14)) Congress included
certain classes of employees i in the
Collort. jection 3626 of the!Act (42
U.SIC. 7384q) authorizes the addition to
the Cohort of other classes of
employees. This authority Has been
delégated to the Secretary of HHS by
Executive Order 13179, |

gaat What is the purpose of the
procedures in this part? \

EEOICPA authorizes the President to
add classes of employees to! the Cohort,
while providing Congress with the
opportunity to review and expedite or
reverse these decisions. The President
delegated his authority to the Secretary
of HHS. This part specifies the
procedures by which HHS will
detérmine whether to add new classes
of employees from DOE and AWE

- facillities to the Cohort. HHS will

consider adding new classes of
employees i in response to petitions by,
or dn beHalf of, such classes of
employees. The procedures specify
requirements for petitions and for their
consideration. These requirements are
intended) to ensure that petitions are
submitted by authorized parties, are
justified, and receive uniform, fair,
scigntifid consideration. The procedures
are also designed to give Petitioners and

interested parties opportunity for
appropriate involvement in the process,
and to ensure that the process is timely.
and consistent with requirements
specified in EEOICPA. The procedures
are not intended to provide a second
opportunity to qualify a claim for
compensation, once HHS has completed
the dose reconstruction and DOL has
determined that the cancer subject to
the claim was not “at least-as likely as
not” caused by the estimated radiation
doses. DOL has established procedures
separate from those covered by this part,
under 20 CFR part 30, for cancer
claimants who want to contest the
factual determinations or how NIOSH
conducted their dose reconstructions.

§83.2 How will DOL use the designations
established under the procedures in this
part?

DOL will adjudicate compensation
claims for members of classes of
employees added to the Cohort
according to the same general
procedures that apply to the statutorily
defined classes of employees in the
Cohort. Specifically, DOL will
determine whether the claim is for a
qualified member of the Cohort with a
specified cancer, pursuant “to the .
procedures set forth in'20 CFR part 30.

Subpart B—Definitions |

i .
§83.5 Definitions of terms used inthe -
procedures inthis part...

(a) Advisory Board on Radiation and
Worker Health (“the Board”) is a federal
advisory committee established under
EEOICPA and appointed by the
President to advise HHS in
implementing its responsibilities under
EEOICPA.

(b) Atomic Weapons Employer
(“AWE”) is a statutory term of EEOICPA
which means any entity, other than the
United States, that:

GQ) Processed or produced, for use by
the United States, material that emitted
radiation and was used in the
production of an atomic weapon,
excluding uranium mining and milling:

and,

(2) Is designated by the Secretary of
Energy as an atomic weapons employer
for oses of EEOJCPA.

{c "C lass of employees means, for the
purposes of this part, a group of
employees who work or worked at the
same DOE facility or AWE facility, and
for whom the availability of information
-and recorded data on radiation
exposures is comparable with respect to
the informational needs of dose
reconstructions conducted under 42
CFR part 82. b

(d) HHS is the U.S. Department of
Health and Human Services.



30768 Federal Register / Vol.

69, |No.

104/Friday, May 28, 2004/Rules and Regulations

As discussed above, NIOSH is issuing
internal procedures concurrently with
the promulgation of this rule that
provide more detailed procedures for
how it will evaluate petitions. While
these procedures do not establish any
substantive rights, they specify how
NIOSH will identify available
information and the general methods for
determining whether such information
will be sufficient to estimate maximum
radiation doses for employees in the
class, when such estimates are
necessary. The internal procedures
supplement the guidelines already
provided in this final rule under section
83.13(c)(1). The internal procedures also
provide limited generic information on
how maximum radiation doses can be
estimated when necessary. More
specific detail outlining how available
information would be used to conduct
dose reconstructions would be provided
within each NIOSH evaluation of a
petition that finds that it is feasible to
estimate radiation doses with sufficient
accuracy for the class.

One individual commented that the
rule puts excessive emphasis on
estimating the maximum possible doses
of radiation.

This emphasis was unintended. The
proposed rule defined only the limits of
dose reconstruction. The public should
realize, however, that HHS may receive
petitions for classes of employees for
whom there is sufficient information to
conduct dose reconstructions that
provide more precise estimates than
maximum doses, using, for example,
personal or area monitoring records. For
these petitions, methods for estimating
maximum radiation doses would not be
addressed in the NIOSH evaluation
because they would not be relevant,
since more precise dose reconstr
would be feasible. HHS has clarified the
rule on this point, adding the following
provision (identified below in italics) to
section 83.13(c)(1):

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, for
every type of cancer for which radiation
doses are reconstructed, that could have been
incurred in plausible circumstances by any
member of the class, or if NIOSH has
established that it has access to sufficient
information to estimate the radiation doses of
members of the class more precisely than an
estimate of the maximum radiation dose.

HHS has also supplemented the
guidelines previously included in the
rule regarding the feasibility of
estimating the radiation dose of a class
of employees with sufficient accuracy.

A new § 83.13(c)(1)(iii) specifies the
following additional guidelines:

In'many|circumstances, to establish a
positive fi hding under paragraph (b)(1)(i) of
this sectioh would also require information
describing! the process through which the
radiation exposures of concern may have
occurred and the physical environment in
which the exposures may have occurred.

One labor organization interpreted the
NPRM as|indicating that NIOSH would
use analytic models, presumably to
estimate’ maximum doses when
necessary, at the expense of:the timely
completion of dose reconstructions.

The use of analytic models in such
instances|is efficient, not delaying. Dose
reconstructions that rely more
extensively on analytic exposure models
can;be completed far more quickly than

ig data, which may still ©
involve the use of analytic exposure
models as well.

An individual commented that this
ruld should define how NIOSH

inthe the reliability of dosimetry

-information for use in dose

The HHS dose reconstruction rule (42
CFR Part 82) and related dose
recénstruction guidelines specify how
doses arelreconstructed and explain
how NIOSH takes into account various
factors that affect the interpretation of
dosimetry information, particularly the
limitations of dosimetry progratns from
the early Hecades of nuclear weapons
production. The types of studies the
commenter cited, that have evaluated
the short¢omings of dosimetry
programs, are used by NIOSH to
interpret the records of such dosimetry
programs |

The NHRM and this final rule,
however,|do not reflect an assumption
that it will be feasible to estimate
maximum doses or to more precisely
estimate doses. The determination by
NIOSH, the Board, and the Secretary of
HHS as to whether dose reconstruction
is feasible for a particular class of
employees is a central element of this
tule.

Related to this latter point, an

advocacy group and a laborjorganization
questioned whether petitioning is
“futile” under the provisions of this rule
concerning feasibility, because, in the
view of the commenters, NIOSH “raised
the bar” for evaluating whether doses
can be estimated with sufficient

| j

accuracy from the first NPRM to the
second NPRM, from when a dose
reconstruction cannot be completed to
when maximum doses (nor more precise
doses) cannot be estimated.

The provisions of the second NPRM
discussed in the comment are no more
exclusive than those of the first NPRM,
only more specific. The specificity was
requested by the Board and sought by
other public commenters as well.

There is, however, a substantial
difference between the minimal
requirements for submitting a petition,
when such a petition is not based on
NIOSH having already found that a
claimant’s dose reconstruction cannot
be completed, and the requirements for
adding a class of employees to the
Cohort. Such petitions provide NIOSH
with basic information necessary to
begin the determination process, but
NIOSH is likely to have more extensive
access to information for dose
reconstructions than petitioners. NIOSH
will consider all information as
necessary, not only information
provided by the petitioner, to determine
whether or not the radiation doses of the
class of employees can be estimated:
with sufficient accuracy. °

One labor organization commented
that NIOSH had failed to address 4
limitations of the NPRM. In explanation,
the commenter asserted that the .
estimation of maximum doses would
not be sufficient to estimate lifeti
exposure and would not be valid i in
circumstances involving a mixture of
radionuclides.

If NIOSH can estimate the maximum
quantity of a radionuclide that could
have been inhaled, ingested, or absorbed
by an employee, then the maximum
doses resulting from such internal
exposure can be estimated ‘for the entire
period between exposure and the
occurrence of cancer, as is necessary for
NIOSH dose reconstructions.

With respect to mixtures of
radionuclides, the critical issue is the
extent of information about the mixture
(e.g., quantities and identities). The
involvement of multiple radionuclides
is not inherently an obstacle to dose
reconstruction. On the other hand, in
situations involving exposure of a class
of employees to a mixture of
radionuclides of uncertain identity and
quantity, NIOSH may not be able to
estimate radiation doses and the class
may be added to the Cohort, as provided
for under this rule.

Two labor organizations questioned
how NIOSH could estimate radiation
doses for workers who move between
buildings or facilities and who may not,
themselves, have any knowledge of
radiation sources.



Page 2 — The Secretary

Congress on both decisions to add and decisions to deny a designation within 30 days of HHS
receiving a recommendation by the Advisory Board on Radiation and Worker Health (Board) to
add the class to the SEC. Failure to report to Congress within this 30-day deadline would result
in the automatic addition of the class to the SEC.

42 C.F.R. § 83.14 permits a NIOSH-initiated SEC petition when National Institute for
Occupational Safety and Health (NIOSH) has attempted to conduct a dose reconstruction for a
cancer claimant and finds that the dose reconstruction cannot be completed because there is
insufficient information to estimate the radiation doses of the claimant with sufficient accuracy.
NIOSH reached this conclusion for a Combustion Engineering claimant and subsequently both
notified the claimant and provided information to the claimant about the SEC petitioning
process. NIOSH assisted the claimant in completing the SEC petition for qualification (Tab C).
NIOSH evaluated the petition and presented the findings (Tab D) at the Board meeting in Las
Vegas, Nevada, on January 9, 2008. The NIOSH evaluation recommended adding the following
proposed class to the SEC:

Atomic Weapons Employer (AWE) employees who worked at the Combustion Engineering site
in Windsor, Connecticut, from January 1, 1965, through December 31, 1972, for a number of
work days aggregating at least 250 work days or in combination with work days within the
parameters established for one or more other classes of employees in the Special Exposure .
Cohort.

During the time period of the proposed class, employees at Combustion Engineering were
involved with research activities, uranium processes, and shipments of uranium to the Fernald
Site. Of the 30 claimants in the proposed class, only one had internal monitoring data for the
relevant time period, which consisted of two bioassay results. Four claimants had limited
external dose records for this time period. The two available bioassay results were for natural
uranium and were less than the detection limits for urinalysis at the Fernald Site for this time
period. The highest recorded external cumulative whole-body dose for a claimant for the period
1965-72 was approximately 5 rem.

There were no workplace monitoring records, area monitoring, or air sampling data found for the
time period 1965-72. No documentation on the work activities or processes associated with the
uranium shipments to Fernald has been located. Although other sites supplied uranium to the
Fernald site, there is no way to determine if their work activities were similar to Combustion
Engineering’s given the limited Combustion Engineering data currently available. Based on
available information, NIOSH can make no reasonable assumptions regarding the possible
source term during Combustion Engineering’s operational period as an atomic weapons
employer (AWE).

NIOSH concluded that there are not sufficient personnel monitoring data, area monitoring data,
or source term data to estimate internal or external exposures for the proposed class.

The health endangerment determination is governed by EEOICPA and 42 C.F.R. § 83.13(c)(3)
and § 83.14(b). Pursuant to these requirements, if it is not feasible to estimate with sufficient
accuracy radiation doses for members of the class, then NIOSH must determine that there is a



75954

Federal Register/Vol. 70,

No. 245

Thursday, December 22, 2005/Rules and Regulations

(c) The Secretary will decide whether
or not to revise a final decision
contested by the petitioner(s) under this
section after considering information
and recommendations provided to the
Secretary by the Director of NIOSH, the
Board, and from the HHS administrative
review conducted under paragraph (b)
of this section. HHS will transmit a
report of the decision to the
petitioner(s).

(d) If the Secretary decides under
paragraph (c) of this section to change
a designation under § 83.17(a) of this
part or a determination under § 83.16(c)
of this part, the Secretary will transmit
to Congress a report providing such
change to the designation or
determination, including an iteration of
the relevant criteria, as specified under
§ 83.13(c), and a summary of the
information and findings on which the
decision is based. HHS will also publish
a notice summarizing the decision in
the Federal Register.

(e) A new designation of the Secretary
under this section will take effect 30
calendar days after the date on which
the report of the Secretary under
paragraph (d) of this section is
submitted to Congress, unless Congress
takes an action that reverses or
expedites the designation. Such new
designations and related congressional
actions will be further reported by the
Secretary pursuant to paragraphs (d)
and (e) of § 83.17.

Dated: September 13, 2005.
Michael O. Leavitt,

Secretary, Department of Health and Human
Services.

[FR Doc. 05-24358 Filed 12-21-05; 8:45 am)
BILLING CODE 4163-10-P

DEPARTMENT OF THE INTERIOR .
Bureau of Land Management

43 CFR Part 3160

RIN 1004-AD80

Onshore Oil and Gas Operations;
Correction

AGENCY: Bureau of Land Management,
Interior.

ACTION: Correcting amendment.

summary: This document contains a
correcting amendment to a final rule
reorganizing regulations of the Bureau
of Land Management (BLM) relating to
onshore oil and gas operations, which
was published in the Federal Register of
Friday, February 20, 1987 (52 FR 5384).
The amendment corrects an error in a
cross-reference.

DATES: Effective date December 22,
2005.

FOR|FURTHER INFORMATION CONTACT: Ted
Hudson, 02452-5042. Individuals
who use 4 telecommunications device
for the deaf (TDD) may contact him
individudlly through the Federal
Informatipn Relay Service at 1-800—
877-8339, 24 hours a day, seven days a
week. a

SUPPLEMENTARY INFORMATION:
Background !

1
‘The regulations that are the subject of
this|correcting amendment have been in
effect for more than 20 years. They
pertain specifically to onshore oil and
gas operations programs, and
particularly to the penalty provision for
knowingly submitting false, misleading,
or inaccurate reports or other
information required by the regulations,
taking oil] or gas from a Federal or
Indian lease without authority, or
receiving such oil or gas knowing or
having reason to know it was stolen or
unlawfully diverted or removed from a
Federal of Indian lease site.;

Need for Correction ~

When
revised.t
52 FR 53

final rule redesignated and

e pertinent sections in 1987, at
4, it created an’ertor in ‘a
cross-reference. This error is misleading
and|needs clarification. The provision
assigns a criminal penalty for an act for
whith a divil penalty is prescribed in
another section, referring to'that other
section by number. However, the
section ahd paragraph number stated,
section 3163.4—1(b)(6), does not exist in
the current regulations, having been
redésignated as section 3163.2(f) in the
1987 rule, The 1987 rule failed to adjust
the cross-reference, which now needs to
be corrected to eliminate confusion.

ust oipiees in 43 CFR Part 3160

Government contracts; Indians-—
lands; Mineral royalties; Oil and gas
exploration; Penalties, Public lands—
mineral rbsources; Surety bonds.
TM Accordingly, 43 CFR part 3160 is
corzected| by making the following
amendment: |

i
Pant 3160—ONSHORE OIL AND GAS
RATIONS i

] :
m 1/The duthority citation for part 3160
continues to read as follows:

Authority: 25 U.S.C. 396d and 2107; 30
U.S.C. 189} 306, 359, and 1751; and 43 U.S.C.
1732(b), 1733, and 1740.

| oe
I

Subpart 3163—Noncompliance,
Assessments, and Penalties

m 2. Revise section 3163.3 to read as
follows: "

§3163.3 Criminal penalties.

Any person who commits an act for
which a civil penalty is provided in
§ 3163.2(f) shall, upon conviction, be
punished by a fine of not more than
$50,000, or by imprisonment for not
more than 2 years, or both.

Dated: December 7, 2005.
Chad Calvert,
Acting Assistant Secretary of the Interior.
[FR Doc. 05-24371 Filed 12-21-05; 8:45 am]
BILLING CODE 4310-84-41

DEPARTMENT OF HOMELAND
SECURITY

Coast Guard

46 CFR Part 4
[USCG-2001-8773]
RIN 1625-AA27 (Formerly RIN 2115-AGO7)

Marine Casualties and Investigations;
Chemical Testing Following Serious
Marine Incidents .

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

SUMMARY: This final rule revises Coast
Guard requirements for alcohol testing
after a serious marine incident to ensure
that mariners or their employees
involved in a serious marine incident
are tested for alcohol use within 2 hours
of the occurrence of the incident as
required under the Coast Guard
Authorization Act of 1998. This final
rule also requires that most commercial
vessels have alcohol testing devices on
board, and authorizes the use of saliva
as an acceptable specimen for alcohol
testing. This rule also makes some
minor procedural changes, including a
32-hour time limit for collecting
specimens for drug testing following a
serious marine incident.

DATES: This final rule is effective June
20, 2006.

ADDRESSES: Comments and material
received from the public, as well as
documents mentioned in this preamble
as being available in the docket, are part
of docket USCG-2001-8773 and are
available for inspection or copying at
the Docket Management Facility, U.S.
Department of Transportation, room PL—
401, 400 Seventh Street SW.,
Washington, DC, between 9 a.m. and 5
p.m., Monday through Friday, except



30776

Federal Register / Vol.

69, No.

04/Friday, May 28, 2004/Rules and Regulations

doses that can be estimated to support
compensation without taking into
account any potential radiation
exposures that cannot be estimated.
NIOSH may be able to estimate all
radiation doses of certain employees,
depending on the type of cancer they
incurred. NIOSH may also be able to
estimate radiation doses for some
current members of the Cohort, who
were included in the Cohort by statute
but have a cancer that is not one of the
specified cancers for which an
individual can be compensated as a
member of the Cohort. However, NIOSH
is not authorized under EEOICPA to
administratively assign radiation doses
to employees for whom radiation doses
cannot be estimated using methods of
dose reconstruction. For any claimant
referred to NIOSH who is a member of
the Cohort and. has a cancer not defined
as a “specified cancer” under EEOICPA
(and so is not eligible for compensation
under EEOICPA without a dose
reconstruction), NIOSH will continue to
attempt to complete a dose
reconstruction, using whatever
information is available about that
member's entire work history.

M. Non-Regulatory Coniment: Reporting
+ Estimated Completion Dates for Petition
Evaluations: .* ! ot
;, One advocacy group and two labor"
organizations suggested that NIOSH *
report to Congress an estimated * "
completion date for petitions whose
evaluations by NIOSH will not be
completed within 180 days.

An automatic reporting procedure
would divert HHS resources from
reviewing Cohort petitions and
completing dose reconstructions.
Moreover, a “one-size-fits-all” reporting
procedure of the type proposed would
be inappropriate, considering the wide
variability that is likely in the scope and
volume of petitions, and in the duration
of Board evaluations and proceedings
involving the petitioner(s) associated
with each petition.

Two advocacy groups and two labor
organizations recommended that NIOSH
provide grants to fund health physicists
and other experts to assist petitioners, as
well as training workshops to address
the informational requirements of a
petition. .

Petitioners should not need the
assistance of health physicists to
address the requirements for a petition
under § 83.9. Most petitioners should
find the petition instructions and
petition form provided by NIOSH will
be sufficient guidance. NIOSH, in
coordination with the DOL/DOE
resource centers, will assist petitioners
on an individual basis as well. Section

83.11 of the rule commits NIOSH to
providing further assistance to
petitioners whose petitions have not
met the basic requirements for
evaluation.

N. Non-Regulatory Comment: Reporting
on the Rate of Success of Petitions and
Claimants

Two individual commenters
recommehded HHS report on the
success rate of petitions for the addition
of tlasses of employees to the Cohort.
The'commenters also recommended that
DOL repart on the success rates of
cancer claimants seeking compensation
under EEOICPA, providing individual
rate’ by class of employees in the
Cohort arid a separate rate for claimants
who are not members of the:Cohort.

NIOSH provides extensive public
information through its OCAS internet
homepage (www.cdc.gov/niosh/ocas) on
tl ‘tus of its dose reconstruction
activities|and plans to be informative
conterning petitions as well. The
homepage will provide information on
the statug and the outcomes of petitions.
The commenters should contact DOL if
they wish to recommend specific types
of reportg on claims adjudication
outcomes that might be useful to the
public. oo

O. Non-Regulatory Comment:
Recommendations To Add Specific
Classes td the Cohort

Three labor organizations and one
individud] commented that various
employee groups might or should
qualify td become members ‘of the
Cohort.
NIOSH} will send notices including
this final jrule and related information to
all individuals or organizations who
have indicated to NIOSH their intent to
petition.

P. Non-Regulatory Comment:
Completion of Dose Reconstructions for
Mallincktodt Chemical Company
Employees !

One individual reports that NIOSH
has jaccess to complete dosimetry data
on émployees of Mallinckrodt Chemical
Company and that minimal dose
reconstruction is required for these
workers. On this basis, the commenter
recommends that NIOSH be required to
complete) these dose reconstructions
within 180 days.

The commenter assumes that if
extensive radiation monitoring
information is available, then dose
réconstructions require “minimal”
work. This is generally true.for claims
for whic the monitoring data alone,
prior to dose reconstruction, indicate
high leve] exposures. In such cases,

NIOSH would only conduct dose
reconstruction to the extent sufficient to
document dose levels that meet the
threshold for compensation. In most
settings, however, the majority of
workers are unlikely to have records
indicating high level radiation
exposures. For these workers, NIOSH
needs to carefully evaluate the adequacy
of monitoring and monitoring records
and to account for any deficiencies that
might otherwise lead NIOSH to
underestimate radiation doses.

The full process for dose
reconstructions is outlined'in 42 CFR
Part 82 and described in greater detail
in technical documents available from
NIOSH. These procedures were
designed to be as efficient as possible.

Q. Non-Regulatory Comment: Inclusion
of Transcripts of Board Meetings in the
Administrative Record of the
Rulemaking

One advocacy group recommended
that HHS include the transcripts of
Board meetings for March 7, 14, and 28,
2003, and May 1, 2003 in the
administrative record of this
rulemaking. These Board meetings
included discussions and‘decisions by .
the Board concerning its advice on this
rulemaking, as well as public comment
on issues considered by the Board.

HHS has included the transcripts of
the referenced Board meetings.in the -
NIOSH docket for this rule. «+

III. Recommendations of the Advisory
Board on Radiation and Worker Health

HHS requested the Board to provide
advice concerning these procedures for
making additions to the Cohort. As
discussed above, the Board has an .
integral role in the evaluation of )
petitions to add classes of employees to
the Cohort. °

The Board reviewed issues related to
the Cohort during its meeting on May 2-
3, 2002, and reviewed the initial NPRM,
which was published on June 25, 2002,
during its meetings on July 1-2, August
14-15, and August 22, 2002. After
making substantial changes based on
public comment and Board
recommendations, NIOSH issued a
second NPRM on March 7,.2003. The
Board reviewed the second NPRM
during meetings on March 7, 14, and 28,
2003, and May 1, 2003. The members
also considered public comments on the
two NPRMs provided during meetings
of the Board and at four regional
meetings held in July and August 2002.
In addition, NIOSH staff members gave
formal presentations on the two NPRMs
and related issues during the Board
meetings. The transcripts and minutes
of these meetings are available to the



Federal Register / Vol.

69, No. 104/Friday, May 28, 2004/Rules and Regulations

30785

considering the petition, both NIOSH
and the members of the Board will take
all steps necessary to prevent the
disclosure of information of a personal
nature, concerning the petitioners or
others, where disclosure would
constitute a clearly unwarranted
invasion of personal privacy:

(c) In considering the petition, the
Board may obtain and consider
additional information not addressed in
the petition or the initial NIOSH
evaluation report.

(d) NIOSH may decide to further
evaluate a petition, upon the request of
the Board. If NIOSH conducts further
evaluation, it will report new findings to
the Board and the petitioner(s).

(e) Upon the completion of NIOSH
evaluations and deliberations of the
Board concerning a petition, the Board
will develop and transmit to the
Secretary a report containing its
recommendations. The Board's report
will include the following:

(1) The identification and inclusion of
the relevant petition(s);

(2) The definition of the class of
employees covered by the
recommendation;

(3) A recommendation as to whether
or not the Secretary should designate
the class as an addition to the Cohort;

(4) The relevant criteria under
§ 83.13(c) and findings and information
upon which the recommendation is
based, including NIOSH evaluation
reports, information provided by the
petitioners, any other information
considered by the Board, and the
deliberations of the Board.

§83.16 How will the Secretary decide the
‘outcome(s) of a petition?

(a) The Director of NIOSH will
propose, and transmit to all affected
petitioners, a decision to add or deny
adding classes of employees to the
Cohort, including an iteration of the
relevant criteria, as specified under
§ 83.13(c), and a summary of the
information and findings on which the
proposed decision is based. This
proposed decision will take into
consideration the evaluations of NIOSH
and the report and recommendations of
the Board, and may also take into
consideration information presented or
submitted to the Board and the
deliberations of the Board. In the case of
a petition that NIOSH has determined
encompasses more than one class of
employees, the Director of NIOSH will
issue a separate proposed decision for
each separate class of employees.

(b) HHS will only allow the
petitioner{s) to contest a proposed
decision to deny adding a class to the
Cohort or to contest a health

endangerment determination under

§ 83.13(c)(3)(ii). Such challenges must
be submitted in writing within 30%.
calendar days and must include
evidence that the proposed decision
relies on a record of either substantial
factual errors or substantial errors in the
implementation of the procedures of
this part. Challenges may not introduce
new information or documentation
concerning the petition or the NIOSH or
Board evaluation(s) that was not
submitted or presented by the
petitioner{s) or others to NIOSH or to
the Board prior to the Board's issuing its
recommendations under § 83.15.

(c) A panel of three HHS personnel,
independent of NIOSH and appointed
by the Secretary, will conduct an
administrative review based on a
challenge submitted under paragraph (b)
of this section and provide
recommendations of the panel to the
Secretary concerning its merits and the
resolution of issues contested by the
challenge. Reviews by the panel will
consider, in addition to the views and
information submitted by the
petitioner(s) in the challenge, the
proposed decision, the NIOSH
evaluation report(s), and the report
containing the recommendations of the
Board issued prior to the proposed
decision under § 83.15. The reviews
may also consider information
presented or submitted to the Board and
the deliberations of the Board prior to
the issuance of the recommendations of
the Board under § 83.15. The panel shall
consider whether HHS substantially
complied with the procedures of this
part, the factual accuracy of the
information supporting the proposed
decision, and the principal findings and
recommendations of NIOSH and those
of the Board issued under § 83.15.

(d) The Secretary will make the fina]
decision to add or deny adding a class
to the Cohort, including the definition
of the class, after considering
information and recommendations
provided to the Secretary by NIOSH, the
Board, and from an HHS administrative
review when such a review is
conducted under paragraph (c) of this
section. HHS will transmit a report of
the decision to the petitioner(s),
including an iteration of the relevant
criteria, as specified under § 83.13(c),
and a summary of the information and
findings on which the decision is based.
HHS will also publish a notice
summarizing the decision in the Federal
Register.

§83.17 How will the Secretary report a
final decision to add a class of employees
to the Cohort and any action of Congress
concerning the effect of the final decision?

(a) If the Secretary designates a class
of employees to be added to the Cohort,
the Secretary will transmit to Congress
a report providing the designation, the
definition of the class of employees
covered by the designation, and the
criteria and findings upon which the
designation was based.*

(b) A designation of the Secretary will
take effect 180 calendar days after the *
date on which the report of the
Secretary is submitted to Congress,
unless Congress takes an action that
reverses or expedites the designation.

(c) After either the expiration of the
congressional review period or
notification of final congressional
action, whichever comes first, the
Secretary will transmit to DOL and to
the petitioner(s) a report providing the
definition of the class and one of the
following outcomes:

(1) The addition of the class to the
Cohort; or

(2) The result of any action by
Congress to reverse or expedite the
decision of the Secretary to add the
class to the Cohort. ,

(d) The report specified under * -
paragraph (c) of this section will be
published on the Internet at
www.cdc.gov/niosh/ocas and in the
Federal Register.

§83.18 How can the Secretary cancel or
modify a final decision to add a class of
employees to the Cohort?

(a) The Secretary can cancel a final
decision to add a class to the Cohort, or
can modify a final decision to reduce
the scope of a class added by the
Secretary, if HHS obtains records
relevant to radiation exposures of
members of the class that enable NIOSH
to estimate the radiation doses incurred
by individual members of the class
through dose reconstructions conducted
under the requirements of 42 CFR Part
82.

(b) Before canceling a final decision to
add a class or modifying a final decision
to reduce the scope of a class, the
Secretary intends to follow evaluation
procedures that are substantially similar
to those described in this part for adding
a class of employees to the Cohort. The
procedures will include the following:

(1) Publication of a notice in the
Federal Register informing the public of
the intent of the Secretary to review the
final decision on the basis of new
information and describing procedures
for this review;

See 42 U.S.C. 73841(14)(C)lii).


Federal Register / Vol.

et ee

69, No. 104/Friday, May 28, 2004/Rules and Regulations

30771

diffusion plants to be included in the
Cohort by aggregating their employment
across all three of the plants, and hence
believe classes added to the Cohort
should be treated similarly.

DOL is interpreting a section of
EEOICPA that establishes a single,
multi-facility class (42 U.S.C.
73841(14)(A)), while HHS is interpreting
a different section of EEOICPA (42
U.S.C. 7483q), which does not allow
HHS to define a class as a group of
employees from multiple facilities.
However, HHS agrees with the principle
of aggregating employment within
separate classes of the Cohort for the
purpose of determining health
endangerment. There is no compelling
health reason to distinguish between
employment within one class of the
Cohort and employment distributed
among several classes of the Cohort, nor
to distinguish whether such classes
were employed at the same facility or at
separate facilities. In any case, the
employee would have accumulated 250
work days of employment involving
exposure to radiation that either cannot
be estimated by dose reconstruction
under the provisions of this rule or for
which Congress determined there was
not a need for dose reconstruction when
Congress included the various groups of
employees in the Cohort.

Accordingly, HHS has added a
provision to the rule to implement this
principle of aggregating employment.
Whenever HHS adds a class of
employees to the Cohort for which the
250 work days requirement is
applicable, HHS will define class
eligibility such that DOL can aggregate
the work days of an employee from
among all other classes in the Cohort for
which the employee meets all of the
other requirements for membership,
except for the work days requirement.
For this purpose, section 83.13(c)(3)(ii)
of the rule includes the following
additional text (in italics):

(ii) For health endangerment not
established on the basis of a discrete
incident, as described under paragraph
{b}(3)(i) of this section, NIOSH will specify a
minimum duration of employment to satisfy
the health endangerment criterion as having
been employed for a number of work days
aggregating at least 250 work days within the
parameters established for the class or in
combination with work days within the
parameters established for one or more other
classes of employees in the Cohort.

An advocacy group and two labor
organizations recommended that the
rule allow for the health endangerment
test to be met in fewer than 250 work
days for work operations lasting fewer
than 250 days. The commenters
indicated that certain short-term

operations may have involved high level
exposures. The comments also reflected
the assumption that high level #
exposures could have occurred through
the omission of radiation protection
controls, versus their failure, only the
latter of which was identified in the
NPRM.

HHS has not established a separate
criterion that would waive the 250 work
days employment requirement for any
short-term operation, since
exceptionally high level exposures are
not inherent to such operations. Section
83.13(c)(3)(i) of the HHS rule already
provides for waiving the 250 work days
employment requirement whenever
classes of employees may have been
exposed to radiation during discrete
incidents likely to have involved
exceptionally high level exposures,
including any such incidents that may
have occurred during projects of short
duration. HHS has revised the text of
this section to allow for the possibility
that exceptionally high exposures could
result from circumstances involving the
omission of radiation protection
controls, as well as their failure. With
respect to this change, however, HHS
advises potential petitioners that the
omission of radiation protection
controls, in and of itself, is not
substantial evidence that exceptionally
high level radiation exposures were
likely. The provision of the rule
allowing HHS to waive the 250 work
days requirement is intended to address
exposure scenarios distinctly more
certain and severe than would be
represented by exposure conditions
generally at the gaseous diffusion
plants, for which Congress established
the precedent of setting an employment
duration requirement at 250 work days.

‘An advocacy group recommended
HHS incorporate into the rule a text
excerpt of the NPRM preamble that
explained that HHS will use the 250
work days employment requirement
“only when it lacks sufficient basis to
establish a lower minimum standard.”

HHS has not incorporated this text
into the rule for two reasons. First, the
term “only” may be misleading. HHS
has no basis to predict that the 250 work
days employment requirement would be
waived for the majority of classes of
employees that may be added to the
Cohort. Moreover, the text is not
appropriate for the rule, since it could
be interpreted to require HHS to
demonstrate that it lacks sufficient basis
to waive the 250 work days
requirement, versus demonstrating that
there is sufficient basis to waive the
requirement. This would amount to
requiring HHS to “prove the negative,”
that it lacks certain information.

One labor organization commented
that EEOICPA provides no basis for
considering the effects of radiation in
isolation when considering health
endangerment.

EEOICPA specifically requires that
HHS consider whether “* * * such
radiation dose may have endangered the
health of members of the class”
(emphasis added) 42 U.S.C. 7384q(b)(2).
This might allow HHS to take into
account a synergistic or risk-
potentiating relationship betweena_ —,
chemical and a radiation exposure, if
such a relationship were known.
Otherwise, EEOICPA does not authorize
HHS to consider health risks other than
exposure to radiation.

Two individuals commented that
HHS should use epidemiological data to
compare the cancer risks of classes of
employees petitioning for addition to
the Cohort with those of the groups
included in the Cohort by statute. The
commenters recommended that classes
with cancer risks that are roughly
comparable be added to the Cohort.

HHS cannot add classes to the Cohort
on the basis of health endangerment
alone. As discussed above, pursuant to
42 U.S.C. 7384q(b)(1), HHS must also
find that dose reconstruction is not.
feasible. Moreover, as discussed in the
second NPRM in response to this
comment, there is no practical and
scientifically defensible method for
making such epidemiological
comparisons for a variety of reasons,
including limitations concerning
timeliness, statistical power, and other
matters (68 FR 11297).

One labor organization asserted that
Congress intended for HHS to use the
same criteria for considering whether to
add classes of employees to the Cohort
as were used by Congress itself to
include groups in the Cohort by statute.

As discussed above, Congress
specified in EEOICPA, 42 U.S.C.
7384q(b), the criteria that it intended
HHS to use.

E. Eligibility To Petition

Section 83.7 of the NPRM specified
parties that would be eligible to submit
a petition on behalf of a class of
employees. This included: “(c) One or
more individuals or entities authorized
in writing by one or more DOE, DOE
contractor or subcontractor, or AWE
employees, who would be included in
the proposed class of employees, or
their survivors.”

HHS received conflicting comments
concerning this provision. One labor
organization recommended that HHS
narrow the above provision specifically,
and implied HHS would have to narrow
another provision of § 83.7 that would



IV. Designation Findings

Feasibility of Estimating Radiation Doses with Sufficient Accuracy

The Secretary established the feasibility determination for the class of employees
covered by this report based upon the findings summarized below.

(1) NIOSH has not found information on the analytical methodology or the work
activities for the proposed class. In addition, NIOSH does not have access to
sufficient personnel monitoring data, area monitoring data, or source term data to
estimate internal exposures for the proposed class.

(2) NIOSH could not determine which individuals should have been monitored for
external exposure or the magnitude of this potentially unmonitored dose.
Therefore, NIOSH does not have access to adequate information to estimate with
sufficient accuracy the external occupational exposures for the proposed class.

(3) Pursuant to 42 C.F.R. § 83.13(c)(1), NIOSH determined that there is insufficient
information to either: (1) estimate the maximum radiation dose, for every type of
cancer for which radiation doses are reconstructed, that could have been incurred
under plausible circumstances by any member of the class; or (2) estimate the
radiation doses of members of the class more precisely than a maximum dose
estimate.

(4) The Board concurred with the NIOSH evaluation and recommended the proposed
class for addition to the SEC.

(5) Although NIOSH found that it is not possible to completely reconstruct radiation
doses for these employees, NIOSH determined that it is possible to reconstruct
occupational medical dose. Therefore, individuals with non-presumptive cancers
may be considered for partial dose reconstructions.

Health Endangerment

The Secretary established the health endangerment determination for the class of
employees covered by this report based upon the findings summarized below.

(1) Pursuant to 42 C.F.R. § 83.13(c)(3), NIOSH established that there is a reasonable
likelihood that such radiation doses may have endangered the health of members
of the class. Pursuant to 42 C.F.R. § 83.13(c)(3)(ii), NIOSH specified a minimum
duration of employment to satisfy this health endangerment criterion as “having
been employed for a number of work days aggregating at least 250 work days
within the parameters established for this class or in combination with work days
within the parameters (excluding aggregate work day requirements) established
for one or more other classes of employees in the Cohort.”

HHS Special Exposure Cohort Designation:
Combustion Engineering



SEC-00099

12-14-07 _|

Combustion Engineering

i
Table 4-1 lists uranium shipments known by NIOSH to have been sent from Combustion Engineering

to the Fernald Feed Center (NMMSS).

Table 4-1: Uranium Shipments from Combustion Engineering to Fernald Feed Center
Date Material Walshe Weight Units
12-31-67 DU | 1 0 Kilograms
12-31-67 EU _| 60,075 1,033 Grams
07-23-69 EU_| 608,486 10,150 Grams
07-25-69 EU 127,142 2,536 Grams
10-03-69 EU | 404,798 l 11,042 Grams
10-20-69 EU 397,418 ! 10,676 Grams
12-01-69 EU 346,903 5,766 Grams
12-01-69 EU! 36,729 j 769 Grams
12-01-69 EU | 125,318 i 3,187 Grams
12-01-69 EU _| 88,462 2,831 Grams
12-04-69 EU_| 17,405 290 Grams
12-04-69 EU 34,799 Lil Grams
12-11-69 EU 48,412 1,015 Grams
12-11-69 EU_| 219,683 5,572 Grams
12-29-69 EU _| 236,396 | 3,974 ° Grams

~_ 12-29-69 EU | 93,321 2,372 Grams +
12-29-69 * EU | 457,261 14,616 Grams
01-12-71. EU | 40,479 820 Grams +
01-17-71 - EU | 40,003 807 Grams
01-20-71 EU. - 35,892 723 Grams
01-20-71 EU "1,225 25 Grams
01-28-71 EU | 28,029 570 Grams
10-28-71 EU | 76,710 1,284 Grams

¢

In addition to AWE work activities! many commercial operations were occurring simultaneously,

including fuel fabrication and research.
buildings used for AWE-related work wi
covered period, radiological exposures fi
included for dose reconstruction.

4.3. Time Period Associated w

1

ith Radiological Operations

Indications are that, with the exception of one building, all of
ere also used for commercial work (CE, 1991). During the
om AWE related work and commercial activities must be

Per the DOE Office of Health, Safety and Security, the time period associated with the uranium

shipments from Combustion

(http://www.hss.energy.gov/healthsafety
assumes the period of potential AWE ral

through December 31, 1972.

Engineerin;

|
10 of 20!

& to the Fernald site is between 1965 and 1972
/fwsp/advocacy/faclist/findfacility.cfm). This evaluation -
diological exposures to be the period from January 1, 1965



Tab C

SEC Petition


|

18/63/2087 08:19 8606784998 PAGE 01/07

—_

At

A2

A3

c

‘Spacial Exposure Cohort Petition
under the Energy Employees Oocupatonal lneng
Wness Compensation Act * National Institute for Oc ational Safety end Health

Special Exposure Cohort Petitiori — Form A Page 1of2

You should use this petition form only if NIOSH has reported to you in writing that it canhot complete the
dose reconstruction needed for your cancer claim, i

All other petitioners should use Petition Form B to submit a petition to NIOSH.

toll-free phone number and request to speak to someone in the Office of Compensatl:
Support about an SEC petition: 1-800-366-4674.

A NIOSH Claim Information — Complete as much information as you can in Section A.

For Further Information: If you have questions about these instructions, please call ; foilowing NIOSH

S. Department of Health and Human Services
Cantors for Disegse Control and Prevention

OMB Number. 0920-0639 Expires: 05/31/2007

instructions on Completing this Form:

n Analysis and
|

NIOSH Tracking Number (indicated on all NIOSH correspondence):

MrJMrs.JMs. First Name Middle initial Last flame
Social Security Number of Energy Employee for whom this claim was. filed:

|
i
Print Name of Energy Employee for whom this ctaim was filed: |

Signature of Person Submitting this Potition — Comptete Section B.

Print and sign your name below to indicate that you ara pelitioning for HHS to consider adding a class
of employees to the Special Exposure Cohort that would inctude the employee indicated by the
tracking number ar name under entry 1 above.

Print your name below: Sign your name bejaw: |

FirstName Midd intial LastName ~ PPSt Nghe Widale mit] ‘Last Name”

Please send this form to NIOSH at the address below,

Once NIOSH receives this form, the U.S. Department of Heaith and | Human Services w(il consider adding a
class of employees to the Special Exposure Cohort. Your contact at NIOSH will be availiable to inform you ot
the progress of your petition. H

‘Send this form to: ‘SEC Petition

(Name or Socie Security Number of First Petitioner:

Office of Compensation Analysis and Support
NIOSH

4876 Columbia Parkway, MS-C-47
Cincinnati. OH 45228

ae. aA rls ta



HHS Designation of Additional Members of the
Special Exposure Cohort ©
under the
Energy Employees Occupational Illness Compensation Program Act of 2000

Designating a Class of Employees from

Combustion Engineering
Windsor, Connecticut

HHS Special Exposure Cohort Designation:
Combustion Engineering