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.”

(2) NIOSH found that the primary radiation exposure hazard to employces resulted
from episodic inhalations of radionuclides that cumulatively resulted in chronic
exposures. The NIOSH evaluation report documents substantial exposures from this
hazard. Additionally. employees in the class involved in other radiological activities,
separate from the calutron enrichment process, may have incurred substantial
external, as well as internal, radiation exposures.

(3) 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.
such as a nuclear criticality incident, as defined under 42 C.F.R. § 83.13(c)(3)(i).

(4) The Board concurred with the finding of NIOSH that the health of the class may
have been endangered and further concurred with NIOSH in this respect by defining

the class according to the 250 work day employment requirement specified under 42
CFR. § 83.13(c)(3)(ii).

Vv. — Effect and Effective Date of Designations

The Secretary submits this report on designations 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.FLR. §
83.16(b). 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 criterion and findings on which the decision was based.

HHS Special Exposure Cohort Designation:
Y-12 Plant, Oak Ridge, Tennessee


HHS Designation of Additional Members of the

Special Exposure Cohort
under the
Energy Employees Occupational IIIness Compensation Program Act

Designating a Class of Employees from

Y-12 Plant
Oak Ridge. Tennessee

HHS Special Exposure Cohort Designation:
Y-12 Plant, Oak Ridge, Tennessee


1. Designation

1, Michael O. Leavitt. Secretary of Health and Human Services (“the Secretary”),
designate the class of employecs defined in Section II of this report for addition to the
Special Exposure Cohort (SEC), as authorized under the Energy Employees
Occupational IIIness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. §

7384q.

Date: ,
AUG 2 5 2005 WH} de LO. ae A
TO T

Michael O. Leavitt

Il. | Employee Class Definitions

Department of Energy (DOE) employees or DOE contractor or subcontractor
employees who worked in uranium enrichment operations or other radiological
activities at the Y-12 facility in Oak Ridge. Tennessee from March 1943 through
December 1947 and who were employed for a number of work days aggregating at
least 250 work days. either solely under this employment or in combination with
work days within the parameters (excluding aggregate work day requirements)
established for other classes of employees included in the SEC

I. Designation Criteria and Recommendations

Pursuant to 42 U.S.C. § 7384q, the Secretary has determined for the class defined in
Section II of this report. upon recommendation of the Advisory Board on Radiation
and Worker Health (“the Board”), 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, 42 C.F.R. § 83.13(c)(1). states that it is feasible to estimate the
radiation dose that the class received with sufficient accuracy under two situations.
First, the rule states that radiation doses can be estimated with sufficient accuracy if
NIOSH has established that it has access to sufficient information to estimate the
maximum radiation dose 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 can 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. 42 C.F.R. § 83.3(c)(1)(i).

HHS Special Exposure Cohort Designation:
Y-12 Plant, Oak Ridge, Tennessee


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 dated July 26. 2005 and received on July 29,
2005.

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 upon the findings summarized below.

(1) As governed by 42 C.F.R. § 83.13(c)(1). NIOSH determined that it lacks access to
sufficient information to either 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 to estimate
the radiation doses of members of the class more precisely than a maximum dose
estimate with sufficient accuracy.

(2) NIOSH found that employees involved in the calutron uranium enrichment
process were exposed to levels of airborne uranium products that cannot be
determined because of the absence of bioassay data for the time period and the
lack of air sampling sufficient to develop maximum exposure scenarios.

(3) NIOSIL is unable to estimate such doses based on source term and process
information for lack of documentation on the varying levels of enrichment of the
source materials and on the production rate of the operations, and because the
manual recycling and cleaning activities are unique and not comparable to any
operations for which NIOSH has access to adequate monitoring data.

(4) There is not sufficient information for individual dose reconstruction on other
radiological activities during this time period, including the development of
beneficial radiological isotopes. development and testing of a neutron monitor.
maintenance and use of a large Radium 226 sealed source. and thorium extraction.
However. NIOSH has determined that it is possible to estimate the exposure that
resulted from occupational medical x-rays, but lacking other information, NIOSH
can not rely on the x-ray doses alone to complete sufficiently accurate dose
reconstructions for this class.

Health Endangerment

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

(1) As governed by 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

HHS Special Exposure Cohort Designation:
Y-12 Plant, Oak Ridge, Tennessee