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 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).

V. 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:
Y-12 Plant



(4) NIOSH has no air monitoring data, source term, or process information
associated with the other radiological activities at Y-12. Consequently, NIOSH
is unable to estimate internal exposures based on the data available.

(5) NIOSH lacks external dosimetry or source term information regarding the
external exposures resulting from other radiological activities at the facility
during this time period.

(6) Although the main mission of the Y-12 site during the period evaluated in this
report was the electromagnetic enrichment of uranium in the calutrons, it also
included a range of other smaller-scale radiological operations. Since exposure
potential at the site may not have been limited to only specific buildings or
groups of workers, NIOSH recommends that the class definition include all
employees who worked at the site during the specified time period.

(7) 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.

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

(9) Although NIOSH found that it is not possible to completely reconstruct radiation
doses for these employees, NIOSH intends to use any available internal
monitoring data that may be available for an individual claim (and can be
interpreted using existing NIOSH dose reconstruction processes or procedures).
Further, NIOSH has determined that calutron-related external exposures for
workers directly associated with the calutron enrichment processes, and the
occupational medical dose for all workers, can be reconstructed. Therefore, dose
reconstructions for individuals with non-presumptive cancers or fewer than 250
days employment in the class period may be performed using these data as
appropriate.

Health Endangerment

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

- ()-Pursuant:to:-42-C:F:R-§-83:13(c)(3)-NIOSH-established-that-thereis‘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

HHS Special Exposure Cohort Designation:
Y-12 Plant



HHS Designation of Additional Members of the

Special Exposure Cohort
under the .
Energy Employees Occupational IIIness Compensation Program Act of 2000

Designating a Class of Employees from

Y-12 Plant
Oak Ridge, Tennessee

HHS Special Exposure Cohort Designation:
Y-12 Plant



1.

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.

I.

AuG 15 2008 VbebOF act

Date Michael O. Leavitt

Employee Class Definition

All employees of the Department of Energy (DOE), its predecessor
agencies, and DOE contractors or subcontractors who worked at the Y-12
Plant in Oak Ridge, Tennessee from March 1, 1943 through December 31,
1947 for a number of work days aggregating at least 250 work days occurring
either solely under this employment or in combination with work days within
the parameters established for one or more other classes of employees in the

oe ~- dose é

Special Exposure Cohort.

III. Designation Criteria and Recommendations

Pursuant to 42 U.S.C. § 7384q, 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

timate——-- en a

NIOSH previously evaluated (in evaluation report SEC- 00018) the » feasibility of
performing dose reconstruction for workers at Y-12 who were employed from

HHS Special Exposure Cohort Designation:
Y-12 Plant



March 1943 through December 1947. In that report, NIOSH concluded that it was
not feasible to estimate radiation doses with sufficient accuracy for workers who
worked in uranium enrichment operations and other radiological activities at the Y-
12 site. The Board and the Secretary concurred with NIOSH’s determination; the
recommended class was added to the SEC on September 24, 2005. During its
initial phase of administering the class, the Department of Labor (DOL)
experienced difficulties in administering the class because of potential ambiguities
in the class definition. To resolve those ambiguities, NIOSH developed a new
evaluation report (SEC-00098) which clarifies that the class definition includes all
workers at the Y-12 site from March 1943 through December 1947. NIOSH
determined that the potential for radiation exposure existed for all Y-12 employees
who were present at the site, due to operations related to uranium enrichment and
other radiological activities. In effect, the class defined in the latest evaluation
report subsumes the class that was added to the SEC on September 24, 2005, and
therefore the SEC-00098 class should be the class used by DOL to process and re-
evaluate all claims during this period at Y-12. NIOSH believes that all employees
who meet the three requirements of the class: (1) employment at Y-12 from March
1943 through December 1947; (2) 250 work days at the Y-12 facility or in
combination with work days in another SEC class; and (3) a specified cancer,
should be covered by this class.

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 July 17, 2008.

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 does not have access to sufficient uranium urinalysis records to estimate
internal exposures, nor does NIOSH have records relating to other in vitro
(fecal, nasal, sputum, etc.) or in vivo (whole-body, lung or other organ count)
analyses.

(2) Available air sampling data are not suitable for an accurate estimate of intake
scenarios. The sampling strategy and frequencies are unknown and it is not
possible to determine whether the data represent high, low, or average
concentrations to which a worker could have been exposed. The absence of
breathing zone data makes it impossible for NIOSH to establish maximum
exposure scenarios ba: cess data or source term'data.

(3) The caliitron operations and related support activities, Such as the recycling’ and
cleaning processes, are not comparable to any other operations for which
NIOSH has access to adequate monitoring data.

HHS Special Exposure Cohort Designation:
Y-12 Plant