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


Page 2 - The Secretary

May 28. 2004 (Tab C). Since promulgation of these procedures, Congress has amended
EEOICPA, mandating that HHS report to Congress on designations and decisions to deny
a designation within 30 days of receiving a recommendation by the Advisory Board on
Radiation and Worker Health (“the 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.

Under the HHS procedures to designate additional members to the SEC, NIOSH received
three SEC petitions representing certain employees who worked at Y-12 from 1943
through 1957 (Tab D). NIOSH evaluated most of the petitions and. meeting the statutory
conditions for adding a class to the SEC, determined that it is not feasible to estimate the
radiation doses of employees who worked in uranium enrichment operations or other
radiological activities at Y-12 from March 1943 through December 1947 with sufficient
accuracy and that the health of these employees may have been endangered by such doses
(Tab E). NIOSH has not completed the evaluation of the portion of one petition which
concerns the period 1948 to 1957.

NIOSH presented the findings of the evaluation regarding March 1943 — December 1947
at the Board meeting on July 5, 2005. NIOSH reported that there is insufficient air
sampling and bioassay data to estimate maximum radiation dose for employees involved
in the calutron uranium enrichment process during that period. NIOSH was also unable
to obtain sufficient area monitoring data, source term, or process information for other
radiological activities such as 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 determined that it is
possible to estimate the exposure that resulted from occupational medical x-rays. As a
result of all of the findings. NIOSH concluded that there is insufficient 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.

Subsequently, the Board considered the information presented by the petitioners and
NIOSH. After deliberations, the Board concurred with NIOSH, recommending the
addition to the SEC of the class of employees who worked in uranium enrichment or
other radiological activities from March 1943 through December 1947 (Tab F). The July
5, 2005 vote was 8-0, with one abstention, one recusal, and one absence (Tab G).

The petitioners will be given the opportunity to seek an administrative review of certain
HHS decisions, either a class denial or a 250-day health endangerment requirement, as
specified in the HHS SEC procedures (See § 83.16(b) in Tab C).


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


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


4 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

National Institute for

Occuptional Safety and Health
Centers for Disease Control

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

DATE: July 29, 2005
TO: The Secretary
Through: DS
COS
ES
CDC Be pase
FROM: Director

National Institute for Occupational Safety and Health (NIOSH)

SUBJECT: Designating Certain Employees of the Y-12 Plant in Oak Ridge.
Tennessee (““Y-12”) as Members of the Special Exposure Cohort (SEC)
under the Energy Employces Occupational Illness Compensation Program
Act of 2000 (EEOICPA) -- ACTION

Action Required By: August 29, 2005
ISSUE

Attached for your approval and signature is a proposed designation to add certain
employees from Y-12 as members of the SEC under EEOICPA, 42 U.S.C. § 7384q (Tab
A).

DISCUSSION

EEOICPA established an SEC, a designation applied to certain classes of employees who
worked in United States nuclear weapons production facilities of the Department of
Energy (DOE) or Atomic Weapons Employers (AWEs). EEOICPA confers to SEC
designees a presumption of causation regarding the relation of their cancer to their
employment at a DOE or AWE facility. This presumption allows them to obtain federal
compensation under EEOICPA if they incur one of a list of ‘specified cancers” that,
under EEOICPA, are presumptively linked with occupational exposures to radiation at
DOE and AWE facilities. EEOICPA included four classes of employees in the SEC
initially and further provided that the President could designate additional classes as
members of the SEC if certain statutory conditions are met. This authority to designate
additional members was delegated by the President to the Secretary of the Department of
Health and Human Services (HHS) (Tab B), who promulgated procedures for doing so on

09044 205003!


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

AUG 25 2005

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

Dear Mr. President:

Pursuant to the Energy Employees Occupational IIIness Compensation Program Act of 2000
(EEOICPA) and 42 C.F.R. pt. 83, three petitions were filed on behalf of workers employed at the
Y-12 facility in Oak Ridge, Tennessee. who worked in uranium enrichment operations or other
radiological activities from March 1943 through December 1947. The petition requested
inclusion as a Special Exposure Cohort (SEC). Under 42 C_F.R. §§ 83.7 — 83.9, the petitions
qualified for evaluation by the Centers for Disease Control and Prevention’s (CDC) National
Institute for Occupational Safety and Health (NIOSH).

NIOSH evaluated the petitions using the procedures set forth in 42 C.F.R. § 83.13. At the
July 5, 2005. meeting of the Advisory Board on Radiation and Worker Health (the Board).
NIOSH presented its finding to the petitioners and the Board. Based on the meeting. in a letter
dated July 26. 2005, the Board recommended granting SEC status to this petition; and in a
subsequent letter dated July 29. 2005, the Director of NIOSH concurred with the
recommendation.

Based upon consideration of the findings. deliberations, and recommendations of the Board
and concurrence by the Director of NIOSH and by the Director of CDC, I have designated the
following class for addition to the SEC:

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, cither 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.

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


Page 3 — The Secretary

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 who worked in uranium enrichment operations or other radiological activities
at Y-12 during the period from March 1943 through December 1947.

DECISION

¢
Approved Am" pisapproved Date U6 25 2005

Z Howard, M.D.
Seven Attachments:

Tab A — Designation of a Class of Employees from Y-12

Tab B — Executive Order #13179

Tab C - 42 CFR Pt. 83

Tab D - Y-12 SEC Petitions 00018, 00026, 00028

Tab E — NIOSH SEC Petition Evaluation Report, Petition SEC-00018
Tab F — Board Recommendation Letter to Secretary Leavitt. July 26, 2005
Tab G - Transcript of the July 5. 2005 Board Meeting



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


Page 2 - The Honorable J. Dennis Hastert

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

Sincerely,

ZA”. Kat

Enclosure


a

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

AUG 25 2005

The Honorable J. Dennis Hastert
Speaker of the House of Representatives
Washington. D.C. 20515

Dear Mr. Speaker:

Pursuant to the Energy Employees Occupational Illness Compensation Program Act of 2000
(EFOICPA) and 42 C.F.R. pt. 83, three petitions were filed on behalf of workers employed at the
Y-12 facility in Oak Ridge. Tennessee, who worked in uranium enrichment operations or other
radiological activities from March 1943 through December 1947. The petition requested
inclusion as a Special Exposure Cohort (SEC). Under 42 C.F.R. §§ 83.7 - 83.9, the petitions
qualified for evaluation by the Centers for Disease Contro] and Prevention’s (CDC) National
Institute for Occupational Safety and Health (NIOSH).

NIOSH evaluated the petitions using the procedures set forth in 42 C.F.R. § 83.13. At the
July 5. 2005. meeting of the Advisory Board on Radiation and Worker Health (the Board).
NIOSH presented its finding to the petitioners and the Board. Based on the meeting, in a letter
dated July 26, 2005, the Board recommended granting SEC status to this petition: and in a
subsequent letter dated July 29, 2005, the Director of NIOSH concurred with the
recommendation.

Based upon consideration of the findings. deliberations. and recommendations of the Board
and concurrence by the Director of NIOSH and by the Director of CDC, | have designated the
following class for addition to the SEC:

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.

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


Page 2 — The Honorable Richard Cheney

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

Sincerely.

7) ALO. 7 rane
Michtel O. Leavitt

Enclosure