I. Designation

I, Michael O. Leavitt. Secretary of Health and Human Services (“the 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.
OCT 14 2005 G7} tL EE (
; O SS ie
Date Michael O. Leavitt

Il. | Employee Class Definition

Department of Energy (DOE) employees or DOE contractor or subcontractor
employees who worked in the Uranium Division at the Destrehan Street facility of
Mallinckrodt Chemical Works from 1949 to1957 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.

II. 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
(“the 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, 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 it
is established there is 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 it is
established that there is 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:
Uranium Division of Mallinckrodt Chemical Works, Destrehan Street Facility


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. §
83.16(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:
Uranium Division of Mallinckrodt Chemical Works, Destrehan Street Facility


HHS Designation of Additional Members of the

Special Exposure Cohort
under the

Energy Employees Occupational IlIness Compensation Program Act

Designating a Class of Employees from

Uranium Division of Mallinckrodt Chemical Works
Destrehan Street Facility
St. Louis, Missouri

HHS Special Exposure Cohort Designation:
Uranium Division of Mallinckrodt Chemical Works, Destrehan Street Facility


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 September 15, 2005 and received by
the Secretary on September 16, 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) Between 1949 and 1957. the Mallinckrodt facility processed large quantities of
pitchblende ore, known to contain equilibrium activities of the radionuclides
present in the natural uranium decay series. After uranium was extracted from the
pitchblende ore. more than 100,000 tons of residues. known as raffinate. were
generated. The uranium progeny present in the pitchblende raffinate (e.g..
thorium-230, protactinium-231, and actinium-227) ore were known to be present
in substantial disequilibrium. The collection and storage of the raffinate at the
Destrehan Street facility of Mallinckrodt Chemical Works represented a
significant potential source term for internal exposure.

(2) There is not individual bioassay monitoring or other monitoring information that
can be used to quantify internal exposures to thorium-230, protactinium-231, and
actinium-227 for raffinate workers specifically at the Destrehan Street facility of
Mallinckrodt Chemical Works.

(3) The specific air sample data that exists for the Destrehan Street facility of
Mallinckrodt Chemical Works is insufficient to establish the internal doses from
inhalation of thorium-230, protactinium-231. and actinium-227 at the site with
sufficient accuracy. This is because 1) the air sample data found at Destrehan
Street facility of Mallinckrodt Chemical Works do not provide radionuclide-
specific information for the site; and 2) very little data are available to
characterize the degree of disequilibrium in the raffinate source term at the
Destrehan Street facility of Mallinckrodt Chemical Works.

(4) Records from the Destrehan Strect facility of Mallinckrodt Chemical Works
indicate that during the time frame of 1949 through 1957, employees may have
rotated through a number of different jobs. The changes in work assignments
make it difficult to distinguish the raffinate-exposed workers from the workers
who never worked with raffinate.

(5) Thus, as governed by 42 C.F.R. § 83.13(c)(1), it is determined that there is
insufficient information either 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, or to estimate

HHS Special Exposure Cohort Designation:
Uranium Division of Mallinckrodt Chemical Works, Destrehan Street Facility


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

OCT 1 4 2005

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 (EEOICPA) and 42 C.F.R. Pt. 83. a petition was filed to add a class of certain workers of
Mallinckrodt Chemical Works to the Special Exposure Cohort (SEC).

After the petition qualified for evaluation under 42 C.F.R. § 83.7-83.9, the Centers for
Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health
(NIOSH) evaluated the petition using the procedures in 42 C.F.R. § 83.13. NIOSH presented
findings to the Advisory Board on Radiation and Worker Health ("the Board") at Board meetings
in February, April, July, and August 2005. On September 16, 2005, I received from the Board a
recommendation to designate the class; in a memorandum dated September 22. 2005. the
Director of NIOSH provided me with a proposed decision.

Based upon consideration of the findings, deliberations, and recommendations of the
Board and the concurrences 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 the Uranium Division at the Destrehan Street Facility of Mallinckrodt
Chemical Works from 1949 to 1957 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. Please call me if you have any questions regarding this matter.

Sincerely,

OFA LO, CO o-
Michael O. Leavitt

Enclosure


the radiation doses of members of the class more precisely than a maximum dose
estimate with sufficient accuracy.

(6) It should be noted that the Board believes, and NIOSH concurs, that the available
external dose monitoring information is adequate for the reconstruction of
individual external exposures; where appropriate. individual external doses can be
reconstructed for specific types of cancer (e.g.. skin).

Health Endangerment

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

(1) It was found that members of the class received episodic exposures of a non-
critical nature to radionuclide dusts and radon gas that could have cumulatively
resulted in chronic. potentially substantial exposures to radiation. As governed by
42 C.F.R. § 83.13(c)(3), it has been established that there is a reasonable
likelihood that such radiation doses may have endangered the health of members
of the class.

(2) There was no 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).

(3) The Board found that the health of the class may have been endangered and that
radiation exposures were not associated with a discrete incident. indicated by the
Board's recommendation that the class be defined according to the 250 work day
employment requirement specified under 42 C.F.R. § 83.13(c)(3)(ii).

(4) Thus, pursuant to 42 C.F.R. § 83.13(c)(3)(ii). it is specified that a minimum
duration of employment to satisfy this health endangerment criterion consists of
“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.”

V. — Effect and Effective Date of Designation

The Secretary submits this report on 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

HHS Special Exposure Cohort Designation:
Uranium Division of Mallinckrodt Chemical Works. Destrehan Street Facility


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

OCT 1 4 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
(EEOICPA) and 42 C.F.R. Pt. 83, a petition was filed to add a class of certain workers of
Mallinckrodt Chemical Works to the Special Exposure Cohort (SEC).

After the petition qualified for evaluation under 42 C.F.R. § 83.7-83.9, the Centers for
Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health
(NIOSH) evaluated the petition using the procedures in 42 C.F.R. § 83.13. NIOSH presented
findings to the Advisory Board on Radiation and Worker Health ("the Board") at Board meetings
in February. April. July, and August 2005. On September 16, 2005, | received from the Board a
recommendation to designate the class: in a memorandum dated September 22. 2005. the
Director of NIOSH provided me with a proposed decision.

Based upon consideration of the findings, deliberations, and recommendations of the
Board and the concurrences 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 the Uranium Division at the Destrehan Street Facility of Mallinckrodt
Chemical Works from 1949 to 1957 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. Please call me if you have any questions regarding this matter.

Sincerely,

O74 ALO. oe
Michael O. Leavitt

Enclosure


Tab A

Designation of Additional Members of the Special Exposure Cohort