HHS Designation of Additional Members of the

Special Exposure Cohort
under the

Energy Employees Occupational Illness Compensation Program Act

Designating a Class of Employees from

Iowa Army Ammunition Plant (IAAP)
Burlington, lowa

HHS Special Exposure Cohort Designation:
Towa Army Ammunition Plant


Page 2 — The Secretary

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
SEC petitions representing certain employees at IAAP for the years 1947 through 1974 (Tab
D). The Board and the NIOSH Director: recommended the designation of an SEC class for
the employees who worked at IAAP, Line 1, from March 1949 through 1974 (the class
became effective on June 19, 2005); determined that a class would not be added for the Line 1
employees who worked from June 1947 through May 1948; and deferred decision on the
petition for employees who worked as radiographers from May 1948 to March 1949 in
support of Line | operations until more information was obtained by NIOSH.

On July 5, 2005, NIOSH reported at the Board meeting the completed evaluation findings
regarding radiographers who worked from May 1948 to March 1949 in support of Line 1
operations (Tab E). There is insufficient information to estimate either the maximum
radiation dose incurred or to estimate such radiation doses more precisely than a maximum
dose estimate. There is insufficient information on the radiographic operations during that
time period to allow for monitoring data from a subsequent time to be used as surrogates;
additional information on the radiological sources, shielding, and the radiography process
would be needed. NIOSH concluded that it is not feasible to estimate with sufficient accuracy
the external doses incurred by these radiographers at IAAP from March 1948 to March 1949.

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 at IAAP as radiographers from May 1948 to March
1949 in support of Line 1 operations (Tab F). The July 5, 2005 vote was 10-0 with 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).

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 as radiographers from May 1948 to March 1949 in support of Line 1 operations
at IAAP.

DECISION
O Pedo LO, aan! isapproved Date AUG 25 2005

fohn Howard, M.D.



The Board, pursuant to 42 U.S.C. § 7384q, advised the Secretary to designate the
class as an addition to the SEC ina 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 there is insufficient information to estimate either the
maximum radiation dose incurred by the workers defined in the class or to
estimate such radiation doses more precisely than a maximum dose estimate.
Additional information is needed on the radiological sources, shielding, and the
radiography process of radiographic operations during the period May 1948 -
March 1949 to reconstruct dose using surrogate data from later time periods.
NIOSH concluded that it is not feasible to estimate with sufficient accuracy the
external doses incurred by these radiographers at IAAP during the time period in
question.

Health Endangerment

The Secretary established the health endangerment 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)(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.”

(2) NIOSH finds that it is likely that radiation doses for this group of workers at the
IAAP during this time period could have endangered the health of members of this
class.

HHS Special Exposure Cohort Designation:
Towa Army Ammunition Plant


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.

Date: 5 2005 OP }-4~LO . Loop

Michael O. Leavitt

II. | Employee Class Definitions

Department of Energy (DOE) employees or DOE contractor or subcontractor
employees who worked as radiographers from May 1948 to March 1949 in support of
Linel operations at the lowa Army Ammunition Plant and who were employed for a
number of work days aggregating at least 250 work days, occurring under this
employment in combination with work days of employment occurring within the
parameters (excluding aggregate work day requirements) established for other classes
of employees included in the SEC

Il. 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:
Iowa Army Anununition Plant


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
CD we.

-

FROM: Director
National Institute for Occupational Safety and Health (NIOSH)

SUBJECT: Designating Certain Employces of the lowa Army Ammunition Plant (IAAP)
as Members of the Special Exposure Cohort (SEC) under the Energy

Employees 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 IAAP 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 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

080420050032


REE)

THE SECRETARY OF HEALTH ANDO 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 IlIness Compensation Program Act of
2000 (EEOICPA) and 42 C.F.R. pt. 83, petitions were filed on behalf of certain workers
employed as radiographers in support of Line | operations at the lowa Army Ammunition Plant
(IAAP). from May 1948 to March 1949, requesting inclusion as a Special Exposure Cohort
(SEC). This petition was filed in conjunction with a request for SEC inclusion for Line 1
workers employed at IAAP from March 1949 through 1974.

After the petitions 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 petitions using the procedures in 42 C.F.R. § 83.13. The Advisory Board
on Radiation and Worker Health (the Board) and the Director of NIOSH both recommended the
designation of an SEC class for the employees who worked at IAAP, Line 1, from March 1949
through 1974, which became effective on June 19. 2005. However, they deferred decision on the
petition for radiographers until more information was obtained by NIOSH.

At the July 5, 2005. Board meeting. NIOSH presented the completed evaluation report of the
petition for employees who worker as radiographers from May 1948 to March 1949 in support of
Line | operations. Based on the meeting. in a letter dated July 26, 2005. the Board
recommended granting the SEC status to this petition: and in a subsequent letter dated July 26.
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 as radiographers from May 1948 to March 1949 in
support of Line | operations at the lowa Army Ammunition Plant and who were
employed for a number of work days aggregating at least 250 work days.
occurring under this employment in combination with work days of employment
occurring within the parameters (excluding aggregate work day requirements)
established for other classes of employees included in the SEC.


Page 3 — The Secretary

Seven Attachments:
Tab A — Designation of a Class of Employees from IAAP

Tab B — Executive Order #13179

Tab C—42 CFR Pt. 83
Tab D — IAAP SEC Petition 00006 (combination of 00006, 00007, 00014, 00015)

Tab E— NIOSH SEC Petition Evaluation Report, Petition SEC-00006-2
Tab F — Board Recommendation Letter to Secretary Leavitt, July 26. 2005
Tab G — Transcript of the July 5. 2005 Board Meeting


(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 becn endangered and further concurred with NIOSH in this respect by defining
the class according to the 250 work day employment requirement specified under 42
CER. § 83.13(c)G)(ii).

V. . 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.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:
lowa Army Ammunition Plant


Page 2 - The Honorable J. Dennis Hastert

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

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

Sincerely.

Michael O. Leavitt

Enclosure


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

AUG 25 2005

The Honorable J. Dennis Hastert
Speaker of the louse 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, petitions were filed on behalf of certain workers employed as
radiographers in support of Line | operations at the lowa Army Ammunition Plant (IAAP). from
May 1948 to March 1949. requesting inclusion as a Special Exposure Cohort (SEC). This
petition was filed in conjunction with a request for SEC inclusion for Line | workers employed
at [AAP from March 1949 through 1974.

After the petitions 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 petitions using the procedures in 42 C.F.R. § 83.13. The Advisory Board
on Radiation and Worker Health (the Board) and the Director of NIOSH both recommended the
designation of an SEC class for the employees who worked at IAAP, Line 1, from March 1949
through 1974, which became effective on June 19, 2005. However. they deferred decision on the
petition for radiographers until more information was obtained by NIOSH.

At the July 5, 2005, Board meeting. NIOSH presented the completed evaluation report of the
petition for employees who worker as radiographers from May 1948 to March 1949 in support of
Line | operations. Based on the meeting, in a letter dated July 26, 2005, the Board
recommended granting the SEC status to this petition; and in a subsequent letter dated July 26,
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 as radiographers from May 1948 to March 1949 in
support of Line | operations at the lowa Army Ammunition Plant and who were
employed for a number of work days aggregating at least 250 work days.
occurring under this employment in combination with work days of employment
occurring within the parameters (excluding aggregate work day requirements)
established for other classes of employees included in the SEC.


Page 2 - The Honorable Richard Cheney

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

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

Sincerely.

Michael O. Leavitt

Enclosure