The Honorable Michael O. Leavitt - Page 4

Sincerely,

WW: Lhward ly —

W. Howard Cyr, Ph.D. 7

Leader, Radiation Biology Laboratory

Office of Science and Engineering Laboratories
Center for Devices and Radiological Health
Food and Drug Administration

Oren Lyi

C. Norman Coleman, M.D.

Head, Experimental Therapeutics Section
Senior Principal Investigator

Radiation Oncology Branch

Clinical Center

National Institutes of Health

‘
Kh M ola

Kiyolfiko Mabuchi, M.D., Dr.P.H.

Division of Cancer Epidemiology and Genetics
National Cancer Institute

National Institutes of Health

ec. John O. Agwunobi, M.D., M.P.H., M.B.A.
Assistant Secretary for Health
Department of Health and Human Services



May.17. 2008 2:02PM “ No.6188  P. 2

4

May 17, 2005

U.S. Department of Health and Human Services
200 Independence Ave., SW.

Washington, DC

20201

95-17-05P04:53 Revo
Att : Honorable Secretary Michael Levitt
Secretary of Heaith and Human Services

Re: Mallinckrodt SEC

Dear Sir:

| would like to respectfully contest and appeal the decision regarding the 250 day
requirement under section 83.16 B of the EEOICPA, health endangermant issue.
The proposed decision of the 250 day requirement for this group of workers
relies upon or is based upon a record of factual error

The episodic releases or short discrete incidences were not taken into account
and therefore discriminates against certain employees or classes of employees
who may have been exposed fo radiation during discrete incidents likely to have

involved exceptionally high level exposures,

This section states that presence with potential exposure during the discrete
incident, rather than a quantified duration of potential exposure, will satisfy the
health endangerment criterion.

| hope that you will be able to advise me in this matter.

Sincerely,

cc: Mr. John Howard NIOSH
Mr. Larry Elliot NIOSH


The Honorable Michael O. Leavitt - Page 3

With respect to your April 11, 2005, proposed decision, your findings regarding health
endangerment are set out in section IV., “Health Endangerment,” paragraphs (2) and (3). Having
determined that it is not feasible to estimate with sufficient accuracy the radiation dose that the
class received because of lack of sufficient information, you conclude that there is sufficient
evidence to determine that there is a reasonable likelihood that such radiation dose may have
endangered the health of the members of the class. In particular, in paragraph (2), you state that
“NIOSH found members of the class received episodic exposures to radionuclide dusts and
radon gas that could have cumulatively resulted in chronic, potentially substantial exposures to
radiation.” Therefore, you propose that a class of Mallinckrodt employees who meet the 250
work day criterion set out in 42 CFR § 83.13(c)(3)(ii) be added to the Special Exposure Cohort.
Although not stated directly in your proposed decision, we believe this conclusion is consistent
with the November 20, 1950, Blatz and Eisenbud report regarding employees with high
inhalation doses, as well as with the statement in the January 31, 1951, memorandum that was
the cover letter to that report, which says “The report shows that there are 17 employees whose
lungs have had more than 1000 rem of exposure.” In addition, the Mallinckrodt Site Profile
(ORAUT-TKBS-0005) indicates that there were especially high inhalation doses with exposures
that were as much as 100 — 200 times the maximum allowable concentration of 50 micrograms
per cubic meter (see section 5.3.2). Section 7.3.3 of the Site Profile assumes that workers
exposed in the time period of 1942 to 1945 received doses that were comparable to those of later
workers with the same jobs.

We think it is particularly important that, while you note that members of the class received
episodic, chronic, and potentially substantial exposures to radiation, as described in the
paragraph above, you then conclude that there is no evidence to indicate that any of these
episodic events was significant enough to be similar to a criticality incident. In paragraph (3),
you state that “NIOSH did not identify any evidence from the petitioners or 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 CFR § 83.13(c)(3)(i).” Both the NIOSH SEC
Petition Evaluation Report (SEC 0012-2) and the November 20, 1950, Blatz and Eisenbud
report. contain descriptions of possible exposures to and internal doses from several different
types of isotopes, but contain no data on any discrete incidents in which employees were exposed
to very high doses of radiation, similar to that of a criticality event. In addition, as stated in the
previous paragraph, the Mallinckrodt Site Profile (ORAUT-TKBS-0005) referred to possible
elevated doses in the class members, but did not describe any events that could be considered to
be equivalent to a criticality event. Finally, the petitioners did not present any evidence of any
such discrete criticality-type events either in the petition and accompanying materials, in the
letter challenging your proposed decision, or in the open meeting of the Advisory Board, held on
February 8 and 9, 2005.

Based on our analysis of the record, we conclude that an extensive investigation was conducted
pursuant to the EEOICPA statute and implementing regulations, and that your decision contained
no evidence of factual error, was supported by accurate information from both written and verbal
testimony, and was factually correct. Accordingly, we believe that the challenge to your
proposed decision is without merit.



The Honorable Michael O. Leavitt - Page 1

Documents Reviewed by the ial Exposure Cohort Administrative Review Panel:

1,

Special Exposure Cohort Petition Submitted on behalf of the Mallinckrodt Employees,
dated 7/17/04, and supporting attached documents A1-A18 (with fax cover sheet from

to Larry Elliot, transmitting Special Exposure Cohort Petition under the
Energy Employees Occupational Illness Compensation Act, dated 7/15/04)

Supplements to Mallinckrodt Petition, dated 7/21/04, 9/30/04 (with fax cover sheet from
to Dave Sunin, dated 9/30/04), 10/13/04, and 10/22/04

Identical letters, dated December 8, 2004, to Robert W. Presley, Wanda I. Munn, Richard
L. Espinosa, James M. Melius, Antonio Andrade, Charles Leon Owens, Genevieve S.
Roessler, Henry A. Anderson, Mark A. Griffon, Michael H. Gibson, and Roy DeHart,
from Larry J. Elliott, Director, Office of Compensation Analysis and Support, NIOSH,
with the following three enclosures: (1) Petition Evaluation Plan SECO0012, dated
12/8/04; (2) Summary of SEC Petition 00012, dated 12/8/04; and (3) Mallinckrodt
Special Exposure Cohort Petition, dated 7/17/04

NIOSH SEC Evaluation Reports for Mallinckrodt Petition SEC-00012-1 (dated 2-1-05)
and SEC-00012-2 (dated 2-2-05)

Supplement to NIOSH SEC Evaluation Reports for Mallinckrodt Petition (SEC-00012-1
and 2): Discussion of Issues Identified During the Advisory Board Deliberation of thé
Mallinckrodt Evaluation Reports on 2/08-2/09/05 in St. Louis, dated 3/30/05

Letter, dated March 11, 2005, from Larry J. Elliott, Director, Office of Compensation
Analysis and Support, NIOSH, to Paul L. Ziemer, with enclosed Mallinckrodt Site Profile
—“ORAU Team, Dose Reconstruction Project for NIOSH - Basis for Development of an
Exposure Matrix for the Mallinckrodt Chemical Company St. Louis Downtown Site and
the St. Louis Airport Site, St. Louis, Missouri, Period of Operation: 1942-1958,”
Document Number: ORAUT-TKBS-0005, dated 3/10/05

Letter, dated March 11, 2005, from Dr. Paul L. Ziemer, Chairman, Advisory Board on
Radiation and Worker Health (ABRWH), to Michael O. Leavitt, Secretary of HHS

Letter, undated. from John Howard, Director, NIOSH, to the Secretary, HHS, Re:
Designating Employees of Mallinckrodt Chemical Company as Members of the Special
Exposure Cohort (“the SEC”) under the Energy Employees Occupational LiIness
Compensation Program Act of 2000 (*EEOICPA”): Action Required by April !t, 2005

Letter, dated April 11, 2005, from Michael 0. Leavitt, Secretary of HHS, to the
Honorable J. Dennis Hastert, Speaker of the House of Representatives, with enclosed
“HHS Designation of Additional Members of the Special Exposure Cohort under the
Energy Employees Occupational Ilness Compensation Program Act: Designating a Class



THE SECRETARY OF HEALTH AND HUMAN SERVICES
WASHINGTON, 0.c. 20202

MAR 29 2006

Dear Ms.

This is in response to your letter contesting part of the designation of a certain class of employees
from the Mallinckrodt Chemical Works facility in $t. Louis, Missouri, to be added to the Special
Exposure Cohort established under provisions of the Energy Employees Occupational Iliness
Compensation Program Act (EEOICPA).

Specifically, this designation was as follows:

Employees of the Department of Energy (DOE) or DOE contractors or subcontractors employed
by Uranium Division of Mallinckrodt Chemical Works, Destrehan Street Facility, during the
period from 1942 through 1948, 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.

As you know, the regulations implementing EEOICPA provide that a panel of three employees of
this Department, independent of the National Institute for Occupational Safety and Health (NIOSH),
will conduct an administrative review when such a désignation is contested. Such a panel was
established, and a copy of its report to me is enclosed. In deciding whether to revise my decision,

I considered this report, as well as the information and recommendations provided to me by the
NIOSH Director and by the Advisory Board on Radiation and Worker Health, prior to the
administrative review. After careful consideration of these documents, I have decided not to revise
my April 11, 2005, designation.

Thank you for your efforts in this important area.

Sincerely,

°

Michael O. Leavitt
Enclosure



The Honorable Michael O. Leavitt - Page 2

12,

13.

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

Identical letters, dated Febraury 2, 2005, to Paul Ziemer, Robert W. Presley, Wanda
Munn, Richard Espinosa, James Melius, Antonio Andrade, Charles Leon Owens,
Genevieve S. Roessler, Henry Anderson, Mark A. Griffon, Michael Gibson, and Roy
DeHart, from Larry J. Elliott, Director, Office of Compensation Analysis and Support,
NIOSH

Transcript of the Meeting of the Advisory Board on Radiation and Worker Health, held at
the Adam’s Mark, St. Louis, Missouri, on February 8 and 9, 2005 (excerpt conceming the
Mallinckrodt SEC Petition)

Powerpoint Presentation, dated February 8, 2005, by Larry Elliot, re: Mallinckrodt SEC
Petition Evaluation Report

Identical letters dated Febraury 17, 2005, from Larry J. Elliott, Director, Office of
Compensation Analysis and Support, NIOSH, to and

with enclosed “Notes and Summary of Visit by M.E. Mason - t~ August 1975,”
dated 9/2/1975

Letter dated May 17, 2005, from to Michael Leavitt, Secretary of HHS
(with fax cover sheet transmitting letter, dated 5/17/05)

Executive Order 13179, “Providing Compensation to America’s Nuclear Weapons
Workers,” dated December 7, 2000

Federal Register Final Rule, dated May 28, 2004, “Procedures for Designating Classes of
Employees as Members of the Special Exposure Cohort Under the Energy Employees
Occupational IIness Compensation Program Act of 2000,” 42 C.F.R. Part 83



Soom

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@ DEPARTMENT OF HEALTH & HUMAN SERVICES

: LS

JAN 20 2006

The Honorable Michael O. Leavitt
Secretary of Health and Human Services
Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, DC 20201

Re: Special Exposure Cohort Administrative Review Panel
Dear Mr. Secretary:

On April 11, 2005, as authorized under the Energy Employees Occupational Illness
Compensation Act of 2000 (EEOICPA), 42 U.S.C. § 7384q(b), you designated the following
class of employees as an addition to the Special Exposure Cohort (SEC):

Employees of the Department of Energy (DOE) or DOE contractors or subcontractors
employed by Uranium Division of Mallinckrodt Chemical Works, Destrehan Street
Facility during the period from 1942 through 1948 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.

On May17, 2005, a Mallinckrodt SEC petitioner, (“the petitioner”), filed a
challenge to that decision, contesting the health endangerment determination under EEOICPA.
implementing regulations at 42 CFR § 83.13(c)(3)(ii) — this section sets out a 250 work day
minimum duration of employment to satisfy the health endangerment criterion. The petitioner
argued that instead 42-CFR § 83.13(c)(3}{i) should apply — this section states as follows:

For classes of employees that may have been exposed to radiation during discrete
incidents likely to have involved exceptionally high level exposures, such as nuclear
criticality incidents or other events involving similarly high levels of exposures resulting
from the failure of radiation protection controls, NIOSH will assume for the purposes of
this section that any duration of unprotected exposure could cause a specified cancer, and
hence may have endangered the health of members of the class. Presence with potential
exposure during the discrete incident, rather than a quantified duration of potential
exposure, will satisfy the health endangerment criterion.

The petitioner's May 17, 2005, letter states that:

The proposed decision of the 250 day requirement for this group of workers relies upon
or is based upon a record of factual error. The episodic releases or short discrete
incidences were nat taken into account and therefore discriminates against certain
employees or classes of employees who may have been exposed to radiation during
discrete incidents likely to have involved exceptionally high level exposures.



The Honorable Michael O. Leavitt - Page 2

EEOICPA implementing regulations at 42 CFR § 83.16(b) provide that a petitioner may contest
a health endangerment determination by including evidence that the proposed decision relies on
arecord of either substantial factual errors or substantial errors in the implementation of the
regulatory procedures set out in 42 CFR Part 83. We note that the petitioner's challenge is to the
factual basis of the proposed decision; the challenge does not allege any error in HHS’
implementation of regulatory procedures.

Because of that challenge and pursuant to 42 CFR § 83.16(c), you appointed a panel of three
HHS personnel, independent of NIOSH, to conduct an administrative review and provide
recommendations conceming the merits of the challenge and the resolution of the issues
contested by the challenge. The undersigned, W. Howard Cyr, Ph.D., C. Norman Coleman.
M.D., and Kiyohiko Mabuchi, M.D., Dr.P.H., comprise that panel. Pursuant to 42 CFR §
83.16(c), we examined the views and information submitted by the petitioner in the challenge,
the proposed decision, the NIOSH evaluation reports, the report containing the recommendations
of the Advisory Board on Radiation and Worker Health issued prior to the proposed decision, the
information presented to the Advisory Board, and the deliberations of the Board prior to the
issuance of its recommendation. We were charged with considering whether or not the proposed
decision was supported by accurate factual information, and the principal findings and
recommendations of NIOSH and the Advisory Board. Since the petitioner did not raise any
errors in regulatory procedures in the challenge, we conclude that we are only addressing the
merits of the factual basis of the decision, i.¢., whether the Mallinckrodt employees were
exposed to exceptionally high levels of radiation during a discrete incident, such as a nuclear
criticality event.

Since 42 CFR § 83.16(b) prohibits petitioners from introducing any new information or
documentation, our review was based entirely on the administrative record in this case, as
destiibed above. A list of the specific documents we reviewed is included at the end of this
letter. In particular, we paid special attention to the following documents: (1) the April { 1, 2005,
teport in which you set our your proposed decision (“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 Uranium Division of Mallinckrodt
Chemical Works, Destrehan Street Facility, St Louis, Missouri”); (2) a memorandum that was a
cover letter from Merril Eisenbud to W.E. Kelley, dated January 31, 1951, re: Report on
Mallinckrodt Employees (Attachment A1!4 of the Mallinckrodt petition), with the attached
report, dated November 20. 1950, entitled “An Estimate of Cumulative Multiple Exposures to
Radioactive Materials: Mallinckrodt Chemical Works - Plants 4 and 6 - July 1942 to October
1949,” written by Hanson Blatz and Merril Eisenbud (Attachment A15 of the Mallinckrodt
petition - we note that the attachment included only pages 1-11 of the report, which do not
contain the report’s Conclusions); (3) the Mallinckrodt Site Profile (QRAU Team Dose
Reconstruction Project for NIOSH, Document Number ORAUT-TKBS-0005, dated March 10,
2005); and (4) the transcript of the open meeting of the Advisory Board, held on February 8 and
9, 2005, at which both NIOSH and the petitioners made presentations.