The Honorable Kathleen Sebelius — Page 4

members of the evaluated class more precisely than a maximum dose estimate. The
memorandum also indicates that the Board concurred with this NIOSH determination,

With respect to the six points above as enumerated by NIOSH and the conclusions which they
supported, we provide the following responses from our administrative review:

1.

With regard to the first point, this panel concurs with the finding that no unsealed
radioactive materials were handled or stored at the Hangar 481 facility. Further, any
materials handled by Hangar 481 workers were in sealed Department of Transportation
(DOT)-compliant containers showing no sign of leakage based on routine radiological
surveys of aircraft and swipe monitoring of package surfaces, which would identify
removable contamination. This panel did not find any evidence indicating violation of
established DOT regulations with respect to handling of radioactive materials. For
example, NIOSH submitted a questionnaire to the DOE Office of Secure Transport
(OST) for evaluation and input, and conducted a site visit at the Hangar 481 building and
adjacent areas at Kirtland AFB, which was attended by NIOSH staff, the petitioner and
the petitioner’s representative. In response to the questionnaire, and in response to
questions raised by NIOSH and the petitioner/petitioner’s representative at a meeting
conducted in conjunction with this site visit, DOE OST confirmed that radioactive
materials were only handled at Hot Pads 2 and 5 (which were at least three kilometers
from Hangar 481) by monitored personnel in a secure area (See SEC Petition Evaluation
Report SEC-00139, Rev #1 - Addendum, August 2, 2011, pages 7-8). In the absence of
any evidence of security or safety violations, there is no basis for an exposure pathway at
Hangar 481.

With regard to the second point, this panel concluded, based on the evidence, that
internal radiological exposures to Ross Aviation employees resulting from services
rendered for the DOE at Hangar 481 were unlikely to have occurred. For example, in
1997, the Transportation Safeguards Division of DOE’s Albuquerque Operations Office
issued a “Technical Basis for Radioactive Material Intake Potential” regarding activities
performed by Ross Aviation at Hangar 481, which states that Ross Employees at Hangar
481 did not have any contact with package contents; examination of the operational
history, including “confirmatory surveys,” showed no evidence of signs of leakage and;
the program used DOT-compliant packages and procedures. The report concluded that
there was not a credible pathway for an intake of radioactive materials (See SEC Petition
Evaluation Report SEC-00139, Rev #0, December 11, 2009, page 17; SRDB Ref. ID
71009).

With respect to the third point above, this panel concurs with the approach by NIOSH to
utilize ambient environmental monitoring data from Sandia National Laboratories (SNL)
to bound an estimate of internal dose for workers at Hangar 481 during the covered
period (See SEC Petition Evaluation Report SEC-00139, Rev #0, December 11, 2009,
page 19; ORAUT-TKBS-0037). We believe this approach is valid. Even though Hangar
481 workers were not directly exposed to radioactive materials from the handling of
containers, it is conceivable that they might have received low-level exposures from
effluent releases at SNL, though it is unlikely. Because of the significant distance from


. : : “RECEIVED "* .
. . Jun 15.2012 11:44:52 WS#20 .
Jennifer M. Cannistra OSNUM: 061520121638.

Executive Secretary to the Department of OP NORRESEONDEMe :
Health and Human Services CONTROL CENTER. .
June 14, 2012

Page 2

Petitioner takes exception to the Determination Findings as to the feasibility ‘of estimating radiation
doses with sufficient accuracy and other findings set forth in the Determination Conceming a

Petition for Employees from Hangar 481, Kirtland Air Force Base, Albuquerque, New Mexico

- dated May 11,2012. The exceptions include the following matters:

1. Petitioner disputes the NIOSH determination that no unsealed radioactive materials were handled
at Hangar 481 and that radioactive materials were, in all casés, in sealed DOT-compliant containers.

2. Petitioner disputes the NIOSH finding that available information on the radiological program and ° ”
potential for internal exposure sources support its conclusion that internal radiological exposures to
Ross Aviation employees resulting from services rendered for the DOE at Hangar 48 are unlikely

to have occurred. : _

3. Petitioner disputes the NIOSH assessment that Sandia National Laboratories may properly be
used to provide-a bounding estimate of the dose from ambient environmental intemal dose during
the-covered SEC period. : : . .

4. Petitioner disputes the assertion that external dose records that may exist for "many" Ross
‘Aviation personnel and the Radiation Exposure Information and Reporting System (REIRS)
reported data or the use of the highest dose received by monitored personnel adequately bounds
external dose for all unmonitored workers. ” :

5. Petition is informed that x-ray testing of equipment was performed at Hangar 481 during certain
time periods but Petitioner does not dispute NIOSH position that annual occupational x-ray
examinations were not performed at Hangar 481. ‘ 7

6. Petitioner disputes the NIOSH contention that the existence of TLD data for the covered years of

employment may be utilized to bound the evaluated worker class external dose with sufficient

accuracy. _ 0 . -
7. Petitioner takes exception to NIOSH position that it has access to sufficient Hangar 481, Kirtland -
Air Force Base information to either (1) estimate the maximum intémal.and external 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 evaluated class; or (2).estimate the internal and
external radiation doses to members of the evaluated class more precisely than a maximum dose

- estimate. . . .

Petitioner offers the following documents as the source of evidence for the statements set forth
above. Petitioner maintains that the information preserited in the attached documents was not
adequately addressed in the evaluation process of SEC00139 and that administrative review is
therefore appropriate. These documents are each believed to be in the Administrative Record
concerning this matter: . .


The Honorable Kathleen Sebelius ~ Page 6

As aresult of our administrative review of this case, we have concluded:

1, HHS complied with the regulatory procedures set out in 42 CFR part 83.

2. Your decision contained no evidence of factual error and was supported by factually
accurate information.

3. There were no errors of fact or in the methods of evaluation, or omission in the principal
findings and recommendations of NIOSH and the Advisory Board.

In summary: Based upon our review of the administrative record in this case, this panel
believes that the regulatory procedures have been complied with in making your decision, that
credible sources of information have been used as allowed for under EEOICPA implementing
regulations, 42 CFR parts 82 and 83, and that you, NIOSH, and the Advisory Board came to
reasonable and appropriate conclusions. In short, we have concluded that petitioner’s
challenge to your decision is without merit, and we see no reason to recommend any change to
your decision to deny adding a class of Hangar 481 employees to the SEC.


The Honorable Kathleen Sebelius — Page 5

SNL to Hangar 481 and the resulting dilution in the atmosphere that would inevitably
occur, ambient measurements at the boundary between SNL and Kirtland Air Force Base
would represent the upper bound of potential exposures to Hangar 481 workers.

4. NIOSH states that external records exist for many Ross Aviation personnel. These
records were verified by individual dose records for the period of 1990-1994, which
NIOSH obtained from Eberline. This panel concurs that these monitoring results,
including the use of the highest doses received by monitored workers, effectively bound
the external dose for unmonitored workers in the proposed class.

5. With respect to the fifth point, this panel notes that there does not appear to be any
dispute that annual occupational X-ray examinations were not conducted for Hangar 481
workers. Hence, there is agreement that medical X-ray dose for Hangar 481 workers is
not an issue for consideration. We acknowledge the petitioner’s statement regarding X-
ray testing of aviation equipment at Hangar 481 (“non-destructive testing” or NDT).
Records indicate that this testing was only performed during the evenings by trained
radiation workers, One incident of an exposed dosimeter appeared to be related to a pilot
leaving his dosimeter in his locker during an evening when NDT was conducted. (See
SEC Petition Evaluation Report SEC-00139 Rev #1 - Addendum, August 2, 2011, page
22.) However, this is not indicative of exposures to other (unmonitored) workers.

6. Regarding the sixth point above, this panel agrees with NIOSH that the existence of
individual TLD data for the covered period makes it feasible to bound the external dose
of covered workers with sufficient accuracy. TLD data from a DOE-accredited
laboratory are among the most reliable sources of exposure information for occupational
workers. Further, the methods described in ORAUT-OTIB-0008 appropriately allow for
the over-estimation of dose (giving claimants the benefit of the doubt) in 1996, the only
year for which dosimetry results were not collected, since radiological operations had
ceased by that time.

In regard to the petitioner’s allegation that the information provided to NIOSH was “to a certain
degree unreliable and unverifiable,” we note that Ross Aviation’s occupational safety program
utilized well-established methods for assessing radiological hazards, including surveys and
personnel monitoring by an accredited dosimetry provider. Further, NIOSH verified dosimetry
records by confirming entries in the REIRS database and obtaining historical dosimetry records

from the provider.

In reference to the petitioner’s allegation that information attached to his appeal letter was not
adequately addressed in the evaluation process of SEC00139, after reviewing the record in this
appeal, we concluded that NIOSH and the Board sufficiently addressed this information during
the evaluation process. We believe that NIOSH and the Board considered all the relevant
information when evaluating SEC00139. In addition, NIOSH has indicated in the record that
“all available documents (including additional documents acquired through recent data capture
efforts) have been evaluated and incorporated into this review” (See SEC Petition Evaluation
Report SEC-00139, Rev #1 - Addendum, August 2, 2011, page 21).


+ RECENED""
__ dun 15.2012 11:44:52 WS# 20
‘OSNUM: 061520121035
OFFICE OF THE SECRETARY
CORRESPONDENCE ..
* CONTROL CENTER

"Phone:
June 14, 2012

* Jennifer M. Cannistra
Executive Secretary to the Department of
Health and Human Services
Room 603-H

* 200 Independence Avenue, S.W.
Washington, DC 20201

Re: _ ADMINISTRATIVE REVIEW REQUEST
Petitioner:
SEC Tracking No: SEC00139
Our File No.: - a

Dear Ms. Cannistra:

This letter is submitted in compliance with the provisions set forth in the letter, dated May 16, 2012,
of Mr. Stuart L, Hinnefeld, Director, Division of Compensation Analysis and 1 Support, National
Institute for Occupational Safety and Health (NIOSH).

On behalf: of Petitioner we hereby réquest an Administrative Review of the _

. Secretary's final determination to deny adding this class of employees(SEC000139) to the Special
Exposure Cohort (SEC) under the Energy Employees Occupational iIness Compensation Program
Act (EEOICPA).

” Under SEC000139 Petitioner sought SEC status for “All employees who worked at Hangar 481,
Kirtland ‘Air Force Base, from March 1, 1989 through February, 29, 1996." .

Petitioner contends and maintains that the Secretary's final determination relies on (1) a record of
substantial factual errors , and/or (2) a record of substantial errors in the implementation of the
procedures enumerated in 42 C.F.R. pt. 83.

By submission this request Petitioner does not wish to cast aspersion on the well intentioned efforts
of personnel of NIOSH who made investigations and recommendations concerning this matter.
Rather Petitioner maintains that the information provided to NIOSH representatives was to a certain -
degree unreliable and unverifiable. Moreover in certain cases documentation to substantiate oral
statements was nonexistent due to the passage of time and other factors.

Petitioner maintains that in | regard to the parameters of this SEC class (1) it is not feasible to
estimate with sufficient accuracy the radiation dose that the class received and (2) there is 4
reasonable-likelihood that such radiation dose may havé endangered the health of members of the

class. °


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

July 22, 2013

Dear

Thank you for your letter on behalf of petitioner requesting an administrative
review of my determination not to add a class of employees from Hangar 481, Kirtland Air Force
Base in Albuquerque, New Mexico, to the Special Exposure Cohort (SEC).

Pursuant to 42 CFR § 83.18(b), and because you filed a challenge to this determination,

I appointed a panel of three Department personnel, independent of the National Institute for
Occupational Safety and Health (N TOSH), to conduct an administrative review. The panel
completed its review of the challenge.

After reviewing the administrative record in this case, the panel concluded that: (1) The
Department complied with the regulatory procedures set out in 42 CFR part 83; (2) my decision
contained no evidence of factual error and was supported by factually accurate information; and
(3) there were no errors of fact or in the methods of evaluation, or omission in the principal
findings and recommendations of NIOSH and the Advisory Board on Radiation and Worker
Health. In summary, the panel concluded that the challenge to my decision is without merit, and
they have not recommended any change to my decision to deny adding a class of Hangar 481
employees to the SEC.

After review of the administrative review panel’s thorough report, I have decided not to revise
my May 11, 2012, final decision. Iam enclosing a copy of the administrative review panel’s
final report to me. I hope you find this information helpful.

Sincerely,

Kathleen Sebelius

Enclosure


“RECEIVED 7"
un 18,2092 11-4452 WS# 20

“Jennifer M. Cannistra . ‘OSNUM: 061520121035,
Executive Secretary to the Department of ; OTS ReSP ON eT ARY
Health and Human Services : ‘ ‘CONTROL CENTER
June 14, 2012 °

Page 8S

L. Affidavit of _ dated Novembers 9, 2010, with attachments.

2. Letter from: Petitioner's counsel to James M,,Melius, M.D., Dr. Ph., dated February 22, 2012,
With attachments.” a . -

To the extent that it may be-determined, on thé basis of the documentation presented in support of
~this request for administrative review, that it is not feasible to estimate with sufficient accuracy the °

"radiation dosés encountered by all employees who worked at Hangar 481,Kirtland Air Force Base,

from March 1, 1989 through February 29, 1996, a determination of health endangerment should be

In accordance with the Provisions of 42 C.F.R. § 83.18, Petitioner respectfully requests that the

Secretary direct that this matter be submitted for an administrative review, that the Determination

made concerning this matter on May 11, 2012 be set aside, and that this SEC Petition be ultimately
recognized and recommended to Congress for approval. . .

Respectfully Submitted,

Enclosures: Affidavit of — dated Novembers 9, 2010, with attachments.
Letter from Petitioner's counsel to James M. Melius, M.D., Dr. Ph., dated February 22,
2012, with attachments. . .

ce: a (w/o enels.)


The Honorable Kathleen Sebelius ~ Page 7

WAL CMe —

Michael A. Noska, M.S.

Senior Advisor for Health Physics

Employee Safety and Environmental
Management Staff

Office of the Commissioner

Food and Drug Administration

She L : ee

Steven L. Simon, Ph.D.

Dosimetry Unit Head

Radiation Epidemiology Branch

Division of Cancer Epidemiology and Genetics
National Cancer Institute

National Institutes of Health

a

Pataje G. Prasanna, Ph.D.

Program Director, Radiation Research Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute

National Institutes of Health

Attachments:

Petitioner’s Appeal Letter, dated June 14, 2012


The Honorable Kathleen Sebelius — Page 3

Reports (including the initial report, dated December 11, 2009, the revised report dated
September 23, 2010, and the addendum to the report, dated August 2, 201 1), which evaluated the
feasibility for completing dose reconstructions for all employees who worked at Hangar 481,
Kirtland Air Force Base (AFB), from March 1, 1989 through February 29, 1996. Specifically,
this April 11, 2012 memorandum states as follows:

NIOSH determined that:

1.

No unsealed radioactive materials were handled nor were radioactive materials stored at
the Hangar 481 facility. Radioactive materials handled by workers at Hangar 481 were in
sealed DOT-compliant containers and monitored in accordance with DOT regulations to
verify radiation and contamination levels on package exteriors.

Based on the available information on the radiological program and potential for internal
exposure sources, NIOSH concluded that internal radiological exposures to Ross
Aviation employees resulting from services rendered for the DOE at Hangar 481 are
unlikely to have occurred.

Sandia National Laboratories, being an adjacent facility, was used to provide a bounding
estimate of the dose from ambient environmental internal dose during the covered period.

External dose records exist for many Ross Aviation personnel and the Radiation
Exposure Information and Reporting System (REIRS) reported data have been verified
using Eberline dosimetry data from 1990-1994, The individual results of these records or
use of the highest dose received by monitored personnel, adequately bounds external
dose for unmonitored workers.

Responses to questions and interviews with former Hangar 481 workers indicate that
annual occupational X-ray examinations were not performed at Hangar 481. Based on
this information, medical X-ray dose for Hangar 481 personnel is not a covered exposure
to be included in the dose reconstruction. Therefore, medical X-ray dose is not a
consideration for workers at Hangar 481.

After reviewing the additional information and data obtained subsequent to the original
evaluation, NIOSH has concluded that the original feasibility determination is confirmed.
Specifically, given the availability of TLD data for the covered years of employment, it is
feasible to bound the evaluated worker class external dose (reconstruct external doses
with sufficient accuracy). The TLD data available from 1989 through 1995 is believed to
adequately assess the radiological exposures at Hangar 481, Kirtland AFB during this
timeframe and is, therefore, adequate for performing dose reconstructions. Using the
methods described in ORAUT-OTIB-0008, dose for 1996 can be overestimated by using
the highest individual dosimetry data for all previous covered years (1989 through 1995).

In sum, in that memorandum, NIOSH determined that it has access to sufficient site-
specific information to either (1) estimate the maximum external and internal radiation dose
for every type of cancer that could have been incurred under plausible circumstances by any
member of the evaluated class; or (2) estimate the external and internal radiation doses to


The Honorable Kathleen Sebelius — Page 2

challenge to your May 11, 2012, determination. A copy of petitioner’s appeal letter is
attached. EEOICPA implementing regulations at 42 CFR § 83.18(a) provide that, in order to
contest a final decision by the Secretary to deny adding a class to the Cohort, a challenge "must
include evidence that the final decision relies on a record of either substantial factual errors or
substantial errors in the implementation of the procedures" set out in 42 CFR part 83.

The petitioner’s appeal letter states: "Petitioner contends and maintains that the Secretary’s final
determination relies on (1) a record of substantial factual errors, and/or (2) a record of substantial
errors in the implementation of the procedures enumerated in 42 C.F.R. pt. 83." Further, the
petitioner’s letter includes several specific allegations, including: (1) that “the information
provided to NIOSH representatives was to a certain degree unreliable and unverifiable;” (2)
petitioner takes exception to the Determination Findings set out in the Secretary’s May 11, 2012,
“Determination Concerning a Petitioner for Employees from Hangar 481, Kirtland Air Force
Base, Albuquerque, New Mexico;” and (3) that the information presented in the attachments to
his appeal letter were “not adequately addressed in the evaluation process of SEC00139,.”

Because of this challenge and pursuant to 42 CFR § 83.18(b), you appointed a panel of three
Department of Health and Human Services (HHS) personnel, independent of the National
Institute for Occupational Safety and Health (NIOSH), to conduct an administrative review and
provide recommendations concerning the merits of the challenge and the resolution of the
issues contested by the challenge. The undersigned, Michael A. Noska, M.S., Steven L. Simon,
Ph.D., and Pataje G. Prasanna, Ph.D., comprise this panel. Our collective expertise includes
radiation biology, health physics, radiation exposure, dose assessment and dose reconstruction,
and radiation risk analysis. We were charged with conducting an administrative review of your
determination not to add a class of Hangar 481 employees to the SEC, which included
reviewing the data and information that formed the basis of your decision, Pursuant to 42 CFR
§ 83.18(b), we considered whether HHS substantially complied with the regulatory procedures
set out in 42 CFR part 83 and whether the Secretary's final decision was supported by accurate
factual information, and we also reviewed the principal findings and recommendations of
NIOSH and the Board. As explained below, we concluded that petitioner’s challenge to your
decision is without merit, and we do not recommend any change to your decision to deny
adding a class of Hangar 481 employees to the SEC.

In conducting our review, pursuant to 42 CFR § 83.18(b), we examined the views and
information submitted by the petitioner in the challenge, the NIOSH evaluation reports, the
report containing the recommendations of the Board, the recommendations of the Director of
NIOSH to the Secretary, information presented or submitted to the Board, and the deliberations
of the Board prior to the issuance of its recommendations. Since 42 CFR § 83.18(a) prohibits
petitioners from introducing any new information or documentation, our review was based
entirely on the administrative record in this case, as described above.

A memorandum to you, dated April 11, 2012, from the Director of NIOSH, which was
initialed by the Director of the CDC and which you approved and signed, states that, based on
its full research of the class under evaluation, NIOSH determined that the available monitoring
records, process descriptions and source term data are sufficient to complete dose reconstructions
for the evaluated class of employees. This conclusion was reflected in the NIOSH Evaluation


5

“"'y, DEPARTMENT OF HEALTH & HUMAN SERVICES

y

June 26, 2013

The Honorable Kathleen Sebelius
Secretary of Health and Human Services
Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, DC 20201

Re: Hangar 481, Kirtland Air Force Base Special Exposure Cohort Administrative Review
Panel

Dear Madam Secretary:

The undersigned Administrative Review Panel unanimously concurs with your decision of May
11, 2012, as authorized under the Energy Employees Occupational Ilness Compensation Act
of 2000 (EEOICPA), 42 U.S.C. § 7384q(b), in which you determined that the following
class of employees does not meet the statutory criteria for addition to the Special Exposure
Cohort (SEC):

All employees who worked at Hangar 481, Kirtland Air Force Base (AFB), from March 1,
1989 through February 29, 1996.

Pursuant to 42 U.S.C. § 7384q, a class may be designated for addition to the SEC if the
Secretary determines, 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 reasonable likelihood that such radiation dose may
have endangered the health of members of the class. The basis for your decision in this case
was the determination that it is feasible to estimate with sufficient accuracy the radiation doses
encountered by employees at Hangar 481, Kirtland Air Force Base (hereinafter “Hangar 481”),
located in Albuquerque, New Mexico; thus, a determination of health endangerment was not
required.

In a letter dated June 14, 2012, attorney on behalf of petitioner
a surviving spouse of a former employee of Ross Aviation, which was a
Department of Energy (DOE) contractor that performed services at Hangar 481, fileda