Signature on File
February 19, 2016 

The Honorable Sylvia M. Burwell. 

Secretary of Health and Human Services 

Department of Health and Human Services 

200 Independence Avenue, S.W. 

Washington, DC 20201 

RE: Pantex Plant Special Exposure Cohort Administrative Review Panel 

Dear Madam Secretary: 

BACKGROUND 

On September 30, 2013, as authorized under the Energy Employees Occupational 

Illness Compensation Act of 2000 (EEOICPA), 42 U.S.C. § 7384q(b), the Secretary of 

the Department of Health and Human Services (HHS) at that time, Kathleen Sebelius 

(hereafter ~the Secretary") determined that the following class of employees does not 

meet the statutory criteria for addition to the Special Exposure Cohort (SE;C): 

All employees ofthe Department ofEnergy (DOE), its predecessor agencies, 

and their contractors and subcontractors who worked at the Pantex Plant in 

Amarillo, Texas, from January 1, 1951, through December 31, 1957. 

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 the Secretary's decision In this case was the determination that it is feasible to 

estimate with sufficient accuracy the radiation doses encountered by employees at the 

Pantex Plant In Amarillo Texas (hereinafter "Pantex"); accordingly, a determination of 

health endangerment was not required. 

, filed a challenge to the September 30, 2013, determma 10n. 

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 SEC, 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 Panel wishes to provide a full and satisfactory response to the petitioner. Although 

we cannot answer the questions raised In the petitioner's appeal letter that are outside 

the scope of our review, we have responded to those questions that are within our 

purview. We interpret the letter as raising two relevant points: 
The Honorable Sylvia M. Burwell-Page 2 

1. An allegation that there is • ... no evidence that records adequate for dose 

reconstruction were found or considered for all those employees at risk following 

documented exposure to radiationu; 

2. 	 An allegation that "For production, maintenance and waste remediation workers, 


the exposures appear to have been direct and indirect, routinely unguarded, 


uncommonly monitored, [and] mostly unrecorded ... • 


The Panel addresses these allegations through its review of the National Institute for 

Occupational Safety and Health (NIOSH) findings, which were incorporated into the 

Secretary's September 30, 2013, determination. 

ADMINISTRATIVE REVIEW PANEL 

Pursuant to 42 CFR § 83.1 B(b), the Secretary appointed a panel of three Department 

of Health and Human Services (HHS) personnel, independent of the 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, 

John Koerner, MPH, CIH, Francesca Macchiarini, MS, PhD, and Donald Miller, MD, 

comprise that panel. Our collective expertise includes radiation medicine, occupational 

radiation protection, industrial hygiene, health physics, radiation exposure, dose 

assessment and dose reconstruction, and radiation risk analysis. The panel was charged 

with conducting an administrative review of the determination not to add a class of 

Pantex employees to the SEC, which included reviewing the data and information that 

formed the basis of the prior decision. 

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 Report, 

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 petitioner from introducing any new information or 

documentation, our review was based entirely on the administrative record in this case, 

as described above. The Panel did not have access to any classified material: the 

review was conducted based solely on the unclassified material. 

STANDARD OF REVIEW AND MAIN CONCLUSION 

Pursuant to 42 CFR § 83.1 B(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. We also reviewed the principal 

findings and recommendations of NIOSH and the Board. As explained below, we 

concluded that petitioner's challenge does have merit and, thus, we recommend a 

revision to the Secretary's September 30, 2013, determination that denied adding a class 

of Pantex employees to the SEC. 

SUMMARY OF THE PRIOR DETERMINATION 

A memorandum to the Secretary, dated September 13, 2013, from the Director of 

NIOSH states that NIOSH concluded that dose reconstruction is feasible for all Pantex 

employees who worked from January 1, 1951, through December 31, 1957. This finding 

was based on the full administrative record, including the NIOSH Evaluation 

Report for the Pantex Plant, SEC Petition Evaluation Report: Petition SEC-00068, Report 
The Honorable Sylvia M. Burwell-Page 3 

Rev. #0, (August 8, 2008), (hereafter •pantex Evaluation Report"), which evaluated the 

feasibility of reconstructing doses for all employees of the Department of Energy, its 

predecessor agencies, and their contractors and subcontractors who worked at the 

Pantex Plant in Amarillo, Texas, from January 1, 1951, through December 31, 1957. 

Specifically, this memorandum states as follows: 

Based on its full review of the SEC petition 00068, N!OSH determined: 

1. 	 The principal source ofinternal radiation dose for workers at Pantex 

during the years from 1951-1957, was depleted uranium. 

2. 	 It was confirmed that there were no weapons system dismantlements 

before 1958. Fresh depleted uranium (DU) forms were handled, but 

there is no evidence of exposure potential because ofthe negligible 

amount ofoxidation present. The bum pits and hydroshot testing 

involved DU, but there are sufficient air sampling data available to 

NIOSH to support dose reconstruction. The Board concurred with 

NIOSH's finding that dose reconstruction for internal uranium exposures 

during the period from 1951 through 1957 is feasible. 

3. 	 Consequently, NIOSH finds it is feasible to estimate, with sufficient 

accuracy, the internal dose for workers at the Pantex Plant from January 

1, 1951, through December 31, 1957. 

4. 	 NIOSH has access to sufficient personnel monitoring and workplace 

monitoring data to bound potential external exposures for workers at the 

Pantex Plant during the period from January 1, 1951, through December 

31, 1957. NIOSH a/so finds it is feasible to reconstruct occupational 

medical dose, when appropriate, for this period. Consequently, NIOSH 

finds that it is feasible to estimate, with sufficient accuracy, the total 

external dose and occupational medical dose for the class of employees 

covered by this evaluation. 

5. 	 In sum, NIOSH determined that it has access to sufficient site-specific 

information to either ( 1) estimate the maximum internal and external 

radiation dose for every type ofcancer for which radiation doses are 

reconstructed that could have been incurred under plausible 

circumstances by workers at the Pantex Piant for the time period from 

January 1, 1951, through December 31, 1957; or (2) estimate the internal 

and external radiation doses to workers at the Pantex Plant for the time 

period from January 1, 1951, through December 31, 1957, more precisely 

than a maximum dose estimate. The Board also concurred with this 

determination. 

FINDINGS OF THE ADMINISTRATIVE REVIEW PANEL 

The Panel recognizes that the radiation protection practices used at Pantex from 1951 
The Honorable Sylvia M. Burwell-Page 4 

to 1957, while inferior to today's best practices, were consistent with the practices in 

widespread use at the time. With respect to the five points above, we have separated 

out each of NIOSH's findings and conclusions into individual bullet points, and 

provide the following comments for each bullet point as part of our review and 

analysis: 

A. 	 The principal source of internal radiation dose for workers at Pantex during the 


years from 1951-1957, was depleted uranium. 


The Panel agrees that the principal source of Internal radiation dose for workers at 

Pantex during the years from 1951-1957 was depleted uranium. However, it was not 

the only source; tritium was also a source and first arrived at Pantex in late 1956 or 

early 1957. See Technical Basis Document ORAUT-TKBS-0013-1, "Pantex Plant ­

Introduction", Rev. 02, (May 11, 2007), at 8. Further, the Technical Basis Document 

ORAUT-TKBS-0013-5, "Pantex Plant- Occupational Internal Dose~, Rev. 01, (June 

22, 2007), § 5.2.2.1 at 20 {hereafter "ORAUT-TKBS-0013-5"), notes that ·Du 

manufactured after 1952 could have contained contaminants from movement of 

recycled U and DU throughout the Portsmouth, Paducah, K-25, Y-12 complex. 

Exact levels of contaminants in Pantex DU have not been discovered and probably 

varied from batch to batch: This section of ORAUT-TKBS-0013-5 also notes 

plutonium (

239Pu), neptunium (237Np) and technetium (~c) as contaminants. 

B. 	 There were no weapons system dismantlements before 1958. 

· The Panel agrees that there were no weapon dismantlements prior to 1958. 

C. 	 Fresh depleted uranium (DU) forms were handled. 

The Panel agrees that fresh depleted uranium (DU} forms were handled. 

D. 	 There is no evidence ofexposure potential because of the negligible amount of 


oxidation present [on the DU forms]. 


The Panel disagrees that there is no evidence of exposure potential because of the 

negligible amount of oxidation present on the DU forms. The Technical Basis 

Document ORAUT-TKBS-0013-2, "Pantex Plant - Site Description", Rev. 02, (May 8, 

2007) § 2.6 at 16, states that, "During assembly, the DU was relatively clean and 

there was minimal removable contamination." (Emphasis added). This statement is 

annotated (annotation [91). Annotation [9] states, "Assemblies involved new, clean 

components that were generally free of radioactive contamination. Contamination 

tests were routinely done on new components and results were usually negative: Id. 

at 18) (emphasis added). In§ 2.3.1, fn the discussion of early Pantex operations, this 

report states, "Because these DU components were new at the time of assembly, 

this analysis assumed that removable DU oxide contamination on the components 

was minimal." Id. at 8 (emphasis added). The evidence demonstrates that there was 

some degree of contamination. Therefore, the explicit assumption in the analysis that 

DU contamination was minimal is not justified. This assumption is further weakened 

by the lack of worker monitoring or exposure records to support it. 
The Honorable Sylvia M. Burwell-Page 5 

E. 	 The burn pits and hydroshot testing involved DU, but there are sufficient air 


sampling data available to NIOSH to support dose reconstruction. 


The Panel disagrees that there are sufficient air sampling data to support dose 

reconstruction for employees involved with various bum pit and hydroshot testing 

operations. In the Data Capture Document: Discovery and Review, ~Documented 

Communication ... on Weapons Disassembly Operations at Pantex," Project 

Document Number 030086460 (May, 26, 2011) at 4, the inteiviewee specifically 

stated that, •... Mark 6 units tended to have considerable DU oxidation.~ No air 

samples appear to have been collected .to assess this potential exposure route. 

Additionally, for burning pad and firing site operations, air samples were collected, 

but only in the operations bunker area. ·rhe burning pad operators were part of the 

transportation group and operating the burning pad was just a part-time task - a few 

hours approximately once a week. The ash was scooped up and put into 1 Oto 20 

gallon cans for burial. The workers wore half-face, HEPA filtered masks during the 

collection of the ash." Data Capture Document: Discovery and Review, Project 

Document Number 030001035, (August 24, 2004) at 3 (hereafter "Telephone 

lnteiview of June 16, 2004•). Although the interviewee believed that these workers 

were subject to bloassay, there is no evidence in the record of such and no personal 

air samples or dosimetry were collected on anyone performing burning pad and firing 

site operations. 

Further, with respect to the hydroshot firing sites, Telephone lnteiview of June 16, 

2004 states, "After a denotation [sic], the operators would retrieve instruments from 

the firing site while the driver was returning to the area, then they all would leave. 

The total exposure time was less than a half ~hour. The cloud from the detonations 

was quite visible.· Id. Since air samples collected at the time were within the 

operations bunker and later air samples were collected by drones at altitude, these 

samples should not be used as objective data to accurately estimate or support the 

exposure of operators, firemen, truck drivers, firing site technicians, and others as 

they conducted ash removal and Instrumentation retrieval following a bum or 

detonation as these samples do not represent actual exposure. Furthermore, the 

only air samples collected were area samples that would not accurately reflect 

breathing zone concentrations of those In the operations bunker or others as 

described above. 

Finally, given the limited radiation controls applied during that period, the very 

different operations and devices handled, the near total absence of bloassay or other 

exposure assessment data from the period, the Panel concludes that there are 

significant limitations in applying data from later operations in the assessment of the 

exposures for operations in earlier time periods. 

F. 	 The Board concurred with NIOSH's finding that dose reconstruction for internal 

uranium exposures during the period from 1951 through 1957 is feasible. 
The Honorable Sylvia M. Burwell-Page 6 

The Panel agrees that the Board concurred with NIOSH's finding that dose 

reconstruction for internal uranium exposures during the period from 1951 through 

1957 is feasible. 

G. NIOSH finds it is feasible to estimate, with sufficient accuracy, the internal dose for 

workers at the Pantex Plant from January 1, 1951, through December 31, 1957. 

There were no contamination areas established in the early years, and individuals 

were allowed to eat, drink, or smoke in the work areas. S. Cohen & Associates: 

Technical Support for the Advisory Board on Radiation & Worker Health Review of 

NIOSH Dose Reconstruction Program - Draft Pantex Plan Site Expert Interview 

Summary, Rev. 0, (July 25, 2011} at 23 (hereafter "Pantex Plant Site Expert 

Interview Sumrnaryn). Nin the early days, workers could have water or coffee on the 

bench at their work location during assembly. Workers would take their lunches into 

the work area and drink coffee while they were working on weapons up to the mid1980s. The plant also allowed smoking on parts of the llne and in break areas. These 

were common practices. Everyone knew about it and no one ever questioned it." Id. 

at 23-24. Therefore, the Panel believes that there was substantial opportunity for oral 

and respiratory ingestion of uranium as a result of common work practices. ORAUTTKBS-0013-5, § 5.2.2.1 at 21 notes that "there is no evidence that workers were 

routinely monitored for uranium before 1991.n 

There are no personnel monitoring data upon whic:h to base a dose reconstruction 

for internal uranium exposure. There is evidence of potential routes for oral and 

respiratory ingestion of uranium as a result of common work practices. NIOSH's 

assumption that removable DU oxide contamination on the components was 

minimal is therefore only an assumption. As noted above in response to (A), there 

was also potential for internal exposure to unknown amounts of 239Pu, 237Np and 

99Tc contaminants. 

Minimal air sampling data are available for the operations bunker area for the 

burning pad and firing site operations. See bullet (E), above for further discussion. 

Because (a) there was a substantial opportunity for oral and respiratory ingestion of 

uranium as a result of common work practices, {b) there are no personnel dosimetry 

data for exposure during routine work practices (workers were not routinely 

monitored for uranium) and (c) the air sampling data used as surrogate data are not 

ad.equate to bound exposure, the panel concludes that it is not feasible to estimate, 

with sufficient accuracy, the internal dose for workers at Pantex from January 1, 

1951, through December31, 1957. 

H. NIOSH has access to sufficient personnel monitoring and workplace monitoring data 

ta bound potential external exposures for workers at the Pantex Plant during the 

period from January 1, 1951, through December 31, 1957. 

The Technical Basis Document ORAUT-TKBS-0013-6, "Pantex PlantOccupational External Dose''. Rev. 01, (June 22, 2007), § 6.4 and Table 6-1, at 
The Honorable Sylvia M. Burwell-Page 7 

11-12 (hereafter "ORAUT-TKBS-0013-6"), shows that external dose data 

(dosimeter doses) during the period 1951-1957 are available only for 

radiographers. Between 1951 and 1957, only radiographers were monitored 

routinely, and no more than three individuals per year were monitored. At this 

time, there were wa few hundred personnel at the plant." Pantex Plant Site 

Expert Interview Summary at 17. 

The job of radiographers was different from all other Pantex workers. 

Radiographers were not exposed to radiation because the x-ray machines were 

enclosed in shielded cabinets. In an Interview with a former Pantex employee, a 

worker's response to a question about the use of lead aprons is summarized as, 

·x ray machines were enclosed in cabinets and were surveyed routinely" ( See 

Data Capture Document: Discovery and Review, "Documented Communication 

on Dosimetry and Radiological Controls at the Pantex site," Project Document 

Number 030032527, (April 7. 2008) at 4, (hereafter uoocumented 

Communication·). The same individual also noted that, "all of the X-ray 

machines were placed in enclosed cabinets,• implying that there was no 

potential for exposure to radioactivity. Id. at 4. Similarly, ORAUT-TKBS-0013-6, 

§ 6.5.5.6, at 37, states that "radiography machines were inside shielded 

f acllitles." 

ORAUT-TKBS-0013-6, § 6.5.4.1, at 25-26, states usignificant beta exposures to 

Pantex workers were rarely detected by film badges or thermoluminescent 

dosimeters, based on a review of shallow and deep dosimetry data.• This 

statement regarding beta exposures cannot refer to workers other than 

radiographers in the period 1951-1957, as only radiographers were issued 

dosimeters during this time period. 

ORAUT-TKBS-0013-6, § 6.7.1, at 43, advises, "For years before 1959, when no 

measured gamma dose equal to or greater than 40 mrem was measured, use 

the median dose for 1960 for each year of employment,· However, for the period 

1951-1957, the only monitored workers who could have had measured gamma 

doses were radiographers, whose job was different from all other Pantex 

workers. There are no dosimetry data for the hundreds of other workers at the 

site. 

Other Pantex workers were exposed to radiation. ORAUT-TKBS-0013-6, § 

6.6.2, at 40, notes that, for the sample of 316 claims by Pantex workers 

evaluated, "most of the collective dose was received by assembly, inspection, 

and warehOl!Se operators: (See a/so Id. at 41, Table 6-16.) None of these 

workers were issued dosimeters during the period 1952-1957. ORAUT-TKBS0013-6, § 6.4, at 11-12. In addition, the record establishes that there were 

"ladies doing inventory of devices and receiving significant exposure.• 

Documented Communication at 5. The Panel is unable to identify evidence in 

the record that this scenario is incorrect or was dlsproven. The Pantex Plant Site 

Expert Interview Summary at 16, states, uworkers routinely functioned outside of 

their job titles performing work for which they had appropriate clearance and 

qualifications. For example, office staff sometimes transported material and 

parts from storage or labs to assembly points, or the reverse. Production 
The Honorable Sylvia M. Burwell-Page 8 

Technicians. assisted with inventories. When available, personnel helped out 

where they were needed." None of these workers were issued dosimeters during 

the period 1952-1957. ORAUT-TKBS-0013-6, § 6.4 at 11-12. 

ORAUT-TKBS-0013-6, § 6.5.4.1, at 25, states MA bare slab source of DU 

contributes an Hp(0.07) dose of approximately 200 mrad/hr at the surface (BRH 

1970) compared to an Hp(10) dose of approximately 2 mrad/hr (ORAUT 

2004a)." ·seta radiation from DU could contribute to extremity and skin dose to 

workers unless precautions were taken to protect workers from the radiation. 

Protective clothing and gloves provide a protection factor of 2 or more, 

depending on the thickness (DOE 2000): Id. No information an protective 

clothing for workers is provided in the record for the period 1951-1957, except 

for the mention that "Lead aprons were available to early radiography workers at 

Pantex....the use of lead aprons was not included in procedures until the mid1980s." ORAUT-TKBS-0013-6, § 6.5.5.6, at 37. ·one long-term worker indicated 

that when he initially started work at Pantex In the early days, they did not wear 

gloves or lead aprons, or use shielding. Nowadays, Pantex would require a 

worker to wear lead aprons, leaded glasses, and leaded gloves. During pit vault 

inventories, one worker reported wearing street clothes, safety shoes, and safety 

glasses, while his coworker wore cotton coveralls with underclothes 

undemeath.u Pantex Plant Site Expert Interview Summary at 24. Even when 

provided, use of protective clothing was not standard procedure in the 1950s. 

·Although lead aprons were provided to workers, there was no requirement to 

wear them; thus, not all workers wore them. No training on the aprons was 

provided." Id. at 25. The panel is unable to identify any evidence that Pantex 

workers other than radiography workers were provided with any protective 

clothing or gloves, or that their use was required. 

It is apparent from the record that there were substantial changes in the use of 

protective clothing and radiation monitoring after 1958, so data from later years 

cannot be applied appropriately to earlier years as surrogate data for dose 

reconstruction. ORAUT-TKBS-0013-6, § 6.5.2, at 16 states, •pantex Plant 

dosimetry methods evolved with the development of improved technology and a 

better understanding of the complex radiation fields encountered In the 

workplace." During 1952-1957, a Safety Engineer ·oversaw Radiation Safety in 

addition to several other safely disciplines." Pantex Plant Site Expert Interview 

Summary, at 17. A healttl physicist was not hired until about 1970. Id. 

Even after 1957, when plutonium .was present at the plant, workers were not 

appropriately educated with respect to radiation hazards: "The workers had no 

concept of the degree of hazard. Originally, the workers were not aware they 

were working with plutonium. The plant was not required ta tell the workers what 

they were working with: Id. at 18. Even in later years, when dosimeters were 

issued to other workers and not just radiographers, compliance was not 

universal. "The actual use of extremity dosimeters at Pantex has not always 

been rigorously managed, and there were times when workers did not wear the 

assigned extremity dosimeters." ORAUT-TKBS-0013-6, § 6.7.6, at 50. 

Because {a) only radiographers were monitored during the period 1951-1957, 
The Honorable Sylvia M. Burwell-Page 9 

(b) radiographers were not exposed to radiation because the x-ray machines 

were enclosed in shielded cabinets, (c) other workers were exposed to radiation 

but were not monitored, (d) there is no evidence that workers other than 

radiographers were provided with protective clothing during the period 1951­

1957, and (e) work practices changed after this time period so that surrogate 

data from a later time period cannot be used to reconstruct the dose that Pant~x 

employees encountered during an earlier time period, the Panel concludes that it 

is not feasible to estimate, with sufficient accuracy, the external dose for workers 

at Pantex from January 1, 1951, through December 31, 1957. 

Also see discussion under (J), below. 

I. 	 NIOSH finds it is feasible to reconstruct occupational medical dose, when 

appropriate, for this period. 

The Panel agrees that it is feasible to reconstruct occupational medical dose, 

when appropriate, for the period from January 1, 1951, through December 31, 

1957. 

J. 	 NIOSH finds that it is feasible to estimate, with sufficient accuracy, the total external 

dose and occupational medical dose for the class ofemployees covered by this 

evaluation. 

The Panel believes that It Is feasible to reconstruct occupational medical dose for 

workers at the Pantex Plantfrom January 1, 1951, through December 311 1957. but 

the Panel concludes that it is not feasible to estimate, with sufficient accuracy, the 

total external dose for the class of employees during this same time period. 

K. 	 In sum, NIOSH determined that it has access to sufficient site-specific information to 

either (1) estimate the maximum Internal and external radiation dose for every type 

of cancer for which radiation doses are reconstructed that could have been Incurred 

under plausible circumstances by workers at the Pantex Plant for the time period 

from January 1, 1951, through December 31, 1957; or (2) estimate the Internal and 

external radiation doses to workers at the Pantex Plant for the time period from 

January 1, 1951, through December 31, 1957, more precisely than a maximum 

dose estimate. 

The Panel concludes (a) that there is insufficient site-specific information to 

estimate the maximum internal and external radiation dose for every type of 

cancer for which radiation doses that could have been incurred under plausible 

circumstances by workers at Pantex for the time period from January 1, 1951, 

through December 31, 1957, and (b) that there is insufficient site-specific 

information to estimate the internal and external radiation doses to workers at the 

Pantex Plant for the time period from January 1, 1951, through December 31, 1957, 

more precisely than a maximum dose estimate. 

The Panel has made this determination based on: 

1. 	 The presence of uranium, tritium, and possibly other radionuclides in the plant 

during that period. 
The Honorable Sylvia M. Burwell-Page 1O 

2. 	 The limited radiation controls applied during that period. 

3. 	 The conduct of operations with exposure potential beyond radiography, such 

as handling DU forms, various burning pad and hydroshot operations and 

other non-characterized operations. 

4. 	 The near total absence of bioassay or other exposure assessment data from 

the period. 

5. 	 Limitations in applying objective data from later operations given the very 

different operations and devices handled, controls in place, and sophistication 

of the overall radiation safety program 

L. 	 The Board also concurred with this determination. 

The Panel agrees that the Board concurred with NIOSH's determination. 

ADMINISTRATIVE REVIEW PANEL CONCLUSIONS 

In our review of this case, we have concluded that: 

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

2. 	 The Secretary's prior decision was not supported by factually accurate 


information; 


3. 	 There were errors of fact or omission In the principal findings and 


recommendations of NIOSH and the Board; 


4. 	 Therefore, the petitioner's two relevant allegations raised in the appeal have merit. 

SUMMARY AND RECOMMENDATIONS 

Based upon our review of the administrative record in this case, this Panel believes that 

the regulatory procedures have been complied with as set out In the EEOICPA 

implementing regulations at 42 CFR parts 82 and 83. However, the Secretary's decision 

to deny SEC status to the workers at the Pantex Plant for the time period from January 1, 

1951, through December 31, 1957, was not supported by factually accurate Information. 

The Administrative Review Panel has concluded that the petitioner's challenge has 

merit, and we recommend that you revise the September 30, 2013, determ.ination 

that denied SEC status to the class of employees who worked at the Pantex Plant from 

January 1, 1951, through December 31, 1957. 
National Institutes of Health 

Signature on File

Don~ld LAiller, MD FACR 

Chief Medical Officer for Radiological Health 

Center for Devices and Radiological Health 

Food and Drug Administration 

Signature on File

ie 

Koerner, MPH, CIH 

Chemical, Biological, Radiological, Nuclear, and Explosives Branch 

Office of Emergency Management 

Assistant Secretary for Preparedness and Response 

Attachment 

Petitioner's Appeal Letter dated November 14, 2013 
November 14, 2013 

To: Jennifer M. Cannlstra 

Ex. Sec'y DHHS 

Room 603H 

200 Independence Ave, s.w. 

Washington, DC 20201 

Re: Secretary's determination excluding from Pantex SEC workers employed 1951 - 1957 

Petitioner's Request for an Administrative Review [#SEC00068] 

Our prior letter of November 6, 2013 sought additional Information Illuminating the 

empirical basis for the NIOSH recommendation to the Secretary. Both what we received and 

failed to receive justifies this appeal for reconsideration of the Secretary's exclusion from the 

existing SEC of those employed at Pantex in the years 1951 through 1957. 

The fast and courteous reply, we gratefully acknowledge, .directed us to the published 

record: two transcripts and the regulations on conflict of Interest. A review of that material 

reveals no eyfdence that reGords adequate for dose reconstruction were found or considered 

for all those employees at risk following documented exposure to radiation. Thus, In addition 

to recollections of Interviewed workers from that era,1 we reviewed EPA's Pantex Superfund 

Site Report of 09/10/2013 on activities begun in 1951. This generated two unanswered 

questions: 

• Waste management was restricted to the site, requiring remediation 

workers on site. Ought not the record display the presence of these workers 

and the absence of their records, and recollection or notation of the presence 

or absence of personal protective equipment and environmental monitoring 

(personal or area) for these workers? 

• Waste waters and solids included "depleted ura~lum", (EPA pS) and 

"releases to soils ... pose a direct contact risk to onslte workers." (EPA 

1 The writer, in interviewed Pantcx workers, 

family nnd peers in evaluating community resources of the Texas.New Mexico region. noted in 

commendations of the Attorney General, State of New Mexico and USEPA. 
2 

p4) Other than a discussion of natural background sources, why Is there no 

discussion In the transcripts of this additional exposure issue? 

The publicly-accessible transcripts (6/18/13 & 7/17/13] of meetings of the Board and 

it's Investigating committee provide no evidence that radiation records ofi!.11 workers 

Including remediation workers from the era in contention were discussed or sought. 

Pantex never was just a warehouse or passive shipping point. In the second transcript 

of 7/17/13, Fitzgerald makes clear to the Board what actual industrial activity took place from 

the beginnings of operations, which necessarily resulted In radiation exposure: the "first 

depleted uranium forms arrived at Pantex in 1951 ... they were mating the depleted uranium 

with high explosives." [p58) 

In the first transcript of 6/18/13, the Chair of the Investigating committee, Mr. 

Clawson, says [pp35-36] that exposures [by Implication of all workers] "were never discussed 

at that time ... because the uranium and the HE were bonded together ...."The Inference Is 

that In this process the physical state of the uranium permi~ed complete contamlnant 

containment. This belief is refuted by Mr. Fitzgerald. 

Fitzgerald discusses [pp 37-45] visual evidence of oxidation, which he 

characterizes as being "minor". BEIR reports of the National Academy of Science on the 

sources and effects of low levels of radiation, with which he is familiar, lead us to assume that 

he must mean "minor" relative to the function of the weapon, not as a source of chronic 

radiation exposure. Even the low levels of radiation from radioactive flakes resulting from 

oxidation and deposited in the respiratory system during long-term continuous exposure and 

contact with the metallic source may result tn significant elevated risk. 

Fitzgerald does note exposure-resulting "Incidents". (p43J These "incidents" 

occurred in "mating high explosives to depleted uranium." [p45J He asserted that 

"major handling'" may not have taken place during mating. Apparently, "major" events as 

judged by Mr. Fitzgerald [p44), did not Include this revealing assessment: "you could lift the 

unit up and the DU would just fall out." [p54} 

For production, maintenance and waste remediation workers, the exposures appear to 

have been direct and indirect, routinely unguarded, uncommonly monitored, mostly 

unrecorded, to be assessed not empirically, but by extremes of professional judgment 

expressed In the construction and application of hypothetlcal models of population exposure, 

supposedly enabling calculations of probabilities of causation for any Individual in the 

population. 

The Secretary ought to note the absence of any discussion by the Board In Its public 

transcript of this subjective process of judgment In whlch numbers are used In an arlthmorphlc 

fallacy noted and rejected by a joint committee of the National Institutes of Health 

and the National Academy of Science as an Inappropriate, un-heuristic exercise. 

It Is true that the joint committee does not write laws, and the agency Is bound to the 

law. However, 1) It Is a mistake, an error, not to report their opinion to the Congress, and 2) 
3 

untll a legislative remedy Is crafted, It Is a mistake, an error, not to minimize application of 

the questionable method. This leads us to our final point. 

In our prior letter of November 6, 2013 we raised the Issue of conflict-of-interest. The 

reply referenced the Department's published rules. I accept responsibility for poorly 

expressing a request for Information on an error-generating Judgmental Issue seldom 

delineated clearly in discussions of governmental decision-making. 

We are not aware of, nor do we allege, any breach or Intent to breach these 

regulations. More, the existing rules amply provide appropriate restraints when 

conflicts occur. 

The rules do not cause to surface conscious deliberation of critical human values that 

guide judgment of the conceptual constructions In the' 'as If' universe of scientific discourse. 

Yet these values are binding characteristics of the scientist's selection of data-evaluating 

models or molding of Investigating methods, as well as the Interpretation of the products. 

There Is no evidence that the Board considered this subjective selectlon and molding. It is an 

error to fall to delineate these expressions of fundamentally variable moral values prior to 

making a final decision. 

The genesis and development of scientific fact, to paraphrase the title of Ludwlk 

Fleck's examination of scientific discovery as a human process, Incorporates the roles of habit, 

professional community acceptance and rewards, and training. In the variable perspectives of 

the humans In this process, chimera-of-fact are easily confused with the results of relatively 

objective efforts to un-conceal real fact in the universe of truth. 

I have known and worked with many members of this professionally-distinguished 

Advisory Board during six decades of s~rvlce in this field. There Is no cause to doubt their 

ability to make rationally necessary moral judgments. 

Yet, it Is an eM'Or if the Board has failed to discuss and consciously make critical 

judgments on the relative objectivity of the committee and staff on Issues of reconstructed 

dose, especially when they propose ruling out inclusion of the early, grossly neglected and 

abused populations In the existing SEC: the wise legislated remedy in the law! 

The errors displayed In the record provided to the Secretary to support her 

determination mainly are those of silence and omission! An administrative review of 

the Secretary's decision would be the appropriate first step corrective. 

Respectfully submitted, 

Petitioner 

Coples: Mr. Kinman 
October 7, 2016 

The Honorable Sylvia M. Burwell 

Secretary of Health and Human Services 

Department of Health and Human Services 

200 Independence Avenue, S.W. 

Washington, DC 20201 

RE: Pantex Plant Special Exposure Cohort Administrative Review Panel 

Dear Madam Secretary: 

In our letter of February 19, 2016, we noted the standard of review that applies to appeals filed 

under the Energy Employees Occupational Illness Compensation Program Act of 2000 

(EEOICPA). Specifically, pursuant to 42 CFR § 83.18(b), administrative review panels "shall 

consider whether HHS substantially complied with the procedures of {42 CFR part 831, the 

factual accuracy of the information supporting the final decision, and the principal findings and 

recommendations of NIOSH and those ofthe Board . ..." Using this standard, in our original 

report, we stated the following conclusions: 

1. 	 HHS compiled with the regulatory procedures set out in 42 CFR part 83; 

2. 	 The Secretary's prior decision was not supported by factually accurate information; 

3. 	 There were errors of fact or omission In the principal findings and recommendations of 

the National Institute for Occupational Safety and Health (NIOSH) and the Advisory 

Board on Radiation and Worker Health (the Board). 

4. 	 Therefore, the petitioner's two relevant allegations raised in the appeal have merit. 

On September 21, 2016, we had the opportunity to engage in a productive conversation with 

NIOSH regarding these conclusions, and we offer this addendum to our letter to further clarify 

our second and third conclusions. As articulated by John Howard, Director of NIOSH, in his 

letter of July 1, 2016, what we have characterized as factual errors is an acknowledgement that 

certain data and facts regarding the history of early operations at the Pantex Plant do not exist 

or are substantially conflicting In the record available to us. From our review of the 

administrative record as provided to us by NIOSH, we were unable to agree with the 

recommendations of NIOSH and the Board that internal dose reconstruction is possible for 

employees in the January 1, 1951, through December 31, 1957 time period. To be clear, our 

conclusions focus on and are derived from the record. These conclusions in no way reflect 

negatively upon the scientific Integrity of NIOSH, NIOSH scientists, the Board, or the important 

work that they perform. 

The Panel's unanimous conclusions, based upon the standard of review, reflect only the 

insufficiency ofthe record, which does not permit us to confirm "the factual accuracy ofthe 
important program, and serve you and the affected energy employees well. We would also like 

to thank Dr. Wanda Jones for facilitating the September 21, 2016, conversation with NIOSH, as 

well as skillfully managing the administrative review process. 

Thank you for the opportunity to serve on this interesting and important panel. 

Respectfully submitted, 

Signature on File

Fr;;;~esca Macchiarlni, MS, PhD 

Program Director - Biological Resources Branch 

Division of Aging Biology 

National Institute on Aging National Institutes of Health 

Signature on File

Don;;a-r.-Mff?r: MD, FACR 

Chief Medical Officer for Radiological Health 

Center for Devices and Radiological Healt~ 

Food and Drug Administration 

Signature on File

oerner, MPH, CIH 

hemical, Biological, Radiological, Nuclear, and Explosives Branch 

of Emergency Management 

Assistant Secretary for Preparedness and Response 
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 

Cantara for Disease Conlrol 

and Prevention (CDC) 

National Institute ror Occupational 

Safely and Heallh (NIOSH) 

395 E Street, S.W. 

Suite 9200, Patriots Plaza 

Washington, o.c, 20201 

PHONE: (202) 245-0625 

FAX: (202) 245-0628 

TO: 

FROM: 

I Institute for Occupational Safety and Health (NIOSH) 

DATE: 

SUBJECT: 	 Pantex Plant Special Exposure Cohort (SEC) Petition Administrative Review 

Panel's Final Recommendation to the Secretary 

Thank you for sharing the Pantex Plant SEC Petition Administrative Review Panel's ("the Panelu) 

October 7, 2016, letter to the Secretary. I particularly want to thank you for facilitating a meeting 

between NIOSH and the Panel on September 21, 2016. During that meeting, the Panel clarified Its 

findings and discussed the basis for Its conclusions. As an outcome of the meeting, NIOSH now 

understands the Panel's finding that the administrative record Is Insufficient to permit them to 

confirm the factual accuracy of the Information supporting the Secretary's flnal decision, the principal 

findings and recommendations of NIOSH, and those of the Advisory Board. 

In light of the Panel's conclusions, NIOSH concurs that It Is appropriate for the Secretary to conclude 

that It Is not feasible to reconstruct Internal exposures to uranium during the years 1951 through 

1957. Therefore, NIOSH also recommends that the Secretary revise her prior decision and add the 

following class of Pantex Plant workers to the SEC: 

"All emplovees of the Department of Energy, Its predecessor agencies, and their contractors and 

subcontractors who worked at the Pante,c Plant In Amarillo, Te,cas during the period from January 1, 

1951, through December 31, 1957, for a number of work days aggregating at least 250 work days, 

occurring solely under this employment or In combination with work days within the parameters 

established for one or more other classes of employees Included In the SEC." 

Iwould like to thank the Panel members for their hard work and dedication to this administrative 

review. It Is clear to me and others at NIOSH that the Panel members took this matter very seriously 

and conducted a thorough and complete review of the record and Issues before them. 

Thank you again for your assistance with the administrative review process, and congratulations on 

your new assignment. I hope we will work together again In the future.