THE SECRETARY OF HEALTH AND HUMAN SERVICES

WASHINGTON, D.C. 20201

September 22, 2015 

 

 

Dear : 

Thank you for your request for an administrative review of the February 2, 2012, determination 

not to add a class of employees from the Hooker Electrochemical Corporation (Hooker), 

Niagara Falls, New York, to the Special Exposure Cohort (SEC), established by the Energy 

Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA). 

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

a panel of three Department of Health and Human Services (HHS) personnel, independent of 

the National Institute for Occupational Safety and Health (NIOSH), was appointed to conduct 

an administrative review. The panel has now completed its review of your challenge. 

After reviewing the administrative record in this case, the panel recommended two actions: 

(1) The panel concluded that petitioner's challenge has merit in regard to the Hooker 

employees who worked during the "operational period from January 1, 1943, through 

December 31, 1948," and they recommend revising that portion of the February 2, 

2012, determination that denied SEC status to these workers. 

(2) Further, the panel concluded that your challenge does not have merit in regard to the 

Hooker employees who worked during the "residual period from January 1, 1949, to 

December 31, 1976," and they recommend upholding that portion of the February 2, 

2012, determination that denied SEC status to these workers. 

NIOSH agreed to provide a new designation comporting with the panel's recommendation. I 

have approved that designation, and it is being sent to Congress, as required by the EEOICPA 

regulations. You will be provided with additional information from NIOSH in due course. 

I am enclosing a copy of the administrative review panel's final report and the NIOSH response, 

which I hope you will find helpful. 

 Sincerely,

 [Signature on File] 

 Sylvia M Burwell

Enclosure 

 

 
The Honorable Sylvia M. Burwell 

Secretary ofHealth and Human Services 

Department ofHealth and Human Services 

200 Independence Avenue, S.W. 

Washington, DC 20201 

Re: 	 Hooker Electrochemical Corporation Special Exposure Cohort 

Administrative Review Panel 

Dear Madam Secretary: 

The Energy Employees Occupational Illness Compensation Program Act of 2000 

(EEOICPA), 42 U.S.C. § 7384-7385 et seq., established a compensation program for 

workers who may have developed specific cancers associated with duties performed on 

nuclear weapons programs administered by the Department of Energy (DOE) and its 

predecessor agencies (hereafter "Energy workers"). 

In order to qualify for compensation under EEOICP A, individual workers with a 

specified cancer may file claims with the Department of Labor (DOL). For individual 

claims, a radiation dose reconstruction is performed by the National Institute for 

Occupational Safety and Health (NIOSH), and a probability of causation estimate is 

calculated by DOL to determine whether the cancer was incurred as a result of exposure 

to radiation at a DOE facility. 

Workers may also qualify for compensation from DOL, without completion of a radiation 

dose reconstruction or a probability of causation estimate, ifthey incur a specified cancer 

and are members of a class of Energy workers designated as the Special Exposure Cohort 

(SEC). To qualify for the SEC, a representative of a class of Energy employees must file 

a petition with the Department ofHealth and Human Services (DHHS) and meet the 

appropriate requirements under regulations implementing EEOICP A at 42 CFR part 83. 

Then, pursuant to 42 U.S.C. § 7384q, the Secretary ofDHHS may designate the class for 

addition to the SEC, when it is recommended by the Advisory Board on Radiation and 

Worker Health (hereafter "ABRWH" or "the Board") that:(!) 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 ofthe class. Ifthe petition to add a class to the SEC is denied, the petitioners 

may request an administrative review ofthe final decision by the Secretary. 

Background 

On February 2, 2012, the Secretary ofDHHS at that time, Kathleen Sebelius (hereafter 

"the Secretary'') determined that the following class of employees from the Hooker 

Electrochemical Corporation (hereafter "Hooker"), Niagara Falls, New York, could not 

be added to the SEC because it did not meet the necessary statutory criteria for such a 

designation: 
The Honorable Sylvia M. Burwell- Page 2 

All employees who worked in any location at the Hooker Electrochemical 

Corporation during the operational period from January 1, 1943, through 

December 31, 1948, and during the residual period from January 1, 1949, to 

December 31, 1976. 

This determination was based upon the recommendation by the Board, in a letter the 

Secretary received on January 4, 2012, advising that the Board agreed with the NIOSH 

finding "that radiation dose can be reconstructed with sufficient accuracy for certain 

Hooker Electrochemical employees ... " See "'DHHS Determination Concerning a 

Petition to Add Members to the Special Exposure Cohort Under the Energy Employees 

·Occupational Illness Compensation Act of2000: Determination Concerning a Petition for 

Employees from Hooker Electrochemical Corporation, Niagara Falls, New York," 

February 2, 2012 (hereafter "DHHS Determination Concerning a Petition for Hooker 

Employees"). 

Subsequently, petitioner in a letter dated February 29, 2012 (attached to 

this report as Appendix I), requested an administrative review ofthe Sec.,'J'etary's February 

2, 2012, decision. 6 is the representative for petitioners and surviving 

daughter of a former employee ofHooker. Her appeal letter {'4

AL") lists a total of 16 

"'arguments in favor ofreversal,'' 12 of which are presented in the main body of the AL, 

and the other 4 are included as an attachment ("AX") to the AL. On July 31 , 2012, the 

petitioner submitted a second appeal document as an attachment to an email, referred to 

as an addendum ("AD") (attached to this report as Appendix II). This addendum listed an 

additional 60 "challenges." The petitioner had requested to supplement her appeal with 

an addendum because she had received additional infonnation, which was previously 

requested under a Freedom ofInformation Act (FOIA) request, after the time that she 

filed her initial appeal letter. The total 76 arguments and challenges were all accepted by 

DHHS as part ofthe appeal. 

Pursuant to 42 CFR § 83. l 8(b ), the Secretary appointed a panel ofthree DHHS 

personnel, independent ofNIOSH, to conduct an administrative review and provide 

recommendations concerning the merits of the challenge and the resolution ofthe issues 

contested by the challenge. The undersigned, Orban H. Suleiman, Ph.D. (Chair), Eric 

Bernhard, Ph.D. and James A. Deye, Ph.D., comprise that panel. Our collective expertise 

includes: health physics, radiation exposure, dose assessment, dose reconstruction, and 

radiation health effects. 

Our Charge 

The review panel was charged with conducting an administrative review ofthe 

Secretary's determination not to add a class ofHooker employees to the SEC. This 

included reviewing the data and information that formed the basis ofthe February 2, 

2012, decision. 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 Coho~ a 

challenge '~ust include evidence that the final decision relies on a record ofeither 
The Honorable Sylvia M. Burwell-Page 3 

substantial factual errors or substantial errors in the implementation ofthe procedures" 

set out in 42 CFR part 83. 

In conducting our review, pursuant to 42 CFR § 83.18(b), we examined the 76 arguments 

and challenges submitted by the petitioner; the NIOSH evaluation report; the report 

containing the recommendations ofthe Board to the Secretary; the recommendations of 

the Director ofNIOSH to the Secretary; the information presented or submitted to the 

Board by NIOSH, NIOSH contractors, the petitioner, and others; and the deliberations of 

the Board (and Board working groups), contained in transcripts and otherwise, prior to 

the issuance ofits recommendations. The documents that we relied upon most often in 

the writing of this report were titled as follows: 

(1) NIOSH Evaluation Report for the Hooker Electrochemical Corporation ("SEC 

Petition Evaluation Report: Petition SEC-00141, Report Rev. #0, May 3, 2010") 

(hereafter "Hooker Evaluation Report"); 

(2) Technical Basis Document for the Hooker Electrochemical Company ("Division of 

Compensation Analysis and Support Technical Basis Document for the Hooker 

Electrochemical Company, Niagara Falls, New York, Document Number: DCAS-TKBS0009, Revision No. 0, 04/04/2011" - supersedes "Batelle-TBD-6001 Appendix AA, 

Rev. 0) (hereafter "Hooker TBD"); 

(3) Site Profiles document for Atomic Weapons Employers that Refined Uranium and 

Thorium ("Site Profiles for Atomic Weapons Employers that Refined Uranium and 

Thorium, Document Number Battelle-TBD-6001, Rev. FO, Battelle Team Dose 

Reconstruction Project for NIOSH, 12/13/2006") (hereafter "Site Profiles"); and 

(4) Criteria for the use of Surrogate Data, Prepared by the ABRWH Work Group on Use 

of Surrogate Data, May14, 2010 (hereafter "Board Surrogate Data Policy"). 

Regulations in 42 CFR § 83.18(a) prohibit petitioners from introducing any new 

information or documentation that was not previously submitted to NIOSH or to the 

Board prior to the Board issuing its recommendations. Our review was based entirely on 

the written documentation provided to us in this case. 

Main Conclusions 

Although the petitioner's arguments are broadly stated and sometimes difficult to follow, 

the most relevant point concerns the use of surrogate data to reconstruct dose at the 

Hooker site. This concern, which comes up repeatedly, is exemplified in argument 7 in 

the AL: "There is still the question ofthe use of 'surrogate data' in order to use dose 

reconstruction. Neither ofthese two procedures should have been used for Hooker since 

it no longer exists and there are no records" (emphasis added) (AL, p. 3). The review 

panel interprets this argument ofthe petitioner as questioning the validity of the use of 

surrogate data in this case. 
The Honorable Sylvia M. Burwell-Page 4 

The review panel concludes that petitioner's challenge has merit in regard to a subset of 

the class of Hooker employees for which the petition was submitted. We unanimously 

find that the use of surrogate data to assess internal radiation doses to the Hooker workers 

during the operational period from January 1, 1943, through December 31, 1948, does 

not meet the standard ofreasonable application of scientific methods (see Section A 

below),, nor does it meet the standards for use of such surrogate data as agreed to by the 

Board itself (see Section B below). Consequently we feel that the use of surrogate data 

in this case resulted in a "substantial factual error." Consequently we feel that the use of 

surrogate data in this case represents a "substantial factual error." We conclude that this 

error invalidates the determination that exposure could be accurately reconstructed for the 

time period 1943 through 1948 using only surrogate data. Thus, we recommend reversal 

ofthe portion of the Secretary's February 2, 2012, determination that denied SEC status 

to "All employees who worked in any location at the Hooker Electrochemical 

Corporation during the operational period from January 1, 1943 through December 31, 

1948." 

Finally, because ofthe different timeframe and very different working conditions that 

existed after January 1, 1949, we do accept the basis for reconstruction of doses for the 

Hooker workers in the "residual period from January 1, 1949, to December 31, 1976." 

We conclude that the petitioner's challenge with respect to this subset ofworkers does 

not have merit and we, therefore, recommend that you uphold the portion of the 

Secretary's February 2, 2012, determination that denied SEC status to workers at Hooker 

during the residual period from January 1, 1949, to December 31, 1976. 

Structure of Report 

The body ofthis report contains the following sections: 

A. 	 In Section A ofthis report, we address the points in the Secretary's February 2, 

2012, determination, as this is what the petitioner is challenging in this appeal. 

This section largely focuses on the reasons why, in our view, the use of surrogate 

data to reconstruct doses for employees that worked at Hooker prior to January 1, 

1949 was erroneous. 

B. 	 In Section B ofthis report, we further address the surrogacy issue, which is 

central to our recommendation. Specifically, we review the use of surrogate data 

within the context of the criteria set out in the May 14, 2010, Board Surrogate 

Data Policy, as the application ofthese criteria are crucial to the "factual accuracy 

of the information supporting the final decision" (42 CFR § 83.18(b)). This 

section includes our discussion of how the Board failed to follow these criteria. 

C. 	 In Section C ofthis report, we address each of the 76 arguments and challenges 

set forth in the petitioner's appeal letter (AL), attachment (AX), and following 

addendum (AD). This clearly expanded our effort, but the review panel felt it was 

essential to address each of the petitioner's concerns to the best of our abilities. 

These arguments and challenges have been grouped into common subject 

categories and addressed accordingly. 
The Honorable Sylvia M. Burwell-Page 5 

Section A. DHHS Secretary's Determination Letter of February 2, 2012 

Pursuant to 42 CFR § 83.18(b), part ofthe review panel's charge was to determine 

whether the Secretary's final decision was supported by accurate factual information, and 

to consider the principal findings and recommendations ofNIOSH and the Board. 

Section IV of the Secretary's February 2, 2012, "DHHS Determination Concerning a 

Petition for Hooker Employees" summarizes the Determination Findings. These 

Findings are based upon the memorandum from the Director ofNIOSH, dated January 9, 

2012, and the Board's letter to the Secretary, concurring with the "Findings," dated 

December 29, 2011 (received January 4, 2012). The complete Determination Findings are 

listed in bold text below; the review panel's analysis follows each point along with our 

conclusions. 

IV. Determination Findings 

1. 	 NIOSH determined principal sources of internal and external radiation 

exposure for members of the evaluated class were gamma and beta 

radiations associated with handling and working in proximity to uraniumbearing slag material (C-2 and C-2 concentrate). 

While we agree that gamma and beta radiation were principal sources of external 

radiations during the handling of, and working in proximity to, uranium-bearing slag 

material (C-2 and C-2 concentrate), we note that this Finding is misleading and not 

factually correct. This is because it does not address internal dose, and alpha radiation is 

considered the primary source and the most significant contributing radiation source term 

for the internal exposures to these workers. This was recognized in the Hooker 

Evaluation Report, which states (p. 15): 

" ... The primary source ofinternal radiological exposure resulting from Hooker 

Electrochemical operations was inhalation and/or ingestion of uranium metal 

present in magnesium-fluoride residues obtained from the uranium-tetrafluoride 

reduction process utilized at the Electro-Metallurgical Corporation. The 

radiological hazard presented by uranium metal or compounds results primarily 

from alpha particles emitted by uranium -238 ... and its isotopes uranium-235 

... and uranium-234." 

The panel also notes that alpha radiation, when deposited internally, is recognized as a 

significant contributor to health effects such as lung cancer. 

Thus, the review panel challenges the "factual accuracy" ofFinding 1. 
The Honorable Sylvia M. Burwell-Page 6 

2. 	 NIOSH has fonnd a significant amount of air sampling data relevant to the 

materials and processes used at the Hooker Electrochemical site. In addition, 

the method proposed for establishing a bounding dose for the operational 

periods in Battelle-TBD-6001 Appendix AA has been compared to available 

air monitoring data from related sites and has been found to be bounding in 

each case (based on the assessment of the dose using the appropriate dose 

reconstruction approaches and methodologies). 

(emphasis added for clarity of discussion as follows) 

3. 	 NIOSH has access to sufficient information to estimate the maximum 

internal radiation dose that could have been incurred from exposure to 

uranium-bearing slag during the operational period. NIOSH has a 

significant amount of air sampling data relevant to the materials and 

processes used at the Hooker Electrochemical site. In addition, the method 

proposed for establishing a bounding dose for the operational periods in 

Battelle-TBD-6001 Appendix AA has been compared to available air 

monitoring data from related sites and has been found to be bounding in 

each case (based on the assessment of the dose using the appropriate dose 

reconstruction approaches and methodologies). 

(emphasis added for clarity of discussion as follows) 

Except for the first sentence, Finding 3 is essentially identical to Finding 2 and, thus, we 

address them together. The key elements of Findings 2 and 3 (underlined in each above) 

relate to the adequacy ofthe air sampling data for bounding the internal doses during the 

operational period 1943 through 1948. Thus, the review panel considered the following 

elements ofFindings 2 and 3 to be: (a) "significant amount of air sampling data;" (b) 

"relevant to the materials and processes;" ( c) "bounding dose for the operational time 

periods;" and ( d) "data from related sites." 

(a) 	 "significant amount of air sampling data": 

Regarding the amount of data, section 6.0 of the Hooker Evaluation Report 

indicates that "NIOSH did not locate any data relating to the occupational internal 

or external doses received during the Atomic Energy Commission (AEC) work at 

Hooker Electrochemical" (p. 17). In addition, Section 6.1 ofthis same report 

presents "relevant data from sites that processed the same material" as Hooker. 

This section includes 3 Tables: "Table 6-1: Pertinent Air Monitoring Data from 

Electro-Metallurgical Corporation;" "Table 6-2: Summary ofPertinent Air 

Monitoring Data from the Mallinckrodt Facility;" and "Table 6-3: Summary of 

Pertinent Air Monitoring Data from Fernald." There are 2 data points in Table 6­

1 from Electro-Metallurgical Corp, dated 1947/1948 and 1949; 10 measurements 

in Table 6-2 from Mallinckrodt, dated 1948 through 1953; and 12 measurements 

in Table 6-3 from the Fernald site, dated from 1956 through1959 (see pp. 18-21 of 

the Hooker Evaluation Report). 
The Honorable Sylvia M. Burwell-Page 7 

We note that, ofthe total 24 data measurements used as surrogate data in this 

report, only 2 were prior to 1949; and these 2 data points - 456 dpm/m3 

(Hooker Evaluation Report, p. 18, citing Site Research Database (SRDB) Ref ID: 

8917, p.7) and 398 dpm/m3 (Hooker Evaluation Report, p. 18, citing SRDB Ref 

ID: 8930, p. 19) - are averages ofmeasured values. In addition, these averages are 

6.5 and 2.2 times higher, respectively, than the "tolerance" levels ofthe era per 

stated values and "tolerances" in Table 6-2. 

Thus based on the very limited amount of data used, the review panel questions 

the "factual accuracy" ofthe statement that "NIOSH has a significant amount of 

air sampling data relevant to the materials and processes used at the Hooker 

Electrochemical site,"( emphasis added) particularly in regard to the operational 

(pre-1949) period. 

(b) "relevant to the materials and processes": 

The panel again notes that 22 of 24 samples referenced above were from 1949 and 

after. As discussed below (and shown in Figure 1), the panel finds it to be 

inaccurate to claim that source terms for dust samples after 1949 are relevant to 

the materials and processes used at the Hooker site from 1943 through 1948, 

which is the operational radiation exposure period identified in the DHHS 

Determination Concerning a Petition for Hooker Employees. This earlier period 

oftime was very different in terms of dust levels, since after 1949, major 

improvements in the uranium refining processes were made to reduce the hazard 

from uranium dust, including more stringent enforcement of air quality standards, 

resulting in "alpha-emitting dust concentrations for the years 1953-1957 - roughly 

100 times lower than they were in 1948." (Site Profiles, p. 52). 

(c) "bounding dose for the operational periods": 

The review panel disagrees that "available air monitoring data from related 

sites" can be used as bounding for the operational period at Hooker, since the 

amount and relevance ofthe data are insufficient and the variance and 

uncertainties ofthe data are too large. This is acknowledged in the Hooker TBD, 

Section 4.0 (p. 8), which states that: 

"No data were found in the Site Research database related to occupational 

internal dose during MED work. The work performed at Hooker 

Electrochemical involved concentrating C-2 slag. Much ofthat work 

involved either liquid or material with a high moisture content which 

would result in little or no airborne activity. The one task involving dry 

material was the dumping of barrels ofMgF2 slag. The slag came directly 

from the nearby ElectroMet facility. Two air sample results from handling 

this material at ElectroMet were found. The first result was an average of 

an unknown number of samples taken on December 24, 1947, March 30, 

1948 and May 14, 1948. The average ofthe samples was 456 dpm/m3

. The 

second result was an average ofthree samples taken between August 17th 
The Honorable Sylvia M. Burwell-Page 8 

and the 19th of 1949. The average value was 398 dpm/m3 .Work 

associated with these samples included shoveling the material into the 

barrels. 

Since there are only two results and they were reported as averages, they 

provide little information about the variability ofthe data." 

Strong support ofthis panel's position also comes from Section 8.4 of Site 

Profiles. Specifically, this section includes Figure 1, as pasted below, which is 

taken from a paper written by Christofano and Harris in 1960 (Christofano, Emil 

and Harris, William, "The Industrial Hygiene ofUranium Refining," Archives of 

Environmental Health, Nov. 1960, vol. 1, pp. 438-460) SRDB RefID:15724, p. 

24, (note, despite the figure caption in TBD-6001 which says this is Figure 1, this 

is actually Figure 16 in the Christofano paper) . This Figure shows the decreasing 

trend in time- weighted average air concentrations of alpha-emitting dust. 
The Honorable Sylvia M. Burwell-Page 9 

Doc:nment No. Battellr-TBD-6001 Rei."ision No. FO Effective Date: 12/1312006 page 50 

8.4 Time-DE'pendent Air Concentration Data 

The air concentration in ttiining plants "'3ricd with time.. The following infonnatioo was ex:tractcd from 

Strom (2006). Cbristof:ano and Hanis (1960) showed that therewas a large reduction over the years in 

time-weighted a""ttage air conccottations ofuran1um in various rdiningplant<> (Figure 1). 

• • 

••• 

• • • • • • • • • • • • • • 

• • • • •• 

•• •• 

• ••••• 

• • • 

• 

• • 

1,000 

•• 

OCCUPATIOtiAL EXPOSURES TO 

ALPHA EM11"flNG OUST 

• 

• 1 •

•

• 

• 

..

•• • • ~l,000 • .,, 

:::> •• • • •

• 

f • :• • x .. • • •• • • w • • • • • . .: . ... b=r-------1....--.L.--~~.L--n--- ,. ..,. ... .. . •.... 1:._,.• .! •. • • 

.-. • 

0.2 

10 


4* 4~ SO 5 I 52 53 5 4 55 56 


YF AR 

Figure l. Data. from Figure I ofChristofmo and Hams (1960) shcrwing the decreasing tm:id in timcweighted average air concentrations ofalpha-emitting dust. 

From these data the panel notes: 1) that there are no measured data prior to 1948; 

2) the measurements after 1948 show a 100 times reduction in the occupational 

exposures to alpha emitting dust due to major changes in the work processes and 

enforcement ofsafety standards; and 3) during the period ofhigh exposures (1948 

and likely before) there is a variation in measured exposure values of 100 times. 

Hence the review panel believes it is simply incorrect, and also not supported with 

any reliable scientific data, for NIOSH to claim that there is " ... significant 

amount of air sampling data relevant to.•.the Hooker Electrochemical site" 

and that these data allow for a " ...bounding dose for the operational period..." 

The large variations in what measured data exists, along with the sparse amount 

of such data, preclude using average values with such high levels ofstatistical 

uncertainties for realistic bounding. Thus, the panel does not accept that 2 out of 
The Honorable Sylvia M. BlllWell- Page 10 

24 measurements represents "sufficient information to estimate the maximum 

internal radiation dose that could have been incurred" (emphasis added) for 

this operational period since the 2 values used for the pre-1949 period are 

"averages" for which the maximum values are not known. 

These very large and unpredictable variations in the air concentrations ofalphaparticle containing dust are supported by the statements made by former Hooker 

employee, 6 , in an interview conducted by NIOSH contractor, Oak 

Ridge Associated Universities (ORAU), on December 12, 2009, as follows (see 

"Data Capture Docwnent Discovery and Review (SRDB) RefID:77828: 

Documented Communication with 6 regarding Hooker 

Electrochemical," dated January 14, 2010, p. 3): 

"Question: Was it dusty where you worked? 

6 : It was so dusty that he couldn't see sometimes (when .....--=-----.._,........-.
 they dumped the barrels)." 

Question: Did you have a mask? 

6 .: He had a gas mask. The cartridge on the front ofthe ---,---;---­ mask would get full ofdust but he didn't know it. But he would get a 

new cartridge for the mask at lunch time." 

It is worth noting that worked at Hooker from 1944-45, which is 

within the 1943 to 1948 operational time period. 

(d) "data from related sites": 

The review panel believes that any comparisons to "related sites" with regard to 

measured radioactive dust concentrations during the pre-1949 operational period 

are essentially anecdotal, since only two data points from that period were applied 

to the evaluation ofthe Hooker site without any ability to validate the results. 

Nonetheless, we do note that there is evidence that prior to 1949, the ''related 

sites" - Electro Metallurgical Corporation (hereafter "Electro-Met"), 

Mallinckrodt, and Fernald- had very significant Uranium dust exposures that 

could not be accurately assessed. Some evidence is set out below. 

1) 	 With respect to Electro-Met, a data capture document, which included a 

report on "Dust Hazards at Electrometallurgical Company," dated June 18, 

1948 (SRDB Ref ID: 8917), states as follows: 

"Ifno respirators were worn different groups would inhale from 2 

to 25 times the preferred limit ofuranium bearing dusts." 

The NIOSH Evaluation Report for Electro-Met ("SEC Petition Evaluation 

Report: Petition SEC-00136, Report Rev. # I, 0113112012") also states (p. 21): 

"The primary source ofinternal radiological exposure resulting 

from Electro Met operations was inhalation and/or ingestion of 
The Honorable Sylvia M. Burwell-Page 11 

uranium metal or uranium tetrafluroide. The hazards represented 

from uranium-bearing dust in the air were well documented, 

particularly in the years preceding 1948, with exposures greater 

than 500 times the tolerance level of the day being routinely 

measured (Dust sample Results, Aug 1949)." 

In addition, in the DHHS Designation related to a class of employees from the 

Electro Met site ("DHHS Designation ofAdditional Members ofthe Special 

Exposure Cohort Under the Energy Employees Occupational Illness 

Compensation Act of2000: Designating a Class ofEmployees from Electro 

Metallurgical Site, Niagara Falls, New York," May 11, 2012), NIOSH determined 

that (p. 3): 

" ...neither the bioassay nor the early limited air sampling data are 

sufficient to bound the dose at Electro Metallurgical for the August 13, 

1942 through December 31, 1947 portion ofthe period under evaluation. 

Based on health improvements described as occurring in late 194 7, the 

internal dose related data collected after 194 7 cannot be extrapolated to 

exposures occurring prior to 1948 at Electro Metallurgical" (emphasis 

added). 

2) 	 With respect to Mallinckrodt, the NIOSH Evaluation Report completed for 

this site ("SEC Petition Evaluation Report: SEC-00012-2, Report Rev. 

#Draft 2"), states as follows (p. 36): 

"This evaluation has attempted to address in reasonable detail the 

scientific and technical matters concerning the feasibility of 

completing dose reconstructions. NIOSH has also come to a 

determination concerning the extent to which the documentation 

concerning data integrity casts excessive doubt on the validity of 

data available for dose reconstruction. NIOSH has determined that 

it cannot provide reasonable assurance of validity for dose 

reconstructions involving internal exposures ofradiological dusts 

during the 1946-1948 period, which would include all employees 

working during this time period, because all employees had 

potential exposure to such dust" (emphasis added). 

3) Finally, regarding Fernald, all ofthe Fernald site data used in the Hooker 

Evaluation Report that are given in Table 6-3 are measurements dated 

from 1956 or later. Furthermore, unlike the operational conditions at 

Hooker, the NIOSH Evaluation Report for Fernald ("SEC Petition 

Evaluation Report: Petition SEC-00046, Report Rev# FINAL, 10-25-06") 

states that, for all the Fernald data (p. 44): 

"Routine air sampling was used in all plants and operational 

processing areas to evaluate internal exposure potential via 
The Honorable Sylvia M. Burwell-Page 12 

inhalation and served as the primary means of controlling intakes. 

This sampling was performed over the entire operational period 

evaluated in this report, from the start ofFMPC [Feed Materials 

Production Center, in Fernald Ohio] operations through 1989." 

Notwithstanding those later dates and stricter operational standards, all ofthe air 

monitoring average measurements from 1956 through 1958 set out in Table 6-3 of the 

Hooker Evaluation Report (see pp. 19 and 20) are still above the "tolerance"1 value of 70 

dpm/m3 by factors that range as high as 11.8 times. 

In summary, concerning the "data from related sites," the review panel finds that 100% 

ofthe air sampling data used in the Hooker Evaluation Report were from surrogate sites, 

and only 2 ofthose 24 surrogate measurements (as set out in Tables 6-1, 6-2 and 6-3 in 

the Hooker Evaluation Report) were within the earlier 1943 to 1948 operational time 

period. The remaining 22 measurements came from the post-1948 time period for which 

the historical data (as set out in Figure 1 above) correlates with the major improvements 

in processes and procedures that were undertaken, in order to reduce the earlier high 

levels of radioactive dust air concentrations. Additionally, the review panel notes that the 

2 measured values prior to 1949 (154 and 456 dpm/m3 ) were 2.2 and 6.5 times above 

"tolerance" levels (Hooker Evaluation Report, p. 19, citing SRDB RefID: 9340, p. 4) of 

that era (later reduced), when the standards were less stringent. In fact, these values 

represented averages, without known variation or maximum values that simply do not 

allow for any precise or accurate scientific bounding ofthese very large exposures to the 

alpha particle emitting Uranium slag dust. Thus, the review panel concludes that Findings 

2 and 3 are based on highly questionable data from different sites and different time 

periods and, thus, represent "substantial factual errors" for the context in which they were 

used. 

4. 	 NIOSH reviewed and assessed the available airborne radioactivity and 

source term data against the methodology provided in Battelle-TBD-6001 

Appendix AA, and NIOSH believes that internal dose during both the 

operational and residual periods can be bounded using the methodology 

defined in Battelle TBD- 6001 Appendix AA. 

The review panel notes again, as in Findings 2 and 3 above, that data referred to in the 

Hooker Evaluation Report and the Hooker TBD was 100% surrogate data from nonHooker sites, and was collected during or after 1948. Therefore, as shown in Figure 1 

above, it cannot be claimed to be either comparable or "bounding" for the earlier 

operational period oftime, specifically January 1, 1943 -December 31, 1948. The 

review panel asserts that this finding is based on "substantial factual errors." 

1 "NIOSH has determined from the limited air sampling data available that alpha-emitting dust 

concentrations from 1943-1947 were high by 1958 standards; that concentrations of50 to 100 times the 

MAC level of70 dpm/m3 occurred; ("SEC Petition Report: Petition SEC-00012-1 [Mallinckrodt], Report 

Rev# Draft, 07-21-2004," p. 18. See also, Christofano, Emil and Harris, William, "The Industrial Hygiene 

ofUranium Refining," Archives ofEnvironmental Health, Nov. 1960, (Vol l, pp 438-460), SRDB Ref!D: 

15774, p.24 
The Honorable Sylvia M. Burwell-Page 13 

5. 	 There are no available data on contamination levels or source term 

quantities left at the Hooker Electrochemical facility after the cessation of 

operations. A bounding assessment of external photon and beta dose is 

presented in Battelle-TBD-6001 Appendix AA, based on the assignment of 

dose from surface contamination present during scrap recovery operations, 

with no adjustment for cessation of processing activities. That is, the dose 

assigned is the same as would be from exposure to surface contamination at 

an operating scrap recovery facility. 

The review panel agrees with this Finding, as it addresses the "quantities left at the 

Hooker Electrochemical facility after the cessation ofoperations" (i.e., the residual 

period, January 1, 1949 to December 31, 1976), and it also addresses only "external 

photon and beta doses." 

6. 	 NIOSH reviewed and assessed the available source term and external 

monitoring data against the methodology provided in Battelle-TBD-6001 

Appendix AA. NIOSH determined that the calculated external dose assigned 

in Battelle-TBD-6001 Appendix AA can be used to bound exposures at the 

Hooker Electrochemical site during the residual period. With the removal of 

the source material at the onset of the residual contamination period, the 

likely exposure scenario during the post-operations period would be 

consistent with the scenario evaluated in Battelle-TBD- 6001 Appendix AA. 

The review panel agrees with this Finding as it addresses only external doses during the 

residual period. 

7. 	 Although no specific information regarding occupational medical dose has 

been identified specific to Hooker Electrochemical Corporation, the dose 

associated with medical X-ray exams, if required as a condition of 

employment, can be assessed using the methodology defined in ORAUTOTIB- 0006. NIOSH believes that this methodology supports its ability to 

bound the occupational medical X-ray doses for the Hooker Electrochemical 

evaluated class. 

The review panel agrees with this Finding since it addresses radiation exposures 

associated with medical X-ray exams. 

8. 	 NIOSH determined that the reconstruction of internal and external doses is 

feasible for the operational period from January 1, 1943, through December 

31, 1948, and for the residual period from January 1, 1949, to December 31, 

1976. 

The review panel does not agree with this Finding since it is based on "factually 

inaccurate" information, specifically for internal doses during the operational period of 

January 1, 1943, through December 31, 1948. As previously stated, the surrogate sites 

and the time periods from which the surrogate data were collected are not comparable to 
The Honorable Sylvia M. Burwell-Page 14 

the Hooker site's environmental working conditions dnring the 1943-1948 time period. 

However, we do agree with this Finding with respect to the residual period. 

9. 	 NIOSH determined that it has access to sufficient Hooker Electrochemical 

Corporation 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 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. 

The review panel finds that this overall Finding is "factually inaccurate," as stated in our 

analysis ofFindings 2, 3 and 4 above. As we explained above, the surrogate data used 

for internal exposure for the earlier period ofJanuary 1, 1943 through December 31, 

1948, are not representative and not valid "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 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." 

10. 	 The Board concurred with the NIOSH findings. 

Following its deliberations, the Board voted on a motion to accept the Work Group's 

recommendation and NIOSH's finding that dose reconstruction is feasible for both the 

operational and the residual radiation periods (i.e., to recommend not adding the class to 

the SEC). The motion passed with 10 members voting in favor of denying the addition of 

a class (Anderson, Field, Griffon, Lockey, Melius, Munn, Poston, Richardson, Roessler, 

and Ziemer). Five members voted against the motion to deny the class (Beach, Clawson, 

Gibson, Lemen and Schofield). 

Thus, although the majority ofthe Board concurred with the NIOSH findings, the review 

panel believes that the Board's multiple discussions and final vote were based upon 

inaccurate and misleading surrogate data with which to estimate internal doses for 

workers at Hooker during the January 1, 1943 - December 31, 1948, period oftime. 

Section B. Review of Board Surrogate Data Policy and its Application to Hooker 

In our assessment ofwhether the petitioner's arguments and challenges regarding the use 

of surrogate data have merit, we reviewed the Board Surrogate Data Policy (this 

document is also included in its entirety in Appendix III). The relevance to the review 

panel ofthis surrogate data policy derives from the fact that the Board adopted these 

criteria, as developed by the Board Work Group on the Use of Surrogate Data, for its 

evaluation ofthe use of surrogate data at Hooker. In fact, the specific use ofsurrogate 

data at Hooker, as evaluated against the criteria, was also approved by the Board at its 

December 07, 2011, meeting. Although the May 14, 2010, document indicates that the 
The Honorable Sylvia M. Burwell-Page 15 

document is a final draft from the Board's working group, we understand from NIOSH 

that it is, in fact, the final version ofthe surrogate data criteria adopted and used by the 

Board. The title ofthe document was still listed as a draft after the Board adopted the 

document as its own. 

The review panel wants to emphasize that surrogate criteria were being revised during the 

entire time that the Hooker SEC petition was being reviewed and evaluated, and, in our 

view, it was essential that we understood which criteria the Board eventually used in 

order for us to properly assess the appeal.2 

Given the centrality ofthe issue of the appropriate application of surrogate data in the 

review panel's conclusion regarding the "factual accuracy of the information supporting 

the final decision" (42CFR§ 83.IS(b)), we have set out below the Board Surrogate Data 

Policy in its entirety and have included our analysis following each point. Please note 

that the bold text in the sections below represent the exact wording used in the original 

document. 

FINAL DRAFT 

CRITERIA FOR THE USE OF SURROGATE DATA 

Prepared by the ABRWH Work Group on Use of Surrogate Data 

May 14,2010 

For the purposes of this report, the term "surrogate data" will refer to the use of 

exposure data from one site for individual dose reconstruction for workers at 

another site. In reviewing this topic for the Work Group SC&A distinguished 

between "Type I" surrogate data use (as described above) and "Type II" surrogate 

data where these data are used as part of a scientific effort to develop parameters 

for use in dose reconstruction activity calculations rather than as a substitute for the 

lack of adequate data needed for dose reconstruction. 

"Surrogate data" are used in the NIOSH dose reconstruction program because of 

the lack of complete and comprehensive exposure monitoring records for many of 

the workers at the sites covered by the program (SC&A September 2007). It is more 

often considered for dose reconstruction during the early years of some DOE and 

AWE facilities because of the lack of reliable monitoring methods, the urgency of 

developing production capabilities, and other reasons. 

This report will review a number of criteria that need to be considered in 

determining whether the specific use of surrogate data for individual dose 

2 We also reviewed the Implementation Gnideline issued by NIOSH in 2008 related to the use of surrogate 

data ("The Use ofData from Other Facilities in the Completion ofDose Reconstructions Under the Energy 

Employees Occupational Illness Compensation Program Act," Document No. OCAS-IG-004, August 21, 

2008). It is unclear ifthis NIOSH policy was used in its Evaluation Report or recommendation to the 

Secretary. However, it is clear that the Board adopted and used the May!4, 2010, document in evaluating 

the use of surrogate data at Hooker. The criteria in the two policies are essentially the same, with the May 

14, 2010, document further clarifying the earlier NIOSH policy on surrogacy. 
The Honorable Sylvia M. Burwell-Page 16 

reconstruction is scientifically sound and appropriate for that particular 

application. 

1. 	 Hierarchy of Data: It should be assumed that the usual hierarchy of data 

would apply to dose reconstructions for that site ((1) Individual worker 

monitoring data followed by (2) co-worker data followed by (3) workplace 

monitoring data such as area sampling followed by (4) process and source 

term data.) This hierarchy should be considered when evaluating the 

potential use of (5) surrogate data. Surrogate data should only be used to 

replace data if the surrogate data have some distinct advantages over the 

available data and then only after the appropriate adjustments have been 

made to reflect the uncertainty inherent in this substitution. 

(Numbers added to original text for clarity.) 

The review panel notes that surrogate data is 5th on a list of 5 in the preferred hierarchy of 

data to be used in dose reconstruction and, in the case of Hooker, it was the only method 

used for internal dose estimation. 

2. 	 Exclusivitv Constraints: In many cases, surrogate data are used to 

supplement the available monitoring data from a site. In those cases, the 

surrogate data is usually used to justify certain assumptions about the 

distribution or range of possible exposures or assumptions about the source 

terms. In those cases, no special justification is necessary beyond the usual 

scientific evaluation. This is akin to the Type II use described above. 

However, in other situations, there are no or very little monitoring data 

available. In those cases, the use of the surrogate data as the basis for 

individual dose reconstruction would need to be stringently justified. This 

judgment needs to take into account not only the amount of surrogate data 

being relied on relative to data from the site but also the quality and 

completeness of that surrogate data. (emphasis added) 

The review panel believes that the use of surrogate data for Hooker fails on all 3 counts 

of "stringent justification:" 

AMOUNT: Surrogate data accounts for 100% ofthe data used for internal dose 

reconstruction, with no Hooker data available to corroborate. Additionally, even where 

surrogate data was used, most of it comes from one surrogate site, Fernald, and was from 

a time period later than the operational period at Hooker. 

QUALITY: The Fernald data, which accounts for the major share ofthe surrogate data 

used to reconstruct doses at Hooker, is from the post-1949 period. After 1949, major 

improvements in the uranium refining processes were made to reduce the hazard from 

uranium dust, including more stringent enforcement of air quality standards. In addition, 

much of the data pre-1948, sparse as it is, has very large variations and uncertainties, 

which challenges the quality of such data. This calls into serious question any attempts 
The Honorable Sylvia M. Bunvell- Page 17 

at statistical analysis and reasonable scientific conclusions. (See Figure 1 and related 

discussion in Section A. above). 

COMPLETENESS: The surrogate data used for Hooker are not complete in that there 

are no data before 1948; and the data from after 1948 are fragmentary in description and 

method, and they largely derive from a period after 1949 when they no longer represent 

comparable processes and procedures. 

3. 	 Site or Process Similarities: One ofthe key criteria for judging the 

appropriateness ofthe use ofsurrogate data would be the similarities 

between the site (or sites) where the data were generated and the site where 

the surrogate data are being utilized. The application of any surrogate data 

to an individual dose reconstruction at a site should include a careful review 

ofthe rationale for utilizing that source of data. Factors that could be 

considered include, but are not limited to, similarity ofthe production 

processes, presence or absence of conditions that might affect exposure, and 

monitoring methods employed at the site(s). The potential availability of 

other sources ofsurrogate data needs to be considered and the selection of 

the surrogate data used for dose reconstruction justified. Some ofthe 

questions to be considered where appropriate are: 

•Are there other sources ofsurrogate data that were not used? 

•Do these other potential sources contradict or undermine the application 

ofthe data from the selected site? 

•Are there adequate data characterizing the site being used that would 

help support its application to other sites? 

•Do the surrogate data reOect the type of operations and work practices 

in use at the facilities in question? 

Surrogate data should not be used if the equivalence ofworking conditions, 

source terms, and processes ofthe surrogate facility to the one for which dose 

reconstructions are being done cannot be established with reasonable scientific 

or technical certainty as outlined here. (emphasis added for use below) ) 

The review panel notes that it is highly unlikely that the surrogate data for internal 

exposures accurately reflects the Hooker site, since the processes were just being 

developed in 1943-44. This is supported by testimony from a former Hooker worker 

about the on-the-job creation ofprocesses (see "Data Capture Document Discovery and 

Review: Documented Communication with 6 regarding Hooker 

Electrochemical,'' dated January 14, 2010, p. 2) . The earlier hazardous environment at 

Hooker is further supported by statements such as the "dust" was so thick that the "gas 

mask cartridge had to be changed at lunch" (Ibid at p. 3). These process details are not 

found with the surrogate site characterizations and they argue for potentially much more 

severe conditions at Hooker than the surrogate sites. Additionally, a "process" which 

entailed opening barrels ofslag and dumping the material through a sizing screen onto a 

conveyor belt (see Hooker Evaluation Report p. 13) is by its very nature idiosyncratic and 

subject to very wide variations in the way it is carried out and the resulting dust dispersal. 
The Honorable Sylvia M. Burwell-Page 18 

The review panel took special note ofthe major documented changes to the work process 

post-1949 as reflected in statements in various references (see, e.g., Site Profiles, p. 52: 

"Clearlr, the mean concentration drops rapidly from 1948 through 1950, from 7,400 

dpm/m to 350 dpm/m3 (a factor of over 20), as engineered workplace controls were 

installed at the dustiest locations. Alpha-emitting dust concentrations for the years 1953­

1957 are roughly 100 times lower than they were in 1948."; and NIOSH Evaluation 

Report for Electro-Met ("SEC Petition Evaluation Report: Petition SEC-00136, Report 

Rev.# 0, 04/21/2009"), p. 17) states:" The hazards represented from uranium-bearing 

dust in the air were well documented, particularly in the years preceding 1948, with 

exposures greater than 500 times the tolerance level of the day being routinely 

measured."; and the data in Figure 1. (above) from Christofano (1960), where it is 

especially noted that there were major improvements in the operational processes post1948. This calls into serious concern whether "surrogate data reflect the type of 

operations and work practices in use at the facilities in question" and lead the panel 

to conclude that "surrogate data should not be used" since "the equivalence of 

working conditions, source terms, and processes of the surrogate facility to the one 

for which dose reconstructions are being done cannot be established with reasonable 

scientific or technical certainty" (see underline above) for the Hooker operational 

period in the mid 1940's with data that is almost exclusively post- 1948. The Christofano 

paper describes the working conditions before and after the 1948-1950 time period, and 

provides a wealth of data, all of which has been collected in later years. 

4. 	 Temporal Considerations: Consideration also needs to be given to the period 

in question, since working conditions and processes varied in different 

periods. Surrogate data should belong in the same general period as the 

period for which doses are sought to be reconstructed unless it can be 

demonstrated that the working conditions, procedures, monitoring methods, 

and (perhaps) legal requirements were comparable to the period in question. 

The review panel does not consider the data from selected surrogate sites to meet this 

criterion. As in 3. above we again note that there are multiple references to the fact that 

process conditions in the early 1940's were substantially worse than those after 1948. 

For example, Christofano (1960) and the NIOSH Evaluation Report for the Electro 

Metallurgical Corporation ("SEC Petition Evaluation Report: Petition SEC-00136, 

Report Rev.# 1, 01/31/2012") states (p. 21): 

"The primary source of internal radiological exposure resulting from 

ElectroMet operations was inhalation and/or ingestion of uranium metal or 

uranium tetrafluroide. The hazards represented from uranium-bearing 

dust in the air were well documented, particularly in the years preceding 

1948, with exposures greater than 500 times the tolerance level ofthe day 

being routinely measured (Dust sample Results, Aug 1949." 

In addition, with respect to our conclusions regarding temporality, see also our additional 

comments above under Findings 2 and 3 in Section A. 
The Honorable Sylvia M. Burwell-Page 19 

5. 	 Plausibility: The manner in which the surrogate data are to be used must be 

"plausible" with regard to the reasonableness of the assumptions made. The 

plausibility determination should address issues of: 

• 	 Scientific plausibility. Are the assumed models (e.g., bioassay, concentration 

gradients) scientifically appropriate? Have the models been validated (where 

feasible) using actual monitoring data collected in a similar situation? 

• 	 Workplace plausibility. Are the assumed processes and procedures 

(including monitoring) plausible for the facility in question? Have all of the 

factors that could significantly impact exposure been taken into account? Is 

adequate information available about the facility in order to be able to make 

a fair assessment? 

With respect to "scientific plausibility," the review panel notes that there is no evidence 

that the models have been validated for the Hooker case since no measured data exist for 

Hooker by which such validation may occur. In addition, the values used pre-1949 are 

averages for which the maximum is unknown so it is not scientifically plausible to use 

them to place upper bounds on the doses. 

Regarding "workplace plausibility," as stated above, the surrogate workplaces used for 

Hooker - Electro-Met, Mallinckrodt, and Fernald- were demonstrably different in time 

and processes to such an extent that any remaining similarities are of questionable 

scientific value for determining Hooker processes and internal exposures. 

Claimants will have significant concerns about the credibility of using surrogate 

data. To the extent that the use of surrogate data for individual dose reconstruction 

can be avoided, this will help to minimize concerns about the credibility of the 

individual dose reconstruction process. This is especially important given that the 

use of surrogate data often relies on information on the operations and 

characteristics of industrial facilities operated many years ago. Many of the people 

knowledgable about the facility have died, and records are usually incomplete 

(which is the reason for needing to use surrogate data in the first place). Given the 

difficulties in obtaining the comprehensive information needed for validating the use 

of surrogate data for individual dose reconstruction and the inherent concerns 

about its use by claimants, the Work Group recommends that the use of surrogate 

data be limited to the circumstances where other approaches are not feasible and 

then only after the rigorous review of the proposed use to determine if the above 

criteria have been fully met. 

The review panel concludes that it is demonstrable, if not self-evident, that these criteria 

have not been fully met regarding the use of surrogate data for internal exposures to 

employees ofHooker during the operational period from 1943- 1948.3 

3 In performing this review, the review panel took note of a working document prepared by David Allen (a 

NIOSH contractor), dated April 2011 - updated May 2011, and titled "Surrogate Data Evaluation - Hooker 

Electrochemical Company." While we acknowledge the views expressed in that paper, we note that our 

analysis is in ahuost complete disagreement with the conclusions ofthat evaluation. 
The Honorable Sylvia M. Burwell-Page 20 

Section C. Review Panel's Analysis of 76 Points Raised on Appeal 

As explained on page 2 ofthis report, the petitioner's appeal consists of a total of 76 

separate points identified in the February 29, 2012, appeal letter (AL), the attachment 

to the appeal letter (AX), and the July 31, 2012, addendum to the appeal (AD). In this 

section, these 76 points have been categorized and grouped into several common 

subject areas, although some ofthe points seem to include overlapping and, at times, 

difficult to characterize issues. The review panel has done its best to address each of 

the appeal points. We did this to ensure that we were in accordance with our 

responsibility to respond to all ofthe petitioner's arguments and challenges, in 

addition to that of the surrogacy-related issues. For each category, we have included a 

reference to where the issue was raised in petitioner's appeal documents, our analysis, 

and conclusion. 

Surrogacy Issue 

The use of surrogate data is the major part of the Appeal, and is raised directly or 

indirectly in the following specific challenges 

AL-3, 4, 7-10, 12, AX-1-4, and AD-2, 6, 9, 10, 12, 14, 17, 19-26, 28, 30-42, 45-46, 48­

60: 

The review panel's opinions and recommendations with respect to surrogate sites and 

surrogate data are addressed fully in earlier Sections A and B ofthis report, and are not 

further discussed here. The review panel considers this issue to have significant merit, 

and concludes that this issue points to substantial factual error in the final decision to 

deny SEC status to employees ofHooker during the operational period from 1943- 1949. 

The 180-day Rule 

AL-1, and AD-8: 

The petitioner alleges that "NIOSH passed the 180-day requirement for evaluation" (AL, 

p. 1). The requirement to which she is referring is set out in both statute (see 42 U.S.C. § 

7384q(c)(l)) and in the EEOICPA SEC regulations at 42 CFR 83.13(e), and indicates 

that NIOSH must submit its recommendation and evaluation report to the Board within 

180 calendar days ofreceiving the petition. We understand that an Interim Final Rule 

amending the procedures for designating a class to the SEC published on December 22, 

2005 (70 Fed. Reg. 75949), as well as the references in§ 83.13(e) to § 83.11 (which sets 

out the procedures for qualifying a petition), make clear that the 180 days is counted from 

when a petition qualifies for evaluation, not from when it is first received by NIOSH. 

The review panel believes that the petitioner is correct that NIOSH failed to " ... submit a 

report ofits evaluation findings to the Board and to the petitioner(s)" (42 CFR § 83.13(d) 

and "within 180 calendar days ofthe receipt ofthe petition by NIOSH" (42 CFR § 

83.13(e). The petition was received March 6, 2009, was qualified on October 16, 2009, 

and the SEC evaluation report was submitted to the Board May 3, 2010. 
The Honorable Sylvia M. Burwell-Page 21 

However, the review panel does not feel that the missed deadline qualifies as a 

substantial error in the procedures of 42 CFR part 83. There is no penalty provision 

specified in the regulations for missing the deadline, and considering the complexity of 

the petition and the fact that the delay was only a few weeks, the review panel did not 

believe the missed deadline had a substantive effect on the outcome of the petition for 

SEC status. 

Radiation Sources 

AD-3, 4, and 27: 

We interpret several ofthe petitioner's challenges to be about the appropriate 

consideration of external source radiation and medical x-rays. The panel does not 

consider external x-rays to be a significant contributor to cancer risk relative to the 

uranium dust exposure that occurred at Hooker, where internal exposure to alpha particle 

irradiation would be the predominant radiologic hazard. As indicated in Section 7 .2 of the 

Hooker Evaluation Report, "The principal source of internal radiation doses for members 

ofthe class under evaluation was inhalation of uranium-bearing dust that was generated 

during the processing of uranium-bearing slag material (C-2 and C-2 concentrate)" (p. 

24 ). Therefore, the review panel does not judge challenges based on external radiation 

sources to be significant relative to the determination to deny SEC status in this instance, 

and does not believe that petitioner's challenges related to radiation sources constitute a 

substantial factual error. 

Freedom of Information Act Requests 

AL-2, 5, 6, and AD-43, 44: 

We understand that the petitioner submitted two separate requests under the Freedom of 

Information Act (FOIA) for documents related to the Hooker SEC. The petitioner states 

that at the time ofthe determination by the DHHS Secretary, she had not received all 

FOIA requested material and that she was questioned as to what material she was 

seeking. However, after the petitioner received documents in response to her first FOIA 

request, in which she was essentially seeking the package ofmaterials sent to the 

Secretary in order to make a determination, she was allowed to file an addendum to this 

appeal to include information made available to her as part ofthe FOIA request. 

In petitioner's second FOIA request, she was seeking all emails pertaining to Hooker. In 

her appeal, she seems to be alleging that, had she had these emails, she could have 

provided further information to the Board in her favor, the Board may have voted 

differently and, thus, the Board should have waited to vote until she received the FOIA 

requested information. The transcript ofthe Board's December 7, 2011, meeting in 

Tampa, Florida, at which the final vote was taken, shows that the Board addressed the 

fact that petitioner had not yet received a response to this FOIA request and concluded 

that they did not want to delay the vote to wait for a broad data request, rather than for 

technical documents. In fact, the Board noted that the second FOIA request "was a rather 

generic request for all email traffic ofwhich now NIOSH has identified some 4,000 

documents" (Transcript, December 7, 2011, Advisory Board meeting in Tampa Florida, 

p.123) and "is unlikely to uncover a great deal of new, or any new technical information" 
The Honorable Sylvia M. Burwell-Page 22 

(Ibid at p.124) and that they "have never delayed it for sort of a broad data request, 

particularly one dealing with emails and other information, not for technical documents" 

(Ibid at p.163). The review panel does not consider this action by the Board to rise to the 

level of a substantial error in the procedures of 42 CFR part 83. Furthermore, with 

respect to DHHS's delay in providing the FOIA response, the EEOICPA SEC regulations 

are silent with regard to FOIA, so it is not possible for this delay to constitute procedural 

error under 42 CFR part 83. 

Advisory Board Process Issues 


AX-2, and AD-41, 43, 51, 52, 54, 57, 59-60: 


The Petitioner's general challenge is that the Board "was too much in a hurry to deny 

Hooker" workers eligibility for SEC status (AX-2). She attempts to reinforce this 

perception many times. The review panel feels that the petitioner's concern may have 

merit. Upon extensive review ofthe transcripts of the Board (and aware that transcripts 

may be interpreted out of context), we found numerous examples where members ofthe 

Board, and the working groups, asked questions regarding surrogate data use which 

appear to have never been satisfactorily answered. Often these questions were answered 

as a deferral to a working group, or as a previously resolved issue. In reviewing these 

transcripts, the review panel never found specific answers to these critical questions. 

Examples concerning the seemingly rushed decision making process are included in 

Appendix IV and some excerpts of these are cited below. 

Sometimes the answers to questions appeared to be misleading or incorrect, such as the 

dialogue at the December 7, 2011, Board meeting in Tampa, Florida, between Board 

Member David Richardson and Dr. John Mauro from Sanford Cohen & Associates 

(SC&A), a Board contractor, in which Member Richardson made the incorrect statement 

that "the process was relatively consistent over time and so despite the fact that samples 

are separated by a period of 15 years there's a sense that there weren't process changes." 

(Ibid at p. 139). (For more lengthy excerpts from this dialogue, as well as other 

discussions from this meeting described below, see Appendix IV, "Excerpts from 

transcript ofDecember 7, 2011, Board Meeting in Tampa, Florida," p.13 8, line 10 to p. 

141, line 16.) As explained in Sections A and B above, the process of uranium refining 

was not constant over time, and changed dramatically during the 1948-1949 period of 

time due to concerns about the hazardous uranium dust levels. 

Another example ofmisleading or incorrect statements made during Board meetings can 

be found in the dialogue between Dr. Jim Neton, from the Division of Compensation 

Analysis and Support, NIOSH, and Board Chairman James Melius, during that same 

December 7, 2011, meeting, where the fact that Hooker operated earlier than 194 7 was 

not clarified. This discussion includes Dr. Neton's false question or statement: 

" ... that the surrogate data used for the natural right dumping operations 

collected between 194 7 and '59. So all the surrogate data was in that time 

frame. And I forget the years now that Hooker is under review for but it's 

in that same." (Ibid at p. 141) 
The Honorable Sylvia M. Burwell-Page 23 

The implication ofthis discussion was that Hooker operated only during that period. The 

fact is that Hooker began operations in January l, 1943. 

Finally, we see evidence of doubt in this same meeting just before the final vote, when 

Board Member Bradley Clawson, in a discussion with Board Member Henry Anderson, 

sums up his concerns about the use of surrogate data (Ibid at p. 152): 

"I guess, you know I realize we have to use surrogate data and we've had 

high debates over surrogate data. But the thing that bothers me about 

Hooker a little bit is how much data do you have? According to the 

paperwork there, zero. Is there any air sampling data from them or 

bioassay from Hooker? So it's zippo. And I understand, I just really have a 

hard time using surrogate data from a site, three sites actually that are in 

question, in my mind in question. I just, that to me is using, you know, you 

can use as much information as you want but ifit's no good. Just 

wondering." 

These are a few examples from the Board transcripts of apparently unanswered questions 

or statements, some ofwhich occurred in the meeting during which the vote to deny SEC 

status was taken. This raises the possibility that if these questions by Board members had 

been correctly answered, the final vote might have been different. In spite of these 

incomplete answers, the review panel cannot conclude, on the basis of the evidence we 

were given, that the overall process with which the findings were reached constituted a 

substantial procedural error as per 42 CFR part 83. The processes with which the 

meetings were conducted were, in general, procedurally correct. Although some 

individual members raised relevant questions, which the review panel felt were never 

completely answered, the final decision was a collective Board decision. However, we 

do note that if these omissions conceptually affected the Board's vote, which in tum 

impacted the Secretary's final determination, then this could rise to the level ofboth a 

substantial factual and procedural error. 

Outside of the Scope of the Panel's Review 


AL-11, and AD-1, 5, 7, 11, 13, 15, 16, 18, 29, 47, 52, 53, 56: 


The petitioner also raises a wide variety of administrative and miscellaneous issues 

throughout the appeal. These challenges include, but are not at all limited to, issues 

relating the Ombudsman, the Ten Year Review, updating the Federal Register, unrelated 

sites, and employee interviews. The review panel believes that these points raised by the 

petitioner are outside the scope ofthe panel's review.4 Accordingly, although we have 

4 SEC regulations at 42 CFR § 83.18(a) make clear that proper challenges must "include evidence that the 

final decision relies on a record of either substantial factual errors or substantial erfors·in the 

implementation ofthe procedures ofthis part." In addition, challenges "may not introduce new information 

or documentation concerning the petition or the NIOSH or Board evaluation(s) that was not submitted or 

presented by the petitioner(s) or others to NIOSH or to the Board prior to the Board's issuing its 

recommendations under§ 83.15." Thus, to the extent that the petitioner in this case included information 

in the appeal that was not evidence of a substantial factual or procedural error, or any new information that 

was not previously submitted to NIOSH or to the Board, we believe it is outside the scope ofour review. 
The Honorable Sylvia M. Burwell-·Page 24 

addressed these administrative issues insofar as we have carefully considered them and 

analyzed them, we determined that they are outside of our charge, and did not reach a 

conclusion with respect to whether they have merit. 

Overall Conclusion: 

Based on the documentation provided to the review panel in this case, we conclude that 

petitioner's challenge has merit in regard to the application of surrogate data to evaluate 

the eligibility for SEC status ofthe subset ofthe Hooker workers employed during the 

operational period from January 1, 1943 through December 31, 1948. We unanimously 

find that the use ofsurrogate data to assess internal radiation doses to the Hooker workers 

during the operational period from January 1, 1943, through December 31, 1948, does 

not meet the standard of reasonable application of scientific methods, nor does it meet the 

standards for use ofsuch surrogate data as agreed to by the Board itself. Consequently 

we feel that the use of surrogate data in this case resulted in a "substantial factual error." 

We conclude that this error invalidates the determination that exposure could be 

accurately reconstructed for the time period 1943 through 1948 using only surrogate data. 

Thus, we recommend reversal of the portion ofthe Secretary's February 2, 2012, 

determination that denied SEC status to "All employees who worked in any location at 

the Hooker Electrochemical Corporation during the operational period from January 1, 

1943 through December 31, 1948." 

However, because ofthe different timeframe and very different working conditions along 

with a greater amount ofmeasured data that existed after January 1, 1949, we do accept 

the basis for reconstruction of doses for the Hooker workers in the "residual period from 

January 1, 1949, to December 31, 1976." We conclude that the petitioner's challenge 

with respect to this subset of workers does not have merit and we therefore recommend 

that you uphold the portion of the Secretary's February 2, 2012, determination that 

denied SEC status to workers at Hooker during the residual period from January 1, 1949, 

to December 31, 1976. 

Sincerely, 

[Signature on File]

Orhan H. Suleiman, M.S., PhD, FAAPM, FHPS 

Senior Science Policy Advisor 

Center for Drug Evaluation and Research 

Food and Drug Administration 
Honorable Sylvia M. Burwell-Page 25 

[Signature on File] 

d, hD 

Chief, · therapy Development Branch 

Radiation Research Program (RRP) 

Division of Cancer Treatment and Diagnosis (DCTD) 

National Cancer Institute/National Institutes of Health 

[Signature on File] 

J

DireciQt, Radiation Research Program (RRP) 

Division of Cancer Treatment and Diagnosis (DCTD) 

National Cancer Institute/National Institutes of Health 

Attachments: 

Appendix I - Petitioner's Appeal Letter with attachment, dated February 29, 2012 

Appendix II - Petitioner's Addendum to Her Appeal Letter, dated July 31, 2012 

Appendix III - Board Surrogate Data Policy, dated May 14, 2010 

Appendix IV - Board Transcript Excerpts 

APPENDIX I: 


Petitioner's Appeal 


Letter with Attachment 

(b) (6) 


'"R£CEIVEO "' 

Mii 07 ,2012 09:09:39 WS# 20 

OSl'l.JM: 030720121011 

OFFICE OF THE SECRETARY 

Dawn L. Smalls 

Executive secretary to the Department 

of Health and Human Services 

200 Independence ~ve sw #603H 

Washington, DC 20201 

Re : SEC Tracking Number SEC0014 l 

Dear 	Ms. Smalls: 

Please accept the following as the reauirements set up for 

filing a request for an Administrative Review by the threeperson panel in regard to the Secretary's agreement with the 

~dvisory Board's decision to deny qranting an SEC status for 

all employees in all locations of Hooker ~lectrochemical Corp. 

headquartered in Niagara Falls, NY. 

·,.,re, the petitioners, list the :t'olJowinq arguments in favor of 

a reversal. 

1. 	 The SBC status rightfully should h~ve b~en granted when 

N~OSH passed the 180-~ay requirement for evaluation. 

This ruJe is still on the books as evjdenced by current 

s~c petitions under evaluation . Sither the rule applies 

or it doesn't. 

WHY ~AS HOOKER TREATSD THIS WAY? 

2 . 	 NIOSH has requested the FOIA in Atlanta to forward all 

material to the petitioner that was sent to the Secretary 

prior to her decision-making on Hooker. This has net been 

accomplished. Therefore, asking the petitioners to 

respond via this ~equest for an ~dministat ive Review is 

not glving "due process". 

WHY I5 HCOKER BEING TRZATE~ THI~WAY? 

3. 	 •The Work Group on Hooker dealt within a program called 

TDD-600l (Battell~) fer a leng~hy time making all determinations on so-Cft1)ed fincings. Then after the petitioner pointed out some thJngs in the evaluatjon of 

NTOSFJ's Zv&lu?t~on, whi~h ha~ passed the ien-d~y re1uic~­

::i!?nt , !;UdrJenly thP T1D 1•1tis !na:.iP- 1 st.?.nd<>.1orie and the 

Group .,.as di:-termir>ed to use •·sul'.".r.0gate data'' . ';'ney ev<:n 

changed the name of t he group. In the past , companies 

such as Hooker, no longer in existence with no records 

were automatically granted the award as lonq as claimants 

~in work for an atomic locatJon anc did become ilJ or died. 

This method should have still applied for Hook er. 

'.'H-!Y ·::As :-i:orK:::R ':.'R[;ITt;D TIES ~;:i.y? 

• see 	Attachment 
-- ~ --- - ------------

"'RECEIVED'" Mar 07,2012 09;0.9:39 WS# 20 

OSNUM: 030720121011

OFFICE OF THE SECRETARY 

CORRESPONDENCE 

CONTROL CENTER

-2-

SEC Tracking Number SEC00141 

~rguments Continue£: 

4. 	 'Ihe use of ., surrogate data" in dealing with compensatory 

programs is not viewed favorably even by all members of 

this Advisory Board. Yet the Work Group insisted on 

accepting it with the Hooker claim. NJOSH se~rched and 

found three companies that they thought did the same 

process as Hooker. These c ompanies are Mallinckrodt , Electromet and Fernald. Only MalJinckrodt had been 

granted an sec in the past and only because the Board 

felt that there were insufficient cecords and the 

Congress failed to act wit~in the 30 day requirementp 

The other two were still being considered by other work 

groups when the Hooker ~ork Group made its decision to 

deny. ~allinckrodt is still in business and there were 

insufficient records but the Work Group and NIOSH saw 

fit to use it as ''Surrogate Data" for Hooker which no 

longer exists. How can the Work Group be 100% certain 

that they can trust Mallinckrodt's procedures? 

6REAKJNG NEWS: 	 The Majority of the surrogate data used 

to reconstruct dose is from Fernald. 

The Chair of the Pernald 1'iork Group 

stated that the '•'ork Group cannot verify 

the accuracy o~ the air monitoring used 

for Hooker Chemical . Therefore, NJOSH 

can~ct guarantee that the data they used 

from Fernald is accur3te. Since this 

data cannot be verified as tru e air 

monitorl ng re3dings , it cannot h e u~A~ 

tc reconstruct ~cse . 

Jn arlditjon it shoul~ be n0ted thct ~er~al~ h3~ e~2n 

heen cited ty ~court for !mproper hAn~1inq nf records 

in cr~ec to deceive . 

Bi1E AJ< ING N2WS: 	 hi JOSH H.!\:, R:::VP.RSE Ll Il'S :::: E:CISJON 0N 

ST. SCT~OMt:T ~.NO CLI\ n:s I1' CAt-rnOT DO 

··oosr. RECCN.:>1'RTJC'!'JON". 

Please note that both of these annouccements above ~ere 

made 	 just recently whjch is after the denial of the 

Hooker SEC ~e~ition. The Soard was in too rnuch of a 

hurry to deny . 

The cluirr1 beln9 	maC:<: re9arcl.1ng tne prucess u::;..;:~: bv 

these ccm~anje& is that lt 1s 51n1lar to ~~LJke~. 

Ho•"·~ver, since the ~·os i t.j on t<J.J..:en :i. s that it \v.3.S both 

an inside 3nd o utside proc~ss, the p~citioners disagree 

since they know 	it ffiainly as an inside jnb. ~o evidence 

has been giver. to indicate othe::1..:ise. 	 · 
-3-	 •••RECEIVED'" 

Mar 07,2012 09:09:39 WS#:tO 

OSNUM: 030720121011 

OFFICE OF THE SECRETARY 

CORRESPONDENCE 

CONTROL CENTER 

SEC TrackinQ Number SEC0014l 	

~rguments Continued: 

5. 	 nefcre the BoRrj vot ed, tl·H:i petitioner asl:td for rnore 

time sincE=- the i:eq~ie::;t for ln.Eorm<lt: ·ion ft"on P')JI'... rn3:le 

Jr August 2011 had ~ot been Lecoived. This request was 

denied. They went ahead and voted de~ying th~ petition. 

It w&s not a unanimous riecision. Consi~~rinq NIOSH's 

"faux pas 11 on t:ie lEiO- day requir ement , the qu~s tion 

aqa i n is, 

WHY 11:As !-IOCK;!;R TRC:l\TE:'1 TP.Jf. 1·IAY? 

6. 	 The Federal ~dvocate, at the behest o f the Chair of the 

A..dviso.cy Boarc, callee the petitioner to find ·out 1r1hat 

in£ormation was looked £or from FOI' · Th~s is d~nying 

the right of the petitioner to sear.ch for information. 

The petitioner objected to the Board abou t this cross 

examination anc it demonstrates or.cP. again further proof 

of how much in a hurry the Roard was to deny the petition. 

7. 	 There JS st.iJl the question 0f the tise ~f '

1 surro1ate 

data'' in order to use ccse ceconstruc:tion . r<either of· 

these two pl'.'ocedures shouJd hnve been userl for 

Hooker sine~ jt no longer exists ar.d there are no recoc?s. 

Tne Federal Advocate ~..ias involved in the creation of dM.e 

reconstruction and has been terrr.ed by petitioners as a 

"person of conflic ~ of in terests" and this cslso gives proof 

that NIOSH is bent on using this method no matter what. 

The use of "surrogate data 11 plays an important role for 

NIOSH in order to use "dose reconstruction". Once again, 

neither should be used in regard to Hooker since Jt no 

longer exists and there are no r ecords . 

viHY \•1AS HOOKER TRi::.U.1'ED 'I'!-nS '!!A Y? 

B. 	 •The Board has requested the EPA ~o further support their 

use of nsurrogate data'' . This request was made and not 

ans~ered before tne vote. The pe~itioners have not been 

not1fied even yet if it has ever been answered . This 

information should have.been re~uested lon~ ~efore and 

no vote taken until received. ~gajn, further proof of 

the rush on the part -or tne Board ~o deny . 

";t.JV "· .... 

"See attachment 
----- --- ----------

'"RECEIVED"' 

Mar 07,2012 09:09:39 WS# 20 

OSNUM: 030720121011 

OFFICE OF THE SECRETARY 

CORRESPONDENCE CONT~OL CENTER 

- 4-

SEC ~racking Number SCC0014J 	

Arguments Continued : 

9. 	 The Work Grau~ and the ;dvisory Board have become so 

dependent on the use of "sui::-rogate data" that they have 

beco~e blinded by their own methods . Case in ?Dint , at one of the teleconferences that the petitioner was 

allowed to listen in on, one of the Board members 

C'IUestioned , "J:f we <ion ' t use surrogcJte data, what ca.n 

we use? ue use surrogate data ~veryday . I use it when 

I decide hov.• J am qoing to prepare my zucchini. Ha, ha ." 

~ell, the answer is don ' t use it for companies that no 

Joncer exist and there are no records. The Board members 

sho~ld have realized that paying the awards would certainly be less. expensive than all the ''rigamarole'' that 

these groups have expended and the fact that they hav~ 

gone way beyond the original executive order or "act" 

siyned by President Clinton to ke~v thjngs simple and 

not to frustrate the petitio~ers. S~rrogate data ~ay he 

$Omethiny to joke about by Doa~d ~embers ~ut to the 

petitioners it has b9come a very serJo~s i~su~. 

lC. 	 '!'his p'anel i.s fol lo\~ing the "rule of three•· . So such a 

rule does exjst. Usi ng Ma l linckrodt ~lone does not serve 

tre rule o-: ttree - \!hy three:: c.oMpanies and then go do1·m 

to one7 Jn the rule or three , selections are maie of 

compan ies thut a.1:;e wi till n c Jose proximlty to the company 

being analy~ed . If not that cJor,e, then within the same stat~. This was not done with the Hooker claim. The 

only company that may have qualified in this designation 

would have been Electromet. Howe v er, F.lectromet has now 

been disqualified by NJOSH itself since it cann~t do 

dose reconstruction. Again, proof of ho~ much in ~ hurry 

the Eoard was to deny . 

WHY ~AS HOOK~R TR~AT2D THJS WAY? 

ll. 	 The petitioners found that the role of the ombudsman did 

not serve them weJJ after t~e init1al stages. Filing for 

the szc was encouraged by ~he ombudsman and assistance 

~as given in the correct phrasin~ ~efore filing. However , 

es time went on , it was more and more ~ifficvJt to aet 

ombudsman help. The reasons given were the overloiid of 

case s, phone messages , e-ma iJs , etc . to h~ndl~ . Also, 

that th1s Pact" doesn't al low more h elp. The OJl'lbudsman 

did make a· request of the Federal Advocate to have a μhone 

conference witn the ~etitioner, ~~t it never hap?ened . 

Instead the Federal .'\evocate told Hie ombudsman that he 

could well understand how laymen foun d it difficult to 

understand all the scient1£ic jargon. This is further 

proof of not keeping i t s1mple and frustratin~ the 

petitione.t. s. 

~HY ~AS HOOKCR TR~ATED THI S WAY? 
···RECEIVED••• 

Mar07.2012 09:09;39 WS# 20 

OSNIJM; 030720121011 

OFFICE OF Tl£ SECRETARY 

CORRESPONDENCE 

CONTROL CENTER

. 

-5-

SEC Tracking Number SEC00141 	

Arguments Continued: 

i2. 	 Included in this ~recess is the Work Group's use of 

SC & A to review ~IOSH's findin9s. Upon advice from 

the ombudsman, the petitioner requested the input of 

SC & A. This was a mistake since SC & A really did 

not do a fair job. Even when they found differences, 

they conceded to ~IOSH ' s findings saying because it was 

more favorable to the claimant. ~hen questioned by the • 

petitioner how was it more favorable - SEC or dose 

reconstruction? Tha SC & A response was dose reconstruction. The truth is SEC is more favorable. 

As turn of events will have it, the petitioners suggest 

that this group be investiqated for allowino the 

atmosphere of "rnakinq book11 on its employees to e:<ist 

in the work pJa~e. 

1 111HY T:JAS HCOJ<::R 'l'RS.~TJ:;D TtU.S 1°1.4.Y? 

We, the petitioners, therefore , r el!uest tha t the Board's denial 

be rejected. We also request that the three-person panel deem 

it necessary for the in£ormat1on from all of the F'O!A locations 

that have not so far complied with the requests from the 

petitioners and NIOSH be made available to the petitioners 

without delay. Also that the app~al to F0IA be speeded up. 

This request definitely spells out that the three- person panel 

set a 11moratox: ium" on the SEC status for. Hooker and that 

Congress be advised 0£ same in order to allow the oetitioners 

access to the FOIA material and tlme to digest it.· After all 

of this is handled properly, the ;etitioners are :ertain that 

the panel wilJ encou=age the ~ccretary to reverse her decision 

and Hooker will be granted SEC status. 

The petitioners thank the panel for the time spent with this 

Review and know ~hat after realizing the truth of the present 

situation and the latest developmer.ts coming from discoveries 

about Electromet and ~ernald, they will encourage the Secretary 

to reverse her decision and then notify Congress accordingly 

that Hooker ~lectrochemical Corp. workers in all locations 

have been added to the SEC category. 

PL:ASG NOTE THI.,,T AN ATTACHMSNT HAS BEi:N ADDSD 11HTH CURRC:NT DATA . 

Very 	rruJy yours, 

(b) (6'1 
 ---.. ­ ~eprPsentative fc~ PPl1 tion~r 3 
•"RECEIVED"' Mer 07,2012 09:09:39 WS# 20 

OSNUM: 030720121011 

OFFICE OF THE SECR.CTARY 

CORRESPONDENCE 

SEC Tr~~h<ijNTffl.imber SEC00141 

-6-

ATTACHMENT: 	

Further ~~guments in suppo!t of a reversal to give Hooker 

Electrochemical Corp. workers the SEC Status. 

1. 	 The petitioners suggest that the three-person panel consult 

this link Jisted below to see what the Advisory Board has 

laid out as a foundation for surrogate data: 

www.cdc.gov/niosh/ocas/pdfs/abrwh/proc/abrwh-proc-sd-rO.pdf 

This is dated May 14, 2010. 

As you can see, it is very general and could be made to go 

along with any choice made as surrogate data. ~t is not 

credible. When the ~etitioner asked NIOSH who the author 

was. the response was that there was no author. This did 

not allow the petitioner to discuss this forroat with anyone 

to tie ln a~y historical backgrcund on surrogate data. The 

reference given by NTOSH anG also found by the petitioner 

is exfJained in the main body of this Request for Review 

whereby a co~pany must be close by or no farther than the 

same state. 111h en t he petitioner explained this to the 

Board, an objection was raised and this fact was reject~d. 

The petitioner still su~ported it and tnere has been no 

follow-up frcm the Board. Surrogate data cannot be turned 

into anything to suit NJOSH's decisions. They claim that 

they are following the guidelines from the 3oard. However, 

the guidelines are not credible. Simplicity would say the 

following: 

a. 	 Is the location an atomic worker location? Yes or No 

b. 	 \.'las the person an employee of t.:-is location? Yes or No 

c. 	 Did the person have a serious illness? Yes or No 

d. 	 Did the person die? Yes O.!'.' No 

e. 	 Are the survivors '.vho they say. they are? Yes or No 

End 	 of story. 

If fraud is suspected in any of these categories, i t 

can 	be ha.rid led by a fr a 1.ld unit. 

E:nd 	 of .story. 

Tryjng to put peo~le and their sickness into a percentile 

is realJy out of line. 

With all due .:=espect to th.z- people running tt1ese g.coU}JS 

an~ their education and bac~ground, simplicity i~ not 


lhejr "'forte". 


...

~ 
•••RECENED ••• 

Mar 07,2012 09:09:39 WS#20 -7­ OSNUM: 030720121011 

OFFICE OF THE SECRETARY 

SZC '!'r~~~~~~i~mber SECC.0141 

2. 	 An Advisory Eoard session was he l d on rebruary 28, 2012 

to discuss Electromet. The Bodrd voted to give the sec 

status t0 this corn~any. Once aqain, the Board was too 

much in a hurry to deny H-:ioker-. 

The basis for giving the 3:C is that th~re wa5n't suFficlent 

documentation to do dose reconstruction by NIOSH. Sven 

SC & A's input didn't counterac t this decision. 

Remember Clectromet is the only company of the three 

(surrogate data) in close prox imity to Hooker. Having 

been given the SEC takes it o u t of the grouμ of three. 

This leaves two. 

Fernald represents most of ~he documents used against 

Hooker and Pernald has also been eliminated since dose 

reconstruction cannot be done. This new l eaves one. 

Mallinckrodt is too far away for a choice as svrrogate 

data and so that lea"\eS zero. The manner in which 

Mallinckrodt received an S3C is suspect anc goes hack 

as another company with insufficient records. So how 

can NIOSH, SC a A, the Work Group o~ the ~dvisory Bourd 

recognize it as v alid in judging Hooker? •SEE SELOW-N.B. 

3. 	 Tn listening in via t h e teleconference on Februar y 28, 2012, 

the petitioner was amaz~d at how difficult it was for the 

NlC.SH rep to try to ~xplain t h eir decision change. Here 

are some comments - sound bites if you wiJl: 

a. 	 Air data doesn't make sense 

b. 	 Much better after 1948 - no documentation existed 

before that time. 

c. 	 Major health improvements but NIOSH doesn't know 


what they did. (Health and Safety Lab) 


d. 	 Different concl~sion arrived at, can't do dose 


reconstruction. 


e . 	 GA - samples - not t oo good. 

f. 	 Electromet can't give them info needed. 

g. 	 DOL Cdn•t do without the info. 

h. 	 SC & A countered with dose reconstruction could be 

done for later years and not e~lier. 

i. 	 Chair of the Work Group understood the stand of both 

but felt the group hadn 't had enough .time to study this. 

J · 	 Objection from the Doard that doing partials - giving 

a segment of worke~s the s~c and the others not had 

not worked in the past. 

FINALE:: SEC given to ~lectromet. 

•?lease 	Note We ll: ~s erious lawsuit has just recently been 

Filed against ~aJljnckrodt fo~ cont3minating 

Cold Water Creek with ~uclear wastes based 

on resident s develo~ing various cancer 

condit~ons who are under age 50. 
------- '"RECEIVED"' 

Mar 07,20t2 09:09:39 WSJ20 

sec Tai:mtii!~~n1Q21cN\Jrnber .:.EC0014 l 

OFFICE OF THE1lECRETARY 

CORRESPONDENCE 

ATTACHM~NT - Continued 	

4. 	 As a reminder to this panel, referen~~riw~mi'rfude in the 

ma1n body of this Req~est for Review to the TBD. One 

of the comments that really cinches or clinches the truth 

about this is the following· made by NIOSH and i t i s : 

"After the TBD fell apart or whatever way you want to 

say it ••• " 

A slip of the lip - probably not. T~e truth will out. 

Jn cc>nc)u$:ion , t r 1j 5 e.tta.chment illust rates .furl·ller how '-iooker 

worke1:s v;er ? nis jtJd<JE>d by NJOSH, SC ~ A, t he i.toi:-k Grou p, <::. n d 

thP Advisory B0 ard. 

(b) (6) epres~nt tive for •~ it ~ners 

::' 

APPENDIX II: 


Petitioner's Addendum 


to Her Appeal Letter 

Page 1of1 

From: 

Sent: Tuesday, July 31, 2012 9:16 AM 

To: Jones, Wanda K. (DHHS/OS/OASH) 

Subject: b 6 F NY USA- HERE IS THE ADDENDUM 

Attachments: ADDENDUM.doc 

Dear Dr. Jones, 

Attached to this e-mail is the addendum to the Request for Review by the Three-Person Panel 

of the decision of the Advisory Board to deny the SEC status to Hooker Electrochemical Corp. 

petitioners. Please acknowledge receipt b'f return e-mail. This should satisfy the deadline 

imposed on the petitioners. Thank you. b (6 

file:// IC :/Users/Jocelyn.Mendelsohn/ AppData/Local/Microsoft/Windows/Temporary%20Int... 91512014 
1 


ADDENDUM OF CHALLENGES IN SUPPORT OF A REVERSAL OF THE 

DENIAL FOR SEC STATUS FOR HOOKER ELECTROCHEMICAL CORP. 

CHALLENGE ONE: 

111. Decision Criteria and Recommendations 

How can NIOSH prove sufficient accuracy ifthey have not established what this means 

according to the Ten Year Review? 

www.cdc.gov/niosh/docket/review/docket/194F/pdfs/DRAFTFINALTimeliness 

Section_5161 l.pdf 

NIOSH claims to be able to reconstruct dose for certain employees, but not all. 

this clearly indicates that dose reconstruction is very limited and restricts 

employees' rights. 

An example which further proves the drawback of dose reconstruction is the use of 

the 50% ile. In the case oflung cancer, points are taken away from the worker who 

smoked. This is not legal. None ofthe workers knew the danger they were in. They 

were not made aware that they were more susceptible to disease in this work environment ifthey smoked. No one knew what they were involved in. Probably not even 

the supervisors. Better yet, why were these men hired ifsmoking was a drawback? 

This alone should rule out dose reconstruction. 

OBSERVATIONAL STUDY: 

An example ofobservational study is one that explores the correlation between smoking 

and lung cancer. This type ofstudy typically uses a survey to collect observations about 

the area ofinterest and then performs statistical analysis. In this case, the researchers 

would collect observations ofboth smokers and non-smokers, perhaps through a casecontrol study, and then look for the number ofcases oflung cancers in each group. 

Even Sir Richard Doll who did research in the relationship ofsmoking to cancer is seen 

as a controversial figure because ofhis ties to chemical companies Monsanto and Dow 

and asbestos company Turner and Newall. He received payments from them. His 

defense was that he had to go along so that he could get the data. He also caused 

controversy when interviewed on BBC radio in 2001 by claiming that "the effects of 

other people smoking in my presence is so small, it doesn't bother me." 

Ref.: en. wikipdia.org/wiki/Richard _Doll 

Note: there are no observational studies for workers who smoked and a risk of 
2 


developing lung cancer faster than anyone else in an A WE location. 

CHALLENGE TWO: 

IV. Determination Findings 

Since TBD-6001 was cancelled, how can a Battelle-TBD-6001 Appendix AA still apply 

to Hooker? The same question applies to all paragraphs under this part IV. 

CHALLENGE THREE: 

X-ray exams, under the guise of a condition of employment, cannot be used after the 

fact when time has passed and the workers had been exposed. This data was not 

available to the petitioners. 

CHALLENGE FOUR: 

Regardless ofthe methodology used in ORAUT-OTIB-0006, this assumptive reasoning 

does not apply and is invalid for Hooker Electrochemical workers. ORA UT also carries 

a cloud ofsuspicion similar to Battelle. 

CHALLENGE FIVE: 

Health Endangerment: 

It would be impossible for the Secretary to establish feasibility to estimate sufficient 

accuracy since that reasoning is based on the NIOSH suppositions and are invalid 

according to the Ten Year Review. 

CHALLENGE SIX: 

V. Effect ofthe Determination: 

The only reason behind this Part V is to continue the ploy that dose reconstruction is 

the way to go according to NIOSH. Petitioners say it is not. It is restrictive and unfair 

to the petition process. It relies on surrogate data and results in stats from companies 

that are not true surrogates as in the case ofthose used against Hooker. 

The petitioners challenge the use ofBattelle since the Work Group ceased using it and 

went to surrogate data which was another false move since all companies selected as 

surrogate data candidates have proven to be "bogus". Also all three companies have been 

granted SEC status which further proves that their records are not trustworthy and should 

never have been used in analyzing Hooker. How can the Work Group flip from one 

(Battelle) to the other (Surrogate Data) and back again? This does not make any sense. 
3 


Remember the original law (executive order) states that the petitioners were to be 

spared frustration. This went on for several years. 

CHALLENGE SEVEN: 

FEDERAL REGISTER 

The copies submitted to the petitioners as part ofthe material used by HHS in agreeing 

with the Board's decision dates back to 2004. In light of all that has developed during the 

past 8 years, it would have been wise to update the Register in regard to this program. 

CHALLENGE EIGHT: 

Page 30765 ofthe Federal Register: 

Time limit of 180 days was proposed for determining the feasibility ofdoing dose 

reconstruction. In the Hooker case, NIOSH went beyond the 180 days, using the 

Dept. of Energy as their excuse, and got away with it. The Board should have granted 

the SEC on this fact alone. One of their reps. (NIOSH) told the petitioners that the 

RULE was not written in stone. So why should the petitioners honor anything in the 

Register? 

CHALLENGE NINE: 

Page 9 of 51 

3.3 NIOSH - Proposed Class to be Added to the SEC 

Based on research, NIOSH has obtained applicable monitoring data from other sites 

that performed similar work. So NIOSH determined that it could estimate dose from 

these sites with sufficient accuracy. 

Petitioners disagree since all the sites have been granted SEC status that were used 


against Hooker. In order to get this status, they would have to have had no records 


and NIOSH could not do dose. So how can a denial ofHooker still stand? The 


petitioners strongly object to the manipulation ofthe manner in which NIOSH, the 


Work Group and the Board went against Hooker. 


CHALLENGE TEN: 


Page 11 of 51 (bottom) 


It is clear here that the dose reconstructions done for Hooker were based on info 


from other sites. So even though the cases completed were done with dose 


reconstruction, the data is "bogus" since it is based from other sites which now 


have SEC status. You cannot trust this math! 

4 


CHALLENGE ELEVEN: 

4.5 Manhattan is mentioned but not elaborated on and leaves a void as to its relevance in 

this report. 

CHALLENGE TWELVE: 

5.0 Still repeating the dependence on other sites which info is now null and void. 

CHALLENGE THIRTEEN: 

5.1 First paragraph: Nice history but still Manhattan cannot be relevant simply because 

of a bi-product (hydrochloric acid). 

CHALLENGE FOURTEEN: 

Third paragraph: Still dependent on surrogate which has not stood the test oftime. 

CHALLENGE FIFTEEN: 


As for the employee interviews, the impression ofthese is that most of them had memory 


lapses or refused to talk so that they wouldn't ruin their individual chances at an award. 


They are just hit and miss. Any sensible person wouldn't put much stock in them. 


CHALLENGE SIXTEEN: 


Rest of this section is a nice historical interlude but does not make or break the case for 


Hooker. 


CHALLENGE SEVENTEEN: 


Lake Ontario Ordinance Works is now SEC. 


CHALLENGE EIGHTEEN; 


5.2.2 External Radiological Exposure Sources from Hooker Electrochemical Operations 


In the explanation ofPhoton, Beta, and Neutron, the implication is that there wasn't 

much danger to employees. Ifthat is the case, why did NIOSH use dose reconstruction 

for anyone? Ifthis is true, how could surrogate overcome it? 

CHALLENGE NINETEEN: 

6.0 Again, "bogus" surrogate info used against Hooker. The "so-called" scientific 

information was good enough (supposedly) to use against Hooker but not for the 
5 


surrogates themselves namely, Electro-Met, Lake Ontario Ordnance Works, 

Mallinckrodt and Fernald. How scientific is that? 

CHALLENGE TWENTY: 

6.1 Misuse once again ofsurrogate data. 


All info and stats for pages 18, 19, 20 and 21 of 51 have to be disregarded as not 


trustworthy and damaging to the Hooker SEC Petition request. 


CHALLENGE TWENTY-ONE 


6.2 No outside monitoring available at Hooker. IMAGINE THAT! 

CHALLENGE TWENTY-TWO 

7.0 NIOSH does not have sufficient information to feasibly conduct dose 


reconstructions. They have gone every which way to state their position to be 


able to do dose. However, they have failed. They cannot say that both EEOICP A 


and 42C.F.R.& 83.13(c) (1) have governed anything that they claim. They have 


truly just put up a smokescreen to crimp Hooker! 


CHALLENGE TWENTY-THREE 


7.1 Pedigree? Come on now! With pedigree, there must be the quality of"class". 


There is no class in 7 .1, 7 .1.1, 7 .1.2. Any reference to the surrogate companies makes 


all ofthe 7.1 category false. You cannot ethically use data from those companies. 


Since TBD was cancelled, its use is also suspect. 


CHALLENGE TWENTY-FOUR 


7 .2 This follows the same pattern as 7 .1 and cannot be used by NIOSH to prove 


anything. Again the use ofthe surrogates has become invalid. 


NIOSH continues to repeat and repeat how unavailable data from Hooker actually 


was and in each case used surrogate which is "bogus". 


Also the use ofBattelle-TBD-6001 Appendix AA is a poor excuse for stats. 

CHALLENGE TWENTY FIVE: 

7.2.4 NIOSH has not proven feasibility to do dose reconstruction based on the 

poor choice ofdata. 
6 


CHALLENGE TWENTY SIX: 

7.3 Again NIOSH repeats how there was no available data from Hooker and once again 


have used surrogate improperly. 


CHALLENGE TWENTY SEVEN 


The two paragraphs on the x-ray exam is a hit and miss entry. 


CHALLENGE TWENTY EIGHT 

The rest of the 7.3 's are unbelievable. Battelle has such a cloud over its head since they 

are DOE contractors, who would believe their stats? Let's not forget that they played a 

major role in creating dose reconstruction. 

Check out this link: 


http://www.eecap.org/PDF Files/ ANWAG/Newsletters/2012 July ANW AG newsletter. 


mif 

CHALLENGE TWENTY NINE: 

7.4.1 Call it poor reading skills especially in the area ofcomprehension, but the 


petitioner never stated that her husband had experienced ... 


The person or employee was the father ofthe petitioners. So one must change the word 


husband to father to be correct. 


CHALLENGE THIRTY: 


7.5 This further shows the lengths that NIOSH has gone to in order to use dose 


reconstruction and since it needs surrogate data and the surrogates are now "bogus", 


one questions why they went through all this rigamarole? 


CHALLENGE THIRTY ONE: 


8.0 Not valid since "other sites" meaning the surrogates used are invalid. 

CHALLENGE THIRTY TWO: 

9.0 Conclusion: 


Paragraph One: False since they have not established what sufficient accuracy is. 


CHALLENGE THIRTY THREE: 


Paragraph Two: False since they repeatedly claim no records available from Hooker and 

7 


their need to use surrogate which has negative aspects and is detrimental to the 


petitioners. 


CHALLENGE THIRTY FOUR: 


Paragraph Three: NIOSH has not complied with the so-called standards ofperformance 


since they are bent on using dose reconstruction which relies on surrogate and in this case 


is totally false. 


CHALLENGE THIRTY FIVE: 


Attachment One: Data Capture Synopsis 


The name Oldbury never appears anywhere. So their synopsis is incomplete. Notice that 


in the first block, with all those contacts, no relevant data identified. Too many 


references to DOE especially since the executive order's intent was to "curb" the DOE 


so that claimants got a fair deal. It is nice that they gave us all the Hooker keywords and 


Phrases, but what did they actually come up with? Again no reference to Oldbury where 


this got started. There is no mention ofwho was responsible for Oldbury manufacturing 


a product which led it to become an Atomic Worker location. Was it a government 


contract? 


CHALLENGE THIRTY SIX: 


Dr. Melius' letter affinns the Board's complicity in NIOSH's claim to be able to 


reconstruct dose with sufficient accuracy knowing full well that the term has not 


been defined according to the Ten Year Review. 


CHALLENGE THIRTY SEVEN: 


Dr. Henry Anderson, head ofthe Work Group, confesses the break-up ofTBD and 


going into surrogate data which is now "bogus". The question that needs to be asked 


is - Why was Hooker given an AWE status ifwhat was done there was so insignificant? 


CHALLENGE THIRTY EIGHT: 


Dr Anderson discusses Electro-Met as easy as rolling off a log. How come it wasn't that 


easy to do dose for Electro-Met? He goes on to the TBD 6001 history only to further 


show the maneuvering that went on with no consideration for the petitioners for the SEC. 


CHALLENGE THIRTY NINE: 


On p. 3, Dr. Anderson continues with the confession ofusing the three surrogates which 


are "bogus". 

8 


CHALLENGE FORTY: 

The S C & A points are not accepted by the petitioners since they only add wood to 

~fua · 

CHALLENGE FORTY ONE: 

Remember all this was going on while other Work Groups were still investigating the 

surrogate companies themselves for SEC status. This supports the fact once again how 

premature the vote was against Hooker. The Chair ofthe Advisory Board "sloughed off' 

the idea ofwaiting for further investigation by the other Work Groups. 

CHALLENGE FORTY TWO: 

On page 4, Dr. Anderson continues with what a wonderful thing they had done with 

surrogate data. Imagine Dr. Anderson saying that they asked NIOSH about Fernald? 

So they just supported each other with "bogus" material. 

CHALLENGE FORTY THREE: 

The FOIA request is here documented and part ofthe record. The petitioners are being 

penalized by the Board for the inefficiency ofFOIA by not assisting them in this regard 

but ignoring it only for a rush to vote. They assumed that it was just technical documents 

that petitioners are in the habit ofrequesting. This is false. FOIA has informed the 

petitioners that they are not allowed to question the reasons behind a request for 

information. So the Chair was very wrong to have Mr. Katz call the petitioner to demand 

information about the FOIA request. 

CHALLENGE FORTY FOUR: 

The petitioners maintain that the e-mails are evidence and need to be part ofthis review. 

They have gone into an appeal with FOIA and have been given the "runaround". At the 

present time, the appeal is with the CDC from whom there has been no response to its 

status even after several inquiries from the Program Support Center. Based on all ofthis, 

the petitioners maintain that the panel is being deprived of all evidence in defense of 

Hooker and an important avenue in order to see if the Board did do a just assessment 

with the denial which the petitioners feel that they did not. 
9 


CHALLENGE FORTY FIVE: 


To continue with the minutes, pay attention to the ''jockeying around" about Fernald 


data which gets interesting with Member Richardson's comments on p. 9. They all 


knew they were "jumping the gun". 


CHALLENGE FORTY SIX: 


Check p. 10 to see how they feel that what one surrogate didn't have, the other did 


so it didn't matter about Hooker. This is a negative view ofwhat surrogate was 


intended to be. It would be very difficult for anyone to call this a "class act". 


CHALLENGE FORTY SEVEN: 


The petitioner's comments are contained on pp. 12-15. They are self-explanatory. 


CHALLENGE FORTY EIGHT: 


Please note Member Clawson's remarks at the bottom ofp. 15. He spells out what is 


wrong. 


CHALLENGE FORTY NINE: 


Dr. Anderson's reply is a smokescreen and the question is how come his words didn't 


apply to the surrogate companies when their time came for SEC deliberations? 


CHALLENGE FIFTY: 


Member Clawson continued with questioning the reason for SEC and this time the Chair 


interjects with more hyperbole, claiming sufficient accuracy when they don't know what 

that means and playing down Hooker's operation. 

CHALLENGE FIFTY ONE: 


The Chair goes on to keep the "rush" going stating the time delay to wait on the Fernald 


Work Group. 


CHALLENGE FIFTY TWO: 


Member Munn added her "two cents" by crimping any idea ofa postponement with no 


reasons at all. She advanced the idea that if they wait, they will look bad and speaks for 


all with- "nobody's going to be happy with that". Who is she referring to? There was 

10 


no reason not to delay the vote except plain stubbornness and misdirection from the 

Chair. 

CHALLENGE FIFTY THREE: 

Member Beach countered with a line ofreasoning in favor ofthe petitioners and the 

copies sent to the petitioner do not have the number ofreasons from the Chair. 

CHALLENGE FIFTY FOUR: 

Member Beach also pointed out that the petitioner requested that the Board wait on the 

vote. The Chair ignored the comment since he proceeded as planned. 

CHALLENGE FIFTY FIVE: 

Dr. Anderson's comments on p. 18 are just a rehash ofwhat he said before and they do 

not make Fernald acceptable. 

CHALLENGE FIFTY SIX: 

Then the Chair goes on to say how the petitioner can come back again with new data 

whenever. He calls it opportunity. What does he call what might be a wasted "four" 

years already spent by the petitioner listening to all this "bogus" reasoning? 

CHALLENGE FIFTY SEVEN: 

So consider p. 19 - (top)- the Chair offers the idea of"reopening". Now shouldn't 

they be ashamed at the way this was handled? His comments confirm that there was 

every indication o(''unknown" things to come with the surrogates. Further proofof 

the "rush" to get rid ofHooker. 

CHALLENGE FIFTY EIGHT: 

The rest ofp. 19 is so taken up with Fernald. How come? 

CHALLENGE FIFTY NINE: 

The Chair continues with his reasoning about FOIA requests being solely for technical 

info. Ifthey have been doing this to other petitioners, then they have been out ofline for 

quite some time based on FOIA rules. He would not know what was in all the e-mails. 

The Chair should be made accountable for his action. He ordered the Federal Advocate 

to call the petitioner to demand what the purpose ofthe e-mails was. He was wrong 

in doing this. The Advocate mentioned technical data also. He was wrong, too. He 

went on with a need to close the Hooker case since they were on a budget. Now anyone 
11 


knows that ifsomething is held until new info arrives, there is no cost to the budget. 

They go on doing other things. As the Senator from NY recently said that a budget 

should not interfere with good science. Of course, he never has applied for SEC 

status . 

.CHALLENGE SIXTY: 

Ifyou notice on p. 20, they proceeded with the vote, even though a copy ofthe 

petitioner's address was requested by the Federal Advocate as necessary because 

many issues had been brought up and needed concentration. How come they didn't 

wait for the copy ofthe address before voting? Could it be there was a need to "rush"? 

PETITIONER'S CONCLUSIONS: 

The petitioners are very serious in their displeasure as to the manner in which the Hooker 

Electrochemical Corp. request for SEC status was handled. 

In the original request for this Review, the petitioners have explained the role ofthe 

ombudsman in this SEC process. Comments can be found on p.4 number 11. The 

Review Panel should consult this link to further update them on what the ombudsman 

has encountered in this program which strengthens the petitioner's experience as 

found on p. 4. 

www.dol.gov/eeombd/20 l lannualreport/2011.pdf 

It is clear that the report contains a series of complaints from the petitioners and shows, 

without a doubt, high dissatisfaction with the Petition Process. 

A reference to the Ten Year Review has been given in the main body ofthis addendum. 

Consider Numbers 28 and 29 as listed below: 

28. Because NIOSH did not give added meaning to the phrase "with sufficient accuracy" 

in the SEC regulations, it has created a "zero sum game" where approval of a SEC 

petition is beneficial for some while at the same time limiting the dose considered 

in the claims of others. NIOSH should revisit whether this policy choice is reasonable. 

29. 	NIOSH should explain the rationale for its decisions, and its change ofposition, 

clearly and succinctly. The rationale behind its choices should be transparent. 

It should not be necessary for the petitioners to elaborate any more than numbers 28 

and 29. Both ofthese recommendations in the Ten Year Review spell out the plight of 

the petitioners for Hooker Electrochemical Corp. 
12 


In regard to _the FOIA request for Hooker e-mails, here are two links that spell out how 

in fact e-mails revealed that a NIOSH rep was not totally honest. 

http://www.eecap.org/PDF _Files/ Colorado/Rocky _Flats/Thorium _FOIA _ Emails/2007% 

2c_May_ 15_Thorium_ Strikes_ email_ between_Chew,_ Ulsh.pdf 

http://www.eecap.org/PDF Files/Colorado/Rocky Flats/Thorium FOIA Emails/2007% 

2c May 25 Rocky conference cal1 email between Ulsh, Wade.pdf 

It is well for this panel to be aware that it is not an easy road for petitioners to get a 

review panel set up since this appeal started with being lost in the electronic system, 

had to be retrieved and staff had to be searched for to get it in motion and since there 

is a no-time-limit involved, no one hurries. You will notice that the original request 

went to a Dawn Smalls who had left government service some time before unbeknownst 

to NIOSH. The new replacement refused to even sign a letter to the petitioner 

acknowledging receipt ofthe request. Can you see that the Review process is part of 

the traffic on the road of frustration which is forbidden by the executive order. 

The petitioners take this opportunity to thank each of the three-person panel for the 

time taken to consider all avenues of this review and look forward to a reversal of 

the denial by the Advisory Board. 

We also especially want to thank the five Board members who saw the light and stood 

for petitioners' rights. This is the true basis for an Advisory Board. 

Submitted by: 
APPENDIX III: 


Board Surrogate Data 


Policy 

FINAL DRAFT 

CRITERIA FOR THE USE OF SURROGATE DATA 

Prepared by the ABRWH Work Group on Use of Surrogate Data 

May 14, 2010 

For the purposes of this report, the term "surrogate data" will refer to the use of exposure data from 

one site for individual dose reconstruction for workers at another site. In reviewing this topic for the 

Work Group SC&A distinguished between "Type I" surrogate data use (as described above) and "Type II" 

surrogate data where these data are used as part of a scientific effort to develop parameters for use in 

dose reconstruction activity calculations rather than as a substitute for the lack of adequate data 

needed for dose reconstruction. 

"Surrogate data" are used in the NIOSH dose reconstruction program because ofthe lack of complete 

and comprehensive exposure monitoring records for many of the workers at the sites covered by the 

program (SC&A September 2007). It is more often considered for dose reconstruction during the early 

years of some DOE and AWE facilities because of the lack of reliable monitoring methods, the urgency of 

developing production capabilities, and other reasons. 

This report will review a number of criteria that need to be considered in determining whether the 

specific use of surrogate data for individual dose reconstruction is scientifically sound and appropriate 

for that particular application. 

1. 	 Hierarchy of Data - It should be assumed that the usual hierarchy of data would apply to dose 

reconstructions for that site ( Individual worker monitoring data followed by co-worker data 

followed by workplace monitoring data such as area sampling followed by process and source 

term data.) This hierarchy should be considered when evaluating the potential use of surrogate 

data. Surrogate data should only be used to replace data if the surrogate data have some 

distinct advantages over the available data and then only after the appropriate adjustments 

have been made to reflect the uncertainty inherent in this substitution. 

2. 	 Exclusivity Constraints - In many cases, surrogate data are used to supplement the available 

monitoring data from a site. In those cases, the surrogate data is usually used to justify certain 

assumptions about the distribution or range of possible exposures or assumptions about the 

source terms. In those cases, no special justification is necessary beyond the usual scientific 

evaluation. This is akin to the Type II use decribed above. However, in other situations, there 

are no or very little monitoring data available. In those cases, the use of the surrogate data as 

1 

the basis for individual dose reconstruction would need to be stringently justified. This 

judgment needs to take into account not only the amount of surrogate data being relied on 

relative to data from the site but also the quality and completeness of that surrogate data. 

3. 	 Site or Process Similarities - One of the key criteria for judging the appropriateness of the use of 

surrogate data would be the similarities between the site (or sites) where the data were 

generated and the site where the surrogate data are being utilized. The application of any 

surrogate data to an individual dose reconstruction at a site should include a careful review of 

the rationale for utilizing that source of data. Factors that could be considered include, but are 

not limited to, similarity of the production processes, presence or absence of conditions that 

might affect exposure, and monitoring methods employed at the site(s). The potential 

availability of other sources of surrogate data needs to be considered and the selection of the 

surrogate data used for dose reconstruction justified. Some of the questions to be considered 

where appropriate are: 

• 	 Are there other sources of surrogate data that were not used ? 

• 	 Do these other potential sources contradict or undermine the application of the 

data from the selected site? 

• 	 Are there adequate data characterizing the site being used that would help 

support its application to other sites? 

• 	 Do the surrogate data reflect the type of operations and work practices in use at 

the facilities in question? 

Surrogate data should not be used if the equivalence of working conditions, source 

terms, and processes of the surrogate facility to the one for which dose reconstructions are 

being done cannot be established with reas9nable scientific or technical certainty as outlined 

here. 

4. 	 Temporal Considerations: Consideration also needs to be given to the period in question, since 

working conditions and processes varied in different periods. Surrogate data should belong in 

the same general period as the period for which doses are sought to be reconstructed unless it 

can be demonstrated that the working conditions, procedures, monitoring methods, and 

(perhaps) legal requirements were comparable to the period in question. 

5. Plausibility: The manner in which the surrogate data are to be used must be "plausible" with 

regard to the reasonableness of the assumptions made. The plausibility determination should address 

issues of: 

2 
• 	 Scientific plausibility. Are the assumed models (e.g., bioassay, concentration 

gradients) scientifically appropriate? Have the models been validated (where 

feasible) using actual monitoring data collected in a similar situation? 

• 	 Workplace plausibility. Are the assumed processes and procedures (including 

monitoring) plausible for the facility in question? Have all of the factors that 

could significantly impact exposure been taken into account? Is adequate 

information available about the facility in order to be able to make a fair 

assessment? 

Claimants will have significant concerns about the credibility of using surrogate data. To the extent that 

the use of surrogate data for individual dose reconstruction can be avoided, this will help to minimize 

concerns about the credibility of the individual dose reconstruction process. This is especially important 

given that the use of surrogate data often relies on information on the operations and characteristics of 

industrial facilities operated many years ago. Many of the people knowledgable about the facility have 

died, and records are usually incomplete (which is the reason for needing to use surrogate data in the 

first place). Given the difficulties in obtaining the comprehensive information needed for validating the 

use of surrogate data for individual dose reconstruction and the inherent concerns about its use by 

claimants, the Work Group recommends that the use of surrogate data be limited to the circumstances 

where other approaches are not feasible and then only after the rigorous review ofthe proposed use to 

determine if the above criteria have been fully met. 

3 

APPENDIX IV: 


Board Transcript 


Excerpts 

Appendix IV: Board Transcript Excerpts: 

One ofour observations was that several Board members asked questions throughout the 

review ofthe Hooker petition for SEC status, which were never factually answered. If 

they had been, we believe the final vote may have been different. These questions were 

sometimes deferred to working groups, or the questioner was assured that the question or 

surrogacy issue was in the process ofbeing resolved, or had been resolved. Search as we 

did, we never found complete resolution ofthese critical questions, despite the fact that 

we reviewed all ofthe transcripts made available to us, including the many Advisory 

Board meetings, and especially the Surrogate Working Group meetings. Since these are 

part ofthe administrative record in this case, we did not feel it necessary to reproduce all 

ofthe relevant transcripts as part ofthis report. However, we felt it important to present a 

select few sections below supporting our thesis that these critical questions were never 

satisfactorily answered. 

Excerpts from transcript of August 24, 2011, Board Meeting in Richland, 

Washington 

Page 18, line 1 to Page 20, line 19 then skipping to Page23, lines 4-14 regarding the use 

ofsurrogate data from Fernald: 

CHAIRMAN MELIUS: Look at me, Brad. Brad, ask me the question. 

(Laughter.) 

MEMBER CLAWSON: Using the Fernald 4 data there was a question, with that being 

on the Fernald Work Group these air samples were in question from the very beginning. 

On the Fernald Work Group we can't use the air sampling data. It's been questioned and 

falsified and everything else but we are now using it as surrogate data to do another 

facility. 

MR. ROLFES: Hi, this is Mark Rolfes with NIOSH. Brad, to address what you had 

mentioned about the specific allegation of a Fernald employee falsifying some ofthe air 

sampling data, we did look into that issue. We believe that that was a limited issue 

associated with one particular individual. We had no indication that was a widespread 

occurrence at the Fernald site. · 

MEMBER CLAWSON: It was an issue and you had a signed affidavit stating ofhow 

these air samples were being done. And now we want to take questionable information 

and use it to do another facility. Basically the bottom line is is it gets down to Hooker has 

its own data and we're going to use another site's -- in rily eyes that were questionable 

from the beginning. It just doesn't make common sense. 

CHAIRMAN MELIUS: Any other questions for Henry? Dick. 

MEMBER LEMEN: I again have trouble with the use ofsurrogate data from other 

facilities for a compensation program. I'm not -- I don't have that much concern of 

1 

surrogate data ifused in an epidemiological.study, one that's justified. And the caveats 

are all spelled out. But it seems to me totally inappropriate in a compensation program 

such as we are here to represent, to take data from other plants and use that data to 

determine what the compensation eligibility is for individuals within a plant that is 

geographically and physically not in the same location and work practices are not taken 

into account between these two facilities which is something that should be taken into 

account. I just, I'm going to have to disagree with the committee's recommendation solely 

based upon I have still, as I've expressed in previous meetings, this serious problem with 

surrogate data. 

MEMBER ANDERSON: Yes, I think-- I mean we discussed that considerably and I 

think what we looked at in this case is that it's a -- the surrogate data where we're using 

and the issues related to it as far as comparability was really focused on a specific activity, 

not, you know, the whole plant. 

* * * * * 

I understand your issues and we did discuss them and this -- we wouldn't want to use this 

as a precedent for how data ought -- or we would like to use it actually to say that this is a 

good example ofhow you can use specific activity surrogate data. Other? Oh yes. 

Excerpts from transcript ofDecember 7, 2011, Board Meeting in Tampa, Florida 

Page 130, lines 10-21 regarding dates when Fernald air sampling data may have been 

manipulated: 

MEMBER ANDERSON: Could you comment on the dates when this happened? 

MR. ROLFES: The individual did not specify a particular date, he only specified a 

particular operation which was the plant 5 jolting operation where they were compacting 

green salt and magnesium prior to reducing it into uranium metal. It is possible, well the 

Fernald facility didn't operate until after Hooker was closed. So as far as the specific data 

I don't have one because one was not provided to us. 

Page 134, Jines 2-14 regarding the quality ofthe Fernald air sampling: 

MEMBER CLAWSON: I just bring into question because the Fernald Work Group is not 

using air sampling data because it was in question and that's why we went to the bio part. 

And Mark brought that up but we have not dug into ifthe air sampling data is good. 

There is an affidavit out there that it was questioned and Mark brought up numerous 

times that there's nothing to say that this was taken out, this information, but there's 

nothing to, you know. There's many questions with the air sampling data on it, especially 

with Fernald. 

2 

Page 138, line 10 to page 141, line 16 regarding the timeliness ofthe surrogate data: 

MEMBER RICHARDSON: Could I ask one question ofSC&A? 

CHAIRMAN MELIUS: Sure. 

MEMBER RICHARDSON: This was about-- I mean, one ofthe other issues with using 

surrogate data is not just extrapolation between places but also extrapolations over time. 

And here some ofthe samples that we're talking about are taken let's say a decade to two 

decades after the period of operations. You're shaking your head no. 

DR. MAURO: The timeliness -- I remember the surrogate data report, I reviewed it, Bill 

prepared it and timeliness was one ofthe issues. And I recall the position, and I'd have to 

look at it again, was that the timeliness was supportive. In other words, it wasn't that we 

had a break there. There's five criteria and that was one ofthem. And I can't give you the 

dates but I recall our finding was that the timeliness worked in a favorable way. 

MEMBER RICHARDSON: And from what I recall from what's in the report it's that the 

process was relatively consistent over time and so despite the fact that samples are 

separated by a period of 15 years there's a sense that there weren't process changes. 

DR. MAURO: Your recollection is better than mine. I wish I could say that I could -- we 

could probably get our hands on it because I remember the summary page where we have 

the criteria, we summarize each one. That may very well have been some ofthe language 

in there. I'm sure that the language itself is relatively brief. The summary level at the end 

of the report. If we could bring it up maybe it's even possible to show it on the screen, 

each of the -- our findings and the rationale why we felt they met the exclusivity 

requirement. That had to do with 95th percentile, the impact. And then the second one 

had to do with timeliness and I remember coming out favorably but it wouldn't hurt to 

just take a look at that ifit's possible to just grab it. 

CHAIRMAN MELIUS: Ifyou let me get a word in I can point out where it is. Page 5 of 

7, sort ofthe middle ofthe page there. I don't think it's, I'm not sure ifputting it up is 

even necessary. I mean, the process is slag handli.ng, and slag handling is I think unlikely 

to have changed significantly over that time period. I think that's -- and that's the rationale 

that's stated in the SC&A report. I actually had the same question so I had to look back to 

the report while we were talking earlier. 

DR. MAURO: Thanks for helping me out on that. 

CHAIRMAN MELIUS: Which is why I had it up, because I think it is an important 

question that came up. Jim, did you have a comment? 

DR. NETON: I was just going to read from the report that the surrogate data used for the 

natural right dumping operations collected between 1947 and '59. So all the surrogate 

3 

data was in that time frame. And I forget the years now that Hooker is under review for 

but it's in that same. 

CHAIRMAN MELIUS: Okay. Any additional questions? 

Page 152, line 3 to page 153, line 17: 

MEMBER CLAWSON: I guess, you know I realize we have to use surrogate data and 

we've had high debates over surrogate data. But the thing that bothers me about Hooker a 

little bit is how much data do you have? According to the paperwork there, zero. Is there 

any air sampling data from them or bioassay from Hooker? So it's zippo. And I 

understand, I just really have a hard time using surrogate data from a site, three sites 

actually that are in question, in my mind in question. I just, that to me is using, you know, 

you can use as much information as you want but ifit's no good. Just wondering. 

MEMBER ANDERSON: I think the, I mean that's part ofthe issue. And what we tried to 

do was use the criteria that we set up to see. And the criteria don't really say you have to 

have some measurements or something at a facility at all. This basically was just a, you 

know, a fairly simple process ofmoving stuff through and dissolving it and then filtering 

it out and re-bagging it so the process was very similar at these things. I think as a 

committee when we looked at it it was kind of, of all the possible surrogate data uses that 

the committee has looked at this seemed to be the closest to the measurements are of 

activities that are performed at all ofthese various facilities rather than trying to use some 

others. So it's about as good as you can get but the fact that there are no measurements 

from the facility at least as I understand it at all, that, you know, again that is an issue. 

But we don't have any indication that anything here was done differently. 

4 

Of.P \Rnffl\T OF HE .\LT ll .. 'l Ill \ IA 'I SFR\ .~ Public Health Service 

Centers k r 01sease Cornrol 

and Prov 11\100 (CDC) 

Naoonal Institute tor Occupational 

Safety nnd Health (NIOSHI 

395 E' Slrf!AI SW 

Suite 9200. Patriots Plaza 

Wasltlngt;>n O.C 20201 

PHONE (202l 245-0625 

FAX (202) 245·0628 

TO: Dr. Wanda Jones 

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

DATE: March 27, 2015 

SUBJECT: Hooker Electrochemical Corporation Special Exposure Cohort (SEC) 

Dr. Jones: 

Thank you for providing to NIOSH the final report of the Hooker Electrochemical Corporation 

Special Exposure Cohort (SEC) Administrative Review Panel, dated September 10, 2014. 

The National lnst1tute for Occupational Safety and Health (NfOSH) very much appreciates the 

review conducted by the Administrative Review Panel ofthe decision by the Secretary to deny 

adding the following class of employees to the SEC: 

All employees who worked in any location at the Hooker Electrochemical 

Corporation during the operational periodfrom January I, i943 through December 

31, 1948, and during the residual period from January 1, 1949, to December 31, 1976. 

Although NIOSH may not agree with the Administrative Review Panel's finding that the use of 

surrogate data in the Hooker Electrochemical SEC petition resulted in "substantial factual error," 

NIOSH respects the findings of the Administrative Review Panel and will provide a new 

designation package to the Secretary that comports with the Panel's recommendations, as set out 

in their final report. 

Additionally, NIOSH understands that it is not the Administrative Review Panel's intention to 

define the class of Hooker Electrochemical Corporation employees for inclusion into the SEC as 

"all workers," but rather to allow NIOSH to define the class such that non-radiologic workers 

would not ultimately be included in the class for a specified time period. 

The new designation package that NIOSH is preparing for the Secretary's review and action will 

reflect NIOSH 's understanding ofthe Panel' s intention and include a class definition that will 
Page 2- Dr. Wanda Jones 

not encompass non-radiologic workers. The exact start date for the class is currently under study 

and will be included in the new designation. 

Again, please express NIOSH's appreciation to the Administrative Review Panel for tbeir review 

of the Hooker Electrochemical SEC Petition. 

[Signature on File] 

John Howard