Petitioner comments to State of IL letter recommending rejection of said petition

["Sandy Perle" <sandyfl@EARTHLINK.NET>]

To facilitate an on-going dialogue regarding my petition for 

rulemaking, I am providing my response I submitted to the USNRC this 

morning, regarding the recently posted State of IL letter 

recommending that my petition be rejected. While I respect many of 

the state's comments, it is my opinion that they are "throwing the 

baby out with the bath water" and really did not address the 

reasoning and real intent of my petition. The IDNS is the only 

"posted" comment so far. I know Bill Lipton recommended some 

excellent modifications (that I concur with) but they have not been 

either submitted, or just haven't been posted on the NRC site yet.



===============================================

Response to State of Illinois Department of Nuclear Safety letter in 

regards to Docket Number Petition Rule PRM-20-25, May 4, 2003



The State of Illinois provided the following comments to my petition 

for rulemaking:



1. While IDNS agrees that it is generally desirable for dosimetry to 

be NVLAP accredited, there are certain situations where NVLAP 

accreditation is impossible. For example, NVLAP accreditation is not 

available for all neutron fields. Adoption of the petitioner's 

proposal would leave no compliance options for licenses with 

radiation fields beyond the standard NVLAP parameters.



Petitioner's Response: The IDNS is accurate when they state that 

NVLAP does not include all neutron fields that can be found in the 

field. This is also true for high and low energy photons as well as 

beta radiation. NVLAP testing is based on ANSI N13.11-2001 

requirements. The current ANSI N13.11-2001 expanded the NIST beam 

codes to be available for testing from 5 up to a possible 59. In 

addition, bare Cf-252 was added to supplement the previous moderated 

Cf-252 field. The licensee or facility that uses x-ray-generating 

equipment may chose what NVLAP categories to test in. The facility is 

not required to test in every category, only those that are 

representative of the filed use in which their employees are exposed 

to. The categories chosen for testing are to be validated by the NRC 

and/or state regulatory agency when the facility is inspected. Based 

on the state's position with respect to this petition, they would 

have one never test to any standard if the standard does not address 

all photon, beta and neutron possible energy spectra. The intent of 

NVLAP is top test the various energies across a broad spectra. The 

newly revised ANSI N13.11-2001 does do just that. As far as the last 

sentence where IDNS states "Adoption of the petitioner's proposal 

would leave no compliance options for licenses with radiation fields 

beyond the standard NVLAP parameters", that is the case today with 

the photons tested. Does IDNS then assume to state that if a facility 

works with an x-ray filed that does not get tested in the standard, 

that the facility need not test to NVLAP? The answer is no, since the 

IDNS, as do all other states, requiring personnel who wear a whole 

body dosimeter that is processed, wear one that is NVLAP accredited. 

The petition does not change that. The petition states that all whole 

body as well as extremity dosimeters shall require NVLAP 

accreditation. If there is no specific test for a specific energy, be 

it photon, beta or neutron, then there is no test. That does not 

change the fact that there is a standard to be met. Where there is no 

current test, the facility still must demonstrate to the regulatory 

agency how they justify using the specific dosimeter they provide 

their employees. This has been the case in the past and that fact 

does not change with this specific petition.



2. The petitioner does not propose a satisfactory solution for backup 

dosimetry. Although the petitioner points out that certain licensees 

issue redundant dosimetry to their personnel, that does not 

completely eliminate solutions where the primary dosimetry is lost, 

contaminated, or otherwise not useable. In these cases, the license 

must still assign a dose of record and should be able to do so using 

secondary non-NVLAP dosimetry. USNRC or Agreement State inspectors 

should carefully evaluate the use of secondary Dosimetry for 

compliance purposes.



Petitioner's Response: In the IDNS comment above, they are simply 

stating what is the current situation with secondary dosimetry. To 

consider the effect of using a secondary dosimeter, at the same time 

that IDNS does not support the primary dosimeter to be NVLAP 

accredited, as recommended in the petition, does not make any sense 

to the petitioner. Granted, I do not address secondary dosimetry. My 

intent is not to have every facility NVLAP approve both the primary 

and secondary dosimeter that is worn. In that a facility can 

calculate a dose when the primary dosimeter is lost, that is an 

accepted method. My intent is not to force a facility to NVLAP test 

every dosimeter they may wear, when they have provided additional 

dosimetry, where a facility may only wear a single dosimeter. The 

facility may elect to test both the primary and secondary dosimeter, 

but that is not a requirement the petition proposes. The USNRC and 

Agreement State inspectors should evaluate any dose of record that 

was derived from a secondary dosimeter or from a calculation based on 

surveys, stay times or other parameters that were used to perform the 

dose reconstruction. That issue has nothing to do with this petition. 

The petition addresses primary dosimetry only. If the USNRC believes 

that they want to also include secondary dosimetry as requiring NVLAP 

accreditation, that is their option. However, the petition does not 

require that.



3. The petitioner makes the argument that the mandatory use of NVLAP 

dosimetry would somehow require licensees to better evaluate 

dosimetry use conditions and ensure that appropriate dosimetry is 

employed. We disagree. Although the proper matching of a personnel 

dosimeter with use conditions and radiation fields is critical to 

proper dose assignment, the mandatory use of NVALP devices would not 

address this problem. Only the USNRC or Agreement State inspector is 

in position to evaluate whether the licensee made the correct choice.



Petitioner's Response: I agree with the following statement, "Only 

the USNRC or Agreement State inspector is in position to evaluate 

whether the licensee made the correct choice." The intent of NVLAP is 

to provide a standard that addresses both for proficiency testing of 

the dosimeter to specific categories, that the facility elects to 

test ion. Additionally, there is an on-site assessment by a technical 

expert, to evaluate the entire quality system. The technical expert 

addresses the dosimetry program in detail. The technical expert does 

not address the regulatory implications as to whether the dosimeter 

is tested in the most appropriate categories, leaving that to the 

regulatory agencies. The assessor may recommend that they test in 

certain categories, but that's not a significant part of the 

assessment. What the NVLAP process does provide for is a thorough 

assessment of the quality system whereby when a facility provides a 

dose they can demonstrate that it meets current standards and that a 

technical expert assessed the program. 



The IDNS recommends that the petition not be approved. The result of 

this would be that extremity dosimeters, ring or wrist dosimeters, 

will continue to be worn, and, there will never be any requirement 

that they be tested under any proficiency testing program, nor will 

there ever be any assessment by a technical expert, in the area of 

dosimetry and the proper processing of Dosimetry. This would also be 

true for a facility that elects to only wear an electronic dosimeter 

for dose of record. There would be no required testing or assessment 

of the program. While the petitioner does not question the 

capabilities of the IDNS inspectors, it is my opinion that when it 

comes to a detailed assessment of the dosimeter ands the method it is 

processed, and the algorithms used to derive the dose of record, the 

NVLAP technical expert is more capable of assessing the overall 

quality system, where there is ample time allotted to accomplish the 

assessment.



-------------------------------------------------

Sandy Perle

Director, Technical

ICN Worldwide Dosimetry Service

ICN Plaza, 3300 Hyland Avenue

Costa Mesa, CA 92626



Tel:(714) 545-0100 / (800) 548-5100  Extension 2306

Fax:(714) 668-3149



E-Mail: sandyfl@earthlink.net

E-Mail: sperle@icnpharm.com



Personal Website: http://sandy-travels.com/

ICN Worldwide Dosimetry Website: http://www.dosimetry.com/



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