ML23156A481

PR-MISC - 59FR61906 - National Voluntary Laboratory Accreditation Program for Ionizing Radiation Dosimetry

ML23156A481
Person / Time
Issue date:	12/02/1994
From:	NRC/SECY
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PR-MISC, 59FR61906
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ADAMS Template: SECY-067 DOCUMENT DATE: 12/02/1994 TITLE: PR-MISC - 59FR61906 - NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM FOR IONIZING RADIATION DOSIMETRY CASE

REFERENCE:

PR-MISC 59FR61906 KEYWORD: RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

DOCKET NO. PR-MISC (59FR619O6)

In the Natter of NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM FOR IONIZING RADIATION DOSIMETRY DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT

12/01/94 11/25/94 FEDERAL REGISTER NOTICE FOR NRC AND DEPT OF COMMERCE NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM FOR IONIZING RAD DOSIMETRY 12/27/94 12/24/94 COMMENT OF PHILLIP PLATO, PH.D. ( 1) 02/01/95 01/31/95 COMMENT OF NUCLEAR ENERGY INSTITUTE (JOHN F. SCHMITT) ( 2) 02/06/95 01/31/95 COMMENT OF LANDAUER, INC. (R. CRAIG YODER, PH.D.) ( 3) 02/08/95 01/31/95 COMMENT OF FLORIDA POWER AND LIGHT COMPANY (W.H. BOHLKE) ( 4)

Florida Power & Light Company, P.O. Box 14000, Juno Beach, n :eqQ~4'2t.. ll u<,*e,.

DOCKET NU ~BER PROPOSED RULE,.!.!.!..~ ~- JAN 3 1 1995

( SC\ ~R. ~ \ C\00 L-95-36 Mr. John C. Hoyle, Acting Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 Attn: Docketing and Service Branch Re: National Voluntary Laboratory Accreditation Program for Ionizing Radiation Dosimetry 59 FR 61906, December 2, 1994 Request for Comments On December 2, 1994, the Nuclear Regulatory Commission (NRC) published for public comment a change of proficiency testing associated with the "National Voluntary Laboratory Accreditation Program (NVLAP) for Ionizing Radiation Dosimetry." The following comments are submitted on behalf of Florida Power and Light Company (FPL), a licensed operator of two nuclear power plant units in Dade County, Florida and two units in St. Lucie County, Florida.

The Nuclear Energy Institute (NEI) is offering comments on the revised ANSI standard, ANSI N13 .11-1993, "Personnel Dosimetry Performance Criteria for Testing." FPL endorses these comments and recommendations. Additionally, FPL provides the following comments.

The most significant change which will affect dosimetry processors in the ANSI N13.ll-1993 standard is not highlighted in the proposed changes issued by the NRC. The most significant change affects the "dose conversion factors used in the revised standard, and NVLAP's plans to implement these changes and the modifications to the Ck values."

NVLAP, in a Laboratory Bulletin, Volume II, No. 1, Dosimetry, effective date January 1995, states the following, "This bulletin is intended to provide the NVLAP accredited dosimetry laboratories with information on the dose equivalent conversions factors Ck which will be used by the NVLAP proficiency testing laboratory for proficiency testing personnel dosimeters to the revised ANSI N13.11-1993. NVLAP has modified some of the ck values found in Tables 2, 3, and C3 of N13.ll-1993. This change is necessary because the set of conversion coefficients has received considerable criticism both in the U.S. and abroad. 11 The changes in the specific Ck values can cause a change of up to 22% compared to the values used in ANSI N13.11-1983.

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L-95-36 Page Two This change will require NVLAP certified dosimetry processors to insure high costs to both modify their existing dose algorithms, and to conduct testing with a facility that has a National Institute for Standards and Technology (NIST) traceable calibration to validate that the revised Ck values have been incorporated correctly. This change will have no bearing on whether or not a processor produces "accurate and precise" dose determinations for badged personnel. What it demonstrates is that a processor has expended dollars for the sole purpose of passing a standard. Up to 8% of the change in the Ck is due to a correction for the backscatter of the ANSI test phantom (PMMA) relative to the International Committee on Radiological Units (ICRU) tissue which has been included in the conversion coefficients in ANSI N13.11-1993. The NVLAP Laboratory Bulletin states that the primary reason for the change in the Ck values is as quoted: "This inclusion was justified by the assumption that all dosimeters should respond perfectly to backscatter. However, this situation will never be true, since all dosimeter systems respond differently (if at all) to backscatter."

An additional factor to be considered is the current state of dose assessment being used by a majority of NVLAP certified laboratories. Nuclear power plant dose assessment, either by in-house or vendor processing, makes up the majority of those funding NVLAP. With the focus on cost reduction within the industry, and the move towards e*lectronic dosimetry with the inevitable reduction or total elimination of Thermoluminescent Dosimeter (TLD), or film badge monitoring for "final dose of record determination,"

consideration should be given for the cost benefit of passing a standard that does not provide for improved accuracy and precision in dosimetry results. The net effect of the change results in no improvement in the welfare and safety of badged personnel.

Exception (3) which addresses Category IX states that 11 * *

• testing will be required only once for each dosimeter model that is to be tested in Category III or IV. A retest will be required whenever the dosimeter design is changed or the dose algorithm is modified. 11 To require a retest for "any" algorithm modification appears to be excessive. Specific criteria need to be provided to determine under what conditions an algorithm modification requires a retest.

FPL appreciates the opportunity to comment on this standard.

W. H. Bohlke Vice President Nuclear Engineering and Licensing WHB/spt

OOCKFr TED I'\

• U.:, L, LANDAUER

• 95 FEB -6 P 2 :4 3 OF rl U , _!fl i' -, Y R. Craig Yoder, Ph.D. QQ CV:. -j L; r"T Vice President, Operations i3R ,. h 1, ,

January 31, 1995 DOCKET NUMBER PB Secretary PROPOSED RULE..!-!!.J.U.~-

U.S. Nuclear Regulatory Commission (5<:i\ f~lo\°tD~

Washington DC 20555 Attention: Docketing and Service Branch

Subject:

Change to NVLAP Proficiency Testing Program; 59FR61906

Dear Sir:

Landauer, Inc. wishes to submit the following comments concerning proposed changes to the proficiency testing program adopted by the National Voluntary Laboratory Accreditation Program (NVLAP) for accrediting radiation dosimetry processing organizations. Landauer has participated in the NVLAP dosimetry accreditation program since its inception. The Company has also participated in proficiency testing programs conducted by the U.S. Department of Energy; the Atomic Energy Control Board of Canada; and the Health Safety Executive of the United Kingdom.

The unification of categories Illa and lllb listed in ANSI N13.11-1 993 as

- 1.

proposed in the Federal Register release is preferred without the special stipulation regarding the selection of x ray beam qualities. A single category for x ray testing is sufficient but there should be no constraints placed on the selection of the beam quality. The current testing program has had no constraint and all processors have had to assure adequate performance for all x ray conditions. This has benefited the radiation user by reducing the complexity of selecting the appropriate dosimetry system. That is, any system accredited for low energy photons could be used in such environments without having to assure the work environment corresponds exactly to the test condition. The single category avoids t he possibility that radiation users will become confused about having two x ray categories. Our experience reveals that few radiation users understand the complex arrangement of test categories and the subtle distinction between Illa and lllb will be missed. Additionally, the M150 beam quality is specified for hig h level (accident) tests involving low energy photons, there is no need to require it or a similar beam quality to be a mandatory beam quality for low dose testing. No beam quality restrictions have been in place since testing began ten years ago and none is warranted .

MAR -1 1995

, -Acknowledged by card .. """................-

Landauer, Inc. 2 Science Road Glenwood, Illinois <,0425-1586 Telephone: (708) 755-7000 Facsimile: (708) 755-70!6

U.S. NUCLEAR REGULATORY COMMISSIOf'..

DOCKETiNG & SERVICE SECTION OFFICE OF THE SECRETARY OF THE CO,v1 ~ISSION D*, u

• S!a**sucs Postmaik Date -~lfl__,______

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2. The elimination of the AmBe neutron source from testing is unfortunate and should be reconsidered. It is our experience that many radiation workers such as those working for oil service companies are exposed to high energy neutron environments that are not adequately simulated by the moderated Californium-252 test environment. We recognize the need for a high quality standard from NIST for AmBe; however there exist many sources whose fluence rate has been calibrated by NIST or otherwise traceable to a national standard. For these sources, the use of published fluence to dose conversion factors should be suitable to provide an estimate of the delivered dose with an acceptable error. We believe the differences between the moderated Cf-252 sources used at NIST and PNL, the proficiency testing laboratory, introduce an error comparable to that resulting from the use of an AmBe source. We think it important for neutron systems to demonstrate performance under conditions similar to the work environment. The energy dependence of many neutron dosimetry systems makes the test condition important. One's performance for moderated Cf-252 may mislead the user about the system performance for high energy neutrons like those emitted by AmBe. The history of the moderated Cf-252 source revolves around developing a test condition for albedo TLD systems. Many people now use solid state track detectors such as CR-39 which have very different performance characteristics. The neutron energy spectrum for AmBe coincides with the detection range of the new solid state technologies.

3. The requirement to perform an angular dependence category test once should be reconsidered. The random selection of irradiation angles, radiation qualities and dose levels makes one's test result hig hly dependent on chance. That is, repeated tests may reveal difference performance characteristics solely on the basis of the selected test conditions. The number of dosimeters evaluated in this category is too few to obtain a meaningful angular test result if on ly performed once. The value of requirin g repeated angular tests is that one builds a body of data from which to judge the overall performance. A single test is insufficient to achieve the intent of the ANSI standard. Additionally, it is very difficult to define much less police meaningful changes in design or algorithm. To avoid differences of interpretation for such a subjective subject, a test should be conducted each time proficiency testing is required.

Thank you for considering these comments .

LANDAUER, INC,j.

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? ,,, I R. Craig ~ otfer, Ph .D.

Vice President, Operations

I DOCKET NUMBER PB ffit;;>Sz, PROPOSED RULE NUCLEAR ENERGY INST I TUTE (5G\FR-b\G\Db; OOCt~EH*_ O us. *itc John F. Schmitt DIRECTOR, RADIOLOGICAL PROTECTION, EMERGENCY PREPAREDNESS, &

WASTE REGULATION

'95 FEB -1 P2 :21 January 31, 1995 OFFICt I  :., ' :E \RY j

DOCK FTI I. 1t':E tr "r

• Mr. John C. Hoyle Acting Secretary Office of the Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 ATTENTION: Docketing and Service Branch

SUBJECT:

Nuclear Energy Institute (NEI) Comments on the Notice of Change of Proficiency Testing Standard for the National Voluntary Laboratory Accreditation Program (NVLAP) for Ionizing Radiation Dosimetry, noticed in the Federal Register on December 2, 1994 (59 Fed. Reg. 61906)

Dear Mr. Hoyle:

This letter provides NEP comments on behalf of the nuclear industry in response to the subject Federal Register notice. These comments have been developed from a review of t h e revised proficiency standard and related documents by nuclear industry radiation protection staff responsible for ionizing radiation dosimetry programs subject to NVLAP accreditation requirements due to NRC's regulations.

We support the practice of independent third-party evaluation and recognition of dosimetry laboratory performance to assure doses of record are acceptably accurate to fulfill their role in protecting health and safety. However, we have concerns about the regulatory process for promulgating and applying NVLAP requirements for NRC licensees, specifically with regard to circumvention of NRC backfit analysis requirements, limitation of opportunity for public comment, burdensome schedules 1

NEl is the organization responsible for establishing unified nuclear industry policy on matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEI' s members include all utilities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect/engineering firms, fuel fabrication facilities, materials licensees, and other organizations and individuals involved in the nuclear energy industry. NEI is the successor organization to the Nuclear Management and Resources Council (NUMARC).

MAR -1 1995

• Acknowledged by card .......................... ...M 1776 I STREET NW SU ITE 400 WASHINGTON, DC 20006-3708 PHONE 202 739 8000 FAX 202 785 4019

U.S. NUCLEAR REGULATORY COMMISSIOl'-4 DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document StatlsticS Postmark Date J..l.l.\U~~:alR.l~ - -

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Mr. John C. Hoyle January 31, 1995 Page 2 for implementation, and the lack of performance-based standards for on-site assessments (see Enclosure 1). Specific comments regarding NRC's proposed use of ANSI N13.ll-1993 are provided in Enclosure 2.

We intend to request the opportunity to discuss our comments with NRC staff responsible for coordinating NRC requirements for NVLAP accreditation of licensee ionizing radiation dosimetry programs. In t he meantime, if NRC staff have any questions, please contact Ralph Andersen at (202) 739-8111 or me at (202) 739-8108.

Sincerely,

• cr:.~~~~

JFS/RLA:amw Enclosures

Enclosure 1 Nuclear Energy Institute (NEI) Comments Regarding the Regulatory Process for Promulgating and Applying NVLAP Accreditation Requirements for NRC Licensees

1. The process for promulgating NVLAP standards and criteria circumvents NRC requirements for a systematic and documented analysis of backfits, as described in 10 CFR Part 50.109. For example, the Department of Commerce National Institute of Standards and Technology (NIST) adopted substantial changes to their regulations pertaining to NVLAP (15 CFR Part 285), on May 3, 1994, and NRC is currently proposing the application of new requirements for NVLAP accreditation (59 Fed. Reg. 61906, dated December 2, 1994). To our knowledge, a backfit analysis was not performed for either of these regulatory actions, despite t he fact that NVLAP-accreditation is required by 10 CFR Part 20, which applies to Part 50 licensee radiation dosimetry programs.

We recommend that the NRC consider applicability of backfit analysis requirements to situations involving revision to the NVLAP accreditation criteria, beginning with the current proposal to apply ANSI N13.11-1993. Such an evaluation is necessary to determine if the presumed improvements to dosimetry accuracy associated with NRC's proposed adoption of the revised proficiency testing criteria provide a substantial benefit to the protection of health and safety in light of t he costs that will be incurred by NRC licensees.

2. Opportunity is limited for timely and comprehensive review by affected licensees of proposed standards and criteria prior to their implementation as de facto requirements for NVLAP-accreditation. For example, on November 29, 1993, NIST notified NVLAP-accredited facilities that newly revised dosimetry on-site assessment checklists would be applied to the accreditation process beginning November 30, 1993. In August 1994, NIST published Handbook 150-4, NVLAP- Ionizing Radiation Dosimetry, addressing the new requirements of ANSI HPS Nl3.ll-1993, although the ANSI standard had only been published one month earlier in July 1994. Publication of the NIST Handbook and the ANSI standard did not entail the broad public review process of the documents in draft that is typical of NRC's process for proposing new requirements. The Federal Register notice (59 Fed. Reg. 61906, dated December 2, 1994) announcing NRC's intended use and implementation schedule for the NIST handbook and ANSI standard was published with a sixty day comment period, stating that " ... the NRC and NIST I NVLAP intend to institute a phase-in period of testing against the revised standard, beginning January 1, 1995," i.e., midway through the actual comment period.

We recommend that the NRC consider means whereby public comments regarding proposed changes to NVLAP accreditation criteria (including ANSI standards and NIST handbooks and checklists) will be requested, properly evaluated, and addressed by the NRC, prior to issuance of final documents with the force of regulatory requirements.

3. Scheduling of implementation of new requirements has been untimely and burdensome. For example, application of that newly revised dosimetry on-site assessment checklists was accomplished with one day notice, although subsequent relief was provided upon request in some cases to remedy items not in compliance with the checklists. Implementation of NIST Handbook 150-4, addressing the new requirements of ANSI HPS N13.11-1993, is being required by NRC on a "phased-in" basis beginning January 1, 1995, although NRC is currently in the process of receiving comments regarding how the new requirements should be applied. Notwithstanding NRC's proposal that licensees that fail the proficiency test due to changes made in the revised standard will have until January 31, 1997, to retest and pass the revised criteria, such failures will create the appearance of a poor program to workers, the public, and other interested parties. Such situations lead to licensees having to anticipate new requirements that may eventually be applied, i.e., at the risk of potentially "reworking" programs, procedures and training if finalized regulations differ from what has been proposed. Also, licensees may have to rearrange priorities and resources to accommodate the brief periods allowed for implementation preparations. Such burdens are not justified on the basis of protection of health and safety.

We recommend that the NRC consider adequate periods for implementation of new requirements for NVLAP accreditation, including ANSI standards and NIST handbooks and checklists. With regard to the implementation schedule currently being proposed by the NRC, we recommend that the "phase-in" period beginning January 1, 1995, be dropped entirely, with implementation being required 2 years after the NRC has appropriately reviewed and responded to public comments on the proposal. In the interim (i.e., until required by NRC regulation), testing against the revised criteria should be voluntary on the part of NRC licensees, independent of NVLAP accreditation with regard to compliance with Part 20.

4. The standards for on-site assessments are highly prescriptive and programmatic, generally lacking a performance basis. For example, the General Operations Checklists includes detailed requirements for a laboratory quality manual, stipulated in at least one assessment as required to be distinct and separate from the nuclear power plant quality assurance program documents and procedures as required by 10 CFR Part 50. Another example includes the Specific Operations Checklist, which contains 17 criteria regarding 2

personnel, including subjective criteria such as, "[s]taff are not subjected to undue pressure or inducement that can infl,uence their judgment or the results of their work." Accreditation may be denied solely on the basis of failure to resolve deficiencies arising from on-site assessments, even if specific performance and proficiency criteria are met.

We recommend that the NRC consider cooperative efforts with the NIST to promulgate on-site assessment criteria that are performance-based, consistent with NRC's current philosophy of effective regulatory practices. Such efforts, if undertaken, would benefit from involvement by affected NRC licensees.

3

Enclosure 2 NEI Comments Regarding NRC's Proposed Use of ANSI N13.11-1993 for NVLAP Accreditation (59 Fed. Reg. 61906, dated December 2, 1994)

1. A significant change affecting dosimetry processors that is not addressed in the subject Federal Register notice relates to dose conversion factors used in ANSI N13.ll-1993 and NIST's plans for modifying these factors for use in the NVLAP, effective January 1995. On November 21, 1994, NIST issued a NVLAP Laboratory Bulletin, Volume II, No.I, Dosimetry, that includes " ... information on the dose equivalent conversion factors (Ck) which will be used by the NVLAP proficiency testing laboratory for proficiency testing personnel dosimeters to the revised ANSI N13.11-1993. NVLAP has modified some of the Ck values found in Tables 2, 3, and C3 of ANSI N13.11-1993. This change is necessary because the set of conversion coefficients has received considerable criticism both in the U. S.

and abroad." This change will require that NVLAP-accredited dosimetry processors expend considerable resources to modify existing dose algorithms and conduct testing with a NIST-traceable calibration facility to validate that the revised Ck values have been incorporated correctly. It is not clear that such expenditures are justified on the basis of providing a substantial improvement to protection of health and safety because the potential differences are not expected to significantly affect the accuracy and precision of reported doses for monitored personnel. We recommend that the NRC review the proposed changes in light of the related potential health and safety benefits and provide guidance in its final notice on the change in proficiency testing standard.

2. The lower energy x-ray techniques (i.e., M30, M50, MI00, and M150) indicated for Category III, Low Energy Photons, may require a significant expenditure of time and resources by nuclear power plant licensees for algorithm development without a substantial benefit to protection of health and safety. Technique H150, with an average energy of 117 ke V, is representative of the low end of photon energies typically observed at nuclear power plants. We suggest that the NRC consider permitting nuclear power plants to use only the H150 technique for Category III testing, and the H150 technique along with 137 Cs for Category IX testing.

3. Category IX testing may be better accomplished by dosimeter manufacturers because it is denoted in NIST Handbook 150-4 as a performance requirement for the dosimeter. The standard proposed in the subject Federal Register notice would result in repeated testing and analysis of the same dosimeter design type by multiple licensees. The basis and intent for repeating the angular dependence test if the algorithm is modified should be clarified, or the proposed criteria should be dropped. Note that the proposed criteria for retesting exceeds that described in NIST Handbook 150-4.

4. Test Category VIII in ANSI N13.ll-1993 includes a tolerance level (L) of 0.5 for the neutron component of the deep dose equivalent. NRC regulations for radiation protection (10 CFR Part 20) do not require a breakdown of the deep dose equivalent by radiation types, e.g., neutron dose. We recommend that this criterion for proficiency testing against the tolerance level for neutron dose not be applied with regard to NVLAP accreditation to meet NRC regulatory requirements.

2

PHILLIP PLATO, INC.

2819 S. E. 22 Place DOCKET NUMBER Cape Coral, Florida 33904 PROPOSE* :-'ULE ~

(81 3) 549-6969 ( r; q FR 6 /'1ob)

~ QI, FAX : (813) 549-9311 ut.C 2 7 t J'1

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December 24, 1994

• 0, Secretary, U.S. Nuclear Regulatory Commission ATTN: Dock eting and Services Branch Washington, D.C. 20555

Dear Sir/Madam:

I woul d l ike to comment on your proposal to change the I proficiency testing portion of NVLAP's accreditation program for personnel dos i metry. I was a member of the working group that wrote the original ANSI Nl3.11-1983 standard, I conducted an NRC-financed pilot study during 1977-81 to evaluate the concept of proficiency testing, I directed NVLAP's first proficiency test l aboratory, and I have provided consulting services to numerous dosimetry processors that must adhere to NVLAP's accreditation program. In my opinion, the NVLAP accreditation program has had more positive effect on the qual ity of personnel dosimetry than anything else in the past 40 years. Given my past and continued involvement with this program, and my strong opinion concerning its va luable contribution, I respectively offer the following suggestions concerning the proposed changes in this program.

You plan to announce in December, 1994 that the testing method will change beginning January 1, 1995 to coincide with the N13.11-1993 standard. You acknowledge that some processors might fail due to these changes during a two-year phase-in period, but you will allow them to re-test without losing their accreditation, provided that the failure is due to the changes between the Nl 3.11-1983 and N13.11-1993 standards. I am opposed to this phase-in approach for the following reasons.

I believe this policy reflects a lack of sensitivity to the seriousness with which dosimetry processors view NVLAP accreditation. Most NRC licensees view a "failure" as a major stigma on their record. The stigma can be mitigated somewhat by passing a re-test, but the stigma is there for all time. The many assessors, auditors, and inspectors that continuously review NRC licensees react very adversely to a "fail" among quality assurance data, even if there are footnotes to the data that offer an explanation. In fact, NVLAP's on-site assessors frequently grade the performance of processors even though the proficiency testing program was originally designed to be a pass / fail test. If a phase-in policy results in a processor failing, or marginally passing with large values of IBl+S, many auditors (most notably NVLAP's on-site assessors) will be highly critical of the processor's quality. MAR _ 1 1995 .

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2 During the NRC's pilot study of the N13.ll-1983 standard, many processors took the "phase- in" approach. They allowed the initial tests to show them where changes were required, which resulted in unrealistically poor performance data. This approach was acceptable when "failure" carried no stigma because each participant's results were kept confidential, even from the NRC.

This approach is not acceptable today when the results are public knowledge, and careers depend on excellent (not just passing) proficiency test results.

My objection to a phase-in approach (try it - if you fail due to the changes, you can try it again) is compounded by a lack of confidentiality among NVLAP's on-site assessors. I can't imagine a consultant discussing a c l ient's problems with other people, but NVLAP's assessors do this routinely. Since there is little effort to protect the confidentiality of the I proficiency test results or the on-site assessment results, it is inappropriate to have a casual phase-in approach to implementing the new N13.11-1993 standard.

I believe the best policy is to set a date (perhaps one year) in the future to change from N13.11-1983 to N13.11-1993, with no provision for re-testing due to a processor not being ready. Processors will need time to have calibration irradiations done, make adjustments in their algorithm, test their new algorithms to develop confidence, change the programs on their computers, and verify these changes.

Processors will also need time to prepare for the increases in the reported doses to workers due to the changes from ex to Ck values. The fact that the Ck values are being changed as late as December, 1994, does not inspire confidence in the validity of N13.ll-1993.

The NRC also proposes to take t h ree exceptions to the requirements of the Nl3.11-1993 standard. My comments on these three exceptions are given below.

A working group of experts with in the Health Physics Society spent 5 years reviewing and changing the Nl3.11-1983 standard.

This working group was composed of technical experts in the field of personnel dosimetry, and NIST was represented on the working group. Therefore, it is difficult to understand why the NRC is proposing the first two exceptions to Nl3.11-1993. The first exception (selection of low-energy photon sources) is a professional decision already made by the working group. The second exception (use of the AmBe source) should have been handled by the working group with input from NIST. These two exceptions seem to negate the professional decisions of the working group.

3 The third exception (angular response testing only once) is essentially the requirement of N13.11-1983. This requirement was never enforced by NVLAP. It is unfortunate to commission a working group of experts and then pick and choose which portions of their standard will be enforced.

I hope you find my comments to be of some value. Please accept them as coming from a loyal supporter of the NVLAP accreditation program.

Sincerely, Phillip Plato, Ph.D.

I

Origi *a1 ,,

• Office of Feoeral Register DOCKET NUMBER .

PROPOSED RULE PR MI 5 G for publication (51 F Ye. 6 f q o 6) DOC ETED

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[7590-01-P]

NUCLEAR REGULATORY COMMISSION *94 er - 1 r 4 :39 DEPARTMENT OF COMM ERCE National Institute of Standards and Techno1Jp.-g r - er* . t v ODCI' . 1 1. ., t .

National Voluntary Laboratory Accreditation Program 3p ~' "

• for Ionizing Radiation Dosimetry AGENCY: Nuclear Regulatory Comm i ssion and Department of Commerce.

ACTION: Notice of change of proficiency testing standard.

I

SUMMARY

The Nuclear Regulatory Col1'1lission {NRC) and the National Institute of Standards and Technology (NIST}, Department of Commerce, began a joint effort in 1981 through an Interagency Agreement to provide an accreditation program for processors of personnel dosimeters, now known as the National Voluntary Laboratory Accreditat ion Program (NVLAP} for Ionizing Radiation Dosimetry. The purpose of this notice is to acknowledge publication of a revised proficiency testing standard for th e NVLAP, to inform the public and dosimetry processors of this action, to provide an effective date for use of I the revised standard, to identify significant changes in the standard and req uest public comments on use of the standard.

DATES: Submit comments by January 31, 1995. Comments received after this date will be considered if it is practical to do so but there is no assurance that consideration can be given to comments received after this date.

ADDRESSES: Mail written comments to Secretary, U.S. Nuc l ear Regulatory Commission, Washington DC 20555, Attention: Docketing and Service Branch.

Hand deliver comments to 11555 Rockville Pike, Rockvi l le, Maryland between 7:45 am and 4:15 pm on Federal workdays.

EFFECTIVE DATE: January 31, 1997.

FOR FURTHER INFORMATION CONTACT: Donald O; Nellis, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-6257, or Paul R. Martin, National Institute of Standards and Technology, Department of Commerce, NVLAP , Building 411, Room Al62, Gaithersburg, MD 20899, telephone (301) 975-3679.

I SUPPLEMENTARY INFORMATION: The NRC's regulations, (§ 20.1501), require that all personnel dosimeters that require processing must be processed and evaluated by a dosimetry processor holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP), of the National Institute of Standards and Technology. Proficiency testing, required as part of the NVLAP accreditation process for Ionizing Radiation Dosimetry, is based upon American National Standard ANSI Nl3.ll-1983, "Personnel Dosimetry Performance - Criteria for Testing" as specified in I NIST Handbook 150-4. A revision to this ANSI standard was approved by the American National Standards Institute, Inc., in September 1993, and published as ANSI Nl3.ll-1993 in July 1994. The revision embodies changes in the following irradiation categories: Category III, low energy photons; Category V, beta particles; Category VIII, neutron-photon mixtures; and adds a new Category IX, angle of incidence.

Accreditation under the NVLAP for Ionizing Radiation Dosimetry is renewed annually, with proficiency testing taking place every 2 years after the initial test. To prevent the possible loss of accreditation that could occur as a result of changing from the origi nal test standard ANSI Nl3.ll-1983, to 2

the revised standard ANSI N13.11-1993, the NRC and NIST\NVLAP intend to institute a phase-in period of testing against the revised standard, beginning January l*, 1995. During th is phase-in period, dosimetry processing laboratories will be tested against the revised standard when their normal accredi tation proficiency testing date comes due. Any laboratory that fails the proficiency test due to changes made in the revised standard will not have their current accreditation suspended, but will be required to retest and pass those failed categories before January 31, 1997, in order to maintain I accredited status.

Any failure of proficiency testing during this phase-in period that is not attributable to changes in the test standard, however, could affect the processing laboratory's accreditation status.

The revised standard, ANSI N13.ll-1993, will be implemented as published with the following exceptions:

1) Categories III(a), III(b) and VI. The requirement for choosing a primary low energy source and at least one other source from Category III as described in the standard wi ll not be used. For each group of dosimeters tested, the source used will be randomly sel ected from the five sources listed in Category IIl(a) or the three sources listed in Category Ill(b), with the stipulation that for at least one of the groups, the source chosen wi l l be either M150 or H150.

2) Category VIIIB testing will not be provided initially because a suitable source with traceability to NIST is not available at the present time.

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3) Category IX testing will be required only once for each dosimeter model that is to be tested in Category III or IV. A retest will be required whenever the dosimeter design is changed or the dose algorithm is modified.

Dated:

For the Department of Commerte.

0 Albert D. Tholen, Chief Laboratory Accreditation Program, NIST I Dated: J,.)o v 2 s- ., I~ 'l 4--

For the Nuclear Regulatory Commission

&; IN\ r v \ ~

Bill M. Morris, Director Division of Regulatory Applications Office of Nuclear Regulatory Research 4