ML20209B932
| ML20209B932 | |
| Person / Time | |
|---|---|
| Issue date: | 02/14/1983 |
| From: | Dircks W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| Shared Package | |
| ML20209A892 | List:
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| References | |
| FRN-49FR1205, RULE-PR-20, TASK-RINV, TASK-SE AA39-2-035, AA39-2-35, SECY-83-063, SECY-83-63, NUDOCS 8302280067 | |
| Download: ML20209B932 (127) | |
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February 14, 1983 SECY-83-63 (Notation Vote)
For:
The Commissioners From:
William J. Dircks Executive Director for Operations
Subject:
PROPOSED AMENDMENTS TO 10 CFR PART 20 TO REQUIRE THE USE OF ACCREDITED PERSONNEL 00SIMETRY PROCESSORS
Purpose:
To obtain Commission approval to publish the subject proposed amendments in the Federal Register for public comment.
Category:
This paper covers a minor policy question.
Issue:
Should the Commission require the use of accredited personnel dosimetry processors by its licensees as a means of improving personnel dosimetry?
Background:
NRC-licensees are required to perform personnel monitoring as specified in 10 CFR Part 20, Section 20.202, and to record and maintain radiation exposure records as specified in Section 20.401.
Personnel dosimeters are devices worn by workers to i
monitor their exposures to radiation. After being exposed to J
radiation, dosimeters must be processed to estimate the radi-ation dose received by the individual. Dosimeters are collected from workers at various prescribed time intervals by the licensee and processed either by the licensee or by a commercial dosimetry processor (s).
Data from these personnel dosimeters are the bases for licensee and NRC records of external dose to workers.
The NRC previously has not established requirements regarding the competency of personnel dosimetry processors.
Several dosimetry Contact-Alan K. Roecklein, RES I
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processor performance studies
- conducted between 1967 and 1976 indicated poor performance (excessive bias and variance) of processor's dosimeters when tested against a number of early performance standards; these studies clearly demonstrated the need for common performance criteria for both film and thermoluminescent dosimeter (TLD)processortesting.
As a result of these studies and strong encouragement by the Task Force on Personnel Dosimetry of the Conference of Radiation Control Program Directors (which represents the States), the NRC, the Bureau of Radiological Health, and the Energy Research and Development Administration (now the Department of Energy) jointly conducted a public meeting in 1976 at which the personnel dosimetry performance problem was discussed in an open forum by personnel dosimetry processors, dosimetry users, and representatives of State governments and Federal agencies.
These discussions revealed general agreement that a personnel dosimetry problem does exist and that the problem is sufficiently broad in scope that it should be addressed by the Federal govern-ment since voluntary standards programs for personnel dosimetry processors, such as the National Sanitation Foundation Program, have historically failed to achieve wide participation and accept-ance from the personnel dosimetry processing industry. Also, copies of a draft performance standard which was designed to estab-lish uniform criteria for testing the performance of film and TLD dosimetry processors were distributed at the meeting. The draft standard was written by a working group of the Health Physics Society Standards Committee (HPSSC) and was subsequently published in draft form by the American National Standards Institute (ANSI) as ANSI Standard N13.11. Attendees recommended that a regulatory program be developed after thorough testing of criteria in the draft performance standard.
Subsequently, 59 dosimetry processors participated voluntarily in two rounds of dosimetry proficiency testing in a pilot study **
using draft ANSI N13.11 (available upon request).
It was esti-mated that these 59 dosimetry processors actually provide dosim-etry for approximately 90% of the personnel dosimeters used for
- C M. Unruh, et al., "The Establishment of and Utilization of Film Dosimeter l
Performance Criteria," BNWL-542, (1967), Battelle Pacific Northwest Labora-tories, Richland, Washington.
L. Nichols and C. Newton, Jr., " Performance Tests of Comercial Personnel Monitoring S::rvices," July 25, 1974-January 25, 1975, Battelle Pacific Northwest Laboratory, Richland, Washington.
Unpublished Report Available NRC Public Document Room.
L. L. Nichols, "A Test of The Performance of Personnel Dosimeters, "BNWL-2159 (1977),
Battelle Pacific Northwest Laboratory, Richland, Washington.
- Plato, P. and G. Hudson, " Performance Testing of Personnel Dosimetry Services:
Final Report of a Two-Year Pilot Study October 1977 - September 1979," NUREG/CR 1064, January 1980, University of Michigan, Ann Arbon, Michigan.
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the nuclear worker population in the U.S.
This study was conducted for the NRC by the University of Michigan. Results indicated a widespread. dosimetry processor performance problem which in turn indicated that the doses received by workers may often be considerably different from the doses recorded. Thus, dose control is not always being accomplished as. perceived, and compliance with regulatory dose limits is not always verified with an adequate degree of certainty.
In SECY 80-44, the staff recommended publication of an Advance Notice of Rulemaking (ANR) for regulations which would require licensees to use dosimetry processors that have demonstrated competency by passing the tests specified in the standard (45 FR 20493)..The Commission authorized publication in the Federal Register on March 28, 1980, of the ANR which presented four alternatives for the operation of a proficiency testing laboratory (PTL).
Forty-six comment letters were received; an analysis of these comments may be found in Enclosure C.
The majority stated a preference for a Federal-Government-controlled laboratory.
During the coment period, the NRC sponsored a second public meeting with processors and other interested persons to obtain further comments on the proposed rulemaking and to discuss ele-ments for a quality assurance program for dosimetry processing.
Attendees at the meeting strongly suggested the need for a third round of performance _ testing of processors against the newly revised ANSI Standard N13.11 prior.to the beginning of any regu-latory program. The NRC staff subsequently authorized the University of Michigan to conduct a third round of testing using the revised standard.
Also, NRC's contractor, the University of Michigan, sponsored several meetings with dosimetry processors in 1980 to obtain comments concerning the value and impact of the proposed program.
Coments received are reflected in Section 2 of Enclosure B.
At the close of the comment period, a fifth method for the operation of a PTL was identified by the National Bureau of Stan-dards, viz., the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Bureau of Standards (NBS), which is a part of the Department of Comerce (DOC). According to this method, NBS through NVLAP would contract for the services of a laboratory to test the proficiency of processors against the standard. This program would also include on-site reviews of each processor's routine dosimetry processing and quality assurance activities. All costs for establishing and operating the laboratory and for on-site reviews would be recovered through accreditation fees paid by dosimetry processors.
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The NRC staff subsequently requested the DOC to establi,sh such a
' laboratory accreditation program. The DOC, in accordance with NVLAP procedures and authority stated in 15 CFR Part 7b, pub-11shed NRC's request in the Federal Register for coment (46 FR 9689) on January 29, 1981 and distributed copies of the notice to all known dosimetry processors and other known interested persons. Nineteen letters were received, all in favor of the NVLAP approach.
The NRC staff has coordinated the development of this program with industry and other interested Federal agencies.
Represent-atives on the Interagency Policy Comittee on Personnel Dosim-etry Processing (composed of seven Federal agencies including the National Center for Devices and Radiological Health
- of HHS, DOE, 000, EPA, NBS, OSHA of D0L, NRC and the Conference of Radiation Control Program Directors which represents the States) have endorsed the NVLAP alternative and plan to recomend this program for adoption by their agencies. The Conference of Radiation Control Program Directors has supported the development of this rule since 1973. The Conference recently advised its member States of the status of this rulemaking and suggested that letters be written to Chairman Palladino and the Comissioners urging that they approve this rule. About ten such letters have been received at the time this is being written and more are expected.
Copies of letters from the States are provided as Enclosure H.
An Industry Overview Comittee, established by the personnel dosim-etry processing industry in 1977 to ensure that any regulatory action would be effective and appropriate, has endorsed the adop-tion of the NVLAP alternative and has worked with the NRC and NBS/
NVLAP staffs (1) in recomending criteria for use in the program, (2) in providing guidance toward selecting, training, and defining the role of NVLAP assessors, and (3) through participation in conducting a public workshop sponsored by NBS/NVLAP in April 1982.
l Thus far, NRC staff has accepted NVLAP general and specific l
accreditation criteria, which will serve as the basis for granting accreditation to processors, and has participated in the development of supplemental information, which interprets NVLAP general and specific criteria in personnel dosimetry processing jargon. NBS/NVLAP sponsored a technical workshop for l
dosimetry processors and interested persons in April 1982 to discuss aopropriate technical benchmarks to be used in eval-I uating a processor's compliance with NVLAP criteria. After analysis of this workshop by NBS, NRC, and members of the Industry Overview Comittee, a questionnaire was drafted for assessors to use in conducting on-site assessment of a pro-cessor's compliance with quality assurance measures specified in NVLAP criteria and supplemental information was finalized.
- Formerly the Bureau of Radiological Health (BRH) a
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The NBS and the NRC signed an Interagency Agreement for the establishment of the Laboratory Accreditation Program on July 17, 1981, and a revision to that agreement on June 18, 1982, which delineates each agency's responsibilities for this program.
NBS will assume responsibility for the operational phase of the program.
Implementation:
The NBS is currently preparing a competitive procurement action for selecting the proficiency testing laboratory (PTL). The PTL is to be ready to conduct proficiency testing six months after award of contract. Currently the schedule would indicate that announcement of the availability of the laboratory accreditation program (LAP) should be made in early 1983.
Processors will have three months to request application materials, complete their application forms, and submit fees to NVLAP for proficiency testing and administration which includes on-site assessment by one or more NVLAP assessors. The operational LAP and actual proficiency testing should begin in the fall of 1983.
Copies of the LAP availability notice will be sent to all known personnel dosimetry processors, licensees, and known interested persons as soon as the notice is available. Processors who wish to be accredited must register immediately upon notification of LAP availability in order to have full benefit of additional periods of proficiency testing should they fail to pass any of the initial testing categories they attempt. According to current projections, the first accreditations could be announced as early as nine months after the announcement of the LAP availability. All acredita-tion costs (establishing the testing, laboratory, its operation and on-site reviews) are to be recovered through fees paid by dosimetry processors.
A total of five alternatives were considered by the staff.
A description of these may be found in Section 2 of the Regulatory Analysis (Enclosure B) and in the attached Federal Register Notice (Enclosure A).
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Conclusions:==
The staff recommends a regulation which would require NRC licensees currently required to conduct personnel monitoring to utilize the services of a personnel dosimetry processor (s)
(in-house or contracted) that has been accredited by the NBS/NVLAP program for personnel dosimetry processors. An analysis of the values and impacts for this alternative 7,nd the pros and cons concerning other alternatives considered is available in Section 2 of Enclosure B.
This alternative would have little long-term impact on staff resources (less than.5 person years per year).
Processors woul,d be tested and evaluated for technical competency biennially.
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The program would become self-supporting from fees paid by pro-cessors. Processors would have numerous opportunities for correction of identified deficiencies in their quality assurance programs; NVLAP accreditation procedures permit additional pro-ficiency testing at the processor's expense and formalized appeal procedures are available as specified in 15 CFR Part 7b.
TMI Action Plan Review Criteria and Regulatory Flexibility Analysis The staff finds that the Periodic and Systematic Review of the Regulations (TMI Action Plan review criteria) and the Regulatory Flexibility Act requirements have been met.
Enclosure D contains i
i the Periodic and Systematic Review of the Regulations. Tne review
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finds that the effects of these propos,ed regulations and public comments have been considered, the least burdensome of the accept-able alternatives has been accepted, the proposed regulations ara understandable, reporting requirements have been estimated and that these proposed regulations are needed.
Enclosure E contains the Initial Regulatory Flexibility Act Analysis which is summa-rized in the Federal Register Notice (Enclosure A).
Rzcommendation:
That the Comission:
(a) Approve publication in the Federal Register of the proposed amendments to Part 20 (Enclosure A).
(b) A) prove the staff's conclusions set forth in Enclosure D, w11ch provides the analysis called for by the Periodic and Systematic Review of the Regulations.
(c) Approve the staff's preliminary conclusions set forth in the Initial Regulatory Flexibility Act Analysis, Enclosure E, that the benefits to the public health and safety that would result from the proposed accreditation requirement and program are necessary in spite of the program's possible economic impact upon small entities.
Comments on these pre-liminary conclusions would be solicited from the public in i
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the proposed Federal Register Notice (Enclosure A).
(d) Note that NRC's final rule will be scheduled to become lifTective approximately 26 months after proficiency testing is scheduled to begin (December 1985) to allow processors ample opportunity to participate in performance tests administered by NBS's contractor PTL.
NRC staff plans to recommend issuance of the final rule as soon as possible after analysis of comments to this Proposed Rulemaking as an incentive to processors for early participation in the program.
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(e) Note that with respect to the Agreement States, this item will be made a matter of compatability because it concerns basic radiation standards.
(f) Note that:
1.
The Subcommittee on Nuclear Regulation of the Senate Comittee on Environment and Public Works, the Sub-comittee on Energy and the Environment of the House Comittee on Interior and Insular Affairs, the Sub-committee on Energy and Power of the House Comittee on Interstate and Foreign Commerce, and the Subcomittee on Environment, Energy and Natural Resources of the House Comittee on Government Operations will be informed of this action by letter such as Enclosure F;.
2.
A public announcement such as Enclosure G will be issued when the Federal Rerister Notice is filed with the Office of the Federal Fegister.
3.
Copies of the Notice of Proposed Rulemaking will be sent to all NRC licensees, to all known personnel dosimetry processors, and to other interested persons -
and organizations by the Office of Administration.
4.
The application for reporting and recordkeeping requirements contained in this Proposed Rulemaking have been approved by the Office of Management and Budget (OMB), OMB approval No.:
3150-0014.
5.
Pursuant to K 51.5(d)(3) of the Comission's regu-lations, neither an environmental impact statement nor a negative declaration need be prepared in connection with the amendments since the amendments are non-i-
substantive and insignificant from the standpoint of environmental impact.
6.
The Chief Counsel for Advocacy of the Small Business Administration will be infonned of the accreditation pro-gram and the reasons for it, as required by section 605(b) of the Regulatory Flexibility Act.
O William J. Dircks n
Executive Director for Operations i
Enclosures:
See Next Page L
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Enclosures:
A - Federal Register Notice B - Regulatory Analysis C - Analysis of Comment Letters to ANR D - Periodic and Systematic Review of Regulations E - Initial Regulatory Flexibility Analysis F - Congressional Letter G - Public Announcement H - Copies of Letters from States Commi,ssioners' comments or consent should be provided directly to the Office of the Secretary by c.o.b. Thursday, March 3, 1983.
Commission Staff Office comments, if any, should be submitted to the Commissioners NLT Thursday, February 24, 1983 with an information copy to the Office of the Secretary.
If the paper is of such a n'ature that it requires additional time for analytical review and comment, the Commissioners and the Secretariat should be-apprised of when comments may be expected.
DISTRIBUTION:
Commissioners OGC OPE OCA OIA OPA REGIONAL OFFICES EDO ELD I
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ENCLOSURE A r
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j NUCLEAR REGULATORY COMMISSION 10 CFR Part 20 1
Improved Personnel nncimatrv prneaccinn 1
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AGENCY:
Nuclear Regulatory Commission ACTION:
Proposed rules.
SUMMARY
- Tests have indicated that a significant percentage of personnel dosimetry processors may not be performing with a reasonable degree of accuracy.
Current regulations do not address the competency of these processors. The Nuclear Regulatory Commission (NRC) is proposing amend-ments that would require its licensees to utilize the specified services of processors that have been accredited by the National Voluntary Labora-tory Accreditation Program of the National Bureau of Standards.
FOR FURTHER INFORMATION CONTACT: Alan K. Roecklein, Division of Facil-ity Operations, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Mail Stop NL 5650, Washington, D.C. 20555, tele-phone (301)443-5970; inquiries regarding the Laboratory Accreditation Program for Personnel Dosimetry Processors at the National Bureau of Standards should be addressed to Robert L. Gladhill, Office of Laboratory Accreditation, National Voluntary Laboratory Accreditation Program, National Bureau of Standards, Technology B-141, Washington, D.C. 20234, telephone (301)921-3431.
l DATES:
Comments must be received or before
- Comments I-received after this date will be considered-if it is practical to do so, but assurance of consideration cannot be given except as to comments 3
received on or before this date.
" Insert date 60 days after publication in the FEDERAL REGISTER.
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l ADDRESSES:
Interested persons are invited to submit written comments and suggestions on the proposed rule, the supporting Regulatory Analysis and the Initial Regulatory Flexibility Analysis to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, Attention: ' Docketing and Service Branch.
Comments may also be delivered to Room 1121, 1717 H Street NW., Washington, D.C., between 8:15 a.m. and 5:00 p.m.
Copies of the Regulatory Analysis, the Initial Regulatory Flexibility Analysis, and of co:nments received by the Commission regarding this rulemaking may be examined in the Commission's Public Document Room at 1717 H Street NW., Washington, D.C.
Single copies of the Regulatory Analysis and Initial Regulatory Flexibility Analysis may be obtained on request from Alan K. Roecklein, Occupational Radiation Protection Branch, Division of Facility Operations, Office of Nuclear Regulatory Research, Mail Stop NL 5650, U.S. Nuclear Regulatory Commission,iWashington, D.C.
20555.
SUPPLEMENTAL INFORMATION:
Personnel dosimeters are devices worn by workers to monitor their exposure to radiation.
NRC licensees are required to perform personnel monitoring as specified in 10 CFR Part 20, $20.202, and to record and maintain radiation exposure records as specified in $20.401.
j Several types of personnel monitoring devices are available:
1.
Whole body or whole body and skin personnel dosimeters, such as film badges including track-etch type dosimeters, and thermoluminescent dosimeters (TLDs) including albedo dosimeters;.
2.
extremity dosimeters for assessing dose equivalent to hands and forearms, feet and ankles; and 3.
pocket ionization chambers, including direct-reading and
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indirect-reading dosimeters.
After being exposed to radiation, personnel dosimeters (with the exception of pocket ionization chambers) must be processed to estimate the radiation dose received by the individual while wearing the device.
Dosimeters are collected from workers at various prescribed time intervals and processed either by the licensee in-house or by a commercial dosimetry I
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Personnel dosimeters appear to be capable of providing l
y consistently accurate information on the amount of radiation received, Li ti 2
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j provided,the dose recorded by the dosimeter is above the detection
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threshold, e.g., about 20 mress for photons.
However, personnel l
dosimeters must be processed accurately and consistently, and interpreted correctly to provide adequate dose estimates.
Data from the processing of personnel dosimeters are the basis for licensee and NRC records of
'i-external doses to workers.
Several dosimetry processor performance studies conducted between 1967 and 1976 indicated poor performance (excessive bias and variance) of, processor's dosimeters when tested against a number of early performance standards;* these studies clearly demonstrated the need for common performance criteria for both film and thermoluminescent dosimeter (TLD) processor testing.
As a result of these studies and strong encouragement by the Task Force on Personnel Dosimetry of the Conference of Radiation Control Program Directors (which represents the States),
the NRC, the Bureau of Radiological Health (now the National Center for Devices and Radiological Health), and the Energy Research and Development Administration (now the Department of Energy) jointly conducted a public meeting in 1976 at which the personnel dosimetry performance problem was discussed in an open forum by personnel dosimetry processors, dosimetry users, and representatives of State governments and Federal agencies.
These discussions ' revealed general agreement that a personnel dosimetry problem does exist and that the problem is sufficiently broad in scope that it should be addressed by the Federal government, since voluntary standards programs for personnel dosimetry processors have historically failed to achieve wide participation and acceptance from the personnel l
dosimetry processing industry. Also, copies of a draft performance standard, which was designed to establish uniform criteria for testing the performance of film and TLD dosimetry processors, were distributed
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M. Unruh, et al., "The Establishment of and Utilization of Film jj Dosimeter Performance Criteria," BNWL-542, (1967), Battelle Northwest Laboratories, Richland, Washington.
L. Nichols and C. Newton, Jr., " Performance Tests of Commercial Personnel l
Monitoring Services," July 25, 1974 - January 25, 1975, Battelle North-west Laboratory, Richland, Washington.
Unpublished Report - Available NRC Public Document Room, 1717 H St.
N.W., Washington, DC 20555.
t L. L. Nichols, "A Test of the Performance of Personnel Dosimeters, "BNWL-2159 (1977), Battelle Northwest Laboratory, Richland, Washington.
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4 at the meeting. The draft standard was written by a working group of the Health Physics Society Standards Committee (HPSSC) and was subsequenty published in draft form by the American National Standards Institute
' (ANSI) as ANSI Standard N13.11.
Many of the 1976 public meeting attendees cautioned against precip-itious action by any Government agency and strongly recommended a pilot study (1) to evaluate the newly formulated draft HPSSC/ ANSI Standard N13.11, and (2) to provide processors the opportunity to take any necessary corrective actions in their operations prior to the implementa-tion of new Federal regulations on the dosimetry performance problem.
As a result of these recommendations, two rounds of personnel dosim-etry processor proficiency testing were conducted for NRC by the University of Michigan (UM) from 1977-1979.* Fifty-nine personnel dosimetry pro-cessors, who provide dosimetry services for approximately 90% of the nuclear worker population in the U.S., voluntarily participated in these tests.
Proficiency testing was conducted in accordance with the draft HPSSC/ ANSI standard.
The HPSSC/ ANSI Standard, " Criteria for Testing Personnel Dosimetry Performance", includes criteria for performance testing of personnel dosim ~
etry processors who provide whole body or whole body and skin dosimetry services in eight radiation categories including x-ray, gamma, beta, neutron, and mixtures of these radiations.
Criteria for testing the performance of extremity dosimeter processors and for use in evaluating the performance of pocket ionization chambers were specifically excluded l
from the scope of the HPSSC/ ANSI Standard by the working group who wrote the Standard.
Results of the two rounds of proficiency testing of dosimetry proces-l sors indicated that improvement is needed on the part of many processors i
and that a significant percentage of the processors are not performing I
with a degree of accuracy acceptable to the NRC.
Criteria for dosimetry processor performance acceptable to the NRC are specified in the draft HPSSC/ ANSI Standard, " Criteria for Testing Personnel Dosimetry Performance."
Results also indicated that the whole body or whole body and skin dose
" Plato, P. and G. Hudson, " Performance Testing of Personnel Dosimetry Services:
Final Report of a Two-Year Pilot Study, October 1977 -
September 1979," NUREG/CR 1064, January, 1980, University of Michigan, Ann Arbor, Michigan.
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d received by occupationally exposed personnel may often be considerably O
different from the dose recorded.
N Because of the importance of personnel dosimetry measurements and j
the apparent poor performance of some processors, NRC considers that j
there is a need to evaluate the performance of personnel dosimetry processors periodically and to make a specific determination of competency.
Interagency coordination and cooperation was initiated very early in the program with the formation of the Interagency Policy Committee on Personnel Dosimetry (IPCPD) in 1977 to guide and coordinate correc-tion of the dosimetry processor performance problem.
NRC staff members have participated and reported to the IPCPD on the progress of thi.s rule-making action at all meetings. The IPCPD Committee includes representa-tives from:
the National Center for Devices and Radiological Health
- which is a part of Health and Human Services (HHS), the Department of Defense (D00), the Department of Energy (DOE), the Environmental Protec-tion Agency (EPA), the National Bureau of Standards (NBS), the NRC, the Occupational Safety and Health Administration which is a part of the Department of Labor (DOL), and the Conference of Radiation Control Program Directors which represents the States.** The representatives of these agencies consider the NRC to be the lead agency for the b
overall problem, and they plan to recommend to their various agencies l
that similar programs be adopted.
Industry coordination and cooperation from personnel dosimetry proc-essors has been sought since 1977 when the Industry Overview Committee I
on Personnel Dosimetry was formed to monitor the progress and development of this program and to ensure that any regulatory action would be effec-tive and appropriate to the need.
The NRC published in the FEDERAL REGISTER (45 FR 20493) an Advance Notice of Rulemaking (ANR) on March 28, 1980.
The ANR fully described V
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- The Conference of Radiation Control Program Directors has strongly L
supported the development of this rule since 1973. The Conference recently advised the States of the current status of this program 4,
and encouraged individual letters to the Commission urging their Y
strong endorsement for this rule.
Several such letters have already i
been received.
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the results of the UM tests,' discussed the need for improved dosimetry processing through rulemaking, and presented and requested comments on four methods for the operation of a proficiency testing laboratory (PTL) that would conduct perfo'rmance testing against the criteria in the HPSSC/ ANSI Standard. Any PTL established in accordance with one of these methods would be monitored for technical competency by the National Bureau of Standards (NBS) for the NRC.
Licensees would be required to obtain or provide dosimetry services which satisfied criteria as estab-lished by the NRC and administered by the PTL. The four methods for PTL~
operation as described in the ANR are:
1.
NRC would not specify the PTL; processors and licensees would be left to their own initiatives to establish one or more PTL(s)'to administer proficiency testing against the standard.
2.
The PTL would be a Federal government facility managed and operated by NRC.
3.
NRC would contract the services of a PTL and utilize the contractor's facilities.
4.
Other government agencies experienced in laboratory testing would operate a PTL in Federal government-owned facilities.
Of the forty-six letters of comment received in response to the ANR, twenty-one letters did not state a preference for a method of operating the PTL.
Three commenters felt no program at all was necessary.
In the remaining 22 comment letters, one or more preferences were expressed as being acceptable for the operation of the PTL. Twenty preferences were for the various types of Federal government-controlled laboratories (methods 2, 3, or 4).
Commenters asked questions and commented on who should control the testing laboratory and on procedures to be used in the regulatory program, as addressed in the ANR.
Other commenters dis-cussed potential administrative, contractual, and legal problems that could result from a processor failing to achieve accredited status.
These problems have been investigated by the NRC staff.
There was con-cern regarding the values and impacts of this regulatory program. Many commenters discussed the importance of defining and requiring minimum elements of a generic quality assurance program that should be estab-lished.
Several dosimetry processors who replied requested that a third round of performance testing be conducted to allow processors to be 6
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tested against the revised standard before a program becomes effective.
1 (Such testing has been conducted, and is discussed later in this notice.)
j The major technical questions raised concerned the selection of dose con-d version factors within the standard and. the appropriateness of currently required dose measurements at three tissue depths described in NRC Form 5.
4 These comments war.e examined, and a response is contained within the sun-mary analysis of comments, which is available for review at the Commis-I sion Public Document Room (see Addresses section of this notice).
Subsequently, on April 15, 1980, the NRC staff briefed the Commission on interim actions that could be taken by NRC staff to improve personnel 9,
dosimetry processing prior to the date of the effective rule.
The Commission discussed the importance of examining a processor's routine processing activities to ensure appropriate quality assurance techniques 0
were being utilized and to determine that routine dosimetry processing was being conducted with the same processing protocols that a processor might use when participating in performance testing.
On May 28 and 29, 1980, the NRC held a two-day public meeting with personnel dosimetry processors and other interested persons to discuss i-alternative methods for the operation of a PTL as stated in the ANR and to obtain comments from the dosimetry processing industry on the appro-priate elements of a quality assurance (QA) program for personnel dosim-etry processing.
During the comment period, a fifth method for PTL operation was
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identified by the National Bureau of Standards (NBS) which would be part
[
of the National Voluntary Laboratory Accreditation Program (NVLAP) of the NBS which is a part of the Department of Commerce (DOC).
The NBS, l;
through NVLAP, could contract the services of a PTL to administer proff-O ciency testing of processors which would utilize the contractor's facil-t:'.
itie:. under currently existing NVLAP procedures. The NVLAP method would j
include a thorough examination of each participating processor's routine li dosimetry processing and quality assurance activities through an on-site
!i review. The NVLAP method would essentially offer a system of third party accreditation by a Federal government agency, the DOC, through the N85.
j In a letter dated December 23, 1980, the NRC staff requested the DOC to work together with NRC to establish a Laboratory Accreditation Program for Personnel Dosimetry Processors.
The DOC, in accordance with 7
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f NVLAP procedures and authority, stated in 15 CFR Part 7b, published NRC's request for the development of such a Laboratory Accreditation Program i
i (LAP) in the FEDERAL REGISTER on January 29, 1981 (46 FR 9689) and re-quested public comment. The NRC sent a copy of the DOC's FEDERAL REGISTER Notice and a description of the NVLAP method to all known dosimetry processors, and known interested persons on February 6,1981.
l Nineteen letters of comment were received on the NVLAP method for operating the PTL as part of an accreditation program. The 19 letters were unanimous in favoring this method for operating a program for improved dosimetry. These comments are available for review at the Consission's Public Document Room (see Addresses section of this notice).
The HPSSC, which developed the draft standard that was used in the UM personnel dosimetry performance testing studies, has completed and adopted the final Health Physics Society Standard which has also recently been accepted as a final American National Standard, ANSI N13.11, by the Board of Standards Review of ANSI.
Provisions will be made in the program associated with this rulemaking action to allow for changes in the ANSI standard as research or practical experience shows the need for revision.
Since the draft HPSSC/ ANSI standard was significantly revised follow-ing the UM pilot study, the NRC staff. authorized the UM to conduct a third round of performance testing of processors against the revised standard.
This round of testing has been completed." Essentially the same condi-tions under which processors were tested in rounds 1 and 2 were also present for this final round of testing.
l.
II-Seventy dosimetry processors voluntarily participated in the third
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round of testing.
It is estimated that these 70 dosimetry processing h
services develop and/or process more than 90% of the dosimeters worn by l;
radiation workers in the U.S.
Fifty-four of the 70 dosimetry processors
~
completed these tests; seven processors dropped completely from the program during the testing period while the other nine processors submitted dosimeters but f:.iled to return reported doses for these
" Plato, P. and J. Kiklos, " Performance Testing of Personnel Dosimetry Services:
Final Report of Test #3," NUREG/CR-2891, November 1982, University of Michigan, Ann Arbor, Michigan.
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't dosimeters to the proficiency testing laboratory at the UM.
The accuracy O;
1 of the irradiations performed by the UM for all radiation categories was
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verified by the NBS. All pilot study results have been maintained con-l fidential by the University, and results of the pilot study are. coded so i
that processors' names and results remain anonymous, even to the NRC.
N Processors chose the categories in whi.ch they were' tested.
The standard provides for tests to be conducted from a total of six radia-tion protection categories and two radiation accident categories. The radiation protection categories include high-energy photons, low-energy
^
photons, beta particles, neutrons plus high-energy photons, mixtures of high-and low-energy photons, and beta particles plus high-energy photons.
Radiation accident categories are for high-and low-energy photons.
t Participants sent the prescribed number of dosimeters to the UM where they were irradiated to doses known only to the UM and returned to the processor. The processor then determined the dose for each dosimeter and reported the results back to the UM.
The ANSI standard evaluates a processor's ability to determine the dose within a specific tolerance limit, L.
Statistical criteria used in the standard include bias and precision terms.
For each category, the average performance index (bias term), P, and its standard deviation (precision term), S, are calculated. The performance index for a single dosimeter, P, is calculated by:
p,H' - H where.
H = delivered quantity H
H' = reported quantity For each category, an average performance index, P, and its standard deviation, S, are calculated.
A processor passes a category if P +S{L where a: L = 0.3 (accident categories) b: L = 0.5 (protection categories) 9
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It should be noted that the individua! results
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can be very scattered and still have a'n average result very near, or even equal to, the true value. Widely scattered results,have a large value of S; if the individual results are all very near the true value, S is very small.
Results from the third round of tests have been analyzed.
Several dosimetry processors submitted more than one model of dosimeter for performance testing. Of the models submitted for testing, 75% of all categories attempted were passed; thus, 25% of all category tests
[
attempted were failed.
In total, 86 different models of dosimeters were submitted for these tests.
Six percent of all models of dosim-eters failed every category attempted and 44% passed every category attempted.
Therefore, 50% of all models submitted for testing did not successfully pass all categories for which they were tested. The highest overall passing rate for all models of dosimeters among the eight radia-tion categories was 94% for high-energy photons in the protection dose range, and the lowest passing rate of 55% was achieved for low-energy photons in the protection dose range.
An alternative method of examining the overall performance of dosimetry processors would be to examine the performance index, P, of each of the dosimeters irradiated without regard to S.
When the reported dose estimate is compared with the delivered dose, 78% of the dosimeters tested during the third round were within 130% of the correct delivered dose. When the individual results are evaluated using criteria of 150% of the correct delivered dose, 89% of all processed dosimeters met this criterion.
Although the identity and individual results of the dosimeter test data are confidential to the UM, the contractor reports that the cate-l -
gories failed in this round of testing are evenly distributed among i
large and small, commercial and in-house processors.
NRC considers that improvement *n the part of most dosimetry processors is needed and that the regulations should be amended to include competency requirements to improve the quality of dose measurements.
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i7 REGULATORY APPROACHES CONSIDERED FOR THE PROPOSED RULES H':
The Commission recognizes that any performance testing program can j
only test the ability of a processor to meet the criteria of a standard at a given point in time.
A performance testing program, by itself, will not determine whether the processor actually treats its routine client's dosimeters with the same competency accorded to dosimeters received from the PTL. Therefore, it is necessary to supplement the performance testing program with checks of a processor's quality assurance program regardless of the method chosen.
The Commission considered five alternative approaches for establish-ing a regulatory program intended to ensure improved personnel dosimetry processing. The following regulatory alternatives are presented by ranking these options from the least restrictive (no action necessary) to the most restrictive.
Alternative 1 - No change in current requirements.
Alternative 2 - Change in the regulation to require that licensees obtain personnel dosimetry processing from (1) processors who have successfully participated in dosimetry performance testing administered in accordance with the ANSI Standard N13.11, and (2) processors who have a documented quality assurance program.
NRC would not specify the proficiency testing laboratory (PTL).
The necessary elements of the QA program would be specified in the regulations.
NRC inspectors would require from the licensee proof of successful performance testing and evidence that its processor's QA program complied with the regulation whether the dosimetry service was performed in-house or commercially.
Alternative 3 - Change in the regulation to require that licensees obtain personnel dosimetry processing from (1) processors who.have successfully participated in dosimetry performance testing administered in accordance with the ANSI Standard N13.11 by an NRC-specified testing laboratory, and (2) processors who have a documented QA program that contains necessary elements as specified in the regulation.
This alternative differs from the previous alternative in that NRC would t
specify the PTL.
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This alternative could be accomplished by either of the following approaches:
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Alternative 3.- Option A - NRC would obtain the services of a con-e tractor laboratory through the competitive bidding process.
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licensees would be required to obtain personnel dosimetry services from a processor who had successfully participated in performance testing by NRC's contractor PTL.
NRC inspectors would, during licensee inspection, examine written proof provided by the licensee (1) that such performance testing was completed by the processor of licensee's personnel dosimetry, and (2) that the processor maintained a QA program that included the elements specified in the regulations.
Alternative 3, Option B - Third Party Accreditation: NRC would specify in the r,egulation that licensees utilize the services of personnel dosimetry processors accreditated under the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Bureau of Standards (NBS) which is a part of the Department of Commerce (DOC).
NVLAP accreditation for personnel dosimetry processors would be based on three primary elements:
(1) performance testing of personnel dosimetry processors in accordance with ANSI Standard N13.11 to be performed by a laboratory contracted by NBS, (2) information collected from the personnel dosimetry processor by questionnaire, and (3) on-site inspection of routine dosimetry processing and QA techniques by NVLAP contracted The NBS would establish with NRC's approval general and assessors.
specific accreditation criteria for a laboratory accreditation program (LAP) for personnel dosimetry processors which are consistent with NVLAP's established general and specific criteria currently used in programs for assessing the competency of laboratories, (44 FR 12982).
t As appropriate, any exceptions to NVLAP accreditation criteria would be published in the FEDERAL REGISTER for public comment, and the necessary procedural steps to complete the NVLAP accreditation process for this LAP based on NRC's recommendations and the public response would be taken. The NBS, as the DOC's designee, would grant certificates of accreditation to those processors complying with NVLAP criteria. NBS, which is responsible for the on-site evaluation of laboratories under NVLAP procedures, would identify and contract with dosimetry processing experts, and it would conduct training regarding AVLAP procedures to prepare these technical experts to assess compliance of dosimetry n-
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d-processors with NVLAP criteria to ensure that an acceptable QA program j
is documented as well as implemented.
Alternative 4 - Since many dostmetry processors are not NRC licensees, and since dosimeters in themselves are not radioactive but are passive 3
monitors which measure dose received by die worker, NRC would request from the Congress the authority to license personnel dosimetry processors directly.
If this authority were granted, the regulations would be y
appropriately amended regarding proficiency testing and quality assurance o
criteria acceptable to the NRC.
Alternative 5 - Change in the regulation to require that licensees obtain their personnel dosimetry services from an NRC-operated or NRC-L contracted dosimetry service.
NRC would issue, through its laboratory, dosimeters for licensee use, and the laboratory would perform all dosin-l etry processing.
In addition, all processing would be performed in accordance with an NRC-specified quality assurance program.
A complete analysis of these alternatives is included in the Regu-latory Analysis which is available from Alan K. Roecklein (see section entitled, "For Further Information Contact"), or the analysis may be examined in the Commission's Public Document Room (see section entitled, j
" Addresses").
CONCLUSIONS l
The Commission is proposing amendments which endorse Alternative 3 -
Option B, which would, by amendments to the regulations, require NRC licensees to utilize the services of personnel dosimetry processors accredited by the National Bureau of Standards under the NVLAP program.
The laboratory accreditation program, as previously described, would be administered by another Federal agency, the N85, in accordance with NVLAP procedures specified in 15 CFR Part 7b.
The NBS plans, through a
[i competitive solicitation process, to contract with a laboratory to conduct performance testing of processors against criteria specified in ANSI Standard N13.11 and plans to contract the personal services of l
personnel dosimetry experts to conduct on-site review of an applicant processor's routine dosimetry processing and quality assurance activ-ities. This alternative would help correct the personnel dosimetry t
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processor performance problem with minimus NRC staffing and resources.
This program has been designed to become self-supporting from processor fees and will biennially test and evaluate the technical competency of personnel dosimetry processors performing dosimetry services for NRC-
. licensees.
It would also establish uniform minimum quality assurance criteria for routine and special dosimetry processing.
4 The NRC and NBS signed an Interagency Agreement on July 17, 1981, for the establishment of a Laboratory Accreditation Program (LAP) for Personnel Dosimetry Processors and a revision to that agreement on June 18, 1982 (copy available upon request). The DOC /NBS NVLAP staffs have worked with the NRC staff to develop this program within an appro-priate time frame.
The Interagency Policy Committee on Personnel Dosimetry has been kept abreast and consulted about the development of the laboratory l
accreditation program by NBS for NRC.. Representatives on the Committee plan to recommend the NVLAP program for their respective agency programs.
The Industry Overview Committee has worked closely with NRC and NVLAk personnel (1) in reviewing and suggesting proposed accreditation criteria for use in the development of this laboratory accreditation program, (2) in providing guidance toward selecting, training, and defining the role of NVLAP assessors who will be responsible for conducting on-site review of personnel dosimetry processors' quality assurance programs, and (3) by participation in a recent two-day public j
workshop sponsored by NVLAP, which was held in Washington, D.C.,
April 12 and 13, 1982, at NBS to discuss technical benchmarks for j
determining compliance of personnel dosimetry processors with NVLAP accreditation criteria.
l Although complete details and schedules for the laboratory accredita-tion program are not yet ready, copies of NVLAP general and specific criteria are available in 15 CFR Part 7b, and single copies are available l
l upon request from Robert L. Gladhill (see " Addresses" section).
NVLAP criteria address the operation of the laboratory by focusing on the organi-zational structure, technical management, professional and ethical business practices, and the system for assuring the quality of test
]results. The criteria also generically indicate those fundamental elements necessary for the successful performance of routine services by 14
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applicants including staff competence and training, laboratory facil-1 ities and equipment, test plans, equipment calibration procedures, laboratory records, data handling procedures, and quality control checks
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and audits.
As soon as the availability of the laboratory accrediation program l
is announced by NBS/ DOC in the FEDERAL REGISTER, supplemental information will be provided to NVLAP program applicants which details, using dosimetry processing terminology, the way general and specific criteria apply to i;
dosimetry processors.
The NVLAP/NBS staffs have worked closely with the personnel dosimetry processors, the Industry Overview Committee on 4 -
Personnel Dosimetry, the Interagency Policy Committee on Personnel Dosimetry, and the NRC in developing appropriate supplemental informa-tion for this LAP which will be used in writing the application booklet that will provide the details of NVLAP accreditation. The criteria and supplemental information establish a framework for uniformly evaluating personnel dosimetry processors, for minimizing accreditation costs, and for administering the program.
SCOPE OF PROPOSED RULES These proposed rules are specifically applicable to the processing of personnel dosimeters used to satisfy NRC requirements for determining the whole body or whole body and skin dose from x-rays, gamma, beta, and neutrons, or mixtures of these radiations for which dosimeter processing is required including film, track-etch, thermoluminescent and albedo-type dosimeters.
While the NRC recognizes the importance of assessing the accuracy of extremity dose measurements made by. dosimetry processors, performance criteria for testing processors for extremity dosimeters are not avail-able at this time.
The NRC has formally requested the HPSSC to form a working group to establish such performance and quality assurance criteria for extremity dosimeter processing testing.
The Chairman of the HPSSC has acknowledged the NRC's request for development of such a standard and has announced that such a group has been formed.
It is estimated that a minimum of two years will be required for development and publication of a final ANSI Standard after formation of the working l
15
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group.
If publication of a draft ANSI Standard for public trial and use is desirable, a minimum of one and a half years would be required after working group formation. The NRC will consider appropriate amendments to 9 20.202(c) when such performance criteria are available, and it is expected that such criteria will subsequently be added to the LAP for personnel dosimetry processors at the NBS.
' While the NRC. recognizes that some licensees use pocket ionization chambers for the purposes of recording the official whole body dose of in,dividual employees and that this is an acceptable method of providing uosimetry services in accordance with 6 20.202 of the NRC regulations, pocket ionization chambers do not require the services of a personnel i
dosimetry processor for interpretation or dose assessment. Appropriate calibration of pocket ionization chambers is necessary for their correct utilization.
Performance criteria and calibration guidance for appro-priate use and selection of pocket ionization chambers are available in
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NRC's Regulatory Guide 8.4, " Direct-Reading and Indirect-Reading Pocket Dosimiters," and from ANSI standards; but since these dosimeters do not require processing, they are beyond the scope of these proposed rules.
4 Personnel dose determinations can also be derived from survey mea-surements and exposure time; but, these determinations are also not included in the scope of these proposed rules.
4 PROPOSED IMPLEMENTATION 4
[,
Currently the schedule would indicate that announcement of the avail-ability of the laboratory accreditation program ~(LAP) will be made in 1983.
Processors will have three months to request application materials, l
complete their application forms, and submit fees to NVLAP for proficiency i
testing and administration which includes on-site assessment by one or l
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more NVLAP assessors.
The operational LAP and proficiency testing is currently scheduled to begin by October 1983.
Copies of the LAP avail-l, ability notice will be sent to all known personnel dosimetry processors, l
licensees, and known interested persons.
Processors who wish to have full benefit of additional periods of proficiency testing before NRC's final rule becomes effective (to ensure that they pass the initial test-ing categories they attempt) should register immediately upon notifica-16 1
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tion of LAP availability.
According to current projections, the first accreditations could be announced as soon is.six months after the 3
beginning of proficiency testing.
NRC's firtal rule will be scheduled.to become effective approximately 26 months aft h proficiency testing begins (December 1985) to allow processors ample opportunity to participate in j J
s performance tests administered by NBS's contractor PTL. NRC plans to act on the final rule as soon as possible after analysis of comments to this Notice of Proposed Rulemaking.
9 With respect to Agreement States, thisjitem will be made a matter of compatibility because it concerns basic radiation standards.
Paperwork Reduction Statement
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l INITIAL REGULATORY FLEXIBILITY STATEMENT
~l The need for these rules has been described in the Regulatory s\\
a Analysis which is available for copy at the Commission's Public Document Room,1717 H Street NW., Washington, D.C. 20555 or qfrom Alan K. Roecklein (see section eiititled "For Further Information Con' tact").
The Regu-latory Analycis contains a complete analysis of all technical and /
procedural alternatives and a statement of $tatutory cdnsiderations.
1 These rules as proposed would require hRC licensees to utilize the services of personnel dosimetry processors who are accredited under the i>!,
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National Voluntary Laboratory Accreditation Programt(NVLAP) of the National Bureau of Standards (NBS).
Currently, NRC licensees are not 6;
required to obtain' services of accredited processors because NRC does,
f not have competency requirements for personnel dosimetry processors in,j its regulations. These ruies are, however, being developed concomitantly 1
I with a Laboratory Accredir.ation Program for Personnel Dosimet'ry Processors /
being established for NRC by the NBS.
It is impoitant to note that all.l dosimetry' processors are not NRC licensees but that nearly all commercial dosimetry processors do business with NRC licensees.
It is further t
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expected that the members of the Interagency Policy Committee on Personnel Dosimetry will recommend programs of the same nature for their respective agencies.
f Approximately 4,500 licensees are currently performing personnel y
monitoring for their employees as prescribed in 10 CFR Part 20, i 20.202, and are maintaining radiation exposure records as specified in 10 CFR Part 20, g 20.401.5 NRC's contractor, the University of Michigan (UM),9 has estimated that there are about 90 personnel dosimetry' processors in '
1
'the United Stated who perform personnel dosimetry services in-house or 4
commercially. These processors were initially categorized in a June 13, 1
1981, letter which was updated in a November 6, 1982 letter from UM to NRC.* Eightyt of these processors may be considebd as large entities; 3
theyinclude(Sevenlargecommericalprocessors,sevenlargeprivate
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corporations, nine national laboratories, 31 nuclear power plants,10 00E contractors, eight military oiga'nizations, three large universities, four state public health departments, ar.d one medical facility. These entities do not fall within the definition of "small entities," as set forth;in section 601(3) of the Regulatory Flexibility Act, or within the definition of "small business" as found in section 3 of the Small BusinessAct,15U.S.C.6.J2,ortheSmallBusinessSizeStandardsin regulations issued bys thi? Small Business Administration -of 13 CFR' Part 121. The remaining' ten processors may, for purpods of this Regulatory Flexibility Statement, be considered "small entities" as i
defined in'Section 501(3) of the Regulatory Flexibility Act.
It was further estimated that as a group, these ten processors process only about 0.5% of all personnel dostmeters processed in the United States.
- ^
It is estimated that NRC licensalts currently euploy approximately 23%
of the 1.4 million workers in the United States who require personnel monitoring as a resatt of their potential exposure to ionizing radiation.
The costs for participating in performance testing and the accredita-tion program, whether a processor.is performing these services in-house r
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analysis approximately the same.
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3 spend approximatehi $7,800 on a one-time basis to prepare for the accredita-F tion program. )A$$ostcases,theNRCbelievesthesecostshavealready
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been incurred by processors because of the third round of testing at the r.
UM against the revised standard and the frequent discussions and meetings thatNRCstaffhasheldwithlicenseesanddosimetryprocessorsin discussing the need for improved dosimetry processing and plans for NRC 3
rulesonthissdt,het.' Processors will also incur biennial costs for s
[ accreditation which include NVLAP administrative fees and costs associated
.with the proficiency testing administered by the PTL contracted-by NBS y to administer such tests in accordanct with ANSI Standard N13.11.
NVLAP administrative fees will include costs for (1) processing an application for accreditation, (2) conducting on-site inspection of an applicant 4
processor's re$yine dosimetry processing and quality assurance tech'-
niques, and (5) for evaluating the competency and quality assurance efforts.of the PTL. These biennial costs (which also include projected irc house costs to the processor) for the average processor which submits l
one model dosimeter for testice.Jn eight radiation categories are 7
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estimated to be approximately $14,000 or $7,000 annually.
Unlike the average dosimetry processor which participated in the, third round of 4!
testing,theaverage"smallentity"procahorsubmittedonemodelof b
dosimeter for testing in 4 radiation categories.
Phtetedcostsfor NVLAP accreditation fees, profichncy testing, and in-house costs for accreditation of a "small entity" processor, total $11,800 for each i:
2 year accreditation per'od, or $5,900 annuaYly. The.4egulatory Anal-ysis fully discusses the details of these esiimates and projects that the individual processor costs could range from $6,200 to $17,200 every 9
two years.
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The total volume of business within the dosimetry processing industry
-l is estimated at $34 million annually.
The ten small personnel dosimetry processors which could be effected by this rule account for approximately^
0.5%, or $170,000 of this business annually
- While the NRC does not h
know the distribution of this volume of business among the ten dosimetry processors, an even distribution would create an average annual businecs of $17,000.
Thu's, the estimated biennial accreditation costs of $11,800 19 h
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- ($5,900 annual cost) for the NVLAP program is likely to have a significant economic impact on their dosimetry processing business.
Complete details of these estimated accreditation costs are available in the Regulatory Analysis and in the Initial Regulatory Flexibility Analysis (available as explained under the heading " Addresses" earlier in this notice).
It is the finding of the Commission in the Preliminary Regulatory
- Analysis that the only acceptable alternative procedure for solving this problem is by rulemaking action and that the particular alternative proposed, third party accreditation by the National Voluntary Laboratory Accreditation Program (NVLAP), offers equal benefits for small and large processors and will almost certainly guarantee improvements in the quality lf1 of reported dose estimates. The costs necessary for compliance with this
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proposed regulatory program are well justified and worth the health and safety benefits that will result from improved dosimetry. The Commission has carefully examined the elements of the proposed NVLAP accreditation program and finds that differing compliance, reporting requirements, or simplification of the accreditation program are not acceptable for evaluating a processor's ability to perform accurate and consistent personnel dosimetry for NRC licensees. The NRC and NVLAP staffs have taken actions to reduce the costs associated with the accreditation of processors. The ultimata effect of a dosimetry processor not gaining accreditation could mean that it would no longer be feasible for the processor to remain in business.
The accreditation process, however, offers a participating dosimetry processor considerable opportunities for correction of identified inadequacies, for repeat performance testing, and for appeal of any accreditation decisions.
4 In summary, the Commission has considered the impact of the NVLAP accreditation program upon the small entities affected, and has concluded that the benefits gained by workers, licensees, the general public and the NRC from providing improved personnel dosimetry services that would result from the proposed accreditation requirement and program are
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necessary in spite of the program's possible economic impact upon a few I
small entities.
"It should be noted that only 4 of the 10 identified "small entity"
. processors participated in the third round of testing at the UM.
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2273, 9 20.401-20.408, issued under sec. 161o., 68 Stat. 950, as amended; I
42 U.S.C. 2201(o).
Secs. 202, 206, Pub. L.93-438, 88 Stat. 1244, 1246 (42 U.S.C. 5842), unless otherwise noted.
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New paragraph (c) is added to 9 20.202 to read as follows:
5 20.202 Personnel monitoring, i
(c) After December 1985, all personnel dosimeters, except extremity dosimeters and pocket ionization chambers, that require processing to yield a dose value and that are provided to comply with 6 20.101, with the requirements of paragraph (a) of this section, or with the applicable terms and conditions of any license issued by the Nuclear Regulatory Commission:
(i) shall be processed by a processor currently accredited by the National Voluntary Laboratory Accreditation Program for Personnel Dosimetry Processors of the National Bureau of Standards in accordance with accreditation criteria established in 15 CFR Part 7b; and (ii) shall be approved in this accreditation process for the type of radiation or radiations for which the individual wearing the dosimeter is monitored.
I 3.
New paragraph (d) is added to 9 20.401 to read as follows:
9 20.401 Records of surveys, radiation monitoring, and disposal.
(d) Each licensee subject to 9 20.202(c) of this part, in addition to preserving personnel monitoring records in accordance with 6 20.401(c)(1) of this part, shall also preserve with these records copies of pertinent personnel dosimetry processor accreditation certificates from the National g
Voluntary Laboratory Accreditation Program as necessary to demonstrate compliance with 6 20.202(c) after December 1985.
Dated at Washington, D.C. this __ day of 1983.
For the Nuclear Regulatory Commission.
i' Samuel J. Chilk
- i Secretary of the Commission 1
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l Any'small entity subject to this regulation which determines that because of its size that it is likely to bear disproportionate, adverse,.
economic impact should apprise the Commission of this in a written comment that indicates:
(a) the processor and/or licensee's size in terms of annual receipts derived from service, number of employees, and the number of dosimeters processed annually; (b) how the proposed regulations would. result in a significant economic burden upon the licensee or processor as compared to larger licensees or processors; (c) how the proposed regulations could be modified to take into account its differing needs or capabilities; (d) the benefits that would accrue, or the detriments that would be avoided, if the proposed regulations were modified as suggested by the commenter; and (e) how the regulations, as modified, would still adequately protect public health and safety and provide adequate radiation dosim-etry services for U.S. nuclear workers.
List of Subjects in 10 CFR Part 20 Byproduct material, Licensed material, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Packaging and containers, Penalty, Radiation protection, Reporting requirements, Special nuclear material, Source material, and Waste treatment and disposal.
Pursuant to the Atomic Energy Act of 1954, as amended, and sections 553 of title 5 of the United States Code, notice is hereby given that adoption of the following amendments to 10 CFR Part 20 is contemplated.
PART 20 - STANDARDS FOR PROTECTION AGAINST RADIATION 1.
The authority citation for Part 20 continues to read as follows:
AUTHORITY:
Secs. 53, 63, 65, 81, 103, 104, 161, 68 Stat. 930, 933, 935, 936, 937, 948, as amended; 42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201.
For the purposes of sec. 223, 68 Stat. 938, as amended; 42 U.S.C.
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4 ENCLOSURE B r
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Enclosure B DRAFT REGULATORY ANALYSIS 1.
PROPOSED ACTION 1.1 Description The Nuclear Regulatory Commission (NRC) is publishing for comment proposed amendments to its regulations, 10 CFR Part 20, to require licensees performing personnel monitoring to:
1.
Utilize personnel dosimetry services accredited under the National Voluntary Laboratory Accreditation Program (NVLAP) for Personnel Dosimetry Processors of the National Bureau of Standards (NBS) which is a part of the Department of Commerce (DOC); and to 2.
Obtain and maintain a record of NVLAP accreditation certificates with all individual external dose records as necessary to demonstrate compliance after December, 1985.
~
- 1. 2 Need for Proposed Action The need for this regulatory program has been discussed in several documents, including the following:
1.
C. M. Unruh, et al., "The Establishment and Utilization of Film Dosimeter Performance Criteria," BNWL-542, (1967), Battelle North-l, west Laboratories, Richland, Washington.
2.
L. Nichols and C. Newton, Jr., " Performance Tests of Commercial 9
Personnel Monitoring Services," July 25, 1974 - January 25, 1975,
^
Battelle Northwest Laboratory, Richland, Washington.
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3.
L. L. Nichols, "A Test of the Performance of Personnel Dosimeters,"
I BNWL-2159 (1977), Battelle Northwest Laboratory, Richlan6 lashington.
These early performance studies demonstrated poor performance by personnel dosimetry processors when they were tested against a variety of performance standards.
Nichols' study evaluated all three existing dosimetry performance standards.
This study concluded that the draft American National Standards
. Institute (ANSI) as ANSI Standard N13.11,* " Criteria for Testing Personnel Dosimetry Performance," which provides criteria for performance testing of j
film and TLD processors, should be recommended for use in establishing a test-
)
ing program for the personnel dosimetry industry.
Nichols' study was initiated by the Bureau of Radiological Health (BRH) as a result of strong encouragement by the Task Force on Personnel Dosimetry of the Conference of Radiation Control Program Directors.
In response to mnclusions of the previously mentioned publications and NRC investigations, NR' and other Federal agencies conducted a public meeting November 30 and December 1, 1976, to discuss the personnel dosimetry performance problem in an open forum.
Personnel dosimetry processors, dosimetry users, and representatives of State governments and Federal agencies participated.
Other co-sponsors of this meeting were the Energy Research and Development 1
Administration (now part of the Department of Energy) and the Bureau of Radio '
l logical Health.
From these discussions, there was general agreement that a personnel dosin-etry problem does exist, that the problem is sufficiently broad in scope that it should be addressed by the Federal government, and that there is a need to evaluate the performance of personnel dosimetry processors periodically and to make a specific determination of competency.
However, many of the attendees cautioned against precipitous action and strongly recommended a pilot study 7
(1) to evaluate the draft HPSSC/ ANSI
- Standard N13.11, and (2) to provide pro-cessors the opportunity to take any necessary corrective action's in their opera-tions prior to the implementation of any new Fedaral regulations on the dosim-1 etry performance problem.
(
i; "This draft ANSI standard was originally written by a working group of the Health Physics Society Standards Committee (HPSSC) and subsequently adopted by ANSI; this standard is commonly referred to as the draft HPSSC/ ANSI Standard.
2 Enclosure B 7
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i Further interagency coordination and cooperation was initiated very early r
in the program with the informal formation of the Interagency Policy Committee
~
on Personnel Dosimetry (IPCPD) in 1977 to guide and coordinate correction of
~
the dosimetry processor performance problem. The following Federal agencies have representatives on this Committee:
the Bureau of Radiological Health which is a part of Health and Human Services (HHS), the Department of Defense (000),
the Department of Energy (DOE), the Environmental Protection Agency (EPA), the National Bureau of Standards (NBS), NRC, the Occupational Safety and Health Administration (OSHA) part of the Department of Labor (DOL), and the Conference of Radiation Control Program Directors (States).
The representatives of the agencies on the Committee consider the NRC to be the lead agency for the overall problem, and they plan to recommend to their various agencies that regulations j
or intra-agency rules similar to the NRC regulations be adopted.
In 1979 the industry formed the Industry Overview Committee on Personnel DosimetryIoj6nitortheprogressanddevelopmento'thisprogramandto help assure that any proposed regulatory action would be effective and appro-priate to the need.
The recommendations of public meeting attendees were accepted, and the NRC subsequently issued a contract in 1977 to the University of Michigan (UM) to conduct a 2 year pilot study.
The objectives of this study were:
To determine whether the draft ANSI standard provides an adequate 1.
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and practical test of dosimetry performance; 2.
To give processors an opportunity to correct any problems that are j
uncovered; and l'
3.
To develop operational and administrative procedures to be used l:
later by a permanent testing laboratory.
o R
l The study.was conducted for the NRC by the UM, beginning in September 1977,
,l' and was completed December 31, 1979.
l L
The results of the two rounds of performance testing of dosimetry proces-sors and associated reports completed by the UM for the NRC were made available in four NUREG/CR reports:
h NUREG/CR-1063-Plato, P. and Hudson, G., Performance Testing of Personnel Dosimetry Services:
Procedures Manual, NRC/GPO Sales Program, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, January 1980.
1b 3
Enclocure B f
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1 l
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,NUREG/CR-1064-Plato, P. and Hudson, G., Performance Testing of Personnel Dosimetry Services: Final Report of a Two-Year Pilot Study, NRC/GPO Sales Program, U.S. Nuclear Regulatory Commission, e
Washington, D.C. 20555, January 1980.
NUREG/CR-1304-Plato, P. and Hudson, G., Performance Testing of Personnel Dosimetry Services: Supplementary Report of a Two-Year Pilot y
Study, NRC/GP0 Sales Program, U.S. Nuclear Regulatory Commis-sion, Washington, D.C. 20555, April 1980.
NUREG/CR-1593-Plato, P. and Hudson, G., Performance Testing of Personnel Dosimet75ervices: Alternatives and Recommendations for a Personnel Dosimetry Testing Program, NRC/GPO Sales Program, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, August 1980.
In addition, monthly progress reports were prepared by the University of Michigan and were placed in file OH 506-1 (subsequently renamed OP 506-1) in the Commission's Public Document Room.
In summary, 59 dosimetry processors voluntarily participated in the two rounds of performance testing and were tested against the draft HPSSC/ ANSI Standard.
It is estimated that these 59 dosimetry processing services process 90% of the dosimeters used by radiation workers. The accuracy of the irradia-tions performed by the UM during the pilot study were verified by N8S's Center for Radiation Research.
The pilot study was conducted under well-defined conditions of irradiation.
The study did not attempt to evaluate the variety of problems produced when dosimeters are actually worn by people.
Yet the results indicate that the dose received by occupationally exposed personnel may often be considerably different from the dose recorded by the dosimetry processor.
Considering that NRC's occupational radiation protection program is based in part on the accuracy of exposure information, the present state of affairs gives cause for some concern since compliance with regulatory dose limits may not be achieved. The test results indicate that individual doses may be either overstated or understated.
A complete review of pilot study results can be found in NUREG/CR-1064 and C
After considering the results of the pilot study, the IPCPD made the
[
following recommendations:
4 Enclosure B
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The actual causes of the poor performance of personnel dosimetry
~
processors in the pilot study should be determined with a greater degree of certainty before completing plans for corrective action; 2.
A notice 'should be published in the Federal Register to notify all personnel dosimetry processors and the public that the Federal government is determined to take action, as necessary, to correct the personnel dosimetry problem.
Subsequently, the' NRC staff authorized the VM to conduct a series of on-site visits to all pilot study participants to determine the causes of poor perfor'mance.
A preliminary report was written by UM personnel at the concluaion of site l
visits to eight major processors.
The report indicated four major causes of poor performance during the pilot study:
(1) inadequate or inappropriate calibration factors, (2) variability in the thermoluminescent dosimeter chips, 4
(3) clerical errors, and (4) lack of effort on the part of the processors to make the changes necessary to pass the tests.
This report, dated May 1979, is available in the Commission's Public Document Room in the OP506-1 file on personnel dosimetry performance testing.
NUREG/CR-1593 contains a comprehensive discussion about the need for
)
these proposed regulations. This report discusses the major problems identified during site visits to processors.
In summary, the four major problems identified in the pilot' study were observed in the routine operation of many dosimetry processors. Although it is doubtful that these problems could lead to results that would constitute a significant hazard to radiation workers in the United States, it is clear that, on an individual worker basis, the performance of many processors is unacceptable.
There is little doubt that these problems can be corrected and, in general, at a minor cost to the dosim-etry industry.
This report, NUREG/CR-1593, also discusses three other areas of need.
The following material is from that report:
i "1.
Epidemiological Studies:
There is considerable interest today in low-dose effects of ionizing radiation.
Since a large number of workers are exposed to low doses, it is tempting for some organizations to attempt to correlate dose to effect.
A nationally recognized testing program would
. t help many people to understand and document the accuracy and limitations of personnel dosimeters which, in turn, would probably help the inter-
- i pretation of dose /effect investigations." Since it is quite probable
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l that many people will continue to look at epidemiological studies of s
low-dose effects of radiation, every effort should be made to assure the accuracy of personnel monitoring data.
2.
Use of appropriate calibration and correction factors: The radiation sources used in the pilot study were selected in accordance g
.with the performance standard, ANSI N13.11. These sources may be differ-
~
ent from those used by many processors who calibrate worker dosinisters i:
to sources that simulate the individual's working conditions. Dosimetry processors who use different sources for calibration would then need to apply appropriate correction factors for dosimeters used for performance testing in order to* perform well during per.ormance tests.
Asaresultofthepilotstudy,itwasdiscoveredthatEnyradia-tion workers are using dosimeters that have not been calibrated for their special needs.
Commercial processors must generally calibrate for what they perceive to be average radiation energies for their users, although they should have the technical capability to provide custos calibrations if asked. A dosimetry testing program will require a process'or to develop calibration factors necessary to pass the test.
This effort may, in turn, focus attention on the use and calculation of r
calibration factors appropriate for the needs of the radiation workers served by the processor.
3.
"U'niformity: Many processors have developed a dosimetry lan-guage that only they can understand, and sometimes even they are con-fused." For example, ANSI N13.11 clearly defines shallow and deep depths for dose recording purposes.
Currently processors report doses in terms of beta and gamma, skin and whole body, or non penetrating and penetrating radiations.
A standardized testing program would probably lead to a standardized vocabulary and dose recordkeeping in a standard set of units.
Cumulative doses assigned to radiation workers that fre-l quently change jobs, and therefore change processors, would probably be more accurate if all processors subscribed to the same set of dosimetry definitions.
On March 28, 1980, the NRC published in the Federal Register (FR) an Advance Notice of Rulemaking (ANR) (45 FR 20493) that summarized the results of the pilot study and outlined four possible alternatives for the operation of a testing laboratory.
After considering the seriousness of the problem, the Commission requested a briefing on interim actions for improving personnel dosimetry in the period i
before the entire rulemaking process could be completed. The Commission brief-ing was held April 15, 1980.
A number of alternative actions were presented.
The NRC staff held a 2-day public meeting with personnel dosimetry pro-cessors and other interested persons in Washington, D.C. on May 28 and 29, 1980
~
(45 FR 31118), to (a) obtain further public comment on the alternatives for i
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p the operation of the testing laboratory specified in the ANR and (b) industry comments on the appropriate elements of a personnel dosimetery quality assurance program that should be considered by NRC. The meeting was attended by approxi-mately 60 persons, many of who commented verbally on a wide range of topics pertinent to this regulatory program.
In general, the attendees favored a regulatory test and certification requirement, with the testing laboratory operated'by an NRC contractor and strongly supported the need for a third round of performance testing against the revised ANSI Standard N13.11 prior to the beginning of any regulatory program. The NRC staff subsequently authorized the University of Michigan to conduct a third round of testing using the revised Standard.
Published results are available in NUREG/CR-2891.
Further details regarding the comments received at the May 1980 meeting are available for inspection and duplication at the Commission's Public Document Room, 1717 H Street NW., Washington, DC 20555, under File PR 20 (45 FR 20493).
1
- 1. 3 Value/ Impact of Proposed Action i
1.3.a.
Summary Description of Program Operation Before discussing the value and impact of these rules, it is important to understand briefly how the program resulting frw these rules would work.
THIRD PAR 1Y ACCREDITATION-NRC would specify in its regulations that i-licensees must utilize the services of personnel dosimetry processors l
accredited under the National Voluntary Laboratory Accreditation Program l
(NVLAP) of the National Bureau of Standards (NBS) of the Department of l
Commerce (DOC) (15 CFR Part 7.b).
NVLAP accreditation would be based l'
on three primary elements:
(1) Proficiency testing of each personnel dosimetry processor in accordance with ANSI Standard N13.11 to be per-formed by a laboratory contracted by NBS, (2) information collected from the personnel dosimetry processor by questionnaire, and (3) on-site I-assessment of dosimetry processing and quality assurance techniques.
\\;
These elements will be used by NBS to assess a processor's compliance with NVLAP criteria ~for accreditation.
1 l
7 Enclosure B
j The NRC and the NBS would establish or approve the. final general and specific accreditation criteria for a Laboratory Accreditation Program (LAP) for Personrrel Dosimetry Processors consistent with NVLAP's estab-lished general and specific criteria, used in current programs for accessing the competency of laboratories (44 FR 12982) and (46 FR 37029).
NVLAP criteria include fundamental elements of laboratory operation and quality assurance, i.e., facilities, equipment, personnel, and quality control procedures.
NRC would specify, as supplemental.information to
/
these criteria, the elements of a dosimetry quality assurance program. '
As appropriate, exceptions to NVLAP general and specific accreditation criteria would be published in the Federal Register for public comment.
Subsequently, the neces:ary procedural steps to complete the NVLAP accreditation process for the development of the LAP would be taken by NBS based on public comments and NRC's recommendations. The NBS would grant certificates of accreditation on behalf of DOC to processors that comply with NVLAP criteria.
NBS would select and train dosimetry experts to serve as assessors who would conduct on-site assessments of the compliance of dosimetry processors with NVLAP criteria.
This on-site assessment of applicant processors will ensure that an acceptable quality assurance program is implemented and documented by the processor.
1.3.b.
Cost Analysis To assess properly the impact of this regulation, it was first necessary to determine the cost to industry for personnel dosimetry services pro-vided either in-house or commercially under current regulations.
The staff has estimated the costs for contracting the services of and equip-ping a testing laboratory to conduct proficiency testing, operating the proficiency testing laboratory (PTL), in-house costs for processors to participate in the NVLAP laboratory accreditation program, costs for processors for repeat proficiency testing in one or more categories, total costs to the public in general for these proposed amendments, and a summary of all costs associated with these rulemaking actions.
.i 8
Enclosure B r._
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M 1.3.b.1 Normal Personnel Monitoring Costs to Industry.
It was recog-a F
nized very early in this analysis that the cost for providing personnel dosie-b etry services is a function of the size of the processor operation.
Large commercial processors which handle a large volume of dosimeters monthly can process dosimeters at a lesser cost per dosimeter than is incurred by in-house processors.
It is recognized that there are certain benefits from performing dosimetry in-house such as (1) quickly having available extra dosimeters.for special studies or special personnel monitoring (2) quickly evaluating parti-cular dosimeters that potentially were exposed to higher levels of radiation e
than normal and (3) providing specially designed dosimeters particularly suited for studies of a specific work environment.
In the past year, a large number of utilities have begun personnel dosimetry processing for these reasons.
1 It is important to de/elop a weighted average for the cost to licensees per worker per year for personnel monitoring in order to determine the average cost of personnel monitoring per radiation worker.
(Figures used in this portion of the cost analyses are based upon a telephone survey of costs charged for dosimetry services by commercial and in-house processors.)
Tables B-1 and B-2 contain the figures used for this analysis.
l If it is assumed that 50% of the dosimeters are processed commercially and 50% in-house, 50% at $17.40 each and 50% at $30.60 each, the average cost /
j worker / year is $24.00 for personnel monitoring.
Estimates for the 1979 worker
[
population indicate that NRC Ifcensees monitor approximately 327,000 workers annually.*
i i
4 l
" Figures were taken from N' REG-0714, Vol.1, Occupational Rad!ation Exposure, J
Twelfth Annual Report 1979, U.S. Nuclear Regulatory Commission, National Technical Information Service, Springfield, Virginia 22161, August, 1982.
i l
9 Enclosure B I
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- 2 Table B-1 Average Personnel Monitoring Cost For Commercial Dosimetry Services / Worker Dosimeter Change Commercial Number of Periods Cost Per TOrganization Workers Per Year Change Cost / Worker / Year A (py)*
300,000 12 1.10 13.20 (N)**
50,000 12 3.75 45.00 B (py) 100,000 12 1.10 13.20 (N) 25,000 12 3.75 45.00 C (py) 50,000 12 1.10 13.20 D (py) 80,000 12 80 9.60 (N) 18,000 12 3.75 45.00 E (py) 13,000 12 1.10 13.20 636,000 weighted avg. = $17.40 "py - beta and gamma dosimetry services.
- N - neutron dosimetry service.
Table B-2 Average Personnel Monitoring Cost For In-House Dosimetry Services / Worker Dosimeter Change Private Periods Cost Per Organization Workers Per Year Change Cost / Worker / Year-A 4,000 4
9.00 36.00 B
3,000 12 2.50 30.00 C
34,000 12 2.50 30.00 41,000 weighted avg. = $30.60 Therefore, it was estimated that approximately $7.8 million per year is now spent by NRC-licensees on personnel monitoring for workers in NRC-licensed activities.
It can be estimated based on Environmental Protection Agency 1'.
L-10 Enclosure B l'
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s projections that $33.6 million is spent for personnel monitoring services for the total 1.4 million* radiation workers in the U.S.
Assuming 4500 affected licensees and an even distribution among licensees,* the cost per NRC-licensee for personnel monitoring services is estimated to be about $1,744 per facility on the average.
327,000 workers x $24/per worker / year + 4500 licensees = $1,744/ year / licensee.
1.3.b.2 Estimated Costs for Equipping and Operating a Contractor-Operated Proficiency Testing Laboratory (PTL). The PTL will have initial costs for equipping the laboratory with the necessary radiation sources and will have normal operating costs for conducting proficiency testing.
The initial costs for equipment and amortization rates for equipment are projected based upon costs noted during the UM pilot study which are shown in Tables B-3 and B-4.
Initial costs are included here simply to show the basis for amortization figures for replacement of these sources.
The majority of the equipment costs have already been incurred by the NRC for use in the University of Michigan pilot study.
The competitive solicitation package that NBS is preparing for procurement action to obtain the services of a contractor for conducting proficiency testing states that prospective bidders should possess or have access to appropriate x-ray machines as speci-fied for conducting testing in accordance with ANSI N13.11. The NRC will 2
transfer the two cesium-137 sources and the D 0 moderated californium-252 source from the University of Michigan to the selected offeror as soon as appropriate NRC-licenses for these sources are in place.
" EPA 520/4-81-003 Background Report, Proposed Federal Radiation Protection Guidance for Occupational Exposure, page 20, U.S. Environmental Protection Agency Washington, D.C. 20460, January 16, 1981.
1 11 Enclosure B
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Table B-3 Initial Costs for Equipping and Calibrating Equipment for the Proficiency Testing Laboratory (PTL) r 1.
Equipment Costs Equipment Initial Cost ($)
Two x-ray machines, $160,000 and $50,000 210,000 One 400 Ci Cs-137 source 12,000 One 20 Ci Cs-37 source 6,000 One Sr-90/Y-90 source 3,000 One Cf-252 source 6,000 One shipping cask for Cf-252 source 2,000 Heavy water for Cf-252 source 6,000 Sphere for Cf-252 Moderator 2,000 Beam monitors for all sources 8,000 Phantoms 1,000 Telescopes and Lasers 8,000 TOTAL 264,000 2.
Labor Costs One person year labor for source procurement and calibration activities at $24,000 a year 24,000 Overhead and fringe benefits (100% of salary) 24,000 48,000 3.
Total Initial Costs (Equipment and Labor)
$312,000 4
l 12 Enclosure B
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Table B-4 4
Projected Biennial Operating Costs for a Proficiency Testing Laboratory (PTL) 1 l
1.
Biennial Labor Costs Biennial Costs A.
Direct Labor Cost Director ([75personyear)
$31,350
?
Assistant Director (1.5 person years) 36,000 Three technicians (3 person years) 45,000 Secretary, quarter time (.4 person years) 3,750 Keypunch operator (.4 person years) 3,750 l
$119,850 B.
Overheads and fringe benefits (100% of salaries)
$119,850 TOTAL 5239,700 2.
Supply Costs t
Duplicating
$ 1,000/ year Postage 2,000 y
Telephone 2,000 Maintenance of equipment 5,000 Travel 3,000 Calibrations with N85 3,000 Computer time 2,000 TOTAL
$18,000 3.
Equipment Costs and Amortization Rates Biennial Amortization Type of Equipment Initial Cost Life (years)
Rate Two X-ray machir.as, $160,000 and $50,000
$210,000 20
$21,000 One'400 Ci Cs-137 source 12,000 10 2,400 I:
One 20 Ci'Cs-137 source 6,000 10 1,200 r
One Sr-90/Y-90 source 3,000 10 600 One Cf-252 source 9 $6,000 each 6,000 2
6,000 One shipping cask for Cf-252 source 2,000 30 133
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Heavy water for Cf-252 source 6,000 10 1,200 Sphere for Cf-252 moderator 2,000 30 133 Beam Monitors for all sources 8,000 10 1,600 Phantoms 1,000 30 67 Telescopes and Lasers 8,000 30 533 l!
TOTAL
$264,000
$34,866 4.
Total biennial operating costs Labor 5230,700 i:
Supplies 18,000 Equipment 34,866
$292,566
' Estimates are based on costs incurred for equipping and operating ttle PTL during the University of Michigan pilot study.
20verhead includes rental chargos for existing floor space, electricity, and heating.
13 Enclosure B
[
... ~*i l
3t 1.3.b.3 Estimated Fees for Accreditation. The accreditation fees would J
j-be based on two components:
(1) A fee of approximately $2500 is anticipated for administrative costs
[
[
that will cover NBS costs for evaluation of applications, review of 9,
proficiency testing results, all other accreditation actions such as renewals and revocations, and one on-site assessment by a NVLAP assessor for each applicant dosimetry processor every two years to assess compliance with NVLAP criteria, and (2) proficiency testing fees that will cover the PTL's expenses. The proficiency testing fees will be based on the number of radiation categories in which the processor is tested for each dosimeter model.
Proficiency testing will be offered in all 8 categories offered in the ANSI N13.11 Standard.
Categories I through V require the use of one radiation source each and will probably cost approximately $260 i
per category.
Categories VI through VIII will require the use of two radiation sources each and will probably cost twice as much as a single U
source category. These figures were obtained,in consultation with
[
Dr. Phillip Plato and Mr. Joe Miklos of the University of Michigan.
Fees for NVLAP accreditation may vary from this estimate although signifi-j cant differences are not anticipated (see Table B-5, B-6, and B-7).
During the third round of proficiency testing at the UM, processors chose
- !i to participate in a number of categories.
Processors submitted 116 dosimeter models for testing in 424 total radiation categories.
The smallest number of dosimeter models submitted by a given processor for testing was one dosimeter model for one category test.
The largest number of dosimeter models submitted for testing by a processor was 6 models for 16 radiation categories.
Most l1 processors submitted one type of dosimeter for 8 radiation category tests.
!j Processors that could be classified as "small entities" in accordance with d
the Regulatory Flexability Act on the average submitted one dosimeter model for testing in 4 radiation categories. These four processors participated in j;
a total of 14 radiation categories.
Preliminary results from the third round
.{
indicate that average passing rate for processort is 75% of the categories attempted.
Refer to Table B-6 for range of costs for proficiency testing among ji processors.
14 Enclosure B
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i Table B-5 Projected. Proficiency Testing Costs for Processors 4
Category Title as Specified Number of Radiation Fee to Test In in ANSI N13.11 Sources Required Fee / Category All Categories
~
1-5 1
$ 260
$1300 6-8 2
$ 520
$1560 All 8 categcries Mixed 1 ano 2 (Mixed) 57EEU 4
Table B-6 Projected Range of Proficiency Testing Costs for Processors
- l Total Costs for Dosimeter Proficiency Testing Models Initial Category Repeat Category in All Attempted Submitted Tests Requested Tests Requested Categories Categories 1-5 Categories 6-8 Categories 1-5 Categories 6-8 Minimum 1
1 0
0
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$ 260 Maximum 6
10 6
2 1
$6,760 Average 1
5 3
1 1
$3,640 Small
' l 0
$1,560 Entity 4
3 1
"Information is based upon processor participation in t'he third round of proficiency testing being conducted at the University of Michigan against the revised ANSI N13.11 Standard.
Table B-7 Total Estimated Accreditation Fees for an Individual Processor i
Administrative Fee Proficiency Testing Fee Total 1.
Minimum Fees
$2,500
$260
$2,760 Maximum Fees
$2,500
$6,760
$9,260 Average Fees
$2,500
$3,640
$6,140
^
g Small Entity
$2,500
$1,560
$4,060 15 Enclosure B r,
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- 1 processors have already absorbed costs projected in this section whila preparing j
for the third round of testing in the UM study against the revised ANSI N13.11 Standard.)
The UM has identified for NRC 71 commercial and in-house processors who provide personnel dosimetry services for NRC licenses.
By 1983, when this program would begin, NRC expects this number to increase to 83 NRC licensee-processors.
It is anticipated that several nuclear power plants that are noit contracting their dosimetry processing will begin processing their dosimeters in-house.
Assuming that, on the average, all processors would average $7,770 for pretesting adjustments
- prior to publication of the effective rule (see Table B-8), the total cost for the in-house and commercial dosimetry processor industry to prepare for a mandatory accreditation program would be:
90 x $7,770 = $699,300 The one-time cost / radiation worker /NRC-licensed. facility to prepare for mandatory performance testing assuming they are all licensees and in-house processors would be:
$699,300 + 327,000 workers at NRC-licensed facilities = $2.13/ worker.
l Of course the majority of licensees do not perform in-house dosimetry and would incur a much smaller increase in costs / worker / dosimetry services because of obtaining services from a large commercial processor.
l Since the average cost per worker for personnel dosimetry services is $24
(
per year, this is a net increase of 8.2% in personnel dosimetry costs for i
in-house dosimetry processors on a one-time basis only.
"Although at least one processor estimates no addition cost to their current program to comply with the proposed program and another processor at the 7
other extreme estimates $200,000.00 for initial costs.
i 16 Enclosure B
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1:
j Table B-8 4
i Processor Estimates of Initial (One-Time) Potential Preparatory y
Costs / Processor for Initial Proficiency Testing
- 4 t
j Initial, one-time costs to prepare for testing are summarized as follows; A suming that the,)rocessor is already recording dose as is called j
ror on NRC Form 5, the official form for recording individual worker " Current Occ*upation External Radiation Exposure," and that
.j labor cost is $30,000/ year with overhead at 100% of labor, then i
the costs for one person week or equal I
kg $1,154 per week.
If a processor spends up to 5 person-weeks reviewing the ANSI standard, reviewing results of previous performance tests, and making corrective actions, the labor costs would total:
$5,770 It is possible that a processor may require external recalibration services (consulting) for some categories at a cost up to:
$2,000 The total cost per processor to prepare for proficiency testing is estimated to be:
$7,770 n
NRC staff believes most dosimetry processors have already absorbed the costs described in this table while preparing for the UM performance tests of ANSI N13.11.
t Of the currently known 90 dosimetry processors, 19 processors are DOE or 00E prime contractors facilities which are generally speaking exempt from NRC licensing as a result of special provisions in 10 CFR Part 30 or are specifically named as exemptions in the Energy Reorganization Act.
Since it is almost certain that other government agencies will recommend l_
similar regulatory programs and since most commercial dosimetry processors'also process dosimeters from workers at non-NRC licensed facilities (i.e., DOE licensed facilities), it would probably be more correct to consider the entire hll population and look at the costs collectively.
d 17 Enclosure B li
- n
r;
.f
.. 9 1
f i
102* x $7,770 = $792,540 to prepare for a mandatory testing program imple-1
~
mented by all Federal agencies that regulate activ-ities involving potential radiation exposure to workers.
The one time cost to prepare for such a testing program would add to the j
costs for monitoring a worker by i
$792,540 + 1.4 x los** workers = $0.57 per worker 5
Since the average cost per year per worker for personnel dosimetry monitor-ing is $24, this is a net increase of about 2.4% in personnel dosimetry costs on a one-time basis.
2.
Normal In-House Testina Costs to the Processor for Subsequent Biennial Accreditation (after the initial accreditation)
It was estimated by dosimetry processors who attended meetings at the UM that there would be an initial cost of approximately $7,770 for a processor to make its dosimetry system compatible with the standard (see B-8).
This initial calibration cost should be a one-time cost and will vary greatly from processor to processor. As previously mentioned, NRC believes these costs have already been incurred by processors.
In-house labor for subsequent accreditation would be estimated at 3 person weeks including overhead and fringe benefits (see Table B-9).
Table B-9 Potential In-House Processor Labor Costs for Routine Biennial Accreditation Cost 3 person weeks at $1,154 ea (See Table B-8)
$3,462 TOTAL 53,462 4
"This estimate includes the 90 known dosimetry processors plus the projected a
number of utilities that will begin providing their own dosimetry by 1983 as h
discussed earlier in this se: tion.
- It is not projected that the nuclear worker population will increase i
significantly by 1983.
l'!i 18 Enclosure B
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3.
Potential In-House Costs to Processors for Repeat Proficiency Tests
}-
j-Additional in-house costs will probably be incurred by processors that fail one or more of the categories tested on the first time attempted. The
-~!
estimates given below in Table B-10 are based on a processor failing 25%
of the categories attempted.
ti Table B-10 Potential Estimated Additional In-House Costs for Processors for Repeat Proficiency Testings 1.
3 person weeks at $1,154 each (See Table B-8)
$3,462 2.
Cont.alting services 1,000
$4,462 i
4.
Total In-House Expenses i
Total in-house expenses of $3,462 and $4,462 total $7,924.
(See Tables B-9 and B-10.)
'~
5.
Total Biennial Accreditation Costs for Processors The total range of estimated costs to a processor for in-house labor and testing fees for annual accreditation is shown in Table B-11.
Table B-11 i
Total Potential Biennial Costs for a Processor for Accreditation Efforts (Accreditation Costs and In-House Costs) 1 Accreditation Costs Potential In-House Costs Total 4
Minimum Costs
$2,760
$3,462
$ 6,222 Maximum Costs
$9,260
$7,924
$17,184 Average Costs
$6,140
$7,924
$14,064 Small Entity
$4,060
$7,924
$11,784 19 Enclosure B t
- i
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A i
^
The total average accreditation costs for the industry today for the 90 known dosimetry processors for accreditation would be:
90 processors x $14,064 = $1,265,760 biennially
$632,880 annually
=
$583,656/ year + 1,400,000* radiation workers = $0.42/ year increase for personnel monitoring per worker.
This represents a net increase in personnel monitoring costs of 1.7%.
r g
If the number of processors increases as projected to 102 processors by the time these rules become effective the costs could be:
102 x $14,054 = $1,434,528 biennially 717,264 annually
=
f
$717,264/ year + 1,400,000 workers = $0.51/ year increase for personnel monitoring per worker.
l This represents a net increase in personnel monitoring services of 2.1%.
1.3.b.5 Total Cost to the General Public for a Laboratory Accreditation Procram for Personnel Dosimetry Processors.
The costs for conducting the three
~
rounds of proficiency testing in the pilot study at the UM totals $536,387.
Costs incurred also by the public include $150,000 for development of the laboratory accreditation program by N85 for NRC and $250,000 advance funding for conducting procurement activities at N8S in order to make the LAP opera-tional.
It is expected that the $250,000 will be recovered from fees charged to processors and returned by NBS to NRC.
Total costs, therefore, include 536,387 and $150,000 which totals $686,387 for testing the HPSSC/ ANSI standard which serves for the basis of this program and for establishing a laboratory accreditation program.
"It is not projected that the nuclear worker population will increase signifi-cantly by 1983.
20 Enclosure B
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Table 8-12 i
Estimated Suemary Table g
5 1.
Estimated Costs for Equipping and Operating a Proficiency Testing Laboratory.
A.
Initial Equipping and Calibration Costs
$312,000 8.
8iennial Operating Costs
$292,566 2.
Estimated Biennial Fees for the Laboratory Accreditation Program.
A.
Administative Fees as described previously
$2,500/ processor 8.
Proficiency Testing Costs / Category /0osimeter Model 1.
Categories 1-5 (one radiation source categories)
$260.each 2.
Categories 6-8 (two radiation source categories)
$520 each 3.
Participation in all 8 radiation categories
$2,860 total C.
Minimum Accreditation Costs for any Processor (1 model in one category only + administrative fees)
$2,760 D.
Maximum Accreditation Costs for any Processor (6 models in 19 categories 2 + administrative fees)
$9,260 E.
Average Accreditation Costs for any Processor (1 model in 10 categories * + administrative fees)
$6,140 3.
Accreditation Costs Per Processor A.
Initial Preparations for Accreditation (One-time Costs): $7,770 8.
In-House Costs Occurred Biennially 1.
Preparations for Inf tial Testing
$3,462 2.
Corrections and preparations for repeat proficiency testing (including potential consulting charges)
$4,462 3.
Total in-house cost biennially
$7,924
~
C.
Total Routine Costs Per Processor for Attaining Accreditation (Accreditation costs + In-House Costs)
Biennial Annual 1.
Minimum (1 model one category)
$ 6,222
$3,111 2.
Maximum (6 models in 19 categories)
$17,184
$8,592 3.
Average (1 model in 10 categories) 314,064
$7,032 4.
Sma17 Entity (1 model in 5 categories) 311,784
$5,892 0.
Projected Total Costs to the Oosimetry Processing Industry
$1,434,528
$717,264 4
4.
Costs to the Public Taxpayers from Government Expenditures (One-Time Costs) 4 A.
Estabitshing a Laboratory Accreditation Program at N85
$150,000 l
8.
Pilot Study at University of Michigan (performance testing processors against dsaft and revised ANSI Standard)
$536,387 4
i C.
Total One-Time costs
$686,387 4
5.
Net Annual Increase in Personnel Monitoring Costs A.
Current Average Cost of Personnel Monitoring / Worker / Year
$24 8.
Met annual increase in Cost for Providing j
Monitoring / Worker / Year
$0.51 C.
Percent annual increase in the Cost of
..)
Providing Monitoring / Worker / Year 2.1%
'5 (1) These figures were obtained in consultation with Dr. Phillip Plato and Joe Miklos of the University of Michigan based upon costs incurred for i
conducting three rounds of proficiency testing of personnel dosimetry processors.
(2) Average repeat proficiency testing included in the estimate.
(3) As previously discussed, NRC belleves these costs have already incurred by processors.
Z1
- f
-6
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g 1
i,
(
- i Costs for NRC staff time associated with this rulemaking and contract monitoring have not been included in this analysis.
(
I kl 1.3.b.6 -Summary of All Costs Associated with These Rulemaking Actions 9(
(see Table B-12).
1 4
1.3.1 NRC Operations
(
I A description of values and impacts in this section assumes that a
-r'equirement for NRC licensees to obtain dosimetry services from a NVLAP I
k accredited process $r will lead to improvements in the accuracy and quality of dose estimates.
(This alternative is midway between the most stringent regulatory action that could be recommended and'no action at all.).
\\
A.
Values: NRC does not have direct authority over personnel dosimetry processors.
NRC does have' authority to require its licensees to obtain qualifieddosimetryprocessingservicesandN8,Ccanestablis$.tbe
_1
\\, minimum / acceptable criteria for such services. The hVLAP method of s e j accreditation for personnel dosimetry processors of the Department of I Commer'ce (DOC) allows NRC an ' indirect way of improving personnel dos'im-l etry processing across the entire country.
1.
The COC is willing to_ establish and administer for NRC within an acceptable timeframe a Laboratory Accreditation ' Program (LAP) for personneldosimetryprecessortestingandeNaluatf[n. The DOC has l
authority to provide for and develop nation #al multidisciplinary laboratory evaluation systams through the National Bureau of Standards (N8S) in any tes' ting area for which a need is demon-t strated by requesting Federal agencies.* V 2,
NRC staff has the opportunity through an Interagency Agreement with l
N85 to participate in the development,of laboratory accreditation criteriaforaprogramcompatiblewithNRC/sneedstoestablisha 1
responsible regulatory program to improve 't5c processing of personnel dosimeters.
NBS through the'NVLAP accreditation program has consulted "In 1976, at the request of American Society for Testing Materials (ASTM), 00C established the National Voluntary Laboratory Accreditation Program (NVLAP) s (15 CFR Part 7.11(d)).
22 Enclosure B t
~ '-
y 9'
, 'e ipitn representatives of the personnel dosimetry processing industry, j and'known interested members of the public through the development of the program in an effort to design the most responsible accreditatlor, j
program for NRC while at the same time factoring in industry needs and comments.
)
3.
' NVLAP is experienced in the operation of laboratory accreditation programs which rdds additional expertise and,creditibility to the development of the dosimetry LAP for NRC purposes.
4.
Assurance of quality performance by processors performing dosimetry services, for NRC licensees by successful participation in the NVLAP accreditation program,would essentially satisfy NRC regulatory needs.
The NVLAP accreditation p'rocess will result in improved personnel dosimetry processing since the evaluation of applicant processors covers all fundamental elements of personnel dosimetry processing including routine quality assurance procedures as well as proficiency
- testing, h,
5.
NRC's Office of Inspection and Enforcement (I&E) staff estimated that at least 8 person years / year will be gaved by using the MLAP program instead of NRC personnel to conduct on-site assessment of processors.'
(
This would also relieve NRC inspectors from current examinadion of existing personnel dosimetry processing pro ~ grams of in-house',or NRC i
q processors. ' Staff at NRC's regional offices will not be burdened j
with additional inspection duties in the general area of personnel
]
dosimetry and auditing QA activitieJ of the NRC licensaa processor ll as a result of this rulemaking.
NRC inspectors would only verify t
j the use of appropriate services for specified dosimeter models from u
accredited processors during routine licensee inspections of cersonnel (j
dosimetry records.
p 6.
NRCstaffresourceshavebeenminimizedinthedevelEpmentof<this P
regulatory program, because NVLAP and NRC have signed an Interagency L
Agreement to delineate clearly each agency's respective responsibilities l
I l9 23 Enclosure B
-~
n-
.y e.'
D r
j in developing a NVLAP program for personnel dosimetry processors.
]
This agreement assigns operation of the LAP for proce,ssors of personnel dosimehrdto NBS.
Future use of NRC's staff resources will'be limited f4, to project monitork g by a representative of the NRC's Office of Nuclear
[
Regulatory Research and cognizant individuals of other NRC program t
o f'.i ces.
e 7.
No continuing long-tern NRC financial commitments will be t.ecessary
' after the initial development of the accreditation progrm'. '
/
'\\
8.
The HVLAP accreditation process offers a participating dosimetry
\\'
processor' opportunities for correction of identified inadequacies in their quality 4:ssurance activities and opportunities for repeat pro-c 'i ficiency testing at the processor's expense. NRC would not be involved
/-
in the settling of disputes that may arise regarding the performance testing ce assessment of the adequacy of quality assurance measures developed by respective processors. Technical administration of the proficiency testing will be monitored by the Center for Radiation 4
Research at the NBS.
Dosimetry processors would be free to request hearings for re evaluation of accreditation actions under the Admini-strative Procedure Act, 5 U.S.C. 556. '
9.
This regulator'y program would enable NRC staff to have a more accurate data base of$ facts concerning dosimetry and personnel dose records upon which to base licensing and inspection decisions and in ascertaining
+
that licensees are meeting current regulatory requirements.
10.
Confidence in the quality of dose measurements will be improved since all accredited c:osimetry processors will have to meet minimum QA criteria to ensure that routine dosimetry is performed with the same uniform
)
processing procedures as proficiency test dosimeters (even though
' ifferent calibration factors can be applied to the raw data measurements d
from the dosimeters). An added benefit of the NVLAP program is that each processor will be evaluated by uniform criteria which should 24 Enclosure B f
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32: 2 :.. J - f 6
remove any individual inspector's interpretation or bias.
NVLAP criteria
.i
.i include general and specific requirements with which all successful participants of accreditation programs must comply.
These requirements
]
include criteria for recordkeeping, calibration, employee training, i
j facilities operation, and uniform elements of a quality assurance
,j program.
11.
Dosimetry services previously outside NRC scrutiny will now be evaluated 4
directly by DOC through the NVLAP program. This evaluation process will add greater reliability to all dosimetry data produced for NRC D
licensees.
- 12. The Interagency Policy Committee and the Industry Overview Committee as well as industry in general have supported the adoption of this program'and have participated in its development. NVLAP encourages and promotes good laboratory practices and improved test methods.
This alternative will allow the NRC to improve the personnel dosimetry processor performance problem with (1) minimum staffing and resources, (2) 1-initiation of a self-supporting program toth to test and accredit on a biennial basis the technical competency of personnel dosimetry processors performing dosimetry services for NRC Ifcensees, and (3) the establishment of minimum uniform quality assur nce criteria for routine and proficiency test dosimetry processing.
The staff feels the dosimetry processor performance problem would be significantly improved by periodic determination of a processor's competency by performance tests and examination of routine processing activities and associated quality assurance measures.
p.
B.
Impacts:
?'
1.
Costs to NRC total $150,000 for NVLAP development of a laboratory accreditation program and $536,387 for the pilot study conducted by the University of Michigan for NRC which consisted of two rounds of performance testing of U.S.~ personnel dosimetry processors against the draft ANSI Standard N13.11 and a final round of testing against a revised version of ANSI N13.11.
NRC staff resources for develop-ment of.this program have not been included in this estimate.
ij
~
25 Enclosure B
-_y
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2.
This alternative indirectly extends the Federal government into the q
personnel dosimetry processing private industry sector.
+
3.
If an inadequate number of.large commercial dosimetry processors now providing the majority of dosimetry services in U.S. do not receive accreditation in the first biennial period, the NRC will almost assuredly i
be pressed for immediate remedies.
1.3.2 Other Government Aaencies*
A.
Values:
1.
This alternative is acceptable and has been supported by the Inter-r agency Policy Committee (see Section 1.2).
Members of this committee plan to sponsor similar programs in their respective agencies.
. 2.
Other agencies will benefit from NRC's program and from continuous updates as a result of participation in the Interagency Policy Committee on Personnel Dosimetry without sharing in the funding of the proficiency testing pilot study or the development of the laboratory accreditation program.
3.
NRC has demonstrated and documented the need for a regulatory program and has formulated a regulatory approach that can easily be adopted by other agencies whose contractors, military bases, licensees, etc.,
are responsible for conducting personnel monitoring for their workers.
B.
Impacts:
None identified.
t l
Cost estimates for other agencies have not been provided.
It is probable that 4..
other agencies can also use the NVLAP accreditation program and testing 4
laboratory.
I 26 Enclosure B
- l
- 1.....
_..-.i_..,
' - ~ ~ '
- 1. _
1.
_.. ~ J..b r
1.3.3 Industry i
l A.
Values:
a 1.
NVLAP encourages and promotes good laboratory practices and improved
(
test methods.
The NVLAP system incorporates mechanisms into the assessment process to allow processors time to correct identified problems and improve their deficiencies in routine processing or quality assurance activitie.s.
Repeat proficiency testing of processors will.be allowed prior to the final accreditation decision if the processor so desires to pay for such services.
2.
Each employer in industry has a responsibility to provide appropriate health and safety to employees who work with byproduct and special nuclear materials.
Since dosimetry results form the bases of verifica-tion that regulatory limits have been achieved or exceeded, successful participation or atilization of the accreditation program for personnel dosimetry processors will be very valuable in demonstrating the licensee's compliance with the regulations.
3.
Another major value of a testing program is credibility. There is a nation-wide concern about the unknown biological effects of ioniz-ing radiation, and many lawsuits have been brought against employers of exposed workers.
Dosimetry processors feel an increasing need to demonstrate their ability to measure doses of workers accurately.
Self-designed and self-administered testing and quality control programs do not carry the legal credibility of a nationally-recognized accreditation program.
4.
One value to commercial dosimeters processors of a nationally-recognized testing program would probably be a reduction in the number of customer-organized tests, many of which are improperly 4
designed and implemented.
L 27 Enclosure B
.n
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,7,.
5.
Better quality control through processing activities should result in fewer defective dosimeters (i.e., those improperly assembled or defective in some other way) from being put into the licensee's system and subsequently issued to workers at an NRC-licensed facility.
6.
The NVLAP accreditation program will bring about uniform and, in most cases, improved documentation which will aid licensees in maintaining personnel dose histories and in transfer of information i
for terminating employees.
7.
This is not a new system of laboratory accreditation. A number of laboratories (over 100) are now successfully accredited by NVLAP for the other currently operating LAPS in carpet, concrete, or thermal insulation materials. This is not a new system of laboratory accreditation.
8.
Processors who are accredited will have an advertising advantage over other processors who are not.
NVLAP accredited processors can advertise their accredited status on their letterhead, brochures, test reports, trade publications and other laboratory services advertising media.
9.
The Industry Overview Committee has assisted NRC in developing qual-ity assurance criteria to be used with this LAP and has supported the adoption of this alternative.
10.
If uniform recordkeeping critaria are implemented nationwide, it is likely that clerical errors would be minimized.
11.
This alternative would improve the public image ol' the entire personnel dosimetry service industry.
12.
Industry has had an unusual amount of input into this regulation.
If any portion of it proves to be unrealistic, industry would probably be called upon to share in any resolution.
3 4
28 Enclosure B y.
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B.
Impacts:
q p
i 1.
NVLAP management and project leader staff who will administer the l
program do not currently include any personnel with personal experience
)
in personnel dosimetry processing. Misunderstandings among applicant processors and NVLAP are probable during the first rounds of accredi-tation unless communications of a technical nature which are directed to NVLAP personnel are directed to the experts from the Center for Radiation Research of NBS that will provide all technical support needed in the program.
2.
Accreditation will not be without initial or continuing costs to industry (see 1.3.b).
3.
Estimates indicate that this regulation will increase the cost of processing personnel dosimeters by approximately $0.51/ year / worker (see 1.3.b).
4.
Failure to achieve accreditation or loss of accreditation by a processor in a particular" category will be an inconvenience, an embarrassment, and will be costly to the processor.
It would also probably cause an increase in the dosimetry processing industry's insurance premiums (see 1.3.b).
5.
A licensee performing dosimetry services in-P,ouse who fails to gain accreditation will have to make new contractual arrangements with a processor who has current NVLAP accreditation.
a 6.
The consequences of not obtaining NVLAP accreditation in one or more
~
categories may have a severe effect on the ability of an individual dosimetry processor to stay in business.
7.
Most processors have calibrated their dosimeters to radiation sources other than those specified in ANSI N13.11.
If an applicant processor changes calibration sources because of the requirements of the test-ing program, this could cause a noticeable increase or decrease in 29 Enclosure B
..':t o
the doses regularly reported to its users. This could result in a serious impact on the processor if its users challenge its past cali-bration efforts. A noticeable increase in assigned doses could imply past uncertainties that resulted in an underestimate of true doses.
A noticeable decrease in assigne~d doses could imply a new effort to reduce doses artificially.
Either sharp change in assigned doses could be viewed with suspicion by the users and would probably be costly to licensees in view of ALARA program implementation at their facilities.
8.
Several processors from industry have conjectured that one impact of a testing program would be the discouragement of new developments in pm'sonnel dosimetry. They fear that the goal of dosimetry processors will be to pass the test and that once a processor's dosimeter passes the test that there will be little incentive for a processor to research and develop new types of dosimeters. The cost for accrediting a new dosimetry system is likely to be very small when compared to the conts for developing a new dosimeter system.
1.3.4 Workers A.
Values:
1.
A laboratory accreditation program will no doubt lead to improvements on the part of dosimetry processors assigning radiation dose to indi-l l
vidual radiation workers. Workers have the right to know that their personnel monitoring is as accurate as possible and that the processor used by the employer is competent.
It is clear that personnel dosimetry records can be considered as medical-type information records and could be valuable in assessing L
any potential health effects from dose received by the worker.
In h
the scrictest definition, dosimetry records may not be considered L
official medical records since they are not usually generated by a l
medical doctor.
However, there'is a trend in Federal legislation ll L
30 f
l
- m.. -
.m.
~
t 1
1
]
toward recognizing the right of individuals to know information about j
themselves contained in the records of institutions both inside and outside of the Federal sector.
Examples are:
the Privacy Act of j
1974, which sets out rules for recordkeeping for Federal agencies; I
the Fair Credit Reporting Act and related acts, which give consumers the right to know information about themselves contained in the records of credit-reporting bureaus; and the Family Education Rights and Privacy Act, which grants students the right to see personal records held by educational institutions.
The Privacy Act of 1974 allows an individual to ensure that the information maintained as a part of his medical care relationship is accurate, timely, and relevant to his care.
From a legal stand-point, it is clear that dosimetry records can be considered as medical-type information records that could be valuable in assess-ing any potential health effects from dose received by a worker.
l l
2.
If overexposures do occur, documentation associated with this program will assist in rapid verification of dosimetry processing conditions and associated accuracy of the measurements that may arise from ques-tions associated with litigation of health effects suits brought by radiation workers.
3.
It is basic that workers' doses should be properly documented with all the current public concern over the biological effects of low doses of ionizing radiation.
B.
Imoacts:
1.
If a processor which has been performing an employee's dosimetry fails to become accredited, the employee's previous dosimetry measurements may be questioned.
31 Enclosure B
NOTE:
Personnel monitoring for workers who receive less than 25% of the j
maximum permissible doses, which is now provided voluntarily by some licensees, may be terminated if the cost of dosimetry services is increased substantially by this rule.
This does not produce a decrease j
in radiativn protection since such voluntary actions are commendable but are beyond minimum requirements imposed upon NRC licensees.
1.3.5 Public S
A.
Values:
1.
Perceived public confidence in dose measurements and in the adequate health and safety of workers would be improved because personnel dosimetry processors would be required to participate in performance testing and to maintain minimum quality assurance measures to gain accreditation.
2.
Establishing minimum criteria for personnel dosimetry processors defines uniform dosimetry processing practices for the first time which will bring increased public trust in accredited processor services.
B.
Impacts:
1.
If a large number of processors fail to gain accreditation, the public may question the abilities of other dosimetry processors.
2.
Previous dosimetry conducted by a pro.cessor who fails to achieve accreditation will be in question, and this may result in more law suits against that processor which will result in increased costs to the public.
~
3.
The public will pay for the entire cost of this program indirectly through developmental costs incurred by the Federal government for this program and indirectly through increased prices by industry for services rendered to the consumer.
1 e
32 Enclosure B f
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.a lu.c.
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1.3.6 Decision on Proposed Action y
The values enumerated in this statement that are perceived to arise as a result of this proposed program are substantially larger than the costs. This conclusion is further justified by the:
Overwhelming support for this. alternative by dosimetry processors
- 1. -
-]
and other interested persons in response to the letter from NRC which described the NVLAP alternative (100% of the comments received were in favor of this alternative);
2.
' Support of this alternative by the Interagency Policy Committee on Personnel Dosimetry and the Industry Overview Committee; 3.
Assistance of the Industry Overview Committee in recommending accreditation criteria and supplemental information for use in this NVLAP Program; and by 4.
Positive response from the industry and affected licensees in tele-phone conversations and during recent meetings.
==
Conclusion:==
The Commission should authorize publication of the proposed rules for comment in the Federal Register which endorse the NVLAP alternative since it has many advantages for NRC, industry, workers, the general public, and other government agencies.
2.
TECHNICAL ALTERNATIVES 2.1 Description of Technical Alternatives and Assumptions i.
2.1.a Alternatives s
Any performance testing program can only test the ability of a processor to perform within the limits of a standard at a given point in time and will not determine if the processor actually treats its regular users' dosimeters 33 Enclosure B f
1
.~
.:,.* i
~
with the same competence accorded to the proficiency testing dosimeters. Therefore, it is necessary to supplement the testing program with checks of a processor's quality control, calibration, and administrative procedures. The Commission
~
had five available alternatives under consideration for the establishment of a regulatory program intended to ensure improved personnel dosimetry processing.
The following five alternatives are presented by ranking these regulatory options from no action necessary to the most restrictive Federal government program.
Alternative 1.
No change in current requirements.
Alternative 2.
Change in the regulation that would require that licensees obtain personnel dosimetry processing from (a) processors who have successfully participated in dosimetry performance testing administered in accordance with ANSI N13.11 and (b) processors who have a documented quality assurance program.
Nf.C would not specify the performance testing laboratory (PTL). The necessary elements of the QA program would be specified.
NRC inspectors would require from the licensee proof of successful performance testing and evidence that their processor's QA program complied with the regulation whether the dosimetry service was performed in-house or commercially.
Alternative 3.
Change in the regulation that would require licensees to obtain personnel dosimetry processing from (a) processors who have successfully L
participated in dosimetry performance testing administered in accordance with ANSI N13.11 [by an NRC-specified testing laboratory] and (b) processors who have a documented QA program that contains elements specified in the regula-tion.
This alternative differs from alternative 2 by the material presented in brackets.
This alternative could be accomplished by either of the following approaches:
Option A.
NRC would obtain the services of a contractor laboratory through
/
the competitive bidding process.
NRC licensees would be required to obtain personnel dosimetry services from a processor that had successfully partici-pated in performance testing by NRC's contractor PTL.
NRC inspectors would, 34 Enclosure B 7
.---,---,.-..--,,e
-..--,-...,,,-.---_,w,--,.,,----r,
- a
_...:_.._ e ta _~
during licensee inspection, examine written proof provided by the licensee j
(1) that this performance testing was successfully completed by the processor of licensee's personnel. dosimetry, and (2) that the processor maintained a QA program that included t!)e elements specified in the regulation.
Option B.
Third party ac reditation:
NRC would specify in the regula-tion that licensees utilize the services of personnel dosimetry processors accredited under the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Bureau of Standards (NBS) which is a part of the Department of Commerce (DOC) (15 CFR Part 7b).
NVLAP accreditation would be based on three primary elements:
(1) proficiency testing of personnel dosimetry processors in accordance with ANSI N13.11 to be performed by a laboratory contracted by NBS, (2) information collected from the personnel dosimetry processor by questionnaire, and (3) on-site assessment of routine dosimetry processing and QA techniques.
NRC and the National Bureau of Standards would establish general and specific accreditation criteria for a Laboratory Accreditation Program (LAP) for Personnel Dosimetry Processors consistent with NVLAP's established general and specific criteria (44 FR 12982) used in current programs for assessing the competency of laboratories. NRC would specify, as supplemental information to these criteria, the elements of a dosimetry quality assurance program.
As appropriate, exceptions to NVLAP accreditation criteria would be published in the Federal Register for public comment.
Subsequently, NVLAP would take the necessary procedural steps f complete the accreditation' process for this LAP based upon HRC's recommenda
.ns and public response.
N8S would grant certificates l'
of accreditation to processors that comply with NVLAP criteria.
NBS would provide and train dosimetry experts as inspectors who would conduct on-site inspections of dosimetry processors that request NVLAP accreditation to assure that an i
acceptable QA program is documented and implemented.
NBS would collect appro-I priate accreditation fe~es from applicant processors.
The fees would cover costs for administration, on-site inspections, and proficiency testing.
Alternative 4.
Since many dosimetry processors are not NRC licensees and since dosimeters are not radioactive material but are" passive monitors which measure dose received by the worker, NRC would request from the Congress the 35 Enclosure B 7
- ~.
-.--w-
authority to license personnel dosimetry processors directly.
If this author-ity were granted, NRC regulations would be appropriately amended regarding performance testing and quality assurance criteria acceptable to the NRC for licensees to provide adequate dosimetry.
Alternative 5.
Change in the regulation that would require licensees to obtain their personnel dosimetry services.from an NRC-operated or NRC-contracted -
dosimetry service.
NRC would issue, through its laboratory, dosimeters for licensee use, and the laboratory would perform all dosimetry processing.
In addition, all processing would be performed in accordance with an NRC-specified quality assurance program.
2.1.b Assumptions Several basic assumptions are common to any potential regulatory program for the personnel dosimetry problem and are set forth below:
1.
Any testing and certification laboratory that would be established by any of the alternative methods presented would be monitored by the National Bureau of Standards (N8S) for a.
satisfactory technical performance, b.
traceability of all primary standards to the National Bureau of Standards, and c.
conformance with the American National Standards Institute's (ANSI) standard, ANSI N13.11, Criteria for Testing Personnel Dosimetry I
Performance.
l-The NRC would consider NBS approval of the dosimetry performed by the testing laboratory as adequate evidence of technical competence.
1 4.
ln 36 Enclosure B 7
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=
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w 2.
Each of the five alternatives considered would require that NRC issue new regulations stating that personnel dosimetry results would be acceptable only if provided by a processor which is (a) certified by a testing labora-tory or (b) accredited by a laboratory testing and accreditation program that is approved or specified by the NRC.
3.
All processors which provide commercial dosimetry services or in-house dosimetry services for employees within the same company would be pre-sumptively considered to have a conflict of interest and therefore would be ineligible to operate the testing laboratory and/or accreditation program.
4.
Both grievance and appeals procedures should be established to create mechanisms by which personnel dosimetry processors could register com-plaints or disputes for resolution.
2.2 Analysis of Technical Alternatives 1.
No Change in Current Requirements, i.e., do nothing about the dosim-eter performance problem.
A.
Pros:
1.
There is no absolute guarantee that adoption of a regula-tory program will improve the quality of the processor's service to its regular users even if a processor can pass a proficiency test or successfully participate in an accreditation program (which includes proficiency testing, thorough documentation, and implementation of a stringent quality assurance program).
i 37 Enclosure B m
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w
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-w
).
a n
2.
The inaccuracies that exist with personnel dosimeters probably do not constitute a major health hazard for the worker population.* A summary of occupational exposures for in 1978, indicates that 0.1% of all monitored workers (103 out of 105,893) were reported as being overexposed, and only two individual exposures exceeded 10 rems.**
Additional information regarding the nature of these exposures may be obtained in:
NUREG-0593 Occupational Radiation Exposure, Eleventh Annual Report 1978, National Technical Information Service, Springfield, VA 22161 (November 1980).
3.
With the current inflation problem in this country and the increasing volume of regulations, it appears that any cost that would be incurred by the processor and passed on to the general public, and any increase in current regulatory requirements, would be undesirable.
Three comment letters (4.5%) received were in support of this alternative.
4.
No new government resources would be required.
B.
Cons:
1.
The results of the pilot study show that even with the statistical method of the revised ANSI N13.11 standard, results indicate that 25% of all the category tests attempted were failed in the third round of testing. This shows that there are still wide-spread inaccuracies in personnel dosimetry processing.
KAll persons licensed by the NRC must submit reports of all incidents involving personnel radiation exposures that exceed certain levels.
Licensee reports of these exposures are in accordance with 10 CFR S 20.403 (a and b), or 9 20.405.
There is little doubt that considerable investigative work was done beyond the dosimetry processing for all workers who received any amount over the regulatory limits for whole-body exposure.
38 Enclosure B
- m.
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~
The major problems identified during the pilot study that con-
]
2.
1 tributed to poor performance among tested processors (i.e.,
inadequate calibration sources, variability in TLD dosimeter chips, clerical errors, and lack of effort on the part of the processor to make changes necessary to pass the tests) can be corrected by the implementation of a regulatory program.
For at least some processors, this will result in improved accuracy for reporting of occupational doses received by employees of their regular clients.
3.
The associated increased cost of personnel dosimetry services is minimal to society and is well justified in that the Commission is required by the Atomic Energy Act of 1954, as amended, "to 4
establish rule, regulation or order, such standards and instruc-tions to govern the possession and use of byproduct material as the Commission may~ deem necessary or desirable to protect health
~
or to minimize danger to life or property."
4.
The uncertainties associated with currently reported dose estimates 4
for nuclear workers and the magnitude of the problem is very difficult to access. The uncertainty of individual dose estima-tions by dosimetry processors as demonstrated by the pilot study is unacceptable on an individual dose assessment basis. A regu-latory program would help correct these uncertainties and appears to be warranted.
D, 5.
This alternative would probably not be acceptable to the general public, the dosimetry processing community, other Federal i:
agencies, (including EPA, BRH, DOE, 000, and DOL (OSHA)), or the I:
Conference of Radiation Control Program Directors who feel that a serious problem has been identified and that it should be dealt with by development of an appropriate, unified interagency regulatory program.
4 i;a 4
39 Enclosure B 4
m-w
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s' e
si r e-+
y
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y v-v--
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4-Change in the regulation to require that licensees obtain ;;ersonnel dosia-
- 2.
etry processing from (1) processors who have successfully participated in dosima.try performance testing administered in.accordance with ANSI N13.11, and (2) who have a documented quality. assurance program.- NRC would not specify the performance testing agent.
The necessary elements of the Q.A.
program would be specified..NRC inspectors would require proof of success-
^
ful performance testing and evidence that the QA' program complied with the regulation.
A.
Pros:
1.
No government resources would be required for operation of the testing laboratory.
2.
This alternative leaves personnel dosimetry processors and users free to establish one or more. testing laboratories on their own initiative, although one laboratory would be sufficient to handle the entire workload of a nation-wide proficiency testing program.
This alternative would preclude government selection of a single contractor proficiency testing latoratory and remove any ques-tion of the government establishing a monopoly for personnel dosimetry testing.
Therefore, direct government involvement in private business would be avoided.
3.
The potential for establishing more than one testing labora-tory would permit processors to select their testing facility based not only on competitive pricing or costs but also on the technical ability and experience of the laboratory staff.
It would also permit processors to evaluate, on their own, question-able results from a testing laboratory to the extent that they would be willing to pay for duplicate services.*
"Although the free enterprise syst m gene ally encourages competitive pricing, e
r a large number of fixed costs are associated with the procurement, installa-tion, and calibration of the radiation sources required by the ANSI Standard.
It is not presumed that there would be a really significant cost. difference to most processors.
However, in the case of the small in-house processor, i.e., university, hospital, or small research foundation, a reduction in the testing fees per category could become significant if the processor participated in several different categories.)
l'!
40 Enclosure B f
~
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4.
If more than one testing laboratory is independently established by industry, the continuity of the program would not be inter-rupted if one or more of these laboratories chose (for whatever reason) to no longer perform testing services.
In addition, if the transition from more than one independently operated testing laboratory to a single testing laboratory were to occur, there
, would be a testing laboratory still available.
5.
The establishment of more than one test and certification labora-tory would provide an opportunity for frequent intercomparison between testing laboratories. Once a year, NBS could spot check the laboratories, but intercomparisons could be much more frequent between laboratories.
6.
This alternative would probably be acceptable to the general public and to affected dosimetry processors; and would probably not be associated with any specific government regulatory agency.
Seven comment letters (10.6%) favored operation of the testing laboratory in this manner.
7.
This alternative would free the operation of the testing labora-tory from cyclic Federal budget and manpower constraints and cutbacks.
8.
An industry-operated laboratory would be free to pursue new avenues of study or research on its own initiative which might be outside the basic definition of a dosimetry performance test-ing laboratory as long as these activities did not pose a con-1 i
flict of interest.
l 9.
NRC would specify minimum elements of a quality assurance program.
i l
41 Enclosure B l
l
.~.,
=.
j 8.
Cons:
1.
There is no guarantee that any testing laboratory would be estab-lished by industry or that it would be formed expeditiously.
This could be disruptive to the regulatory program.
2.
There is no guarantee that more than one testing laboratory would be established by industry in which case, pros number 3, 4, and 5 above would not be relevant.
3.
There is a finite number of dosimetry processors.
If the work load were handled by more than one testing laboratory, to a large degree, the fees as,sociated with testing would become less volume dependent.
4.
If questions of administrative creditability of the industry-operated, unspecified laboratory arose, it would be very diffi-cult for the Government to investigate the allegations or to effect a change without an interruption of the regulatory program.
5.
The licensee could have an excellent quality assurance program on paper but in practice could be violating the regulation if it were not implemented.
This alternative would require major NRC Region Inspection and Enforcement (I&E) effort in assessing the adequacy of licensee'or licensee's contractor dosimetry program.
Initial I&E estimates projected 8 staff years effort annually to conduct such a program.
6.
The Federal government would have no control over the administra-i tion of the testing process.
This is a large responsibility for the NRC to delegate.
7.
This alternative may not be acceptable to other involved Federal agencies who may be hesitant to base a regulatory program that incorporates proficiency testing under the auspices of an industry-operated proficiency testing laboratory.
42 Enclosure B
.. 2
~~
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m.
3 a'
j.
8.
NRC Regional inspectors would probably not be allowed to inspect i
a processor which was a non-NRC licensee or private contractor l
unless the vendor program was extended to include dosimetry pro-cessing.
NRC legal staff has advised against this extension.
i 3.
Change in the regulation to require that licensees obtain personnel dosimetry processing from (1) processors who have successfully participated in dosimetry performance testing administered in accordance with ANSI N13.11 by an NRC-specified testing laboratory and (2) who have a documented quality assurance.
program which contains necessary elements as specifed in the regulation.*
4 3a.
NRC would obtain the services of a contractor laboratory through the com-j petitive bidding process.
NRC licensees would be required to obtain personnel dosimetry services from a processor which had successfully 4
f participated in performance testing by NRC's contractor laboratory.
NRC inspectors during licensee inspection would examine written proof provided by the licensee (1) that such performance testing was completed by the processor of licensee's personnel dosimeters and (2) that the processor maintained a quality assurance (QA) program that includes the elements a
?
QA program as specified in the regulation.
A.
Prcs:
1.
The pilot study that tested personnel dosimetry processors per-formance with the draft ANSI N13.11 Standard was conducted tsing 1 -
an NRC-contracted laboratory operated by the University of A
"The staff has determined that three Federal Agencies (National Institute for Occupational Safety and Health (NIOSH), Environmental Protection Agency (EPA),
and the National Bureau of Standards (NBS)) have legislative authority to f!
operate and do now currently operate research and/or testing laboratories.
q However,.the alternative of a Federal government (non-NRC) operated testing l:
laboratory has not been considered, since none of the three agencies are will-ll ing to operate a laboratory for performance testing of personnel dosimetry 1:
processors.
NIOSH and EPA do not currently have adequate funds, facilities, j'
or expertise in the area of personnel dosimetry to enable them to expand their current laboratory capacities to include performance testing of personnel lr dosimetry processors.
NBS' mission encompasses the research, development,
- l and maintenance of national standards, and the current staffing level does not l
include the operation of service-type laboratories. Ten comment letters were received in support of this alternative method with specified preference for an NBS-operated testing laboratory.
Under NVLAP, NBS would monitor the tech-nical performance of the proficiency testing laboratory (PTL) by (a) verifying satisfactory performance of the PTL prior to the first round of proficiency l ~:
testing and (b) monitorinq the technical performance of the PTL at regular intervals during proficieacy testing in accordince with ANSI N13.11.
Twenty-one letters of support were received for the NVLAP alternative.
43 Enclosure B l
l-
y Michigan. This alternative worked well in the past for NRC during the performance testing program.
2.
NRC staff resources for' administrative and contract review of an NRC-contracted laboratory would be minimal.
3.
Should conditions warrant, contract mechanisms are available to terminate the contractor's laboratory services for poor perfor-mance. Contracts are also awarded for a finite period and require extensive review for renewal of services.
c 4.
Award of a government contract for personnel dosimetry services under current contractual minimum requirements would necessitate that all contenders for bid have demonstrated capabilities and technical expertise in operating such a laboratory.&s a pre-requisite for bid.
5.
This alternative seems acceptable to both dosimetry processors and the general public.
Eleven comment letters received by NRC 4
(16.6%) endorse the selection of this alternative. This alter-native would also probably be acceptable to other Federal govern-ment agencies planning to adopt simultaneous regulations for improved personnel dosimetry processing.
6.
NRC financial resources would be limited to funds for establish-ing the initial PTL. The assessment of fees would allow the PTL to operate on a non profit basis and to become essentially self-supporting.
B.
Cons:
1.
The NRC would be involved in the settlement of any non-technical, administrative disputes that may arise between dosimetry proces-sors and the testing laboratory.
i i
l 44 Enclosure B
~
i i te '*
g-W--lh
- +
?
j..
2.
Opponents of government intervention in the private sector may criticize NRC for essentially establishing a single laboratory
- j for the testing of personnel dosimetry processors (monopoly) j although there are other precedents, i.e., the EPA labs.
3.
This alternative would require major NRC Regional Inspection and Enforcement (I&E) effort in assessing the adequacy of licensee or licensee's contractor dosimetry program by on-site evalua-tion of quality assurance criteria as specified in t'he regula-ll tions which would be proposed if this alternative were selected.
i.
Estimates of I&E requirements project 8 staff years / year inspection effort.
4.
Long-term Federal resources would have to be budgeted to sub-sidize the operation of the laboratory in the event that the program did not become self-supporting.
Current budget plans and forecasts do not include funds for this activity.
If this alternative is selected, it could mean a delay in the beginning of a regulatory program.
3b.
Third party accreditation by NVIAP (This technical alternat1ve was described in Section 1.3a of this enclosure.
Costs associated with this alternative were analyzed in Section 1.3b of this enclosure.
Values and impacts for this alternative were itemized in detail in Sections 1.3.1-1.3.6.
Repeating this material in summary form does not appear to be necessary.)
4.
Since many dosimetry processors are not NRC licensees and considering that dosimeters, in themselves, are not radioactive but are passive monitors which measure dose received by the worker, NRC could request from the Congress the authority to license personnel dosimetry processors.
If this authority were granted, NRC regulations 'would be appropriately amended regarding performance testing and quality assurance criteria acceptable to the NRC for licensees to provide adequate dosimetry.
A.
Pros:
1."
NRC would have direct control over dosimetry processors.
45 Enclosure B
~.~ T~L - - - -
q t
a 8.
Cons:
i 1.
Although NRC can request specific legislation, there are no
}!
guarantees that the legislation wanted would be passed.
t 2.
It is unclear how long it would take for Congress to pass new l
1egislation even assuming this option is feasible.
Congress would probably not give this legislation much priority. This alternative does not provide for any-measures in the interim.
4 3.
It is unclear whether the effort is warranted in terms of the benefits received, especially if processors can be controlled through imposing requirements on licensees.
5.
Change in the regulation to require that licensees obtain their personnel dosimetry services from an NRC-operated or NRC-contracted dosimetry service.
NRC would issue, through its laboratory, dosimeters for licensee use; the NRC laboratory would perform all dosimetry processing. All pro-cessing would be performed in accordance with an NRC-specified quality assurance program.
A.
Pros:
1.
This alternative would ensure the existence of an uninterrupted regulatory program.
1 2.
A government-operated, national dosimetry service would probably
/
be acceptable to the general public as an exercise of NRC's 4
responsibility to ensuring public and worker health aad safety.
NRC received two letters of comment supporting this alternative.
3.
NRC processing of all personnel dosimeters would expedite the h
investigation and reporting of abnormal occurrences.
5 4.
Nationalized dosimetry programs do exie,t in other countries, j_
e.g., Great Britain and Canada, u
a
!!y 46 Enclosure B
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B.
Cons:
1.
The technical expertise, staff, complete set of radiation sources, supporting equipment and general facilities to perform dosimetry processing are currently not in existence or avail-able for NRC's use.
2.
' Budget planning and approval of these expanded activities has not been sought and therefore expeditious creation and staffing of such a laboratory would not be possible and would delay the beginning of the regulatory program.
3.
The NRC has no experience in the operation of such a laboratory and therefore no precedent for conducting such activities.
4.
Although the technical competency of such a laboratory could be verified by NBS, this alternative would probably not be accept-able to dosimetry processors and users since it would put most of them out of business.
5.
This alternative may not be acceptable to other government agencies which plan to implement simultaneous programs in their respective agencies.
Ideally, if government programs are estab-lished in other agencies, the same NRC-operated dosimetry processing service could be used by other government agencies.
6.
This would further extend government activities into the private sector.
No comment letters in support of this alterna-tive were received by NRC.
2.3 Decision on Choice of Technical Alternatives The staff proposes to recommend rule changes that would require that licensees utilize the services of personnel dosimetry processors accredited by the NBS as competent to perform such technical measurements.
The NVLAP alternative, 38 - third party accreditation, has many advantages not only 47 Enclosure B
~
5 for the NRC but also for industry (see Sections 1.3a and 1.3.1-1.3.6 of this
~
enclosure).
This alternative is midway between the most stringent regulatory action that could be recommended and no action at all.
The NVLAP and DOC staffs c
have worked with NRC to ensure the development of a LAP for personnel dosin-i etry processors within an appropriate time frame. This alternative offers industry more participation in the development of a regulatory program than any of the other alternatives presented. The selection of this alternative would allow the NRC to resolve the problem with minimum staffing and resources and would begin a self-supporting program that would test and certify the technical competency of personnel dosimetry processors performing dosimetry services or for NRC licensees.
It would also establish minimum uniform quality assurance criteria for routine and special dosimetry processing.
i 3.
PROCEDURAL APPROACH j'
Several actions could have been chosen by the Commission for improving the personnel dosimetry problem.
These actions included issuing a NUREG staff report, endorsing the ANSI Standard N13.11, issuing a regulatory guide, and by developing and finalizing amendments to the regulations.
3.1 Description 1.
Regulation:
Improving the personnel dosimetry processor problem by
[
amending the regulations is the preferred alternative.
The proposed regulatory
[
program would be achieved by the addition of two rules to 10 CFR Part 20.
n l'
2.
Regulatory Guide:
This would have involved preparation of a regula-tory guide on personnel dosimetry processing and elements of an associated quality assurance program.
t#
9 3.
ANSI Standard endorsed by a Regulatory Guide:
There is an ANSI standard on performance testing of personnel dosimetry processors ANSI N13.11.
g A Regulatory Guide could have been written which endorses the ANSI Standard as minimum acceptable practices acceptable to NRC.
~
t i.
48 Enclosure B 4
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^
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c.
Et i,
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4 4.
NUREG Report: A technical report by NRC staff could have been written on personnel dosimetry processing in the form of a NUREG Report.
3.2 Value/ Impacts of Procedural Approaches 1.
Regulation A.
Pros:
1.
The seriousness of the problem justifies development of a regulatory program and the need for mandatory regulations.
(Participation in i'
the voluntary testing program' administered by the National Sanitation Foundation was less than 10%.)
2.
Regulations uniformly affect all licensees required to provide personnel monitoring.-
3.
Rulemaking allows maximum industry participation through the Industry Overview Committee, public meetings, and opportunity to comment.
4.
NVLAP encourages industry comment to standards writing bodies for the improvement of test methods and quality assurance criteria.
It also encourages processors to upgrade any deficiencies that might be noted in compliance with NVLAP criteria so they can achieve accreditation.
5.
Elements of this regulatory program have been carefully examined through the pilot studies, which examined the performance standard, by frequent communications with the dosimetry processing industry, through publi-cation of an Advance Notice of Rulemaking, which indicated our intent to proceed with a regulatory program, and by NRC's participation in several public meetings.
l 6.
By providing a third round of testing, the Government has given pro-cessors multiple opportunities to recognize any deficiencies in their programs and to make corrections before the final rules are implemented.
T 49 Enclosure B
~ ~ ~ ^ -
}
1 e
8.
Cons:
i-c 1.
- The program will present one more regulation that industry will have to meet.
2.
The regulation will definitely result in financial costs to industry and the public.
2.
Preparation of a Regulatory Guide d
A.
Pros:
This alternativ'e would:
1.
Provide guidance to processors on the minimum acceptable elements of a dosimetry quality assurance program without mandatcry regulation.
B.
Cons:
1.
This alternative would require a substantial staff effort in training and inspection activities to evaluate whether or not a licensee was following the recommendations of the guide.
2.
Since a guide is not enforceable, its success depends on (a) its incorporation into license conditions or amendments by the two NRC licensing offices, the Office of Nuclear Materials and Safety Safe-guards and the Office of Nuclear Reactor Regulation and (b) I&E's F
inspection efforts for evaluating whether license conditions as specified in the guide are being met.
3.
This alternative would not assure that all licensees were treated S
uniformly or equally.
- ]
4.
This alternative would not guarantee a competent NBS-monitored test-T' ing laboratory.
!)
'i 4 50 Enclosure B j
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1 3.
ANSI Standard Endorsed,by a Regulatory Guide.
j A.
Pros:
1.
There is an ANSI standard on criteria for personnel dosimetry perform-j ance testing.
NRC could write a companion regulatory guide to endorse
}
the use of this ANSI Standard.
There is a precedent for this type of guide on dosimetry in ANSI Standard N545-1975 and Regulatory Guide 4.13..
2.
It would require minimum staff effort to develop an endorsing regu-h latory guide.
3.
This action would put the standard on the free market system and would allow anyone to develop and set up a testing laboratory.
4.
Historically, there has been very poor participation of dosimetry processors in voluntary standard programs, as evidenced by the National Sanitation Foundation (NSF) Program (see NUREG/CR-1064).
If the Regulatory Guide was endorsed by NRC licensing offices, licensees would be required by license condition to follow or provide acceptable alternatives to demonstrate successfully meet-ing the requirements of ANSI Standard N13.11 for performance testing.
S.
Cons:
1.
The greatest weakness in this alternative is that this ANSI Standard only discusses performance testing criteria. Without additional gu'idance on quality assurance in dosimetry processing, the dosimetry problem would not be resolved.
This alternative would only solve a small piece of this complex problem.
^
2.
The effectiveness of this alternative would depend on NRC's licens-ing offices willingness to incorporate the guide into individual licenses on a case-by-case basis.
'4 51 Enclosure B b
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Pros:
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1.
This alternative would provide guidance to the processor.
a B.
Cons:
1.
There are insufficient NRC staff resources to write such guidance without use of an assistance contract or outside agency consultants.
Consequently, this could mean a long delay in achieving a partial solution to the problem.
2.
The effectiveness of this alternative could also depend on NRC's licensing offices endorsenent and incorporation into license conditions.
3.
Historically, there has been very poor participation of dosimetry processors in voluntary standard programs, as evidenced by the NSF Program (see NUREG/CR-1064).
3.2 Decision on Procedural Approach It is believed that amendments to 10 CFR Part 20 would best resolve this problem.
The use of any other procedural alternative would not provide a uniform, feasible or workable approach for improving personnel dosimetry processing.
Since voluntary programs have historically received minimum processor participation and demonstrated little, improvement in personnel dosim-etry processing, it is the consensus of the NRC staff, the Interagency Policy Committee, and the Industry Overview Committee that a regulatory program is needed.
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4.
STATUTORY CONSIDERATIONS 1
4.1 NRC Regulatory Authority Applicable Authority:
Under the Atomic Energy Act of 1954, as amended (42 U.S.C. 2011, et seq.)
and section 201 of the Energy Reorganization Act of 1974, as amended (42 U.S.C.
5841), including the rules and regulations issued pursuant to these acts, NRC is 'uthorized to regulate and license the manufacture, production, receipt, a
acquisition, delivery, possession, ownership, use, and transfer of byproduct, source and special nuclear material as well as the construction and operation of production and utilization facilities (as these terms are defined in sec-tion 11 of the Atomic Energy Act (42 U.S.C. 2014)).
NRC licensees include nuclear power facilities, research and development laboratories, universities, hospitals, radiopharmaceutical facilities, as well as industrial and various other miscell-aneous users of byproduct, source, and special nuclear material.
Under 10 CFR Part 20 of its regulations, NRC requires its licensees to have adequate pre-cautionary procedures to protect the health and safety of personnel an'd the public against radiatian hazards arising out of activities under their licenses.
These precautionary procedures include the making of surveys under 10 CFR 120.201
- and the supplying.of appropriate and adequate personnel monitoring equipment under 10 CFR 120.202.
4.2 Need for NEPA Statement The proposed action is not a major action as defined in 10 CFR 6 51.5, and therefore, does not require an environmental impact statement, assessment, or negative declaration.
5.
RELATIONSHIP TO OTHER EXISTING OR PROPOSED REGULATIONS OR POLICIES Associated regulations are found in 10 CFR Part 20 and in 10 CFR Part 34.
Sections 20.4 (c) and (d) define the tem and exposures from x-or gamma-rays up to 3 Mev, and 6 20.401(a) discusses the form on which individual dose s
53 Enclosure B
a s.
~
measurement records are maintained. These regulations specifically apply to the theory of dose definition and could constitute unnecessary scientific debate if changed at this time. These sections will be discussed and revised appro-priately in the major revision to Part 20 that is now underway.
Until the major proposed revision to Part 20 is completed, it is important to place these rules into the existing Part 20 which should lead to improvements in accuracy of measurements and quality assurance programs associated with personnel dosimetry.
Any revision to Part 20 should include regulations which would require licensees to obtain dosimetry services from NVLAP accredited processors and to obtain a record of accreditation certificates with indi-vidual external exposure records for as long as these record are maintained.
Licensees which are required to conduct personnel monitoring in accordance.
with 134.33 are also under the regulations specified in 10 CFR Part 20.
The rules being proposed for addition to 10 CFR Part 20 will also apply to Part 34 licensees.
6.
SUMMARY
AND CONCLUSIONS The NRC staff has thoroughly studied the personnel dosimetry processor performance problem.
The proposed regulatory program is acceptable from both technical and procedural aspects.
The values and impacts associated with this proposed rulemaking have been carefully examined, and the staff finds that the values outweigh the impacts.
Therefore, it is recommended that the proposed amendments to Part 20 and the associated Federal Register Notice be published.
4 i
54 Enclosure B f
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ENCLOSURE C f
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ENCLOSURE C REVIEW 0F COMMENTS ON 45 FR 20493 AND 46 FR 9689 Forty six comment letters were received in response to the Advance Notice of Rulemaking (ANR) published in the Federal Register on March 28, 1980 by the NRC (45 FR 20493).
The ANR described the results of the first two rounds of proficiency tests conducted in accordance with criteria in a draft Health Physics Society Standards Committee (HPSSC) Standard, which was also accepted by the American National Standards Institute (ANSI) for publication as a draft ANSI Standard, N13.11.
The ANR also discussed the need for improved dosimetry
- processing through rulemaking, and presented and requested comments on four alternative methods for the operation of a proficiency testing laboratory (PTL) i that would conduct testing in accordance with the HPSSC/ ANSI Standard.
A h
A PTL established according to any of the four alternatives would be monitored for technical competency by the National Bureau of Standards (NBS).
Licensees would be required to obtain or provide dosimetry processing services which satisfied performance standards and quality assurance criteria as established i
by NRC and administered by the PTL.
The four methods for PTL operation as stated in the ANR include:
1.
NRC would not specify the PTL; processors and licensees would be left to I
their own initiatives to establish one or more PTL(s) to administer j
proficiency testing against the standard.
l
[
2.
The PTL would be a Government facility managed and operated by NRC.
3.
NRC would contract the services of a PTL and utilize the contractor's facilities.
4.
Other Government Agencies experienced in laboratory testing would operate a PTL in Government owned facilities.
Of the forty-six letters of comment received, twenty-one letters did not state a preference for a method of operating the PTL.
Three commenters felt no 1
Enclosure C f
3l
.l program at all was necessary.
In the remaining 22 comment letters, one or more preferences were expressed as being acceptable for the operation of the PTL.
Twenty preferences were for the various types of Federal Government-controlled laboratories (methods 2, 3, or 4).
During the comment period, a fifth method for PTL operation was identified by a comment letter from National Bureau of Standards (NBS) which is a part of the Department of Commerce (DOC).
Under currently existing procedures, NBS, through the National Voluntary Laboratory Accreditation Program (NVLAP), could contract the services of a PTL to administer proficiency testing of processors in accordance with the final ANSI Standard N13.11.
In addition, the NVLAP method would include a thorough examination of a processor's routine processing and quality assurance activities through an on-site review.
The NVLAP method would essentially offer a system of third party accreditation by a Government agency, the DOC through the NBS.
The NRC staff requested the DOC to work with the'NRC to establish a Laboratory Accreditation Program (LAP) for Personnel Dosimetry Processors in a letter dated December 23, 1980.
The DOC, in accordance with NvLAP procedures and authority stated in 15 CFR Part 7b, published NRC's request for the development of such a LAP in the Federal Register (46 FR 9689) and requested public comment.
NRC sent a copy of the DOC Federal Register Notice and a description of the NVLAP method to all known dosimetry processors, licensees, and known interested persons.
Nineteen letters of comment were received on the NVLAP method for operating the PTL as part of an accreditation program.
The letters were unanimous in favoring the selection of the NVLAP method.
l The major concerns reflected in the forty-six comment letters on the ANR are summarized below:
i 2
Enclosure C
u l
(1) Annual certification
- or ren*<al of certification of processors is likely to create problems in the development of contracts between users and commercial processors.
Response
The staff recognizes that the proposed accreditation program program would require significant rewording of contracts between dosim-etry users and processors.
However, it appears that the necessary contractual provisions could be arrived at without great difficulty.
The Commission is now proposing that its licensees utilize personnel dosim-etry processing services from processors accredited in the 2 year NVLAP accreditation program as opposed to the one year program indicated in the ANR which will help to minimize this problem.
(2) Loss of certification status, which would in general require an abrupt change in the supplier of dosimetry services, would create problems asso-ciated with the establishment of new contracts for personnel dosimetry services.
Response
It is anticipated that abrupt changes in accreditation status would be rare since accreditations are awarded for a two year term and since processors have had opportunities for participating in the NRC pilot study of the draft and revised ANSI Standard.
Also, many oppor-tunities exist under NVLAP procedures for processors to correct identi-fled deficiencies in their quality assurance programs and repeat profi-ciency testing so that NRC believes that competent dosimetry processors will rarely experience loss of accreditation.
"The ANR used the term certification.
Comments received are expressed here using the language presented in the comment letters.
It was brought to NRC's attention that certification implied an approval on the particular product, whereas, accreditation could imply approval of a service activity such as dosimetry processing.
The response to questions concerning the ANR, use the term accreditation to better reflect the type of ptogram in the proposed rulemaking.
3 Enclosure C
2:
(3) This program could create a wide variety of legal problems.
Response
The staff does not foresee any serious legal problems arising as a result of this regulatory program and does not believe that potential
~
difficulties should be a deterrent to a solution of the personnel dosimetry problem.
The objective is a carefully worked out regulatory program that-would be fair in every way to all participants.
(4) Processors should not fail a category _ test because of dose overestimates.
3 )
Response
It is possible that from a narrow viewpoint of immediate safety-
% i problems that there should be no penalty for overestimating doses.
- However, gross errors in either direction could be indicative of inability to obtain L U accurate results in general and could raise the concern of long term safety.
Overestimates mean that workers will receive reports of radiation that they never received.
This can lead to less efficient work performance qand greater cumulative dose.
There would be little guarantee that all s'gfutureerrorsontheprocessorspartwouldbeonthesafeside.
(5) This program may result in the discontinuance of some personnel monitoring that is now being performed voluntarily.
Response
The staff is of the opinion that most of the persor.nel monitoring that is conducted voluntarily by NRC licensees is motivated by concerns that will not be affected by this program.
l (6) The government should establish requirements for thermoluminescent chip l
screening by the manufacturers rather than depend on proficiency testing l
of the processors.
Response
The staff believes that the accreditation program being proposed will result in adequate screening of dosimeter chips by the manufacturers and/or by the processors.
The accreditation program has been specifically designed to incorporate on-site assessment of a dosimetry processor's routine processing and quality assurance activities.
Although it may be possible 4
Enclosure C
- ^:
'*1 i
for a processor to submit highly screened and characterized dosimeters-for proficiency testing purposes, it is highly improbable that a processor could demonstrate an adequate quality assurance program without screening j
or acceptance criteria for new dosimeters or dosimeter components.
Accreditation will require successful performance testing for _each specific category by dosimeter model and correction of any deficiencies noted during the processor's on-site e.ssessment.
The decision of who does the screening should be left with the processors or specified by the dosimetry user rather than being dictated by the Government.
(?) Careful attention should be given to assuring that the costs of this program are commensurate with the benefits.
Response
The NRC agrees with this comment and with the assistance of the University of Michigan, the staff has prepared a comprehensive Regulatory Analysis statement for the program (Enclosure B).
As a result of industry comments during a recent workshop sponsored at NBS which directly concerned issues specific in the development of the NVLAP program for personnel dosimetry processors, cost of accreditation was a major concern expressed by participants.
As a result of these comments, NRC has adjusted its initial recommendation for annual qualification of processors to a biennial accreditation program to be administered by NBS/NVLAP which included both performance testing and independent evalua-tion of quality assurance and routine dosimetry processing activities for i
each applicant processor.
NBS and NRC staffs have been very sensitive to minimizing costs associated with the program where possible.
l (8) The role of quality assurance should receive appropriate attention.
l
Response
The NRC considers quality assurance to be the essential link between proficiency testing and routine dosimetry processing performance.
Under the proposed accreditation program, processors would be accredited only if they establish and implement quality assurance programs in 5
Enclosure C
3.*
o.'
o conformance with NVLAP specified criteria, and only after successful, periodic, on-site inspections of their routine processing and quality assurance activities by NVLAP assessors.
(9) Rather than the pass / fail approach, a processor grading system should be used.
Response
A processor grading system could only apply to the proficiency testing portion of an accreditation program.
The NVLAP alternative, in addition, identifies deficiencies in a processor's routine dosimetry processing and quality assurance activities.
This facet of the program encourages improvement in routine dosimetry processing and assures that successful performance in proficiency testing is reflected in routine processing services.
(10) The proficiency testing laboratory (PTL) should offer irradiations with a wide variety of radiation sources, rather than only those specified in the ANSI standard.
Response
The staff is in complete agreement with the intent of this comment.
In accordance with present planning, only the sources specified in ANSI Standard N13.11 would be used in the actual conduct of requird performance tests.
The PTL ideally would have available all major types of calibration sources, and would, on request and for an appropriate fee, irradiate a processor's dosimeters to any type of source requested as well as irradiate proficiency testing dosimeters to the type specified in the standard.
The competitive solicitation package for the procurement of a PTL has been designed to allow such activities by the contractor and to clearly avoid any conflict of interest.s that may arise from additional consulting activities performed by the contractor.
The dosimetry processor could then generate an appropriate correction factor that could easily allow the processor to determine the response factor for his dosimeter.
This will allow the processor to continue to use alternate calibration sources appropriate to the needs of the workers served.
6 Enclosure C
'. s (11) This problem should be solved by issuing a regulatory guide rather then by establishing new regulations.
Response
Regulatory guides are used to provide one or more acceptable methods for complying with a specified NRC regulation. At present, the NRC has no regulation on this subject.
It might be possible to adopt a non-specific regulation and to issue program specifics in an explanatory regulatory guide.
This procedure may provide the flexibility desired by the commenter, but it would be difficult to enforce since regulatory guides are not mandatory.
(12) Rather than a test and certification program, the Government should establish a processor inspection program.
Response
The NRC staff agrees that review of a dosimetry processor's routine personnel dosimetry services and associated quality assurance practices is an essential part of this program, and, as mentioned above, peer review inspection is provided for in the NVLAP accreditation program.
However, the staff believes that proficiency testing against a concensus standard is also essential.
It does not appear likely that inspectors could fully evaluate the capability of a processor without some form of proficiency testing.
The NVLAP accreditation program incorporates both of these critical elements.
In addition, the NVLAP accreditation program incorporates on-site assessment of processors by dosimetry experts.
Adoption of this method will minimize NRC staff and financial commitments while improving personnel dosimetry services provided for NRC licensees.
NRC staff does not currently employ dosimetry experts needed to conduct such a program and currently has budget constraints that would not allow increased manpower.
(13) In addition to test irradiation services, the laboratory should offer a calibration service and conduct basic dosimetry research.
7 Enclosure C
t.'.
Response: - The NRC would have no objection if'the testing laboratory would chose also to offer calibration services and to conduct dosimetry research.
However, these efforts would, as the program is proposed, be outside the basic contract for proficiency testing and would be at the discretion of the' National Bureau of Standards (NBS).
(14) This program will require a great deal of emphasis on the use of correction factors to convert exposure measurements to dose-equivalent (res).
Response
The PTL will administer the tests for NBS~in accordance with the criteria of the ANSI Standard.
Conversion factors are specified within the Standard. All irradiation values for photons will be based l
in part upon the appropriate use of these factors by the processors.
It was discovered in the University of Michigan teste that many processors who calibrate their dosimeters with radiation sources different from the sources specified in the ANSI Standard, did not know how to calculate correction factors (quite different from a conversion factor) which are used to relate a dosimeter reading from a known spectra of radionuclides used for calibration of their equipment to the spectra representative of the worker's environment.
Competent dosimetry processors will not only
.know how to generate this factor, but will also be able to relate their calibrated dosimeter response to the expected dosimeter response to the radionuclide used in administering proficiency testing for category (s) as specified in the ANSI standard.
(15) Processors should agree not to use their accredited status for advertising purposes.
t
Response
The staff would have no objection to such an agreement amcrg i
l l
the processors, but does not plan to make any such agreement a part of the regulatory program.
The NVLAP criteria prohibit a processor from referencing its accredited status in consumer media, on product labels or l
containers, and in product advertising.
However, a NVLAP accredited processor may reference its accredited status on its letterhead, brochures, test reports, in trade publications and other laboratory services l
advertising media.
8 Enclosure C
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'. s (16) Processors being tested should be told the sources to which each dosimeter has been exposed.
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Response
Section 3.2 of the ANSI N13.11 Standard which is the basis for proficiency testing specifically states, "For all but the accident Cate-j gories I and'II and the neutron Category VIII, the categories in which individual dosimeters were irradiated shall not be divulged to the processor until after he has been sent test results.
In the low energy I
photon Category III the National Bureau of Standards (N85) technique used for the irradiation shall not be divulged to the processor until after he has been sent test results."
1 l
Acceptance of this commentor's suggestion would be a major departure from j
the standard, which has been developed as a consensus standard.
The Commission wishes to avoid such departures if at all possible.
In addi-tion, this suggestion would be a relaxation of the standard that would L
make it too lenient.
(17) The HPSSC/ ANSI Standard requires dose determinations at depths of 7 and 5
2 1000 mg/cm ; NRC Form 5, the official record of Current Occupational External Radiation Exposure for, individuals, requires a dose determina-2 tion at 300 mg/cm unless a specified degree of eye protection is provided (which might be rare); a dosimeter designed to permit compliance with NRC i
Form 5 will present great difficulty for processors being tested with such high-energy beta sources as SrS0/Y80
Response
Most dosimeters are not designed to provide compliance with 4
NRC Form 5 directly.
Dosimeters are designed by different processors to l
measure many varieties of radiation exposures and to allow interpretation of these exposures in terms of absorbed dose at various depths in tissue under applicable conditions of geometry and backscatter.
ANSI Stand-l ard N13.11 was primarily designed to test the processor's capability (1) to measure exposures from different radiation categories or mixed categories in which a processor chooses to be tested, and (2) to interpret these exposures in terms of dose equivalent for radiation protection l
purposes.
Dosimeters normally are not designed to determine directly, l
9 Enclosure C i
^
without appropriate analytical interpretation, all doses that may require reccrding in compliance with the regulations.
For the majority of radia-tion exposures encountered, estiinating the whole body dose at a depth of 2
300 mg/cm, where eye protection is not provided, would overestimate the dose at 1000 mg/cm2 and thus provide an additional margin of safety.
It may be assumed that any processors capable of passing the criteria of ANSI Standard N13.11 in a given category will also be capable of calculating 2
that dose at 300 mg/cm as required using the best methodology applicable to their particular dosimeter design.
Thus, it should be apparent that appropriate correction factors should be developed by the processor for each specific dosimeter design as required.
Appendix C of ANSI N13.11 gives conversion factors at the 300 mg/cm depth as supplemental 2
information.
(18) Passing a performance standard does not ensure gooo personnel dosimetry.
Response
The staff is aware that processors may not take the same approach to their work while participating in proficiency testing as they do in day-to-day, routine processing.
However, passing the proficiency tests prescribed in ANSI Standard N13.11 does indicate acceptable capa-bility.
It is the intent of the NRC and NVLAP to assure that this capability is used in routine applications by making NVLAP accreditation contingent on the establishment and implementation of an adequate quality assurance program by the processors.
Both elements are included in NVLAP accreditation criteria.
(19) An additional test of the HPSSC/ ANSI Standard, as revised, should be conducted.
Response
The staff agrees; a third round of testing has been conducted using the revised standard, and results are available in NUREG/CR 2891.
The Commission feels that ANSI N13.11 has been thoroughly tested and will serve as an appropriate base for the NVLAP accreditation program.
10 Enclosure C l
.s (20) Since the NRC already has authority over its licensees, requiring them to use the services of accredited processors is repetitive.
Response
There is no competency requirement in the regulations at present for action by the NRC staff to assure that personnel dosimetry, performed for or by its licensees, is conducted in a technically accept-able manner.
The NRC can only impose requirements on its licensees.
The only way the NRC can affect non-NRC-licensed dosimetry processors is by requiring its licensees to.have their dosimeters processed by accredited dosimetry services.
(21) An entirely voluntary program is preferred.
Response
Many comments were received to the contrary.
It is believed that participation in a voluntary program would be minimal, as evidenced by the present National Sanitation Foundation program for testing personnel dosimetry processors.
(22) A grace period of three years should be provided.
Response
By the date of the effective rule, considerably more than 3 years of notice time will have been provided.
The staff believes that the approach that has been adopted will provide more than adequate opportunity to prepare for the new regulatory program.
(23) Blind testing should not be considered necessary.
l
Response
The staff believes that blind testing would be preferable.
However, experience in the University of Michigan pilot study indicates
(
that blind testing of in-house processors is essentially impossible.
A discussion of the blind testing experience is reported upon in NUREG/
CR 1064 (pages 10-11).
The staff agrees with the findings of the University of Michigan and does not believe it would be equitable or fair to blind test comniercial processors only.
Therefore, the staff proposes to rely instead on the imposition of adequate, inspected quality assurance programs as a condition for obtaining and retaining accredited status.
11 Enclosure C
2.'
(24) The regulatory program should be delayed until two technical questions are answered:
(1) R-to rem conversion factors, and (2) averaging of the skin dose.
Response
The conversion factor issue has been resolved to the satisfaction of the working group that developed the ANSI Standard and of the NRC.
In addition, the conversion factors which appear in the revised ANSI Standard were also endorsed when the Board of Standards Review of ANSI approved the final ANSI N13.11.
Conversion factors are under study by a committee of the International Commission on Radiation Units and Measurements and internationally accepted values should be available in about two years.
The staff is investigating the possibility of revising NRC regulations to permit averaging of the skin dose, rather than specifying the dose at a given depth.
This question will be resolved in connection with basic revisions of the Commission's occupational health protection standards, Part 20 of Title 10 in the Code of Federal Regulations, that are now under consideration, and on which public hearings are planned.
It is believed that these basic revisions will require considerable time to conclude.
The staff believes it would be imprudent to delay implementation of this regulatory program until that time.
12 Enclosure C
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ENCLOSURE D 4
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PERIODIC AND SYSTEMATIC REVIEW OF REGULATIONS i
(TMI ACTION PLAN TASK IV.G.2) l
SUBJECT:
Proposed Amendments to 10 CFR Part 20 That Would Require Licensees Who Must Perform Personnel Monitoring to Utilize the Services of an Accredited Personnel Dosimetry Processor and to Maintain Appropriate Records i
Criteria for Periodic and Systematic Review of Regulations h'4C Compliance 4
l 1.
The proposed regulations are needed.
The proposed amendments are intended to improve the accuracy !
I and consistency of reported occupational dose estimates by requiring licensees who are currently performing personnel monitoring in accordance with the regulations to obtain the services of personnel dosimetry processors who are accredi-tated under the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Bureau of Standards (NBS) which is a part of the Department of Commerce.
NVLAP i
accreditation will require processors to demonstrate:
- 1) successful performance in p,roficiency tests administered i
in accordance with ANSI Standard N13.11, Criteria for l
Testing Personnel Dosimetry Performance, 2) successful com-j pletion of NVLAP's questionnaire and application materials, j
and 3) on-site inspection by NVLAP assessors of a proces-sor's routine dosimetry service with respect to processing protocols and associated minimum quality assurance criteria i
which are specified in NVLAP general and specific criteria, and in supplemental information supplied to the processor j
upon application to the program.
i The need for processor testing and an accreditation
]
program was clearly established by the' poor performance j
of personnel dosimetry processors in recent tests of proc-i essor performance against a draft of the standard conducted j
by the University of Michigan for NRC.
A complete descrip-tion of tne need for this regulation was discussed in an Advance Notice of Rulemaking on the subject (45 FR 20493).
l 1
Enclosure D i
Criteria for Periodic and Systematic Rsview of Regulations NRC Compliance 2.
The direct and indirect effects of the The direct and indirect effects of these rulemaking actions regulations have been adequately considered.
were considered in the Regulatory Analysis prepared in connection for these proposed rules in Enclosure B.
3.
Alternative approaches have been considered Alternative approaches were carefully considered prior to and the least burdensome of t.ne acceptahle these proposed rulemaking actions.
Enclosure B discusses alternatives has been chosen.
each of the technical and procedural alternatives considered.
Since regulation appears to be the only acceptable procedural alternative to accomplish the purposes of these actions, the conclusion of the analysis of technical alternatives is of prime importance (see Section 2 of Enclosure B).
4.
Public comments have been considered and an In response to the Advance Notice of Rulemaking (45 FR adequate response has been prepared.
20493) forty-six letters of comment were received.
Nineteen additional public comments were received in response to a letter written by NRC to all personnel dosimetry processors and other interested persons, February 18, 1980, which described another alternative method for operation of a testing laboratory not described in the Advance Notice of Rulemaking.
A summary analysis of all comment letters received in response to the ANR is found in Enclosure C to this Commission paper.
Oral comments were also received from dosimetry processers and users of dosimetry services at two public meetings sponsored by the NRC and other Federal agencies in 1976 and in 1980.
Comments received in 1976 were analyzed and incorporated into the Advance Notice of Rulemaking (45 FR 20493).
Comments from the 1980 public meeting supported statements made in written comments which are analyzed in Enclosure C to this Commission paper.
The University of Michigan sponsored meetings of dosimetry processors in 1980 to obtain comments concerning the valve and impact of the proposed program.
These are reflected in Section 2 of Enclosure B.
Finally, in April 1982, NBS/NVLAP sponsored a 2 day technical workshop for processors and other interested persons to discuss technical benchmarks for conducting on-site review 2
Enclosure D l
Criteria for Periodic and Systematic R: view of Regulations NRC Compliance e'
of an applicant processor's compliance with NVLAP accredita-tion criteria.
Comments from the workshop were analyzed by.
the NBS/NVLAP staff and have been included in the finalized criteria which have been reviewed and accepted by NRC staff.
5.
The regulation is written so that it is under-The proposed amendments to 10 CFR Part 20 have been reviewed standable to those who must comply with it.
and edited for the specific purpose of ensuring that the regulations are clear and can be understood by persons who are required to comply with them.
6.
An estimate has been nade of the new reporting A justification for and estimation of all reporting and burdens and recordkeeping requirements necessary recordkeeping requirements necessary for compliance with for compliance with the regulation.
the proposed regulations has been submitted to and approved by the Office of Management and Budget (0MB), OMB approval No.:3150-0014.
7.
The name, address, and telephone number of a The Federal Register notice promulgating the proposed knowledgeable agency official is included in rules contains the name, address, and telephone number of a the publication.
knowledgeable agency official, viz., the project leader for these rulemaking actions.
8.
A plan for evaluating the regulation after Licensee and staff experience with the regulation and its issuance has been developed.
actual processor accreditation with NVLAP will be used to evaluate the regulation.
In addition, this regula-tion will be reviewed in the second cycle of NRC's periodic and systematic review process (1986-1991).
3 Enclosure D
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ENCLOSURE E INITIAL REGULATORY FLEXIBILITY ANALYSIS These proposed rules would require NRC licensees'to have personnel dosimetry processing performed by personnel dosimetry processors who have been accredited under the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Bureau of Standards (NBS).
Currently, NRC licensees are not required
~
to obtain services of accredited processors because such competency require-ments are not included in the regulations or in license conditions.
These rulemaking actions are, however, being developed concomitantly with a Labora-tory Accreditation Program (LAP) for Personnel Dosimetry Processors being established by the N85 at the request of the NRC.
These rules are intended to improve the accuracy and consistency of occupational radiation dose measure-ments by improving personnel dosimetry processing performed for licensees.
These rules are being proposed under the authority provided by the Atomic Energy Act to establish standards which protect the public health and safety.
NVLAP accreditation would be based on three primary elements:
(1) pro-ficiency testing of each personnel dosimetry processor in accordance with ANSI Standard N13.11, Criteria for Testing Personnel Dosimetry Performance, to be administered by a proficiency testing laboratory (PTL) which will be contracted by the National Bureau of Standards (NBS), (2) information collected from the personnel dosimetry processor by questionnaire, and (3) on-site assessment of routine dosimetry processing and quality assurance techniques.
Approximately 4,500 NRC licensees are currently required to conduct personnel monitoring to measure the amount of radiation occupationally received by workers and to maintain records of these exposures.
There are currently 90 known personnel dosimetry processors in the United States who perform personnel dosimetry services in-house or commerically.
Eighty of these processors may be considered large entities; they include seven large commercial processors, seven large private corporations, nine national laboratories, 31 nuclear power plant licensees, 10 DOE contractors, three l
large universities, eight military organizations, four state public health
{
departments and one medical facility.
These entities do not fall within the definition of "small entities," as set forth in section 601(3) of the Regulatory Flexibility Act, or within the definition of "small businesses" as 1
Enclosure E
p found in section 3 of the Small Business Act, 15 U.S.C. 632, or the Small Business Size Standards in regulations issued by the Small Business Administra-tion at 13 CFR Part 121.
A listing of the 90 known processors is included in
- a. letter from the University of Michigan to the NRC dated July 13, 1981, which was updated by a November 8,1982 letter in conjunction with a study entitled,
" Performance Testing of Personnel Dosimetry Services" performed for the NRC by the University of Michigan (UM).
This letter and study are available for ::" cec-tion upon request or copy for a fee at the NRC's Public Document Room, 1717 h Street, Washington, D.C. 20555.
The remaining ten known personnel dosimetry processors may, for purposes of this Regulatory Flexibility Analysis, be consid-ered "small businesses," as defined in section 601(3) of the Regulatory Flexi-bility Act.
It should be noted that only four of the ten identified "small business" processors participated in the final performance tests conducted for the NRC by the University of Michigan.
Compliance Requirements Each NRC licensee performing personnel monitoring for the whole body or whole body and skin in accordance with the regulations would be required to obtain and maintain a copy of their dosimetry processing service's accredita-tion certificate (s) which will be granted after successful participation in the LAP for Personnel Dosimetry Processors at the NBS.
Separate accreditation certificates will be granted by NVLAP to processors for services with each type and model of dosimeter successfully meeting NVLAP criteria for specific radiT-tion categories.
The certificate of accreditation will be valid for a period of 2 years.
Licensees would be required to retain a copy of all appropriate and current processor accreditation certificates with individual dosimetry records for as long as the dosimetry records are maintained.
The NRC inspector would examine these records during inspection of the licensee to determine compliance with 620.201(c) and 620.401(d).
The licensee would not be required to submit a report to the NRC.
The estimated burden per NRC licensee for this recordkeeping requirement is less than half an hour / year.
This time estimation is based on the amount of time required oy the licensee to telephone or write the processors for copies of accreditation certificates, i
2 Enclosure E
Cost of Program to Processors Processors will incur (1) an initial, one time cost when preparing for proficiency testing and (2) NVLAP accreditation fees every two years which will include NVLAP administrative fees, costs for conducting assessments of a l
processor's routine dosimetry processing and quality assurance techniques, and proficiency testing fees.
Accreditation Costs Accreditation costs incurred every two years by large or small dosimetry processors include NVLAP administrative fees, proficiency testing fees and in-house costs associated with accreditation activities.
There is also an addi-tional one-time cost for preparing for the initial round of accreditation which was estimated by the processors to average $7,800 (Table E-1).*
Table E-1*
Processor Estimates of Initial (One-Time) Potential Preparatory Costs / Processor for Initial Proficiency Testing Initial, one-time costs to prepare for testing are summarized as follows:
If we assume that the processor is already recording dose as is called for on NRC Form 5, the official form for recording individual worker " Current Occupation External Radiation Exposure," and that labor cost is $30,000/ year with overhead at 100% of labor, then the costs for one person week is equal to:
$6 '
52 ekg$1,154perweek.
If a processor spends up to 5 person-weeks reviewing the ANSI standard, reviewing results of previous performance I
tests, and making corrective actions, the labor costs would total:
$5,770 It is possible that a processor may require external recalibration services (consulting) for some categories at a cost up to:
$2,000 The total cost per processor to prepare for proficiency testing is estimated to be:
$7,770 "NRC staff believes that the majority of dosimetry processors have already incurred these costs in association with the three rounds of performance testing of the ANSI Standard N13.11 by the University of Michigan.
3 Enclosure E
g Preliminary estimates of the NVLAP administrative fee are approximately
$2,500 every two years.
These administrative fees cover the costs NVLAP incurs in administering the LAP, costs asscciated with the on-site assessment of a processor's routine dosimetry services and quality assurance techniques including labor and per diem costs for the NVLAP assessor (s) incurred in the assessment of each applicant dosimetry processor every other year, and costs associated with conducting technical review of PTL by NBS.
The proficiency testing fees will cover costs incurred by a testing laboratory under contract to NBS to conduct proficiency testing of each applicant processor.
Proficiency testing fees charged to the processor will be based on the number and type of categories in which the processor is tested for each dosimeter model.
Proficiency testing will be offered in all eight categories included in the ANSI Standard N13.11.
Categories I through V require the use of one radiation source each and Categories VI through VIII use 2 radia-tion sources.
In addition to certain fixed costs, the estimated costs for operating a proficiency testing (PTL) laboratory are dependent on the number of processors who participate in the program and the number of categories the processors select for testing.
These costs will be reflected by the fees charged by the contractor-PTL selected by NBS to perform the proficiency tests.
The figures included below were developed in consultation with Dr. Phillip Plato and Joe Miklos of the University of Michigan (UM) based upon expenses incurred in operating 3 rounds of proficiency testing at the UM.
Proficiency testing fees are summarized in Table E-2.
Table E-2 Projected Proficiency Testing Costs for Processors l
Category Title as Specified in Number of Fee to Test ANSI Standard Sources Required Fee / Category All Categories 1-5 1
$260
$1,300 6-8 2
$520
$1,560 All 8 categories Mixed 1 and 2 (Mixed)
$2,860 I
During the third round of proficiency testing at the UM, processors chose to participate in a number of categories.
Processors submitted 86 dosimeter 4
Enclosure E
'f d
models for 424 tests in the 8 radiation categories.
The smallest number of dosim-eter models submitted by a given processor for testing was 1 dosimeter model for 1 category test.
The largest number-of dosimeter models submitted for testing by a processor was 6 models for 16 radiation categories.
On the average, most pro-L, cessors submitted 1 model dosimeter for 8 radiation category tests.
The average "small entity" processor who participated in the third round of testing submitted I model of dosimeter for testing in 4 radiation categories.
Preliminary results from the third round indicate that average passing rate for processors is 75% of the categories attempted.
(Refer to Table E-3 for a projected range of costs for proficiency testing among processors, and to Table E-4 for the range of total estimated accreditation fees / processor.)
Table E-3 Projected Range of Proficiency Testing Costs for Processors
- Dasimeter Total Costs for Models Initial Category Repeat Category Categories Submitted Tests Requested Tests Requested All Attempted Categories 1-5 Categories 6-8 Categories 1-5 Categories 1-6 Minimum 1 1
0 0
1
$ 260 Maximum 6 10 6
2 1
$6,760
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Average 1 5
3 1
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$3,640 Smal1 Entity 3
1 1
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$1,560 "Information is based upon processor participation in the third round of proficiency testing conducted at the University of Michigan against the revised ANSI Standard.
1 Table E-4 Total Estimated Accreditation Fees for a Processor Administrative Fee Proficiency Testing Fee Total Minimum Fees
$2,500
$ 260
$2,760 Maximum Fees
$2,500
$6,760
$9,260 l
Average Fees
$2,500
$3,640
$6,140 Small Entity
$2,500
$1,560
$4,060 i
Three person-weeks for recalibrations
$3,462 i
Consulting service (irradiations) 1,000 Total additional in-house costs for processors that must j
repeat proficiency testing
$4,462 5
Enclosure E
4:
o The in-house labor per processor to prepare for normal testing is estimated at three person weeks, including overhead and fringe benefits, excluding the first year for which initial costs were already estimated previously.
Assuming the same labor costs as previously listed for initial testing in Table E-1, three person-weeks would cost $3,500.
It is expected that processors would also incur in-house costs for addi-tional proficiency testing in any categories failed by the processor in initial proficiency testing assuming that they desire to be accredited in that category.
The estimates given in Table E-3 are based on projected processor failing rates as indicated by the third round of testing in the UM study and the assumption of retest only for those categories failed initially.
Costs for proficiency testing in these categories were included previously in Table E-3.
These estimates do not include the loss of business to a commercial processor that fails one or more categories or fails to become accredited in one or more categories.
Many details of the accreditation program are not finalized and any of the cost estimates could change depending on several policy issues currently being evaluated.
i Total Estimated Cost of Accreditation Program to Processors After the first period of accreditation, the total annual costs incurred by a processor are summarized below, Table E-5:
Table E-5 Total Potential Biennial Costs for a Processor for Accreditation Efforts (Accreditation Costs + In-House Costs)
Accreditation Potential Total Biennial Pro-Rated Total Costs In-House Costs Costs Annual Costs Minimum Costs
$2,760
$3,462
$ 6,222
$3,111 Maximum Costs
$9,260
$7,924
$17,184
$8,592 Average Costs
$6,140
$7,924
$14,064
$7,032 Small Entity
$4,060
$7,924
$11,784
$5,892 Initial, one-time costs for large or small processors to prepare for pro-ficiency testing will be approximately $7,800 (see Table E-1).
The estimated costs to the average processor for continued NVLAP accreditation is approximately 6
Enclosure E
$14,100 every_other-year or annual costs of approximately $7,000 (see Table E-5).
The estimated costs for the average "small entity" processor is approximately
$11,800 biennially or $5,900 annually.
The costs for participating in the accre-ditation. program, whether the processors are performing these services in-house or commercially, and regardless of their size, are, for purposes of this Regulatory j.
Flexibility Analysis, approximately the same.
(These costs are explained in detail in the Regulatory Analysis, which is available for review at the Commission's Public Document Room, 1717 H Street, Washington, D.C. 20555.
The Regulatory Analysis also contains a complete analysis of all technical and procedural alternatives and a statement of statutory considerations.)
The total volume of business within the dosimetry processing industry is estimated at $34 million annually.
The ten small personnel dosimetry processors which would be affected by this rule account for approximately 0.5% of the dosimetry processing business in the United States.
(This volume of business
[
was determined by Dr. Phillip Plato of the UM.) This 0.5% represents a total volume of business of approximately $170,000 annually. While the NRC does not know the distribution of this volume of business among these dosimetry pro-cessors, an equal distribution of the business would create an average annual business per company of $17,000.
Thus, the estimated initial, one-time cost for each of these ten small entities of $7,800 and the estimated and pro-rated annual accreditation fees of approximately $5,900 each for the NVLAP program is likely to have a significant economic impact on small dosimetry processing businesses.
It is important to recognize that all dosimetry processors are not NRC licensees but that most commercial dosimetry processors do business with NRC i
licensees.
It is further expected that the members of the Interagency Policy Committee on Personnel Dosimetry which include representatives from the Environmental Protection Agency, the Bureau of Radiological Health (now the National Center for Devices and Radiological Health), the Department of Energy, the Department of Defense, the Occupational Health and Safety
(
Administration, the National Bureau of Standards, NRC, and the Conference of j
Radiation Control Program Directors, are planning to recommend programs of the j
same nature for their respective agencies.
They all consider NRC to be the i
lead agency in this effort to bring about improved dosimetry in the United States.
It is the finding of the Commission in the Initial Regulatory Analysis that the acceptable procedure for solving this problem is by rulemaking 7
Enclosure E
.g action and~that the particular technical alternative proposed, third party accreditation by the National Voluntary Laboratory Accreditation Program (NVLAP) of the N8S offers equal benefits for small and large processors and will almost certainly guarantee improvements in the quality of reported dose estimates.
It is the NRC's preliminary finding that the benefits from improved dosimetry received by workers, licensees, the NRC, and the general public from this proposed regulatory program justify the costs for compliance (as described in the Regulatory Analysis, Enclosure B).
The Commission has carefully examined the elements of the proposed LAP and finds that differing compliance and/or reporting requirements for small and large processors, or simplification of the accreditation program, are not acceptable and cannot replace proposed documented tests or other elements of the accreditation program which independently evaluate a processor's ability to perform accurate and consistent personnel dosimetry for NRC licensees.
The NBS/NVLAP and NRC staffs have taken several actions to minimize the cost of accreditation for all processors, i.e., requiring accreditation biennially instead of annually, etc.
The ultimate effect of a dosimetry processor not gaining accreditation could mean that it would no longer be feasible to remain operable.
The accreditation process, however, offers a participating dosimetry processor opportunities for correction of identified inadequacies, for repeat performance testing and appeal of the decision.
(It is helpful to remember that few dosimetry processors failed all categories attempted and that the overall passing rate for categories attempted in the third round of testing at the UM was 75%.)
The Commission has considered the impact of the NVLAP accreditation program upon the small entities affected, and has concluded that the benefits that would result from the proposed accreditation requirement and program are necessary in spite of the program's possible economic impact upon small entities.
The Commission specifically invites written comments on the initial regulatory flexibility analysis.
Comments should be sent to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, Attention:
Docketing and Service Branch.
Comments may also be delivered to Room 1121, 1717 H Street NW., Washington, D.C., between 8:15 a.m. and 5:00 p.m.
Copies of all comments received by the Commission regarding this initial regulatory flexibility analysis may be examined in the Commission's Public Document Room at 1717 H Street NW.,
Washington, D.C. 20555.
8 Enclosure E
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Dear Mr. Chairman:
The Nuclear Regulatory Commission (NRC) is publishing for comment proposed amendments to Part 20 of Title 10, Code of Federal Regulatio'ns, to require NRC H
licensees performing personnel monitoring to (1) utilize personnel dosimetry li services from processors accredited as competent to perform these services under the National Voluntary Laboratory Accreditation Program (NVLAP) for Personnel Dosimetry Processors of the National Bureau of Standards (N85) and, i<
(2) require NRC licensees to obtain and maintain copies of NVLAP accredita-tion certificates with all individual external dose records to demonstrate compliance with the regulations after December 1985.
Personnel dosimeters are used to measure the radiation dose received by workers from external sources of radiation. Although the use of dosimeters is required by NRC regulations, there is no requirement at present regarding the technical
~
competency of personnel dosimetry processors performing these measurements.
Evidence exists indicating that improvement is needed on the part of some pro-cessors.
The proposed rule is intended to solve this problem.
Use of the NVLAP for personnel dosimetry processors would allow the Commission to select l;
a regulatory program which has many advantages for NRC and for industry.
The program has been designed to be continuous and self-supporting. This program
+
would biennially test and accredit the technical compentency of personnel dosimetry processors performing dosimetry services.
i This program is acceptable to and has been supported by the Interagency Policy Committee on Personnel Dosimetry (IPCPD) composed of representatives from all ii i
other interested Federal agencies; it is also supported by an industry committee
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formed to monitor this program. Members of the IPCPD plan to recommend to their agencies that programs similar to NRC's be adopted.
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Several dosimetry processor performance studies conducted between 1967 and 1976 indicated poor performance of processor's dosimeters when tested against
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I a number of early performance standards. As a result of these studies and strong encouragement by the Task Force on Personnel Dosimetry of the Confer-ence of Radiation Control Program Directors (which represents the States),
the NRC, the Bureau of Radiological Health, and the Energy Research and Devel-
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opeent Administration (now the Department of Energy) jointly conducted a public meeting in 1976 at which the personnel dosimetry performance problem was discussed in an open forum by personnel dosimetry processors, dosimetry users, and representatives of State governments and Federal agencies. These P
discussions revealed general agreement that a personnel dosimetry problem does i!
exist and that the problem is sufficiently broad in scope that it should be j
addressed by the Federal government since voluntary standards programs for I
personnel dosimetry processors, such as the National Sanitation Foundation Program, have historically failed to achieve wide participation and acceptance from the personnel dosimetry processing industry.
In 1980, the NRC sponsored
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a public meeting for dosimetry processors, licensees and other known inter-ested parties to obtain further comments on an Advance Notice of Rulemaking on this subject and to discuss with representatives from industry the appropriate elements for a quality assurance program for personnel dosimetry processors.
f' In April,1981 N8S/NVLAP sponsored a public workshop for dosimetry processors l
and other known interested persons to obtain comments on appropriate technical i
benchmarks for evaluation of a dosimetry processor's on-site quality assurance program. This program has had wide public review and has been strongly l
supported by the States through the Conference of Radiation Control Program l
l; Directors.
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Copies of the Federal Reaister Notice and draft Public Announcement are j
i enclosed for your inspection. A period of 60 days will be allowed for public comment.
This notice will be published in a few days.
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l' Sincerely, iI l
Robert 8. Minogue, Director J
Office of Nuclear Regulatory Research
Enclosures:
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Federal Register Notice l
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Draft Public Announcement l
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i The Nuclear Regulatory Commission (NRC) is publishing.for comment pro-posedamendmentstoPart20ofTitleio,CodeofFederalRegulations,to require NRC licensees performing personnel monitoring to (1) utilize the services of personnel dosimetry processors accredited under the National Voluntary Laboratory Accreditation Program (NVLAP) for Personnel Dosimetry Processors of the National Bureau of Standards (N85) which is a part of the Department of Commerce (DOC) and, to (2) obtain and maintain copies of NVLAP accreditation certificates with all individual external dose records for as long as these personnel monitoring records are preserved in accordance with the regulations.
Personnel dosimeters are those devices carried or worn by radiation workers to monitor their external exposure to radiation.
Dosimeters are collected at various prescribed time intervals by the licensees and then pro-cessed by a dosimetry service which may be provided by the licensee in-house or through the use of commercial processors.
Data from the processing of per-sonnel dosimeters are the basis for licensee and NRC records of individual externa-1 doses of workers.
There are 90 known dosimetry processors in the United States.
Because of the critical nature of dosimetry measurements and the poor performance of dosimetry processors during recent tests of a performance stand-ard which were conducted by the University of Michigan for the NRC, there is a need to periodically evaluate the performance of each dosimetry processor and to make a specific determination as to competency. The results of the Univer-sity of Michigan tests were described in an Advance Notice of Rulemaking (45 FR 20493) published in the Federal Reafster March 28, 1980.
l The NRC has requested the Department of Commerce to establish a laboratory accreditation program (LAP) for personnel dosimetry processors (46 FR 9689) in accordance with 15 CFR 7b.
The NRC and the National Bureau of Standards have signed an Interagency Agreement for the development and implementation of this i
i LAP.
NVLAP accreditation of personnel dosimetry processors will be based on an applicant processor's compliance with NVLAP published general and specific criteria which include:
1 Enclosure G l
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(1) Successful participation in performance testing against a performance standard, Criteria for Testing Personnel Dosimetry Performanco, approved by the American National Standards Institute.
Proficiency testing will be con-ducted by a laboratory contrNted by NBS; and (2) Written application.Information supplied by the personnel dosimetry processor in response to accreditation application form questions; and (3) On-site NVLAP assessment of a processor's routine dosimetry proc-essing operation, including quality assurance measures as specified in NVLAP -
criteria. NVLAP will :antract with personnel dosimetry experts to conduct '
assessment. Nominations for assessors have been solicited by NBS from profes-sional and technice.1 societies, academia, NRC, the Interagency Policy Committee on Personnel Dosimetry and the Industry Overview Committee on Personnel Dosimetry.
Upon application to NVLAP, a processor will receive supplemental information detailing how NVLAP general and specific criteria are to be interpreted.
NVLAP general criteria address a processor-laboratory's organi-zational structure, technical management, professional and ethical business practices, and a system for assuring the quality of test methods.
The specific criteria address elements of quality assurance including staff training and competence, facilities and equipment, dosimetry processing protocols, calibra-tion procedures, recordkeeping, data handling precedures, and quality control checks and audits.
NVLAP general and specific criteria are generi in form and also apply to other laboratory accreditation programs which are now offered by the 00C.
A single copy of NVLAP generic general and specific criteria may be obtained from:
Robert L. Gladhill National Voluntary Labcratory Accreditation Program Bldg. 225-8141 National Bureau of Standards Washington, D.C.
20234 301-921-3431 Supplemental information will not be available until thd LAP is more fully developed.
The accreditation process offers a participating dosimetry proc-essor considerable opportunities for correction of identified deficiencies, for I
2 Enclo;ure G
g additional proficiency testing, and a formal appeals process. Accreditation will
+
I be granted for dosimeter model by specific radiation category use by the processor for two years.
Public comments are invited on this proposed program.
The comment period expires
- 1983.
Comments should be addressed to the SecretaryoftheCommission,b.S.NuclearRegulatoryCommission, Washington, D.C. 20555, Attention: Docketing and Service Branch.
Copies of comments received may be examined at the Commission's Public Document Room, 1717 H Street NW., Washington, D.C. 20555.
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" Insert date 60 days after publication in the Federal Reaister of the proposed amendments to 10 CFR Part 20.
3 Enclosure G
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4 ENCLOSURE H
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January 27, 1983 h
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Chairman Nunsio J. Palladino
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United States Nuclear Regulatory Comunission Washington, D.C.
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l The Conference of Radiation Control Program Directors, Inc. (CRCPD) h has been working with NRC staff and other federal agencies for nearly
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ten years to achieve a national program for the proficiency testing u
5 and accreditation of personnel dosimetry processors.
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Nealth physicists and other radiation control personnel have suspected for many years that the accuracy of dose estimates reported by personnel dosimetry processors often have not been within acceptable
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limits.
Recent testing performed by the University of Michigan for ths NRC has substantiated these suspicions.
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Accurate personnel dosiastry reports will provide the ability to 3
make better assessments of potential health effects resulting fron l
esposure to ionizing radiation.
Because of this and the importance of 6
I personnel dosinstry sensurerents which serve as the basis for licensee, l-state tend NRC records of extqrnal radiation doses to workers, there is l
a strong need for mar.datory secteditation through testing of personnel
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dosimetry pro.:essors.
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Mechanisms for proficiency testing and accreditation will be functional within a few months.
A regulation is necessary which will i
assure full participation in the accreditation program by all processors l
supplying personnel dosimetry services to NRC licensees.
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The need for a mandatory accreditation program was evidenced by the experience of the National Sanitation Foundation (NSF) during the i
1960's.
NSF established ~ a proficiency testing program for personnel dosimetry processors but only a few processors participated, and then l
not on a continuing basis.
It is my understanding that the Commission will soon consider a i
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utilise personnel dosimetry processors which are accreditated' by the staff proposal to amend 10 CFR 20 which would require NRC licensees to l
i National Bureau of Standards, National Voluntary Laboratory Accreditation Program (NVLAF).
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- Nuncio J. Pciladino January 27. 1983 Page 2 The Conference, as an organization, recently submitted the following
. position statement to our membership for confirmation; The CRCPD recommends that the United States NRC amend 10 CFR 20. and that such amendment requires NRC licensees to use NVLAP accredited personnel dosimetry processors.
I and to maintain records which would document the use of such processorst I
of those members who voted. 95% voted to confirm the above position.
The problem of inaccurate dose estimates by personnel dosimetry processors has been studied for a number of years by various state and federal agencies and by, professional organizations. The above confirmation indicates that this is the best way to provide assurance that personnel dosimetry dose estimates are reliable.
As a further step to assure full participation by personnel dosimetry i
processors in the accreditation program, the CRCPD Personnel Dosimetry Committee is recommending that all states adopt regulations requiring that their licensees and registrants use only NVLAP-accredited personnel dosimetry services.
Yours very truly.
ll> -
l ard.C. Shealy Chairman i
Conference of Radiation Control Program Directors. Inc.
NGS/CMH/sah cc Executive Board Federal Liaisons Larry Lloyd William Spell O
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Q.QQg D.m , 'l lC COLORADO DEPARTMENT OF ' HEALTH.
Richard D. Lamm b
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Frank A. Traylor. M.D.
- g OEC -j ExgtgDirector Governor 87 November 16, 1982 e e, 0 'lU.'E:;[Q',',g BRAncy Mr. Nunzio J. Palladino, The Chairman Nuclear Regulatory Commission Mail Scop H-ll49
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1717 H. Street, NW Washington, D. C. 20555 C ' . 3 M r M.zoh3 Dear Mr. Palladino This letter is in regard to the Commission's review of the need to l
require that personnel dosimetry processors be accredited.
Colorado urges the commission to amend 10 CFR Part 20 to require that licensees required to use film badges or TLD's only use services of a processor who actively participates in an approved, national testing and accredi-dation program, and who's results are acceptable to the. testing laboratory.
We have seen many instances where the exposures stated by a processor could not possibly be accurata.
Inaccurate determination of an individual's exposure has adverse effects on the licensee and the individual.
Licensees are changing procedures and equipment, and resssigning employees based on personnel dosimetry reports.
How many unnecessary chan3es are made. and how many necessary changes go over-looked? In the case of a significant over-exposure, an individual's medical treatment may be based on the estimated exposure.
If the dosimetry is incorrect, the treatment may be too.
The need for accurate personnel monitoring is too important to be lef t unattended or lef t to a fev ' companies who might try to monitor themselves.
t Therefore, we believe that 10 CTR Part 20 must be amended to address this issue.
Sincera1y, 4
0212160422 021116 J. Hazif Dire or gR R204M PDR Radiati n control Division AJH WJter l
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Victor Gilinsky l
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Thomas M. Roberts l
James J. Asselstina I
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November 26,1982
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'O' Dear D ladino:
t' RE: Proposed Amendment to No.10 CFR 20 Requiring Accreditation of Personnel Dosimetry Services We strongly endorse the referred proposal which would mandatority require licensees to use personnel dosimetry services which are accredited by the National Voluntary Laboratory Accreditation Program, a part of the National Bureau of Standards.
There are significant detrimental disparities between methods of calibrating or standardizing of both the dosimeter processing equipment and the respective dosimeters. These result in disparate interpretation of personnel dose among the dosimetry services whether they are commercial suppliers,,or of governmental or private industrial in-house origin. It is difficult to reconcile a comparative dose from the same exposure which could vary, for example, from 3 to less than 30 millirems as determined by several services.
The proposed amendment, which we support, is apparently the only way to have personal dosimetry systems tested, evaluated, and accredited so that more uniform and meaningful dose reporting might be realized in that important area of personal radlological health.
Very truly yours,
//Cht-i THOMAS M. GERUSKY, Director Bureau of Radiation Protection l
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STATE DEPARTMENT OF HEALTH
. sr State Capitol M. A. K. Lommen, M.D., R.P.E.
.x _y' Bisrnarck, North Dakota 58505
- f,[.E State Health Officer g g y E' jrgental Health Section p
MissouriOffice Building November 24, 1982 1200 Missouri Avenue Ec'cEd dst,%'"' "*"" ***** ****'
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Mr. Nunzio J. Palladino
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Chairman g
Nuclear Regulatory Commission
^'"" " DD Mail Stop H-ll49 m ggg I n" 80 1717 H Street NW Washington, DC 20555 ff5 FAc20493 Re Personnel Dosimetry Processing Accreditation Program
Dear Mr. Palladino:
At this time this' Department wo0ld like to take the opportunity to express its support for the nood for approved personnel dosimetry processing.
Sinco fadoral and stato regulations have established standards which limit radiation dosos and require
~
personnel monitoring to measuro the radiation exposure received during work, it is necessary that personnel dosimetry provido reliable measurements.
If the monitoring and measurement of radiation work or dosos are to be considered important, it should be considered important that those measuromonts be re-liable and accurato.
This Department has boon informed that somo of the dosimetry processors, during recent tests conducted by the University of Michigan for the NRC, have indicated poor performance.
In addition, because of dosimatry processops failure to participate in the testing and certification program offorod by the National Sanitation Foundation during the 60's, there is evidence that a mechanism which would assure acceptable limits of personnel dosimetry processing should be established.
It may well be that the only acceptable way under which a testing, and accreditation program can be effectively implomonted is to requiro such a program by regulation.
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ana K. Mount, P.E.
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Director, Division of Oa:E Environmental Engincoring
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ROMUNO o, teoWN JR., co emer r
DEPARTMENT OF HEALTH SERVICES
'5 'O 714/74J P StattT SACAAMtHfo, CA 95014
.p Q hD N (916) 445-0931 November 22, 1982 W.dr[.[SR E
00Cf g u nCH Nunzio J. Palladinog The Chairman Nuclear Regulatory Commission Mail Stop H-1149 gg; ItcM3tNf 4, 1717 H Street, NW I
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Dear Sir:
The California Department of Health Services strongly recommends the adoption of the proposed 10 CFR 20 amendments by the NRC to require that all NRC licensees use personnel dosimetry services that are accredited under the National Voluntary Laboratory Accreditation Program (NVLAP) and that licensees maintain records showing that their personnel dosimetry services are accredited.
The need for the mandatory testing and accreditation of personnel dosimetry processors is eminent. The participation in a voluntary testing program conducted by the National Sanitation Foundation (NSF) during the 1960s was poor (only a few of the processors participated). The recent, tests conducted by the University of Michigan for the NRC revealed apparent poor performance of some processors.
Personnel dosimetry measurements, which serve as the basis for licensee, state and NRC records of external radiation doses to' workers, cannot tolerate gross inaccuracies. Good health physics practice and judgement depend on reasonably accurate personnel dosimtery measurements.
Presently, the only effective means of implementing a mandatory testing and accreditation program is by amendment of 10 CFR and subsequently the same amendment be adopted by the Agreement States.
Sincerisly, qw Gerard C. Wong, Ph.D.
Senior Health Physicist for Radiologic Health Branch cc Commissioner victor Gilinsky Commissioner John Ahearne Commissioner Thomas M. Roberts Commissioner James J. Anselstine 4
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47 TRINITY AVENUE. S.W ATI' ANTA. oEoRolA 30334
'82 NOV 29 P1:30 R
November 22,1982' gg,a ; p,cc, ;,,a,
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'3 BRANCM Nunzio J. Palladino The Chaiman Nuclear Regulatory Commission Mail Stop H-ll49 0055 ERWS 1717 H. Street, N.W.
PR-a Washington. 0.C. 20555 M000MB W o
FR.10413.g)
Dear Chaiman Palladino:
This letter is written in support of NRC proposing an amendment to 10 CFR 20 which would require NRC 1,1censees to use personnel dosimetry services accredited under the NVLAP program.
Currently the regulations require that any individual in a restricted area not receive in any one calendar quarter more than a specified total occupational dose and that the licensee shall supply appro3riate personnel monitoring equip-ment to individuals who (1) receive or are 11(ely to receive 25 percent of likely to receive 5 percent of these limits; or (3) ge who receives or are these limits; (2) to individuals under 18 years of a to individuals who enter high radiation areas. The definition for personnel monitoring equipment describes it as " devices designed to be worn or carried by an individual for the purpose of measuring the dose received," however, it does not refer to the ability or accuracy of those devices.
In practice, regulatory personnel and Itcensees have assumed that these devices are approximately 100% accurate. Recent tests of the Health Physics Society personnel dosimetry testing standard have shown that this is not the case.
Although this study was free, it is our understahding that not all personnel dosimetry processors participated.
Therefore, in order for all processors to participate there should be a mechanism to make the accreditation mandatory.
By requiring the licensee to use an accredited processor, participation would essentially be mandatory for the processors. As long as we rely on these devices and their ability to accurately measure exposure, there needs to be a quality assurance program such as NVLAP to add a degree of confidence to health physics.
decisions, especially when an incident occurs.
Sincerely, DobbyGlut edge Direc o Radiological Health Sectic BGR/CC/fp cc:
Victor Gilinsky John Ahearne Thomas M. Roberts James J. Asselstine p
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DEPARTMENT Of HEALTH cwamastom to u s November 12, 1987.
Nunzio J. Palladino, Chairman U.S. Nuclear Regulatory Mail Stop H-1149 1717 H Street, N.W.
Washington, D.C.
20555
Dear Chairman Palladino:
This is to urge an amendment to 10 CFR 20 which would require that purveyors of Jersonnel dosimetry services be subjected to accreditation by t1e Department of "omerce's National Voluntary Laboratory Accreditation Program (NVLAP).
Such a step by the NRC has been long overdue.
Sincerely yours, hhYrl..<rv William H. Aaroe, Director Industrial Hygiene Division WHA:gp cc: Victor Gilinsky, Comissioner John Ahearne, Comissioner Thomas M. Roberts, Comissioner James J. Asselstine, Comissioner
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Illinois Department of \\uclear Safety 1035 Outer Park Drive Springfield, Illinois 62704 (217)5448100 Philip F. Custafson Director November 15, 1982 Nunzio J. Palladino, Chairman Nuclear Regulatory Commission Mail Stop H-1149 1717 11. Street, NW Washington, D.C.
20555 Dear Chairman Palladino It is my understanding that the NRC staff will be requesting that the Commission approve a proposed amendment to 10 CFR 20 requiring licensees to utilize personnel monitoring services accredited by the Department of Commerce's National Voluntary Laboratory Accreditation Program.
Our De-partment of Nuclear Safety supports this proposed amendment. We have recognized the need to have an accreditation process for personnel monitoring services since 1963 when the Illinois 1cgislature granted authority to the Department to evaluate and approve persons or firms furnishing personnel radiation monitoring services in the state.
Due to the lack of national standards, we have relied upon the testing program conducted by the National Sanitation Foundation (NSF). The major problem we faced with that policy was that the testing process with NSF in voluntary which then limited personnel radiation monitoring services in our state. The mandatory testing and accreditation process proposed by the NRC staff in conjunction with the Personnel Dosimetry Committee of the Conference of Radiation Control Program Directors, Inc., is both necessary and appropriate.
We encourage the Commission to support the forthcoming proposal as we feel this could be a significant improvement in establishing mandatory and uniform accreditation neandards for all personnel dosimetry processors.
3SincefelyS
// Q&ts, W t.<
Ma ry Nuuweg, Manager Office of Radiation Safety itEN imho cc Victor Gilinsky John Ahearno Thomas Roberts UL 2 7,. o James Asselstine Hayward Shealy Chuck liardin Larry Lloyd Discover The Magnilicant Miles ofIllinois 5
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STATE OF UTAH DEPARTMENT OF HEALTH:,
DIVISION OF ENVIRONMENTAL HEALTH
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150 West North Temple.P.O Boa 2500 Salt Lake City. Utah 84110 2500 j1 lQ)
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Mary H.
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(801) 533-6734 MANCH uraa,a arector soi m.aisi December 1,1982 DIVI $lON$
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l7 S",3$'N.'."!l Mr. Nunzio J. Palladino, Olairman
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20555 a-a M,dt.Ilaemner t.,, urene t 6.,,,.'
Dear Mr. Palladino:
l It has been our exoerierce that personnel dosimetry services have been unreliable in the low dose range.
We have not tried to check accuracy by submitting a dosimeter with a callurated exposure, but the reported exposures did not always coordinate with our activities.
Wnile our reported exposures have been less than 20 mrem / month, wa have wondered how reliaole the dosimetric services are even at higher doses.
We would like to go on record in support of a federal requirement that providers of Personnel Dosimetry Services must show eviderce of reliability such as certification by a national laboratory.
l Sireerely, 4e_4 &. W w ~
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Darrell M. warren, Director l
Eureau of Radiation Control and l
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.f November 18, 1982 Nunzio J. Palladino, The Chairman Nuclear Regulatory Connission Mail Stop H-1149 1717 H. Street, NW Washington, D.C.
20555
Dear Mr. Palladino:
The purpose of this latter is to encourage the Commission to propose the amending of 10CFR20 to require the testing and accreditation of personnel dosimetry processors.
Personnel dosimetry measurements obtained by the evaluation of thermal luminescent dosimeters and film badges are the source of most records of external radiation doses received by workers.
Therefore, the proper pro-cessing of these dosimeters is paramount in determining exposures to the workers. However, as studies have indicated that the dose assessments re-ported by some processors may not be reliable, there is a clear need for an accreditation, program for all processors.
Amending 10CFR20 would be an acceptable way of instituting such a program.
Further, the quality and quantity of participation by processors in voluntary programs indicated that an accreditation program must be mandatory.
Your consideration of this proposal is appreciated.
Sincerely, E.FrankWilslonl_fl6 Director Olvision of Environmental Health Protection EFW:GDN: tit CC:
Victor Gilinsky John Ahearne lt a Thomas M. Roberts James J. Asselstine
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STATE BOARD OF HEALTH-Address Reply to:
I Indiana State Board of Health' AN EQUAL OPPORTLNITY EMPLOYER 1330 West Michigan Street 82 EC 27 P3:54 P.O. Box i964 l
December 17, 1982 Indianapolis. IN 46206 1964 I
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Nunzio J. Palladino, The Chairman l
Nuclear Regulatory Commission i
Mail Stop H-1149 1717 H. Street, NW Washington, D.C.
20555 h
Dear Mr. Palladino:
1 Re: Recommendations for Personnel j
Dosimetry Processors At this time the U.S. Nuclear Regulatory Commission (NRC) has the means available to remedy a' situation which has long needed therapy.
Personnel dosimetry device suppliers have long had a voluntary. quality control program which has been poorly utilized.
Personnel dosimetry measurements serve as the basis for licensee, state, and NRC records.
The performance of some processors has been poor as determined in an NRC study conducted by the University of Michigan:
The available means are for the NRC to amend 10 CFR 20 and require that all NRC licensees requiring personnel dosimetry services utilize services that are accredited by the NVLAP, National Voluntary 2
Laboratory Accreditation Program. The NVLAP is part of the National Bureau of Standards and will provide accreditation to proc,essors that pass the personnel dosimetry testing standard which was adopted by the 3
Health Physics Society and approved by ANSI.
This program has had over 20 years of experience in attempting to interpret personnel dosimetry results for the people in Indiana. The only practical system for achieving an effective quality assurance system for the suppliers of personnel dosimetry devices is for the NRC to amend 10 CFR 30 and require that NRC licensees requiring personnel dosimetry services utilize only the services accredited by the NVLAP.
This single action would result in all personnel dosimetry services
,I either becoming accredited or going out of business.
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Sincerely, 42 s.h Hal S. Stocks, Chief Radiological Health Section Division of Industrial Hygiene
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and Radiological Health AC 317/633-0150 cc: Victor Gilinsky John Ahearne Thomas M. Roberts James J. Asselstine 9
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DEPARTMENT OF PUBLIC HEALTW co-ssenu NASHVILLE 37219 gg
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Mr. Numzio 3. Palladino, Chairman W NUMitgg U.S. Nuclear Regulatory Commission
"#000sgp g Lg Mall Stop H-1149 1717 H. Street, N.W.
[p.. pg gg Washington, D.C. 20555
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Dear Chairman Palladino:
The determination of the extent of radiation exposure to persons working with radiation sources or who otherwise have need to enter areas influenced by radiation scurces is of critical concern to all of us in the fields of health and radiation regulation. To make such determinations there is a need for improvements in the processing of personnel dosimetry devices. It is understood that the Commission staff is preparing a proposal to amend 10 CFR20 to require that personnel dosimetry services to NRC licensees be proylded by suppliers of such services who are accredited by the Department of Commerce's National Voluntary Laboratory Accreditation Program.
From the experience of the program offered during the 1960's by the National Sanitation Foundation, it is believed that improvements in personnel dosimetry processing can best be achieved through a mandatory testing and certification program. The effective implementation of a mandatory program appears possible at this time only through amendments to'10 CFR20.
Sincere you,
W. FOWINKLE, M.D.
i Commissioner EWF/CPW/sc i
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'84 JAN D lj January 19,1984 'g.N udii -
l BRANCH Secretary of the Commission
[hM g U.S. Nuclear Regulatory Commission Washington, D. C. 20555 Attention:
Docketing and Service Branch Ladies and Gentlemen:
RE:
Federal Register, Vol. 49, No. 6, January 10, 1984, Notice of Proposed Rulemaking - 10 CFR 20, Parts 20.202 and 20.401.
I am writing to express the support of the Montana Department of Health and Environmental Sciences (DHES) regarding the above-referenced proposed rul e.
Our state radiation control regulations are compatible with those of the NRC and our personnel dosimetry requirements for registrants and licen-sees are identical to those of the NRC.
3 The accuracy of personnel dosimetry dose assessments has been unassured j
since the inception of this type of measurement.
The logic of regulatory agencies requiring licensees and registrants to use personnel dosimetry de-I I
vices of unknown accuracy has been often questioned.
The NVLAP program for testing and accrediting personnel dosimetry pro-cessors will, for the first time, lend credibility to the accuracy of dose assessments reported by the processors.
The proposed rulemaking is necessary to provide incentive to processors to participate in the testing and accredi-tation program.
I The implementation of this rule will effect improvements in personnel j
dosimetry that are critical for the protection of radiation workers.
From the state standpoint, NRC's final promulgation of this rule is necessary because the rule has been determined to be a matter of compatibility.
l The economic impact of this proposed rule to users of personnel dosimetry i
services will be insignificant when compared to the derived benefits.
l I am asking that the NRC expedite the final promulgation of this rule.
- Mcerely, I
Larry +.M2 '
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SN RADIOLOGICAL HEALTH SECTION 00QEJ,E' Jam ** G. L*dt,etter, Ph.D./Commissione' G.M.H.I., Room 425-South /1256 Briarcliff Rd., N.E./ AttaEa, beorgia 30306 2694
'84 JAN 30 P2:15 25 January 1984 LFfi'.: e ii...: ::
DCCYEiIm & sis.:ir.
BRANCH T.'
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..E hf M /pT/88 SECRETARY U. S. NUCLEAR REGULATORY COMMISSION WASHINGTON, D. C. 20555 ATTENTION: 00CKETING AND SERVICE BRANCH
Dear Sir:
I strongly support the proposed rule change to 10CFR20, published in the Federal Register on January 10, 1984, which would require NRC licensees to tse personnel dosimetry processors accredited by the National Bureau of Standards' National Voluntary Laboratory Accreditation Program.
I urge NRC to adopt this rule.
Sincerel,
Bob y G.( utledge, Direct BGR/d Radiologi:al Health Section 4.-
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couu 4RMiC4 January 24, 1984 Secretary of the Ccmnission U. S. Nuclear Regulatory Ccmnission Washington, D. C.
20555 Attention: Docketing and Service Branch Gentlenen:
The Bureau of Radiological Health of the Ccxmonwealth of Virginia welectnes the opportunity to coment on the proposed rule change to 10CFR20 regarding accreditation of personnel dosimetry processors b ' the National Voluntary Iaboratory Accreditation Program.
It is our opinion that this rule change would insure improvanents in personnel dosimetry performance and service to workers.
We, therefore, support this change.
Sin " ly, 7
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'Ibrry M. Bonine RarHation Safety Snecialist Bureau of Radiological Health DB:nc l
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January 26, 1984 00CKETitiG & SEn:':
BRANCH
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Secretary of the Commission EPCSEC ME U.S. Nuclear Regulatory Commission
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Washington, D.C.
20555 L
Dear Sir:
The January 10, 1984, Federal Register invited comments relative to a proposed rule change to 10 CFR 20 which would require NRC licensees to use personnel dosimetry processors accredited by the National Bureau of Standards' National Voluntary Laboratory Accreditation Program (NVLAP).
I would like to take this opportunity to fully support the proposed rule change as I believe it is definitely in the best interest of those radiation workers that utilize some form of personnel monitoring.
NVLAP, through on-site inspections and the establishment of minimum standards, should be able to successfully implement and maintain a processor and accreditation program.
It is my understanding the proposed rule change is supported by the dosimetry industry which does not believe the rule would impose burdensome requirements.
In addition, I believe the proposed rule should be a matter of compatibility for NRC Agreement States should promulgation become reality.
The Conference of Radiation Control Program Directors, Inc. has, for some time, urged the NRC to take action in this area.
From all indicati.ons, it would appear that knowledgeable individuals see a definite need for this type of action; therefore, I strongly recommend that the NRC adopt the proposed rul e.
S ncerely y_
Donald R. H ghes, Manager Radiation Control Program she N
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St:te of Alabama c.
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DEPARTMENT OF PUBLIC HEALTH State Office Buildmg Montgomery, Alabama 36130
'84 J
- 20 IR A L. MYERS. M.D.
STATE HEALTH OFFICER January 24, 1984 gyp t-.. v_.4 00Clu.Ilud a Su. -
BRAhCH
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Secretary
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U.S. Nuclear Regulatory Commission
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Att: Docketing and Service Branch g
Washington, D. C.
20555
Dear Mr. Secretary:
The following comments are submitted concerning the Commission's Proposed Rule, " Improving Personnel Dosimetry,10 CFR 20," as published in 49 FR 1205.
The Bureau of Radiological Health of the Alabama Department of Public Health enthusiastically supports the Commission's proposal to require that personnel dosimetry devices, except extremity dosimeters and pocket ionization chambers, be processed by a processor currently accredited by the National Voluntary Laboratory Accreditation Program for Personnel Dosimetry Processors of the National Bureau of Standards.
This Bureau's experience in inspecting users of radioactive materials who are required to comply with the equivalent of 10 CFR 10 indicates an urgent need for the quality control that would result from such a program. This would make a positive contribution to the public health and cafety by insuring that the exposures reported are within stated standard accuracy of the exposures actually received. The need for the proposed program is so urgent that we recommend that the Commission consider advancing the effective date of February 1986 as now proposed to February 1985.
Sincerely, Aubrey V. Godwin, Director l
Bureau of Radiological Health Environmental & Facility Standards Administration I
AVG:pse l
cc: Don !!ussbaumer m
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W9FLMor) i STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS 0x p, c 7,r h s,n Department of Health g4
_I SI!I4 CANNON BUILDING Davis Street 26 January 1984 GFF,.iTbriff([gya ;
-re Providence, R.I. 0290s 00Ce.
BRAttcn Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555 Attention:
Docketing and Service Bronch
Dear Mr. Secretary:
We are writing to express our firm support for the proposed rule change to 10 CFR 20, to require NRC licensees to use NVLAP accredited personnel dosi-metry processors (Federal Register,10 January 1984).
The' adoption of the proposed rule would facilitate the adoption of equivalent rules by the states. This action, at the state level, would greatly extend the effectiveness of the NVLAP by including, not only state licensees, but also X-ray facility registrants who are subject to the state equivalent of 10 CFR 20. Thus the large medical X-ray workforce and other groups would benefit from an improvement in dosimetric quality.
The need for a performance standard in personnel dosimetry processing is beyond question. We believe that the regulatory imposition of a standard is essential to ensure universal conformity among personnel dosimetry users, and to guarantee reliable services and a fair market for the processing industry.
Sincerely, COM?tVNITY HEALTH SERVICES
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-l James E. Hickey, Chie 4 __
Division of Occupational Health and Radiation Control dls pc:
A. J. Hazle, CRCPD D. Nussbaumer, OSP R. E. Alexander, NRR
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January 30, 1984 BRANCH Secretary of the Commission U.S. Nuclear Regulator.y Commission Washington, DC 20555 ATTN:
Docketing and Service Branch Gentlemen:
This letter is in support of the proposed rules presented in the Federal Register January 10, 1984 concerning personnel monitoring (proposed 10 CFR 20.202 and 20.401).
Accrediation of personnel dosimetry processors has been long needed. The radiation dosimetry values reported by such pro-cessors have served as the basis for assigning occupational radiation doses to individuals. Without the assurance that processors meet a baseline standard of competence, these values are open to question as are many allied facets of a typical radiation safety program which depend upon these values.
Proposed 10 CFR 20.202 and 20.401 should be implemented with-out delay.
S12erely,
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Robert M. Quillin, CHP Radiological Health Program Director RMQ/ka
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ECRET RADIATIONPROTECTIONSCREAUg.j'g-u0' g;,g-January 27, 1984 Secretary of the Comission U. S. Nuclear Regulatory Commission Washington, D.C.
20555 Attention:
Docketing and Service Branch
Dear Sir:
The State of New Mexico strongly urges that the NRC adopt the proposed rule change on " Improved personnel Dosimetry Processing: to 10 CFR Part 20.
The proposed rule change would standardize procedures for dosimetry processing and give Agreement States a much needed service in review of licensee application and eventual licensure.
We wholeheartedly support this proposed rule and if further verification is needed, please contact me at (505) 984-0020, Ext. 272.
Sincerely, Tom Buhl Chief Radiation Protection Bureau TB/mp Y.
,9^?O[ f EQU AL oPPOATUNITY EVALOYEA
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C3:.-i 57 JAMES J. BLANCHARD. Governor DEPARTMENT OF PUBLIC HEALTH 84 FEB -6 A10:41 3500 N. LOGAN P.O. BOX 30035. LANSING. MICHIGAN 48909 g N )' UN Q; ',,
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GLORIA R. SMITH. Pn D., M.P.M., F.A.A.N.. Directo' BRANCH February 2, 1984 Secretary of the Commission U. S. Nuclear Regulatory Commission Washington, D.C.
20555
Dear Secretary:
As the designated radiation control agency for the State of Michigan, we have reviewed the proposed U. S. Nuclear Regulatory Commission (NRC) proposed rule amending 10 CFR Part 20 regarding " Improved Personnel Dosimetry Processing" as published in the Federal Register, Vol. 49, No. 6, Tuesday, January 10, 1984.
We have been following the development of personnel dosimetry standards and processor accreditation criteria from their inception.
Our review has included the development of the Health. Physics Society Standards Committee /American National Standards Institute, ANSI Standard N13.11; the three personnel dosimetry performance tests; the National Voluntary Laboratory Accreditation Program (NVLAP); and the proposed rule.
We strongly support the proposed rule, including ANSI N13.ll and the use of Alternative 3, Option B and the NVLAP for processor accreditation.
The accreditation program is long overdue and should result in improved, more reliable personnel dosimetry.
Establishment of accreditation requirements by NRC rule will assure participation in the program by processors.
In addition, we support and encourage the pending development of standards and an accreditation program for extremity dosimeter processing as discussed on page 1209 of the Federal Register reference.
Thank you for the opportunity for comment.
Sincerely, BUREAU OF ENVIRONMENTAL AND OCC 4AL HEALTH
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rge W. Bruchrann, Chief Division of Radiological Health GWB/JHh cc:
Albert J. Hazie m:w <.
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'84 FEB -6 p11 :33 February 3, 1984 uT7 d c.
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Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555 Attn:
Docketing and Service Branch
Dear Sir:
I support the proposal published in CFR Volume 49 January 10, 1984, concerning accreditation for personnel dosimetry processors.
Such a require-ment should assist all users of such devices in obtaining more uniform results.
I do not support the proposed paragraph 20.401 for the following reasons:
1.
It is a useless piece of paper.
2.
The licensee is required to identify his vendor in his license application.
Surely the U.S. Nuclear Regulatory Commission and/or the appropriate agreement state could easily keep a record of those vendors who are accredited.
The above comments do not necessarily reflect the position of Gulf 011 Corporation.
Sincerely yours, L. Max Scott, Ph.D., C.H.P.
LMS:et dl714 ay ga An-
3 NORTH DAKOTA i
STATE DEPARTMENT OF HEALTH M. A. K. Lomrnen, M.D., R.P.E.
State Capitol p,3 e,
State Health Officer Bismarck, North Dakota 58505 February 2, 1984
'84 FEB -6 P 1 :06 Environmentai seaith Section i
Missouri Office Building 1200 Missouri Avenue Bismarck, North Dakota 58501 gg((7Jgf3 g c BRANG l
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U.S. Nuclear Regulatory Commission M / p 7/ d [
Washington, D.C.
20555 Attention:
Docketing & Service Branch Re:
Proposed Rulemaking Regarding Amendments to 10 CFR Part 20 Gentlemen:
The North Dakota State Department of Health is supportive of the Proposed Rulemaking regarding the amendments to 10 CFR Part 20 which would require NRC licensees to utilize the services of commercial or inhouse dosimetry processors who are accredited by the National Bureau of Standards.
It appears to this Department that there would be at least three beneficial results of this proposed rulemaking:
1.
The recorded exposure of workers who are occupationally exposed to sources of radiation would be consistently more accurate and thereby more valuable in determining an individual's occupational exposure, as well as accident exposure.
f 2.
During the licensing process, it would be reassuring to this Department that the services of an accredited laboratory are used so that the badges or TLDs are processed in a consistent manner using acceptable quality assurance procedures.
3.
Since standards have been set for maximum permissible radiation doses and it is a requirement for radiation workers to monitor their exposure, it seems plausible to have an accurate and reliable method of measuring radiation exposure.
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4 Entarcement Engineering Sanitation Management & Aesearen Pollution Control 70122a3234 701 224 2348 701 224 2382 701 224 2366 701 224 2354
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S:crotory of the 2-February 2, 1984 Commionion Therefore, this Department is supportive of the Proposed Rulemaking regarding the amendments to 10 CFR Part 20, and would adopt the rule as part of the next revision of the North Dakota Radiological Health Regulations, subsequent to adoption by the NRC.
9 Sincerely, det e*~~
Dana K. Mount, P.E.
Director, Division of Environmental Engineering DKM/DPP:saj
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January 31, 1984
- 1 PL /DE Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C.
20555
Dear Sir:
This is in response to the request (49 FR 1205) for comments on the proposed rule which would require NRC licensees to utilize the services of a dosimeter processor who has been accredited by the National Voluntary Laboratory Accreditation Program for Personnel Dosimetry Processors.
Past attempts to achieve uniformity of performance among the processors of persennel dosimeters have not been successful. The problem of nonuniform performance was first documented in 1967 and has not been voluntarily corrected as is evidenced by the fact that a significant fraction of those processors participating in the recent test of their ability to meet the requirements of the American National Standard (ANSI N13.11) failed to pass the test.
For this reason, the Oklahoma State Department of Health urges that the Nuclear Regulatory Commission adopt the proposed rule as quickly as possible.
Vary truly you,rs, h'. 'ba udl#D i GA Joan K. Leavitt. M.D.
Com issioner of Health e
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Indiana State Board of Health AN EQl'AL OPPORTl'NITY EMPLOYER 1330 kest %chipn Street 4' fd 'g
- Indianapota. IN P. O. Bos 1964 February 3, 1984 46206 1964 TO:
Secretary of the Commission U.S. Nuclear Regulatory Commission Attention:
Docketing and Service Eranch TRO.'::
Hal S. Stocks, Chief N Radiological Health Section Division of Industrial Hygiene and Radiological Health AC 317/633-0150
SUBJECT:
Part 20 Rule Change i
As the person responsible for the radiclogical health of the people of Indiana, I wish to be on record as totally in favor of the proposed amendment to 10 CFR Part 20 which would require NRC licensees to utilize the services of dosimetry processors accredited by the National Bureau of Standards under the National Voluntary Laboratory Accretitation ProFram.
We appreciate the opportunity to comment on this important amendment. Thank you.
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~- u n* a 53r.uel S. Chilk Secretary of the Commission U.S. f uclear Regulatory Commission L'ashington, D.C. 20555 Deer t'r. Chilk :
This is to comment relative to the federal register notice of January of the Nuclear Regulatory Commissior,'s intention 10, 1084 include inproved personnel dosimetry crocessing.
to acere 10 CFP Part 20 to The requirement described as Alternative choice when compared to the other octions described.3, Optior F is clearly an excellent The commission should be encouraged to proceed with that option.
In addition, the effective date of February 1986 seems nore than an ample delay to permit processors to begin participatier. in the program.
The connission is encouraged to re-examine the certification progress and consider an earlier effective date if adequate certified services are found to exist at an earlier time, if this office can provide additional comment, please do not hesitate to contact us.
Sincerely, DIVISION OF ENVIPON" EFT Geral d k'. Aller, "i e:t er Bureau of Cadiatica Cert rol GWA/c c/4a cc: Robert E. Alexander, Chief G. Wayne Kerr 1, gn't~5' Y
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U.S. Nuclear Pegulatcry Ccmission 64~'4 Washington DC 20535 Attn Docketing & Service Branch
Subject:
Inproved Personnel Dosi.~etry Processing Ref:
(a) Federal Register /Vol 49.
No. 6/Tues, 10 Jan '84 (b) 10CFR20.401 (a)
Encle (1) Form AEC-5 1.
ICN Dosinetry Service has participated in the voluntary testing program that led to the establishment of NVLAP. We concur in the action proposed in ref (a) and plan to obtain such certification. We request that the proposed changes to 10CFR20, as stated in ref (a), be,inplemented.
2.
In the interest of report uniformity, we also request that Form NRC-5 be changed to reflect the nc::enclature of ANSI Standard N 13.11 i.e. Deep and Shallow Dose. Enci (1) is assumed to reflect the current format of Form NRC-5. We would like to have our Dosimetry Reports follow the format of Form NRC-5 so that our custom 3rs can use our Report as evidence of ccepliance with ref (b).
We would like to receive a copy of Form NRC-5, as modified to reflect the criteria of ANSI Standard N 13.11.
A.L. Baletti Radiological Control Director h Ib p }71V A
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3 42 Bureau of Budget No Is.Rl201 U.S. *lOMIC ENERGY COMMISSION CURRENT OCCUPATIONAL EXTERNAL RADIATION EXPOSURE See Instrunnens on the Back 6000dflFICAT10a4 l NAAe( lPe6NT-Lees. Seer eng nse.e 2 SOClat SICuelfT NQ
- 3. Daft Or taetn saaeam, es,. yeest a Name Of LICEN$tt OCCupatioseAt tIpotutt utTMoD c'.mourfoolNG ge g, F,lm goggg-pg, pgggge 3 DCit etCototD poa(Sees.s, whee bee. 6 of one, tesy, a wwCLE SOC' DCSE Sf afv5 be=1 p
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February 8, 1984 Secretary of the Comission U. S. Nuclear Regulatory Comission Washington, D.C. 20555 ATTN: Docketing and Service Branch
Dear Sir:
The following is offered in coment on the proposed rule published in the Federal Register of Tuesday, January 10, 1984, pp. 1205-1211.
In reference to the proposed subsection 20.401(d) on page 1211, it appears that the purpose of the proposed subsection would be served if an accreditation " seal" were printed on each report page from the accredited processing laboratory.
This would save preparation, sending and filin of separate accreditation certificates.
Subsection 20.401 d) would not then be needed.
Thank you.
Yours truly, wel r.' c.+w Arvin Lovaas Health Physicist AL:rh 4
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71 Fountain Place, Frankfort, KY 40601
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00CXErliJ i Stpy,,,
yN BRANCH Secretary of the Commission
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Nuclear Regulatory Commission
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Washington, D.C.
20555 W/205)
Attn Docketing and Service Branch RE:
Eed= cal Eggigtgt, Vol. 49, No.
6, January 10, 1984.
Notice of Proposed Rulemaking - 10 CFR 20, Parts 20.202
& 20.401.
Gentlemen:
It has been recognized for many years that users of personnel dosimetry devices have had little assurance that reported dose assessments are reliable.
An attempt in the 1960's by a private concern to test and accredit personnel dosimetry suppliers failed, largely because processors declined to participate in that voluntary program.
The Conference of Radiation Control Program Directors, Inc.(CRCPD) established a
Task Force on Personnel Dosimetry in 1973 and initiated action through this task force to coordinate efforts among federal agencies to develop a
testing and accreditiation program for personnel dosimetry processors.
The proposed rule is supported by the dosimetry processing and nuclear power industries.
This position is based on the facts that personnel dosimetry performance is recognized as critical in evaluating worker protection and retrospective studies on radiation exposures, and that the rule will not impose an unreasonably burdensome requirement.
s When this rule is implemented, it will ensure participation by all dosimetry processors in the NVLAP testing and accreditation program.
The NVLAP program of g
accrediation will be self-supporting and obivates the g
J need for further federal or state funding.
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- Also, the promulgation of the final rule as proposed by the NRC will facilitate state implementation of this yp very important requirement because the rule has been new determined to be a matter of compatability for NRC Agreement States.
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In
- January, 1983, the CRCPD membership overwhelmingly voted to strongly urge the NRC to move forward with the
-final promulgation of this rule.
This CRCPD position remains unchanged.
Thank you for the opportunity to comment on this proposed rule.
Sincerely, f
Albert J.
Hazle Chairman cca Larry Lloyd (MT), Task Force Chairman Charles M.
Hardin, CRCPD Exec. Secy.
G. Wayne Kerr, OSP/NRC o
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February 9, 1984 hr[,h[.f (p.y,]615) 476 2987 BR k t.h I
Secretary of the Commission U. S. Nuclear Regulatory Commission Washington, D.C.
20555 Attention:
Docketing and Service Branch f
Dear Sir:
1, In response to the publishing in the Federal Register on January l
a!
10, 1984 of the Notice of Proposed Rulemaking regarding
}
amendments to 10 CFR Part 20 to require NRC licensees to utilize l
i the services of commercial or in-house dosimetry processors accredited by the National Bureau of Standards under the National Voluntary Laboratory Accreditation Program, I would like to enter
{
the following comments.
l I believ.e that this is a requirement that will substantially l
contribute to improved accuracy in reported radiation dose data and that the selection of Alternative 3, Option B is the proper i
i mechanism to achieve the desired goals.
It would seen desirable to change the name of the NVLAP to remove the word " voluntary",
since the use of this organizational function would no longer be voluntary.
The current wording smacks of typical governmental bureaucratic double-talk.
Based' on the premise that the principal motivation behind 4
desiring more accurate dose measurements to occupationally l
exposed workers is aimed at the control of long-term genetic r
ef fects, I can not see the need for extending the accreditation requirements to extremity dose measurements.
.If this aspect of i
personnel monitoring can be incorporated into the accreditation program with minimal impact, then it should be done.
But the Ng i
" cost / benefit" ratio for this aspect of radiation exposure j
monitoring seems to high on the cost side, with minimum benefits.
a 1
benefit to be gained by instituting this accreditation g One l
program that is not addressed in the Federal Register notice is j
t that the status of the processor and the dosimetry user in regard 1
j to legal defense against future liability claims resulting from j
g alleged overexposure health effects will be strengthened.
Much N
confusion exists today in the defense of liability claims due to the fact that real doubt exists regarding the accuracy of the 1
, f radiation dosimetr,y data upon which both the claim and the j
e defense depends for their cases.
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Your review of these comments will be appreciated.
Thank you.
Sincerely,
?fh'd Milton E. McLain, Ph.D., CHP Manager, Engineering P.O. Box 177 Buford, GA 30518 e
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