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RRAMB RD/SUBJ RMinogue Dross KGoller HAY 2 7 M Econti RAlexander Ah MEMORAND'M FOR: Harold R. Denton, Director hNeWQ J
Office of Nuclear Reactor Regulation John G. Davis, Director Office of Nuclear Materials Safety and Safeguards James M. Taylor, Director Office of Inspection and Enforcement G. Wayne Kerr, Director Office of State Programs Guy H. Cunningham, Director Office of Executive Legal Director Patricia G. Norry, Director Office of Administration FROM:
Karl R. Goller,~ Director Division of Radiation Programs and Earth Sciences, RES
SUBJECT:
FINAL AMENDMENT TO 10 CFR PART 20 TO REQUIRE THE USE OF ACCREDITED PERSONNEL DOSIMETRY PROCESSORS Please review the enclosed final rule package and provide your comments and office concurrence. The following is a summary of this request.
1.
Ti tle:
Final Amendments to 10 CFR Part 20 - Improved Personnel Dosimetry Processing.
2.
RES Task Number: OP 506-1 f.,
3.
RES Task Leader: Donald O. Nellis, extension M358 74U F 4.
Cognizant Individuals: Richard Cleveland, NRR; John Hickey, NMSS; l
John Buchanan, IE; Edgar Ashley, SP; Thomas Dorian, ELD; and q( w 0 Sarah Wigginton, ADM 5.
Requested Action:
Provide concurrence for your office.
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OFC: RE R B
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Requested Completion Date:
JUN 12 1906 7.
Background:
NRC regulations require licensees to provide personnel dosimetry under 10 CFR 20.202(a) and 10 CFR 34.33(a). Although some of the dosimeters provided require processing to obtain dose readings, NRC regulations do not require performance standards for personnel dosimetry processing.
Problems concerning the accuracy of dosimetry processing were recognized as far back as 1955 when the AEC contracted with NBS to perform an intercomparison of film badge readings.
In spite of this and several subsequent studies, a suitable performance standard for dosimetry processing did not become available until 1976.
Between 1977-79 the NRC sponsored two rounds of personnel dosimetry testing at the University of Michigan against the 1976 HPSSC draft standard. As a result of these tests, the NRC concluded that rulemaking was needed to require periodic evaluation of dosimetry processors, and on March 28, 1980, issued an Advance Notice of Proposed Rulemaking (45 FR 20493). Of the 4 alternatives proposed in the ANPRM, the majority of comment letters favored the use of a Federal Government controlled Proficiency Testing Laboratory to conduct the periodic evaluations.
A third round of proficiency testing against the revised HPSSC standard (which was subsequently published as ANSI N13.11), was completed in 1982.
On January 10, 1983 the NRC published a Notice of Proposed Rulemaking (49 FR 1205) that would require NRC licensees to use the services of personnel dosimetry processors that had been accredited under the National Voluntary Laboratory Accreditation Program of the National Bureau of Standards.
As a result of the public comments the final rule has been changed to delete the requirement for a licensee to maintain a record of the accreditation certificate of its processor.
In other respects the final rule is unchanged except for those changes made to clarify the intent of the rule.
Karl R. Goller, Director Division of Radiation Programs and Earth Sciences, RES
Enclosures:
(List Attached) 0FC: RES:RRAMB
- RES:RRAMB :RES:RRAMB :RES:DRPES :RES:DRPES :
NAME:DNellis
- ABrodsky
- RAlexander :EConti
- KGoller DATE: 4/,/86
- 4/ /86
- 4/ /86
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-: 4/ /86-1
. 1.
Memo, Minogue to Stello 2.
Commission Paper with
Enclosures:
A.
Federal Register Notice B.
Regulatory Analysis C.
Analysis of Comments D.
Final Regulatory Flexibility Analysis E.
Backfit Analysis F.
Congressional Letter G.
Public Announcement l
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OFC: RES:RRAMB
- RES:RRAM8 :RES:RRAMB :RES:DRPES :RES:DRPES ~:
NAME:DNellis
- ABrodsky
- RAlexander :Econti
- KGoller DATE: 4/.'/86
- 4/ /86
- 4/ /86- : 4/ ' /86
- 4/ '/86 i
/
UNITED STATES
["
g NUCLEAR REGULATORY COMMISSION g
WASH WGTON, D. C. 20555
- ( *...,/
MEMORANDUM FOR: Victor Stello, Jr.
Executive Director for Operations FROM:
Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
FINAL AMENDMENT OF 10 CFR PART 20 TO REQUIRE THE USE OF ACCREDITED PERSONNEL 00SIMETRY PROCESSORS Attached for your signature is a Commission Paper with enclosures amending 10 CFR Part 20 to require NRC licensees to use the services of accredited personnel dosimetry processors.
NRC regulations require licensees to provide personnel monitoring under 10 CFR 20.202(a) and 10 CFR 34.33(a). Although some of the monitoring provided consists of dosimeters which require processing to obtain dose readings, the iegulations do not require performance standards for personnel dosimetry processors.
In spite of the identification of problems with such dosimetry processing as early as 1955, it was not until 1976 that a suitable perfonnance standard became available.
Between 1977-1979, the NRC sponsored two rounds of personnel dosimetry testing against the 1976 draft standard and another test against the revised standard in 1982. The results of these tests indicated a significant percentage of processors were performing with a degree of accuracy unacceptable to the NRC.
While many of those tested exceeded the tolerance limit of the standard by factors of 2 to 4, a few exceeded the tolerance limit by factors as high as 3000. At the same time, the percentage of the test categories passed increased from 48% in pilot test 1 to 75% in pilot test 3, indicating that processors were capable of considerable improvement in their procedures.
In view of these results the NRC concluded that rulemaking was needed to require periodic evaluation of personnel dosimetry processors. An Advance Notice of Proposed Rulemaking was published on March 28, 1980, (45 FR 20493),
and a Notice of Proposed Rulemaking on January 10, 1983, (49 FR 1205). The ANPRM listed 4 alternatives to the selection of a Proficiency Testing Laboratory and the NPRM proposed requiring NRC licensees to use the services of processors who had been accredited under the National Voluntary Laboratory i
Accreditation Program of the National Bureau of Standards.
l l
2 Public comments on the ANPRM were in favor of a Federal Government controlled proficiency testing laboratory. The majority of public comments on the NPRM were favorable, with most of the unfavorable comments directed against the costs to small processors and medical and hospital licensees. As a result of public comments, the requirement for licensees to maintain copies of their processor's accreditation certificate has been deleted from the final rule.
Although the final rule is expected to have a significant impact on about 10 small processors, the benefits to workers, licensees, and the general public render it necessary.
To date over 50 processors have voluntarily applied for accreditation under NVLAP and 38 of these have already been accredited.
Failure to promulgate this rule could result in these processors dropping out of NVLAP in order to compete economically with less qualified processors.
The NVLAP is self supported from fees paid by the processors and will require less than 0.5 person-years / year of NRC staff time to oversee the program.
The Offices of Nuclear Reactor Regulation, Nuclear Materials Safety and Safeguards, Inspection and Enforcement, State Programs, Executive Legal Director and Administration concur in these amendments to 10 CFR Part 20.
Robert B. Minogue, Director Office of Nuclear Regulatory Research
- - ~.
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For:
The Commissioners From:
Victor Stello, Jr.
Executive Director for Operations
Subject:
AMEN 0MENTS TO 10 CFR PART 20 TO REQUIRE THE USE OF ACCREDITED PERSONNEL DOSIMETRY PROCESSORS
Purpose:
To obtain Commission approval of a notice of final rulemaking.
q Category:
This paper covers a minor policy question.
Issue:
Whether to require NRC licensees to use an accredited processor to process personnel dosimeters which are utilized by NRC licensees to comply with certain NRC regulations.
Background:
NRC licensees are required to provide personnel monitoring equip-ment to certain individuals as specified in 10 CFR 20.202(a) and 10 CFR 34.33(a), and to maintain the individuals' radiation exposure records as specified in 10 CFR 20.401(a) and 10 CFR 34.33(e).
Among the various types of monitoring equipment in use are dosimeters such as film badges, track-etch type dosimeters and thermoluminescent dosimeters (TLDs), all of which require pro-cessing in order to determine the radiation dose to an individual 4
Contact:
D:nald O. Nellis, RES 427-4588 i
s
,_,y
The Commissioners 2
by observing a particular radiation induced effect in the dosimeter.
AlthoJgh the processing of these dosimeters must be done accur-ately and consistently to provide acceptable dose values, NRC regulations have not to this time required performance standards for dosimetry processing, despite the fact that the accuracy of the doses reported from these dosimeters is directly related to the ability of licensees to conform to the NRC regulatory requirements.
Problems with dosimetry processing were recognized a's early as 1955 when the Atomic Energy Commission contracted with the National Bureau of Standards (NBS) to conduct an intercomparison of film badge interpretations.
Despite the early recognition and-identification of problems from this and subsequent studies, it was not until 1976 that the Health Physics Society Standards Committee (HPSSC) recommended a suitable performance standard for personnel dosimetry processing.
Between 1977-1979 the NRC sponsored two rounds of proficiency testing of processors against this standard at the University of Michigan.
The results of these tests indicated that a significant percentage of the pro-cessors were not performing at a level of accuracy acceptable to the NRC.
Most of those who failed to pass the tests exceeded the tolerance limit (or criterion) by factors of 2 to 4, indicating that minor adjustments in procedures were needed.
For some pro-cessors however, this factor was as high as 3,000, indicating that major changes in procedures or facilities or both were required.
As a result of these tests, the NRC concluded that rulemaking was needed to require periodic evaluation of personnel dosimetry processors, and on March 28, 1980 issued an Advance Notice of Proposed Rulemaking (ANPRM) (45 FR 20493).
The ANPRM presented four alternatives for the operation of a proficiency testing laboratory.
During the comment period, in which 46 comment letters were received with the majority stating a preference for a Federal Government controlled laboratory, a fifth alternative
The Commissioners 3
for the operation of a proficiency testing laboratory was identified.
This alternative would utilize the National Voluntary Laboratory Accreditation Program (NVLAP) operated by the National Bureau of Standards (NBS).
Several of the comment letters also requested a third round of performance testing against the HPSSC standard which had been revised following the first two rounds of testing.
As a result of these comments, in 1980 the NRC asked NBS to estab-lish an accreditation program under NVLAP for person"el dosimetry n
processors and also, in 1981, authorized a third round of perfor-mance testing against the revised HPSSC standard by the University of Michigan. The third round of performance testing was completed in 1982 and analysis of the results indicated that, although 25%
of the radiation category-tests attempted were failed, 78% of the individual dosimeters readings were within 130% of the true dose delivered to the dosimeters.
This compared to 62% for test 1 and 73% for test 2, indicating that personnel dosimetry processors were capable of considerable improvement.
In light of these results, on January 10, 1983, the NRC published a Notice of Pro-posed Rulemaking (NPRM) (49 FR 1205) that would require NRC licensees to utilize the services of processors that had been ac-credited under the NVLAP of the National Bureau of Standards.
Also included in this NPRM was a notice concerning the availabil-ity of dosimetry accreditation through NVLAP starting in January 1984.
NVLAP has analyzed the results of the first 1-1/2 years operation of that program and found that 90% of the individual dosimeter readings were within 130% of the true dose delivered to the dosimeters.
Since the number of dosimeters in the three pilot tests and in the NVLAP operation for the first 1-1/2 years was essentially the same, the improvement in the results indicates the importance and worth of the accreditation program.
Also, the NVLAP analysis can often detect the source of processor errors, and this information is promptly relayed to the
4 The Commissioners 4
processor.
In addition the analysis indicated all processors should be able to meet a standard deviation of less than 20% for the 15 dosimeters required for each radiation category.
The NRC received 97 public comment letters in response to the NPRM, most of which were favorable.
The major objections to the rule were the costs to small processors and medical and hospital licensees.
An analysis of comments has been prepared and may be found in Enclosure C to this paper.
In early 1984, the American Nuclear Insurers issued a bulletin to their nuclear utility policy holders recommending that they or their commercial dosimetry processors participate in the NVLAP program.
At this time, 54 processors out of the 90 known have voluntarily applied for accreditation under NVLAP, and 45 of these are already accredited.
The staff is concerned that unless the present rule is approved in the near future, these processors may be forced to drop out of the program in order to compete with the less qualified processors which have not yet applied for accreditation.
The program is self-supporting from fees paid by the processors and it will have little effect on staff resources (less than 0.5 person years per year).
RQcommendation:
That the Commission:
1.
Approve publication in the Federal Register of the final amendments to Part 20 (Enclosure A) that are scheduled to become effective 1 year after publication in the Federal Register.
2.
Approve the staff's conclusions set forth in the Final Regulatory Flexibility Analysis (Enclosure D) that the benefits to the public health and safety that would result from the proposed accreditation programs are necessary in
The Commissioners 5
spite of the program's possible economic impact upon small entities.
3.
Approve the staff's conclusions set forth in the Backfit Analysis (Enclosure E) which provides the analysis called for by the Backfit Rule of Part 50 of NRC's regulations.
4.
Note that:
With respect to the Agreement States, this' item will be a.
made a matter of compatibility because it concerns basic radiation standards.
b.
The appropriate Congressional committees will be informed.
c.
A public announcement such as Enclosure G will be issued when the Federal Register notice is filed with the Office of the Federal Register.
d.
Copies of the Final Rule 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.
e.
This final rule does not contain a new or amended infor-mation collection requirement subject to the Paperwork i
Reduction Act of 1980 (44 U.S.C. 3501 et seq.).
Exist-ing requirements were approved by the Office of j
Management and Budget approval number 3150-0014.
f.
The NRC has determined that this final rule is the type of action described in categorical exclusion 10 CFR 51.22(c)(3).
Therefore, neither an environmental
The Commissioners 6
impact statement nor an environneental assessment has been prepared for the final rule.
g.
The Chief Counsel for Advocacy of the Small Business Administration will be informed of the accreditation program and the reason for it, as required by Section 605(b) of the Regulatory Flexibility Act.
Victor Stello, Jr.
Executive Director for Operations
Enclosures:
A.
Federal Register Notice B.
Regulatory Analysis C.
Analysis of Comments D.
Final Regulatory Flexibility Analysis E.
Backfit Analysis F.
Congressional Letter-G.
Public Announcement
,a.
[7590-01]
NUCLEAR REGULATORY COMMISSION 10 CFR Part 20 Improved Personnel Dosimetry Processing AGENCY:
Nuclear Regulatory Commission.
ACTION:
Final rule.
SUMMARY
The Nuclear Regulatory Commission (NRC) is amending its regula-tions to require all licensees, that are obligated by regulations to pro-vide personnel dosimetry devices to their workers, to have these devices processed by those processors which have been accredited by the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Bureau of Standards (NBS).
This action was initiated because performance evalu-ations of dosimetry processors indicated that a significant percentage of personnel dosimetry processors were not performing with a reasonable degree of accuracy.
These amendments would result in greater uniformity and accuracy in personnel dosimetry processing for all affected licensees.
EFFECTIVE DATE:
FOR FURTHER INFORMATION CONTACT:
Donald O. Nellis, Division of Radiation Programs and Earth Sciences, Office of Nuclear Regulatory Research, U.S.
Nuclear Regulatory Commission, Washington, DC 20555, Telephone:
(301) 427-4588.
Inquiries regarding the accreditation program for personnel 1
Enclosure A
[7590-01]
dosimeters at the National Bureau of Standards should be addressed to Robert L. Gladhill, National Voluntary Laboratory Accreditation Program (NVLAP), National Bureau of Standards, Administration A-531, Gaithers-burg, MD 20899, telephone:
(301)921-3431.
SUPPLEMENTARY INFORMATION:
I.
BACKGROUND Personnel dosimeters are devices worn by workers to monitor their exposure to radiation.
NRC licensees are required to provide such moni-toring devices to certain individuals as specified in 10 CFR 20.202(a) and 10 CFR 34.33(a).
Several types of personnel monitoring devices are available:
1.
Personnel dosimeters designed to monitor the exposure to the whole body or to the skin.
These include film badges, including track-etch type dosimeters, and thermoluminescent dosimeters (TLDs), including albedo dosimeters.
2.
Personnel dosimeters designed to monitor the exposure to the hands and forearms, feet and ankles.
These are sometimes referred to as extremity dosimeters.
3.
Pocket ionization chambers, both direct reading and indirect reading, which are normally used as whole body monitors.
All of the dosimeter types mentioned, with the exception of pocket ionization chambers, require processing to determine the radiation dose received.
These dosimeters must be processed accurately and consistently and interpreted correctly for two key reasons:
first, to obtain adequate 2
Enclosure A
(7590-01]
dose estimates and records; and second, to maintain the integrity of the NRC regulatory program, since data from the processing of personnel dost-meters form the basis for establishing conformance with NRC's regulatory requirements. Thus, it is imperative that performance standards be imposed on the personnel dosimetry processing industry.
Dosimetry Processor Performance Studies Problems in the personnel dosimetry processing industry have been i
apparent for many years.
The commercial processing business.is highly competitive with competent and conscientious processors competing with processors which may be unable or unwilling to perform this work in a technically sound manner.
Customers of commercial processors often lack expertise in dosimetry processing and often contract their processing needs to the lowest bidder, with the likely result that the more quali-fied processors may be forced to reduce the quality of their services in order to remain competitive.
Some of the problems became apparent shortly after the Atomic Energy Act of 1954 authorized the commercial application of nuclear technology, when the first intercomparison of film badge interpretations was conducted by NBS in 1955 under an Atomic Energy Commission (AEC) contract.
In 1963 the AEC published a notice in the Federal Register (28 FR 9411) outlining the need for a Film Dosimetry Calibration Laboratory and provided some interim film dosimetry performance criteria.
Subsequently, several studies attempted to evaluate processor performance but no method of comparing actual performance with the interim performance criteria was ever estab-lished.
Consequently, in 1967 the AEC requested that Battelle Northwest 3
Enclosure A
[7590-01]
Laboratory, now called Pacific Northwest Laboratory, conduct a study to determine a basis for film dosimeter performance criteria.1 Although the study revealed that about 85% of the participating pro-cessors had excessive bias and variance, and although the study defined certain performance criteria, no definite standard was promulgated at that time.
During the next few years, four separate standards were devel-oped and in 1976 the NRC contracted with Battelle to conduct a study to compare and evaluate dosimetry processors against the four existing stand-ards.2 Although most dosimetry processors did not fare well against any of the standards, the study recommended adoption of the draft standard being developed by the Health Physics Society Standards Committee (HPSSC).
(This standard was published as a draft in 1978.)
In 1976, at the urging of the Conference of Radiation Control Pro-gram Directors (CRCPD) (representing the States), the NRC, Bureau of Radiological Health and Energy Research and Development Agency jointly conducted a public meeting to discuss personnel dosimetry problems.
As a result of the recommendations made at this meeting, the NRC contracted with the University of Michigan to conduct two rounds (1977-1979) of pro-ficiency testing of dosimetry processors against the draft HPSSC standard.
Fifty-nine personnel dosimetry processors voluntarily participated in these tests.
Results of the tests showed that the standard had to be modified.
(It was modified in June 1981 and was published as ANSI N13.11 in 1983.) The results also showed that a significant percentage of the 1C. M. Unruh et al., "The Establishment and Utilization of Film Dosim-eter Performance Criteria," BNWL-542(1967) Richland, Washington, 99352, 2L. L. Nichols, "A Test of the Performance of Personnel Dosimeters,"
BNWL-2159(1977) Battelle Northwest Laboratories, Richland, Washington, 99352 4
Enclosure A
[7590-01]
processors were not performing to the degree of accuracy acceptable to the NRC, which indicated, in turn, that their records and reports of worker whole body and skin dose could be considerably different from the actual dose received.
Since some specific degree of accuracy is necessary to provide inte-grity to worker dose records, it became apparent to the NRC that the performance and competency of dosimetry processors had to be evaluated on a periodic basis and that rulemaking was needed to provide this periodic evaluation.
Coordination Effort Cooperation and coordination with other interested organizations were initiated in 1977 with the formation of the Interagency Policy Committee on Personnel Dosimetry that includes the Department of Defense, the De-partment of Energy, the Environmental Protection Agency, the NBS, the Occupational Safety and Health Administration which is part of the De-partment of Labor, the Center for Devices and Radiological Health of the Food and Drug Administration which is part of the Department of Health and Human Services, the CRCPD, and the NRC.
Representatives of these agencies have already adopted or are in the process of adopting similar dosimetry evaluation programs.
Cooperation and coordination with the dosimetry processing industry were also initiated in 1977 with the formation of the Industry Overview Committee on Personnel Dosimetry to monitor the progress and development of the evaluation program, and to ensure that any regulatory action taken would be appropriate and effective.
5 Enclosure A
[7590-01]
Advance Notice of Proposed Rulemaking On March 28, 1980, the NRC took the initial step in the rulemaking process with the publication in the Federal Register of an Advance Notice of Proposed Rulemaking (45 FR 2049?).
The Advance Notice fully discussed the results of the proficiency testing against the HPSSC standard and the need for rulemaking to improve dosimetry processing.
It also presented four alternatives for the operation cf a proficiency testing laboratory that would conduct performance testing against the HPSSC standard, and requested comments on the four procedures.
It also specified that any proficiency testing laboratory established according to one of the four procedures would be monitored for technical competency by the NBS, and that licensees would be required to use dosimetry services which satisfied criteria established by NRC and administered by the proficiency testing laboratory.
The four alternatives for proficiency testing labor-atory operations as described in the Advance Notice were:
1.
NRC would not specify a proficiency testing laboratory; proces-sors and licensees would independently establish one or more laboratories to administer proficiency testing against the HPSSC standard.
2.
The proficiency testing laboratory would be a Federal Government facility managed and operated by the NRC.
3.
The NRC would contract the services of a proficiency testing laboratory and use the contractor's facilities.
4.
Other Government agencies experienced in laboratory testing would operate a proficiency testing laboratory in Federal Government-owned facilities.
6 Enclosure A
[7590-01]
Analysis of Comment Letters Forty-six comment letters were received in response to the Advance Notice.
Twenty-one did not state a preference for a procedure to operate the proficiency testing laboratory, three felt no proficiency testing program was necessary and, of the remaining 22, 20 expressed a preference for one of the Federal government-controlled laboratories (procedures 2, 3, or 4).
Commenters also inquired and commented upon control of the testing laboratory, on procedures to be used in the regulatory program, and on various other problems that could result from a processor failing to satisfy the established criteria.
Several discussed the importance of defining and requiring minimum elements of a generic quality assurance program that should be established as part of the dosimetry processing performance criteria.
The major technical questions raised were those concerning the selection of dose conversion factors within the standard.
Several of the dosimetry processors which commented also requested a third round of performance testing to allow processors to be tested against the revised HPSSC standard before any rulemaking on dosimetry processing became effective.
. / LAP Method f
During the comment period for the Advance Notice, a fifth procedure for the operation of a proficiency testing laboratory was identified by the Interagency Policy Committee which would utilize the NVLAP of the NBS.
Under this procedurt, the NBS through NVLAP would contract the ser-vices of a proficiency testing laboratory to administer proficiency test-ing of processors under currently existing NVLAP procedures.
NVLAP ac-7 Enclosure A
r
[7590-01T creditation would require three separate actions:
(1) completion of NVLAP's questionnaire and application materials which involve documenta-tion of responsible
- personnel, equipment, facilities and quality control procedures; (2) successful performance in proficiency testing of dosi-meters in accordance with ANSI N13.11, " Criteria for Testing Personnel Dosimetry Performance"; and (3) on-site inspection by NVLAP assessors of the processor's routine dosimetry service with respect to processing pro-tocols and associated minimum quality assurance criteria specified in NVLAP general and specific criteria and supplied to the processor upon application for the program.
NVLAP would thus offer a system of third-party accreditation by a Federal Government agency, namely, the Depart-ment of Commerce, operating through the NBS.
In December 1980, the NRC asked the Department of Commerce to estab-lish, in coordination with NRC staff, an accreditation program under NVLAP for personnel dosimetry processors.
On January 29, 1981, in accord-ance with NVLAP procedures and authority (15 CFR Part 7), the Department of Commerce published NRC's request (46 FR 9689) for development of such a Laboratory Ac'creditation Program (LAP) and requested public comment.
NRC sent a copy of the Department of Commerce Federal Register Notice and a description of the NVLAP to all known dosimetry processors and inter-ested persons on February 6, 1981.
Nineteen letters of comment were re-ceived which were unanimous in their approval of the NVLAP for desimetry processing.
Consequeatly the NVLAP was started in 1981 under an Inter-agency Agreement between NRC and NBS, and a proficiency te.cting labora-l tory was contracted for by the NBS.
Proficiency testing and NVLAP i
accreditation of processors began in January 1984.
8 Enclosure A
f,
[7590-01]
Additional Performance Testing Since the original HPSSC standard was significantly revised follow-ing the two pilot tests, the NRC staff authorized a third round of per-formance testing against ANSI N13.11 which was completed in 1982.8 Seventy personnel dosimetry processors voluntarily participated in the third round of performance testing and of the category-tests attempted an average of 25% failed.
Thiscomparesto[failureratesof52%forthe first test and 38% for the second as measured against the final standard.
The standard provides a total of eight radiation categories involving high and low energy photons, beta particles, neutrens, and mixtures of these.
The accuracy of the irradiations performed by the testing labora-tory was verified by the NBS for all radiation categories. in addition, the' testing laboratory maintains the confiaentiality of all pilot studies.
These results are coded so that the participating processors' names and results remain anonymous even to the NRC.
The procedure for all pilot tests was for the processor to send 15 dosimeters in each test category to the testing laboratory.
These dosim-eters then were irradiated with doses known only to the testing labora-tory and returned to the processor.
NBS had the responsibility of ver-ifying the accuracy of the irradiations performed by the testing labora-tory.
The processor then determined the dose for each dosimeter and reported the results back to the testing laboratory for evaluation against the standard.
The processor's performance was evaluated in accordance with the performance criterion specified in ANSI N13.11.
For a given category, 3 Plato, P. and J. Miklos, " Performance Testing of Personnel Dosimetry Services:
Final Report of Test #3," NUREG/CR 2891, February 1983.
9 Enclosure A
[7590-01]
performance was considered to be adequate if the specified tolerance level L was not exceeded for that category.
The spacified tolerance levels were L = 0.3 for accident categories and L = 0.5 for protection categories.
The tolerance level L consists of the sum of the absolute value of the average performance quotient P and the standard deviation of the performance quotient, that is:
lPl + S $ L The average performance quotient, P was determined frcm the ' individual values of the performance quotients, P, for the 15 dosimeters that were 4
irradiated for a particular test category:
15 I
1:1 I H'l H '.
P
~
p=
and P =
15 H
g 9
where:
Hg = dose equivalent applied to the test dosimeter by the testing laboratory.
Hj=correspondingdoseequivalentreportedbytheprocessor.
(Dose equivalent is the product of the absorbed dose and appropriate modifying factors).
The standard deviation, S, was determined from:
15 1
i=1 (Pi P)2 3,
14 10 Enclosure A
[7590-01]
Small values of P indicated that the average difference between the dose equivalent applied to the dosimeter and that reported by the pro-cessor was small.
Large values of P indicated the presence of a bias in the processor's reported dose.
Also, since the standard deviation, S, is a measure of the spread in the values of the performance quotients, P,
9 for individual dosimeters, a large value of S indicated inconsistency in the processing procedure.
Although the identity and individual results of the dosimeter test data were confidential to the proficiency testing laboratory., the con-tractor reported that the categories failed in this third round of test-ing were evenly distributed among large and small commercial and in-house processors.
In light of the results from the three pilot tests, the NRC considered that improvement on the part of most dosimetry processors was needed and that the regulations should be amended not only to provide for periodic evaluation but also to include competency requirements to im-prove the quality of personnel dosimetry processing.
II.
REGULATORY APPROACHES CONSIDERED The Commission recognized that any performance testing program can test only the ability of a processor to meet the criteria of a standard at a given point in time.
The performance testing program by itself does not determine whether the processor, in providing routine dosimetry pro-cessing to its clients actually treats the clients' dosimeters with the same care and attention provided to those dosimeters received from the proficiency testing laboratory.
It became apparent, therefore, that 11 Enclosure A
[7590-01]
there was a need to supplement the performance testing program with checks of a processor's quality assurance program.
The Commission considered five regulatory alternatives to ensure improved personnel dosimetry processing, ranking them from the least to the most restrictive.
Alternative 1:
No change in current requirements.
Alternative 2:
Require licensees to have their personnel dosimetry processing performed by a processor which had successfully participated in dosimetry performance testing administered in accordance with ANSI N13.11 and which had a documented quality assurance (QA) program whose elements would be specified in NRC regulations.
NRC would not specify the proficiency testing laboratory in this alternative.
Alternative 3:
Require licensees to have their personnel dosimetry processing performed by a processor which had successfully participated in dosimetry performance testing administered in accordance with ANSI N13.11 by an NRC-specified proficiency testing laboratory and which had a documented QA program whose elements would be specified in NRC regula-tions.
This alternative differs from the previous alternative in that the NRC would specify the proficiency testing laboratory.
This alterna-tive could be accomplished by either of the following options.
Option A:
NRC licensees would be required to utilize the services of a processor which had successfully participated in performance testing at a proficiency testing laboratory that had been contracted by the NRC.
NRC inspectors would examine written proof that the processor had partici-pated in the program and would ensure that the processor maintained a QA
)
program as specified in NRC regulations.
12 Enclosure A
[7590-01]
Option B:
NRC licensees would be required to utilize the services of a processor which had been accredited under the NVLAP of the NBS.
This program would involve:
(a) Performance testing in accordance with ANSI N13.11; (b) Information collected by questionnaire; and (c) Onsite inspection of routine dosimetry processing and QA tech-niques by NVLAP contracted assessors.
Alternative 4:
NRC would request from the Congress the authority to license personnel dosimetry processors directly since many of these processors are not NRC licensees.
Alternative 5:
NRC would change the regulations to require that licensees obtain their personnel dosimetry services from an NRC operated or an NRC-contracted dosimetry service.
(An analysis of each of these five alternatives is included in the Regulatory Analysis which is available for inspection and copying for a fee at the NRC Public Document Room, located at 1717 H Street, NW., Wash-ington, DC.)
The outcome of this analysis was that Alternative 3B appeared to the staff to be the best option and they proposed that it be adopted.
This option would establish common testing and quality assurance procedures on personnel dosimetry processing performance and provide NRC inspection personnel with a much needed benchmark against which to enforce existing regulatory requirements on personnel monitoring.
It also would provide a measure of credibility to the dosimetry processing industry through the use of standard procedures and oversight by NBS, the nationally recog-nized standards authority.
Finally, the quality and accuracy of person-nel dosimetry records would increase, partly as a result of periodic 13 Enclosure A
[7590-01]
retesting requirements and partly as a result of the elimination of incompetent dosimetry processors.
Alternative 1 was rejected outright because the pilot tests indi-cated a significant percentage of processors exhibited an unacceptable level of accuracy.
NRC wants to assure that it and its licensees focus on the same level of accuracy.
Therefore, neasurements taken to insure this level of accuracy must meet certain accepted standards so that NRC's licensees know that they are complying with its regulations and that NRC treats them equitably in its regulatory program, i.e., inspection and enforcement decisions.
The remaining alternatives were rejected primar-ily because of the need for additional Federal funds and NRC staff commitments which are not available.
On January 10, 1983 the NRC published a Notice of Proposed Rulemak-ing (49 FR 1205), which would require NRC licensees to use the services of processors that have been accredited by the NVLAP of the NBS.
III.
SUMMARY
OF PUBLIC COMMENTS The NRC received a total of 97 letters of comment on the proposed rule, two of which were duplicates, one of which was a forgery, and one (a comment letter on a different rule) was included by error, leaving a net of 93 letters, some of which contained more than one comment.
4 All of the public comments have been examined, and the staff res-ponses to these comments have been included in the Analysis of Comments document which is available for review and copying for a fee at the NRC Public Document Room located at 1717 H Street, NW., Washington, DC.
14 Enclosure A
[7590-01]
Of the 93 letters, 40 approved of the proposed rule outright, an-other 20 approved of the rule but also included suggested additions and another 6 approved of that part of the rule requiring accreditation of processors but were opposed to that section requiring them to preserve NVLAP certification records.
(The final rule has been changed in res-ponse to these comments in that the section requiring the preservation of 1
records of NVLAP accreditation has been deleted.)
Nineteen comment letters were opposed to the proposed rule, primar-ily because of the cost, and another 8 comment letters provided miscellan-eous comments on the rule.
The major comment in opposition to the rule came from medical and hospital licensees and appears to be the result of a misunderstanding.
These licensees stated that the imposition of the accreditation requirement would force them, on the basis of cost, to terminate their in-house monitoring services which now provide supplemen-tary or redundant dosimeters to personnel presently using the services of a commercial processor and additional monitoring to persons not required to have such monitoring under 10 CFR 20.202(a).
Other commenters said that a differential fee structure was needed to provide relief to small processors; that the on-site assessment should be waived for small pro-cessors as a means of reducing costs; that the proposed Section 20.202(c)(2) should be clarified by issuance of a Regulatory Guide to assist licensees to determine in which radiation categories they should be accredited; and'that this same section could be interpreted to mean that the accreditation process is equivalent to approval of dosimeters for use in work environments in which people are monitored.
Before responding to the comments, a statement of NRC's overall posi-tion with respect to the rule is in order.
The purpose of the personnel 15 Enclosure A i
[7590-01]
dosimetry accreditation program is to detect and eliminate, wherever pos-sible, those sources of variability which are under the control of thi dosimetry processor.
In sum, the principal health and safety benefit that results from imposition of this rule is the increased credibility of the recorded and reported occupational dose, allowing both the employer and employee to better assess and control the radiation hazards of the workplace.
An additional benefit may well be a reduction in litigation, due to the enhanced injury claim defensibility because of reduced uncertainty and increased objectivity of the new dosimetry proce-dures.
The use of third party accreditation by NBS through its NVLAP progrcm assures that all processors will be evaluated by standard proce-dures against a common standard, thereby providing overall credibility to the personnel dosimetry processing industry.
Accreditation in the test-ing program under appropriate categories, as emphasized in the proposed new $ 20.202(c)(2), does not in itself assure that the processor applies the same care and attention to routine dosimetry processing as it does to test dosimeters.
The onsite visits conducted by NVLAP assessors are not only a part of the mechanism for detecting sources of variability under the control of the processor; they also serve to check on the quality assurance program of the processor as it applies to routine dosimetry and assure that equivalent care is given both to routine dosimetry processing and to test dosimetry processing.
It is for these reasons that the onsite visits cannot be waived for the small or in-house processors.
Turning to the major comment from medical and hospital licensees, it is not the intent of the NRC to discourage voluntary dosimetry or supple-mentary or redundant dosimetry that is a backup to the required dosimetry.
Those licensees which perform an evaluation to determine the personnel who 16 Enclosure A
9
[7590-01]
i'p-I must-be monitored under 10 CFR 20.202(a) or other relevant NRC regulations will be required to use the services of an accredited processor to process the required personnel dosimeters.
NRC will not require the services of
- an accredited personnel dosimetry processor for any redundant or supple-mentary dosimeters supplied to these same personnel, or for any additional t
dosimeters voluntarily supplied to other personnel not required to have such monitoring.
Those licensees which are unwilling or unable to perform an evaluation to determine which personnel require personnel monitoring I
will be required to use an accredited personnel dosimetry processor for all dosimeters issued.
Likewise, a licensee which chooses to issue dosi-meters in order to establish that its personnel do not exceed the regu-latory requirements will be required to use the services of an accredited personnel dosimetry processor.
If, however, licensees choose to meet the requirements of 10 CFR 20.202(a) through the use of other methods, such i
as surveys and time and motion studies or by the use of pocket dosimeters l
or pocket chambers that do not require processing, then the requirements of this rule do not apply.
Those licensees which have a license commitment j
to provide personnel dosimetry to personnel who do not require it under 1
l 10 CFR 20.202(a) or other applicable regulations, should apply for a license amendment to remove such personnel from the license requirement r
j before the effective date of the rule.
Nothing in this procedure precludes the licensee from providing voluntary dosimetry which will not require i
accredited processing to such personnel.
After the effective date of the rule, all personnel named in license applications who are required to be provided personnel monitoring will be required by license conditions to have their personnel dosimeters processed by an accredited personnel i
dosimetry processor.
I 17 Enclosure A i-
[7590-01]
Finally, with respect to the requested clarification of 9 20.202(c)(2) to assist licensees determine appropriate radiation categories, it should be pointed out that it has always been the responsibility of the licensee to provide appropriate and properly calibrated monitoring devices to its workers.
The rule to require NVLAP accreditation does not alter this responsibility.
It view of the comments received, however, the NRC plans to issue a Regulatory Guide to help licensees to determine appropriate testing categories for their specific operations.
While it is recognized that even the minimum costs imposed by the program can seriously affect small processing programs, legal rulings prohibit the application of differential fee structures based on the size of the processor.4 Those processors negatively affected by the imposition of this rule should be aware that grants are available from the Small Business Administration to assist small businesses to meet Federally imposed licensing fees. Also, those licensees which demonstrate that they should be exempted from the requirements of this rule may apply for an exemption in accordance with 10 CFR 20.501.
A number of NRC licensees also expressed the concern, that should their personnel dosimetry processor suddenly lose accreditation, they would be in noncompliance with the regulations.
NRC believes, however, that only a few, if any, dosimetry processors may lose their accredita-tion. This would not occur suddenly.
NVLAP accreditation is given for a two year period and retesting and renewal occur periodically, so that a processor would have ample warning that it is not meeting accreditation
- Two key cases National Cable Television Association v. United States, 415 U.S. 336 (1974) and Federal Power Commission v. New England Power Co., 415 U.S. 345 (1974) are discussed in the following FR notices:
(43 FR 7210, 46 FR 49573 and 49 FR 21293).
18 Enclosure A
[7590-01]
criteria.
NRC believes it may be prudent for its licensees to negotiate agreements with their processors in which they require their processors to inform them if and when the processors run into problems with NVLAP.
The NVLAP testing and accreditation program has been in operation for over two years, and on the basis of this operating experience it has been found that a minimum of about six months is required for processors to receive accreditation.
Since some processors fail the first round of testing, an additional three months is generally necessary.
On the basis of this time frame, the Commission has determined that an effective date of one year after publication is an adequate time period to require imple-mentation of the rule.
ENVIRONMENTAL IMPACT:
CATEGORICAL EXCLUSION The NRC has determined that this final rule is the type of action described in categorical exclusion 10 CFR 51.22(c)(3).
Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this final rule.
PAPERWORK REDUCTION ACT STATEMENT This final rule does not contain a new or amended information col-lection requirement subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501, et seq.).
Existing requirements were approved by the Office of Management and Budget approval number 3150-0014.
19 Enclosure A
[7590-01]
REGULATORY ANALYSIS The Commission has prepared a regulatory analysis on this final rule..The analysis examines the costs and benefits of the alternatives considered by the Commission.
The analysis is available for inspection and copying for a fee at the NRC Public Document Room, 1717 H Street NW.,
Washington, DC.
Single copies of the analysis may be obtained from Donald O. Nellis, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Mail Stop 1130-SS, Washington, DC 20555, Tele-phone:
(301) 427-4588.
FINAL REGULATORY FLEXIBILITY ANALYSIS The NRC has prepared a final regulatory flexibility analysis on the impact of this rule on small entities as required by Section 604 of the Regulatory Flexibility Act.
The analysis indicates that although the final rule has an economic impact of $7,000 initially, and from $3,400 to
$8,400 annually on 90 personnel dosimetry processors of which 10, or 11%,
are small er. cities, the selected alternative is the least costly altern-ative that provides adequate dosimetry processing for licensees and work-ers. A copy of the final regulatory flexibility analysis is available for inspection and copying for a fee in the NRC Public Document Room, 1717 H Street NW., Washington, DC.
Single copies may be obtained from Donald O. Nellis, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Mail Stop 1130-SS, Washington, DC 20555, Tele-phone:
(301)427-4588.
20 Enclosure A
[7590-01]
BACKFIT ANALYSIS As required by 10 CFR 50.109 (50 FR 38097), the Commission has com-pleted a backfit analysis for the final rule.
The Commission has deter-mined, based on this analysis, that backfitting to comply with the requirements of this final rule is justified.
The backfit analysis is available for inspection and copying for a fee at the NRC Public Document Room located at 1717 H Street NW., Washington, DC.
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 and recordkeeping requirements, Special nuclear material, Source material, Waste treatment and disposal.
For reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended,-and 5 U.S.C. 553, the NRC is adopting 'the following amendments to 10 CFR Part 20.
PART 20 - STANDARDS FOR PROTECTION AGAINST RADIATION 1.
The authority citation for Part 20 is revised 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, 21 Enclosure A
[7590-01]
2201); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246, (42 U.S.C. 5841, 5842, 5846).
For the purposes of sec. 223, 68 Stat. 958, as amended, (42 U.S.C.
2273), SS 20.101, 20.102, 20.103(a), (b), and (f), 20.104(a) and (b),
20.105(b), 20.106(a), 20.201, 20.202(a), 20.205, 20.207, 20.301, 20.303, 20.304, and 20.305 are issued under sec.161b, 68 Stat. 948, as amended, (42 U.S.C. 2201(b)); and SS 20.102,20.103(e),20.401-20.407,20.408(b),
and 20.409 are issued under sec. 1610, 68 Stat. 950, as amended, (42 U.S.C. 2201(o)).
2.
In S 20.3, a new definition is added to read as follows:
S 20.3 Definitions (a) As used in this part:
A A
A A
A (20) " Dosimetry processor" means an individual or an organization that processes devices called dosimeters in order to determine the radiation dose delivered to the dosimeter.
3.
In S 20.202, a new paragraph (c) is added to read as follows:
S 20.202 Personnel monitoring.
A A
A A
A (c) All personnel dosimeters (except those designed to measure the dose to hands and forearms, feet and ankles or pocket chambers and pocket dosimeters), which require processing to determine the radiation dose and which are utilized by licensees to comply with paragraph (a) of this section must be:
l 22 Enclosure A
[7590-01]
(1) Processed ty a dosimetry processor holdinc current personnel dosimetry accreditation from the National Voluntary Laboratory Accredita-tion Program (NVLAP) of the National Bureau of Standards in accordance with accreditation criteria established in 15 CFR Part 7; and (2) Processed by a processor approved in this accreditation process for the type of radiation or radiations offered by NVLAP that most closely approximate the type of radiation or radiations for which the individual wearing the dosimeter is monitored.
Dated at Washington, DC, this day of
, 1986.
For the Nuclear Regulatory Commission.
Samuel J. Chilk, Secretary of the Commission.
i l
l 23 Enclosure A
O REGULATORY ANALYSIS FOR PART 20 AMENDMENTS CONCERNING IMPROVED PERSONNEL DOSIMETRY PROCESSING 1.
PROPOSED ACTION NRC licensees are required to provide personnel monitoring (dosimetry) to workers who have the potential for receiving radiation doses as specified in 10 CFR 20.202(a) and 10 CFR 34.33(a).
Data from these personnel dosimeters are the bases for licensee and NRC records of external doses to workers.
At present the NRC does not have performance criteria or quality controls on the processing of personnel dosimeters.
Several studies of dosimetry processor performance conducted between 1967 and 1976 indicated poor performance by processors when tested against available standards.
These studies clearly demonstrated the need for a common performance standard for both film and thermoluminescent dosimeter testing.
Directly as a result of these tests, a new performance standard for dosimetry was developed by the Health Physics Society Standards Committee which was subsequently published as ANSI N13.11.
The ability of dosimetry processors to meet the criteria of this standard was evaluated in a series of three tests conducted for the NRC at the University of Michigan.
The Michigan tests showed an increase in the number passing from 48% to 75% between tests one and three, indicating that personnel dosimetry processors were capable of making much needed improvements.
Subsequent to the three tests discussed above, a dosimetry accreditation program under the National Voluntary Laboratory Accreditation Program of the National Bureau of Standards began operation in January 1984 and for the first quarter recorded a passing rate of 93%.
Based on the results discussed above, the NRC concluded that an amendment to the current regulations was needed to ensure improved personnel dosimetry processing.
The amendment would include not only performance testing but would include checks on the quality assurance program of the processors.
The amend-ment would require all NRC licensees which are required to provide personnel 05/13/86 1
Enclosure B
dosimetry to have the dosimeters processed by an accredited personnel dosimetry processor.
2.
OBJECTIVES The objectives of the regulatory amendments are to improve the health and safety of occupationally exposed workers by requiring that the processing of personnel dosimeters (which provide occupational doses of the workers) be per-formed uniformly through the application of specified accreditation procedures.
Several tests have indicated that many dosimetry processors perform poorly when tested against a variety of standards and some report radiation doses in a language that only they can understand.
Use of standard tests and quality control programs will assure that all occupationally exposed workers will have their personnel dosimeters evaluated against an acceptable national standard, regardless of which processor does the work.
3.
ALTERNATIVES Five alternatives were considered:
(1) No change in current requirements (2) Require licensees to have processing performed by a processor who had successfully participated in dosimetry performan.ce testing admini-stered in accordance with ANSI N13.11 and which had'a documented QA pro-gram whose elements would be specified in NRC regulations.
(3) Require licensees to have their processing performed by a processor l
which had successfully porticipated in dosimetry performance testing administered in accordance with ANSI N13.11 by an NRC specified test-ing laboratory and which had a documented QA program whose elements would be specified in NRC regulations (this alternative differs from the previous alternative in that NRC would specify the proficiency testing laboratory).
This alternative could be accomplished by either of the following options.
05/22/86 2
Enclosure B
0 Option A:
NRC licensees would be required to utilize the services of a processor which had successfully participated in performance testing at a proficiency testing laboratory that had been contracted by the NRC.
NRC inspectors would examine written proof that the processor had participated in the program and would ensure that the processor maintained a QA program as specified in NRC regulations.
Option B:
NRC licensees would be required to utilize the services of a processor who had been accredited under the NVLAP of the NBS.
This program would involve:
(a) Performance testing in accordance with ANSI N13.11 *
(b)
Information collected by questionnaire; and (c) Onsite inspection of routine dosimetry processing and QA tech-niques by NVLAP contracted assessors.
(4) NRC would request from Congress the authority to license per-sonnel dosimetry processors directly since many of these pro-cessors are not NRC licensees.
(5) NRC would change the regulations to require that licensees obtain their personnel dosimetry services from an NRC operated or an NRC contracted dosimetry service.
4.
CONSEQUENCES Alternative 1:
No change in current requirements.
This alternative would probably result in no change in the status quo.
The NRC would continue the practice of attempting to enforce existing regulatory requirements on personnel monitoring without the benefit of any standard or quality control procedures against which to judge conformance by its licensees.
Workers would continue to use dosimeters which are often not calibrated to their 05/13/86 3
Enclosure B
specific needs while responsible processors which have voluntarily joined the NVLAP accreditation program would likely drop out of the program for economic reasons in order to compete with the less responsible and less qualified segment of the dosimetry processing community.
This alternative would entail no costs to the NRC and the only costs to the dosimetry processing industry would be to those processors which had applied voluntarily for NVLAP accreditation.
Alternative 2:
Require licensees to have their processing performed by a pro-cessor who has successfully participated in a testing program administered in accordance with ANSI N13.11 and which has a documented QA program that meets the requirements specified in NRC regulations.
NRC would not specify the test-ing laboratory and would specify the necessary QA elements in its " regulations.
This alternative would allow dosimetry processors and users the freedom to establish one or more testing laboratories without government involvement and to use the laboratory of their choice on the basis of competitive pricing or some other parameter.
No government resources would be used in establishing the testing laboratory.
On the other hand, there would be no guarantee that industry would establish several, or even one, testing laboratory.
- Further, this alternative would require the NRC to develop a set of QA requirements for incorporation in the regulations with an estimated cost to the NRC of a 1/2 man year effort.
Also this alternative would require an inspection and enforce-ment effort estimated to be 8 staff years annually to assess the adequacy of licensees' and processors' QA programs.
Additionally, NRC inspectors could not inspect processors which were not NRC licensees.
d Alternative 3:
Require licensees to have their processing performed by a pro-cessor which has successfully participated in a testing program administered in l
accordance with ANSI N13.11 by an NRC-specified testing laboratory and which has a documented QA program that meets the requirements specified in NRC i
regulations.
This alternative could be met by either of two options:
Option 3A:
The NRC would obtain the services of a performance testing laboratory through a competitive bidding process.
NRC licensees would be required to have their processing performed by a processor which had suc-l cessfully participated in the testing at this testing laboratory.
NRC i
05/13/86 4
Enclosure B
/
inspectors would examine written proof that such testing had been performed successfully and that the processor had a documented QA program that met the requirements specified in NRC regulations.
This alternative appeared to have worked well in the past during the performance testing program where the University of Michigan operated the proficiency testing laboratory under an NRC competitive contract.
This alternative would not require extensive NRC staff resources for administra-tion and contract review.
On the other hand long-term Federal resources would have to be budgeted for operation of the laboratory in the event that the program did not become self-supporting. This alternative would also require an estimated 8 staff years annually to assess the adequacy of the licensees' and processors' QA programs.
Option 3B:
The NRC would specify in its regulations that third party accredi-tation would be utilized and that licensees would be required to have their processing performed by a processor which had been accredited under the NVLAP of the NBS.
The dosimetry laboratory accreditation program was started in 1981 under an Interagency Agreement between the NRC and NBS, and a performance testing laboratory was contracted for by the NBS.
Proficiency testing and NVLAP accreditation of processors began in January 1984.
Since proficiency testing and NVLAP accreditation of processors began in 1984, the costs for implementation of such a program have already been incurred, so that the effective implementation cost of such a program is zero.
The pro-gram is expected to be self-supporting through the accreditation fees charged to the processors.
Costs to processors for accreditation depend upon the size of the processor's operation, on the numberauf dosimeter types to be tested and upon the number of test categories requested for each dosimeter type.
One cost to processors, that is not included in the NVLAP August 31, 1984, fee schedule (49 FR 34547), is that of initiating and maintaining the quality control and quality assurance system required by NVLAP and examined by NVLAP assessors during onsite visits to processor facilities.
05/13/86 5
Enclosure B
4 1
l Based on an estimate of a 5 person-week effort to initiate the quality
. system, combined with some possible retesting and consultation, the initial l
one-time cost is estimated to be approximately $7,000.
Most of the processors which participated in the three voluntary testing programs have already absorbed this initial cost, and nuclear reactor licensees are required under -
$ 50.34(b)(6)(ii) to have a QA system in place so that this initial cost has already been incurred.
Maintenance of the quality systems are estimated by NVLAP to range from $2,000 to $6,500 biennially for small and large processors I
respectively, but these costs would not be considered applicable to reactor licensees since they are required by present regulations to maintain such a quality system.
Biennial accreditation fees vary from $3,700 for a small processor with 4
j one dosimeter type tested in a single category, to $10,250 for a large processor with one dosimeter type tested in all 8 of the test categories.
The total costs l
of the program range from $5,700 to $16,750 (or approximately $3,000 to $8,400 annually) to each of the 90 known dosimetry processors.
Estimates of the annual
)
costs to-the industry indicate that 14 processors may be considered large, with total annual program costs of $118,000, 62 fall in the intermediate category with total annual costs of $310,000, and 14 fall in the small category with l
total annual costs of $42,000, for an overall total of $470,000 per year.
The current costs of providing dosimetry to the 327,000 workers monitored by NRC licensees is $7,850,000 annually, based on an average cost of $24.00 annually per worker with monthly changes of dosimeters.
Assuming that all of the annual costs of accreditation, $470,000, would be passed on to NRC licensees, j
the cost to the estimated 4,500 licensees would be increased by $105 annually,
[
from $1,744 to $1,849 or an increase of 6%.
licen ees f o o to o thi r e he nerea ed c ed b t of he recorded and reported occupational dose, which is of considerable significance in epidemiological studies and in litigation involving worker compensation claims, and which also allows both employer and employee to better assess and i
control the radiation hazards of the workplace.
The annual cost of this
)
increased credibility is $1.44 per worker.
Adoption of this option will allow NRC to impose minimal acceptable criteria, through NVLAP accreditation, on personnel dosimetry processors which are not I
i j
05/22/86 6
Enclosure B I
i
subject to present NRC regulations.
Since it is expected that most dosimetry processors will wish to become accredited, the net effect of this option will be to benefit a much larger community of workers than that of NRC licensees.
These are the same processors which process badges for Agreement State licen-sees and a large and diverse community involved principally with X-ray machines which does not include NRC licensees but which is regulated under the Occupational Health and Safety Administration of the Department of Labor.
In addition, this option is expected to save the NRC about 8 person years / year by using NVLAP assessors instead of NRC's IE personnel to conduct on-site assessments of pro-NRC inspectors would be relieved from inspection of certain QA cessors.
activities and would only be required to perform routine inspections of person-nel dosimetry records.
This option would establish common testing and quality assurance procedures on personnel dosimetry processing performance and provide NRC inspection person-nel with a much needed benchmark against which to enforce existing regulatory requirements on personnel monitoring.
It also would provide a measure of credi-bility to the dosimetry processing industry through the use of standard proce-dures and oversight by NBS, the nationally recognized standards authority.
Finally, the quality and accuracy of personnel dosimetry records would increase, partly as a result of periodic retesting requirements and partly as a result of the elimination of irresponsible or incompetent dosimetry processors.
Alternative 4 Require that Congress grant authority to the NRC to license personnel dosi-metry processors directly, since many are not presently NRC licensees.
This alternative is probably unwieldy in that Congress may balk at providing such authority or at best delay passing the needed legislation for an unacceptable) period of time.
In addition, this alternative would require an increased expenditure of funds for NRC's IE personnel of about 300% above the present expenditures for inspection of licensee processors.
[NRC licensees employ only about 25% of the 1.4 million workers in the U.S. who require personnel monitoring]
Alternative 5 Change the regulation to require that licensees obtain their personnel dosi-metry services from an NRC-operated or an NRC-contracted dosimetry service.
Since 05/22/86 7
Enclosure B
the NRC does not presently have the technical staff, facilities, funding, or experience to operate such a service, the alternative is limited to an NRC-contracted dosimetry service.
Since this option will undoubtedly put most of the dosimetry processors out of business, it is unlikely to be acceptable either to the industry or to Congress and would require a long-term outlay of Federal funds to support such a contracted dosimetry service.
5.
DECISION RATIONALE The staff proposed that alternative 3B be adopted.
Alternative 1 is re-jected outright since it offers no hope of meeting the objective of improving the healthandsafetybenefitsofoccupationallyexposedworkersbyst$indardizing dose determinations obtained by dosimetry processing.
Alternative 2 is re-jected because of the additional costs to the NRC and the uncertainty that indus-try would establish a testing laboratory.
Alternative 3A is rejected because of the requirement for budgeting long-term Federal resources to operate the testing laboratory and the costs to the NRC in assessing the licensees' and processors' QA programs.
Alternative 4 is rejected because of the uncertainty in obtaining the required authority from Congress and because of the additional inspection costs involved.
Alternative 5 is rejected because of the requirement for a long-term outlay of Federal funds and the negative effect it would have on the dosimetry processing industry.
6.
IMPLEMENTATION The final rule, specifying the requirement for accreditation of personnel dosimetry processors, will become effective one year af ter publication of the rule in the Federal Register.
The NVLAP testing and accreditation progran has been in operation for over two years, and on the basis of this operating experience, it has been found that a minimum of about six months is required for processors to receive accreditation.
Since some processors fail the first round of testing, an additional three months is generally necessary.
On the basis of this time frame, the Commission has determined that an effective date of one year af ter publication is an adequate time period to require implementa-tion of the rule.
No additional staff action or additional funding is required.
05/13/86 8
Enclosure B
4 This action is related to and in conformance with Section 20.501(c) of the new proposed 10 CFR Part 20 which was published January 9, 1986 (51 FR 1092)..
No other existing or proposed requirements are affected.
l l,
.i e
j f
i i
a J
1 l
1 I
i 4
j 1
I i
05/13/86 9
Enclosure B I
9 ANALYSIS OF COMMENTS IMPROVED PERSONNEL DOSIMETRY PROCESSING The NRC received 97 comment letters, two of which were duplicates, one of which was a forgery and one (a comment letter on a different rule) was included by error, leaving a net of 93 comment letters, some of which contained more than one comment.
For the purpose of analysis, the comments were classified according to the five general categories listed below:
I.
Simple approval of the proposed rule.
II.
Simple approval of the proposed rule with added suggestions.
III.
Approval of the requirement for accreditation but opposed to the recordkeeping requirement of proposed 10 CFR 20.401(d).
IV.
Opposed to the proposed rule.
V.
Miscellaneous comments.
ORAFT 04/18/86 Enclosure C 9
ANALYSIS OF COMMENTS IDENTITY OF COMMENTERS Commenter Number Cannenter 1
State of Montana Department of Health & Environmental Services 2
Georgia Department of Human Resources Radiological Health Section 3
Commonwealth of Virginia Department of Health 4
Connonwealth of Kentucky Cabinet for Human Resources 5
State of Alabama Department of Public Health 6
State of Rhode Island and Providence Plantations Department of Health 7
State of Ohio Department of Health 8
State of New Mexico Environmental Improvement Division 9
State of Michigan Department of Public Health 10 Gulf 011 Corporation 11 North Dakota State Department of Health 12 Oklahoma State Department of Health 13 State of Indiana State Board of Health 14 State of Kansas Department of Health and Environment 15 ICN Chemical & Radioisotope Division 16 Colorado State University Environmental Health Services i
Connenter Number Commenter 17 Conference of Radiation Control Program Directors, Inc..
18 Radiation Measurement Systems, Incorporated 19 Bethlehem Steel Corporation 20 Eberline 21 Illinois Department of Nuclear Safety 22 State of Colorado Colorado Department of Health 23 Kerr-McGee 24 U.S. Department of Labor Employment Standards Administration 25 State of Tennessee Department of Health and Environment 26 LAND, Inc.
27 Massachusetts Institute of Technology 28 State of Oregon Department of Human Resources 29 State of California Department of Health Services 30 State of Florida Department of Health and Rehabilitative Services 31 Department of Health & Human Service Food and Drug Administration 32 Arizona Radiation Regulatory Agency 33 State of Delaware Department of Health & Social Services 34 U.S. Cepartment of Commerce National Bureau of Standards 35 Applied Radiation Protection Services 36 The University of Oklahora ii
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Commenter Number Commenter 37 Boston University Medical Center 38 Wiscons'in Clinical Cancer Center a
39 Pacific Radiation Corporation 40 Washington Public Power Supply System 41 State of Maryland Department of Health and Mental Hygiene 42 State of New York Department of Labor 43 Edison Electric Institute 44 Nurnberger Radiation Protecticn Service 45 U.S. Department of Labor.
Occupational Safety and Health Administration 46 South Dakota Dept. of Water & Natural Resources 47 Department of Energy 48 The University of Michigan 49 New York Power Authority 50 Arkansas Department of Health 51 Pacific Gas & Electric Company 52 R. S. Landauer, Jr. & Co.
53 Teledyne Isotopes 54.
Tufts University School of Medicine 55 Texas Utilities ~ Generating Company 56 Portland General Electric Company 57 Commonwealth Edison 58 Harvard University 59 The Commonwealth of Massachusetts University of Massachusetts (Forgery) iii 6
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Connenter Number Commenter 60 The Light Company Houston. Lighting & Power Company 61 General Electric Nuclear Energy Products Division 62 Air Transport Association of America 63
- Pennsylvania Power & Light Company 64 Northeast Utilities 65 Veterans Administration Medical Center, Lexington, KY 66 U.S. Environmental Protection Agency Office of Radiation Programs 67 Iowa Electric Light and Power Company 68 Duke Power Company 69 The Light Company Houston Lighting & Power Company (Duplicate) 70 Yale University University Health Services 71 Arizona Public Service Company 72 GPU Nuclear Corporation
~
73 Iowa State Department of Health 74 Atomic Industrial Forum, Inc.
75 Conoco Inc.
76 Tennessee Valley Authority 5
77 Argonne National Lab, oratory 78 Argonne National Laboratory 79 South Carolina Electric & Gas Company 80 Mallinckrodt, Ir.c.
81 Standard Oil Company (Indiana) iv i
3
Commenter Number Commenter 82 Wisconsin Public Service Corporation 83 Ameri'ca'n College of Radiology 84 Minnesota Department of Health 85 Public Service Electric and Gas Company 86 Department of the Navy 87 Washington Public Power Supply System (Duplicate) 88 Arizona Radiation Regulatory Agency (N/A this rule) 89 Nuclear Sources & Services, Inc.
90 American Association of Physicists in Medicine 91 National Aeronautics and Space Administration 92 State of North Carolina Department of Human Resources 93 State of Nevada Department of Human Resources 94 Texas Department of Health 95 Harvard University University Health Services 96 Health Physics Northwest v
l
CATEGORY I.
SIMPLE APPROVAL OF THE PROPOSED RULE Forty of the ninety-three commenters approved the rule without added suggestions or opposition.
Some of the many reasons cited for approving the rule are given below.
Commenter
- 1.
"The implementation of this rule will effect improvements in personnel dosimetry that are critical for the protection of radiation workers."
- 5.
"This would make a positive contribution to the public health and safety by insuring that exposures reported are within the stated accuracy of the exposures actually received."
- 7.
"Without the assurance that processors meet a baseline standard of competence, these values are open to question as are many allied facets of typical radiation safety program which depends on these values."
- 17. ".... personnel dosimetry performance is recognized as critical in evaluating worker protection and retrospective studies on radiation exposures."
- 22. "The need for accurate personnel monitoring is too important to be left unattended or left to a few companies who might try to monitor themselves."
- 36. "It has been the experience of this organization that the quality control of dosimetry suppliers / processors has been less than adequate when compared to the degree of accuracy and assurance required of the NRC licensee."
- 45. "In endorsing the proposed rule I urge NRC to give weight not only to its 1
obvious benefits to radiation protection among NRC-licensed facilities, but also to the highly beneficial side effect it will have among the many thousands of badged workers who are not in licensed facilities."
DRAFT 04/18/86 1
Enclosure C
- 52. "Such a regulation is overdue as evidenced by the poor participation in previous voluntary dosimetry testing programs like that offered by the National Sanitation Foundation.
In 1983 only four processors participated in the Foundation's program."
- 66. "We agree that there is a need to require a reasonable level of compe-tence in personnel dosimetry processing. Without such competence, the readings of personnel dosimeters cannot be relied upon as indicators of protection and accurate record of worker doses."
- 68. " Alternative 3-Option B should be implemented because it ensures high quality dosimetry and because dosimetry processors are already familiar with this approach to dosimetry through previous rounds of NVLAP per-formance testing."
- 72. "The standards and testing protocols referenced in the proposed regula-tion would provide us with uniform criteria for selecting dosimetry vendors.
This would ultimately reduce our quality assurance costs for vendor certification."
- 75. " Based on our past experience with personnel dosimetry processing, we agree that a coordinated assurance program for personnel dosimetry processing would be advantageous to the nuclear industry."
- 84. "In view of the studies conducted by the University of Michigan which indicated that a substantial percentage of the dosimetry processors who currently serve NRC licensees are performing in an inadequate manner, it is evident that the establishment of common acceptable performance criteria such as those which would result from implementation of the i
t proposed rule are not only necessary, but are long overdue."
DRAFT 04/18/86 2
Enclosure C
CATEGORY II.
SIMPLE APPROVAL OF THE PROPOSED RULE WITH ADDED SUGGESTIONS Twenty of the ninety-three comenters approved of the rule but had some added suggestions or comments.
1.
Comenters #5,14, 48:
Commenters approve of the proposed rule but would like the effective date moved to an earlier one.
Staff Response:
In view of the delays involved in developing the final rule, it is not possible to advance the effective date.
2.
Comenter #15:
Commenter concurs in the proposed rule but in the interests of uniformity requests that Form NRC-5 be changed to reflect the nomencla-ture of ANSI N13.11 as it relates to shallow and deep dose reporting.
Staff Response:
This comment is taken under advisement and changes will probably be made to reflect the nomenclature of ANSI N13.11 in the latest revision of 10 CFR Part 20.
3.
Commenter #18:
Commenter approves of the proposed rulemaking and then goes on to indicate some of the benefits to be derived from the program and then he requests changing the name of NVLAP to remove the word
" voluntary."
Staff Response:
The National Voluntary Laboratory Accreditation Program (NVLAP) was established by the NBS in 1976 to accredit laboratories for specific tests or type of tests in certain product or service areas when a need for accreditation is determined.
The NRC has no jurisdiction over the name of the NBS program which is a voluntary program from the NBS per-i.
spective.
In addition, NRC licensees include only about 25% of the 1.4 million workers in the U.S. who require personnel monitoring.
Many of l
these are regulated by OSHA, EPA and other agencies and at least some of l
these are expected to voluntarily participate in the NVLAP program. The present LAP program may be viewed in many respects as similar to Under-writers Laboratories or Good Housekeeping Laboratories where products are sent voluntarily to obtain approval and the right to use the logo of the DRAFT 04/18/86 3
Enclosure C
appropriate laboratory.
In like manner, the NVLAP logo indicates a processor supplies quality processing and will in all likelihood improve business for the processor.
4.
Commenter #42:
Commenter approves of the proposed rule but would like to amend the proposed new paragraph, 10 CFR 20.202(c)(1) by adding the phrase "or equivalent Program approved by NBS."
Commenter argues that this would give NBS the added flexibility to approve other accreditation schemes in the future if the present one does not work as desired or for foreign accreditation.
Staff Response:
NBS currently has eight other LAPS not dealing with dosimetry in its NVLAP program and would seem to have adequate flexibility.
5.
Commenter #43:
Commenter expresses full support for the proposed rule.
He also feels that a definition for " dosimetry processor" should be provided in the regulations and provides a suggested definition. Commen-ter is also concerned that when ANSI N13.11-1983 is revised, it may re-quire processors to upgrade their equipment and procedures to the point where it could be very expensive and time consuming.
Commenter is con-cerned that processors could lose their accreditation just due to the time constraints involved in the upgrading.
He urges NRC to negotiate with NBS to correct this problem.
Staff Position:
The final rule provides a definition for " dosimetry pro-cessor." ANSI standards are reviewed at five year intervals and are revised when thought necessary. ANSI N13.11 is subject to revision beginn-ing in 1987 and current information on this or any other standard may be obtained by calling or writing the American National Standards Institute, 1430 Broadway, New York, NY 10018.
Since an American National Standard implies a consensus of those substantially concerned with its scope and provisions, processors are advised to learn about any proposed revisions to standards of interest and provide their input to the subcommittee charged with updating such standards.
The present regulations governing NVLAP operations provide a period of one year after publication of a revised standard to meet the conditions of the revised standard ORAFT 04/18/86 4
Enclosure C
(15 CFR 7.32(a)(5)).
This should provide adequate time for upgrading pro-cedures and purchase of equipment should it be necessary.
6.
Commenter #49:
Commenter supports Alternative 3, Option B of the proposed rule.
Commenter notes that the pass / fail criterion on page 1207 of the Federal Register notice failed to use the absolute value of P in the equation.
Staff Response:
The correct value of IPl is now used.
7.
Commenter #63:
Commenter encourages implementation of the accreditation program.
Commenter also wants a clarification of the proposed 10 CFR 20.202(c)(2) to include a definition of the term " types of irradia-tions" referred to in this section.
In addition, the commenter acts as a dosimeter co processor, reading out TLDs and sending the raw data to a dosimetry service vendor.
Commenter feels that the final rule should ad-dress the issue of co participation in the accreditation process in order to assure valid and uniform accreditation to all such co participants.
Staff Response: The term " types of irradiations" in 10 CFR 20.202(c)(2) refers to radiation types that fall into the eight categories of irradia-tions found in Table 1 of ANSI N13.11-1983.
This point will be clarified in the final rule.
Co participation or acting as a co processor in the accreditation process is considered by NVLAP as a normal extension of the home-base operation of the accredited processor.
8.
Commenter #68:
Commenter supports the overall concept of this rule but suggests that the processor need be accredited only for those radiations which constitute at least 20% of the total radiation dose.
Staff Response:
The NRC staff position is that it is the responsibility of the licensee to select a processor which is accredited in the appro-priate categories.
The staff understand the point that the commenter is trying to make but rejects the suggested change for the following reason.
Since dose equivalents are additive, it would be possible for a processor not to be accredited for three or more radiation categories each of which DRAFT 04/18/86 5
Enclosure C
could be contributing 19% of the total or 57% of all radiation received.
The licensee would be in clear violation of the rule in this case since its processor would only be accredited to process 43% of the total radia-tion dose.
9.
Commenter #69: Commenter is in agreement with the intent of the change but has some concerns.
The first is the concern with the possible resi-sion of ANSI N13.11-1983 and its effect on processors.
He is also con-cerned with possible duplication of effort between NBS and NRC inspections of the dosimetry processing program.
Commenter suggests that the limits of NVLAP inspection authority or NRC inspection authority in this area be specified in a paragraph in 10 CFR 20.202.
Staff Response:
Commenter is referred to comment 5 as it relates to possible revision of ANSI N13.11.
The NRC inspection program is to be modified to avoid duplication of inspection by NRC inspectors and NBS as-sessors.
NRC inspectors will inspect to deterr.ine if the licensee is using a dosimetry processor which is qualified for those radiation cate-gories appropriate to its establishment.
Incorporation of limits on NVLAP inspection authority in 10 CFR 20.202 is not appropriate.
10.
Commenter #71:
Commenter supports the proposed amendments but states that he believes that the cost estimates for accreditation are understated.
Commenter feels that projected costs included in the proposed rule do not adequately reflect the continuous cost of preparation for QA onsite inspections.
Staff Response:
Since many processors maintained a high degree of QA in their dosimetry programs prior to the advent of the NVLAP program, it was difficult to assess the costs to the average processor.
Original esti-mates called for a start-up cost of around $7,000 for initial preparation for the required QA program.
This is reflected in the original estimate of $14,000 for a typical processor accredited for one dosimeter type in all eight radiation categories.
Maintenance costs of the QA program are estimated to range from $2,000 to $6,500 biennially depending on the size of the operation.
DRAFT 04/18/86 6
Enclosure C
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11.
Commenter #74:
Commenter is generally supportive of the proposed rule but suggests that the rule should include a provision for formal notification of revisions to NVLAP to allow time for implementation by processors.
Commenter is also concerned about the compliance procedures to be imple-mented should a licensee's processor lose accreditation.
Another concern involves clarifying the onsite review process to include criteria for determining whether items are satisfactory or deficient and to specify the qualifications and selection citeria for those persons chosen to review appeals from processors who have lost their accreditation.
Commenter would like the.NRC to issue a Regulatory Guide to address these last issues. Also commenter would like to have radiation categories speci-fled for different kinds of licensees and suggests that licensees be accredited for those radiations that constitute more than 20% of the total dose at the licensees establishment.
Staff Response:
In regard to changes in NVLAP procedures, commenter is referred the staff response to comment 5.
Methods and procedures for handling loss of accreditation are covered in 15 CFR Part 7.
NBS issues quarterly bulletins updating accreditation action including those proces-sors which have lost their accreditation during the previous quarter, and NRC's Office of Inspection and Enforcement will keep abreast of such crises.
The issue of loss of accreditation has been addressed in the supplementary information section of the final rule.
A Regulatory Guide which will discuss radiation categories will be issued.
Insofar as clarifying onsite procedures and qualifications of personnel chosen to review appeals, this is a NVLAP responsibility.
In regard to specifica-tion of radiation categories, commenter is referred to staff response to comment 8.
12.
Commenter #75:
Commenter agrees with the choice of Alternative 3, Option B but is concerned over the proposed costs of accreditation.
Commenter seems to feel that fees could be reduced if onsite visits were eliminated and the dosimetry procedures and QA procedures were handled by written communications.
DRAFT 04/18/86 7
Enclosure C
Staff Response:
A portion of the onsite visit procedures calls for the NVLAP assessor to conduct interviews with members of the processor's staff and to observe critical processing activities and inspect equipment and instrumentation.
This could not be handled by correspondence.
The amount saved by conducting the QA and dosimetry procedures by correspondence would only be some fraction of the currer.t biennial assessment fee of
$1,100 which currently amounts to only 10% to 20% of the accreditation fee depending on the number of categories tested for.
13.
Commenter #76:
Commenter supports certification of dosimetry processors but suggests that there are more efficient and less expensive ways of conducting performance testing.
Commenter suggests that the NRC require each processor to submit routinely used dosimeters on a periodic basis (up to monthly) for exposure to known doses.
Criteria for continuing to ~
be certified would be simply the reporting of the correct doses (within the allowed tolerance) for these dosimeters.
Commenter states that under this procedure testing would be current and act up to two years old, the processor would have to provide competent results frequently rather than on a two year basis, the results could be trended to provide early warning of deterioration in process control.
Also the NRC could select exposure categories based on its knowledge of the radiations being monitored by the processur and finally the program would be simple and as economical as the processor certification program.
Staff Response: There is nothing in the proposed regulation to prevent individual processors from sending additional dosimeters periodically to the PTL for exposure.
Some of the certified processors are now doing this as a means to check on any slippage in their QA program.
The NBS is thinking of changing its reaccreditation procedures to require processors to begin retesting up to one year prior to the required reaccreditation date.
The suggestions of the commenter will be considered when making changes in the present accreditation procedures.
It is not clear however that sending additional dosimeters for exposure on a periodic basis as suggested would be as economical as the present program.
In order to satisfy the statistical requirement for the tolerance, each exposure would have to include at least five dosimeters, and if this were done DRAFT 04/18/86 8
Enclosure C
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monthly the exposure costs would be significant.
Also the suggestion that NRC could choose exposure categories based on a knowledge of radiations being monitored by the processor is not feasible for large processors which monitor in all categories and often with several different dosim-eter types.
Also the NRC does not have the resources to supervise such a program.
14.
Commenter #77:
Commenter feels that the proposed program is necessary but is concerned with the relatively "large" cost to small processors and suggests considering a cost adjustment factor based on processor size.
Staff Response:
The commenter is referred to the staff response to com-ments 1, 10, and 15 under category IV of the analysis of comments.
15.
Commenter #78: This comment is essentially a duplicate of 14.
Staff Response:
See response to comment 14.
16.
Commenter #80:
Commenter feels that the regulatory action is necessary and agrees that the alternative chosen is the most beneficial plan.
Com-menter is concerned that non-NRC licensed individuals will continue to use processors which are not accredited because they are not NRC or Agreement State licensees.
Commenter would also like to see a Regulatory Guide developed to better define which of the testing categories are required for each type of license.
Staff Response: The majority of processors, although not NRC licensees, process dosimeters for NRC licensees.
In order to continue to provide this service, they will be required to obtain NVLAP accreditation.
The staff is aware that other agencies, notably the Department of Labor (OSHA) and the Department of Health and Human Services,have requirements for per-sonnel monitoring of occupationally exposed workers whose employers are not NRC licensees.
Most of the processors which service these workers are f
the same as those which process badges for NRC licensees.
It is thought highly unlikely that these processors would use one standard of processing for customers which are NRC licensees and another standard for processing DRAFT 04/18/86 9
Enclosure C
for customers who are not NRC licensees.
Commenter is referred to the remarks of Commenter #45 listed under Category I of the analysis of com-ments.
NRC will issue a Regulatory Guide which will include information on radiation categories.
Commenter is referred to the staff response to comment 11.
17.
Commenter #82:
Comm' enter agrees that the proposed program would result in overall improvement of dosimetry processing and thus supports the proposed rule.
Commenter urges clarification of the rule so that only dosimeters used for reporting offical dose values as required under 10 CFR Part 20 be included in the scope of the proposed regulation.
Commenter wants to ensure that redundant dosimeters are not subject to the rule. Also commen-ter would like NRC to address as guidance, acceptable methods of reporting dose values in the event that an accredited dosimeter is lost or yicids erroneous values.
Commenter suggests that redundant dosimeters be used to report values in such cases.
Commenter also urges NRC to directly address the potential administrative and contractual problems that could result from a currently used dosimetry processor failing to obtain accreditation or failing to maintain its accredited status.
Staff Response:
The rule has been rewritten to require accreditation only of those dosimeters required under the regulations.
In regard to loss of accreditation, see staff response to comment 11.
Lost dosimeters or erroneous values do not constitute a new problem.
Possibly redundant dosimeters could be used in reconstruction of doses.
A Regulatory Guide l
addressing most of the points raised will be issued following publication of the rule.
18.
Commenter #85:
This comment is essentially the same as comment 5.
Staff Response:
See response to comment 5 and also in Category III of the analysis of comments.
19.
Commenter #86:
Commenter considers the actions required by the proposed rule to be of substantial benefit.
Commenter would have the NRC clarify DRAFT 04/18/86 10 Enclosure C
the conditions under which a licensee monitoring for low-energy or high-energy photons (category III and IV of ANSI N13.11) should seek accredita-tion in an accident category (category I or II of ANSI N.13.11). Commenter is also concerned that the, proposed rule may cause licensees to eliminate monitoring of personnel who are not expected to receive exposures at or above the levels required under 10 CFR 20.202 but who are monitored anyway to confirm that such personnel are receiving minimal exposures even though they may enter restricted areas.
Staff Response:
The NRC staff position is that it is the~ responsibility of the licensee to select a processor which is accredited in the appro-priate radiation categories.
The final rule addresses the issue of dosimeters issued to personnel not required to have them.
A Regulatory Guide will be issued following publication of the rule and will address most of the concerns raised here.
ORAFT 04/18/86 11 Enclosure C
CATEGORY III.
APPROVAL OF THE REQUIREMENT FOR ACCREDITATION BUT OPPOSED TO THE RECORD KEEPING REQUIREMENT OF PROPOSED 10 CFR 20.401(d)
Six commenters were opposed to including the proposed amendment 10 CFR 20.401 (d) in the proposed rule.
This particular section would require licen-sees to preserve copies of their dosimetry processor's accreditation certifi-cate along with the exposure records of personnel that are required under the present rule.
Most commenters felt that this was simply an additional burden with no additional benefits, since the licensee is required to provide the name of the processor in the license application.
Others with multiple facilities indicated the problem of redundancy.
Staff Response:
Since NBS issues a NVLAP directory with quarterly updates on all accreditation actions on all of its LAPS, the NRC staff feel that individ-ual accreditation certificates at licensee facilities are unnecessary.
All NRC inspectors would have available a copy of the most recent quarterly update for use in all inspections.
In view of this, the proposed amendment to Sec-tion 20.401 has been removed from the final rule.
DRAFT 04/18/86 12 Enclosure C
,-.m.
CATEGORY IV.
OPPOSED TO THE PROPOSED RULE Nineteen commenters were opposed to the rule. Most of the comments were directed against the costs of the program.
Four general comments appeared in many of the letters and will be addressed here separately in order to reduce the repetition of staff responses.
General Comments Comment A:
The rule makes no distinction between large and small pro-cessors.
Small processor should not be required to submit to onsite assessments by NVLAP personnel.
Reduction of this requirement should reduce the costs of accreditation significantly.
Staff Response:
The purpose of the personnel dosimetry accreditation pro-gram is to detect and eliminate wherever possible, those sources of vari-ability which are under the control of the dosimetry processor.
The test-ing portion of the accreditation program does not in itself assure that the processor applies the same care and attention to routine dosimetry processing as it does to test dosimeters.
The onsite assessments con-ducted by NVLAP personnel not only check on sources of variability under the control of the processor, they also check the quality assurance pro-grams of the processor as it applies to routine dosimetry and to the appli-cation of equivalent care to both routine and test dosimeters.
For these reasons, the staff position is that the onsite assessments cannot be waived for small processors.
With respect to the reduction in costs, the onsite assessment costs are 31,100 for a two-day visit and $650 for a one day visit, less than 25% of the biennial costs for accreditation.
Not considered in this, of course, are the one-time costs of ir,itiating an appropriate QA program which have been estimated to be around $7,000.
The staff position is that without an adequate in-house QA program (which all processors should already have in place), there is no guarantee that a processor is applying appropriate care and effort to the processing of routine dosimetry.
DRAFT 04/18/86 13 Enclosure C
Comment B:
In view of the costs of the program, a different fee structure could be applied to small or in-house processors.
Staff Position:
Legal rulings prohibit the application of differential fee structures based upon the size of the processor.
Differentiation of fees based on business size is viewed as a tan and is not allowed except by legislation. This issue has been discussed in the final rule and in the Final Regulatory Flexibility Analysis.
Small processors should be aware that grants are available from the Small Business Administration to assist small businesses to meet Federally improved licensing fees.
Comment C:
Commenters are concerned that if their commercial processor should suddenly lose accreditation, NRC licensees would be in noncom-pliance with the regulations.
Staff Position: This problem has been addressed in the supplemental information section of the final rule.
NVLAP procedures presently issue accreditation certificates for periods of two years.
The processor is required to begin testing for reaccreditation one year prior to expiration of its current certificate.
Although the processor may fail one or more tests during reaccreditation, it will have three additional test periods during the year, which, with NVLAP consultation and analysis, should enable the processor to maintain its accreditation on a continuing basis.
It is only in cases of gross neglect or irresponsibility that NVLAP will summarily withdraw accreditation.
There are no requirements in NVLAP procedures to require either the processor or NVLAP to notify customers of the processor of this loss of accreditation.
At present the Office of Inspection and Enforcement will obtain quarterly reports on the accredita-tion status of processors and improved liaison between NBS and NRC is under way to provide prompt notification of such events.
Comment D:
Commenters are concerned that promulgation of this rule will signal an end to voluntary dosimetry, particularly in hospitals and medical research institutions.
DRAFT 04/18/86 14 Enclosure C
Staff Response:
It is not the intent of the NRC to discourage voluntary dosimetry or redundant dosimetry.
There is no requirement for accredited processing of such dosimeters and the final rule has clarified this issue.
1.
Commenter #27:
Commenter feels that the proposed rule makes no distiction between the testing requirements for large commercial processors and small in-house programs.
Commenter feels that the cost of accreditation for small programs involving 250 persons or less would preclude their continu-ation economically.
Commenter suggested that such small in-house programs be allowed to operate under NVLAP without full NVLAP requirements for on-site assessments.
Commenter goes on to say that this should reduce the cost of performance testing for such in-house programs at least 10-fold and allow continuation of such services.
Staff Response:
See response to General Comments A and B.
2.
Commenter #35:
Commenter disagrees with the necessity to make changes in the draft testing standard ANSI N13.11 which were made after initial tests 1 and 2 at the University of Michigan and then goes on to say that the proposed fees for accreditation could drive small firms like his own out of business.
Commenter then goes on to suggest that he be allowed to select assessors from his own locality to conduct the required onsite visits and that he would pay whatever costs are associated with such visits.
Staff Response: The reasons for making the changes in the testing stand-ard ANSI N13.11 are somewhat complex and will not be discussed here. The logic and rationale associated with these changes have been discussed in depth in NUREG/CR-2891, " Performance Testing of Personnel Dosimetry Services" (1983) and in the hearing record on the Shearon Harris Nuclear Power Plant, Docket 50-400-0L and Docket 50-401-0L, pp. 6401 to 6639, November 1, 1984, PDR Accession Number 8411070107.
Both documents are available in the Commission's Public Document Room at 1717 H Street, NW.,
The first document may be purchased from the U.S. Govern-ment Printing Office (GPO) by calling 202-275-2060 or by writing the GPO, P.O. Box 37082, Washington DC 20013-7082.
It may also be purchased from DRAFT 04/18/86 15 Enclosure C
the National Technical Information Service, U.S. Department of Commerce, 5285 Royal Road, Springfield, VA 22161.
In respect to the fees involved, see response to General Comment B.
The suggestion that the commenter be allowed to select assessors from his own locality in order to reduce costs is rejected.
The NVLAP fee of $1,100 for a two-day inspection of each site biennially covers the average costs of travel expenses for all processors.
NVLAP and NRC feel that it would be unfair to set fees according to travel distance.
NVLAP attempts to use local assessors whenever possible so as to reduce the average costs of travel and could possibly use the names and addresses of any qualified assessors known to the commenter.
3.
Commenter #37:
Commenter is opposed on the basis of cost and states:
I would like to express my opposition to this proposed rule-making. We currently use a commercial supplier of dosimeters.
As the rule stands now, it would be a major economic burden to have to pay up to $12,000 a year for a certification fee for a hospital or a university who does its own processing.
While the intent to certify "in-house" personnel dosimetry is important it would force the small user of in-house processing to use a large commercial processor who could afford these l
fees.
Perhaps a more equitable fee structure (in the hundreds) could be utilized for a small user.
Staff Response:
See General Comments A through D.
The costs of accredita-tion range from $4,150 to $10,700 biennially, depending on the number of categories tested for.
The $12,000 per year figure quoted is in error.
l 4.
Commenter #38:
Commenter stated that his organization had planned to convert from using a commercial processor to developing an in-house capa-bility for dosimetry processing.
Since the organization would require i
testing in all eight of the radiation categories, the program would have ORAFT 04/18/86 16 Enclosure C
cost $17,200 biennially.
Even though the commenter indicated that the program would have processed upwards of 3,000 dosimeters per month, it was felt that the program was too expensive and it was scrapped.
Staff Response: The cost of $17,200 bienially which was published in the Federal Register notice announcing the proposed rule, was based on a pro-cessor who submitted up to 6 different dosimeter models for testing in more than one category.
The maximum cost for one dosimeter type tested in each of the 8 categories is $10,700 biennially which would appear to be considerably less than the cost of processing 3,000 dosimeters per month through a commercial processor.
Commenter should also review General Comments A through D.
5.
Commenter #39:
Commenter states that he is a small processor supplying a special TLD badge that he developed exclusively for the purpose of moni-toring workers exposed to semi-infinite clouds of radioactive Krypton 85 gas.
He goes on to state that the gross income in 1983 from this proces-sing service was about $2,500 or "about one half the estimated annual costs for accreditation specified in the proposed rule for small processor."
He states that if the proposed rule is applied without modification he will be forced to cancel the dosimetry processing service.
He then goes on to offer several suggestions as follows:
I continue to support the Alternative 3-Option B requiring dosimeter a.
processors providing services in categories of exposure which are tested by the Health Physics Society Standard to be accredited by the NVLAP program.
I believe, however, that there exist certain exposure categories for which the NVLAP procedures cannot adequately determine the performance level of a processor.
Badges designed for Krypton-85 gas clouds should be exempted from the proposed rule.
(Another example of a category not tested would be radon gas dosim-eters such as the Terradex track etch device.)
b.
I suggest that some relief be given to small commercial processors who desire to continue supplying personnel dosimeters and who can successfully pass the NVLAP criteria.
I suggest that no processor be ORAFT 04/18/86 17 Enclosure C
required to requalify, after an initial passing of the NVLAP tests, more often than a time span determined by the condition that not more than 10% (or perhaps 20%) of their annual gross income from dosimeter processing be expended in accreditation costs.
As an option to totally excluding special dosimeters as suggested c.
in a.), I suggest consideration be given to establishing a "Special" category outside the normal NVLAP program to deal with "research applications" such as our Kr-85 dosimeter.
I further suggest that, for this "Special" category, the submission of dosimeters to the NVLAP testing lab be eliminated since no category even remotely tests the ability of either the personnel dosimeter or the processor to perform under the designated field conditions (e.g., Kr-85 gas clouds).
Instead, the accreditation in the "Special" category should be granted based on a site visit by someone familiar with the special problems encountered in dosimetry under those conditions.
For example, university research personnel working with that radionuclide in that form.
d.
If consideration is given to establishing a "Special" category for radionuclides such as Kr-85 gas and radon exposures, I further suggest that conventional beta / gamma /x-ray processors be restrained from offering their dosimeters to workers exposed to those "Special" cate-gories unless they can demonstrate competence via the site visit procedure suggested in (c) and show that their dosimeter has the necessary sensitivity and has been calibrated under actual field working conditions, i.e., a semi infinite cloud of low energy beta emitting gas.
Staff Response:
The costs to a small processor seeking accreditation in only one category is not $5,000 per year.
The August 31, 1984, Federal Register notice (49 FR 34546) lists the costs at $4,150 for the first biennium and $3,700 for subsequent biennia.
The present NVLAP program and the consensus standard require testing with a limited number of sources.
While no tests are currently provided for DRAFT 04/18/86 18 Enclosure C
i Kr-85 beta particles, the processor, to successfully participate in the program, has only to demonstrate that it can establish an appropriate calibration factor for its dose algorithm that converts the results of its dosimeter's response to sospfsoY beta particles under test conditions to the response to asKr beta particles in the geometry of the workplace.
In regard to financial relief to small commercial processors, see the response General Comment B.
The staff feels that the suggestion for setting up a special category for Kr-85 dosimeters and restraining " conventional beta / gamma /x-ray processors" from offering their dosimeters to monitor for Kr-85 gas is unwarranted.
The service being offered by the commenter is a legitimate monitoring oper-ation an'd not a research application.
Also, monitoring for beta particles in Kr-85 and Xe-133 gas clouds is an important activity around nuclear power plants although this does not qualify as personnel dosimetry.
It would be unreasonable to restrain " conventional beta / gamma /x-ray processors" from offering such a service, provided that they were able to show the NVLAP assessors that they were aware of the users needs and could make the necessary measurements.
Also there is nothing to prevent processors from using properly shielded lithium fluoride or lithium borate chips as part of their dosimeter package to monitor for Krypton-85 beta particles.
If the commenter feels that the staff position does not adequately address his comments on these issues he may wish to apply for an exemption under 10 CFR 20.501 of the regulations.
6.
Commenter #40:
Commenter questions the need for third party accreditation procedures and feels that the approved vendor system currently in use is adequate.
He questions why the NRC staff is no longer capable of perform-ing a review and oversight function and wants to know why external dosim-etry processing now needs to be regulated by accreditation.
Staff Response:
NRC regulations presently require monitoring of certain i
personnel under 10 CFR 20.202 and maintenance of exposure records of such personnel under 10 CFR 20.401, but they do not set any criteria for the I
DRAFT 04/18/86 19 Enclosure C
performance of dosimetry processing.
Present personnel limitations pre-vent NRC inspectors from overseeing the quality control aspects of dosim-etry processing, so that there is a necessity for third party accredita-tion. Accreditation of personnel dosimetry processors is closely related to the approved vendor system except that the approval will be designated by the National Bureau of Standards under its NVLAP program.
As to the reasons why external dosimetry processing needs to be regulated by accre-ditation, the commenter is referred to Category I of this analysis of comments.
7.
Commenter #44:
Commenter feels that the dosimetry processing accreditation requirement is unnecessarily complicated and overly restrictive in light of the following:
1 a.
The bases upon which the public and occupational worker maximum permissible dose (MPD) guides are set certainly have a variability of at least i 100%.
b.
The day to day wearing of personnel monitors by occupationally exposed persons is subject to a very great variation as to position, angle, forgetfulness, etc.
c.
The personnel monitoring devices themselves have an inherent inaccu-racy of perhaps 25% for small exposures, d.
Most important of all, there is no evidence whatsoever to indicate that present levels of occupational worker radiation exposure causes or is likely to cause any significant biological effects to the population or to the general public at large.
Commenter then goes on to say that the required two day onsite visit is overkill for his particular operation which is entirely contained in a room of 100 square feet.
He also objects to the requirement of 1 15%
accuracy in the light of the points made above.
DRAFT 04/18/86 20 Enclosure C
~_
V Staff Response:
It is not the intent of the personnel dosimetry testing program to question MPD guides, inherent inaccuracies (which all measuring systems have to some degree), or question the results of epidemiological studies. The intent rather is to detect and eliminate where possible, i
those sources of variability that are under the control of the processors.
Some of these involve poor quality control of TLD materials used in dosi-meters, incorrect calibration factors, clerical errors and lack of uniform-ity in dosimetry terminology. The significant improvement in the perfor-mance of processors from Pilot Test 1 to Test 3 illustrated that major improvements in processing are possible.
In the early stages of the test-ing program, significant numbers of processors were reporting doses that differed from the delivered doses by 200 to 3000%, errors that far exceed those errors discussed by the commenter.
I For a small one-room facility such as that of the commenter, it is possi-ble that only a one day onsite' visit would be needed.
This would savt
$450 on the initial accreditation fees which range from $4150 to $10,700 for no more than one dosimeter type per test category.
The statement about the + 15% accuracy requirement appears to be a misunderstanding.
Neither the proposed rule nor the ANSI standard use the word accuracy.
The pass / fail criterion is given in terms of a tolerance limit "L", where:
lPl + S < L i
r and L has the value 0.5 for protection categories and 0.3 for accident 4
l categories.
l 8.
Commenter #54:
Commenter objects to the fact that the proposed rulemaking makes no differentiation between the testing requirements for commercial processors and in-house programs.
He then states:
For many years now this institution has been supplementing our l
commercial film-badge service with in-house TLD personnel moni-
[
toring.
Results have consistently been comparable to the com-mercial services with the added advantage of rapid read-out capabilities.
The cost of accreditation for our program would be prohibitive under this proposal.
DRAFT 04/18/86 21 Enclosure C r-
,,,t
,.----,r-,~
-r.
Staff Response:
See General Comments A through D.
9.
Commenter #55: Commenter objects to NVLAP contractor personnel performing onsite evaluations to ensure that an acceptable QA program for dosimetry processing is documented and implemented.
Commenter feels that the QA/QC aspects can be effectively monitored by existing programs and normal NRC licensee inspections and that the proposed rule would place an unnecessary financial burden upon the licensees.
Staff Response:
Present NRC regulations specify the monitoring requirements for workers under 10 CFR 20.202 but do not set any criteria for the perfor-mance of dosimetry processors.
Commenter is referred to the General Coments.
10.
Commenter #58:
Commenter claims that the cost of the accreditation program will force the termination of the present in-house program that provides film badges to approximately 2,000 persons per month.
Comenter is aware that under the regulations he is only required to badge approxi-mately 200 of these but states that he uses the badges to not only evaluate indi-vidual personnel doses, but also to examine the contamination patterns in the establishment as a means of contamination control.
Elimination of these additional dosimeters because of the costs involved could seriously reduce the effectiveness of the overall radiation control program.
Staff Response:
See General Comments A through D.
11.
Commenter #61:
Commenter is opposed to the proposed rule because his dosim-etry services vendor stated that a more sophisticated dosimeter (that would be easier to accredit) may be required.
Commenter stated that the new badge will increase costs per badge and man hours devoted to the dosimetry program.
He also states that only 100 of the 1,200 persons currently badged require badging under 10 CFR 20.202 and further that the new rule will not provide any improvement for workers whose typical exposure is less than 500 mR per year.
He feels that small processors should not be forced to comply with the same requirements as a larger commercial vendor.
He is DRAFT 04/18/86 22 Enclosure C
l also concerned with the situation when a licence's commercial processor suddenly loses accreditation.
Finally he makes the following suggestions:
(a) Establish a de minimis level for implementation of the rule,--i.e.,
accreditation not required for potential exposures below 500 mR per year.
(b). Continue the laboratory accreditation program for processors as a voluntary system under NVLAP where the processing involves badges below the de minimis implementation level.
(c) Issue a Regulatory Guide for an in-house badge processor to supplement the consensus standard ANSI N13.11.
t i
i Staff Response:
It would appear that if the dosimetry vendor's current badge cannot pass accreditation, that the dosimetry service provided is at best inadequate. There are several legal rulings that prohibit the differentiation of. accreditation fees based on the sir.e of the processor.
2 In regard to establishing a de minimis level for implementation of the rule, there is already in effect a de facto de minimis level since licen-sees are now required to provide dosimetry only to those workers who are likely to be exposed to radiation at levels above those specified in 10 CFR 20.202(a).
Also see General Comments A through D.
The establishment of a voluntary LAP system under NVLAP is not feasible either above or below the minimal implementation level.
It has been shown l
(see Section I) that processors routinely ignore voluntary dosimetry
^
improvement programs. Also a Regulatory Guide does not set out require-ments and could be customarily ignored by processors as indicated by past l
experience with nonregulatory guidance.
12.
Commenter #62:
Commenter stated that he does not agree that another regu-lation is necessary or desirable and feels that it would make monitoring more expensive than necessary.
Further, he states that he has no reason j
to believe that his dosimetry processor has been improperly performing l-ORAFT 04/18/86 23 Enclosure C
.,-m.-... - - _
._n__m,,
.___m,_e'
dose measurenests. He is in favor of Alternative Number One -- No change in current requirements.
Staff Response:
Commenter is referred to comment 7 of this section and to the General Comments.
- 13. Commenter #64:
Commenter states that he is pleased that the NRC is addressing a form of testing for dosimetry processing but he would prefer that it be addressed by a Regulatory Guide rather than by a regulation.
Commenter is unsure which revision of ANSI N13.11 is to be used as a crite-rion and he recommends that if this standard is revised that the proposed regulation identify a reasonable period for processors to requalify under the revised standard.
He is also concerned that the proposed regulation does not identify the categories for which a licensee would have to obtain accreditation. In addition, he states that the onsite checklist presents problems in that many of the questions asked are not pertinent and that he estimates that it would cost $30,000 to implement the accreditation pro-l cess, a major portion of which would be due to preparation for the onsite checklist. Commenter then recommends that the implementation date of the proposed regulation be contingent upon issuance for public comment of a Regulatory Guide which would address the issues discussed above relative to determination of radiation categories and the questions in the onsite checklist.
Staff Response:
The Regulatory Guide approach suggested by the commenter is rejected since it does not set out requirements and could be ignored much like the voluntary dosimetry improvement programs of the past have been ignored.
The current standard used for accreditation is ANSI N13.11-1983.
Since it was approved in 1982, and since consensus standards are to be reviewed every five years for possible revision, it is likely that a revised standard will be available in 1987.
Present NVLAP proceduras allow processors one year to meet the requirements of a revised standard.
The suggestion that a Regulatory Guide be issued for public comment on the onsite check list is rejected.
However, the NRC does plan to issue a Regulatory Guide which will discuss cccreditation categories.
Also this issue has been addressed in the Supplemental Information Section of the DRAFT 04/18/86 24 Enclosure C
final rule.
The checklist is designed for the use of the NVLAP onsite assessor; any processor which follows the recommendations of the NVLAP Dosimetry LAP Handbook issued to all applicants for accreditation will have met the requirements of the onsite checklist.
This checklist was developed in coordination with the Industry Overview Comittee on Per-sonnel Dosimetry and the Interagency Policy Committee on Personnel Dosim-etry and its issuance for public comment at'this time would serve no purpose other than to delay passage of the' regulation requiring accredita-tion.
The estimate of $30,000 to implement accreditation procedures is extravagant.
Estimates of onsite costs are believed to be closer to
$6,000.
Commenter is referred to the General Coments and to coment 11, Category II of this analysis.
14.
Comenter #67:
Commenter believes that the concept of dosimetry process-ing is in the best interests of the nuclear industry but does not agree with the proposed methods of accomplishing this.
Commenter feels that there are differences between NRC and NVLAP requirements and that the proficiency testing laboratory will be unable to maintain an objective review of the processor's dosimetry in light of the need to use processor-manufactured measuring equipment.
He concludes that the best method to serve the industry would be simply to adopt ANSI N13.11 which would thereby j
delegate the responsibility of program implementation to the individual licensee.
Commenter also argues that conflicts may occur between an NBS l
provision met by a processor and an NRC requirement on a licensee.
l l
Staff Response:
The staff is not aware of differences or conflicts between NRC and NVLAP requirements. The comment about the proficiency testing laboratory is a misunderstanding. The laboratory delivers a known dose to the processor's dosimeters and senas the dosimeters back to the processor for determination of the dose.
The processor uses its own equip-ment and merely reports the dose back to the labo n tory which compares the reported dose to the delivered dose and notifies NVLAP of the results.
Adoption of ANSI N13.11 as suggested would not relieve licensees of the necessity of submitting dosimeters to an outside testir.g laboratory.
Sec-tion 2.2 of ANSI N13.11 requires irradiation of test dosimeters and evalua-tion of the processor by a testing laboratory that is independent of the DRAFT 04/18/86 25 Enclosure C
licensee's operation. The staff feels that this option is identical to',
Alternative 2 in the proposed regulation which has already been rejected in favor of Alternative 3, Option B.
In regard to the statement that con-flictsmayobcurbetweenanNBSprovisionmetbyaprocessorandanNRC-requirement on a licensee, the staff can think of no conflict.
It is the
/
responsibility of the licensee to use a processor which is able to provide measurements of t'.he radiation fields that exist in the licensee's estab-lishment.
It is assumed in the dosimetry accreditation program, that if a processor can calibrate its dosimetry system to meet the requirements of a testing program, it can and will make any adjustment necessary to meet the requirements of the licensee to whom it provides services.
15.
Commenter #70:
Commenter makes the point that it is unreasonable to expect such fees to be paid by nonprofit organizations and that the regulation y
makes no distinction between profit-making setyhce and' nonprofit-inaking
\\
educational institutions.
Implementation of the rule will discourage t
small institutions from performing their own dosimetry with resulting delays between personnel exposure and readout which should be kept to a minimum.
Commenter then expresses concern that the present rule will set a precedent for requiring accreditation fees 1 for extremity monitoring and bioassay.
?
Staff Response:
Commenter is referred to General Comments A through D.
The accreditation procedure requires the development and testing of accept-able standards and generally requires several years before such procedures can be required by regulation.
16.
Commenter #89:
Commenter expressed the opinian that the testing standards used by the University of Michigan were d t a realistic state-of-the-art level and that:
"U.M. processed and evaluated the proficiency based on a series of " mumbo-jumbo" statistics and standards which defined " deep doses," uin doses, etc., in different terms than were norm in the dosimetry field."
DRAFT 04/18/86 26 Enclosure C
The commenter also goes on to object to the cost stating:
"A company which processes $300,000 of badges will pay from 1-3%
direct cost each year. for proficiency tests and an additional 3-7% of in house expense for the associated quality control."
Staff Response: The NRC staff disagrees with the contention that the test-ing standards were not realistic.
Commenter is referred to the staff response to comment 2 of this section for information on this subject.
With regard to the comment on " mumbo-jumbo" statistics, NUREG/CR-2891,
" Performance Testing of Personnel Dosimetry Services; Final Report on Test
- 3," states that a few processors had not read the standard and did not understand the terminology such as shallow and deep dose equivalents which explained their dismal performance in Test #3.
In regard to the costs to the processor as stated above, these percentages translate to costs rang-ing from $12,000 to $30,000 per year.
Based on the present proficiency testing fee schedule, and an estimate from NVLAP on in-house expenses for QA, the estimated fees are closer to $3,000 to $8,400 per year.
Commenter is referred to the General Comments A through D also.
17.
Commenter #90:
This comment is essentially identical to comment 15.
Staff Response:
See response to comment 15.
18.
Commenter #95:
This comment is essentially identical to comment 10 but goes on to urge that nonprofit organizations be exempt from the fee if 4
they are normally required to monitor only a small number of workers but prefer to provide widespread monitoring for enhanced control.
'f
)s Staff Response: Commenter is referred to the General Comments A through D.
19.
Commenter #96:
Commenter is a small processor that participated in all three testing programs offered since 1978 and who states that the quality of his service has increased as a result of this participation.
Commenter then I
, states that the fees are too high, unrealistic, and anti-small business.
Staf t' Response:
Commenter is referred to the General Comments A through D.
1 1
ORAFT 04/18/86 27 Enclosure C l
l
CATEGORY V.
MISCELLANEOUS COMMENTS:
Nine commenters provided comments in this category.
One of these also commented in another category.
1.
Commenter #26:
Commenter reproached NRC for allowing dosimetry processing to continue for so many years without requiring some form of dosimetry processing accreditation.
Commenter also feels that it is the responsibil-ity of the NRC to reveal the names, addresses, and results of all dosim-etry processors which participated in the third round of testing at the University of Michigan and to reveal the types and models of all dosim-eters that did not pass specific test categories.
Commenter also goes on to recount that one-third of the workers at Three Mile Island are not badged and are at a disadvantage if they ever have health problems since they do not have badges to record their exposure.
Staff Response:
Voluntary dosimetry testing programs have been in exist-ence for years but participation in such programs has been less than sat-isfactory.
It was not possible, however, to institute a requirement for accreditation of such dosimetry processing until a performance standard was developed to establish uniform criteria for such accreditation.
The present performance standard, ANSI N13.11 was not approved until 1982.
The names and addresses of the 56 participants which completed the third round of testing at the University of Michigan were published in NUREG/
CR-2891, " Performance Testing of Personnel Dosimetry Services", Final Report of Test #3,1983 and is available from the National Technical Infor-mation Service.
(See response to Comment IV-2).
The results of the indi-vidual processors and the models and types of dosimeters they used was confidential.
Each processor was assigned a code number known only to the l
testing laboratory and all results were published in reference to these numbers. All processors currently accredited under the NVLAP program are listed in the NVLAP directory.
In regard to the dosimeters at THI, licen-l sees are required to provide badging only to those workers who are likely to be exposed to radiation at levels above those specified in 10 CFR 20.202(a).
l
[
t l
DRAFT 04/18/86 28 Enclosure C
2.
Commenter #47:
Commenter stated that studies conducted by DOE indicated that ANSI N13.11 is inadequate in terms of the complexity and advanced level of the DOE contractor dosimetry programs.
Commenter also objects to the fact that the NVLAP program does not include a requirement to up-grade dosimetry processing performance.
Commenter is asking NRC to include a paragraph in the final rule that would acknowledge the acceptance of a parallel program of equal or greater ouality in place of the NVLAP accredi-which tation program, or exempt licensees whv are also DOE contractors.or which are located on DOE sites and whose dosimetry is performed according to the i
requirements of the DOE Laboratory Accreditation Program (DOELAP).
Staff Response:
NRC is aware of commenter's position but at this time chooses not to grant exemptions to DOE contractors or to include the i
suggested paragraph in the final rule.
It is the staff's understanding that at present the DOELAP program is only a paper program and until successful implementation has been demonstrated, acceptance by the NRC would be premature.
Staff is also aware of plans to merge both the DOELAP and NVLAP programs at some time in the future.
The NVLAP program does have plans to provide data that can be used to upgrade dosimetry.
3.
Commenter #50:
Commenter prefers Alternative 2 but states that Alterna-tive 3B is also acceptable although somewhat more restrictive.
Commenter does not believe that pocket and extremity dosimeters should be exempt from the rule and feels that it might be advisable to wait on the proposed rule until standards have been developed for extremity dosimeters.
An alternative suggestion is to include these dosimeters within the framework of the rule to the extent possible, considering the problem with accept-able standards.
Staff Response: At the present time, there is no acceptable consensus standard for extremity dosimeters.
Even when one becomes available it will be necessary to test it against current dosimetry practices and pro-cedures to determine its suitability, a process that could take two years 4
The staff feels that no good purpose would be served in delaying or more.
the proposed rule to require accreditation of processing for whole body and skin dosimeters.
j DRAFT 04/18/86 29 Enclosure C 4
n.,~
g
,-,-n-
,.,a
,-,,g-.
-,,._----,-m----,-,,..
e---,
--a,,.e-w-w_,.-,n,--,ww
.ne
--- - -. - g
---e,,--e
4.
Commenter #51:
Commenter concurs in the proposed rule and endorses Alter-native 3 - Option B.
Commenter is concerned that if a dosimetry system is designed to accurately assess the primary' component of personnel dose, other components tend to be assessed in a conservative manner.
Commenter J
feels that the NVLAP criterion "L" should be skewed toward higher values for radiations which are not the primary concern, i.e. the tolerance limit should be less stringent for reporting doses high for these radiations.
Staff Response: With the present availability of multi-channel (windows)
TLDs all. radiations can be reported accurately.
5.
Commenter #52:
Commenter approves of the proposed regulation and feels that it is overdue.
Commenter however feels that the proposed amendment, section 20.202(c)(2) as drafted may be interpreted to mean that the f
accreditation process is equivalent to approving dosimeters for use in i
work environments in which people are monitored.
Staff Response:
This section has been rewritten in the final rule to more clearly define the intent of the accreditation process.
In addition, a section of the NVLAP accreditation requirement limits the representation of the scope of accreditation for a processor's clients to only those tests or services for which the processor is granted accreditation.
Also accredited processors are required to inform their clients that the accred-itation process in no way constitutes or implies product certification, approval, or endorsement by NBS.
6.
Commenter #53:
Commenter addresses issues that are not germane to the l
final rule.
T 4
Staff Response:
None.
7.
Commenter #56:
Commenter believes that the proposed rule has merit.
He 4
also feels that a processor could reasonably choose radiation test cate-gories for accreditation purposes and then be placed in an untenable posi-tion by an NRC inspector who disagrees with his decision.
Commenter goes on to point out two radiation categories for which he feels that nuclear DRAFT 04/18/86 30 Enclosure C
-.. _ ~,
..__,_m
power plant licensees need not be tested.
In order to prevent such a situation from arising, commenter recommends that NRC issue guidance on i
choosing such categories either be in a Regulatory Guide or some other document.
Staff Response:
The NRC will issue a Regulatory Guide to address this and l
other identified problems.
i 8.
Commenter #57:
Commenter agrees with the concept of utilizing the services of accredited processors but has numerous concerns regarding implementation of the NVLAP and the specific standards used.
Also commenter is concerned that changes in the LAP be published in the Federal Register with suffi-cient time for comment and with implementation time sufficiently long to allow processors to accommodate the changes.
Commenter has many comments on the contents of the Dosimetry Lap Handbook issued by NBS, particularly in regard to onsite assessment and the freedom of the assessor to make judgements.
Commenter is also concerned that the processor may have to use one algorithm to pass the accreditation tests and another algorithm to 4
process routine badges particularly in situations where the licensees working conditions are not adequately simulated by the ANSI test categories.
2 Staff Response:
In regard to changes in the dosimetry LAP,p e commenter th is referred to the staff response the General Comments in Category IV. The Dosimetry Lap Handbook specifically addresses the considerable latitude 7
granted to assessors in making judgements about laboratory compliance and further specifies that a laboratory (processor) has the right to appeal the assignment of an assessor and request an alternate.
NVLAP is also interested in obtaining names and addresses of potential assessors from processors or others to expand its pool of qualified personnel in this O
shev M
^
_._;gualifiedprocessorsw4+tbeabletodevelop area.
algorithms suited to situations not represented by the ANSI test cate-gories and this ability is one of the areas that is to be addressed in the i
onsite assessment.
Processors not able to demonstrate proficiency in this area will not be accredited.
For other specific questions regarding i
DRAFT 04/18/86 31 Enclosure C i
l 4
,,y.-..--%oy
_,_.__-.,.,m_.,-_,,_.-y.._,_r,,,.,-.-
,,,,--,_--..,...,,_m,w,.,
,,_,y.,yym m-y,,
,-,,,-,-.-,-n,w,,_,.
the dosimetry LAP the comenter is referred to appropriate personnel at NBS whose names appear in the Dosimetry Lap Handbook.
9.
Comenter #83:
Comenter applauds NRC for its intent and makes some suggestions.
The first involves the dilema of confusing exposure of dosimeters with dose to the person wearing the dosimeter.
Comenter urges a general review of the language of the proposed rule to emphasize this distinction.
Comenter then expresses concern over the costs of accred-itation of large medical facilities that process their own dosimeters.and where most of the exposures are minimal.
Comenter then states that at these low levels the statement of a 15% variance is unproductively precise.
Staff Response:
The supplementary information section of the final rule points out that the dosimeters must be processed accurately and consis-tently and interpreted correctly to obtain adequate dose estimates.
This would seem to imply that the dosimeter is an analogue detector and that an algorithm is needed to convert its output into dose, in much the same way that the rotation rate of a car's wheels is converted into a car's speed as indicated on a speedometer.
In regard to the question of costs, the commenter is referred to the General Coments in Category IV.
The reference to a variance of 15% must be a misunderstanding.
ANSI N13.11 uses tolerance criteria of r
protection categories and
.3 for accident categories.
o.3 i
DRAFT 04/18/86 32 Enclosure C
FINAL REGULATORY FLEXIBILITY ANALYSIS For NRC licensees who are required by NRC regulations such as 10 CFR 20.202(a) and 10 CFR 34.33(a) to provide monitoring to workers, this rule will require them to have dosimeters which require processing, processed by a processor which has been accredited by the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Bureau of Standards (N85).
Currently NRC licensees are not required to utilize the services of accredited processors since performance requirements for dosimetry processing are not included in the regulations.
This rule establishes common testing and quality assurance procedures for dosimetry processing based upon a national consensus standard, ANSI N13.11, and 4
should eliminate many current problems that include inappropriate calibration sources, poor process control, inadequate instrumentation, and clerical errors.
The NRC considers that this form of accreditation by NVLAP is needed to provide improved health and safety benefits to occupationally exposed workers
}
through improvements in the accuracy of reported dose estimates and to provide credibility to reports of worker overexposures.
The need for performance requirements for dosimetry processors was recognized as early as 1955 when the Atomic Energy Commission funded the NBS to undertake the first intercomparison i
of film badge response.
Unfortunately, no suitable performance standards were developed prior to 1
ANSI N13.11 in 1983.
At issue are the following:
I The commercial dosimetry processing business is highly competitive.
Well qualified firms compete against less qualified firms.
i Many customers of commercial processors have little expertise in dosimetry processing.
Customers generally contract to the lowest bidder.
Less qualified firms may neglect technical and operational details j
to keep their prices low.
I 05/13/86 1
Enclosure D i
_ _, ~. _.... _ _. _ _ _. _
_~
Well qualified firms may reduce the quality of their processing performance in order to remain competitive.
In order to maintain quality processing, it is imperative that standards of performance and accuracy be adopted.
l Accreditation under NVLAP involves three separate actions:
(1) documenta-tion of responsible personnel, equipment, facilities, and quality control proce-dures; (2) proficiency testing of dosimeters in accordance with the procedures
)
of ANSI N13.11; and (3) on site assessment by NVLAP assessors of operations, equipment, and quality assurance procedures.
Costs to the dosimetry processors for NVLAP accreditation depend to a large extent on the size of the processing l
operation.
These consist of an initial cost associated with documenting and setting up quality control procedures, biennial costs associated with proficiency
}
testing, and maintenance costs for the in-house QA program.
The initial one-time cost of setting up the program is estimated to be about $7,000.
The NRC staff believes that the majority of dosimetry processors have already incurred this cost in association with the three rounds of performance testing conducted by the University of Michigan. Maintenance costs for the QA program are esti-6 mated by NVLAP to range from $2,000 biennially for a small processor to $6,500 biennially for the larger processors.
Proficiency testing costs vary consider-i ably according to the number of different dosimeter types tested.and the number i
)
of categories tested for each type.
Typical costs for a small processor with j
one dosimeter type tested in one category is $3,700 biennially, while costs to a larger processor with one dosimeter type tested in all eight categories is 3
$10,250 biennially.
There is also a one-time fee for new applicants of $450.
There are currently 90 known personnel dosimetry processors in the U.S.
l which perform personnel dosimetry services either in-house or commercially. Ten of these are considered to be "small entities" as defined in Section 601(3) of l
the Regulatory Flexibility Act.
The source of this information is a letter
(
dated November 8, 1982, from the University of Michigan (UM) written in con-junction with a series of three pilot tests on personnel dosimetry processors j
conducted by UM under an NRC contract.
A copy of the letter is available for inspection upon request or copy for a fee at the NRC's Public Document Room, 1717 H Street NW, Washington, DC.
The total volume of business within the dosimetry processing industry is j
estimated at $34 million annually with the 10 small entities identified above l
sharing approximately 0.5% of the market or $170,000.
While the NRC does not 05/13/86 2
Enclosure D 1
l_ _ _ _ _. _ _. _ _. _ _ _. - _, _.. _ _ _ _ _ _.. _ _ _ _
i know the distribution of this volume of business among these small entities, an equal distribution of the business would create an average income of $17,000.
The initial cost of $7,450 and biennial cost of $5,700 for NVLAP accreditation of small processors cited above will have a significant impact on processors whose annual income is only $17,000.
Comments received from licensees and the processing industry on the proposed 4
rule and initial regulatory flexibility statement included many that objected to the costs of the program.
Most of the commenters felt that the costs of the NVLAP program could be reduced significantly for small processors by eliminating the in-house assessments by NVLAP assessors.
Others felt that a differential fee schedule should be adopted for small processors, and a few felt that the quality assurance inspections should be conducted by NRC rather tha'n NVLAP personnel.
The Commission believes that third party accreditation under NVLAP will provide and maintain the much needed improvement in dosimetry processing.
Consideration of this finding and the alternatives considered are described in the Regulatory Analysis. The Commission rejects the concept of different compliance and/or reporting requirements (such as preferentially eliminating in-house NVLAP assessments) between small and large processors since this concept is counter to the initial goal of establishing uniform and consistent procedures throughout the dosimetry industry. The Commission likewise rejects the suggestion that NRC quality assurance inspections should be substituted for NVLAP inspections since these inspections or assessments are an essential part of the laboratory accreditation program and fall under the jurisdiction of NBS.
Also, the Commis-sion has investigated a differential fee schedule based on the size of the pro-cessor and finds that legal rulings prohibit the application of such differen-tial fees (See 43 FR 7210, 1978; 46 FR 49573, 1981; 49 FR 21293, 1984).
Dif-ferentiation of fees based upon business size is viewed as a tax and is not allowed except by legislation.
Small processors should be aware that grants are available from the Small Business Administration to assist small businesses meet Federally imposed licensing fees.
The Commission has considered the impact of a mandatory NVLAP and had con-cluded that the benefits that would result to workers, licensees, the NRC, and the general public render it necessary in spite of the program's possible economic impact on small entities.
05/13/86 3
Enclosure D
I BACKFIT ANALYSIS The NRC "backfit rule" (10 CFR 50.109) states:
"Backfitting is defined as the modification of..., or procedures or organization required to design, construct or operate a facility; any of which may result from a new or amended provision in the Commission rules...."
Since the rule requiring accreditation of dosimetry processors represents a modification of procedures required in the operation of a facility, it is subject to a systematic and documented analysis in conformance with S 50.109(c).
The following represents a systematic and documented analysis according to the nine-factor outline considered in S 50.109(c).
1.
Statement of the Specific Objectives to be Achieved The principal objective of the rule is to improve the accuracy of dosimetry pro-cessing by imposing a uniform set of procedures and performance standards on the personnel dosimetry processors, including those of nuclear utilities. All licensees will be required to obtain accreditation from the National Voluntary Laboratory Accreditation Program operated by NBS if they do their own processing in-house.
Otherwise they will be required to use commercial processors who are accredited by NVLAP.
The use of standard tests and quality control programs for calibra-tion and readout procedures will ensure that all occupationally exposed workers will have their personnel dosimeters evaluated against an acceptable national standard, regardless of which processor does the work.
The principal health and safety benefit that results from imposition of this rule is the increased cred-ibility of the recorded and reported occupational dose, allowing the NRC, the employer, and employee to better assess and control the radiation hazards of the workplace.
1 I
1 Enclosure E
2.
General Description of the Activity to be Required of the Licensee or Applicant The licensee or applicant will be required to have its dosimetry processing activity accredited by NVLAP.
If this activity takes place in-house, the licensee or applicant would be required to develop an in-house quality assurance program, submit certain dosimeters to a proficiency testing laooratory (PTL) for testing, and agree to periodic inspections by NVLAP personnel.
It should be noted that the in-house quality assurance program is now required under Appendix B to Part 50 and does not constitute an additional requirement.
3.
Potential Change in the Risk to the Public from the Accidental Off-Site Release of Radioactive Material The dosimetry accreditation rule will have no effect on accidental off-site releases.
4.
Potential Impact on Radiological Exposure of Facility Employees The dosimetry accreditation rule is expected to provide a more accurate assess-ment of individual worker radiation exposure.
It will therefore result in increased safety by ensuring that those individuals whose doses are now being underestimated, will not be overexposed as a result of poor quality dosimetry processing.
In addition the improved accuracy of measurements is expected to result in improved controls and in benefits under the ALARA concept.
5.
Installation and Continuing Costs, Including the Cost of Facility Downtime or the Cost of Construction Delays The cost of installing the required quality control system is estimated at approximately $7,000, but, since Appendix B to Part 50 requires a quality con-trol system, there should be little or no cost involved among licensees in com-pliance in adapting the existing system to meet NVLAP requirements.
The cost of proficiency testing depends upon the number of dosimeter types used and the number of categories for which each dosimeter must be tested.
For a single j
dosimeter tested for all eight categories in the national standard ANSI N13.11, 2
Enclosure E l
the cost is $10,250 biennially.
No other costs are anticipated.
No facility downtime or construction delays will occur as a result of the requirements specified in this rule.
6.
The Potential Safety Impact of Changes in Plant or Operational Complexity, Including Relationships to Proposed and Existing Regulatory Pequirements The dosimetry accreditation rule will not require changes in plant design or operational complexity except that NVLAP procedures may require a larger area than is currently being used for dosimeter calibrations in order to reduce radiation scattering and other such effects.
No other changes are anticipated and no potential safety impact is expected.
7.
The Estimated Resource Burden on the NRC and the Availability of Such Resources Possible costs to the NRC are those associated with revision of the Office of Inspection and Enforcement inspection procedures to prevent duplication of in-spection in those areas where NVLAP inspections occur.
Since the net effect should be a reduction in required NRC inspection time, no significant costs are anticipated.
One other anticipated cost is the development of a Regulatory Guide to assist licensees to establish the required test categories for their operations.
This Regulatory Guide will require an estimated 0.3 staff years.
No technical support effort is anticipated.
)
8.
The Potential Impact of Differences in Facility Type, Design, or Age on I
the Relevancy and Practicality of the Proposed Action The dosimetry accreditation rule is concerned with operating procedures so that differences in type, design, or age would not contribute any additional impact.
9.
Whether the Proposed Backfit is Interim or Final and, if Interim, the Justification for Imposing the Proposed Backfit on an Interim Basis The backfit is intended as final.
3 Enclosure E
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Conclusion:==
If one assumes that about one quarter, or 300 of the 1200 individuals badged at a typical nuclear reactor site have their dosimeters underestimated by a factor of 3 (a factor found to apply to most dosimetry processors in the early round of prof.iciency testing), and if the average recorded individual annual dose is 0.7 rem, then these 300 individuals have probably been exposed to an additional unrecorded 1.4 rem each.
Adoption of the dosimetry accreditation rule would provide a significant improvement in safety by preventing this addi-tional exposure of 420 person-rem annually.
At an estimated cost of $1,000 per person-rem, this results in a saving of some $420,000 annually, far in excess of the average annual costs of some $5,000 to the reactor facility' to maintain personnel dosimetry accreditation.
An additional benefit of the NVLAP program to nuclear power plant operations has been described by the American Nuclear Insurers in their Information Bulletin 85-1A.
This bulletin points out that although the principal benefit of the NVLAP program is greater worker protection, the accreditation will lead to better claim defensibility because of the reduced uncertainty and increased objectivity of dosimetry methods in the event that dosimetry measurements are used in radiation claims litigation.
4 1
4 Enclosure E
CONGRESSIONAL LETTER
Dear Mr. Chairman:
Enclosed fo. the information of the Subcommittee are copies of a public announcement and a final amendment to 10 CFR Part 20 published in the Federal Register.
The Nuclear Regulatory Commission is amending its regulations dealing with personnel radiation monitoring.
For NRC licensees who are require,d by NRC regulations to provide monitoring to workers, this rule will require them to have dosimeters which require processing to be processed by personnel dosimetry processors who have been accredited under the National Voluntary Laboratory Accreditation Program operated by the National Bureau of Standards. The amendments will result in greater uniformity and accuracy in personnel dosi-metry processing and recording for all affected licensees and are expected to improve the records of non-required dosimetry as well.
The Commission is it suing the final amendment with an effective date one year after publication in the Federal Register.
Robert B. Minogue, Director Office of Nuclear Regulatory Research
Enclosures:
1.
Public Announcement 2.
Federal Register Notice l
l l
i i
l l
l Enclosure F k
PUBLIC ANN 0UNCEMENT NRC AMENDS ITS REGULATIONS ON PERSONNEL MONITORING The Nuclear Regulatory Commission is amending its regulations dealing with personnel radiation monitoring.
The changes will establish performance-standards for the processing of dosimeters that require processing to determine the radiation dose delivered to the dosimeters.
Among the various types of personnel monitoring in use are dosimeters such as film badges, track-etch dosimeters, and thermoluminescent dosimeters, (TLDs),
all of which require processing to yield the radiation dose.
The amendment will require that whenever such dosimeters are provided to personnel in order to meet regulatory requirements, NRC licensees are to use or provide the services of personnel dosimetry processors who have been accredited under the National Voluntary Laboratory Accreditation Program operated by the National Bureau of Standards.
A series of tests of personnel dosimetry processors against a national standard revealed that a significant percentage of processors were not performing at a level of accuracy acceptable to the NRC. While most of these who failed to meet the test criterion did so by factors of 2 to 4, for some processors this factor was much higher.
The amendment will provide more accurate measurements and records for personnel radiation dosimetry records through application of uniform performance standards to the processing of all dosimeters required by regulation.
Although the amendment will not apply to those personnel dosimeters supplied voluntarily to persons not required by regulations to have such dosimeters, the public awareness generated by this amendment is expected to produce significant improvements in all dosimetry processing.
9 i
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Enclosure G
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