ML20212D428
| ML20212D428 | |
| Person / Time | |
|---|---|
| Issue date: | 12/03/1986 |
| From: | Stello V NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| Shared Package | |
| ML20209A892 | List:
|
| References | |
| FRN-49FR1205, RULE-PR-20, TASK-RIA, TASK-SE AA39-2-004, AA39-2-4, SECY-86-360, NUDOCS 8701020005 | |
| Download: ML20212D428 (76) | |
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RULEMAKING ISSUE SECY-86-360 December 3, 1986 gj gj g For:
The Commissioners From:
Victor Stello, Jr.
Executive Director for Operations
Subject:
APENCMENTS TO 10 CFR PART 20 TO REQUIRE THE USE OF ACCREDITED PERS0"'4EL 00SIMETRY FROCESSORS -
Purpose:
To ob. tin Comission approval of a notice of final rulemaking.
Isstie:
Whether to require NRC licensees to use an accredited procescer to pro:ess personnel dosir.eters that are utilized by them to comply with certain hRC requirements.
Discussion:
NRC licensees are required to provide personnel monitoring equip-ment to certain individuals as specified in 10 CFR 20.202(a) and 10 CFR 34.3?(a), and to maintain these individuals' radiation exposure records as specified in 10 CFR 20.401(a) and 10 CFR 31.?'fe). Among the types of monitoring equipment in use arc dosi'eters such as film badges, track-etch-type dosimeters, and thermo.uminescent dosimeters (TLDs), all of which require processir.g in order to determine the radiation dese by observing a partict:D r radiation-induced effect in the dosimeter.
Although the proce; ing of these dosimeters must be done accurate 1y and ccnsistenti/ to p-ovide acceptable dose values, NRC regulations have not 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 licentees to ccnform to the NRC regule. tory requirements.
Problems with dosimetry processing were recognized as early as 1955 when the Atomic Energy Commission contracted with the National Eureau of Standards (NBS) to cceduct an intercomparison of filin badge interpretations.
Des' ite the er.rly recogni d
identification of problems from thi and subsequent stu
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Centact:
Donald O. Nellis, RES 4a3-7989 b
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$ The Cerrrissioners 2
o-r was not until 1976 that the Health Physics Society Standcrds (conittee (HPSSC) recorrended a suitable performance standard for personnel dosimetry processing. Between 1977 and 1979, the NRC sponsored two rounds of proficiency testing of prccessors afainst this standard at the University of Michigan. The results of these tests indicated that a significant percentage of the pro-cessnrs were not performing at a level of accuracy acceptable to the NRC. Most of those who failed to pass one er more of the test categories exceeded the tolerance limit (or criterion) by factors of 2 or more, indicating that only minor adjustments in procedures were probably needed.
For sor.e processors, however, this factor was as high as 2,000, 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 pro-cessors ar.d, on March 28, 1920, issued an Advance !!otice of Pro-posed Rulemaking (AtiPRP) (45 FR 20493). The ANPPM presented four alternatives for the operation of a proficiency testing labora tory. During the comment period, 46 ccrrrrent letters were received. The majority stated a preference for a laboratory controlled by the Federal Governnent, and a fifth alternative for the operation of a proficiency testing laboratory was identified.
This alternative would utilire the National Vrluntary Lctoratory Accreditation Program (NVLAP) operated by the National Bureau of Standards (NBS).
Several of the cerrment letters also rc.ouested a l
third round of performance testing against the HFSSC standard, which had been significantly revised follovirg the first two rounds of testing.
Asaresult,theNRCaskedNBSin19Cbtoestahlishenaccredita-tion program under NVLAP for personnel dosimetry processcrs and, in 1981, authorized a third round of performance testing against i
the revised HPSSC standard by the University of Michigtn.
The third round of performance testing was completed in 1982, and analysis of the results indicated that, although 25% of the radiation cateoory tests attempted v.ere not passed, 78*. of the individual dosiretor readings were within 230% of the true dose delivered to the dosimeters.
This compared to 62% for the first rrund of testing and 73". for the second, indicatirg that person-nel dosinetry processors were capable of ccosiderable improve-nnt.
In light of these results, the hRC published on a flotice of Proposed RulemaHng (NPRM) 10,)1964,that would require NRC licensees tc utilize the January (49 FR 1205 services of processors accredited under the flVLAP of the f ational Bureau of Sterdards for prccessino resonnel dosirreteri that are l
utili:ed te comply with NRC regulations.
Also included in this NPRM was a notice concerning the t.vailability of dosir.'etry l
accreditation through f4VLAP starting in January 1924 L
y.
.The Cemissioners 3
o p
The NRC received 96 public cement letters in response to the NPRM, most of which were favorable. The major objections to the rule were the costs to small processors and rccdical and hospital licensees. Ar analysis of coments has been prepared and rray be found in Enclosure C to this paper.
The NVLAP accreditation program was initiated in January 1984 NVLAP ana1yzed the results of the first 1-1/2 years of operation of that program and found that 90% of the individual dosimeter reedings were within 130% of the true dose delivered to the dosi-neters.
Since the number of dosimeters used in the NVLAP analysis was approximately the same as the number used in each of the three rounds of testing, one can have confidence that the improvement shown in individual dosimeter readings of the NVLAP analysis over the individual dosimeter readings of the pilot tests reflects the value of the accreditation program. Also, the pass-fail criterion used in the NVLAP accreditation ensures that the recorded dose will be within + 50% of the actual dose at the 95% confidence level. The NVLAP aiialysis can often detect the source of processor errors, and this information is promptly relayed to the processor. The analysis iridicates all processers should be able to meet a standard deviation of less than 70% for the 15 dosimeters required for each radiation category.
The long time interval since the early reccgnition of this prob-
'on to the present (about 30 years) without ar effective remedy is disquieting anc' potentially ernbarrassing erd does not reflect the importance anc urgency of impreving the accuracy and relia-bility of worker radi; tion dose records. The integrity of worker dose records is essential because:
(1) The NRC needs accurate dose information on workers in order to regulate properly.
(2) hRC licensees need accurate dose information on workers ir order tc control risks and to ecmply with regulations.
(3) k'orkers need accurate dose information:
(a) Tc assure tbcn that their working cerditions are safe.
(b)
To assure them that their deses are not being overesti-mated ard that their availability for work is thereby being limited ernecessarily.
(4)
Accurate dose informatien will be important in the future use of these data for epidemiology studiet to improve know-ledge concernint] the efftets of low-level radiction.
In early 1984, the American Nuclear Insurors 4rsued a bulletin to their nucleer utility policy holders recomrrendirg that they or their corrercial desinetry procctsers participate in ite FVLAP
[Tr'e iphnissicners 4
o progran.
Fifty-four of the 90 kncwn processcrs have new voluntarily applied for accreditation under NVLAP, and 45 of these are currently accredited.
If this rule is not approved in the near future, these processors may drop out of the program in order to better compete with the processors that have not yet applied for accreditation.
The preposed final rule has been developed ir cencert with other Federal and State agencies that are waiting for MRC to promulgate the rule prior to imposing similcr requirements on persons or organizations under their jurisdictic.n.
The progran is self-supportinc from fees paid by the processors, and it will have little effect er staff rescurces (less than 0.1 FTE per year).
Recowcrdation:
That the Comission:
1.
Approve publication in the Federal Register of the final amendrentstoPart20(EnclosureA)thatwouldbecome effective 1 yeer after publication in the Federal Register.
2.
Approve the staff's conclusions set forth in the Final Regu-letory Flexibility Analysis (Enclosure D) that the benefits to the public health ard safety that would result from the proposed accreditatice programs outweigh the program's pos-sible economic impact upon some small entities.
The Chief Counsel fur Advocacy of the Small Eusiness Administration will be informed of this rulemaking and the ressen for it, as required by Sectiun C0F(b) of the Regulatory Flexibility Act.
3.
Approve the staff'r cenclusions set forth in the Backfit Arolysis (Enclosure F) which provides the analysis called for by the Backfit Rule cf Part 50 of NRC's regulations.
4 Note that:
a.
With respect to the Agreement States, this item will be race a matter of ccepatibility because it concerns basic rtdiation standards, b.
The appropriate Congressional conn.ittees will be informed.
c.
A public ernouncenent such as Ecciosure G will be issued when the Federal Fegister notice is filed with the Office of the Federal Pegister, d.
Copies o' the final rule will be scnt to all NRC licensees, to all known personnel desiretry processors, and to other interested pertens and orger.izations ty the Office of Adminif tration.
' The' do~mnissioners 5
o-e.
This final rule does not contain a new or amended information collection recuirement subject to the Paperwork Reduction Act of 1980(44U.S.C.3501et seq.).
Existing requirements were approved by the Cffice of Management and Budget approval number 3150-0014.
f.
This final rule is the type of action described in categoricalexclusion10CFR51.22(c)(3). Therefore, neither 6n ervironmental impact statement nor an environmental assessment has been prepared for the final rule.
.3
~
'sl
's i
cVTctor'5tello, Jr.'
Executive Dir ctor for Operations
Enclosures:
A.
Federal Register Notice B.
Regulatory Analysit C.
Analysis of Coments D.
Regulatory Flexibility Analysis E.
Backfit Aralysis F.
Draft Congressional Letter G.
Public Announcement Commissioners' comments should be provided directly to the Office of the Sceretary by c.o.b. Friday, December 19, 1986.
Commission Staff Offico comments, if any, should be submitted to the Commissioners NLT Friday, December 12, 1986, with an infornation copy to the Office of the Secretary.
If the paper is of such a nature that it requires additional time for analytical review and comment, the Commissioners and the Socrotariat should be apprised of when comments may be expected.
This paper is tentatively scheduled for affirmation at an Open Moeting during the Week of January 5, 1987.
Please refer to the appropriato Wookly Commission Schedulo, when published, for a specific dato and time.
DISTRIBUTION:
Commissionern REGIONAL OFFICES OGC (11 Stroot)
EDO O!
OGC (MNBB)
OCA ACRS OIA ASLDP OPA ASLAP SECY
r
[7590-01]
e.
o i
NUCLEAR REGULATORY COMMISSION 10 CFR Part 20 Improved Personnel Dosimetry Processing l
AGENCY: Nuclear Regulatory Comission.
l ACTION:
Final rule.
l l
SU* MARY:
The Nuclear Regulatory Comission (NRC) is amending its regula-tions to require all licensees to have personnel dosimetry devices that are utilized to coeply with NPC regulations processed by processors that have been accredited by the Natienal Voluntary Laboratory Accreditation Program (NVLAP)oftheNationalBureauofStandards(NBS). This action was initiated because performance evaluations of personnel dosimetry pro-cessors indicated that a significant percentage of such processors were not performing with a reasonable degree of accuracy. These amendrerits will result in greater uniformity and accuracy in personnel dosimetry.
EFFECTIVE DATE:
12 months from date of publication.
j FOR FURTHER INFORMATION CONTACT:
Donald O. Nellis, Division of l
Regulatory Applications, Office of Nuclear Regulatory Research, U.S.
Nuclear Regulatory Comission, Washington, DC 20555, Telephone:
(301) 443-7989.
Inquiries regarding the accreditation program for persorrel dosimeters at the Natioral Bureau of Standards should be addressed to l
Pobert L. Gladhill, Natieral Voluntary Laboratory Accreditation Prograr 1
Enclosure A
[7590-01].
'I (NVLAP), National Bureau of Standards, Administration A-531, Gaithersburg, MD 20899, telephone:
(301)921-3431.
SUPPLEMENTARY INFORMATION:
I.
DACKGROUND Personnel dosimeters are devices worn by workers to monitor their exposure to radiation. NRC licensees are required to provide such mont-toringdevicestocertainindividualsasspecifiedin10CFR20.202(a) and other applicable provisions of 10 CFR Chapter I.
Among the types of ronitoring equipment in use are dosimeters such as film badges, track-etch-type dosimeters, thermeluminescent dosimeters All (TLD's),anddirectandindirectreadingpocketionizationchambers.
of these, with the exception of the pocket ionization chambers, require processing in order to determine the radiation dose by observing a These dosineters particular radiation-induced effect in the dosimeter.
must be processed accurately and consistently and interpreted correctly to ensure the accuracy and integrity of worker dose records, to ensure that the NRC regulatory dose limits of 10 CFR 20.101 are not exceeded, and to ensure that dosimetry is provided in accordance with 10 CFR 20.202(a),
it is imperative, therefore, that the personnel dosinetry processing industry conform to performance standards that will ensure accuracy and uniformity of results.
Dosimetry Processor Performance Studies Problems in the personnel desinetry processing industry have been The commercial processing business has always apparent for many years.
been hi hly competitive, with corpotent and conscientious processors C
2 Enclosure A
[7590-01]
competirg with processors that are unable or unwilling to perform this work in a technically sound manner.
Customers of comercial processors, however, have often lacked expertise in dosimetry processing aEd often contracted their processing needs to the lowest bidder, so that the more qualified processors may have had to reduce the quality of their services in order to remain competitive.
Some 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 Comission (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 criterie.
Subsequently, several studies attempted to evaluate processor performance, but no method of comparing actual performance with the interim perfornance criterie was ever estt,blished.
Consecuently, the AEC requested in 1967 that Battelle Northwest Laboratory, now called Pacific Northwest Laboratory, conduct a study to determine a basis for film dosimeter performance criteria.I 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 prcmulgated at that time.
During the next few years, four separate standards were developed, and the NRC in 1976 contracted with Battelle to conduct a study to compare and evaluate dosimetry processors against the four I. Unruh et al., "The Establishment and Utilization of Film Dosim-M eter Perfornance Criteria," BNWL Sa2(1967) Richland, Washington, 99352, 3
Enclosure A
[7590-01) existing standards.2 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 Scciety Standards Comittee (HPSSC).
(Thisstandardwaspublishedasadraftin1978.)
In 1976, at the urging of the Conference of Radiation Contrcl ProgramDirectors(CRCPD)(representingtheStates),theNRC,theBureau of Radiological Health, and the 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 proficiency 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 should be modified.
(ItwasrodifiedinJune1981and waspublishedasANSIN13.11in1983.) The results also showed that a significant percentage of the processors were not performing to the degree of accuracy acceptable to the NRC, which indicated, in turn, that records and reports of worker whole body and skin dose could be considerably different from the actual dose received.
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 ensure this periodic evaluation.
2L. L. Nichols, "A Test of the Performance of Personnel Dosimeters,"
BNWL-2159(1977) Battelle Northwest Laboratories, Richland, Washington,
- 99352, 4
Fnclosure A
[7590-01) l Cecrdination Effort Cooperation and coordination with other interested organizations were initiated in 1977 with the formation of the Interagency Pelicy l
Comittee on Personnel Dosimetry, which included the Department of Defense, the Departmer.t of Energy, the Environmental Protection Agency, the NBS, the Occupational Safety and Health Administration of the Department of Labor, the Center for Devices and Radiological Health of l
the Food and Drug Administration of the Department of Health and Human Services, the CPCFD, and the NRC. Cooperation and coordination with the dosimetry processing industry were also enhanced in 1977 with the formation of the Industry Overview Cer.mittee on Personnel Desimetry to l
monitor the progress and development of the evaluation program and to ensure that any regulatory action taken would be appropriate and effective.
Advance Notice of Proposed Pulemaking On March 28, 1980, the NPC took the initial step in the rulemaking prccess with the publication in the Federal Register of an Advance Notice ofProposedRulemaking(ANPRM)(45FR20493).
The ANPPM discussed the y
l results of the proficiency testing against the PPSSC standard and the reed for rulemaking to irprove desirretry processing.
It presented four alternatives for the operation of a proficiency tetting laboratory that would conduct performance testing against the HPSSC standard. The ANPPM specified that any proficiency testing laboratory esttblished would be ronitored for technical conpetency by the NBS and that licensees would be required to use tosimetry services that satisfied criteria established by NRC and administered by the proficiency testing laboratory.
The four l
5 Enclosure A
[7590-01) alternatives for proficiency testing laboratory operations as described in the ANPRM were:
1.
Processors and licensees would establish one or more **
laboratories to administer preficiency 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 proficiercy testing laboratory.
4 Another Federal agercy experienced in laboratory testing would operate the proficiency testing laboratory.
Analysis of Coment Letters Forty-six coment letters were received in response to the AhpPM.
Twenty-one did r,ot state a preference for which alternative should be used in establishirg a proficiercy testing laboratory and three felt no prcficiency testing program was necessary.
Of the remaining 22, 20 expressed a preference for laboratories controlled by the Federal govern-ment (alternatives ?, 3, or 4). Commenters also incuired and cormented on control of the testing laboratory, on procedures to be used in the reputatory progran, and on various other problems that could result from a processor failint to satisfy the established criteria.
Several dis-cussed the importance of defining and requiring minimum elements of a generic quality assurance program that shculd be established as part of the dosimetry processine forformance criteria.
The major technical cuestions raised were those concerning th( selection of dose conversion facters within the standard.
Several of the comenting dosimetry pro-6 Enclosure A
[7590-01) cessors also requested a third round of performance testing to allow pro-cessors to be tested against the revised HPSSC standard before any
~~
rulemaking en dosimetry processing became effective.
National Voluntary Laboratory Accreditation Program (NVLAP) Alternative During the comment period for the ANPRM, a fifth alternative for the operation of a proficiency testing laboratory that would utilize the NVLAP of the NES was identified by the Interagency Policy Comittee.
NBS, in accordance with NVLAP procedures specified in 15 CFR Part 7, would contract the services of a proficiency testing laboratory to admin-ister proficiency testing of dosimetry processors against a performarce standard specified by the NPC (in this case ANSI N13.11).
The process of accreditation acccrding to NVLAP procedures would require three separato actions:
(1) completien of a NVLAF questionnaire and other application materials that involve documentation of responsible personnel, equipment, facilities and cuality control procedures; (2) successful performance in dosimetry proficiency testing in acccrdance with ANS! N13.11. " Criteria for Testing Personnel Dosimetry Performance";
and(3)onsiteinspectionbyNVLAPassessorsoftheprocessor'sroutire l
desir.ctry service with respect to processing protocols and associated minimum quality assurance criteria specified in NVLAP general and specific criteria and supplied to the processor upcn application for the program.
NVLAP would thus offer a system of third-party accredit 6tien by l
l a Federal Government agency, namely, the Department of Commerce (00C) l operating through the NBS.
In accition, the pass-fail criterion for 7
Enclosure A I
accreditation ensures that the recorded dose will be within + 50% of the '
I actual dose at the 95% confidence level.
In December 1980, the NRC asked the COC to establish, in"coordin-ation with NRC staff, an accreditatier program under NVLAP for personnel dosimetry processors.
In accordance with NVLAP procedures and authority (15CFRFart7),theDOCpublishedNRC'srequest(46FR9629)for development of such a Laboratory Accreditation Program (LAP) on January 29, 1981 and reouested public comment.
NRC sent a copy of the DOC Federal Register Notice and a description of the NVLAP to all known dosimetry processors and interested persons on February 6, 1961. All 19 letters of comment received were unanimous in their approval of the NVLAP elternative.
Consequently the NVLAP dosimetry LAP was started,in 1981 under an Interagency Agreement between NRC and NBS, and a proficiency testing laboratory was contracted by the NBS.
Proficiency testing and NVLAP accreditation of processors began in January 1984.
Additional Performance Testing Since the original HPSSC standard was significantly revised follow-ing the two pilot tests, the NRC staff sponsored a third round of per-formance testing against ANSI N13.11, which was completed in 1983.3 Seventy personnel dosimetry processors voluntarily participated in this rourd.
The standard provides a total of eight radiation categories in-volving high-energy and low-energy photons, beta particles, neutrons, and mixtures of these.
The procedure was for the processor to send 15 dost-3 Plato, P. and J. Miklos, " Performance Testing of Personnel Dosimetry Services:
Final Report of Test #3," NUREG/CP 2291, February 1983.
8 Enclosure A
[7590-01]
meters for each test category in which it wished to be tested to the testing laboratory. These dosimeters were then irradiated with doses known only to the testing laboratory and returned to the processor.
NBS had the responsibility of verifying the accuracy of the irradiations performed by the testing laboratory. The processor then determined the dose for each dosimeter and reported the results back to the testing laboratory for evaluation against the standard. The testing laboratory evaluated the processor's performance in accordance with the performance criterion specified in ANSI N13.11. Of the category tests attempted, an average of 25% failed.
This compares to failure rates of 52% for the first test and 387. for the second, as measured against the final standard.
Although the identity and individual results of the dosimeter test data were confidential to the proficiency testing laboratory, the con-tracter reported that the categories failed in this third round of test-ing were evenly distributed among large and small comercial and in-house processors.
In light of the results frcm the three pilot tests, the NRC concluded 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 checks of a processor's quality assurance program to improve the quality of personnel dosimetry processing.
II.
PROPOSED RULE in view of the corrents received in resperse to the ANPRM and the unanirous approval of the NVLAP alternative, the NRC published en January 9
Enclosure A
[7590-01]
10, 1984, a Notice of Proposed Rulemaking (NFRM) (49 FR 1205) that would require NRC licensees to use the services of dosimetry processors that have been accredited by the NVLAP of NBS.
Five alternatives were considered in drafting the NPRM, and an analysis of each of these is included in the Regulatory Analysis, which is available for inspection and copying for a fee at the NRC Public Dccument Room located at 1717 H Street NW., Washington, DC.
III.
SUMMARY
OF PUBLIC COMMENTS The NRC received 96 coment letters on the proposed rule, seme of which were duplicates, leaving a net of 93 letters, many of which contained mere than one coment.
All of the public coments have been considered, and the staff res-perscs to these comments are set forth in the Analysis of Coments document which is available for review and copying for a fee at the !!PC Public Document Roon lucated at 1717 H Street NW., Washington, DC.
Forty commenters approved of the proposed rule outright, 20 commenters approved of the rule but identified suggested changes or additions, and 6 commenters approved of that part of the rule recuiring accreditation of processors but were opposed to requiring the licensee to retain NVLAp certification records.
(This requirement has been deleted from the final rule.)
Nineteen commerters were opposed to the proposeo rule, prirarily because of the cost, and another eight contrenters provided miscellancous commer.ts on the rule.
A repeated comrent in opposition to the rule from medical and hospital licensees appears to be the result of a misunderstanding.
These 10 Enclosure A
[7590-01]
cercenters stated that the imposition of the accreditation requiremert would force them, on the basis of cost, to terminate their in-house monitoring services, which now provide supplementary or redundant dosi-meters to personnel that have their primary dosimeters processed by a corrercial processor, and to terminate dosimetry services not required by 10 CFR 20.202(a).
Other comnenters stated that a differential fec structure is needed to provide relief to small processors, that the onsite assessment should be waived for small processors as a means of reducing costs, and 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.
In regard to the suggestion that onsite assessment be waived for small processors, accreditation in the testing program under appropriate categories,asemphasizedintheproposednewi20.202(c)(2),deesnotin itself ensure 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 ensure 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 ccreent from medical and hospital licensees, it is not the intent of the NRC to discourage voluntary dosimetry or redundant dosimetry that is prcvided in addition to the required dosimetry. The subject regulation will not require the services of an 11 Enclosure A
[7590-01]~
accredited personnel dosinetry processor for such voluntary or redundar.t dosimeters.
It should be noted that there are also other methods of dose assessment such' as surveys, time ard motion studies, or use of pocket ionization chambers that do not require processing, all of which are outside the secpe of this rule.
Licensees who do not make a determination as to which personnel re-quire personnel monitoring te comply with 10 CFR 20.202(a) will be required to use an accredited personnel dosimetry processor for all dosimeters that need processing. Also, licensees who use dosimeters to' determine whether dosimetry is routinely required under 10 CFR 20.202(a) or other relevant NRC regulatiers will be required to use the services of an accredited processor for those test dosimeters. Those licensees that have made a commitment in their license application to provide personnel cosimetry to personnel for whom it is not required (under 10 CFR 20.202(a) or other applicable regulations) may apply for a license amendment to delete this requirement from the license before the effective date of the rule.
Nothing in this regulation precludes a licensee from providing voluntary dosimetry services whether such dosimetry utilizes accredited processing or not. The Comission, however, encourages the use of accredited processing for voluntary
(
dosimetry in order to provide the desired accuracy and reliability for all dose records.
After the effective date of the rule, dosimetry i
required by license conditions (which may reference commitments made in license applicaticos) must be provided by an accredited dosimetry processor.
With respect to clarifications that would enable licensees to deter-mine which radiation categories apply to their operations, it should be 12 Enclosure A l
t
[7590-01~1 pointed out that it has always been the responsibility of the licensee to provide appropriate and properly calibrated personnel inonitoring devices.
The rule te require NVLAP accreditation does not alter this
~
responsibility.
In view of the comments received, however, the NRC plans to issue supplementary information to help licensees to determine appropriate testing categories for their specific operations.
It is recognized that even the minimum fees charged by NVLAP can se-ricusly affect small d sirretry processors.
NRC has no authority to impose a differential fee structure since NES sets the NVLAP accreditation fees. These processors should be aware that grants may be available from the Small Business Administration tc assist small businesses in paying these fees. Also, licensees who believe that they should be exenipted from the requirements of this rule may apply for an exemption in accordance with 10 CFR 20.501.
A number of NRC licensees have expressed concern that, should their personnel dosimetry processor lose accreditation, they could be in non-compliance with the new regulation. The NRC believes, however, that few, if any, dosinietry processors will lose their accreditation and that ac-creditation less would be a relatively lengthy process. NVLAP accreditation is given for a two-year period; a processor would have ample warning during the retesting and renewal process that accreditation criteria were not being met.
It would be prudent for licensees to negotiate with their processors agreements which recuire current information ret;arding the reaccreditation process.
The NVLAP testing and accreditation program has been in operation for more than two years, and on the basis of this operating experience it has been found that a minimum of about six months is requireo for 13 Enclosure A
[7590-C1]
- processors to receive accreditation.
Since sorre processors fail the first round of testing, an additional three months may be necessary. On' i
this basis, the Comission has determined that an effective daie of one year after publication of this rule in effective form would be reascrable.
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 any new or amended information col-lection requirements 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 Budaet approval number 3150-0014.
REGULATORY ANALYSIS i
The Comission has prepared a regulatory analysis on this final rule.
The analysis examires the costs and benefits of the alternatives considered by the Comission. The analysis is available for inspection f
ard copying at the NRC Public Document Room, 1717 P Street NW.,
Washington, DC.
Single copies of the analysis may be obtained from 14 Enclosure A L
[7590-01]
Donald O. Nellis Office of Nuclear Regulatory Pesearch, U.S. Nuclear Regulatory Commission, Mail Stop NL-007, Washington, DC 20555, Telephone:
(301)443-7989.
REGULATORY FLEXIBILITY ANALYSIS The NRC has prepared a final regulatory flexibility analysis en the impact of this rule on small entities as required by Section 604 of the Regulatory Flexibility Act. The analysis indicates that althcugh the final rule could have an economic impact of $7,000 initially, and from
$3,000 to $8,400 annually on each persconel dosimetry processor, of which about 10 are small entities, the selected alternative is the least costly alternative that provides adequate dosimetry processing for licensees and workers. A copy of the firial regulatory flexibility analysis is available for inspection and copying at the NRC Public Document Room, 1717 H Street NW., Washington, DC. Single copies may be obtained from Ocnald O. Nellis, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Mail Stop NL-007, Washington, DC 20555, Telephone:
(301) 443-7989.
BACKFIT AN/ LYSIS As required by 10 CFR 50.109 (50 FR 38097), the Comission has prepared a backfit analysis for the final rule.
The Commission has determined, based on this analysis, that backfitting to comply with the requirerrents of this final rule is justified. A copy of the backfit analysis is available for inspection and copying at the NRC Public l
l 15 Enclosure A
Document Room located at 1717 H Street NW., Washington, DC. Single copies may be obtained from Donald O. Nellis, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Corriission, Mail Stop NL-007 Washington, DC 20555. Telephone (301) 443-7989.
LIST OF SUBJECTS IN 10 CFR PART 20 Byproduct material Licensed material, Nuclear materials, ??uclear power plantr, and reactors, Occupational safety and health, Packaging and containers, Penalty, Radiation protection, Reporting and recordkeeping requirements, Special nuclear material, Source material, and 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 Reorgenization Act of 1974, as amended, and 5 U.S.C. 553, the NRC is adopting the following amendmerts 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, 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): il 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, 1
16 Enclosure A
[7590-01]
20.304, and 20.305 are issued under sec.161b, 68 Stat. 948, as amended (42U.S.C.2201(b));andil 20.102,20.103(e),20.401-20.407,20.408(b),
and 20.409 are issued under sec. 161(0), 68 Stat. 950, as amended (42 U.S.C. 2201(o)).
2.
In i 20.3, a rew definition is added to read as follows:
i 20.3 Definitions (a) As used in this part:
w (20) " Dosimetry processor" means an individual or an organization that processes and evaluates personnel monitoring equipment in order to determine
]
the radiation dose delivered to the equipment.
3.
In 5 20.202, a new paragraph (c) is added to read as follows:
9 20.202 Personnel monitoring.
(c) All personnel dosimeters (except for direct and indirect reading pocket ionization chambers and those dosimeters used to measure the dose to hands and forearms, feet and ankles) that require processing to determine the radiation dose and that are utilized by licensees to comply with paragraph (a) of this section, with other applicable l
provisions of 10 CFR Chapter I, or with conditions specified in a licensee's license must be processed and evaluated by a dosimetry processor:
17 Enclosure A
[7590-01] ~
(1)
Holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Bureau of Standards, and (2) Approved in this accreditation process for the type of radiation or radiations included in the NVLAP program that most closely approxinate the type of radiation er radiations for which the individual weering the dosimeter is monitored.
Dated at Washington, DC, this day of
, 1986.
For the Nuclear Pegulatory Comission.
Samuel J. Chilk, Secretary of the Comission.
18 Enclosure A
REGULATORY ANALYSIS FOR AMENDMENTS TO 10 CFR PART 70 ON IMPROVED PERSONNEL DOSIMETRY PROCESSING 1.
PROPOSED ACTION NRC licensees are required to provide personnel monitoring (dosimetry) to werkers who have the poter.tial for receiving radiation doses as specified in 10 CFR 20.202(a) and 10 CFR 34.33(a).
Data frcm these personnel dosimeters are the bases for licensee and NRC records of external doses to workers. At present the NRC has not specified 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 processcrs when tested against available standards. These studies clearly demonstrated that there was a 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 Cemittee and 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 persconel dosimetry processors j
were capable of making the much needed improvements.
Subsequent to the three tests discussed above, a dosimetry accreditation program urder the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Bureau of Standards (NBS) began operation in January 1984 and, for the first quarter, recorded a pessing rate of 93%.
Based on the results discussed abcVe, the NRC concluded that an amendment to the current reguletions is needed to ensure improved personnel dosimetry l
processing. The amendment would include not only performance testing but would l
include checks on the quality assurance prcgram of the processors. The l
l 1
Enclosure B 1
amendment would require all NRC licensees that are required to provide personnel dosimetry to have the dosimeters processed by an accredited personnel',
dosimetry processor.
- 2..
OBJECTIVES The objectives of the subject amendments are to improve the accuracy and reliability of occupational worker dose records by reoviring that the processing of personnel dosimeters (used to measure occupational doses of the workers) be performed uniforraly through the application of specified accreditation procedures.
Several tests have indicated that many dosimetry processors perform poorly when tested against performance standards, and some report radiction doses in a manner that is difficult to understand. Use of standard performance tests and quality control in an accreditation program will ensure that exposed workers will have the advantage of personnel dosimetry 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)
F.equire licensees to have processing performed by a processor that has successfully participated in dosinetry performance testing 4
administered in accordance with ANSI N13.11 and that has e documented QA program whose elements would be specified in NRC reculations.
i (3) Require litersees to have their processing performed by a processor i
that has successfully participated in dosimetry performance testing acministered in accordance with ANSI N13.11 by an NRC specified test-j ing laboratory and that has a documented QA program whose elements would be specified ir. NPC regulations (this alternative differs from the previous alternative in that NRC would specify the proficiency 2
Enclosure B
,.n.-.n,,--.
t'-
t:stinglaboratory). This alternative could be accomplished by either of the follnving options.
_ Option A:
NRC licensees would be required to utilize the s'ervices of a processor that has successfully participated in performance testing at a proficiency testing laboratory that has been contracted by the NRC.
NRC inspectors would examine written proof that the processor has participated in the progran 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 cf a processor that has been accredited under the NVLAP of the NBS.
This program would involve:
(a)
Performance testinc in accordance with ANSI N13.11 (b)
Infornation collected by cuestionnaire, and (c) Onsite inspection of routine dosiretry 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 licersees obtain their personnel dosimetry services from an NRC-operated or an NRC-contracted desimetry service.
4 CONSEQUENCES Alternative 1:
No change in current requirements.
This alternative would probably result in no change in the status ouo.
The t:PC would cor.tinue the practice of attempting to enforce existing regulatory requirements on personnel monitoring without the benefit of any 3
Enclosure B
~
performance standard or quality control procedures against which to judge conformance by its licensees. Workers would continue to use dosimeters which are often tot calibrated to their specific needs while responsible processors that have voluntarily joined the NVLAP accreditation program would b$ likely to drop out of the program for economic reasons in order to compete with the less responsible and less qualified segment of the desimetry processing cenrunity.
This alterrative would entail no ecsts to the NRC and the only costs to the 1
dosimetry processing industry would be to those processors that had applied volunterily for NVLAp accreditation.
4 Alternative 2: Require licensees to have their processing performed by a pro-cessor that has successfully participated in a testing prograr administered in accordance with ANSI N13.11 and that has a documented QA program that meets the reauireraents specified in NRC regulations.
NRC would not specify the testino 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 gcVernment involvement and to use the laboratory of their choice on the basis of corrpetitive pricing or some other paraneter.
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 reonire the NRC to develop a set of QA requirements for inccrporation in the regulations with an estimated cost to the NRC of 1/2 ran-year of effort. Also this alternative would require an inspection and enforcement effort estimated to be 1 staff-year annually to assess the adequacy of licensees' and processors' QA programs.
Additicnally, NRC inspectors would not inspect processors that are not NRC licensees.
Alternative 3:
Require licensees to have their processing performed by a pro-cessor that has successfully participated in a testing progran administered in arcordance with ANSI N13.11 by an NRC-specified testing laboratory and that has a documented QA program that meets the requirements specified in NRC regulations. This alternative could be net by either of two options:
4 Enclosure B
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 that has suc-cessfully participated in the testing at this testing laboratory.
NRC inspectors would examine written proof that such testing had been performed successfully and that the processor had a documented QA progran that met the requirements specified in NRC regulations.
This alternative appeared to have worked well in the past durine 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 rescurces for administration 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 1 person-year annually to assess the adequacy of the licensees' and processors' QA programs.
Option 3B: The NRC would specify in its reculations that third-party accreditation would be utilized and that licensees would be required to have their processing perforced by a processor that has been accredited under the NVLAP of the NBS.
The dosimetry laboratory accreditation program was started in 1981 under an Interagency Acreement between the NRC and NBS, and a performarce testing laboratory was contracted for by the NBS.
Proficiency testing and NVLAP accreditation of processors began in January 1984.
Because proficiency testing and NVLAP accreditation of processors began in 1984, the initial costs for implementing such a program have already been incurred. The crgoing program is expected to be self-supporting through the accreditation fees charged to the processors.
Costs to processors for accreditation depend upon the sire of the processor's cperation, the number of dosimeter types to be tested, and the number of test categories requested for each dosimeter tyre. One cost to processors that is not included in the NVLAF August 31, 1984, fee schedule (49 FR 34E47) is that of initiating and maintaining the quality cor. trol and 5
Enclosure E
qut.lity assurance systera required ty NVLAP ano ex6 mined by NVLAP assessors curing onsite visits to processor facilities.
Based on an estimate of a 5 person-week effort to initiate the quality system combined with scne possible retesting and consultation, the iEitial or.e-time cost is estimrted to be approximately $7,000. Most of the processors that participated in the three voluntary testing prograns have alreac'y absorbed this initial cost. Maintenance of the cuality systems is estimated by NVLAP to range from $2,000 to $6,500 biennially for small anc large processors respectively.
Biennial accreditation fees vary from $3,700 for a small processor with one ocsineter type tested in a single category to $10,250 for a large processor with ore dosimeter type tested in all 8 of the test categories.
The total costs of the program range from $5,700 to $16,750 (or approximately $2,000 to 18,400 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, 66 fall in the intert:ediate category with total annual costs of $330,000, and 10 fall in the small category with total annual costs of $30,000, for an overall total of $478,000 per year.
The current costs of providing dosir:etry 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 vith monthly changes of dosimeters. Assuming that all of l
the annual costs of accreditation, $478,000, would be passed on to NRC licensees, the cost to the estimated 4,500 licensees would be increased by $106 annually from S1,748 to $1,850, or an increase of 6%.
The principal benefit that would result to the 327,000 workers of NP,C licensees from imposition of this rule is the increased accuracy and reliability of the recorded and reported occupatioral dose, which is of considerable significance in epidemiological studies and which also allows both erployer and employee to better assess and control the radiation hazards cf the workplace. The annual cost of this increased recuracy and reliability is $1.a6 per worker.
Adoption of this option will allow NRC to impose r.inimum acceptable criteria through NVLAP accreditation on personnel dosimetry processors that are not subject to present NRC regulations.
Since it is expected thtt rest l
dosimetry processors will wish to become accredited, the net effect of this cption will be to benefit 6 tuch larger comunity of workers than that of NFC 1
i 6
Enclosure B
licensees. These are the same processors that process badges for Agreement
, State licensees and a large and diverse comrunity involved principally with X-ray machines that does not include NRC licensees and regulated under the Occupational Health and Safety Administration of the Departrent of Labor.
In addition, this option is expected to save the NPC about 1 person-year / year by using hVLAP assessors instead of NRC's IE personnel to conduct onsite assess-ments of processors.
NRC inspectors would be relieved from inspection of certain OA activities and would only be required to perform routine inspections of personnel dosimetry records.
This option would establish connon testing and quality assurance procedures on persennel dosimetry processing and provide NRC irspection person-nel with a much needed benchmark against which to enforce existing regulatory reouirerents on perscnnel monitoring.
It also would bring improved accuracy and reliability to the dosin:etry processing industry through the use of standard procedures and oversight by NBS, the nationally recogn17ed standards autberity.
Firally, the quality and reliability cf personnel dosimetry reccrds would increase, partly as a result of periodic retesting requirements and partly as a result of the elimination of irresponsible or inccmpetent dosimetry processors.
Alternative 4:
Seek Congressional authority fer the NRC to license personnel dosinetry processors directly since many are not presently NRC licensees.
This alternative is probably unwieldy in that Congress may choose not to provide such authority or at best delay passing the needed legislation for an unacceptable period of time.
In addition, this alternative would require ar increased expenditure of funds for NRC's IE personnel of about 300% above the present expenditures for inspectiun of licensee processors.
(NRClicensees enploy only about 25% of the 1.4 nillion workers in the U.S. who require personnel renitoring.)
Alternative 5:
Change the regulations to require that licensees obtain their personnel dosimetry services from an NRC-operated or an NRC-contracted cosimetry service.
i 7
Enclosure P
Since the NRC does not presently have the technical staff, facilities, furding, or experience to operate such a service, the alternative is limited to' an NRC-contracted dosimetry service.
Since this option would 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 contracteo dosimetry service.
5.
DECISION RATIONALE The NRC concludes that alternative 3B should be adopted.
Alternative 1 is rejected because it would not meet the objective of improving the accuracy and reliability of occupational worker dose records by standardizing dose determinations obtained from dosimetry processing.
Alternative 2 is not selected primarily because of the considerable costs to the NRC and the uncertainty that the industry would establish a testing laboratory.
Alternative 3A is not selected because of the requirement for significant ongoing Federal funding to operate the testing laboratory and the costs to the hRC in assessing the licensees' and processors' QA programs. Alternative 4 is not se M ted because of the problems associated with obtaining the required authority from Congress and because of the additional inspection costs involved. Alternative 5 is not selected because of the requirement for ongoing Federal fending and the negative effect it would have on the dosimetry processing industry.
6.
IMPLEMENTATION The requirement for accreditation of personnel dosimetry processors will become effective one year after publication of the rule in the Federal Register. The NVLAP testing and accreditation program has been in operation for more than 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 l
frame, the Ccmission concludes that an effective date of one year after publication is an adequate time period to require implementation of the rule.
8 Enclosure B l
4 This action is related to and in conforrance with Section 20.501(c) of the proposed 10 CFR Part 20 which was published January 9,1986(51FR1092).
No other existing or proposed requirerrents are affected.
No additional staff
~~
action or additional funding is reouired.
T 4
i 1
l t
S Enclosure B
ANALYSIS OF C0KMENTS IMPP.0VED PEPS 0fiNEL DOSIMETRY PROCESSING The NRC received 96 comment letters on the proposed rule, some of which were duplicates, leaving a net of 93 comment letters, many of which contained more than one comment.
For the purpose of analysis, the comments were classi-fied according to the five general categories listed below:
1.
Approval of the proposed rule.
II.
Approvel 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.
4 Enclosure C
s.
ANALYSIS OF COMMENTS IDENTITY OF COPMENTERS Docket File Respense Comr. enter Category Number And Number Commenter 1
I State of Montana Department of Heelth & Environmental Services 2
I Georgia Department of Human Resources' Radiological Health Section 3
I Commonwealth of Virginia Department of Health 4
I Commonwealth of Kentucky Cabinet for Human Resources 5
I State of Alabama Department of Public Health 6
I State of Rhode Island and Providence Plantations Department of Health 7
I State of Ohio Department of Health 8
I State of New Mexico Environmental Improvement Division 9
I State of Michigan Department of Public Health 10
!!I Gulf 011 Corporation 11 I
North Dakota State Department of Health 12 I
Oklahoma State Department of Health 13 I
State of Indiana State Board of Health 14 11-1 State of Kansas Department of Health and Environment 15 11-2 ICN Chemical 8 Padioisotope Division 16 III Colorado State University Envirent: ental Health i
Enclosure C
Docket File Response Commenter Category Number And Number Commenter 17 I
Conference of Pediation Control Program Directors, Inc.
18 II-3 Radiation Measurement Systems, Incorporated 19 III Bethlehem Steel Corporation 20 I
Eberline 21 I
Illinois Department of Nuclear Safety 22 I
State of Colorado Colorado Department of Health 23 I
Kerr-McGee 24 I
U.S. Department of Labor Employrent Standards Administration 25 I
State of Tennessee Department of Health and Environment 26 V-1 LAND, Inc.
27 IV-1 Massachusetts Institute of Technology 28 I
State of Oregon Department cf Human Resources 29 I
State of California Department of Health Services 30 I
State of Florida Department of Health and Rehabilitative Services 31 I
Department of Fealth & Human Services Food and Drug Administration 32 I
Arizona Radiation Regulatory Agency 33 I
State of Delaware Departrent of Health & Social Services 34 1
U.S. Departrent of Commerce National Bureau of Standards 35 IV-2 Applied Radiation Protection Services 36 I
The University of Oklahoma ii Ecciosure C
Docket File Response Comnenter Catescry Number And Number Comenter 37 IV-3 Boston University Medical Center 38 IV-4 Wisconsin Clinical Cancer Center 39 IV-5 Pacific Radiation Ccrporation 40 IV-6 Waahington Public Power Supply Syster 41 I
State of Maryland Pepartment of Health and Mental Hygiene 42 II-4 State of New York Departrent of Labor 43 II-5,III Edisen Electric Institute 44 IV-7 Nurnberger Radiation Protection Service 45 I
U.S. Department of Labor Occupational Safety ano health Administration 46 I
South Dakota Dept. of Water & Natural P.esources 47 V-2 Department of Energy 48 11-1 The University of Michigan 49 II-6 New York Power Authority 50 V-3 Arkansas Department of Fealth SI V-4 Facific Gas & Electric Company i
52 III,V-5 R. S. Landauer, Jr. & Co.
53 V-6 Teledyne Isotopes 54 IV-8 Tufts University School of Medicine 55 IV-9 Texas Utilitics Generating Company 56 V-7 Portland General Electric Company 57 V-8 Corronwealth Edison 58 IV-10 Harvard University (R. Johnson) j 59 The Comrrenwealth of Massachusetts University of Massachusetts (Corrents withdrawn) 111 Enclosure C
+,-
D'ocket File Response Comenter Categery Number And Number Comenter The LiC t Company h
60 II-7,III Houston Lighting & Power Company 61 IV-11 General Electric Nuclear Energy Products Division 62 IV-12 Air Transport Association of America 63 11-8 Pennsylvania Power & Light Company 64 IV-13 Northeast Utilities 65 I
Veterans Administration Medical Center, Lexington, F.Y 66 I
U.S. Environmental Protection Agency Office of Radiation Programs 67 IV-14 lowa Electric Light and Power Corpany 68 II-9 Duke Power Company 69 Il-7,III The Light Company (Duplicate of #60)
Houston Lighting & Power Company 70 IV-15 Yale University University Health Services 71 11-10 Arizona Public Sercice Company 72 I
GPU Nuclear Corporation 73 I
Iowa State Department of Health 74 11-11 Atomic Industrial Forum, Inc.
75 11-12 Conoco Inc.
76 11-13 Tennessee Valley Authority 77 11-14 Argonre National Laboratory (E. Dolecek) 78 11-14 Argonne National Labcratory (R. Wynveen) 79 I
South Carolina Electric & Gas Company 80 II-15 Mallinckrodt, Inc.
81 I
Standard Oil Company (Indiana) iv Enclosure C
Docket File Response Commenter Category Number And Number Commenter 82
!!-16 Wisconsin Public Service Corporation 83 V-9 American College of Radiology 84 I
Minnesota Departrent of Pealth 85 II-5 Public Service Electric and Gas Company 86 11-17 Department of the Navy 87 IV-6 Washington Public Power Supply System (Duplicateof#40) 88 Arizona Radiation Regulatory Agency (Comments on another rule, filed in this docket by error) 89 IV-16 Nuclear Sources & Services, Inc.
90 IV-15 American Association of Physicists in Midicine 91 I
National Aeronautics and Space Administration 92 I
State of North Carolina Department of Human Resources 93 I
State of Nevada Department of Human Resources 94 I
Texas Department of Health 95 IV-17 Harvard University (J. Shapiro)
University Pealth Services 96 IV-18 Health Physics Northwest v
Enclosure C
CATEGORY I.
APPROVAL OF THE PROPOSED RULE Forty one commenters approved the rule without added suggestions or
' opposition.
Some of the many reasons cited for approving the rule are given below.
Commenter fl.
"The implementation of this rule will effect improverents in personnel dosimetry that are critical for the protection of iadiation workers."
- 5.
"This would make a positive contribution to the public health and safety by insurino 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 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."
- 66. "We agree that there is a need to require a reasonable level of competence in personnel dosimetry processing. Without such competence, the reedings of personnel dosimeters cannot be relied upon as indicators of protectice and accurate record of worker doses."
- 72 "The standards and testing protocols referenced in the proposed regulatten would provide us with uniforr. criteria for selecting dosimetry vendors.
This would ultimately reduce our quality assuranco costs for vendor certification."
- 84. "In view of the studies conducted by the University of Michigan which irdicated that a substartial percentage of the dosimetry processors wbc currently serve NRC licensees are performing in an inadequate manner, it is evident that the establishment of conmon acceptable performance criteria such as those which would result from implementation of the proposed rule are not only necessary, but are long overdue."
1 Enclosure C
CATEGORY 11. APPROVAL OF THE PROPOSED RULE WITH A00E0 SUGGESTIONS Twenty comenters approved of the rule but had sore added suggestions or
- coments.
1.
Comenters 14, 48: Comenters approve of the proposed rule but would like the effective date moved to ar 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:
Comenter concurs in the proposed rule but, in the interests of uniformity, requests that Form NRC-5 be changed to reflect the nerenclature of ANSI N13.11 as it relates to shallow and deep dose reporting.
Staff Res1onse:
This coment is taken under adviserent and changes will probably )e made tt, reflect the nomenclature of ANSI N13.11 in the pendirg rajor revision of 10 CFR Part 20.
3.
Ccmmenter (18:
Comenter approves of the proposed rulemaking and then Oces on to indicate some of the benefits to be derived from the program.
He then requests changing the name of NVLAP to remove the word
" voluntary."
Staff Response: The National Voluntary Laboratnry Accreditation Program DVLAP) was established by the NBS in 1976 to accredit laboratories for specific tests or types of tests in certain product or service areas when a need for accreditation is determined. The NRC has nc jurisdiction over the name of the NBS program, which is a voluntary program from the NPS perspective.
In addition, NF.C licensees include only about 25Y cf the 1.4 million workers in the U.S. who require persnnnel monitoring. Many of these are regulated by OSHA, EPA, and other agencies, and at least some of 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 appreval and the right to use the logo of the appropriate laboratory.
In like manner, the NVLAP logo indicates that a processor supplies quality processing and will in all likelihood improve business for the processor.
4 Correnter #42:
Comenter approvcs of the proposed rule but would like to anend proposed rew paragraph 10 CFR 20.202(c)(1) by adding the phrase "or equivalent Program approved by NBS." Comenter argues that this would give NES the added flexibility to approve other accreditation schemes in the future if the present one dees not work as desired er for foreign accreditation.
Staff Pesponse:
During the formative years of the regulatory aspects of this accreditatinn progran it is considered essential that the NRC retain an appropriate degree of influence over the progran as provided ft,r in an Interagency Agreenent signed by representatives of NFC and NBS on July 16
?
Enclosure C
and 17, 1981. This is not considered to be a pemanent requirement.
For example, NBS is currently developing a program for DOE similar to the NVLAP dosimetry program developed for NRC. The program is known under the acronym "DOELAP" and it is expected that sometime in the future the tWo dosimetry LAPS will merge.
5.
Comenters #43 & 85: Comenters express full support for the proposed rule. They also feel that a definition for " dosimetry processor" should te provided in the regulations and provide a suggested definition.
are also concerned that when ANSI N13.11-1983 is revised, it may Comenters require processors to upgrade their equipment and procedures to the point where it could be very expensive and time consuning.
Comenters are concerned that processors could lose their accreditation just because cf the time constraints ir. wived in the upgrading. They urge NRC to negotiate with NBS to correct this problem.
Staff Response: The final rule provides a definition for " dosimetry pro-cessor." AhSI standards are reviewed at five-year intervals and are revised when thought necessary. ANSI N13.11 is subject to revision begin-ning 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 subcomittee 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 (15 CFR 7.32(a)(5)). This should provide adequate time for upgrading procedures and purchase of equipment should it be necessary.
6.
Comenter #49:
Comenter supports Alternative 3, Option B of th'e proposed rule.
Comenter notes that the pass / fail criterion on page 1207 of the Federal Register notice failed to use the absolute value of P in the equatinn.
Staff Response:
Comentor is correct in noting that the absolute value of P was not used.
In the final rule this discussion has been deleted.
^
7.
Comenter #60:
Comenter is in agreement with the intent of the change The first is a concern with the possible revision but has scre concerns.
of ANSI N13.11-1983 and its effect on processors. He is also concerned 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.
i Staff Response:
Comenter is referred to coment II-5 as it relates to possible revision of ANSI N13.11. The NRC inspection program will be modified to avoid duplication of inspection by NRC inspectors and NBS as-NRC inspectors will inspect to determine if the licensea is sessors.
using a dosimetry processor that is qualified for those radiation cate-3 Enclosure C
gories appropriate to its establishment.
Incorporation of limits on NVLAP inspection authority in 10 CFR 20.202 is not appropriate.
B.
Comenter #63: Comenter encourages implementation of the accreditation program. Comenter also wants a clarification of proposed paragraph 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 comenter acts as a dosimeter coprocessor, reading out TLDs and sending the raw data to a dosimetry service vendor. Comenter feels that the final rule should ad-dress the issue of coparticipation in the accreditation process in order to assure valid and uniform accreditation to all such coparticipants.
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 is clarified in the final rule. Coparticipation or acting as a coprccessor in the accreditation process is considered by NVLAP as a normal extension of the home-base operatien of the accredited processor.
9.
Commenter #68: Comenter supports the overall concept of this rule but suggests that the processor need be accredited only for those radiations that constitute at least 20% of the total radiation dose.
i Staff Response:
It is the responsibility of the licensee to selset a processor that is accredited in the appropriate categories. The staff understands the point that the comenter 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 could be contributing 19% of the total or S7% of all radiation received. The licensee would be in clear violation of the rule in this case since its processor would cnly be accredited to process 43% of the total radiation dose.
10.
Commenter #71:
Comenter supports the proposed amendments but states that he believes the cost estimates for accreditation are understated.
Comenter feels that projected costs included in the proposed rule do net 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. A more complete discussion is given in the Regulatory Analysis.
- 11. Comenter #74:
Comenter is cenerally supportive of the proposed rule but suggcsts that the rule should ir.lude a provision for formal notification 4
Enclosure C
. = _ -
of revisions te NVLAP to allow time for implementation by processors.
Comenter 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 td include criteria for determining whether itens are satisfactory or deficient and to specify the qualifications and selection citeria for those persor.s chosen to review appeals from processors who have lost their accreditation. Comenter would like the NP.C to issue a Regulatory Guide to address these last issues. Also commenter would like to have radiation categories specified 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 licensee's establishment.
Staff Response:
In regard to changes in NVLAP procedures, comirenter is referred to cement II-5. Methods and procedures for handlire loss of accreditation are covered in 15 CFR Part 7.
NBS issues cuarterly bul-letins updating accreditation action ir.cluding those processors that have lost their accreditation during the previous quarter, and NPC's Office of Inspection and Enforcement will keep abreast of such actions. The issue of loss of accreditation has been addressed in the supplementary information section of the final rule. NRC plans to issue supplementary information that will discuss radiation categories.
Insofar as clarifying onsite procedures and qualifications of personnel chosen to reviiw appeals, this is a NVLAP responsibility.
In regard to specification of radiation categories, refer to coment II-9.
- 10. Comenter 375: Ccementer agrees with the choice of Alternative 3, Option b but is cor:cerned over the proposed costs of accreditatier.. Comenter seems to feel that fees could be reduced if onsite visits were eliminated and the desimetry procedures and QA procedures were handled by written comunications.
Staff Response: A portion of the onsite visit procedures calls for the WLAP 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 correspordence. The amount saved by conducting the QA and dosimetry procedures by correspondence would only be some fraction of the current biennial assessment fee of
$1,100, which currently amounts to only 101i to 20% of the accreditation fee depending on the number of categories tested for.
i
- 13. Comenter #76: Comenter supports certification of dosimetry processcrs but suggests that there are more efficient and less expensive ways of conducting performance testing. Cementer suggests that the NRC require each prccessor to submit routinely used desimeters 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. Comenter states that under this procedure, testing would be current and not up to two years old, the processor would have to provide competent results frecuently rather thar.
on a two-year basis, and the results could be trended to provide early warning of deterioration ir process control. Also, the NRC could select 5
Enclosure C
exposure categories based on its knowledge of the radiations being monitored by the processor 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 comenter 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 monthly, the exposure costs would be significant. 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 that monitor in all categories and often with several different dosimeter types. Also, the NRC does not have the resources to supervise such a program.
~
14.
Comenters #77 & #78:
Comenters feel that the preposed program is necessary but are concerned with the relatively "large" cost to small processors and suggest considering a cost adjustment factor based on processor size.
Staff Response:
See general coments A through D, Category IV.
- 15. Comenter #80:
Comenter feels that the regulatory action is necessary and agrees that the alternative chosen is the most beneficial plan. Com-renter is concerned that individuals not licensed by NRC will continue to use processors that are not accredited because they are not NRC or Agree-ment State licensees.
Comenter would also like to see a Regulatory Guide developed to better define v:bich of the testing categories are required for each type of license.
Staff Respense: 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 that service these workerr ere the same as those that process badges for NRC licensees.
It is thought highly unlikely that these processors would use one standard of processing for custcmers that are NRC licensees and another standard for processing for customers that are not NRC licensees. Commenter is referred to the remarks of Comenter #45 listed under Category I of the analysis of com-ments. NRC plans to issue supplementary information that will discuss radiaticn categories.
6 Enclosure C
- 16. Commenter #82: Commenter 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 official dose values as reouired under 10 CFR Part 70 would be included in the scope of the proposed regulation. Commenter wants to ensure that redundant dosineters are not subject to the rule.
Also, commenter would like NRC to address, as guidance, acceptable methods of reporting dose values in the event that an eccredited dosimeter is lost or yields 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 reouire accreoitation of only those dosimeters required under the regulations.
In regard to loss of accreditation, see comment 1I-11.
Lost desimeters or erroneous values do not constitute a new problem. Possibly redundant dosimeters could be used in reconstruction of doses.
- 17. Commenter #86: Commenter considers the actions required by the proposed rule to be of substantial benefit.
Commenter would have the NRC clarify the conditions under which a licensee monitoring for low-energy or high-energy photons (category III or IV of ANSI N13.11) should seek accredita-tion in an accident category (category I or II of ANS! M.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 requirec under 10 CFP 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:
It is the responsibility of the licensee to select a processor that is accredited in the appropriate radiaticn categories. The final rule addresses the issue of dosimeters issued to personnel not required to have them.
NRC plans to issue supplementary information that will discuss radiation categories.
CATEGORY III. APPROVAL OF THE REQUIREMENT.FOR ACCPEDITATION BUT OPPOSEP TO THE RECORD-KEEPING REOUIREMENT OF PROPOSED 10 CFR 20 A01(d) l Six commenters were opposed to including proposed paragraph 10 CFR 20.401 (d) in the rule. This particular section would require licensees to retain copies of their dosimatry processor's accreditation certificate along with the exposure records of personneT that are required under the present rule. Most commenters felt that this was' simply an additional burden with no additional benefits. Others with multiple facilities indicated the problem of redundancy.
Staff Response: Since NES issues a NVLAP directory with quarterly updates on all accreditation actions on all of its LAPS, the NRC concluded that individual accreditation certificates at licensee facilities are unnecessary. All NRC inspectors will have available a copy of the most recent quarterly update for 7
Enclnsurc C s
_. _ _ -. _, - -~ _
O A
l use in all inspections.
In view of this, this proposed requirement is not included in the finai rule.
CATEGORY IV. OPPOSED TO THE PROPOSED RULE Nineteen commenters were opposed to the rule. Most of their comments were directed against the costs of the program. Four general comments appeared ir, many of the letters and are addressed generically 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 processors should not be required to submit to onsite assessments by NVLAP persennel. Reduction of this requirement should reduce the costs of accreditation significantly.
Staff Pesponse: The purpose of the personnel dosimetry accreditation pro-gram is to detect and eliminate wherever possible those sources of vari-ability that are under the control of the dosimetry processor. The testing portion of the accreditation program does not in itself ensure that the processor applies the same care and attention to routine dosime-try processing as it does to test dosimeters. The onsite assessments con-ducted by MVLAP personnel not only check on sources of variability under the control of the processor, they also check the quality assurance pro-grars of the processcr as they apply to routine dosiretry and to the application 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 ir. costs, the onsite assessrent costs are
$1,100 for a two-day visit and $650 for a one-day visit, less thar. 25% of the biennial costs for accreditetion.
Not considered in this, of ccurse,
^
are the one-time costs of initiating an apprcpriate QA program, which have been estimated to be around $7,000. The staff position is that, without an adequate in-house OA program (which all processors should already have in place), there is no guarantee that a processor is applying appropriate care and effort to the processino of routine dosimetry.
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:
NRC has no authority to impose a differential fee structure since the NBS sets NVLAP accreditation fees.
Small processors
~
should be aware that grants may be available from the Small Business Administration to assist small businesses in payino these fees.
Comment C:
Commenters are ccreerned that if their~ccamercial processor should suddenly lose accreditation, they woeld be in noncompliance with the regulations.
Staff Position:
This is a legitimate ccocern that we feel has been adequately addressed in the supplemental information section of the final 8
Enclosure C I
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 reaccreditatien, 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 irrespcnsibility that NVLAP will sumarily withdraw accreditation. There are no requirements in NVLAP procedures to require either the processor or NVLAP to notify custoriers of the processor of this loss of accreditation. At present the Office of Inspection and Enforcement will obtain quarterly reports on the accreditation status of processors and irproved liaison between NBS and NRC is under way to provide prompt notification of such events. NRC believes it may be prudent for its licensees to negotiate agreements with their.prccessors in which they require notification when the processors run into problems with NVLAP.
Coment D:
Comenters are concerned that promulgation of this rule will signal an end to voluntary dosimetry, particularly in hospitals and medical research institutions.
Staff Response: The rule may have a slight adverse impact on voluntary dosimetry, t'ut licensees have only to make a determination of those workers who require monitoring under 10 CFR 20.202(a) and those who do not, and apply to amend their licenses accordingly.
It is not the intent of the NRC to discourage voluntary dosimetry or redundant dosimetry.
There is no reouirement for accredited processing of such dosireters, and the supplementury information section of the final rule has made the point that this rule does not affect voluntary or redundant dosimetry.
1.
Comenter #27: Comenter feels that the proposed rule makes no distinction between the testing requirements for large comercial processors and small in-house programs. Comenter feels that the cost of accreditation for small programs involving 250 persons or less would preclude their continuation economically. Comenter suggested that such sitt11 in-house programs be allowed to operate under NVLAP without full NVLAP requirements for on-site assessments.
Comenter 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.
I Staff Response:
See General Comments A and B.
2.
Commenter #35:
Commenter disagrees with the necessity to make the changes in the draft testing standard ANSI N13.11 that 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 coulo drive small firms like his own out of businest.
Comenter then suggests 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 reascos for making the changes in the testing stand-ard FISI N13.11 are somewhat remplex and will not be discussed here. The 9
Enclosure C l
)
,.-.y_
-._,,,,._,-,y_.,-
I logic and rationale associated with these changes have'been discussed in
' depth in NUREG/CR-2691, " Performance Testing of Personrel 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 Comission's Public Document Room at 1717 H Street NW.,
Washington DC. The first document nay be purchased from the U.S. Govern-mentPrintingOffice(GPO)bycalling 202-275-2060 or by writing the GP0, P.O. Box 37082 Washington DC 20013-7082.
It may also be purchased from i
the National Techrical Information Service, U.S. Department of Comerce, 5285 Royal Road, Springficid, VA 22161.
In respect to the fees involved, see General Coment B.
1 The suggestion that the comenter be allowed to select assesscrs from his own locality ir 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 i
assessors known to the comenter.
3.
Comenter #37: Comenter is opposed on the basis of cost and states:
i I would like to express my opposition to this proposed rulemaking.
We currently use a comercial 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 1
who does its own processing. While the intent to certify "in-house" i
personnel dosimetry is important it would force the small user of in-house processing to use a large comercial prccessor who could afford these fees.
Perhaps a more equitable fee structure (in the hundreds) could be utilized for a small user.
Staff Response: Annual costs for accreditation are generally in the range of 52,000 to 58,000 per year depending en size and the number of 4
2, categories for which testing is required. See General Coments A through D.
4 Cc w enter #3E:
Comenter stated that his organization had planned to convert from using a comercial processor to developing an in-house capa-bility for dosimetry processiro. Since the organization would require cost $g in all eight of the radiation categories, the program would have testin j
17,200 biennially. Even though the comenter indicated that the program would have processed upwards of 3,000 dosimeters per month, it was I
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 retice anncuncing the proposed rule, was based en a pro-cessor who submitted up to six different dosimeter models for testing in mere than one category. The maximum ccst for one dosimeter type tested in each of the eight categories is $10,700 biennially, which would appear to i
i i
10 Enclosure C I
~
be considerably less than the cost of processing 3,000 dosimeters per month through a consnercial processor. See also General Coments A through D.
5.
Comenter #39: Comenter 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. Fe 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 desimetry processing service.
He then goes on to offer several suggestions as fnllows:
a.
I cortinue to support the Alternative 3-Option B receiring dosimeter 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 tcVLAP procedures cannot adequately determine the performance level of a processor. Badges designed for Krypton-E5 gas clouds should be exempted from the proposed rule.
(Another example of a category not tested would be radon gas dosimeters such as the Terradex track etch device.)
h.
I suggest that some relief be given to small comercial processers who desire to continue supplying personnel desimeters and who can successfully pass the fWLAP criteria.
I suggest that no processor be required to recualify, after an initial passing of the NVLAP tests, more often than a time span determined by the condition that not more than 10% for 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 in c.
a.), I suggest consideration be given to establishing a "Special" category outside the normal NVLAP program to deel with "research applications" such as our Kr-85 dosimeter.
I further suggest that, for this "Special" category, the submission of dosimeters to the hVLAP testing lab be eliminated since no category even remotely tests the ability of either the persennel dosimeter or the prccessor 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 enccuntered in dosimetry under those conditions. for example, university research personnel working with thet radionuclide in that form.
d.
If consideration is given to establishirg a "Special" category for radionuclides such as Kr-85 gas and radon exposures, I further suggest that conventional teta/ gamma /x-ray processors be restrained from offering their dosimeters to workers exposed to those "Special" categories unless they can demonstrate competence via the site visit procedure suggested in (c) and shov that their dosimeter has the necessary sensitivity and has been calibrated under actual field 11 Enclosure C
working conditions, i.e., a semi-infinite cloud of low energy beta emitting gas.
Staff Response: The cost to a small processor seeking accreditation in oiDy one category is not $5,000 per year. The August 31, 1984,~ Federal Register notice (49 FR 34546) lists the cost at $4,150 for the first biennium and 13,700 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 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 dcse algorithm that converts the results of its dosimeter's response to 90Sr/90Y beta particles urder test conditions te the response to 85Kr beta particles in the geometry of the workplace.
In regard to financial relief to small comercial processors, see General Coment B.
The suggestion for setting up a special category for Kr-85 dosimeters and restraining " conventional beta /gama/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 operation and 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 cualify as personnel dosimetry.
It would be unreasonable to restrain "cenventional beta /ganra/x-ray processors" from offering such a service provided they were able to show the NVLAP as-sessors that they were aware of the users needs and could make the neces-sary 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.
6.
Comenter #40: Comenter ouestions the need for third-party accreditatior 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-4 etry processing now needs to be regulated by accreditation.
Staff Fesponse: The coment seems to imply that the NRC has beer.
performing a " Review and Oversight Function" for performance of " External Dosimetry Processing" using " Approved Vendor Systems." This is r.et the case. NRC regulations presently require monitoring of certain personnel under 10 CFR 20.202 and maintenance cf exposure records of such personnel under 10 CFP 20.401, but they do not set any criteria for the performance of dosimetry processing. The NP.C has no criteria in any other form "such as" Regulatory Guides or Standard Review Plans and thus has had no basis for reviewing and approving dosimetry processors regardless of whether these processors were " vendors."
7.
Comenter #44: Comenter feels that the dosimetry processor accreditatien requirercent is unnecessarily complicated and overly restrictive in light of the following:
12 Enclosure C
The bases upon which the public and occupational worker maximum
~
a.
permissible dose (MPD) guides are set certainly have a variability cf 3
at least + 100%.
The day to day wearing of personnel monitors by occupationally b.
exposed persons is subject to a very great variation as to position, angle, forgetfulness, etc.
The personnel monitoring devices themselves have an inherent inaccu-c.
racy of perhaps 75% 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.
Comenter then goes on to say that the required two-day onsite visit is overkill for his particular operation,~which is entirely contained in a l
room of 100 square feet. He also objects to the requirement of +15%
accuracy in the light of the points made above.
l 2
Staff Respense:
It is not the intent of the personnel dosiretry testing program to question PPD guides, inherent inaccuracies (which all reasuring systems have to some degree), or the results of epidemiological studies, j
The intent rather is to detect and eliminate where possible those sources i
Some of of variability that are under the control of the processors.
these involve poor quality control of TLD materials used in do:imeters, 4
incorrect calibration factors, clerical errors, and lack cf uniformity in i
dosimetry terminology. The significant improvement in the per'ormance of j
processors from Pilot Test 1 to Test 3 illustrated that major improvements in processing are possible.
In the early stages of the testing program, significant numbers of processors were reporting doses that differed from the delivered doses by 200 to 2000%, errors that far exceed those errors i
discussed by the comenter.
For a small one-room facility such as that of the cementer, it is possi-ble that only a one-day onsite visit would be needed. This would save 4
5450 cr the initial accreditation fees which range from $4150 to $10,700 for a single dosimeter tested in one category to a single dominater tested in all eight categories of the standard. The statement about the +15%
accuracy requirerent appears to be a misurderstanding. Neither the proposed rule nor the ANSI stcrdard use the word accuracy. The pass / fail l
criterion is given in terms of a tolerance limit "L", where:
- 17) + S i L i
and L h'as the value 0.5 for protection categories and 0.3 for accident categories.
I Comenter objects to the fact that the proposed rulemaking Comenter #54:
8.
makes ro differentiation between the testing requirements for commercial processors and in-house programs. He then states:
l l
13 Enclosure C
For many years now this institution has been supplementing our comercial film-badge service with in-house TLD personnel monitoring.
Results have consistently been comparable to the comercial services, with the added advantage of rapid read-out capabilities. The ecst of accreditation for our prograr would be prohibitive under this proposal.
i Staff Response:
See General Coments A through D.
4
'g.
Comenter #55: Comenter 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 menitored by existing programs and normal NRC licensee inspections and that the proposed rule would place an unnecessary financial burden upon the licensees.
i Staff Response:
Present_NRC regulations specify the monitoring l
requirements for workers under 10 CFR 20.202 but do not set any criteria for the performance of dosimetry processors.
See also General Coments A through D.
l
- 10. Comenter #58:
Comenter claims that the cost of the accreditation program will force the terminatien 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 required to badge only i
approximately 200 of these but states that be uses the badges not only to evaluate individuai personnel doses but also to examine the contamination patterns in the establishment as a means of contamination centrol.
Elimination of~these additional desimeters because of the costs involved could seriously reduce the effectiveness of the overall radiation control j
program.
Staff Response:
See General Cements A through D.
- 11. Commenter #61:
Commenter is opposed to the proposed rule because his dosimetry services vendor stated that a more sophisticated dosimeter (that woulo be easier to accredit) may be required. Comenter 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 1,700 persons currently bcdoed require badging under 10 CFR 20.202 and further that the i
new rule will not provide any improvement for workers whose typical exposure is icss than 500 mR per year. He feels that small processors should not be forced to ccmply with the same requirements as a larger i
commercial vendor. He is also concerned with the situation when a i
licensee's comercial prccessor suddenly loses accreditation.
Finally he j
makes the following suggestions:
l (a)
Establish a de minimis hvel for implementation of the rule.--i.e.,
j accreditation not required for potential exposures below 500 mR per year.
l i
14 Enclosure C j
m
(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 badpe processor to supplement the consensus standard ANSI N13.11.
Staf' Pesponse:
It would appear that. if the dosinietry vendor's current badge cannot pass accreditation, the dosimetry service provided is at best inadequate.
In regard to establishing a de minimis level for implementa-tion of the rule, there is already in effect a de facte de minimis level since licensees are now required to provide dosimetry coly to those workers whc are likely to be exposed to radiation at levels above those specifiedir.10CFR20.202(a). Also see General Coments A through D.
The establishment of a voluntary LAP system under NVLAP would not be effective either above or below the minimum implementation level.
It has been shown that processors generally ignore voluntary dosimetry improvement progrars.
Regulatory Guides do not set out requirements and could be ignored by processors.
- 12. Commenter #62: Comenter stated that he does not agree that ancther regu-lation is necessary or desirable and feels that it would make monitorin5 more expensive than necessary.
Further, he states that he has no reason to believe that his dosimetry processor has been improperly perfonning dose measurements. He is in favor of Alternative Number One -- No change in current reavirements.
Staff F:esponse:
See comment IV-7 and General Coments A through D.
- 13. Comenter #64: Comenter states that he is pleased that the NPC is addressing a form of testing fer dosimetry processing but he would prefer that it be addressed by a Regulatory Guide rather than by a regulation.
Comenter is unsure which revision of ANSI N13.11 is to be used as a criterion and he recomends that, if this standard is revised, the proposed regulation identify a reasonable period for processcrs to recualify under the revised standard.
He is also concerned that the proposed regulation dces not identify the categories for which a litersee would have to obtain accreditation. In additicn, he states that the ensite checklist presents problems in that mary of the questions asked are not pertirent and he estimates that it would cost $30,000 to implement the accreditation process, a major portion of which would be due to preparation for the onsite checklist. Commenter then recomerds that the implementation date of the proposed regulation be contingent upon issuance for public coment of a Pegulatory Guide that would address the issues discussed above relative to determination of radiation categories and the questions in the onsite checklist.
Staff Response: Section 20.202(a) of NRC regulations bas always required the use of appropriate personnel monitoring devices, but neither the AEC rer the NRC established any criteria for appropriateness. A Regulatory Guide addressing the cuality of processing of dosireters could have been issued and still can te. However, requiring the establishment of an 15 Enclosure C
independent proficiency testing laboratory, as specified in the dosimetry performance standard ANSI N13.11 is not appropriate for a Regulatory Guide. Also, since regulatory guides without supporting regulations have no force of law, they are, in effect, voluntary standards. Past experience with existing voluntary standards for dosimetry processing indicates that they have not solved the problem -- a regulatory standard is needed. The Because it current standard used for accreditation is ANSI N13.11-1983.
was approved in 1982, and 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 procedures allow processors one year to meet the requirements of a revised standard. The suggestion that a Regulatory Guide be issued for public coment on the onsite checklist is rejected. However, the NRC plans to issue supplementary information that will discuss accreditation categories. The checklist is designed for the use of the NVLAP onsite assessor; any processor that follows the recomendations of the NVLAP Dosimetry LAP Handbook issued to all applicants for accreditation will heve met the requirements of the onsite checklist. This checklist was developed in coordination with the Industry Overview Comittee on Personnel Dosimetry and the Interagency l
Policy Cemittee on Personnel Dosimetry and its issuance for public coment at this time would serve no purpose other than to delay passage of the regulation requiring accreditation. The estimate of $30,000 to implement accreditation procedures is excessive.
Estimates of initial onsite costs are believed to be closer to $7,000 as indicated in the Regulatory Analysis. See General Coments A through D and Coment II-11.
- 14. Correnter #67: Comenter 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. Comenter feels that there are differences between NRC and NVLAP requirements and that the proficiency testing laboratory will be unable to reintain an objective review of the processor's dosimetry in light of the need to use processor-manufactured measuring equiprent. He concludes that the best method to serve the industry would be simply to adopt ANSI N13.11, which wnuld thereby delegate the resporsibility of program implementation to the j
individual licensee. Comenter also argues that conflicts may occur between an NBS provision met by a processor and an NRC requirement on a licensee.
j Staff Res,crse:
The staff is not aware of differences or conflicts Fetween NK. and NVLAP requirements.
The comert about the proficiency testing laboratory is a misunderstanding. The laboratory delivers a known l'
dose to the processor's dosincters and sends the dosineters back to the processor for determination of the dose. The processor uses its own i
equipment and merely reports the dose back to the laboratory, which compares the reported dose to the delivered dose ard 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 testing laboratory.
Section 2.2 of ANSI N13.11 requires irradiation of test i
l dosireters and evaluation of the processor by a testing laboratory that is independent of the 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 16 Erclosure C i
the staterent that conflicts may occur between an NBS provision met by a processor and an NRC requirement on a licensee, the staff can think of no It is the responsibility of the licensee to use a processor conflict.
that is able to provide measurements of the radiation fields that exist in the licensee's establishment.
It is assumed in the dosimetry accreditation program that, if a processor can calibrate its dosimetry system to meet the requirerents 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.
Comentes #70 & #90: Comenters make the point that it is unreasonable to expect such fees to be paid by nonprofit organizations and that the regulation makes no distinction between profit-naking services ard nenprofit educational institutions.
Implementation of the rule will discourage small institutions from perforning their own dosimetry with resulting delays between personnel exposure and readout which should be kept to a minimum. Comnenters then express concern that the present rule will set a precedent for requiring accreditation fees for extremity monitoring and bioassay.
Staff Response: The accreditation procedure requires the developmert and testing of acceptable standards and generally requires several years It is true that before such procedures can be required by regulation.
this rule will set a precedent but whether or not that precedent will be followed by other similar rules is another natter. See also General Comments A through D.
16.
Comanter #89: Comenter expressed the opinion that the testing standards used by the University of Michigan were not 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,'
skin doses, etc., in different terms than were norm in the dosimetry field."
The comrenter 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 does not agree with the contention that the testing standards were not realistic. The concept of shallow and deep doses arises from the recommendations of the ICRP and is discussed in the standard ANSI N13.11. The costs cited by the comenter translate to
$12,000 to $30,000 per year while the costs based on the current fee schedule at NVLAP indicate the cost range at from $3,000 to $8,400 per See also General Coments A through D.
year.
Conrenter #95: This corrent is essentially identical to coment 10 but 17.
gets on to urge that nonprofit organizations be exenpt from the fee if 17 Enclosure C L
they are normally required to monitor only a small number of workers bui!
prefer to provide widespread monitoring for enhanced control.
Staff Response: See General Coments A through D.
Comenter #96:
Comenter is a small processor who participated in all 18.
three testing programs offered since 1978 and who states that the quality Comenter of his service has increased as a result of this participation.
then states that the fees are too high, unrealistic, and anti-small business.
Staff Response: See General Coments A through D.
CATEGORY V.
MISCELLANEOUS COMMENTS:
Nine comenters provided coments in this category. One of these also commented in another category.
1.
Comenter #26:
Comenter reproaches NRC for allowing dosimetry processing to contirue for so many years without requiring some forr of dosimetry Comenter also feels that it is the processing accreditation.
responsibility of the NRC to reveal the names, addresses, and results of all dosimetry processors that participated in the third round of testing at the University of Michigan and to reveal the types and models of all dosimeters that did not pass specific test categories. Comenter 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 participetion in such programs has been less than sat-isfactory.
It was rot possible, however, to institute a requirement for accreditrtion of such dosimetry processing until a performance standard The was developed to establish uniform criteria for such accreditation.
present perforrance standard ANSI N13.11, was not approved until 1982.
The names and addresses of the 56 participants that 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), which is available from the National Technical Information Service.
(SeeresponsetoIV-2). The results of the individual processors and the models and types of dosineters they used were confidential.
Each processor was assigned a code nurber known only to the testing laboratory, ard all results were published in reference to these l
numbers. All processors currently accredited urder the NVLAP program are listed in the NYLAP directory.
In regard to the dosincters at TM1, licen-sees are required to provide badging to those workers who are likely to be exposed to radiation at levels above those specified in 10 CFR 20.202(a).
Comenter #47:
Comenter states that studies conducted by DOE indicated l
2.
that ANSI N13.11 is inadecuate in terms of the complexity and advanced l
1evel of the DOE contractor dosimetry programs. Comenter also objects to l
the fact that the NVLAP program does not include a requirement to upgrade l
18 Enclosure C i
i
dosimetry processing performance. Comenter is asking NRC to include a paragraph in the final rule that would acknowledge the acceptance of a
+
parellel program of equal or greater quality in place of the NVLAP accreditation prcgram or exempt licensees that are also DOE contractors or that are located on DOE sites and whose dosimetry is performed a'ccording to the requirerents of the DOE Laboratory Accreditation Program (DOELAP).
Staff Pesponse: The NRC is fully aware of DOELAP. The DOELAP program is still under development; until successful implementation has been demenstrated, acceptance by the NRC would be premature. The concept of merging the DOELAP and NVLAP programs at some time in the future has already been discussed by the NRC and DOE staffs and may come to pass.
The FVLAP program does have plans to upgrade dosimetry processing performance.
3.
Comenter #50:
Comenter prefers Alternative 2 but states that Alterna-tive 3B is also acceptable although somewhat more restrictive. Comenter 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 prcposed 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, censidering the problen with accept-able standards.
Staff Response: At the present time, there is no acceptable consensus stancard for the performance of extremity dosimeters.
Even when one beccees available, it will be necessary to test it ageinst current dosimetry practices and procedures to determine its suitability, a process that could take two years or more. No good purpose wculd be served in delaying the prcposed rule to require accreditation of processing for whole body and skin dosimeters.
4 Comenter #51: Comenter concurs in the proposed rule and endorses Alter-native 3 - Option B.
Cementer is concerned thtt if a dosimetry system is designed to accurately assess the primary componert of personnel dose, other components tend to be assessed in a conservative manner. Comenter feels that the NVLAP criterion "L" should be skewed toward higher values for radiations that are not the primary concern, i.e., the tolerance limit should be less strincent for reporting deses high for these radiations.
Str.ff Responte: With the present availability of multichannel (windcws)
TLDs, all radiations can be reported accurately.
5.
Comenter #52: Comenter appreves of the proposed regulation and feels that it is overdue. CorTenter however feels that proposed paragraph, 20.202(c)(2)asdraftedraybeinterpretedtomeanthattheaccreditation process is equivalent to approving dosimeters for use in work envirorments in which people are monitored.
Staff Response: This paragraph has been changed in the final rule to more clearly state the intent of the accreditation process.
In addition, a l
section of the MVLAP accreditation requirement limits the representation of the scepc of accreditation for a processor's clients te only those 19 Enclosure C
tests or services for which the processor is granted accreditation. Also,'
accredited processors are required by NVLAP to inform their clients that the accreditation process in no way constitutes or implies product certification, approval, or endorsement by NBS.
6.
Comenter #53:
Comenter addresses issues that are not germane to the final rule.
Staff Response:
None.
7.
Comenter #56:
Comenter believes that the proposed rule has merit. He 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. Comenter goes on to point out two radiation categories for which he feels that nuclear power plant licensees need not be tested.
In order to prevent such a situation from arising, comenter recomends that NRC issue guidance on choosing such categories either in a Regulatory Guide or in some other document.
Steff Response: The NRC plans to issue supplementary information that will discuss radiation categories.
8.
Comenter #57:
Comenter agrees with the concept of utilizing the services of accredited processors but has numerous concerns recarding implementation of the NVLAP and the specific standards used. diso commenter is enncerned that changes in the LAP be published in the Federal Register with sufficient time for coment and with implementation time sufficiently long to allow processnrs to accommodate the changes.
Commenter has many coments on the contents of the Dosimetry LAP Handbook issued by NBS, particularly in regard to ensite assessment and the freedom of the assessor to make judgements. Comenter is also concerned that the processor may have to use one algorithm to pass the accreditation tests and another algorithm to process routine badges particularly in situations in which the licensees working conditions are not adequately simulated by the AMS! test categories.
Staff Response:
In regard to changes in the dosimetry LAP, see the Esponse to the General Comr.ents in Category IV. The Dosimetry LAP Handbook specifically addresses the considerable latitude granted to assessors in making judgements about labcratory compliance and further specifies that a laboratory (processor) has the right to appeal the assigerent of an assessor and request an alternate.
NVLAP is also interested in cbtaining names and addresses of potential assessors from processors or others to expand its pool of qualified persennel in this Qualified processors should be able to develop algorithms suited to area.
situations not represented by the ANSI test categories and this ability is one of the areas that is to be addressed in the onsite assessment.
Processors not able to demonstrate proficiency in this area will not be accredited.
For other specific questions regarding the dosimetry LAP the commenter is referred to appropriate personnel at NBS whose nemes appear in the Desimetry Lap Handbook.
4 20 Enclosure C
9.
Cementer #83: Comenter applauds NRC for its intent and makes some suggestions. The first involves the dilerra 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. Comrenter then expresses concern over the costs of accred-itation of large medical facilitics that process their own desimeters 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 Comenter is correct in stating that the processor can only determine the dose delivered to the dosimeter, which is not necessarily the same as the dose delivered to the person wearing the dosimeter. This has always been true, and the recuirement for accreditation only ensures that the processor will accurately and censistently determine the dose delivered to the dosimeter.
In regard tc the question of costs, the comenter 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 cf 0.5 for protec-tion categories and 0.3 for accident categories.
21 Enclosure C
REGULATORY FLEXIBILITY ANALYSIS FOR AMEN 0MENTS TO 10 CFR PART 20 0N IMPROVED PERSONNEL DOS! METRY PROCESSING The Nuclear Regulatory Comission is amending its regulations to reguire all. licensees to have personnel dosimetry devices that are utilized to comply with NRC regulations processed by processors that have been accredited by the NationalVoluntaryLaboratoryAccreditationProgram(NVLAP)oftheNational BureauofStandards(N85). Currently, NRC licensees are not reoutred to utilize the services of accredited processors.
This rule establishes uniform standerds and icsting protocols and quality assurance procedures fnr dosimetry processing based upon a national consensus standard, ANSI N13.11, ard should improve many existing problems such as inappropriate calibration sources, poor process control, inadequate instrumentation, and clerical errors.
The need for cerformance requirements for dosinetry processors was recognized by the unic Energy Comission as early as 1955 when it funded the NBS to undertaka the first intercomparison of film badge response.
Unfortunately, no suitable performance standards were developed prior to ANSI N13.11 in 1983.
In determining the need for accreditation of personnel dosimetry processors the following points were considered:
The commercial dosimetry processing business is highly competitive.
Well-qualified firms compete against less-qualified firms.
Many customers of comercial processors have little expertise in dosimetry processing.
Customers generally contract to the lowest bidder.
1
1 Less-qualified firms may neglect technical and operational details to keep their prices low.
Well-qualified firms may reduce the quality of their processing performance in order to remain competitive.
In view of these the NRC has concluded that accreditation of processors under NVLAP is needed to provide improved accuracy and reliability nf occupational worker dose records and maintenance of ouality processing.
Accreditation under NVLAP involves three separate actions:
(1) documenta-tion of responsible personnel, equipment, facilities, and quality control procedures; (?) proficiency testino 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 dnsirretry processors for NVLAP accreditation depend to a large extent on the size of the processing 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-hnuse OA program.
The initial cre-time cost of setting up the program is estinated to be about $7,000. The NRC staff believes that the maiority of dosimetry processors have already incurred this cost in association with the three rour.ds of performance testing conducted by the University of Michican. Maintenance cests for the OA program are estimated by NVLAP to range fron $7,000 biennially for e small processor to $6,500 biennially for the larger processors.
Proficiency testino costs vary considerably accordina to the nurber of dif'erent dosimeter types tested and the number of categories tested for each type. Tyoical costs for a small processor with one dosimeter type tested in only one category 's $3,700 biennially, while ensts to a larger processor with one dosimeter type tested in all eight categories is $10,250 biennially.
There is also a nne-time fee for new applicants of $450.
There are currently abcut 90 known personnel dosimetry processors in the U.S. that perform persennel dosimetry services either in-house or commercially.
Ten of these are considered to be "small entitics" as defined in Section 601(3)
?
Enclosure D
of the Regulatory Flexibility Act. The source of this information is a letter dated November 8, 1982, from the University of Michigan (UP) written in con-
' unction with a series of three pilot tests on personnel dosimetry proce'ssors j
conducted by UM under an NRC contract. A coov of the letter is available for inspection or copying at the NRC's Public Document pnom, 1717 H Street NW, Washington, DC.
The total volume of business within the dosimetry processing industry is estimated at $34 million annually with the 10 smell entities identified above sharing approximately 0.5% of the market or $170,000. While the NRC does not know the distribution of this volume of business among these small entities, an equal distribution of the business would indicate 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 would have a significant impact or any processor whose annual income is only $17,000.
Comnents received from licensees and the processina industry on the proposed rule and initial regulatory flexibility statement included objections to the costs of the program.
Some 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 fev felt that the quality assurance inspections should be conducted by NPC rather than NVLAP personnel.
The Commission believes that third-party accreditation under NVLAP will provide and maintain the much needed improvement in dosimetry prncessing.
Consideration of this findino and the alternatives considered are described in the Regulatory Analysis.
The Commission does not agree with the concept of different compliance or reporting requirements (such as oreferentially eliminating in-hnuse NVLAP assessments) between small and laroe processors since this concept is counter to the initial goal of establishing uniform and consistent procedures thrcughout the dosimetry industry.
The Comission likewise does not agree with the suggestion that NRC quality assurance inspections he substituted for NVLAP inspections since these inspections nr assessments are an essential part of the laboratory accreditation program and fall under the jurisdiction of NBS.
In recard to a differential fee schedule, NRC has no authority to impose such a schedule since NRS sets NVLAP accreditation fees.
Small processors should be aware that grants ma" be 3
Enclosure D
available from the Small Business Administration to assist small businesses in paying these fees.
The Consission has considered the impact of mandatory NVLAP accreditation and has concluded 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 negative economic impact on small entities.
i 4
Enc 1cture D
s CACKFIT ANALYSIS FOR AMENDMENTS TO 10 CFR PART 20 ON IMPROVED FERSONNEL DOSIMETRY PROCESSING The NRC "backfit rule" (10 CFR 50.109) states:
"Backfitting is detined as the modification of... procedures or organization required to design, construct or operate a facility; any of which may result from a new or amended provision in the Commissior. rules...."
Since the rule requiring accreditation of dosimetry processors may represent a modification of procedures in the operation of some nuclear power plant facilities, it is subject to the provisions of the "backfit rule."
The following represents a systematic and documented analysis according to the nine-factor outline set forth in i 50.109(c).
1.
Statement of the Specific Objectives to be Achieved The principal objective of this rule is to improve the accuracy and reliability of personnel dosimetry and so provide a significant health benefit by eliminating gross underestimates (of measurements due to processing) of the radiation deses received by individual workers in NRC-licensed activities.
This objective can be achieved by imposing a uniform set of procedures and performance standards on personnel dosimetry processors, including nuclear utilities that process their own dosimeters.
The need for such procedures and performance standards was recognized as early as 1955 through dosiretry intercomparison tests. More recent dosimetry tests (1977-1982) showed that less than half of the dosimetry processors met cceepted performance standards. The first of two rounds of testing of dosimetry proc-essors sponsored by the NRC between 1977 and 1979, prior to the start of hVLAP 1
Enc 1csure E
~
i dosimetry accreditatiun in 1984, shewed that approximately one quarter of all i=
worker doses were underestimated.
I Applying the results of the first test (see Appendix) to the 1982 (for example)
I hPP exposure records indicates that more than 6,000 person-rems actually f
received in 1982, were not recorded because of dosimetry that underestimated the workers' doses.
If the dosimetry was more accurate, and higher individual j
doses were then observed, it is believed that most licensees would take action I
to reduce dose rates and working times in order to keep the recorded doses at former levels. Thus an annual collective dose savings of up to 6,000 person-rems or more could theoretically result from improved dosinetry.
However, to some extent extra workers would be used to raintain the status que, l
and the collective dose saved could be less than 6,000 person-rems, say I
6,000 - x.
This unreported occupational dose which may be averted prevides a i
j significant health and safety benefit.
4 The data also indicate that about 3,000 person-rers that were not actually 4
received in 1982 were recorded because of desinetry that overestimated the l
workers' duses.
If this dosimetry was also more accurate and Icwer individual l
doses were observed, few if any licensees weeld deliberately increase dose rt.tes or introduce inefficiencies to increase deses to fomer levels.
In cer-tain cases however, highly skilled workers probably would be allowed to remain in radiatier fields for longer periods of time. Thus the collective dcse added because of cosinetry improvements would be less than 3,000 person-rers per i
year, say 3,000 - y.
The collective dose saved annually by accurate dosimetry would be (6,000 - x) -
(3,0C0-y).
If x and y are similar, the collective dose saved would be 3,000 persen-rems.
Actually y is believed to be greater than x because eFtra Workerk are usually unskilled or semiskilled and do not work extensively in high dose t
rate areas; highly skilled werkers are usually exposed to higher dose rates, i
Therefore, the assumption that x = y is conservative, and tends to support the conclusions stated in this analysis.
In 10 CFR Part 50, Appendix I, the health effects cost of radiation exposure is given as $1,000 per persen-rem.
From i
this viewpoint, improved dosimetry could have saved at least $3,000,000 in i
i 19&?.
?
Enclosure E l
I
'The arrual savings considerably exceed the annual cost to the industry for accreditation, indicating that the direct and indirect costs to the industry
. are fully justified in view of the increased health protection and cost saviros obtained.
2.
General Description of the Activity to be Required of the Licensee or Applicant NRC licensees will bt required to have those desimeters that are used for com-pliar.cc with 10 CFR 20.202(a), or license conditions, processed by a processor accredited under the NVLAP program.
If the licensee processes its own dosir.eters, it will be required to develop an in-houst quality assurance program, submit certain dosireters to the NVLAP proficiency testing laboratory for testing, and agree to periodic inspections by NVLAP personnel.
If a licensee retains arcther organization to process its dosimeters it will have to ensure that the organization has been accredited by NVLAP.
3.
Potential Change in the Risk to the Public frem the Accidental Offsite Release of Radioactive Material The desiretry accreditation rule will have no effect on the probability or magnitude of accidental offsite releases.
4.
Potential Impact on Radiological Exposure of Facility Employees The dosimetry accreditation rule will provide a more accurate assessment of individual worker radiation exposure.
It will therefore result in increased safety by ensuring that those individuals whose doses are row being underesti-nated will have their individual doses more correctly reported as a result of the procedures, performthce standards and tolerances that are imposed under NVLAP. As indicated in Section 1 the radiological exposure of many individuals is expected to decrease.
6.
Installation and Continuing Costs, including the Cost of Facility Downtime or the Cost of Corstruction Delays I
3 Enclosure E
)
i The cost of installing the requirec quality control systen is estimated at approximately $7,000 for the average dosimeter processor. The cost of profi-ciency testing depends upon the nurber of catercries for which the dosimeters must be tested. Most NPP in-house licensees have their dosimeters tested in all eight categories included in the national standard and the fee for this is
$10,250 biennially.
No other costs are anticipated. Those NPP operators that I
do not do in-house processing will probably experience some increase in costs, but the increase should be less than the cost of obtaining their own accredi-tation since commercial processors will pass on only a portion of their increased cost to each customer.
No facility downtime or construction delays will occur as a result of the reovirements specified in this rule.
j 6.
The Potential Safety impact of Changes in Plant or Operationel Complexity, including Relatienships to Proposed and Existine Peculatory Reauirements f
The dosimetry accreditation rule will not require changes in plant design or operational complexity.
NVLAP procedures may require a slightly larger area i
than is currently being used for dosimeter calibrations in order to reduce radiction scattering and other similar effects, but this would be a very minor change in the allocation of space for a NPP.
No other changes are anticipated, and no potential safety impact is expected.
j 7.
The Estimated Resource Burden on the NPC and the Availability ef Such Resources An initici implementation cost to the NRC will be that astociated with revision of the Office of Inspectior and Enforcement inspection procedures to avoid duplication of inspection in these areas where NVLAP inspections will occur.
The long term effect, however, will be a reduction in required NRC inspection time arid therefore costs.
In addition, there will be a very small staff effort within the Office of Research to coordinate contineation of the Interagency l
l Agreerrent between NPC and NBS.
This will take less than a 0.1 persen year / year and would easily be offset by the savings generated by reducticn of the 18E inspection program as stated abeve.
t 4
Enclosure E
O o. '.. *,
8.
The Potential Impact of Differences in Facility Type, Design, or Age on the Relevancy and Practicality of the Proposed Action There is no poter.tial impact of differences in facility type, design, or age on the relevancy and practicality of the proposed action.
9.
Whether the Proposed Backfit is Interim or Final and, if Interim, the Justificatien for Imposing the Proposed Backfit on an Interim fasis The rule is to be published as a final rule.
10.
Findings and Conclusions This analysis indicates that this rule would result in a substantial increase in the overell protection of public health and safety by improving the accuracy and reliability of personnel dosimetry and thereby greatly reducing undertstimates of radiation doses received by workers.
It further shows that the direct and indirect costs of implementation by industry are justified in view of the increased protection that would be provided as well as by corpensating cost reductions.
5 Enclosure E
APPEt: DIX e
Between 1977 and 1979 the NRC sponsored two rounds of proficiency testing of personnel dotinetry processors soeinst the ther, newly recorrended Health Physics $cciety Star.dards Consnittee (HPSSC) performance standard.
Data obtained from the first test revealed that less than 50% of the test categories were passed, the median failure level was a factor of 2-3 times the perfnrrance standard criterior., and the bias values obtained wert equally distributed above and below the delivered doses.l.2 Assuming a conservatively small failure factc r of 2 and applying tHs information to the 1982 exposure records of NPP workers 8, and considerirg only dose ranges above 2 rens, it can be shown that in each of the tcbulated dose ranges:
One quartur of the reported doses are underestimated by a factor of 2.
a.
b.
One quarter of the reported doses are overestimateo by a factor of 2.
c.
Onehalf(2cuarters)ofthereporteddosescanbeacceptedforthis analysis as satisfactory.
Thecollectivedoseineachtabulatedcoserange(2remsandgreater)is estimateo by multiplying the nun,ber of perser.s in each dose range by the midpoint of the dose range. One quarter of the collective dose obtained is then ruitiplied by 2 to estimate the correct dose for the underestimated grour and another quarter is divided by 2 to estfrate the correct dose for the overestimated group.
NUREG/CR 1064 " Final Peport of a Two Year Pilot Study." P. Plato, G. Pudson, University of Michigan, January 1900.
2NUREG/CR-1304 "Suppleentary Report of a Two Year Pilot Study," P. Plato, G. Hudson, University of Michigan, April 1980, 3NUREG 0714. Vol. 4 & 5 " Occupational Radiation Exposure " October 1985.
6 Enclosure E
After these operations have been completed for each tabulated dose range and the results summed, the following values are obtained:
Collective Dose (Person-Rems) l'nderestimated Correctly Estinated Correctly Estimated Overestimated Ouarter Quarter Quarter Quarter 12,000 6,000 6,000 3,000 Dose received but 12,000 - 6,000 = 6,000 person-rens not reported Dose reported but 6,000 - 3,000 = 3,000 person-rems not received Net dose not reported 3,000 person-rees This number represents approximately:
a.
12% of the total annual collective dose reported for the range 2 rens and above, b.
6% of the total annual collective dose.
7 Enclosure E
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CPAFT CONGRESSIONAL LETTEP
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee ere copies of a public anncuncement and a final atendment to 10 CFR Part 20 that will be published in the Federal Register.
The Nuclear Regulatory Commission is amending its regulations with respect to those licensees who are required by NRC regulations to provide radiation monitoring to workers.
This amendrent will require such licensees to have dosineters that need processing to be processed by personnel dosimetry processors who have been accredited under the Natiunal Voluntary Laboratory Accreditation Program operated by the National Bureau of Standards. The amendment will result in greater uniformity and accuracy in personnel dosimetry processing and recording for all affected licensees and is expected to improve the accuracy of dosimetry that is performed voluntarily.
The Connission is issuing the final arendment with an effective date one year after publication in the Federal Pegister.
Eric S. Beckford, Director Office of Nuclear Regulatory Pesearch
Enclosures:
1.
Public Announcement 2.
Federal R(gister Notice Enclosure F
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PUBLIC AMNOUNCEMENT NRC AMENDS ITS REGULATIONS ON PERSONNEL MONITORING I
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 dosimeters used for personnel radiation monitoring are film badges, track-etch dosimeters, ar.o thermoluminescent dosimeters (TLDs), all of The amendment will which require processing to yield the radiation dose.
require that, whenever such dosimeters are provided to personnel in order to meet NRC requirements, licensees are to have the dosimeters processed by 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 performance standard) revealed that a significant percentage of processors were While most of not performing at a level of accuracy acceptable to the NPC.
those who failed to meet the test criterion did so by factors of 2 to 3. for some processors this factor was much higher. The amendment will provide more accurate measurements for personnel radiation exposure control and dosimetry records through application of uniform performance standards to the processing of all dosimeters required by the NRC.
Although the amendment will not apply to persnnnel dosimetry supplied by NRC licensees voluntarily, significant improvement in this type of dosimetry is also expected.
l l
Enclosure G
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