ML20206E669
| ML20206E669 | |
| Person / Time | |
|---|---|
| Issue date: | 07/24/1985 |
| From: | Dircks W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Minogue R NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| References | |
| NUDOCS 8606230492 | |
| Download: ML20206E669 (97) | |
Text
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YJ j JUL 2 41985 I MEMORANDUM FOR: Robert B. Itinogue, Director Office of Nuclear Regulatory Research FROM: William J. Dircks Executive Director for Operations
SUBJECT:
CONTPOL OF NRC RULEMAKING By memorandum of February 13, 1984, " Control of NRC Rulemaking by Offices Reporting to the EDO," Offices were directed that effective April 1, 1984, (1) all offices under ED0 purview must obtain my approval to begin and/or continue a specific rulemaking, (2) resources were not to be expended on rule.
makings that have not been approved, and (3) RES would independently review rulemaking proposals forwarded for my approval and make recommendations to me concerning whether or not and how to proceed with the rulemakings.
In accordance with my directive, the following proposal concerning rulemaking has been forwarded for my approval.
Proposed revision of 10 CFR Part 20, " Improved Personnel Dosimetry Processing."
(Sponsored by RES - memorandum, Minogue to ED0 dated June 12,1985.)
I approve continuation of this rulemaking. The NRC Regulatory Agenda (NUREG-0936) should be modified to reflect the status of this rulemaking.
($g.d)Ch::11.Dh4 William J. Dircks Executive Director for Operations
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,g, JUN 121985 91 MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
CONTROL OF NRC RULEMAKING: RES REVIEW 0F ONG0ING RES SPONSORED RULEMAKING, " IMPROVED PERSONNEL D0SIMETRY PROCESSING -- 10 CFR PART 20" Based on our review of ongoing RES sponsored rulemaking, " Improved Personnel Dosimetry Processing -- 10 CFR Part 20," RES recommends that the NRC should proceed with this rulemaking. This recommendation, in draft form, has been coordinated with the user offices (NMSS, NRR, SP and IE).
The basis for our reconinendations is as follows:
- Accreditation and standardization are needed because most dosimetry processors are known to have difficulty in the measurement of radiation doses in the occupational range.
Inaccuracies in personnel dosimetry processing could lead to overexposures, including the embryo / fetus in the case of pregnant radiation workers.
A recent (1984) personnel dosimetry intercomparison study :+ ORNL showed that only slightly more than half of all dosimeters tested met the guidelines for accuracy, and further, some of the repo"N results differed from the reference value by more than a factoc of 20.
The intercomparison study just cited reported that the 1984 results are even less accurate than those of a similar ORNL study reported in 1982.
Many of the discrepancies and differences occurring in dosimetry processing studies are the result of non-standard procedures such as in the choice and use of calibration sources, exposure phantoms, exposure geometries, and dosimetry readout procedures.
The Interagency Policy Committee on Personnel Dosimetry Processing, which consists of seven Federal agencies and the Conference of Radiation
. S 2 JUN 121985 Control Program Directors (representing the States), have endorsed the program and plan to recommend its adoption by their agencies.
- Accreditation of dosimetry processors will improve the public perception of dosimetry services and will lead to increased credibility of dosimetry records in lawsuits involving radiation exposure.
- Of the comments received on the proposed rule 70% were in favor 21% were against, and 9% were uncommitted.
An accreditation program, requested by and initiated with funds provided by the NRC is now being conducted by NBS, using ANSI N13.11 as the performance standard.
In addition, interagency cooperation and coordination has been solicited throughout the development of the rule from the Interagency Policy Committee on Personnel Dosimetry (IPCPD).
The complete RES review package has been sent to OED0 (Attention: DEDROGR) and to the directors of NMSS, NRR, SP and IE.
Robert B. Minogue, Director Office of Nuclear Regulatory Research i
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millespie MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
CONTROL OF NRC RULEMAKING: RES REVIEW 0F ONG0ING RES SPONSORED RULEMAKING, " IMPROVED PERSONNEL DOSIMETRY PROCESSING -- 10 CFR PART 20" Based on our review of ongoing RES sponsored rulemaking, " Improved Personnel Dosimetry Processing -- 10 CFR Part 20," RES recommends that the NRC should proceed with this rulemaking. This recommendation, in draft form, has been 1 coordinated with the user offices (NMSS NRR, SP and IE).
The basis for our recommendations is as follows:
- Accreditation and standardization are needed because most dosimetry processors are known to have difficulty in the measurement of radiation doses in the occupational range.
Inaccuracies in personnel dosimetry processing could lead to overexposures, including the embryo / fetus in the case of pregnant radiation workers.
- A recent (1984) personnel dosimetry intercomparison study at ORNL showed that only slightly more than half of all dosimeters tested met the guidelines for accuracy, and further, some of the reported results differed from the reference value by more than a factor of 20.
- The intercomparison study just cited reported that the 1984 results are even less accurate than those of a similar ORNL study reported in 1982.
Many of the discrepancies and differences occurring in dosimetry processing studies are the result of non-standard procedures such as in the choice and use of calibration sources, exposure phantoms, exposure geometries, and dosimetry readout procedures.
- The Interagency Policy Committee on Personnel Dosimetry Processing, which consists of seven Federal agencies and the Conference of Radiation 0FC: : : : : : :
NAME: : : : : : :
DATE: : : : : : :
JUN 121985 Control Program Directors (representing the States), have endorsed the program and plan to recommend its adoption by their agencies.
- Accreditation of dosimetry processors will improve the public perception of dosimetry services and will lead to increased credibility of dosimetry records in lawsuits involving radiation exposure.
- Of the comments received on the proposed rule 70% were in favor 21% were against, and 9% were uncommitted.
- An accreditation program, requested by and initiated with funds provided by the NRC is now being conducted by NBS, using ANSI N13.11 as the performance standard.
In addition, interagency cooperation and coordination has been solicited throughout the development of the rule from the Interagency Policy Committee on Personnel Dosimetry (IPCPD).
ThecompleteRESreviewpackagehasbeensenttoOED0(Attention: DEDR0GR)and to the directors of NMSS. NRR, SP and IE.
Originsisigned by:
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Robert B. Minogue, Director Office of Nuclear Regulatory Research ct 6/6/85 *See previous concurrence, m 0FC: RES:0RPB : B : RES; :CHMN : RE : :
.....__.......____.r. y NAME: DNellis* : RAldd nder*: KGoller* : FGillespie*: DR :F nogue :
DATE: 3/27/85 : 3/27/85/ : 3/28/85 : 5/23/85 : 6/ '/85 : 6/ /85 :
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FROM: F. P. Gillespie, Chairman, RIRB cyg ,,g y 3 M d glo 4 ,
TITLE OF RULEMAKING:
Accreditation of Person 1 Dosimeter Processors AGREE WITH RECOPMENDATIONS , ,
' IN RES RULEMAKING REVIEW PACKAGE MODIFY RECOMMENDATIONS IN NOT PARTICIPATING-RES RULEMAKING REVIEW r
PACKAGE AS INDICATED BELOW COMMENTS AND SUGGESTIONS:
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F.ES INDEPENDEf.i 1.E\IEW BOARD V0TINC SHEET TO: F. P. GILLESPIE, CHAIRMAN, RIRB FROM: W. M. Morrison, Member, RIRB I l TITLE OF RULEMAKING: Accreditation of Personnel Dosimeter Processors AGREE WITH RECOMMENDATIONS X
- IN RES RULEMAKING REVIEW PACKAGE MODIFY RECOMMENDATIONS IN NOT PARTICIPATING.
RES RULEMAKING REVIEW PACKAGE AS INDICATED BELOW 1
COMMENTS AND SUGGESTIONS:
Straight approval.
1 I Y[/ / kc W u M '
W. M. MORRISON MEMBER, RIRB APRIL 3, 1985 DATE
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RES INDEPENDENT REVIEW BOARD VOTING SHEET .
TO: F. P. GILLESPIE, CHAIRMAN, RIRB FROM: G. A. Arlotto, Member, RIRB TITLE OF RULEMAKING: . Accreditation of Personnel Dosimeter Processors l
/ AGREE WITH RECOMENDATIONS
- IN RES RULEMAKING REVIEW
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PACKAGE MODIFY RECOMENDATIONS IN NOT PARTICIPATING.
RES RULEMAKING REVIEW PACKAGE AS INDICATED BELOW C0pt4ENTS AND SUGGESTIONS:
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.. n # e 4 P4 mcm {c es a.) l RIRB members are requested to conduct an independent
) review of the attached RES rulemaking review package and provide the Chairman, RIRB, with their voting sheets indicating their positions on the rulemaking..
1 Responses by c.o.b.
will be appreciated. RAMRB will use the voting sheets to assemble the complete RES review package for eventual transmittal to the OEDO and the Director of the user office.
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. MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
CONTROL OF NRC RULEMAKING: RES REVIEW OF ONGOING RES l SPONSORED RULEMAKING Based on our review of ongoing RES sponsored rulemaking, " Improved Personnel
! Dosimetry Processing -- 10 CFR Part 20," RES recomends that the NRC should proceed with this rulemaking. This reconsnendation, in draft fonn, has been coordinated with the user offices (NMSS, NRR, SP and IE).
I The basis for our reconsnendations is as follows:
I Past studies of dosimetry processor performance indicated a need for l comon performance standards.
j -
Voluntary performance standards have not achieved wide participation and
- acceptance from the personnel dosimetry processing industry.
I -
Recent testing programs conducted against the industry standard ANSI j NI3.11 indicate marked improvement is possible in the industry.
I -
The majority of comments received on the proposed rule, which was
! published in January 1984, were in favor of the rule.
In addition, interagency cooperation and coordination has been solicited throughout the development of the rule from the Interagency Policy Consnittee ,
j on Personnel Dosimetry (IPCPD). l i
The complete RES review package has been sent to OEDO (Attention: DEDROGR)and j to the directors of NMSS, NRR, SP and IE.
i I
Robert B. Minogue, Director i
Office of Nuclear Regulatory Research i
l ct 3/27/[5_. /\ _ c a g
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NRC REGULATORY AGENDA ENTRY
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! Regulatory Agenda Entry i
! TITLE:
l
+ Improved Personnel Dosimeter Processing CFR CITATION:
10 CFR 20 i ABSTRACT:
The notice of proposed rulemaking requested comments on a proposal to add amendments to 10 CFR Part 20 that would improve the accuracy and consistency of reported occupational radiation dose measurement by i , requiring proficiency tests of dosimetry processors who perform dosimetry for NRC licensees. The proposed amendments would require NRC licensees 4 to have personnel dosimeters (devices carried or worn by each radiation i
worker to measure radiation exposure received during work) process .a by a i dosimetry service that is accredited by NBS/NVLAP. The Comission considered five alternatives for establishing a regulatory program
, intended to improve personnel dosimetry processing. These alternatives
- included
- no change in current requirements; requiring licensees to
! participate in performance testing without specifying a testing i laboratory; requiring licensees to participate in performance testing conducted by an NRC-specified te:; ting laboratory; a request from Congress for the authority for NRC to license personnel dosimetry processors directly; and requiring licensees to obtain dosimetry services from an 4
NRC-operated or contracted dosimetry service. An evaluation of estimated annual costs to the dosimetry processing industry resulting from an NRC rule requiring licensees to utilize dosimetry processors accredited under an NBS/NVLAP program was projected to be about $781,000. This would
, result in an estimated net annual increase in the cost of providing monitoring for each worker per year of $0.56, a 2.3% annual increase.
The major benefit of the proposed rule would be increased accuracy and d
reliability of dose measurement to workers in licensed installations, i Other benefits include: continued assurance of personnel dosimeter
! processor competence with minimal NRC staff and resource allocation; l fonnulation of a program that can easily be utilized by other agencies; i value to the industrial licensee through legal credibility of a
. natio'nally-recognized accreditation program; and value to the worker -
through more accurate assignment of dose.
1 The coment period closed March 12, 1984. Ninety-six coment letter were J received, most containing three to four coments. The majority of i coments are in favor of the rule but many of these favorable comments
, also suggest changes. Drafting of the final rule will begin when the j -
analysis of coments is completed.
TIMETABLE:
ANPRM 03/28/80 45 FR 20493 1
ANPRM Coment Period Begin 05/12/80 45 FR 31118 i
! l l
1
{
Enclosure D
ANPRM Comment Period End 06/27/80 '
NPRM 01/10/84 49 FR 1205
. NPRM Comment Period Begin 01/10/84 49 FR 1205 '
NPRM Comment Period End 03/12/84 final Action 12/12/85 i
LEGAL AUTHORITY:
42 USC 2073; 42 USC 2093; 42 USC 2095; 42 USC 2111; 42 USC 2134;
~
42 USC 2201; 42 USC 2273; 42 USC 5841; 42 USC 5842 EFFECTS ON SMALL BUSINESS AND OTHER ENTITIES: Yes AGENCY CONTACT:
Donald O. Nellis Office of Nuclear Regulatory Research Washington, DC 20555 301 427-4588 1
~
i l
. 2 Enclosure D
TASK LEADER EVALUATION i
(
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Draft RES Recomendations to EDO Concerning Ongoing Rulemaking for Improved Personnel Dosimetry Processing Past studies of dosimetry processor perfomance, discussed in the proposed rule and draft regulatory analysis, showed that the need exists for a comon performance standard for both film and thermoluminescent dosimetry processors. In a series of tests of dosimetry processors undertaken between 1978 and 1982, improvements in the passing scores increased dramatically as a result of using standard sources and procedures. The passing scores on three tests conducted during this period were 48%, 62% and 75% of all dosimeters
. tested.
RES recomends that efforts continue with this rulemaking to require certification of dosimetry prpeessors for the following reasons:
- Certification or standardization is needed because most dosimetry processors have difficulty in the measurement of gama doses of less than 20 mr and neutron doses of less than 50 mr, a problem that is intensified by the presence of mixed radiations. -
- Inaccuracies in personnel dosimetry processing could result in overexposures, particularly to the fetus in the case of pregnant radiation workers.
- A recent (1984) personnel dosimetry intercomparison study at ORNL showed that only slightly more than half of all dosimeters tested met the regulatory guidelines for accuracy, and further, some of the reported results differed from the reference value by more than a factor of 20.
- The intercomparison study just cited reported that the 1984 results are even less accurate than those of a similar study reported in 1982.
- Many of the discrepancies and differences occuring in 6simetry processing studies are the result of non-standard procedures in choice of calibration sources, exposure phantoms, exposure geometries, and dosimetry readout procedures.
- The Interagency Policy Comittee on Personnel Dosimetry Processing, which consists of seven Federal agencies and the Conference of Radiation Control Program Directors (representing the States), have endorsed the .
program and plan to recomend its adoption by their agencies. '
ENCLOSURE C
Assessment of Compliance by RES With Procedures and Guidance for Rulemaking 10 CFR Part 20 This rulemaking is responsive to the recommendations of the Task Force on Personnel Dosimetry of the Conference of Radiation Control Program Directors, the National Center for Devices and Radiological Health and the Department of Energy.
Interagency cooperation and coordination has been developed through association with the Interagency Policy Comittee on Personnel Dosimetry (IPCPD).
Draft RES recommendations to the EDO have been reviewed and concurrence received from the user offices NMSS, NRR, SP and IE.
The Initial Regulatory Flexibility Analysis incorporates the projected range of accreditation fees for processors.
To the best of our knowledge this rulemaking is in compliance with NRC_.
procedures and guidance for rulemaking.
l l
1 Enclosure E l 1
4 SUPPORTING DOCUMENTATION 1
I
t nos
, Proposed Rules ad-d =*'-
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.; . i Tweeder. Iammary 24 1888
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TMs es1on of he FEDERAL REGtSTER and Initial Regulatory Flexibility annessis namnes to me peas et ma the dose aconied by the dosimeteris personed issuance of ndes sind Analysis may be obtained as request above the detection throehold, e.g., .
'*IPdesonL Th* Insponc et thsee nesses from " ;T_ .V.Federline, about 20 meems for photons. However.
is m she gearund persons an OccupationalRadiation Protection personnel dosimeters must be procepeed
""*"*F" Branch, Division of Facility Operations,
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accuretely and consistently, and i ' , g,,, Office of Nuclear Regulatory Research, interymted correctly to provide Man Stop NLasso, U.S.Neclear adequate does estimates. Data from the Regulatoryr -- '--t Washington.
DC 20555.
processin6 of personnel doelmeters are feUCLEAR MOULATORY pon ruumum esponsnavsoas coerrasm the bests for h=a- and NRC records l C000001001001 Margaret V.Federline. Division of of external doses to workers.
Facility Operetions. OfBce of Nuclear Several dosimetry processor to CPR Part28 performance studies conducted between Regulatory Research, U.S. Nuclear Regulatory e - '-9. Mail Stop NL agg7 and meindiceled poor 8MIProved Personnel t f., performance (excessive bias and W~ -,
Sasc, Washington, DC 30656." ? - variance) of processor's dosimeters (301) 40-70se; inquiries regarding the~
laboratory Accmetados W fu when tested against a number of early memoc.v: N. uclear Regulatory performance standards;
- thm stuses c__-
Personnel Doshnetry Processere at the clearly demonstrated the need for
~-
actioet Propomd rule. National Bureau of Standards abonid be umunon performance criteria for both addressed to Robert L Gladhill, Office '
summaany: Tests have indicated that a d Laboremry Amedtaum, NaHanal film and thermoluminescent dosimeter signi!! cant porosatage of pr=anaal Voluntary Laboratory Accreditation (11D) processor testing. As a result of-i
+- ^ these studies and strong encouragement mey act be National Bureau of Standards, p.,gd , anable dogme of T B-241, Washington, DC by the Task Force on Personnel Dosimetry of the Conference of accuracy. Current regulatione do not 20t34, telephone (301) get-M31.
addrus the - Radiatim ControIProgram Directm R ofabsee ""'""""ramy esponesavicat (which represents the Statas), the NRC, processors. The Nuclee'r Regulatory Personnel doelmters an devices worn by workers to monitor their the Bureau of Radiological Health (ww
) amendaments c .. 3aa(NRC)le that the National P=ne=e for Devices and its exposum to radiation.NRC- Y - z1 Radiol Health), and the Energy Bcensees to enhse b servious are required to performs personnel R of processors that have and Development '
accredited monitoringp la 10 CFR Part
- Administration (now the Department of by the National Voluntary laboretory 20,Iamans, to moord and maintain Energy} lointly conducted a public
!- Accreatenom Program of b National radation expoem meenis as specified Bween of an==da ds, ini2a401. mating in we at which the pmannel dosimetry performance problem was natus rmts met k W on or bion MarM2,1984. hu Several types of permannat monitoring discussed la an open forum by devices a o available: personnel daal==try processors, received after this de" will be 1. hole body w wholMy and dosimtry som,and upmeentauws d considered ifit is practical to do so, but skin personnel doelmeters, such as film .
badges 5=AAng track. etch type State Governments and Federal semance of considersuon cannot be agencies.1hese A==== ions revealed
- I dosimeters, and thermoluminescent
,8',""" [de - dosimeters (11Ds)includmg albedo general agreement that a personnel doelmeters; dosimetry problem does exist and that
^""****"* Interested persons are the problem is sufSdently broad in
- 2. Extremity doehneters for assessin invited to submit written comments and dose equivalent to hand and forearms,g scope thatit should be adddressed by suggestions on the proposed rule, the feet and ankles; arui the Federal government, since voluntary -
supporting Regulatory Analysis and the 3. Pocket lonization chambers, standards programs for personnel Initial Regulatory Mexibility Analysis to including direct-reading and indirect- dosimetry processors have historically the Secretary of the Commission. U.S. reading dosimeters. ' failed to achieve wide participation and Nuclear Regulatory Commission. acceptance from the personnel Washington.DC 20555, Attention:
After being exposed to radiation, personnel dosimeters (with the dos metry processing industry. Also.
Docketing and Service Branch. copies of a draft performanos standard.
exception of pocketlonisation -
Comments may also be delivered to Room 1121.1717 H Street NW., chambers) must be iw -- x i to -
estimato the radiation dose received by 'c M. uer h. .t at. -ne Esembhahment of and Washington, DC, between 315 a.m. and unha tion orramnaaw performance Cnteria.-
the individual while wearing the device. BMder. Dean s neDe Northwat Laboratorkt 5130 p.m. Copies of the Regulatory Analysis. the Initial Regulatory Flexibility Analysis, and of comments Dosimeters are collected froen workers at various prescribed time intervals and processed either by the licensee in-
$*"d g "7 of w pm.o% m,.w g % 7,,,,
as. sememmary as. ses, ante.% serviosa. lair ne Northwest
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received oas nde..m, bymaythebe Commission e.. med in reg"&e house or by a commercial dosimetry
-sso,(s). Pe,sowei doehneare tabaratarr.R*Maad Washinston.unpubhehed
- / s- ra - C - -- -
Commission's Public Document Room at appear to be capable ofproviding
.J1717 H Street NW., Washington, DC. consistently accurate information on the **[* ",,$$7"*T"j' ,,$,r g
p.,,,,,,i o,,;.,i Single copies of the Regulatory Analysis amount of radiation received, provided sNW141M Den). Betwue Norewat taboratory, pi$and Wuhlagten, h#
1206 Federal Register / Vol. 49 No. 6 / Tuesday, January 10, 1984 / Proposed Rules which designed to establish uniform indicated that the whole body or whole requested comments on four methods for <
criteria for testing the performance of body and skin dose received by the operation of a proficiency testing s-film and RD dosimetry processors, occupationally exposed personnel may laboratory,(PII.) that would conduct A w:re distributed at the meeting.no often be considerably different from the performance testing against the criteria .
draft standard was written by a working dose recorded. in the HPSSC/ ANSI Standard. Any 17I1.
group of the Health Physics Society Because of the importance of established in accordance with one of Standards Committee (HPSSC) and was personnel dosimetry measurements and these methudogwoulf be monitored for ,
subsequently published in draft form by' the dpparent poor performance of some technical competency by the National tha American National Standards processors, NRC considers that there is Bureau of Standards (NBS). Licensees Institute (ANSI) as ANSI Standard a need to evaluate the performance of would be required to obtain or provide N13.11. personnel dosimetry processors dosimetry services which satisfied Many of the 1976 public meeting periodically and to make a specific criteria as established by the NRC and cttendees cautioned against precipitious determination of competency. administrated by the ITII. The four cction by any Covernment agency and Interagency coordination and methods for PIL operation as described strongly recommended a pilot study (1) cooperation was initiated very early in in the ANR are:
ta evaluate the newly formulated draft the program with the formation of the 1. NRC would not specify the PIL:
HPSSC/ ANSI Standard N13.11, and (2) Interagency Policy Committee on processors and licensees would be left ta provide processors the opportunity to Personnel Dosimetry (IPCPD) in 1977 to to thelt own initiatives to establish one trke any necessary corrective actions in guide and coordinate correction of the or more Fil(s) to administer proficiency .
j their operations prior to the dosimetry processor performance testing against the standard.
implementation of new Federal problem. NRC staff members have 2.ne PIL would be a Federal regulations on the dosimetry participated and reported to the IPCPD government facility managed and perfonnance problem. on the progress of this rulemaking action operated by NRC.
' As a result of these recommendations, at all meetings.The IPCPD Committee 3. NRC would contract the services of two rounds of personnel dostmetry includes representatives from:He a Pl"L and utilize the contractor's
- l. processor proficiency testing were facilities.
National Center for Devices and conducted for NRC by the University of Radiological Health 8which is a part of 4. Other government agencies j( Michigan (UM) from 1977-1979.' Fifty- Health and Human Services (HHS), the experienced in laboratary testing would l nine personnel dosimetry processors, Department of Defense (DOD), the operate a FILin Federal government-who provide dosimetry services for Department of Energy (DOE), the owned facilities.
cpproxunately 90% of the nuclear EnvironmentalProtection Agency (EPA). Of Ihe fortv. sis letters ut i omment worker population in the U.S., the National Bureau of Standards (NBS), received in response to the ANR, voluntarily participated in these tests. the NRC, the Occupational Safety and twenty-one letters did not state a Health Administration which is a part of preference for a method of operating the .~E c ance th / St the Department of Labor (DOL), and the PIL Three commenters felt no program standard. Conference of Radiation Control at all was necessary. In the remaining 22 ne HPSSC/ ANSI Standard. " Criteria Program Directors which represents the comment letters, one or more 4 for Testing Personnel Dostmetry States.*The representatives of these preferences were expressed as being I Performance," includes criteria for agencies consider the NRC to be the acceptable for the operation of the PIL performance testing of personnel lead agency for the overall problem. and , Twenty preferences were for the varicus dosimetry processors who provide they plan to recommend to their various ' types of Federal government-controlled whole body or whole body and skin agencies that similar pmgrarns be laboratories (methods 2,3, or 4).
dosimetry services in eight radiation adopted. Comments asked questions and categories including x. ray, gamma, beta. - Industry coordination and cooperation commented on who should control the neutron, and mixtures of these fr m personnel dosimetry processors testing laboratory and on procedures to .
radiations. Criteria for testing the I has been sought since 1977 when the be used in the regulatory program, as performance of extremity dosimeter
' Industry Overview Committee on addressed in the ANR. Other processors and for use in evaluating the Personnel Dosimetry was formed to commenters discussed potential performance of pocket ionization administrative, contractual, and legal monitor the progress and development chambers were specifically excluded f this program and to ensure that any problems that could result from a from the scope of the HPSSC/ ANSI Standard by the working group who regulatory action would be effective and processor failing to achieve accredited wrote the Standard.
appropriate to the need. status.nese problems have been The NRC published in the Federal investigated by the NRC staff.There Results of the two rounds of prof;ciency testing of dosimetry Register (45 FR 20493) an Advance was concern regarding the values and
' Notice of Rulemaking (ANR) on March impacts of this regulatory program.
processors indicated that improvement is needed on the part of many . 28,1980.The ANR fully described the Many commenters discussed the results of the UM tests, discussed the importance of defm' ing and requiring processors and that a significant i percentage of the processors are not need for improved dosimetry processing minimum elements of a generic quality performing with a degree of accuracy through rulemaking, and presented and assurance program that should be i
cceeptable to the NRC. Criteria for ,
established. Several dosimetry 8 Formdy me Bunau of Radolosical Heale processors who replied requested that a i dosimetry processor performance
- acceptable to the NRC are specified in I'$e Conference of Radiation Control Programthird round of performance testing be
- ANSI Standard N13.11. Results also oirectors has stronaly supported the development of conducted to allow processors to be i this rule smce 1p3. The Conference recently tested against the revised standard i
- Plato. P. and C. Hudson. " Performance Testins advised the States of the current status of this before a program becomes effective.
' of Personnel Dosimetry Services Final Report of a program and encouraged individual letters to the (Such testing has been conducted, and is .
t l l
' T=4-year Pilot Study. October 1977-September Commission ursiris their strons endorsement for this rule. Several such letters have already been iscusse ater n gs not ce. ge ma or j i
19*9. NUREC/CR 106L lanuary,1980 University of -
i received. techmcal questions raised concerned the l l uchisan. Ann Arbor.nchisan.
l 1' . ;
n, . .:
Federal Register / Vol. 49. N2. 6 / Tuasday Janu ry 10. 1964 / Proposed Rul:s 1207 in the Federal Register on January 29. results remain anonymous, even to the selection of dose conversion factors NRC.
within the standard and the 1961 (46 FR 9680) and requested public comment.%e NRC sent a copy of the Processors chose the categories in
_ 'N appropriateness of currently required which they were tested.no standard DOC's FederalRegister Notice and a dose measurements at three tissue provides for tests to be conducted from D) depths described in NRC Form 5.nesedescription of the NVLAP method to all a totalof six radiation protection
(- comments were examined and a known dosimetry processors, and known laterested persons on February 6. categories and two radiation accident i response is contained within the I summary analysis of comments, which 1961. categories. no radiation protection Nineteenletters of comment were catehories in4ude high energy photons.
is available for review at the . .
low. energy photons, beta particles.
Commission Public Document Roogi received on the NVLAP method for operating the FIL as part of an neutrons plus high-energy photons.
( (see Addresses section of this notice).
Subsequently, on April 15.1980, the accreditation program. %e 19 letters mixtures of high- and low. energy NRC staff briefed the Commission r a were unanimous in favoring this method photons, and beta particles plus high-energy photons. Radiation seddent 1 interim actions that could be taken by
'NRC staff to improve personnel for operating a program for improved dosimetry.nese comments are categories are for high- and low-energy i
dosimetry processing prior to the date of available for review at the photons.
the effective rule.no Commission Commlulon's Public Document Room Partidpants sent the prescribed i t discussed the importance of examining a (see Addresses section of this notice). number of dosimeters to the UM where i
. processor's routine processing activities ne HPSSC which developed the they were irradiated to doses known to ensure appropriate quality assuranc* draft standard that was used in the UM only to the UM and returned to the processor.%e processor then
( techniques were being utilized and to personnel dosimetry performance determine that routine dosimetry testing studies, has ccmpleted and determined the dose for each doelmeter processing was being conducted with adopted the final Health Physics Society and reported the results back to the UM.
the same processing protocols that a Standard which has also recently been %e ANSI standard evaluates a
- processor might use when participating accepted as a final American National processor's ability to determine the dose in performance testing. Standard. ANSI N13.11, by the Board of within a spedfic tolerance limit.L '
- On May 28 and 29.1980, the NRC held Standards Review of ANSL Provisions - Statistical criteria used in the standard s a two-day public meeting with personnel will be made in the program associated include bias and precision terms. Foe dosimetry processors and other with this rulemaking action to allow for each category, the average performance interested persons to discuss alternative rianges in the ANSI standard as index (blas term). P. and its standard methods for the operation of a FIL as research or practical experience shows deviation (precision term). S. are calculated.Re performance index for a i stated in the ANR and to obtain the need for revision.
t comments from the dosimetry Sbee &e draft HPSSC/ ANSI standard abgle dhwr, P.la calculakd h Processing industry on the appropriate was significantly revised following the -
elements of a quality assurance (QA) UM pilot study, the NRC staff program for personnel dosimetry -
authorized the UM to conduct a third
- H'-H Proces round of performance testing of comment perbd. a fif& Processors against the revised standard. H ,
, method for PII. operation was identified %is round of testing has been by the NationalBureen of Standards completed.* Essentially the same .
(NBS) which would be part of the NationalVoluntary Laboratory conditions under which processors were H-delfvered quantity
tested in rounds 1 and 2 were also' H'-reported quantity Accreditatbn Program (NVLAP) of the present for this final round of testing.
NBS which is a part of the Department For each category, an average Seventy dosimetry processors of Commerce (DOC).ne NBS, through voluntarily participated in the third performance index. P. and its standard NVLAP could contract the services of a round of testing. It is estimated that deviation. S. are calculated.
- FII.to administer proficiency testing of these 70 dosimetry processing services A processor passes a category;if processors which would utilize the develop and/or process more than 905 P+s<L l contractor's facilities under currently of the dosimeters worn by radiation where . I' existing NVLAP procedures.%e workers in the U.S. Fifty.four of the 70 a: L-0.3 (accident categorin)
NVLAP method would include a dosimetry processors completed these b: L-o.s (protection categories) thorough examination of each tests: seven processors dropped participating processor's routine
%e standard deviation.S. for a set of completely from the program during the dosimeters is a measure of how results dosimetry processing and quality assurance activities through an on. site testing period while the other nine are scattered. It should be noted that the processors submitted dosimeters but individual results can be very scattered review.The NVLAP method would failed to return reported doses for these and stillhave an average result very essentially offer a system of third party dosimeters to the proficiency testing near, or even equal to, the true value.
accreditation by a Federal government laboratory at the UM.%e accuracy of Widely scattered results have a large agency, the DOC. through the NBS.
in a letter dated December 23.1980, the irradiations performed by the UM value of S;if the individual results are the NRC staff requested the DOC to for all radiation categories was verified all very near the true value. Sis very work together with NRC to establish a by the NBS. All ilot study results have small.
j been maintaine confidentialby the Results from the third round of tests Laboratory Accreditation Program for Personnel Dosimetry Processors.%e University, and results of the pilot study have been analyzed. Several dosimetry f are coded so that processors
- names and processors submitted more than one i DOC.in accordance with NVLAP t procedures and authority, stated in 15 model of dosimeter for performance
} CFR Part 7b published NRC's request for the development of such a P
28."
[o NUREG/CR-28el.
DM November 1ss2. Univerdty testing. Of the models submitted for testing. 75% of all catergories attempted Laboratory Accreditation Program (LAP) of 2cMaan. Ann Arbor.ucMean. were passed; thus 25% of all category
,y
'b
?
(
i
1308 Federal Register / Vcl. es Ns. e / Tuesday, January to.1984 / Ptoposid Rules tests attempted were feded. In total. 88 (no action necessary) to the most wouhl be based on three primary different models of dosimeters were restrictive. elements: (1) performance testing of m submitted for these tests. Six percent of cll asodels of dostmeters failed every Ntemative J-No change in current requirements.
personnel dosimetry processorsin accordance with ANSI Standard N13.11
( }
category attempted and 44% passed Niemotive 3-Change in the to be performed by a laboastery
' l contracted by NBS. (2)Information avery category attempted.Therefore 50% regulagan to require thatlicensees ci all models submitted for testing did obtala personnel dostmetry processing collected from the personnel dostmetry not successfully pass all categories for from (1) processors who have psocessor,by questionnaire, and (3) on- -
which they were tested.De highest i successfuBy participated in dosimetry site inspection of ro'etine dosimetry everall passing rate for all modelswf perfo==- testing administered in processing and QA techniques by
' dosimaaers among the eight radiation accordense with the ANSI Standard NVLAP contracted sesessors.%e NBS categories was 945 for high<nergy N13.11. and (2) prar==-s who have a would establish with NRCs approval phosons in the protection dose range. h==nted quality assurance program. general and specific arEcreditation %
cnd the lowest _ passing rate of 55% was NRC would not specify the proficiency criteria for a laboratory accreditation achieved for low. energy photons in the
~
testing laboratory (Pil.). De necessary Program (LAP) for personnel dosimetry protection dose range. elements of the QA am would be processors which are consistent with An attemative method of e==*== specified in the ations. NRC NVLAP's established general and the overan peeformance of dosimetry triap=c+n== would require from the specific criteria currently used in prosessors would be to ====Ine the licensee proof of successful performance programs for assessing the competency performance index P.of each of Gee tasting and evidenc= that its processor's oflaboratories (44 FR12002). As dosimeters irrediated without regard to QA program complied with the appropriate, any exceptions to NVLAP i S. When the reported dose estunate is regulation whether the dosimetry accreditstion criteria would be ad with the delivmed dose. 78% service was performed in-house or published in the Federal Register for
-r cf the dosimeters tested during the third commercially, pubRc comment and the necessary sound were within i30% of the correct Ntemative Mange in the procedural steps to complete the NVLAP i
delivered dose. When the individual regulation to require that licensus accreditation process for this LAP based results are evaluated using mitaria of obtain personnel dosimetry processing on NRCs recommendations and the ses of the correct delivered dose 80% fsom (1) processors who have public response would be taken.De NBS, as the' DOCS designee, would i
of allV :1 daan==ters met this successfully partidpated in dosimetry grant certificates of accreditation to criterion. performerce testing administered in Although he identity and fr:dividual accordance with the ANSIStandard those processors complyirq with N13.11 by an NRCg- # ' testing NVLAP criteria. NBS, whicn is
. sesults of the dosimetertest data are confidential to the UM, the contractor laboratory, and (2) processors who have responsible for the on-site evaluation of -
a documented QA program that contains laboratories under NVLAP procedures.
reports that the categories failed in this ,
round of testing are evenly distributed necessary elements se = pacified in the would identify and contract with 1 cmong large and small. commercial and regulation.%is attemative differs fmm dosimetry processirs experts, and it ~
/
i in. house processors. NRC considers that the previous alternative in that NRC would conduct training regarang improvement on the part of most would specdy the PIL NVLAP procedures to prepare these dosimetry processors is needed and that This alternative could be technical experts to assess compliance the regulations should be amended to accomplished by either of the following of dosimetry processors with NVLAP include competency requirements to appmaches: criteria to ensure that an acceptable QA improve the quality of dose Ntemative 3. Option A-NRC would program is documented as well as g implemented.
measurements. obtain the services of a contractor laboratory through the competitive Eternative 4-Since many doelmetry Regulatory Appresees t'analda ed for processors are not NRC ll====s, and bidding process. NRC licensees would the Proposed Rules since alosimeters in th===alves are not be required to obtain personnel The Commission recognizes that any dosimetry services from a processor radioactive but are passive monitors i performance testing program can only who had successfully participated in whid measure dose received by the l test the ability of a processor to meet performance testing by NRC's contractor worker.NRC would request from the
- 'the criteria of a standard at a given Fit NRCinspectors would, during Congress the authority to license point in time. A performance testing licensee inspection, examine written personnel heimstry processors directly.
program, by heelf, will not determine s proof provided by the licensee (1) that if this authority were granted the whether the processor actually treats its such performance testing was completed regulatians would be appropriately
- routine client's dosimeters with the by the processor of licensee's personnel amanded regarding proficiency testing j same competency acconded to dosimetry, and (2) that the procesor and quality assurance criteria dosimeters received from the PIL maintained a QA program that included acceptable to the NRC.
%esefore,it is necessary to supplement the alements specified in the regulations. Nternative 5-Change in the the performana testing program with Nternative 3, Option B-%ird Party . regulation to require that licensees checks of a processors qualay assurance Accreditation: NRC would specify in the obtain their personnel dosimetry program regardless of the method regulation that licensees utilize the services from an NRC operated or NRC-chosen. services of personnel dosimetry costsacted dosimetry servia.NRC ne Commission considered five processors accreditsted under the wouldissue & rough its laboratory, alternative approaches for establistung National Voluntary Laboratory dosimeters for licensee use, and the a reipdatory progsam intended to ensure Accreditation Program (NVLAP) of the laboratory would perform all dosimetry improved personneldaeunetry National Bureau of Standards (NBS) processing. In addition, aB processing processing. The fellowing regulatory which is a part of the Department of would be performed in acordance with '
alternaaswes are presamled by senking Commerce (DOC). NVLAP accreditation an NRC-spedfled quality assurance .
these options from the least restrictive for personnel dosimetry processors program.
l Federal Register / W1. 49. N . 8 / Tuisday J:nurry 10. 1964 / Proposed Rules 1209 A complete analysis of these NVLAP personnel (1)in reviewing and personnel doelmeters used to satisfy alternatives is included in the suggesting proposed accreditation
- NRC requirements for determining the
. . N Rege.!stery An:!y:is which is available critaria for usa in the development of whole body cr whole body and skin from Margaret V. Federline (see section this laboratory accreditation program, dose from X-rays, samma. beta, and
( entitled. "For FurtherInformation Contact"), or the analysis may be (2)in providing guidance toward neutrons, or mixtures of these radiations selecting training, and defining the role for which dostmeter processing is examined in the Commission's Public of NVLAP assessors who will be required including film, track-etch.
.1 Document Room (see section entitled, responsible for conducting on-site thqrmoluminescent and albedo type
" Addresses"). , , review of personnel dosimetry dostm&ters. r processors' quality assurance programs. While the NRC recognizes the and (3) by participation in a recent two- importance of assessing the accuracy of
%e Commission is' proposing day public workshop sponsored by extremity dose measurements made by amendments which endorse Alternative NVLAP which was held in Washington. dosimetry processors, performance l 3-Option B which would, by D.C April 12 and 13.1982, at NBS to criteria for testing processors for
- . , amendments to the regulations, require discuss technical benchmarks for extremity dostmeters are not available g NRC lleensees to utilise the services of determining comp!!ance of personnel at this time.%e NRC has formally l
. personnel dosimetry processors dosimetry processors with NVLAP requested the HPSSC to form a working i accredited by the National Bureau of accreditation criteria. group to establish such performance and Standards under the NVLAP program. Copies of NVLAP general and specific quality assurance criteria for extremity He laboratory accreditation program, criteria are available in 15 CFR part 7b. dosimeter processing testing.He
, as previously described, would be and single copies are available upon arim'mintered by another Federal Chairman of the HPSSC has s
request from Robert L. Gladhill acknowledged the NRC's request for agency, the NBS in accordance with (see"ma=====e" section). NVLAP development of such a standard and has NVLAP procedures specified in 15 CFR criteria address the operation of the announced that such a grcup has been Part 7b.He NBS has, through a laboratory by focusing on the competitive solicitation process, formed. It is estimated that a minimum organizational structure, technical of two years will be required for contracted with the University of management, professional and ethical Michigan to conduct performance development and publication of a final business practices, and the sy: tem for ANSI Standard after formation of the testing of processors against criteria assuring the quality of test results.ne i s ed in ANSI Standard N13.11 and working group. If publication of a draft criteria also generically indicate those ANSI Standard for public trial and use p to contract the personal services fundamental elements necessary for the is desirable, a minimum of one and a of personnel dosimetry experts to successful performance of routine conduct on-site review of an applicant half years would be required after services by applicants including staff working group formation.%e NRC will ,
f ,_., processde routine dosimetry processing competence and training. laboratory consider appropriate amendments to
! g and quality assurance activities.Ris facilities and equipment test plans
- l
) altemative would help correct the l 20.202(c) when such performance <
equipment calibration procedures, criteria are available, and it is expected I personnel dosimetry processor laboratory records, data handhng performance problem with minimum that such criteria will subsequently be procedures, and quality control checks NRC staffing and resources.This added to the LAP for personnel and audits.
, program has been designed to become ne availability of the laboratory dosimetry processors at the NBS.
/w self-supporting from processor fees and accreditation program was announced We the NRC recognizu that some
', will biennially test and evaluate the by NBS/ DOC in the Federal Register on licensees use pocket ionization .
technical competency of personnel July 28.1963 (48 FR 34316), and , chambers for the purposes of recording dosimetry processors performing supplementalinformation has been . the official whole body dose of dosimetry services for NRC licensees. It provided to NVLAP program applicants individual employees and that this is an would also establish uniform minimum which details, using dosimetry acceptable method of providing quality assurance criteria for routine processing terminology, the way general dosimetry services in accordance with and special dosimetry processing. and specific criteria apply to dosimetry 5 20.202 of the NRC regulations, pocket
%e NRC and NBS signed an processors.Re NVLAP/NBS staffs ionization chambers do not require the Interagency Agreement on July 17.1981, have worked closely with the personnel services of a personnel dosimetry for the establishment of a Laboratory dosimetry processors, the Industry processor for interpretation or dose Accreditation Program (LAP) for Overview Committee on Personnel assessment. Appropriate calibration of Personnel Dosimetry Processors and a Dosimetry, the Interagency Policy pocket ionization chambers is necessary
. revision to that agreement on June 18. . Committee on Personnel Dosimetry, and for their correct utilization. Performance 1982 (copy available upon request). De the NRC in developing approriate criteria and calibration guidance for DOC /NBS NVIAo staffs have worked supplementalinformation for this LAP appropriate use and selection of pocket i with the NRC staff to develop this which was used in writing the ionization chambers are available in program within an appropriate time application booklet that provides the NRC's Regulatory Guide 8.4. " Direct-
. frame. , details of NVLAP accreditation.%e Reading and Indirect. Reading Pocket Re Interagency Policy Committee on criteria and supplementalinformation Dosimeters." and from ANSI standards; PersonnelDosimetry has been kept establish a framework for uniformly but since these dosimeters do not abreast and consulted about the evaluating personnel dosimetry require processing. they are beyond the development of thelaboratory processors, for minimizing accreditation scope of these proposed rules.
accreditation program by NBS for NRC. costs, and for administering the Personnel dose determinations can Representatives on the Committee have program. also be derived from survey expressed agreement with the NVLAP measurements and exposure time; but.
program. Scope of Proposed Rul" these determinations are also not
%e Industry Overview Committee Rese proposed rules are specifically included in the scope of these proposeo
.- has worked closely with NRC and applicable to the processing of rules.
O
,,.-n. '
P- -
1218 Federal Register / Vol. 49. No. 6 / Tuesday. January to.1964 / PmPosed Rules ation of their potential exposure to ionizing
%- - n " , processors because NRC does not have competency requirements for personnel radiation. ,
Processors must request application He costs for participating in materials complete their application-do8imetry processors in its regulations. j
%ese rules are, however, be!n8 performance testing and the forms, and submit fees to NVLAP for developed concomitantly with a accreditation program, whether a proficiency testing and adannistration Labomkry Accmditsuon Pmgram fw which includes on-site asseammant by processor is performing these services Pusannel Dosimtry Pmenws being in-house or commercially and regardless cne or more NVLAP assessors.The established for NRC by the NBS. It is operational LAP and proficiency testing of size,is for the pulposes of this impbrtant to note that all dosimetry analysis approximately the same.
is currently scheduled to begin by pmcessors are not NRC licensees but january 1984. Copies of the LAP g ,, g p,,
availability notice have been sent to all en co m os ' that the average processor will spend 1 p NRC approximately $7,800 on a one-time known personnel dosimetry processors hemees. It is furew expechd est de - I cnd known interested persons. basis to prepare for the accreditation ors he w sh have fuD benefit "'mbem f eeIn " Pol psogram. In moet cases, the NRC Comminee on P o n 1 D si try Nin m same natum
- estingb ore rule becomes ypmce of C*s f effec ve (to ensure that they pass the
{c '
third round of testing at the UM against Appmximately 4.500 Ucensees are the revised standard and the frequent currently performing personnel ,
should reg e d tely monitoring for their employees as discussions and meetings that NRC staff to current projections, the first has held with licensees and dosimetry ;
prescribed in 10 CFR Part 20, i 20.202, accreditations could be announced as and are maintaining radiation exposure processors in discussing the need for soon as six months after the beginning acords as specified in 10 CFR Part 20, improved dosimetry processing and l of proficiency testing. NRC's final rule 120.401. NRC's contractor, the plans for NRC rules on this subject. 1 will be scheduled to become effective University of Michigan (UM), has Processors will also incur biennial costs approximately 26 months after for accreditation which include NVLAP estimated that there are about 90 proficiency testing begins (February personnel dosimetry processors in the administrative fees and costs associated 1986) to allow processors ample United States who perform peronnel with the proficiency testing opportunity to participate in dosimstry services in-house or administered by the FIL contracted by perforrnann tests administered by ,
commerciaUy.These processors were_ NBS to administer such tests in NBS's contractor FIL NRC plans to act initially categorized in a June 13,1981, accordance with ANSI Standard N13.11.
on the flaal rule as soon as possible letter which was updated in a November NVLAP administrative fees willinclude citer analysis of comments to this 8.19821etter from UM to NRC.* Eighty of costs for (1) processing an application Notice of Ptsposed Rulemaking.
With respect to Agreement States, this 6 processors may be considered as for accreditation (2) conducting on-site '
item will be made a mattei of large entities: they include seven large inspection of an applicant processor's )
Commercial processors, seven large . routine desimetry processing and compatibility because it concerns basic pnvate corporations,nine national radiation standards. quality assurance techniques, and (3) for s 31 nuclear wer plants.10 evaluating the competency and quality Paperwork Radur+ian Stahment isht tary assurance efforts of the FIL Dese he application. reporting, and oganizations, three large universities, biennial costs (which also include recordkeeping requirements contained, inur state public health departments. projected in-house costs to the in this pmposed rule have been and one medical facility. These entities pmc g r approved by the Office of Management do not fab wahin the definition of wh (for, 6e a g9, end Budget (OMB); QMB approval No. ~
small entities " as set forth in section Mung in eigM radiadon cakgodes am 3150 00M 601(3) of the Regulatory Flexibility Act. estimated to be appmximately $14,000 or within the definition of"smaH cr $7,000 annuaDy. Unlike the average i taidal Regulatar$eidhuity Statement business" as found in section 3 of the Smau Business Act.15 U.S.C. 632, or the dosimetry processor which participated The need for these rules has been in the third round of testing the average described in the Regulatory Analysis Small Business Size Standards in which is available for copy at the regulations issued by the Small Business "small entity" pmcessor submitted one model of dosimeter for testing in 4 Commrssion's Public Document Room. ' Administration of 13 CFR Part 121. The remalains ten processors may, for radiation categories. Projected costs for 1717 H Street NW., Washington. DC NVLAP accreditation fees, proficiency 20555 or from Margaret V. Federline (see Purposes of this Regulatory Flexibility testing. and in-house costs for section entitled "For Further Information Staternent, be considered "small accreditation of a "small entity" -
Contact").De Regulatory Analysis eauties" as defined in Section 601(3) of the Regulatory Flexibility Act. It was processor total $11,800 for each 2 year contains a complete analysis of au accreditation period, or $5.900 annually, technical and procedural alternatives further estimated that as a group, these ten processors process only about 0.5% The Regulatory Analysis fully discusses and a statement of statutory the details of these estimates and considerations. of all personnel dosimeters processed in the United caa2=. It is estiamted that projects that the individual processor These rules as proposed would costs could range from $6.200 to $17,200 require NRC licensees to utilire the NRC licensees currently employ services of personnel dosimetry approximately 23% of the 1.4 million every two years.
precessors who are accredited under the workers in the United States who The totalvolume of business within National Voluntary Laboratory require personnel monitoring as a result the dosimetry processing industry is !
Accreditation Program (NVLAP) of the estimated at $34 million annually.The
- Amt ble at the come 6an's pubhc Document ten small personnel dosimetry National Bureau of Standards (NBS).
Currently, NRC heemsees are not fr required to obtain services of accredited infomenon contec4 n [.Y. nI((E5*h U"'* processors which could be affected by this rule account for approximately 0.5%, _
)
l l
l
[
l l
Federal Resister / Vol.' 40. No. 8 / Taeaday, January no.1384 / Proposed Rulas 1211 or 3170.000 of the business annually.' dosimetry services that would result 2. New paragraph (c)is added to While the NRC does not know the from abe pmposed accreditation j 20.202 to read as follows:
/ O distribution of this volume of business - '--" and program are noressary
, amont the tan dosimetry pra===-s an :in'apite of the program's possible iso. *set *wmennestne. *
- k.- even distributian would create an economicimpact upon a few small I average an==at business of $17.000. annues. (c) After February 1 sea, all personnel Thus, the assimated biennial doheten, exc.ept extumhy dosimters .
Any smali entity subject to this and pocketlonizaBon chamben. &at i accreditation costs of $11.a00 (35.900 regulation which determines that annualcost) for the NVLAP am is ' " **I"8 I* II' * * * * *
- mic
- becaus.e of its eine that it is likely to and E"'*brovided tare to comply with -
likely tohave a signiBcast * '
l impact on their dosimetry process!ng . j,,*3 g
, g, i 20.101, with the requirements of impa paragraph (a) of this section. or with the business. Complete details of these Comesica d this in a wMen estimated accreditation costs are applicable terms and conditions of any available in the Regulatory Analysis and canmnt &aundiceks license issued by the Nuclear Regulatory
, in the initial Regulatory Flexibihty (a)The processor and/orlicensee's Commission: .
Analysis (available as explained under size in terms of ananalmoeipts derived (1)shallbe processed by a processor the heading " Addresses" earlier in this imm aervice.:=n* of employees, and currently accredited by the National i the number of dosimeters processed VoluntaryImboratory Accreditation
' notice).
It is the finding of the Commission in armually: Program for personnel Dosimetry the Prelindnary Regulatory Analysis that (b) How the proposed regulations Processors of the NationalBureau of
! the only acceptable alternative would result in.s signific==t economic Standards in accordance with 1 procedum for solving this problem is bF burden upon the licensee or prac - accreditation criteria established in 15 l i
., rulemaking action and that the as compared to largerlicensees or CFR Part 7b: and
'. particular alternative proposed, third pm.m.; (2) shall be approvedin this
! party accreditation by the National accreditatica prooses for the type of (cWow the pmposed mgulades radiation or radiations for which the Voluntary Laboreto Accreditation could be modified to take into account Program (NVIAP), o ers equal benefits id ng es dohris its differms needs or capabilities, for small and large processors and will monitoind.
almost certainly guarantee (d) The benefits that would accrue. or . . . . .
entsin the goahty of reported the detriments that would be avoided,if 3.New paragraph (d)is added to Imm..
dose estunates.The costs necessary for - the proposed regulations wem modified i 2tuel m ad as follows -
compliance with this preposed as suggested by the commenter; and regulatory program are well justified (e) How the regulatic.a. as modified. IsaAe1 fessoresof sumys.ressellen and worth the health and safety benefits would still adequately proted public menhoring, and ansposal.
j ,s tha - * . .
' health and safety and provide adegoate - *
\I a.t will result
.a.,. from improved The Commission has radiation dosimetry earvices for U. S. (d) Each licensee subject to 120.202(c) carefully examined the elements of the nuclear workara- of this part.in addition to preserving proposed NVLAP accreditation program and finds that differing compliance. List of Subjects la le CFR Part as {nnel"onitoring records ing gg,
, reporting requimments, or simphfication Byproduct material.IJconsed part, shall also preserve with these ~
M the accmditadon ymgnm am not ,e material. Nuclear materials. Nuclear records copies of pertinent personnel acceptable for evaluating a ,om ..,o 4
- g power plants and reactors. Occupational dosimetry processor secreditation ability to perform accurate and safety and health. Pedaging and certificates from the National Volontary consistent personnel dosimetry for NRC containers Penalty. Radiation Laboratory AccmditationPmgram as licensees."The NRC and NVLAP staffs protection. Reporting and recordkeepmg necessary to demonstrate compliance have taken actions to redace the costs requirements. Special nuclear material, with I 2tL202(c) after February 1986.
- al. and Weste tmatment Dated at Washiestoa. D.C this 4th day of p . ul effe f January. inst, dosimetry processor not gainbg For thehuclear Regulatory t'a==Iat= -
accreditation could mean that it would Pursuant to the Atomic Energy Act of no longer be feasible for the processor to 1954, as === led, and sections 533 of sammel1.Quk.
remain in business. The accreditation title 5 of the United States Code, motice saaresaryofde comuasseren process, however. offers a pamcipating is herebygiven that adoption of the g,e o .w ,m. e,i i dosimetry processus considerable , following amendments to 10 CFR Part 20 sa.i.sse cosa sees.es.e .
opportunities for correction of identified is contemplated.
inadequacies, for rgeat performance eesting, and for appeal of any PART 20-STANDARDS FOR accreditation decisions. -
PROTECTION AGAINST RADIATION in summary, the Commission has considered the impact of the NVLAP 1.The authority citation for part 20 accreditation program upon the small continues to read as follows:
entitles affected, and has concluded that Authority: Secs 53,83,85.41.183 los. tot, the beneflis gained by workers, es Stat. oso. saa, ess. saa, ss7. osa, as licenseas, the general public and the amended; 42 U.S.C 2073, sess 2005. 2111.
i NRC ime providagimpsowed personnel 2133,2134,2ast. For the pwposes of sec. 223.
es Stat.ess. as amended; 42 UAC 2273. ,
I# I**"N "
,,'It should be assed shot ely e of eie to idsah8ad Stat. 950. as amended; 42 U.S.C 22911o)." Secs.
,gg ,,,,, prossenes pamaposed m the third
,omg % a m 202. 20s. Pub.1.93-638, as Stat.1244.1246 (42
~
- U,.S.C 5642).unless otherwise noted.
l ;
e l
/
Enclosure B DRAFT REGULATORY ANALYSIS
- 1. PROPOSED ACTION 1.1 Description The Nuclear Regulatory Commission (NRC) is publishing for comment proposed amendments to its regulations, 10 CFR Part 20, to require licensees performing personnel monitoring to:
- 1. Utilize personnel dosimetry services accredited under the National Voluntary Laboratory Accreditation Program (NVLAP) for Personnel Dosimetcy Processors of the National Bureau of Standards (NBS) which
- is a part of the Department of Commerce (DOC); and to
- 2. Obtain and maintain a record of NVLAP accreditation certificates with all individual external dose records as necessary to demonstrate compliance after D'ecember, 1985.
- 1. 2 Need for Proposed Action The need for this regulatory program has been discussed in several documents, including the following:
- 1. C. M. Unruh, et al., "The Establishment and Utilization of Film Dosimeter Performance Criteria," BNWL-542, (1967), Battelle North-west Laboratories, Richland, Washington.
- 2. L. Nichols and C. Newton, Jr., " Performance Tests of Commercial Personnel Monitoring Services," July 25, 1974 - January 25, 1975, Battelle Northwest Laboratory, Richland, Washington.
1 Enclosure B
~ ~ ~ ~ ~ '"
=. l l
1
- 3. L. L. Nichols, "A Test of the Performance of Personnel Dosimeters," !
BNWL-2159 (1977), Battelle Northwest Laboratory, Richland, Washington.
These early performance studies demonstrated poor performance by personnel dosimetry processors when they were tested against a variety of performance ;
standards. Nichols' study evaluated all three existing dosimetry performance standards. This study concluded that the draft American National Standards l Institute (ANSI) as ANSI Standard N13.11,* " Criteria for Testing Personnel l Dosimetry Performance," which provides criteria for performance testing of l film and TLD processors, should be recommended for use in establishing a test-ing program for the personnel dosimetry industry. Nichols' study was initiated by the Bureau of Radiological Health (BRH) as a result of strong encouragement by the Task Force on Personnel Dosimetry of the Conference of Radiation Control Program Directors.
In response to conclusions of the previously mentioned publications and NRC investigations, NRC .and other Federal agencies conducted a public meeting November 30 and December 1, 1976, to discuss the personnel dosimetry performance problem in an open forum. Personnel dosimetry processors, dosimetry users, ;
and representatives of State governments and Federal agencies participated. .
Other co-sponsors of this meeting were the Energy Research and Development ,
Administration (now part of the Department of Energy) and the Bureau of Radio- l logical Health. l From these discussions, there was general agreement that a personnel dosim- I etry problem does exist, that the problem is sufficiently broad in scope that it should be addressed by the Federal government, and that there is a need to 4
evaluate the performance of personnel dosimetry processors periodically and to make a specific determination of competency. However, many of the attendees cautioned against precipitous action and strongly recommended a pilot study j (1) to evaluate the draft HPSSC/ ANSI
- Standard N13.11, and (2) to provide pro-cessors the opportunity to take any necessary corrective actions in their opera- .
tions prior to the implementation of any new Federal regulations on the dosim-etry performance problem.
"This draft ANSI standard was originally written by a working group of the Health Physics Society Standards Committee (HPSSC) and subsequently adopted by ANSI; this standard is commonly referred to as the draft HPSSC/ ANSI Standard.
2 Enclosure B 1
O*
Further interagency coordination and cooperation was initiated very early in the program with the informal formation of the Interagency Policy Comittee on Personnel Dosimetry (IPCPD) in 1977 to guide and coordinate correction of the dosimetry processor performance problem. The following Federal agencies have representatives on this Committee: the Bureau of Radiological Health which f is a part of' Health'and Human Services (HHS), the Department of Defense (000),
the Department of Ener~gy (DOE), the Environmental Protection Agency (EPA), the National Bureau of Standards (NBS), NRC, the Occupational Safety and Health Administration (OSHA) part of the Department of Labor (DOL), and the Conference of Radiation Control Program Directors (States). The representatives of the agencies on the Committee consider the NRC to be the lead agency for the overall problem, and they plan to recommend to their various agencies that regulations or intra-agency rules similar to the NRC regulations be adopted.
In 1979 the industry. formed the Industry Overview Committee on Personnel DosimetryHnionitor the progress and development of this program and to help assure that any proposed regulatory action would be effective and appro-
~
priate to the need.
The recommendations of public meeting attendees were accepted, and the NRC subsequently issued a contract in 1977 to the University of Michigan (UM) to conduct a 2 year pilot study. The objectives of this study were:
- 1. To determine whether the draft ANSI standard provides an adequate and practical test of dosimetry performance;
- 2. To give processors an opportunity to correct any problems that are uncovered; and
- 3. To develop operational and administrative procedures to be used later by a permanent testing laboratory.
The study was conducted for the NRC by the UM, beginning in September 1977, l
and was completed December 31, 1979.
The results of the two rounds of performance testing of dosimetry proces-sors and associated reports completed by the OM for the NRC were made available in four NUREG/CR reports:
NUREG/CR-1063- Plato, P. and Hudson, G., Performance Testing of Personnel Dosimetry Services: Procedures Manual, NRC/GPO Sales Program, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, ,
January 1980. l i
Enclosure B !
3 l
.- ,.e. - _ . . . - . . . - - _ -- -
.,__.q+---,p.y,.
. , , . , , - ,,,,m,,, , .,,,..,p-__. , . , . ,w,4,-,, ,,p,..,,,,,,,,,, ypy,p., - . , _g, ,,., _,,
i NUREG/CR-1064- Plato, P. and Hudson, G., Performance Testing of Personnel Dosimetry Services: Final Report of a Two-Year Pilot Study, NRC/GPO Sales Program, U.S. Nuclear Regulatory Commission, l Washington, D.C. 20555, January 1980. , ;
l NUREG/CR-1304- Plato, P. and Hudson, G. , Performance Testing of Personnel l
Dosimetry Services: Supplementary Report of a Two-Year Pilot Study, NRC/GPO Sales Program, U.S. Nuclear Regulatory Commis-sion, Washington, D.C. 20555, April 1980.
2
=l NUREG/CR-1593- Plato, P. and Hudson, G., Performance Testing of Personnel Dosimetry Services: Alternatives and Recommendations for a Personnel Dosimetry Testing Program, NRC/GPO Sales Program, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, [;
4 August 1980. !
In addition, monthly progress reports were prepared by the University of , l Michigan and were placed in file OH 506-1 (subsequently renamed OP 506-1) in )
the Commission's Public Document Room.
In summary, 59 dosimetry processors voluntarily participated in the two rounds of performance testing and were tested against the draft HPSSC/ ANSI Standard. It is estimated that these 59 dosimetry processing services process j 90% of the dosimeters used by radiation workers. The accuracy of the irradia-tions performed by the UM during the pilot study were verified by N8S's Center ,
for Radiation Research.
The pilot study was conducted under well-defined conditions of irradiation.
The study did not attempt to evaluate the variety of problems produced when dosimeters are actually worn by people. Yet the results indicate that the dose received by occupationally exposed personnel may often be considerably different from the dose recorded by the dosimetry processor'. Considering that NRC's occupational radiation protection program is based in part on the accuracy of ;
exposure information, the present state of affairs gives cause for some concern since compliance with regulatory dose . limits may not be achieved. The test results indicate that individual doses may be either overstated or understated. j l
A complete review of pilot study results can be found in NUREG/CR-1064 and l
After considering the results of the pilot study, the IPCPD made the l i
following recommendations:
4 Enclosure B
- -- n.. ..- -.-.
,. ,,. . . _ , , -,+,,,----g p. - , . , .-.~w-,7,,-ne.--e.wn,-g.- ,. - - ,- . , y.m.g-- - - v.www ----a-,, -n---s-,
- 1. The actual causes of the poor performance of personnel dosimetry processors in the pilot study should be determined with a greater degree of certainty before completing plans for corrective action;
- 2. A notice should be published in the Federal Register to notify all personnel dosimetry processors and the pubilic that the Federal government is determined to take action, as necessary, to correct the persohnel dosimetry problem.
Subsequently, the NRC staff authorized the UM to conduct a series of on-site visits to all pilot study participants to determine the causes of poor I
performance. -
A preliminary report was written by UM personnel at the conclusion of site visits to eight major processors. The report indicated four major causes of poor performance during the pilot study: (1) inadequate or inappropriate calibration factors, (2) variability in the thermoluminescent dosimeter chips, (3) clerical errogs, and (4) lack of effort on the part of the processors to make the changes necessary to pass the tests. This report, dated May 1979, is available in the Commission's Public Document Room in the OP506-1 file on personnel dosimetry performance testing.
NUREG/CR-1593 contains a comprehensive discussion about the need for these proposed regulations. This report discusses the major problems identified during site visits to processors. In summary, the four major problems identified in the pilot study were observed in the routine operation of many dosimetry processors. Although it is doubtful that these problems could lead to results that would constitute a significant hazard to radiation workers in the United States, it is clear that, on an individual worker basis, the performance of many processors is unacceptable. There is little doubt that these problems can be corrected and, in general, at a minor. cost to the dosim-etry industry.
This report, NUREG/CR-1593, also discusses three other areas of need.
The following material is from that report:
" 1. Epidemiological Studies: There is considerable interest today in low-dose effects of ionizing radiation. Since a large number of workers are exposed to low doses, it is tempting for some organizations to attempt to correlate dose to effect. A nationally recognized testing program would help many people to understand and document the accuracy and limitations of personnel dosimeters which, in turn, would probably help the inter-pretation of dose /effect investigations." Since it is quite probable 5 Enclosure B
that many people will continue to look at epidemiological studies of low-dose effects of radiation, every effort should be made to assure the accuracy of personnel monitoring data. '
The
- 2. Use of appropriate calibration and correction factors:
radiation sources used in the pilot study were selected in accordanceThese so) ,
r
, with the perfo,mance standard, ANSI N13.11.entOosimetry from those usedI to sources that s.i mulate the individual's working conditions. {
"I processors who use different sources for calibration testing in order to perform well during performance tests.
E As a result of the pilot study, it was discovered that many radia- '
tion workers are using dosimeters that have not been calibrate their special needs. j.
what they perceive to be average radiation energies for their users, <
although they should have the technical capability to provide custom A dosimetry testing program will require a calibrations if asked.
- processor to develop calibration factors necessary to pa '
calibration factors appropriate for the needs of the radiation workers served by the processor.
l
" Uniformity: Many processors have developed a dosimetry lan-
! 3. .
guage that only they can understand, and sometimes even they are con- l 4
fused." For example, ANSI N13.11 clearly defines shallow and deep l Currently processors report doses !
depths for dose recording purposes.in terms of beta and gamma, skin and!
A standardized testing program would probably !
penetrating radiations. lead to a standardized vocabulary and dose recordk t set of units. Cumulative doses assigned to radiation workers that fre-J l
quently change jobs, and therefore change processors l
! definitions.
On March 28, 1980, the NRC publishe'd in the Federal Recister (FR) an Advance Notice of Rulemaking (ANR) (45 FR 20493) that summarized the resu of the pilot study and outlined four possible alternatives for the operation of a testing laboratory.
After considering the seriousness of the problem, the Commission request a briefing on interim actions for improving personnel dosimetry in the period The Commission brief-before the entire rulemaking process could be completed.
A number of alternative actions were presented.
ing was held April 15, 1980.
The'NRC staff held a 2-day public meeting with personnel dosimetry pro- l cessors and other interested persons in Washington, D.C. on May 28 an (45 FR 31118), to (a) obtain further public comment on the alternatives f 6 Enclosure B
~.,,__,,__v----.- , , , , , - . . . - , . , , ._m,w . _.. , , .
the operation of the testing laboratory specified in the ANR and (b) industry I
comments on the appropriate elements of a personnel dosimetery quality assurance program that should be considered by NRC. The' meeting was attended by approxi-mately 60 persons, many of who commented verbally on a wide range of topics pertinent to this regulatory program. In general, the, attendees favored a regulatory test and' certification requirement, with the testing laboratory operated by an NRC contractor.and strongly supported the need for a third round of performance testing against the revised ANSI Standard N13.11 prior to the beginning of any regulatory program. The NRC staff subsequently authorized the University of Michigan to conduct a third round of testing using the revised Standard. Published resul'ts are available in NUREG/CR-2891. Further details regarding the comments received at the May 1980 meeting are available for inspection and duplication at the Commission's Public Document Room, 1717 H Street NW., Washington, DC 20555, under File PR 20 (45 FR 20493).
i 1.3. Value/Imoact of Proposed Action 1.3.a. Summary Description of Program Operation Before discussing the value and impact of these rules, it is important to understand briefly how the program resulting from these rules would work.
THIRD PARTY ACCREDITATION- NRC would specify in its regulations that licensees must utilize the services of personnel dosimetry processors accredited under the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Bureau of Standards (N85) of the Department of Commerce (DOC) (15 CFR Part 7.b). NVLAP accreditation would be based on three primary elements: (1) Proficiency testing of each personnel dosimetry processor in accordance with ANSI Standard N13.11 to be per-formed by a laboratory contracted by NBS, (2) information collected from the personnel dosimetry processor by questionnaire, and (3) on-site l assessment of dosimetry processing and quality assurance techniques.
These elements will be used by NBS to assess a processor's compliance with NVLAP criteria for accreditation.
l l
7 Enclosure B j
=- - >
meam_ _ [ - w. ~ ~ - - - - - = * - - ---v- *-- =w i. r- r-w --we 6---=---w'=-y wwT'
The NRC and the N8S would establish or approve the final general and specific accreditation criteria for a Laboratory Accreditation Program (LAP) for Personnel Dosimetry Processors consistent with NVLAP's estab-lished general and specific criteria, used in current programs for accessing the competency of laboratories (44 FR 12982) and (46 FR 37029).
NVLAP criteria include fundamental elements of laboratory operation and quality assurance, i.e', facilities, equipment, personnel, and quality control procedures. NRC would specify, as supplemental information to these criteria, the elements of a dosimetry quality assurance program.
As appropriate, exceptions to NVLAP general and specific accreditation criteria would be published in the Federal Register for public comment.
Subsequently, the necessary procedural steps to complete the NVLAP.
accreditation process for the development of the LAP would be taken by NBS based on public comments and NRC's recommendations. The NBS would grant certificater of accreditation on behalf of DOC to processors that comply with NVLAP criteria.
NBS would select and train dosimetry experts to serve as assessors who would conduct on-site assessments of the compliance of dosimetry processors with NVLAP criteria. This on-site assessment of applicant processors will ensure that an acceptable quality assurance program is implemented and
' documented by the processor.
1.3.b. Cost Analysis To assess properly the impact of this regulation, it was first necessary to determine the cost to industry for personnel dosimetry services pro-vided either in-house or commercially under current regulations. The staff has estimated the costs for contracting the services of and equip-ping a testing laboratory to conduct proficiency testing, operating the proficiency testing laboratory (PTL), in-house costs for processors to participate in the NVLAP laboratory accreditation program, costs for processors for repeat proficiency testing in one or more categories, total costs to the public in general for these proposed amendments, and a summary of all costs associated with these rulemaking actions.
8 Enclosure 8
. ._= - - .
s 1.3.b.1 Normal Personnel Monitorina Costs to Industry. It was recog-nized very early in this analysis that the cost for providing personnel dosim-Large i
- etry services is a function of the size of the processor operation.
commercial processors which handle a large volume of dosimeters monthly can process dosimeters ,at a lesser cost per dosimeter than is incurred by in-house processors. It is recognized that there are certain benefits from performing dosimetry in-house such as (1) quickly having available extra dosimeters for ,
special studies or special personnel monitoring (2) quickly evaluating parti-cular dosimeters that potentially were exposed to higher levels of radiation ,
than normal and (3) providing specially designed dosimeters particularly suited for studies of a specific work environment. In the past year, a large '
number of utilities have begun personnel dosimetry processingfor these reasons.
It is important to develop a weighted average for the cost to licensees
~
per worker per year for personnel monitoring in order to determine the l average cost of personnel monitoring per radiation worker. (Figures used in this portion of the cost analyses are based upon a telephone survey of costs charged for dosimetry services by commercial and in-house processors.)
Tables 8-1 and B-2 contain the figures used for this analysis.
If it is assumed that 50%' of the dosimeters are processed commercially and 50% in-house, 50% at $17.40 each and 50% at $30.60 each, the average cost /
worker / year is $24.00 for personnel monitoring. Estimates for the 1979 worker population indicate that NRC licensees monitor approximately 327,000 workers annually.*
i
" Figures were taken from NUREG-0714, Vol.1, Occupational Radiation Exposure, l Twelfth Annual Report 1979, U.S. Nuclear Regulatory Commission, National l
Technical Information Service, Springfield, Virginia 22161, August,1982. j 1
l 9 Enclosure B
._ _ . _ _ _ . _ _ _ . _ . _ . . _ . , ._ . _ . _ - - _ . - ~ _ _ _ _ _ .
Table B-1 Average Personnel Monitoring Cost For Commercial Dosimetry Services Norker Dosimeter
- Change Commercial Number of Periods Cost Per Organization Workers Per Year Change Costhorker/ Year A (SV)* 300,000 12 1.10 13.20 (N)** 50,000 12 3.75 45.00 B (Sy) 100,000 12 1.10 13.20 (N) 25,000 12 3.75 45.00 C (sy) 50,000 12 1.10 13.20 D (Sy) 80,000 12 .80 9.60 (N) 18,000 12 3.75 45.00 E (py) 13,000 12 1.10 13.20 636,000 weighted avg. = $17.40 "sy - beta and gamma dosimetry services.
- N - neutron dosimetry service.
Table B-2 Average Personnel Monitoring Cost For In-House Dosimetry ServicesNorker Dosineter Change Private Periods Cost Per Organization Workers Per Year Change CostNorker/ Year ;
A 4,000 4 9.00 36.00 ;
B 3,000 12 2.50 30.00 l C 34,000 12 2.50 30.00 41,000 weighted avg. = $30.60 Therefore, it was estimated that approximately $7.8 million per year is now spent by NRC-licensees on personnel moaitoring for workers in NRC-licensed activities. It can be estimated based on Environmental Protection Agency 10 Enclosure B
projections that $33.6 million is spent for personnel monitoring services for the totai 1.4 million* radiation workers in the U.S. Assuming 4500 affected licensees and an even distribution among licensees,* the cost per NRC-licensee rl I
for personnel monitoring services is estimated to be about $1,744 per facility l
on the average. l i
327,000 workers k $24/per worker / year + 4500 licensees = $1,744/ year / licensee. ,
i l
1.3.b.2 Estimated Costs for Equipping and Operating a Contractor-Ocerated l Proficiency Testing Laboratory (PTL). The PTL will have initial costs for equipping the laboratory with the necessary radiation sources and will have l normal operating costs for conducting proficiency testing. The initial costs for equipment and amortization rates for equipment are projected based upon costs noted during the UM pilot study which are shown in Tables B-3 and B-4. Initial costs are included here simply to show the basis for amortization figures for replacement of these sources.
l The majority of the equipment costs have already been incurred by the NRC for '
use in the University of Michigan pilot study. The competitive solicitation package that NBS is preparing for procurement action to obtain the services of a contractor for conducting proficiency testing states that prospective bidders should possess or have access to appropriate x-ray machines as speci-fied for conductin.g testing in accordance with ANSI N13.11. The NRC will 2
transfer the two cesium-137 sources and the D 0 moderated californium-252 source from the University of Michigan to the selected offeror as soon as appropriate NRC-licenses for these sources are in place.
"EP2 520/4-81-003 Background Report, Proposed Federal Radiation Protection Guidance for Occupational Exposure, page 20, U.S. Environmental Protection Agency Washington, D.C. 20460, January 16, 1981.
l 11 Enclosure B
- e e n , e+
Table B-3 Initial Costs for Equipping and Calibrating Equipment for the Proficiency Testing Laboratory (PTL) 1 i
- 1. Equipment Costs Equipment Initial Cost ($) ,
Two x-ray machines, $160,000 and $50,000 210,000 One 400 Ci Cs-137 source 12,000 One 20 Ci Cs-37 source 6,000 One Sr-90/Y-90 source 3,000 One Cf-252 source 6,000 One shipping cask for Cf-252 source 2,000 Heavy water for Cf-252 source 6,000 Sphere for Cf-252 Moderator 2,000 Beam monitors for all sources 8,000 Phantoms ' 1,000 Telescopes and Lasers ,
8,000 TOTAL 264,000
}
l 2. Labor Costs One person year labor for source procurement and calibration activities at $24,000 a year 24,000 Overhead and fringe benefits (100% of salary) 24,000 .
48,000
- 3. Total Initial Costs (Equipment and Labor) $312,000 1
12 Enclosure 8
_ _ _ _ 1- - _ _ T:1-- -' . .
J
- Table B-4 1
Projected Biennial Operating Costs for a Proficiency Testing Laboratory (PTL)
- 1. Biennial Labor Costs Biennial Costs A. Direct Labor Cost Director (.75 person year) $31,350 Assistant. Director (1.5 person years) 36,000 Three technicians (3 person years) 45,000 Secretary, quarter time (.4 person years) 3,750 Keypunch operator (.4 person years) 3,750
$119,850 B. Overheads and fringe benefits
$119,850 (100% of salaries)
TOTAL $239,700
- 2. Supply Costs Duplicating $ 1,000/ year Postage 2,000 j Telephone 2,000 Maintenance of equipment 5,000 Travel 3,000 Calibrations With NBS 3,000 2.000 Computer time TOTAL $18,000
- 3. Eauipment Costs and Amortization Rates Biennial
- Amortization Type of Eauipment Initial Cost Life (years) irate Two X-ray machines, $160,000 and $50,000 $210,000 20 '$21,000 One 400 Ci Cs-137 source 12,000 10 { 2,400 One 20 Ci'Cs-137 source 6,000 10 1,200 One Sr-90/Y-90 source 3,000 10 600 One Cf-252 source 9 $6,000 each 6,000 2 6,000 One shipping cask for Cf-252 source 2,000 30 133 Heavy water for Cf-252 source 6,000 10 1,200 Sphere for Cf-252 moderator 2,000 30 133 Beam Monitors for all sources 8,000 10 '1,600 Phantoms 1,000 30 67 Telescopes and Lasers 8,000 30 533 TOTAL $264,000 $34,866 ;
- 4. Total biennial operating costs ,
Labor $239,700 1 l Supplies 18,000 l i
Equipment 34,866 l
$292,566
' Estimates are based on costs incurred for equipping and operating the PTL i during the University of Michigan pilot study.
20verhead includes rental charges for existing floor space, electricity, and heating.
o .
13 Enclosure B
- . - - - _ _ - L -. - . .. - _ - - - ---a_-_-_.
- t. ,
1.3.b.3 Estimated Fees for Accreditation. The accreditation fees would be based on two components: [
(1) A fee of approximately $2500 is anticipated for administrative costs that will cover N8S costs for evaluation of applications, review of proficiency testing results, all other accreditation actions such as renewals and revocations, and one on-site assessment by a NVLAP r
assessor for each applicant dosimetry processor every two years to assess compliance with NVLAP criteria, and (2) proficiency testing fees that will cover the PTL's expenses. The ;
proficiency testing fees will be based on the number of radiation i categories in which the processor is tested for each dosimeter model. !
Proficiency testing will be offered in all 8 categories offered in i the ANSI N13.11 Stancard. Categories I through V require the use of {
one radfation source each and will probably cost approximately $260
~
per category.' Categories VI through VIII wi1'1 require the use of two ,
radiation sources each and will probably cost twice as much as a single source category. These figures were obtained in consultation with j Dr. Phillip Plato and Mr. Joe Miklos of the University of Michigan. Fees f for NVLAP accreditation may vary from this estimate although signifi- l.
cant differences are not anticipated (see Table B-5, B-6, and B-7). l 4
I During the third round of proficiency testing at the UM, processors chose ;
i
- to participate in a number of categories. Processors submitted 116 dosimeter j models for testing in 424 total radiation categories. The smallest number of l dosimeter models submitted by a given processor for testing was one dosimeter f model for one category test. The largest number of dosimeter models submitted for testing by a processor was'6 models for 16 radiation categories. Most f processors submitted one type of dosimeter for 8 radiation category tests. [
Processors that could be classified as "small entities" in accordance with the Regulatory Flexability Act on the average submitted one dosimeter model for testing in 4 radiation categories. These four processors participated in ;
a total of 14 radiation categories. Preliminary results from the third round l indicate that average passing rate for processors is 75% of the categories l l attempted. Refer to Table B-6 for range of costs for proficiency testing among i processors. ;
I i
14 Enclosure B i ey9--- - .--- +, - y y p,- -
,--- . , .-- ._-._..--.7,w- - , , . - - . . , - - - , , - ,.,--,.-,em-ww,-g9----, - - -wm_.w-y-y py,gw--i+m-g em
s l
Table B-5 Projected Proficiency Testing Costs for Processors Category Title ' I as Specified Number of Radiation Fee to Test In )
, in ANSI N13.11 Sources Required Fee / Category All Categories 1-5 1 $ 260 $1300 6-8 2 $ 520 $1560 All 8 categories Mixed 1 and 2 (Mixed) 57535 '
Table B-6 Projected Range of Proficiency Testing Costs for Processors
- Total Costs for Dosimeter Proficiency Testir Models Initial Category Repeat Category in All Attempted Submitted Tests Requested Tests Requested Categories Categories 1-5 Categories 6-8 Categories 1-5 Categories 6-8 Minimum 1 1 0 0 0 $ 260 Maximum 6 10 6 2 1 $6,760 Average 1 5 3 1 1 $3,640 Small Entity 4 3 1 1 0 $1,560 "Information is based upon processor participation in the third round of 1 proficiency testing being conducted at the University of Michigan against the revised ANSI N13.11 Standard.
Table B-7 Total Estimated Accreditation Fees for an Individual Processor i
e I Administrative Fee Proficiency Testing Fee Total Minimum Fees $2,500 $260 $2,760 Maximum Fees $2,500 $6,760 $9,260 Average Fees $2,500 $3,640 i$6,140 Small Entity $2,500 $1,'560 :54,060-15 Enclosure B
- -- : - . . - _ - - - - _ .- . .._ _. -.-_ - - . . - . ._..._.L--..__-.-. . . - .
- 1. Cost to Processor to Prepare for Initial Accreditation (Most dosimetry ,
processors have already absorbed costs projected in this section while preparing for the third round of testing in the UM study against the revised ANSI N13.11 l Standard.)
The UM has identified for NRC 71 commercial and in-house processors who provide personnel dosimetry services for NRC licenses. By 1983, when this program would begin, NRC expects this number to increase to 83 NRC licensee-processors. It is anticipated that several nuclear power plants that are now contracting their dosimetry processing will begin processing their dosimeters in-house.
Assuming that, on the svarage, all processors would average $7,770 for pretesting adjustments
- prior to publication of the effective rule (see Table B-8), the total cost for the in-house and commercial dosiastry processor i industry to prepare for a mandatory accreditation program would be:
90 x $7,770 = $699',300 The one-time cost / radiation worker /NRC-licensed facility to prepare for mandatory performance testing assuming they are all licensees and in-house processors would be:
! $699,300 + 327,000 workers at NRC-licensed facilities = $2.13/ worker.
i Of course the majority of licensees do not perform in-house dosimetry and would incur a much smaller increase in costs / worker / dosimetry services because of obtaining services from a large commercial processor.
Since the average cost per worker for personnel dosimetry services is $24 per year, this is a net increase of 8.2% in personnel dosimetry costs for l
in-house dosimetry processors on a one-time basis only, i
i =
- Although at least one processor estimates no addition cost to their current l program to comply with the proposed program and another processor at the other extreme estimates $200,000.00 for initial costs.
16 Enclosure B
l l
}
i l
I Table B-8 Processor Estimates of Initial (One-Time) Potential Preparatory 4
Costs /Processcr for Initial Proficiency Testing
- Initial, one-time costs to prepare for testing are summarized as follows: l l
Assuming that the processor is already recording dose as is called for on NRC Form 5, the official form for recording individual gf worker " Current Occupation External Radiation Exposure," and that : l labor cost is $30,000/ year with overhead at 100% of labor, then -
3
' the costs for one person week or equal r
= $1,154 per week.
3l0 k If a processor spends up to 5 person-weeks reviewing the -
ANSI standard, reviewing results of previous performance -
tests, and making corrective actions, the labor costs $5,770 would total:
It is possible that a processor may require external recalibration services (censulting) for some categories $2,000 at a cost up to: ,
f The total cost per processor to prepare for proficiency $7,770 i testing is estimated to be:
n NRC staff believes most dosimetry processors have already absorbed the costs described in this table while preparing for the UM performance tests of ANSI N13.11.
Of the currently known 90 dosimetry processors,19 processors are DOE or exempt from NRC DOE prime contractors facilities which are generally speaking licensing as a result of special provisions in 10 CFR Part 30 or are specifically named as exemptions in the Energy Reorganization Act.
Since it is almost certain that other government agencies will recommend similar regulatory programs and since most cammercial dostmetry processors also process dosimeters from workers at non-NRC licensed facilities (i.e., 00E licensed facilities), it would probably be more correct to consider the entire population and look at the costs collectively. ,
17 Enclosure B
/
r .
102* x $7,770 = $792,540 to prepare for a mandatory testing program imple-mented by all Federal agencies that regulate activ-ities involving potential radiation exposure to r workers.
I ' The one time cost to prepare for such a, testing program would add to the costs for monitorin'g a worker by I
$792,540 + 1.4 x los** workers = $0.57 per worker Since the average cost per year per worker for personnel dosimetry monitor-ing is $24, this is a net increase of about 2.4% in personnel dosimetry costs on 1 a one-time basis.
- 2. Normal In-House Testina Costs to the Processor for Subsequent Biennial Accreditation (after the initial accreditation)
It was estimated by dosimetry processors who attended meetings at the UM that there would be an initial cost of approximately $7,770 for a processor to make its dosimetry system compatible with the standard (see B-8). This initial calibration cost should be a one-time cost and will vary greatly from processor to processor. As previously mentioned, NRC believes these costs have already been incurred by processors. In-house labor for subsequent accreditation would
~
be estimated at 3 person weeks including overhead and fringe benefits (see Table B-9).
Table B-9 Potential In-House Processor Labor Costs for Routine Biennial Accreditation Cost 53,462 j 3 person weeks at $1,154 ea (See Table B-8) 53,462 TOTAL )
"This estimate includes the 90 known dosimetry processors plus the projected number of utilities that will begin providing their own dosimetry by 1983 as discussed earlier in this section.
- It is not projected that the nuclear worker population will increase significantly by 1983.
18 Enclosure B
/
., /
- 3. Potential In-House Costs to Processors for Repeat Proficiency Tests Additional in-house costs will probably be incurred by processors that l fail one or more of the categories tested on the first time attempted. The estimates given below in Table B-10 are based on a processor failing 25%
of the categories attempted.
Table B-10 Potential Estimated Additional In-House Costs for Processors for Repeat Proficiency Testings
- 1. 3 person weeks' at $1,154 each (See Table B-8) $3,462
- 2. Consulting services 1,000
$4,462
- 4. Total In-House Expenses '
Total in-house expenses of $3,462 and $4,462 total $7,924. (See Tables B-9 and B-10.)
i
- 5. Total Biennial Accreditation Costs for Processors The total range of estimated costs to a processor for in-house labor and testing fees for annual accreditation is shown in Table B-11. I Table B-11 -
Total Potential Biennial Costs for a Processor for Accreditation Efforts (Accreditation Costs and In-House Costs)
Accreditation Costs Potential In-House Costs Total Minimum Costs $2,760 $3,462 $ 6,222 Maximum Costs $9,260 $7,924 517,184 Average Costs $6,140 $7,924 $14,064 Small Entity $4,060 $7,924 $11,784 i
19 Enclosure B
., /
The total average accreditation costs for the industry today for the 90 known dosimetry processors for accreditation would be:
90 processors x $14,064 = $1,265,760 biennially
= $632,880 annually
$583,656/ year + 1,400,000* radiation workers = $0.42/ year increase for personnel monitoring per worker.
This represents a net increase in personnel monitoring costs of 1.7%.
If the number of processors increases as projected to 102 processors by the time these rules become effective the costs could be:
i 102 x $14,064 = $1,434,528 biennially
= 717,264 annually i
$717,264/ year + 1,400,000 workers = $0.51/ year increase for personnel monitoring per worker.
This repre ents a net increase in personnel monitoring services of 2.1%.
\
1.3.b.5 Total Cost to the General Public for a Laboratory Accreditation Program for Personnel Dosimetry Processors. The costs for conducting the three rounds of proficiency testing in the pilot study at the UM totals $536,387.
Costs incurred also by the public include $150,000 for development of the laboratory accreditation program by NBS for NRC and $250,000 advance funding for conducting procurement activities at N85 in order to make the LAP opera-tional. It is expected that the $250,000 will be recovered from fees charged to processors and returned by NBS to NRC. Total costs, therefore, include 536,387 and $150;000 which totals $686,387 for testing the HPSSC/ ANSI standard which serves for the basis of this program and for establishing a laboratory I
accreditation program.
"It is not projected that the nuclear worker population will increase signifi-cantly by 1983.
20 Enclosure B '
l
Table B-12 Estimatad Summary Table l
- 1. Estimated Costs for Equipping and Operating a Proficiency Testing Laboratory.
A. Initial Equipping and Calibration Costs $312,000 B. Biennial Operating Costs $292,566
- 2. Estimated Biennial Fees for the Laboratory Accreditation Program.
- A. Administative Fees as described previously $2,500/ processor B. Proficiency Testing Costs / Category / Dosimeter Model
- 1. Categories 1-5 (one radiation source categories) $260 each
- 2. Categories 6-8 (two radiation source categories) $520 each
- 3. Participation in all 8 radiation categories $2,860 total C. Minimum Accreditation Costs for any Processor (1 medel in one category only + administrative fees) $2,760 D. Maximum Accred'itation Costs for any Processor (6 models in 19 categories 2 + administrative fees) $9,260 E. Average Accreditation Costs for any Processor (1 model in 10 categories 2 + administrative fees) $6,140
- 3. Accreditation Costs Per Processor A. Initial Preparations for Accreditation (One-time Costs)3 $7,770 B. In-House Costs Occurred Biennially
- 1. Preparations for Initial Testing $3,462
- 2. . Corrections and preparations for repeat proficiency testing (including potential consulting charges) $4,462
- 3. Total in-house cost biennially $7,924
. C. Total Routine Costs Per Processor for Attaining Accreditation (Accreditation costs + In-House Costs)
Biennial Annual
- 1. Minimum (1 model one category) $ 6,222 $3,111
- 2. Maximum (6 models in 19 categories) $17,184 $8,592
- 3. Average (1 model in 10 categories) 514,064 $7,032
- 4. Small Entity (1 model in 5 cateoories) $11.784 $5.892 4
99- oc . p.e... e, e , , . _ , . *oo .-.G, -
s **_-
- _.J-...,.w.,---
. i l 1 l I
Costs for NRC staff time associated with this rulemaking and contract monitoring have not been ' included in this analysis.
l
- 1.3.b.6 Summary of All Costs Associated with These Rulemaking Actions
- (see Table B-12).
1.3.1 NRC Operations
! A description of values and impacts in this section assumes that a j requirement for NRC licensees to obtain dosimetry services from a NVLAP accredited processor will lead to improvements in the accuracy and quality of dose estimates. (This alternative is midway between the most stringent regulatory action that could be recommended and no action at all.)
A. Values: NRC does not have direct authority over personnel dosimetry processors. ,NRC does have authority to require its licensees to obtain qualified dosimetry processing services and NRC can establish trie minimum acceptable criteria for such services. The NVLAP method of accreditation for personnel dosimetry processors of the Department of Commerce (DOC) allows NRC an indirect way of improving personnel dosim-l etry processing across the entire country.
- 1. The DOC is willing to establish and administer for NRC within an j acceptable timeframe a Laboratory Accreditation Program (LAP) for j personnel dosimetry processor testing and evaluation. The DOC has
! authority to provide for and develop national multidisciplinary laboratory evaluation systems through the National Bureau of Standards (NBS) in any testing area for which a need is demon- -
strated by requesting Federal agencies.*
! 2. NRC staff has the opportunity through an Interagency Agreement with i NBS to participate in the development of laboratory accreditation criteria for a program compatible with NRC's needs to establish a responsible regulatory program to improve the processing of personnel
) dosimeters. NBS through the NVLAP accreditation program has consulted x 1 In 1976, at the request of American Society for Testing Materials (ASTM), DOC l establis'ert the National, Voluntary Laboratory Accreditation Program (NVLAP) l (15 CFR Pet 7.11(d)).
22 Enclosure B l
. /
)
with representatives of the personnel dosimetry processing industry and known interested members of the public through the development of the program in an effort to design the most responsible accreditation
, program for NRC while at the same time factoring in industry needs 1
and comments.
- 3. NVLAP is experienced in the operation of laboratory accreditation programs which adds additional expertise and creditibility to the development of the dosimetry LAP for NRC purposes. .
. ~
- 4. Assurance of quality performance by processors performing dosimetry services for NRC licensees by successful participation in the NVLAP
- accreditation program would essentially satisfy NRC regulatory needs.
The NVLAP accreditation process will result in improved personnel dosimetry processing since the evaluation of applicant processors covers all fundamental elements of personnel dosimetry processing including routine quality assurance procedures as well as proficiency testing.
- 5. NRC's Office of Inspection and Enforcement (I&E) staff estimated that at least 8 person years / year will be saved by using the NVLAP program i
instead of NRC personnel to conduct on-site assessment of processors.
This would also relieve NRC inspectors from current examination of existing personnel dosimetry processing programs of in-house or NRC processors. Staff at NRC's regional offices will not be burdened with additional inspection duties in the general area of personnel dosimetry and auditing QA activities of the NRC licensee processor as a result of this rulemaking. NRC inspectors would only verify ,
the use of appropriate services far specified dosimeter models from l accredited processors during routine licensee inspections of personnel dosimetry records.
- 6. NRC staff resources have been minimized in the development of this regulatary program, because NVLAP and NRC have signed an Interagency
)!
- Agreement to delineate clearly each agency's respective responsibilities J
l
! l
- 23 Enclosure B i I
l l
l ,_ . n - : -- --- _ -- - ~ ~ ~ '
.~'*~ .l.
in developing a NVLAP program for personnel dosimetry processors.
This agreement assigns operation of the LAP for processors of personnel dosimeters to NBS. Future use of NRC's staff resources will be limited to project monitoring by a representative of the NRC's Office of Nuclear Regulatory Research and cognizant individuals of other NRC program offices. '
- 7. No continuing long-term NRC financial commitments will be necessary after the initial development of the accreditation program.
- 8. The NVLAP accreditation process offers a participating dosimetry processor opportunities for correction of identified inadequacies in their quality assurance activities and opportunities for repeat pro-ficiency testing at the processor's expense. NRC would not be involved in the settling of disputes that may arise regarding the performance testing or assessment of the adequacy of quality assurance measures developed by respective processors. Technical administration of the proficiency testing will be monitored by the Center for Radiation Research at the NBS. Dosimetry processors would be free to request hearings for re-evaluation of accreditation actions under the Admini-strative Procedure Act, 5 U.S.C. 556.
- 9. This regulatory program would enable NRC staff to have a more accurate data base of facts concerning dosimetry and personnel dose records upon which to base licensing and inspection decisions and in ascertaining i
that licensees are meeting current regulatory requirements.
- 10. Confidence in the quality of dose measurements will be improved since l
all accredited dosimetry processors will have to meet minimum QA criteria I to ensure that routine dosimetry is performed with the same uniform processing procedures as proficiency test dosimeters (even though different calibration factors can be applied to the raw data measurements from the dosimeters). An added benefit of the NVLAP program is that-each processor will be evaluated by uniform criteria which should i
24 Enclosure B
. s remove any individual inspector's interpretation or bias. NVLAP criteria include general and specific requirements with which all successful participants of accreditation programs must comply. These requirements include criteria for recordkeeping, calibration, employee training, facilities operation, and uniform elements of a quality assurance program. *
- 11. Dosimetry services previously outside NRC scrutiny will now be evaluated directly by DOC through the NVLAP program. This evaluation process will add greater reliability to all dosimetry data produced for NRC . ,
licensees.
- 12. The Interagency Policy Committee and the Industry Overview Committee as well as industry in general have supported the adoption of this program,and have participated in its development. NVLAP encourages and promotes good laboratory practices and improved test methods.
i This alternative will allow the NRC to improve the personnel dosimetry
- processor performance problem with (1) minimum staffing and resources, (2)
! initiation of a self-supporting program both to test and accredit on a biennial basis the technical competency of personnel dosimetry processors performing dosimetry services for NRC licensees, and'(3) the establishment of minimum uniforn quality assurance criteria for routine and proficiency test dosimetry processing.
The staff feels the dosimetry processor performance problem would be significantly improved by period 1q determination of a processor's competency by performance tests and examination of routine processing activities and associated quality assurance measures.
B. Impacts:
- 1. Costs to NRC total $150,000 for NVLAP development of a laboratory accreditation program and $536,387 for the pilot study conducted by the University of Michigan for NRC which consisted of two rounds of performance testing of U.S. personnel dosimetry processors against the draft ANSI Standard N13.11 and a final round of testing against a revised version of ANSI N13.11. NRC staff resources for develop-ment of this program have not been included in this estimate.
~
t 25 Enclosure B i
__~
- 7 ~ __ .._E _. ._ ____,__ _ _ . _ , _ _ _ _ _ . ,_,__,._,__4-_ _ _ . _ _ , _ _ , _ _ _ , , _ _ , , , _ , _ _ . - . . . . , , _ . _
, . /
- 2. This alternative indirectly extends the Federal government into the personnel dosimetry processing private industry sector. ,
l
- 3. If an inadequate number of large commercial dosimetry processors now providing the majority of dosimetry services in U.S. do not receive !
accredita' tion in the first biennial period, the NRC will almost assuredly be pressed for immediate remedies.
- 1. 3. 2 Other Government Agencies
- A. Values: ,
- 1. This alternative is acceptable and has been supported by the Inter-agency Policy Committee (see Section 1.2). Members of this committee plan to-sponsor similar programs in their respective agencies.
- 2. Other agencies will henefit from'NRC's program and from' continuous updates as a result of participation in the Interagency Policy Committee on Personnel Dosimetry without sharing in the funding of the proficiency testing pilot study or the development of the laboratory accreditation program.
- 3. NRC has demonstrated and documented the need for a regulatory program and has formulated a regulatory approach that can easily'be adopted 4
by other agencies whose contractors, military bases, licensees, etc.,
are responsible for conducting personnel monitoring for their workers.
\
- 8. Impacts:
None identified.
" Cost estimates for other agencies have not been provided. It is ,* bable that other agencies can also use the NVLAP accreditation program and testing laboratory.
l l
26 Enclosure B
l
,- j l
4 1.3.3 Industry l
A. Values: t
- 1. NVLAP encourages and promotes good laboratory practices and improved test meth'ods. The NVLAP system incorporates mechanisms into the assessment process to allow processors time to correct identified '
problems and improve their deficiencies in routine processing or quality assurance activities. Repeat proficiency testing of processors will be allowed prior to the final accreditation [
decision if the processor so desires to pay for such services.
- 2. Each employer in industry has a responsibility to provide appropriate l
health and safety to employees who work with byproduct and special nuclear, materials. Since dosimetry results form the bases of verifica- l 1
tion that regulatory limits have been achieved or exceeded, successful participation or utilization of the accreditation program for personnel dosimetry processors will be very valuable in demonstrating the licensee's compliance with the regulatio,ns.
- 3. Anothermajorvalueofatestingprogramiscredibility. There is t
a nation-wide concern about the unknown biological effects of ioniz-ing radiation, and many lawsuits have been brought against employers of exposed workers. Dosimetry processors feel an increasing need to demonstrnte their ability to measure doses of workers accurately.
Self-designed and self-administered testing and quality control programs do not carry the legal credibility of a nationally-recognized accreditation program.
- 4. One value to commercial dosimeters processors of a, nationally-recognized testing program would probably be a reduction in the i number of customer-organized tests, many of which are improperly designed and implemented.
l l
\
t 1
27 Enclosure B
-,- w,- - --, ~r,- ,e,, ,,,m-ww-,--,--.e< , , , - - -r m , , ,,,,,,,-,-,,r,,, w <--y--,.. -.w,r,,,-,<- ym.,-w-w-,,,, gee,ww.,--ev,,----,r-- e em -w e -w, - - *
- 5. Better quality control through processing activities should result in fewer defective dosimeters (i.e. , those improperly assembled or defective in some other way) from being put into the licensee's ,
system and subsequently issued to workers at an NRC-licensed facility.
- 6. The NVLAP' accreditation program will bring about uniform and, in most cases,' improved documentation which will aid licensees in '
maintaining personnel dose histories and in transfer of information for terminating employees. '
i
- 7. This is not a new system of laboratory accreditation. A number of laboratories (over 100) are now s.uccessfully accredited by NVLAP for the other currently operating LAPS in carpet, concrete, or thermal insulation materials. This is not a new system of laboratory accreditation. !,
- 8. Processors who are accredited will have an advertising advantage over other processors who are not. NVLAP accredited processors can advertise their accredited status on their letterhead, brochures, test reports, trade publications and other laboratory services advertising media. j
\
- 9. The Industry Overview Committee has assisted NRC in developing qual-ity assurance criteria to be used with this LAP and has supported the adoption of this alternative.
- 10. Ifuniformrecordkeepingediteriaareimplementednationwide, itis likely that clerical errors would be minimized.
- 11. This alternative would improve the public image of the entire l
personnel dosimetiy service. industry.
l l
- 12. Industry has had an unusual amount of input into this regulation.
i If any portion of it proves to be unrealistic, industry would probably be called upon to share in any resolution.
4 4
28 Enclosure B
~_ - -: =: 7 - . z _ - _ --- ------,-, _,_ _ __ _ _____ _. _ _
- 8. Impacts:
- 1. NVLAP management and project leader staff who will administer the ,
program do not currently include any personnel with personal experience in personnel dosimetry processing. Misunderstandings among applicant processort and NVLAP are probable during the first rounds of accredi-tation unless communications of a technical nature which are directed
- to NVLAP personnel are directed to the experts from the Center for Radiation Research of NBS that will provide all technical support needed in the program.
, 2. Accreditation will not be without initial or continuing costs to industry i (see 1.3.b).
- 3. Estimatas indicate that this regulation will increase the cost of processing. personnel dosimeters by approximately 50.51/ year / worker j (see 1.3.b).
l
- 4. Failure to achieve accreditation or loss of accreditation by a processor in a particular category will be an inconvenience, an embarrassment, and will be costly to the processor. It would also probably cause an increase in the dosimetry processing industry's insurance premiums (see 1.3.b).
- 5. A licensee performing dosimetry services in-house who fails to gain accreditation will have to make new contractual arrangements with a processor who has current NVLAP accreditation.
- 6. The consequences of not obtaining NVLAP accreditation in one or more categories may have a severe effect on the ability of an individual ;
dosimetry processor to stay in business.
\
l 7. Most processors have calibrated their dosimeters to radiation sources l' other than those specified in ANSI N13.11. If an applicant processor changes calibration sources because of the requirements of the test-ing program, this could cause a noticeable increase or decrease in l
29 Enclosure B
\
l m e-o e . % .. . . . e
--. - n ,. --- - - - , - , --.n---,- ,- - - - - - - - - ,.w--,. - , , _--,-w-, --.,,.-------,n .
,,n.-mm - , , , , , - . - - - . . . - - - - - , . - - -
I the doses regularly reported to its users. This could result in a serious impact on the processor if its users challenge its past cali-bration efforts. A noticeable increase in assigned doses could imply past uncertainties that resulted in an underestimate of true doses.
I A noticeable decrease in assigned doses could imply a new effort to reduce doses artificially. Either sharp change in assigned doses i could be viewed with suspicion by the users and would probably be costly to licensees in view of ALARA program implementation at their facilities.
l
- 8. Several processors from industry have conjectured that one impact of a testing program would be the discouragement of new developments in personnel dosimetry. They fear that the goal of dosimetry processors will be to pass the test and that once a processor's dosimeter passes the test that there will be little incentive for a processor to research and develop new types of dosimeters. The cost for accrediting a new I dosimetry system is likely to be very small when compared to the costs I
for developing a new dosimeter system.
i 1.3.4 Workers i
i A. Values:
- 1. A laboratory accreditation program will no doubt lead to improvements I on the part of dosimetry processors assigning radiation dose to indi-vidual radiation workers. Workers have the right to know that their i
personnel monitoring is as accurate as possible and that the processor used by the employer is compe~ tent.
It i's clear that personnel dosimetry records can be considered as medical-type information records and could be valuable in assessing any potential health effects from dose received by the worker. In
> the strictest definition, dosimetry records may not be considered official medical records since they are not usually generated by a f
i medical doctor. However, there is a trend in Federal legislation 30 Enclosure B
_ .___. _ ___ ___.____ _._ a _ ___ _ _ __ _ . . _ -
i toward recognizing the right of individuals to know information about themselves contained in the records of institutions both inside and outside of the Federal sector. Examples are: the Privacy Act of ,
1974, which sets out rules for recordkeeping for Federal agencies; the Fair Credit Reporting Act and related acts, which give consumers the right to know information about themselves contained in the records of' credit-reporting bureaus; and the Family Education Rights '
and Privacy Act, which grants students the right to see personal
]
records held by educational institutions.
I'
' The Privacy Act of 1974 allows an individual to ensure that the information maintained as a part of his medical care relationship .
is accurate, timely, and relevant to his care. From a legal stand-1 point, it is c1sar that dosimetry records can be considered as l
medical-type information records that could be valuable in assess-l ing any potential health effects from dose received by a worker.
l i
- 2. If overexposures do occur, documentation associated with this program will assist in rapid verification of dosimetry processing conditions and associated accuracy of the measure.ments that may arise from ques-tions associated with litigation of health effects suits brought by I.
! radiation workers.
- 3. It is basic that workers' doses should be properly documented with l
all the current public concern over the biological effects of low doses of ionizing radiation.
B. Impacts:
i 1. If a processor which has been performing an employee's dosis.etry fails to become accredited, the employee's previous dosimetry measurements may be questioned.
l I
l 31 Enclosure B l
i I -- **~M*1_,._._...._______,__ _. ,-.--- - - ---.-.,_ ,_-,.__.--.- _ __ _
t NOTE: Personnal monitoring for workers who receive less thtn 2S% of tha maximum permissible doses, which is now provided voluntarily by some licensees, may be terminated if the cost of dosimetry services is increased substantially by this rule. This does not produce a decrease ,
in radiation protection since such voluntary actions are commendable but are beyond min'imum requirements imposed upon NRC licensees.
1.3.5 Public ,
A. Values:
- I
- 1. Perceived public confidence in dose measurements and in the adequate health and safety of workers would be improved because personnel ,
dosimetry processors would be required to participate in performance l i
testing,and to maintain minimum quality assurance measures to gain accreditation.
- 2. Establishing minimum criteria for personnel dosimetry processors defines uniform dosimetry processing practices for the first time which will bring increased public trust in accredited processor services.
B. Impacts: .
- 1. If a large number of processors fail to gain accreditation, the public may question the abilities of other dosimetry processors.
- 2. Previous dosimetry conducted by a processor who fails to achieve accreditation will be in question, and this may result in more law suits against that processor which will result in increased costs to the public. .
- 3. The public will pay for the entire cost of this program indirectly through developmental costs incurred by the Federal government for l
this program and indirectly through increased prices by industry for i
services rendered to the consumer.
32 Enclosure B f
l .. . .
h t are perceived to arise as Thisa 1.3.6 Decision on Prooosed Action The values enumerated in this statement t abstantially larger tha result of this proposed program are su Wl conclusion is further justified by the: by dosimetry processors ,
1.
Overwhelming support for this alternativee to the letter from and other interested persons in respons f the comments received ,
described the NVLAP alternative (100% o in favor of this alternative); E ncy' Policy Committee on 2.
Support of this alternative byview theComittee; Interage Personnel Dosimetry and the Industry Over i ittee in recommending Assistance of the Industry Overview Coml information for l us 3.
accreditation criteria and supplementa U NVLAP Program; and by >
I
- d affected licensees in tele- L 4.
Positive response from the industry etings.an phone conversations and during recent me ,
fy
Conclusion:
f the proposed rules for coment The Comission should hauthorize publication oNVLAP ent alter }
I!
in the Federal Register which endorse t ethe general publi advantages for NRC, industry, workers, agencies. I
- 2. TECHNICAL ALTERNATIVES d Assumptions s i
Description of Technical Alternatives an 2.1 2.1.a Alternatives test the ability of a processor /
l i and will Any performance testing program can on ytandard at a g to perform within the limits of a s lly treats its regular u not determine if the processor actua Enclosure B 33
l with the same competence accorded to the proficiency testing dosimeters. Therefore, it is necessary to supplement the testing program with checks of a processor's j
quality control, calibration, and administrative procedures. The Commission i, l
had five available alternatives under consideration for the establishent of a regulatory program intended to ensure improved personnel dosimetry processing.
The following five hlternatives are presented by ranking these regulatory options from no action necessary to the most restrictive Federal government program. '
1
,I j Alternative 1. No change in current requirements.
I 4
Alternative 2. Change in the regulation that would require that licensees obtain personnel dosimetry processing from (a) processors who have successfully I participated in dosimetry performance testing administered in accordance with ANSI N13.11 and (b) processors who have a documented quality assurance program.
f !
NRC would not speci.fy the performance testing laboratory (PTL). The necessary elements of the QA program would be specified. NRC inspectors would require from the licensee proof of successful performance testing and evidence that f
l their processor's QA program complied with the regulation whether the dosimetry a
j service was performed in-house or commercially.
1 i Alternative 3. Change in the regulation that would require licensees to j obtain personnel dosimetry processing from (a) processors who have successfully participated in dosimetry performance testing administered in accordance with l
ANSI N13.11 [by an NRC-specified testing laboratory] and (b) processors who l
j have a documented QA program that contains elements specified in the regula-l tion. This alternative differs from alternative 2 by the material presented j in brackets.
i This alternative could be accomplished by either of the following approaches: ,
Option A. NRC would obtain the services of a contractor laboratory through I the competitive bidding process. NRC licensees would be required to obtain f personnel dosimetry services from a processor that had successfully partici-NRC inspectors would, !
! pated in performance testing by NRC's contractor PTL. I i
i-i l 34 Enclosure B j i
_._f"~~~' _.l****_*_~,*L.._.____.-____________.-.___.____.__.._______________.____
l l
! during licensee inspection, examine written proof provided by the licensee !
(1) that this performance testing was successfully completed by the processor of licensee's personnel dosimetry, and (2) that the processor maintained a QA program that included the elements specified in the regulation.
2 Option B. Thi'd r party accreditation: NRC would specify in the regula-
- tion that licensees utilize the services of personnel dosimetry processors j accredited under the National Voluntary Laboratory Accreditation Program (NVLAP)
, of the National Bureau of Standards (NBS) which is a part of the Department of Commerce (DOC) (15 CFR Part 7b). NVLAP accreditation would be based on three primary elements: , (1) proficiency testing of personnel dosimetry processors in accordance with ANSI N13.11 to be performed by a laboratory contracted by
- NBS, (2) information collected from the personnel dosimetry processor by questionnaire, and (3) on-site assessment of routine dosimetry processing and QA techniques. NBC and the National Bureau of Standards would establish general i
and specific accreditation criteiia for a Laboratory Accreditation Program (LAP). \
I i j for Personnel Dosimetry Processors consistent with NVLAP's established general l and specific criteria (44 FR 12982) used in current programs for assessing the competency of laboratories. NRC would specify, as supplemental information to l
i these criteria, the elements of a dosimetry quality assurance program. As 1
l appropriate, exceptions to NVLAP accreditation criteria would be published in j the Federal Register for public comment. Subsequently, NVLAP would take the 1
j necessary procedural steps to complete the accreditation process for this LAP based upon NRC's recommendations and public response. N85 would grant certificates of accreditation to processors that comply with NVLAP criteria. NBS would provide
! and train dosimetry experts as inspectors who would conduct on-site inspections
- of dosimetry processors that request NVLAP accreditation to assure that an j acceptable QA program is documented and implemented. NBS would collect appro-priate accreditation fees from applicant processors. The fees would cover costs for administration, on-site inspections, and proficiency testing.
I i ,
1 1
Alternative 4. Since many dosimetry processors are not NRC licensees and 2
since dosimeters are not radioactive material but are passive monitors which measure dose received by the worker, NRC would request from the Congress the i
i 35 Enclosure B i
l
\. ...
l O
i
~
authority to license personnel dosimetry processors directly. If this author-ity were granted, NRC regulations would be appropriately amended regarding performance testing and quality assurance criteria acceptable to the NRC for licensees to provide adequate dosimetry.
j Alternative 5.' Change in the regulation that would require licensees to obtain their personnel dosimetry services from an NRC-operated or NRC-contracted i dosimetry service. NRC would issue, through its laboratory, dosimeters for licensee use, and the laboratory would perform all dosimetry processing. In addition, all processing would be performed in accordance with an NRC-specified quality assurance program.
! 2.1.b Assumptions i
i Several basis assumptions are common to any potential regulatory program for the personnel dosimetry problem and are set forth below:
i i
! 1. Any testing and certification laboratory that would be established by any of the alternative methods presented would be monitored by the National l
Bureau of Standards (N85) for j a. satisfactory technical performance, t
- b. traceability of all primary standards to the National Bureau of Standards, and 4 c. conformance with the American National Standards Institute's (ANSI) standard, ANSI N13.11, Criteria for Testing Personnel Dosimetry Performance. ,
The NRC would consider NBS approval of the dosimetry performed by the testing laboratory as adequate evidence of technical competence.
1 1
4 36 Enclosure B r
e
_____,_,_.,_.__.._,_,,,.._m..., _ . _ _ _ . . - . _ _ - _ . . . . _ . . . . . _ _ . , _ . . _ _ . - _ . - _ . . . . . .. , , - _ . - , , , _ . ,.-
- 2. Each of the five alternatives considered would require that NRC issue new regulations stating that personnel dosimetry results would be acceptable only if provided by a processor which is (a) certified by a testing labora- r tory or (b) accredited by a laboratory testing and accreditation program that is approved or specified by the NRC.
- 3. All processors which provide commercial dosimetry services or in-house dosimetry services for employees within the same company would be pre-sumptively considered to have a conflict of interest and therefore would be ineligible to operate the testing laboratory and/or accreditation program.
- 4. Both grievance and appeals procedures should be established to create mechanisms by which. personnel dosimetry processors could register com-plaints or disputes for resolution.
- 2. 2 Analysis of Technical Alternatives
- 1. No Change in Current Requirements, i.e., do nothing about the dosim-eter performance problem.
A. Pros:
- 1. There is no absolute guarantee that adoption of a regula-tory program will improve the quality of the processor's service to its regular users even if a proce'ssor can pass a proficiency test or successfully participate in an accreditation program (which includes proficiency testing, thorough documentation, and implementation of a stringent 1 quality assurance program).
1 37 Enclosure B
- 2. The inaccuracies that exist with personnel dosimeters probably do not constitute a major health hazard for the worker population.* A summary of occupational exposures ,
for in 1978, indicates that 0.1% of all monitored workers (103 out of 105,893) were reported as being overexposed, and only two individual exposures exceeded 10 rems.**
A'dditional information regarding the nature of these ,
exposures may be obtained in:
I NUREG-0593 Occupational Radiation Exposure, Eleventh Annual Report 1978, National Technical Information Service, Springfield, VA 22161 (November 1980).
4
- 3. With the current inflation problem in this country and the increasing volume of regulations, it appears that any cost that would be. incurred by the processor and passed on to the general public, and any increase in current regulatory requirements, would be undesirable. Three comment letters (4.5%) received were in support of this alternative.
- 4. No new government resources would be required.
B. Cons: 1
- 1. The results of the pilot study show that even with the statistical method of the revised ANSI N13.11 standard, results indicate that 25% of all the category tests attempted were failed in the third round of testing. This shows that there are still wide-spread inaccuracies in personnel dosimetry processing.
l x
All persons licensed by the NRC must submit reports of all Licensee incidents reports involving of personnel radiation exposures that exceed certain levels. ;
these exposures are in accordance with 10 CFR 5 20.403 (a and b), or 9 20.405.
an There is little doubt that considerable investigative work was done beyond the dosimetry processing for all workers who received any amount over the regulatory limits for whole-body exposure.
i, i
38 Enclosure B
- 2. The major problems identified during the pilot study that con-tributed to poor performance among tested processors (i.e.,
inadequate calibration sources, variability in TLD dosimeter ,
chips, clerical errors, and lack of effort on the part of the processor to make changes necessary to pass the tests) can be corrected by the implementation of a regulatory program. For 1
at least some processors, this will result in improved accuracy
- for reporting of occupational doses received by employees of their regular c11ents.
I
- 3. The associated increased cost of personnel dosimetry services is minimal to society and is well justified in that the Commission 1
is required by the Atomic Energy Act of 1954, as amended, "to establish rule, regulation or order, such standards and instruc-
) tions to govern the possession and use of byproduct material as the Commission may deem necessary or desirable to protect health !
or to minimize danger to 1.ife or property."
j 4. The uncertainties associated with currently reported dose estimates for nuclear workers and the magnitude of the problem is very I difficult to access. The uncertainty of individual dose estima-tions by dosimetry processors as demonstrated by the pilot study is unacceptable on an individual dose assessment basis. A regu-latory program would help correct these uncertainties and
] appears to be warranted.
i
- 5. This alternative would probably not be acceptable to the general public, the dosimetry processing community, other Federal agencies, (including EPA, BRH, DOE, 000, and DOL (OSHA)), or the Conference of Radiation Control Program Directors who feel that a serious problem has been identified and that it should be I
- dealt with by development of an appropriate, unified interagency j regulatory program.
39 Enclosure B
l I
- 2. Change in the regulation to require that licensees obtain personnel dosim-etry processing from (1) processors who have successfully participated in dosimetry performance testing administered in accordance with ANSI N13.11, and (2) who have a documented quality assurance program. NRC would not specify the performance testing agent. The necessary elements of the Q.A.
- program would be specified. NRC inspectors would require proof of success-
. ful performance testing and evidence that the QA program complied with
- the regulation'.
f A. Pros:
i
- 1. No government resources would be required for operation of the testing laboratory. ;
- 2. This alternative leaves personnel dosimetry processors and users free to establish one or more testing laboratories on their own initiative, although one laboratory would be sufficient to handle i the entire workload of a nation-wide proficiency testing program. l This alternative would preclude government selection of a single contractor proficiency testing laboratory and remove any ques-l tion of the government establishing a monopoly for personnel dosimetry testing. Therefore, direct government involvement in private business would be avoided. I
- 3. The potential for establishing more than one testing labora- i tory would permit processors to select their testing facility l based not only on competitive pricing or costs but also on the l technical ability and experience of the laboratory staff. It
! would also permit processors to evaluate, on their own, question- (
able results from a testing laboratory to the extent that they ;
would be willing to pay for duplicate services.* l
- i l
- l i "Althougn the free enterprise system generally encourages competitive pricing, ;
a large number of fixed costs are associated with the procurement, installa- '
tion, and calibration of the radiation sources required by the ANSI Standard.
It is not presumed that there would be a really significant cost difference
. to most processors. However, in the case of the small in-house processor, ;
) 1.e., university, hospital, or small research foundation, a reduction in the i testing fees per category could become significant if the processor participated ,
in several different categories.)
i 1
40 Enclosure B l t
1 !
- _ J : "L-___ - ,- - - - _ . - - - - _ . . . - , _ . . - - . - . . ~ . . - . - _ , . . _ . , - - - - . . - - - - - . -
- 4. If more than one testing laboratory is independently established by industry, the continuity of the program would not be inter-rupted if one or more of these laboratories chose (for whatever f
reason) to no longer perform testing services. In addition, if the transition from more than one independently operated testing t labo'atory r to a single testing laboratory were to occur, there j would be a testing laboratory still available.
I
- 5. The establishment of more than one test and certification labora-tory would provide an opportunity for frequent intercomparison between testing laboratories. Once a year, NBS could spot check i the laboratories, but intercomparisons could be much more frequent
! between laboratories.
- 6. Thts alternative would probably be acceptable to the general public and to affected dosimetry processors; and would probably not be associated with any specific government regulatory agency.
Seven comment letters (10.6%) favored operation of the testing laboratory in this manner.
\
l 7. Thisalternativewouldfreethe$operationofthetestinglabora-
\
tory from cyclic Federal budget,and manpower constraints and cutbacks.
- 8. An industry-operated laboratory would be free to pursue new I avenues of study or research on its own initiative which might l be outside the basic definition o'f a dosimetry performance test-i ing laboratory as long as these activities did not pose a con-j flict of interest.
I , 9. NRC would specify minimum elements of a quality assurance l I program.
l.
! 41 Enclosure B
- - . - _ .- _ -_. - - , __ _ ,_ __________ _ _ _ _ _ _ _\
l B. Cons:
There is no guarantee that any testing laboratory would be estab- pl-l 1.
lished by industry or that it would be formed expeditiously.
This could be disruptive to the regulatory program.
- 2. There is no guarantee that more than one testing laboratory would
- be established by industry in which case, pros number 3, 4, and 5 above would not be relevant. I i
There is a finite number of dosimetry processors. If the work l 3.
load were handled by more than one testing laboratory, to a large degree, the fees associated with testing would become less volume dependent.
li
- 4. If questions of administrative creditability of the industry-l operated, unspecified laboratory arose, it would be very diffi-l cult for the Government to investigate the allegations or to l
l effect a change without an interruption of the regulatory program.
- 5. The licensee could have an excellent quality assurance program on paper but in practice i:ould be violating the regulation if it were not implemented. This alternative would require major l NRC Region Inspection and Enforcement (I&E) effort in assessing the adequacy of licensee or licensee's contractor dosimetry program.
' Initial I&E estimates projected 8 staff years effort annually I to conduct such a program.
l
! 6. The Federal government would have no control over the administra-tion of the testing process. This is a large responsibility for the NRC to delegate.
- 7. This alternative may not be acceptable to other involved Federal agencies who may be hesitant to base a regulatory program that !
incorporates proficiency testing under the auspices of an industry-f I
operated proficiency testing laboratory.
l I Enclosure B 42 j .
~ ~ -w. - , , _ _ - -n,, , ,- , - --- - - . - - - _ - , , , , - - -.,,,.-,,,,_,,---.w.v
,--g - - - , - - - ,,wr,en_,,-. ,,,--,wm -.--,.,n.ncy,_,,,,.<w-
- i i
8.
NRC Regional inspectors would probably not t be allow 1d a processor which was a non-NRC licensee pro- or private con
, unless the vendor program was extended to include dosimetry E l cessing.
NRC legal staff has advised against this extension.
I
, l dosimetry I Change in the' regulation to require that i i ated in dosimetry licensees obtain perso
- 3. processing from.(1) processors who have successfully
- f. lity assurancepart c PS l performance testing administered in accordance h with AN gulation."
m l
specified testing laboratory and (2) who have h the com-g l
3a.
NRC would obtain the services of a contractor sfullylaboratory thr f petitive bidding process. laboratory. NRC personnel dosimetry services from a processor which had suc f provided participated in performance testing by NRC'sl t contractor d by the , ,
by the licensee (1) that such 2) that performance te the processor the elements a d
J l processor of licensee's personnel dosimeters andm =
QA program a's specified in the regulation. ;
/ '
l I Pros:
o I
A.
[
l 1.
The pilot study that tested personnel dosimetry process }
4 formance with the draft ANSI N13.11 Standard was f 7 f an NRC-contracted laboratory operated by the UniversityG o I
'\
l -
titute for Agency (EPA),
l w The staff has determined that three Federalthority Agencies (Natio l Occupational Safety and Health (NIOSH), Environmental to Prot and the National Bureau of Standards (NBS))laboratories. have' legislative d testing au operate and do now currently operate research i and/or are will- testing l
l However, the alternative of a Federal l dosimetrygovernm i
i ing to operate a laboratory for performance f personnel testing of l processors.
j or expertise in the area of personnel dosimetry to enable *
' current laboratory capacities to include performance testin dosimetry processors.
and maintenance of national standards, and ified the current preference for stafTen l include the operation of service-type laborator i an NBS-operated testing laboratory. f proficiency l nical performance of the proficiency testing laboratory lar (PT l
l satisfactory testing and (performance of the PTL SI N13.11. prior Twenty- to the tive.
intervals during proficiency testing Enclosure B in accordan 43
I Michigan. This alternative worked well in the past for NRC during j the performance testing program.
f i
i 2. NRC staff resources for administrative and contract review of
' an NRC-contracted laboratory would be minimal.
- 3. Should' conditions warrant, contract mechanisms are available to !
terminate the contractor's laboratory services for poor perfor-mance. Contracts are also awarded for a finite period and
,1 require extensive review for renewal of services.
1
- 4. Award of a government contract for personnel dosimetry services under current contractual minimum requirements would necessitate that all contenders for bid have demonstrated capabilities and technical expertise in operating such a laboratory as a pre-requisite for bid.
! Se This alternative seems acceptable to both dosimetry processors and the general public. Eleven comment letters received by NRC l (16.6%) endorse the selection of this alternative. This alter-native would also probably be acceptable to other Federal govern-J
! ment agencies planning to adopt simultaneous regulations for
! improved personnel dosimetry processing.
- 6. NRC financial resources would be limited to funds for establish-
)
ing the initial PTL. The assessment of fees would allow the PTL to operate on a non profit basis and to become essentially self-supporting.
k 8. Cons:
- 1. The HRC would be involved in the settlement of any non-technical, l administrative disputes that may arise between dosimetry proces- l 4 sors and the testing laboratory.
i
(
I 44 Enclosure B l
,.rm __,.-,.,%.,.m,.,,.._y-- -v--,_,,-__,_%,3,.-www--+ --..r.,m,.--y --+,+.=+--.-,-,me. - - --e
.-..--,_,-_e _
ys--,...eyrme-=--w,y~_, .,y.--------.-,4w.
l
- 2. Opponents of government intervention in the private sector may c.riticize NRC for essentially establishing a single laboratory for the testing of personnel dosimetry processors (monopoly)
] although there are other precedents, i.e., the EPA labs.
- 3. This' alternative would rr. quire major NRC Regional Inspection I and En'forcement (I&E) eifort in assessing the adequacy of licensee or licensee's contractor dosimetry program by on-site evalua-tion of quality assurance criteria as specified in the regula-tions which would be proposed if this alternative were selected.
Estimates of I&E requirements project 8 staff years /yeai inspection effort.
l
! 4. Long-tern Federal resources would have to be budgeted to sub-sidize the operation of the laboratory in the event that the program -did not become self-supporting. Curront budget plans
! and forecasts do not include funds for this activity. If this
! alternative is selected, it could mean' a delay in the beginning
- of a regulatory program.
3b. Third party accreditation by NVLAP (This technical alternative was described in Section 1.3a of this enclosure. Costs associated with this alternative were analyzed in Section 1.3b of this enclosure. Values and impacts for this alternative were itemized in detail in Sections 1.3.1-1.3.6. Repeating l this material in summary form does not appear to be necessary.) !
- 4. Since many dosimetry processors are not NRC licensees and considering that dosimeters, in themselves, are not radioactive but are passive monitors which measure dose received by the worker, NRC could request from the Congress the authority to license personnel dosimetry processors. If this authority were granted, NRC regulations would be appropriately meended regarding performance testing and quality assurance criteria acceptable to the NRC for licensees to provide adequate dostmetry.
A. Pros:
- 1. .NRC would have direct control over dosimetry processors.
45 Enclosure B
-- . ._ __ . _ _ _ __..__ _ _ _ _ _ - ._1_.____,
- 8. Cons:
- 1. Although NRC can request specific legislation, there are no I guarantees that the legislation wanted would be passed.
i I
- 2. It is unclear how long it would take for Congress to pass new legislation even assuming this option is feasible. Congress would probably not give this legislation much priority. This l alternative does not provide for any measures in the interim. l I
- 3. It is unclear whether the effort is warranted in terms of the benefits received, especially if processors can be controlled l I
through imposing requirements on licensees. i1
- 5. Change in thg regulation to require that licensees obtain their personnel dosimetry services from an NRC-operated or NRC-contracted dosimetry service. MRC would issue, through its laboratory, dosimeters forAll licensee pro-use; the NRC laboratory would perform all dosimetry processing.
cessing would be performed in accordance with an NRC-specified quality assurance program.
A. Pros:
- 1. This alternative would ensure the existence of an uninterrupted regulatory program.
- 2. A government-operated, national dosimetry service would probably be acceptable to the general public as an exercise of NRC's responsibility to ensuring public and worker health and safety.
NRC received two letters of comment supporting this alternative.
- 3. NRC processing of all personnel dosimeters would expedite the~
I investigation and reporting of abnormal occurrences.
- 4. Nationalized dosimetry programs do exist in other countries, e.g., Great Britain and Canada.
46 Enclosure B
- - . . , - + - - . , , , - , - - ..
, -__.._.__._,y _
y .,,g _ , , , . . -y._n , ,c,,- 9 ,,, ,m (_,,,,,_,_.,,,,-y _- ,_ ,,w....,,,.
-._,..,y ,.,w_.,9.,,,g .
B. Cons:
1
- 1. The technical expertise, staff, complete set of radiation r sources, supporting equipment and general facilities to perform dosimetryprocessingarecurrentlynotinexistenceoravail-able' for NRC's use.
- 2. Budget planning and approval of these expanded activities has not been sought and therefore expeditious creation and staffing of such a laboratory would not be possible and would delay the i beginning of the regulatory program.
'i '.
- 3. The NRC has no experience in the operation of such a laboratory f
and therefore no precedent for conducting such activities, j 4. Although-the technical competency of such a laboratory could be verified by NBS, this alternative would probably not be accept-able to dosimetry processors and users since it would put most of them out of business.
- 5. This alternative may not be acceptable to other government agencies which plan to implement simultaneous programs in their respective agencies. Ideally, if government programs are estab-lished in other agencies, the same NRC-operated dosimetry processing service could be used by other government agencies.
A
- 6. This would further extend government activities into the private sector. No comment letters in support of this alterna-tive were received by NRC.
/ 2. 3 Decision on Choice of Technical Alternatives The staff proposes to recommend rule changes that would require that i licensees utilize the services of personnel dosimetry processors accredited by the NBS as competent to perform such technical measurements. The NVLAP alternative, 3B - third party accreditation, has maty advantages not only 47 Enclosure B
for the NRC but also for industry (see Sections.l.3a and 1.3.1-1.3.6 of this enclosure). This alternative is midway between the most stringent regulatory action that could be recommended and no action at all. The NVLAP and DOC staffs have worked with NRC to ensure the development of a LAP for personnel dosim-etry processors within an appropriate time frame. This alternative offers industry more participation in the development of a regulatory program than any of the other alternatives presented. The selection of this alternative would allow the NRC to resolve the problem with minimum staffing and resources
- and would begin a self-supporting program that would test and certify the technical competency of personnel dosimetry processors performing dosimetry services or for NRC licensees. It would also establish minimum uniform quality assurance criter'a for routine and special dosimetry processing.
- 3. PROCEDURAL APPROACH a
Several actions could have been chosen by the Commission for improving the personnel dosimetry problem. These actions included issuing a NUREG staff report, endorsing the ANSI Standard N13.11, issuing a regulatory guide, and by developing and finalizing amendments to the regulations.
- 3.1 Description
\
- 1. Regulation: Improving the personnel dosimetry processor problem by amending the regulations is the preferred alternative. The proposed regulatory program would be achieved by the addition of two rules to 10 CFR Part 20.
- 2. Regulatory Guide: This would have involved preparation of a regula-tory guide on personnel dosimetry processing and elements of an associated quality assurance program.
. 3. ANSI Standard endorsed by a Regulatory Guide: There is an ANSI standard on performance testing of personnel dosimetry processors ANSI N13.11.
A Regulatory Guide could have been written which endorses the ANSI Standard as j minimum acceptable practices acceptajble to NRC.
48 Enclosure B
~' '
L -- -
- 4. NUREG Report: A technical report by NRC staff could have been. written on personnel dosimetry processing in the form of a NUREG Report.
3.2 Value/Imoacts of Procedural Approaches
- 1. Regulatio'n A. Pros:
- 1. The seriousness of the problem justifies development of a regulatory program and the need for mandatory regulations. (Participation in the voluntary testing program administered by the National Sanitation Foundation was less than 10%.)
l
- 2. Regulations uniformly affect all licensees required to provide personnel monitoring. .
- 3. Rulemaking allows maximum industry participation through the Industry Overview Committee, public meetings, and opportunity to comment. -
- 4. NVLAP encourages industry comment to standards writing bodies for the improvement of test methods and quality assurance criteria. It
, also encourages processors to upgrade any deficicncies that might be noted in compliance with NVLAP criteria so they can achieve accreditation.
- 5. Elements of this regulatory program have been carefully examined through the pilot studies, which examined the performance standard, by frequent ;
communications with the dosimetry processing industry, through publi- ;
cation of an Advance Notice of Rulemaking, which indicated our intent to proceed with a regulatory program, and by NRC's participation in several public meetings. -
- 6. By providing a third round of testing, the Government has given pro-cessors multiple opportunities to recognize any deficiencies in their programs and to make corrections before the final rules are implemented. I 49 Enclosure B i
- 3. - _
B. Cons:
- 1. The program will present one more regulation that industry will have to meet.
- 2. The regul*ation will definitely result in financial costs to industry and the publ.ic.
- 2. Preparation of a Regulatory Guide A. Pros:
This alternative wouldi
- 1. Prpvide guidance to processors on the minimum acceptable elements of a dosimetry quality assurance program without mandatory regu ition. ,
B. Cons:
- 1. This alternative would require a substantial staff effort in training and inspection activities to evaluate whether or not a licensee was following the recommendations of the guide.
- 2. Since a guide is not enforceable, its success depends on (a) its incorporation into license conditions or amendments by the two NR'C licensing offices, the Office of Nuclear Materials and Safety Safe-guards and the Office of Nuclear Reactor Regulation and (b) I&E's inspection efforts for evaluating whether license conditions as specified in the guide are being met. ;
- 3. This alternative would not assure that all licensees were treated uniformly or equally.
l
- 4. This alternative would not guarantee a competent NBS-monitored test-ing laboratory.
50 Enclosure B
_ - - - . - _ _ _ _ _ _ _ y - - = . ~ - - - + -.
i
- i. i e
- 3. ANSI Standard Endorsed by a Regulatory Guide.
A. Pros:
1
- 1. There is an ANSI standard on criteria for personnel dosimetry perform-ance testing. NRC could write a companion regulatory guide to endorse the use of this ANSI Standard. There is a precedent for this type of guide on dosimetry in ANSI Standard N545-1975 and Regulatory Guide 4.13. :
- 2. It would require minimum staff effort to develop an endorsing regu-latory guid4.
i 1
- 3. This action would put the standard on the free market system and would allow anyone to develop and set up a testing laboratory.
a
- 4. Historically,-there has been very poor participation of dosimetry processors in voluntary standard programs, as evidenced by the National Sanitation Foundation (NSF) Program (see NUREG/CR-1064).
If the Re'ulatory g Guide was endorsed by NRC licensing offices, licensees would be required by license condition to follow or provide acceptable alternatives to demonstrate successfully meet-ing the requirements of ANSI Standard N13.11 for performance testing.
B. Cons:
- 1. The greatest weakness in this alternative is that this ANSI Standard only discusses performance testing criteria. Without additional guidance on quality assurance in dosimetry processing, the dosimetry problem would not be resolved. This alternative would only solve a
- small piece of this complex problem.
- 2. The effectiveness of this alternative would depend on NRC's licens-ing offices willingness to incorporate the guide into individual l licenses on a case-by-case basis.
51 Enclosure B l
1- -. . . - - - - - - -
9 v.
o
- 4. NUREG Report Written by the NRC Staff on Personnel Dosimetry Processing.
1 A. Pros:
- 1. This alternative would provide guidance to the processor.
B. Cons:
1
- 1. There are insufficient NRC staff resources to write such guidance without use of an assistance contract or outside agency consultants.
Consequently, this could mean a long delay in achieving a partial
~
solution to the problem.
- 2. The effectiveness of this alternative could also depend on NRC's licensing offices endorsement and incorporation into license conditions. .
- 3. Historically, there has been very poor participation of. dosimetry processors in voluntary standard programs, as evidenced by the NSF Program (see NUREG/CR-1064).
3.2 Decision on Procedural Approrch It is believed that amendments to 10 CFR Part 20 would best resolve this problem. The use of any other procedural alternative would not provide a uniform, feasible or workable approach for improving personnel dosimetry
. processing. Since voluntary programs have historically received minimum )
processor participation and demonstrated little improvement in personnel dosim-etry processing, it is the consensus of the NRC staff, the Interagency Policy Committee, and the Industry Overview Committee that a regulatory program is i
needed.
52 Enclosure B
A O.
o,
- 4. STATUTORY CONSIDERATIONS 4.1 NRC Regulatory Authority Applicable Authority:
Under the Atomic Energy Act of 1954, as amended (42 U.S.C. 2011, et seo.)
and section 201 of the Energy Reorganization Act of 1974, as amended (42 U.S.C.
5841), including the rules and regulations issued pursuant to these acts, NRC is authorized to regulate and license the manufacture, production, receipt, acquisition,' delivery, possession, ownership, use, and transfer of byproduct, source and special nuclear material as well as the construction and operation of production and utilization facilities (as these terms are defined in sec-tion 11 of the Atomic Energy Act (42 U.S.C. 2014)). NRC licensees include nuclear power facilities,< research.and development laboratories, universities, hospitals, radiopharmaceutical facilities, as well as industrial and various other miscell-i aneous users of byproduct, source, and special nuclear material. Under 10 CFR Part 20 of its regulations, NRC requires its licensees to have adequate pre-cautionary procedures to protect the health and safety of personnel and the public against radiation hazards arising out of activities under their licenses.
These precautionary procedures include the making of surveys under 10 CFR 120.201
, and the supplying of appropriate and adequate personnel monitoring equipment under 10 CFR 120.202.
4.2 Need for NEPA Statement The proposed action is not a major action as defined in 10 CFR S 51.5, and therefore, does not require an environmental impact statement, assessment, or negative declaration. i l
l
- 5. RELATIONSHIP TO OTHER EXISTING OR PROPOSED REGULATIONS OR POLICIES Associated regulations are found in 10 CFR Part 20 and in 10 CFR Part 34.
Sections 20.4 (c) and (d) define the rem and exposures from x- or gamma-rays up to 3 Mev, and 5 20.401(a) discusses the form on which individual dose 4
53 Enclosure B
. _ _ . _ _ . . . - . _ . _ . _ , _ . - _ . .__._,__._.....__-..-,,,J
t l'.
4 measurement records are maintained. These regulations specifically apply to the theory of dose definition and could constitute unnecessary scientific debate if changed at this time. These sections will be discussed and revised appro-priately in the major revision to Part 20 that is now underway.
I Until the majo'r proposed revision to Part 20 is completed, it is important to place these rules Into the existing Part 20 which should lead to improvements j in accuracy of measurements and quality assurance programs associated with i personnel dosimetry. Any revision to Part 20 should include regulations which would require licensees to obtain dosimetry services from NVLAP accredited processors and to obtain a record of accreditation certificates with indi- i vidual external exposure records for as long as these record are maintained.
Licensees which are required to conduct personnel monitoring in accordance with 134.33 are also under the regulations specified in'10 CFR Part 20. 4 The rules being proposed for addition to 10 CFR Part 20 will also apply to I Part 34 licensees.
- 6.
SUMMARY
AND CONCLUSIONS t
The NRC staff has thoroughly studied the personnel dosimetry processor performance problem. Theproposedregulatoryprogramiskcceptablefromboth technical and procedural aspects. The values and impacts associated with this proposed rulemaking have been carefully examined, and the staff finds that the values outweigh the impacts. Therefore, it is recommended that the proposed
- amendments to Part 20 and the associated Federal Register Notice be published.
j .
4 54 Enclosure B
a INITIAL REGULATORY FLEXIBILITY ANALYSIS These proposed rules would require NRC licensees to have personnel dosimetry processing performe'd by personnel dosimetry processors who have been accredited under the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Bureau of Standards (N85). Currently, NRC licensees are not required to obtain services of accredited processors because such competency require-ments are not included in the regulations or in license conditions. These rulemaking actions are, however, being developed concomitantly with a Labora-tory Accreditation Program (LAP) for Personnel Dosimetry Processors being established by the NBS at the request of the NRC. These rules are intended to improve the accuracy and consistency of occupational radiation dose measure-ments by improving personnel dosimetry processing performed for licensees.
These rules are being proposed under the authority provided by the Atomic Energy Act to establish standards which protect the public health and safety.
4 NVLAP accreditation would be based on three primary elements: (1) pro-ficiency testing of each personnel dosimetry processor in'accordance with ANSI Standard N13.11, Criteria for Testing Personnel Dosimetry Performance, to be administered by a proficiency testing laboratory (PTL) which will be contracted i
by the National Bureau of Standards (NBS), (2) information collected from the personnel dosimetry processor by questionnaire, and (3) on-site assessment of routine dosimetry processing and quality assurance techniques.
Approximately 4,500 NRC licensees are currently required to conduc't personnel monitoring to" measure the amount of radiation occupationally received by workers and to maintain records of these exposures. There are currently 90 known personnel dosimetry processors in the United States who perform personnel dosimetry services in-house or commerically. Eighty of these processors may be considered large entities; they include seven large commercial processors, seven large private corporations, nine national
- laboratories, 31 nuclear power plant licensees, 10 DOE contractors, three large universities, eight military organizations, four state public health departments and one medical facility. These entities do not fall within the definition of "small entities,." as set forth in section 601(3) of the Regulatory Flexibility Act, or within the definition of "small businesses" as i
l 1 Enclosure F
u .__ u . - - _.____c_ _____ _ _ _ _
found in section 3 of the Small Business Act, 15 U.S.C. 632, or the Small Business Size Standards in regulations issued by the Small Business Administra-tion at 13 CFR Part 121. A listing of the 90 known processors is included in a letter from the University of Michigan to the NRC dated July 13, 1981, which l was updated by a November 8,1982 letter in conjunction with a study entitled, l 1
" Performance Testin'g of Personnel Dosimetry Services" performed for the NRC by l the University of Michigan (UM). This letter and study are available for inspec-tion upon request or copy foi a fee at the NRC's Public Document Room,1717 H l Street, Washington, D.C. 20555. The remaining ten known personnel dosimetry ,
processors say, for purposes of this Regulatory Flexibility Analysis, be consid- f ered "small businesses," as defined in section 601(3) of the Regulatory Flexi- !
bility Act. It should be noted that only four of the ten identified "small l business" processors participated in the final performance tests conducted for l f
the NRC by the University of Michigan. !
Compliance Requirements'
~
Each NRC licensee performing personnel monitoring for the whole body or l whole body and skin in accordance with the regulations would be required to !
obtain and maintain a copy of their dosimetry processing service's accredita- f f
tion certificate (s) which will be granted after successful participation in !
the LAP for Personnel Dosimetry Processors at the NBS. Separate accreditation certificates will be granted by NVLAP to processors for services with each type l and model of dosimeter successfully meeting NVLAP criteria for specific radia- l i tion categories. The certificate of accreditation will be valid for a period of 2 years. Licensees would be required to retain a copy of all appropriate !
and current processor accreditation certificates with individual dosimetry l records for as long as the dosimetry records are maintained. The NRC inspector l
> would examine these records during inspection of the licensee to determine I
compliance with $20.201(c) and 520.401(d). The licensee would not be required i to submit a report to the NRC. The estimated burden per NRC licensee for this ,
l recordkeeping requirement is less than half an hour / year. This time estimation is based on the amount of time required by the licensee to telephone or write the processors for copies of accreditation certificates.
2 Enclosure F
I -
\
l Cost of Program to Processors l Processors will incur (1) an initial, one time cost when preparing for proficiency testing and (2) NVLAP accreditation fees every two years which will include NVLAP administrative fees, costs for conducting assessments of a processor's routine dosimetry processing and quality assurance techniques, and proficiency testing' fees.
i Accreditation Costs Accreditation costs incurred every two years by large or small dosimetry processors include NVLAP administrative fees, proficiency testing fees and in-house costs associated with accreditation activities. There is also an addi-tional one-time cost for preparing for the initial round of accreditation which ;
was estimated by the processors to average $7,800 (Table E-1).*
- Table E-1*
Processor Estimates of Initial (One-Time) Potential Preparatory Costs /Proce'sor s for Initial Proficiency Testing Initial, one-time costs to prepare for testing are summarized as follows:
If we assume that the processor is already recording dose as is called for on NRC Form 5, the official form for recording individual worker " Current Occupation External Radiation Exposure," and that labor cost is $30,000/ year with overhead at 100% of labor, then the costs for one person week is equal to:
8
'fekg$1,154perweek.
If a processor spends up to 5 person-weeks reviewing the ANSI standard, reviewing results of previous performance tests, and making corrective actions, the labor costs would total: $5,770 It is possible that a processor may' require external recalibration services (consulting) for some categories at a cost up to: $2,000 The total cost per processor to prepare for proficiency testing is estimated to be: $7,770 "NRC staff believes that the majority of dosimetry processors have already incurred these costs in association with the three rounds of
- performance testing of the ANSI Standard N13.11 by the University of Michigan.
I 3 Enclo'sure F i
Preliminary estimates of the NVLAP administrative fee are approximately
$2,500 every two years. These admin'istrative fees cover the costs NVLAP incurs in administering the LAP, costs associated with the on-site assessment of a processor's routine dosimetry services and quality assurance techniques including labor and per dies costs for the NVLAP assessor (s) incurred in the assessment of each ' applicant dosimetry processor every other year, and costs associated with conducting technical review of PTL by NBS.
The proficiency testing fees will cover costs incurred by a testing laboratory under contract to NBS to conduct proficiency testing of each f applicant processor. Proficiency testing fees charged to the processor will be based on the number and type of categories in which the procauor is tested for each dosimeter model. Proficiency testing will be offered in all eight categories included in the ANSI Standard N13.11. Categories I through V require the use of one radiation source each and Categories VI through VIII use 2 radia-tion sources. In, addition to certain fixed costs, the estimated costs for operating a proficiency-testing (PTL) laboratory are dependent on the number of processors who participate in the program and the number of categories the processors select for testing. These costs will be reflected by the fees charged by the contractor-PTL selected by NBS to perform the proficiency tests.
The figures included below were developed in consultation with Dr. Phillip Plato and Joe Miklos of the University of Michigan (UM) based upon expenses incurred in operating 3 rounds of proficiency testing at the UM. Proficiency testing fees are summarized in Table E-2.
Table E-2 Projected Proficiency Testing Costs for Processors Category Title as Specified in Number of Fee to Test ANSI Standard Sources Required Fee / Category All Categories 1 $260 $1,300 1-5 6-8 2 $520 $1 560 All 8 categories Mixed 1 and 2 (Mixed) $,
During the third round of proficiency tescing at the UM, processors chose to participate in a number of categorier. Processors submitted 86 dosimeter 4 Enclosure F
models for 424 tests in the 8 radiation categories. The smallest number of dosim-eter models submitted by a given processor for testing was 1 dosimeter model for 1 category test. The largest number of dosimeter models submitted for testing by a processor was 6 models for 16 radiation categories. On the average, most pro- ,
cessors submitted 1 model dosimeter for 8 radiation category tests. The average l "small entity" proc *essor who participated in the third round of testing submitted 1 model of dosimeter for testing in 4 radiation categories. Preliminary results j from the third round indicate that average passing rate for processors is 75% of ;
the categories attempted. (Refer to Table E-3 for a projected range of costs for proficiency testing among processors, and to Table E-4 for the range of total estimated accreditation fees / processor.)
Table E-3 Projected Range of Proficiency Testing Costs for Processors
- l Dosimeter Total Costs for !
Models Initial Category . Repeat Category Categories Submitted Tests Requer,ted Tests Requested All Attempted Categories 1-5 Categories 6-8 Categories 1-5 Categories 1-6 Minimum 1 1 0 0 1 $ 260 Maximum 6 10 6 2 1 $6,760 Average 1 5 3 1 1 $3,640 Small Entity 3 1 1 0 $1,560 "Information is based upon processor participation in the third round of proficiency testing conducted at the University of Michigan against the revised ANSI Standard.
i Table E-4 Total Estimated Accreditation Fees for a Processor ;
Administrative Fee Proficiency Testing Fee Total Minimum Fees $2,500 $ 260 52,760 Maximum Fees $2,500 $6,760 59,260 Average Fees $2,500 $3,640 56,140 Small Entity $2,500 $1,560 54,060 Three person-weeks for recalibrations $3,462 Consulting service (irradiations) 1,000 Tital additional in-house costs for processors" that must repeat proficiency testing $4,462 5 Enclosure F
l l
The in-house labor per processor to prepare for normal testing is estimated I at three person-weeks, including overhead and fringe benefits, excluding the first year for which initial costs were already estimated previously. Assuming the same labor costs as previously . listed for initial testing in Table E-1, three person-weeks would cost $3,500.
It is expected'that process 6rs would also incur in-house costs for addi-tional proficiency testing in any categories failed by the processor in initial proficiency testing assuming that they desire to be accredited in that category.
The estimates given in Table E-3 are based on projected processor failing rates as indicated by the third round of testing in the UM study and the assumption I of retest only for those categories failed initially. Costs for proficiency testing in these categories were included previously in Table E-3. These ,
estimates do not include the loss of business to a commercial processor that !
fails one or more categories or fails to become accredited in one or more categories. Many Aetails of the accreditation program are not finalized and any of the cost estimates could change depending on several policy issues currently being evaluated.
Total Estimated Cost of Accreditation Program to Processors -
After the first period of accreditation, the total annual costs incurred by a processor are summarized below, Table E-5:
Table E-5 Total Potential Biennial Costs for a Processor for Accreditation Efforts (Accreditation Costs + In-House Costs)
Total Accreditation Potential Total Biennial Pro-Rated Costs In-liouse Costs Costs Annual Costs Minimum Costs $2,760 $3,462 $ 6,222 $3,111 Maximum Costs $9,260 $7,924 $17,184 $8,592 Average Costs $6,140 $7,924 $14,064 $7,032 Small Entity $4,050 $7,924 $11,784 $5,892 l
Initial, one-time costs for large or small processors to prepare for pro- ;
ficiency testing will be approximately $7,800 (see Table E-1). The estimated l costs to the average processor for continued NVLAP accreditation is approximately l
6 Enclosure F
- r - ---- - - - - _ . - -- - - _ . _ - . . , , _ - _ .
$14,100 every other year or annual costs of approximately $7,000 (see Table E-5).
The estimated costs for the average "small entity" processor is approximately
$11,800 biennially or $5,900 annually. The costs for participating in the accre-ditation program, whether the processors are performing these services in-house or commercially, and regardless of their size, are, for purposes of this Regulatory Flexibility Analysis, approximately the same. (These costs are explained in detail in the Regulatory Analysis, which is available for review at the Commission's Public Document Room, 1717 H Street, Washington, D.C. 20555. The Regulatory Analysis also contains a complete analysis of all technical and procedural alternatives and a statement of statutory considerations.)
The total volume of business within the dosimetry processing industry is estimated at $34 million annually. The ten small personnel dosimetry processors which would be affected by this rule account for approximately 0.5% of the dosimetry processing butiness in the United States. (This volume of business ,
was determined by Dr. Phillip Plato of the UM.) This 0.5% represents a total volume of business of approximately $170,000 annually.' While the NRC does not know the distribution of this volume of business among these dosimetry pro-cessors, an equal distribution of the business would create an average annual business per company of $17,000. Thus, the estimated initial, one-time cost
~
for each of these ten small entities of $7,800 and the estimated and pro-rated annual accreditation fees of approximately $5,900 each for the NVLAP program
' is likely to have a significant economic' impact on small dosimetry processing businesses. i It is important to recognize that all dosimetry processors are not NRC l licensees but that most commercial dosimetry processors do business wif.h NRC licensees. It is further expected that the members of the Interagency Policy Committee on Personnel Dosimetry which include representatives from the j Environmental Protection Agency, the Bureau of Radiological Health (now the ;
National Center for Devices and Radiological Health), the Department of Energy,.the Department of Defense, the Occupational Health and Safety ,
Administration, the National Bureau of Standards, NRC, and the Conference of r
Radiation Control Program Directors, are planning to recommend programs of the :
same nature for their respective agencies. They all consider NRC to be the lead agency in this effort to bring about improved dosimetry in the United l States. !
It is the finding of the Commission in the Initial Regulatory Analysis ,
that the; .cceptable procedure for solving this problem is by rulemaking ;
7 Enclosure F u a ^-^ ** . . . . , ,.- ,-- ,,
~
action and that the particular technical alternative proposed, third party accreditation by the National Voluntary Laboratory Accreditation Program (NVLAP) of the NBS offers equal benefits for small and large processors and will almost certainly guarantee improvements in the quality of reported dose estimates.
It is the NRC's preliminary finding that the benefits from improved dosimetry received by workers', licensees, the NRC, and the general pubife from this proposed regulatory program justify the costs for compliance (as described in the Regulatory Analysis, Enclosure B). The Commission has carefully examined the elements of the proposed LAP and finds that differing compliance and/or reporting requirements for small and large processors, or simplification of the accreditation program, are not acceptable and cannot replace proposed documented tests or other elements of the accreditation program which independently evaluate a processor's ability to perform accurate and consistent personnel dosimetry for NRC licensees. The NBS/NVLAP and NRC staffs have taken several actions to minimize the cost of
- accreditation for all processors, i.e., requiring accreditation biennially j instead of annually, etc. The ultimate effect of a dosimetry processor not gaining accreditation could mean that it would no longer be feasible to remain operable. The accreditation process, however, offers a participating dosimetry processor opportunities for correction of identified inadequacies, for repeat performance testing and appeal of the decision. (It is helpful to remember that few dosimetry processors failed all categories attempted and that the overall passing rate for categories attempted in the third round of testing at the UM was 75L)
The Comission has considered the impact of the NVLAP accreditation program upon the small entities affected, and has concluded that the benefits'that would result from the proposed accreditation requirement and program are necessary
- in spite of the program's possible economic impact upon small entities.
- The Commission specifically invites written comments on the initial regulatory flexibility analysis. Comments should be sent to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, Attention
- Docketing and Service Branch. Comments may also be delivered to Room 1121, 1717 H Street NW., Washington, D.C., between 8:15 a.m. and 5:00 p.m. Copies of all comments received by the Commission regarding this initial regulatory flexibility analysis may be examined in the Commission's Public Document Room at 1717 H Street NW ,
Washington, D.C. 20555.
8 Enclosure F
I USER OFFICE CONCURRENCE
UNITE 80dAWS I
/' %o NUCLEAR RESULATORY COMMISSION d ,I cAssiwoTow.c. c. sossa
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MAR 8 1985 MEMORANDUM FOR: Richard E. Cunningham, Director, FC/NMSS d.
Themis P. Speis, Director, DST /NRR Donald A. Nussbaumer, Assistant Director, SAP /SP James G. Partlow, Director, DDEP/IE FROM: Karl R. Goller, Director DRPES/RES
SUBJECT:
CONTINUATION OF ONG0ING RULEMAKING ACTION SPONSORED BY RES
--10 CFR PART 20: IMPROVED PERSONNEL DOSIMETRY PROCESSING The purpose of this memorandum is to request your concurrence in draft recomendations from the Director, Office of Nuclear Regulatory Research, to the EDO regarding the advisability of continuing in an ongoing rulemaking action.
The draft recomendations are included as Enclosure C in the enclosed Office Review Package. I concur in the recommendations and would like to dispatch the transmittal memorandum (Enclosure G) to the RES Director for his signature within two weeks. Since your office is identified as a user office of the '
subject rulemaking I would like your concurrence in the recommendations before I do this. For your convenience, provision is made below to indicate the position you are taking regarding these recomendations, and for your signature.
The Office Review Package contains several other documents that provide useful infonnation relating to this rulemaking action. Any coments that you would like to provide on these documents would be welcome at this time.
Karl R. Goller, Director Division of Radiation Programs and Earth Sciences, RES
Enclosure:
Office Review Package B Concur without coments.
O Concur with coments provided.
D Major coments provided which must ,
be resolved before I will concur. 1 j51gnature Ri(hard E. Cunningham, Director j Division of Fuel rvela anrf b Title Material Safety '
Enclosure G
e . j r l i
3/26/85 l
2 NRR concurrence in the recommendations to the EDO were obtained by telephone this date. Contacts were E. Branagan, RAB and R. Cleveland, RSCB. Written concurrences are in progress. A draft written concurrence is attached.
4 4
j Enclosure G
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MEMORANDUM FOR: Zditan Rosztoczy, Chief Research and Standards Coordination Branch f Division of Safety Technology, NRR FROM: Frank J. Congel, Chief Radiological Assessment Branch, DSI
SUBJECT:
REVIEW 0F RECOMMENDATIONS ON "lMPROVED PERSONf:EL 00SIMETRY - 10 CFR 20" Per R. Cleveland's request we have reviewed the recommendations regarding an ongoing rulemaking sponsored by the Office of Research.* The rulemaking is concerned with a proposed revision to 10 CFR 20 that would require licensees to use the services of an accredited processor to process all personnel dosimeters (with some exceptions) that are provided to comply with 10 CFR 20. We concur with the Office of Research's recommendation, as described in their draft transmittal memorandum (Enclosure 1), that NRC should proceed with the rulemaking. However, we have some comments on the specific language of the proposed rule (Enclosure 2).
This review was performed by Ed Branagan.
Frank J. Congel, Chief Radiological Assessment Branch Division of Systems Integration
Enclosures:
- 1. RES's draft memorandum
- 2. Comments on the proposed rule cc: P,. Bernero D. Muller
- 0. Lynch R. Cleveland D. Nellis The incoming memorandum was from K. R. Goller to T. P. Speis, dtd March 8, 1985.
l
a astog'o UNITED STATES g
$[p g NUCLEAR REGULATORY COMMISSION WASWNCTON, D. C. 20655 t j
't.,...../ IAAR 8 1985 r,
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Richard E. Cunningham, Director, FC/NMSS MEMORANDUM FOR: ,
Themis P. Speis, Director, DST /NRR Donald A. Nussbaumer, Assistant Director, SAP /SP %
James G. Partlow, Director, DDEP/IE a FROM:
Karl R. Goller, Director. DRPES/RES
[
SUBJECT:
CONTINUATION OF ONGOING RULEMAKING ACTION SPONSO
--10 CFR PART 20: IMPROVED PERSONNEL 00SIMETRY PROCESSING The purpose of this memorandum is to request your concur the ED0 regarding the advisability of continuing in an ongoing rulemaking i action. !
The draft recomendations are included I concur in the recomendations andas Enclosure would C in the enclosed like to dispatch Review Package.
the transmittal memorandum (Enclosure G) to the RES Director for his signature within two weeks.
Since your office is identified as a user office of the subject rulemaking I would like your concurrence in the recomendations before I do this. For your convenience, provision is made below to indicate the position you are taking regarding these recomendations, and for your signatur0.
The Office Review Package contains several Anyother documents coments that provide usefu that you would information relating to this rulemaking action.
like to provide on these documents would be welcome at this time.
d #b Karl R. Goller, Director Division of Radiation Programs and Earth Sciences, RES
Enclosure:
Office Review Package Concur without coments.
O Concur with comments provided.
O Major comments provided which must be resolved before I will concur.
] d b, Avww i R",' L w va a n -g , /
' Title Enclosure G 3/2&/7
W as
/ o UNITED 5TATES NUCLEAR REGULATORY COMMISSION fM C.
P o WASHINGTON, D. C. 20555 i
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- t bfd ;
k..... 8 1985 f !
MAR No 2 l I
MEMORANDUM FOR: Richard E. Cunningham, Director, FC/NMSS 1 Themis P. Speis, Director, DST /NRR Donald A. Nussbaumer, Assistant Director, SAP /SP James G. Partlow, Director, DDEP/IE 4',,
FROM:
Karl R. Goller, Director, DRPES/RES
SUBJECT:
CONTINUATION OF ONGOING RULEMAKING ACTION SPONSORED BY RES
--10 CFR PART 20: IMPROVED PERSONNEL DOSIMETRY PROCESSING The purpose of this memorandum is to request your concurrence in draft recomendations from the Director, Office of Nuclear Regulatory Research, to the EDO regarding the advisability of continuing in an ongoing rulemaking action.
The draft recomendations are recomendations I concur in the included as Enclosureand would C in the like toenclosed dispatch Office Review Package.
tne transmittal memorandun-(Enclosure G) to the RES Director for his signature within two weeks. Since your office is identified as a user office of the subject rulemaking I would like your concurrence in the recommendations before I do this. For your convenience, provision is made below to indicate the position you are taking regarding these recomendations, and for your signature.
The Office Review Package contains several'other documents that provide useful information relating to this rulemaking action. Any coments that you would like to provide on these documents would be welcome at this time.
d Karl R. Goller, Director Division of Radiation Programs and Earth Sciences, RES
Enclosure:
Office Review Package 7-- .
O Concur without coments.
g Concur with comments provided. .(See attached) [, \ '
D Major comments provided which must be resolved before I will concur.
(;~ 3 lil /
Signature James G. Partlow Title Director, Division of Inspection Programs Enclosure G Office of Inspection and Enforcement
xv--- , - - _ _ , _ _ _ _ _ _ _ _.
b l
l l
Date: March 14,1985 1
1 l
IE/DI Comment on Ongoing Rulemaking Action Sponsored by RES - 10 CFR Part 20: l I
I Improved Personnel Dosimetry Processing The following comment was previously provided orally to M. Federline/RES.
l In the proposed new paragraph (c) of section 20.202, the words " extremity j j
dosimeters" should be changed to " dosimeters for the hands and forearms, feet and ankles." -
The tenn " extremity" is not defined in 10 CFR Part 20 and there has been considerable confusion over its meaning.
Contact:
John Buchanan /IE 49-29657
.,. I V ,' . j, 1
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1
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