ML20204B449
| ML20204B449 | |
| Person / Time | |
|---|---|
| Issue date: | 02/09/1987 |
| From: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| To: | |
| References | |
| FRN-49FR1205, RULE-PR-20 PR-870209, NUDOCS 8703250059 | |
| Download: ML20204B449 (18) | |
Text
'
000Gt %UMR
- aanpaarn BULE [7590-01]
(49 FA //f)
US#PM@
NUCLEAR REGL*LATORY COMMISSION
'67 FE910 P2 :59 10 CFR Part 20 Improved Personnel Dosimetry Processing AGENCY: Nuclear Regulatory Commission.
ACTION: Final rule.
SUMMARY
- The Nuclear Regulatory Commission (HRC) is amending its regula-tions to require all licensees to have personnel dosimetry devices that are utilized to comply with NRC regulations processed by processors that j have been accredited by the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Bureau of Standards (NBS). This action was initiated because performance evaluations of personnel desinetry pro-cessors indicated that a significant percentage of such processors were not performing with a reasonable degree of accuracy. These amendrents will result in greater uniformity and accuracy in personnel dosimetry.
EFFECTIVE DATE: February 12, 1988 FOR FURTHER INFORMATION CONTACT: Donald O. Nellis, Division of Regulatory Applications, Office of Nuclear Regulatory Research, U.S.
Nuclear Regulatory Commission, Washington, DC 20555, Telephone: ( 30^,)
443-7989. Inquiries regarding the accreditation program for personnel dosimeters at the National Bureau of Standards should be addressed to Robert L. Gladhill, National Voluntary Laboratory Accreditation Program 0ll 6'QJJa, flb d' S
. 8703250059 870209 r 2 49 1205 PDR J
[7590-01]
(NVLAP),NationalBureauofStandards,AdministrationA-531, Gaithersburg, MD 20899, telephone: (301) 921-3431.
SUPPLEMENTARY INFORMATION:
I. BACKGROUND 4
Personnel dosimeters are oevices worn by workers to monitor their exposure to radiation. NRC licensees are required to provide such mont-toring devices to certain individuals as specified-in 10 CFR 20.202(a) and other applicable provisions of 10 CFR Chapter I. ;
Among the types of monitoring equipment in use are dosimeters such l as film badges, track-etch-type dosimeters, thernoluminescent dosimeters f (TLD's), and direct and indirect reading pocket ionization chambers.
All of these, with the exception of the pocket ionization chambers, require t
processing in order to determine the radiation dose by observing a particular radiation-induced effect in the dosimeter. These dosimeters must be processed accurately and consistently and interpreted correctly to ensure the accuracy and integrity of worker dose records, to ensure that the NRC regulatory dose limits of 10 CFR 20.101 are not exceeded and to ensure that dosimetry is provided in accordance with 10 CFR 20.202(a). It is imperative, therefore, that the personnel dosimetry r
processing industry conform to performance standards that will ensure accuracy and uniformity of results.
4 Dosimetry Processor Performance Studies Problems in the personnel dosimetry processing industry have been apparent for many years. The commercial processing business has always been highly competitive, with competent and conscientious processors 1
.e_,. , _ _..-.
-[7590-01]
competing with processors that are unable or unwilling to perform this work in a technically sound manner. Customers of comercial processors, however, have often lacked expertise in dosimetry processing and often contracted their processing needs to the lowest bidder, so that the more qualified processors may have had to reduce the quality of their services in order to remain competitive.
Some problems became apparent chortly after the Atomic Energy Act of 1954 authorized the commercial application of nuclear technology when the first intercomparison of film badge interpretations was conducted by N8S in 1955 under an Atomic Energy Comission (AEC) contract. In 1963, the AEC published a notice in the Federal Register (28 FR 9411) outlining the need for a Film Dosimetry Calibration Laboratory and provided some interim film dosimetry performance criteria. Subsequently, several studies attempted to evaluate processor performance, but no nethod of comparing actual performance with the interim performance criteria was ever established. Consequently, the AEC requested in 1967 that Battelle Northwest Laboratory, now called Pacific Northwest Laboratory, conduct a study to determine a basis for film dosimeter performance criteria.1 Although the study revealed that about 85% of the participating pro-cessors had excessive bias and variance, and although the study defined certain performance criteria, no definite standard was promulgated at l
that time. During the next few years, four separate standards were i developed, and the NRC in 1976 contracted with Battelle to conduct a l
study to compare and evaluate dosimetry processors against the four IM. Unruh et al., "The Establishment and Utilization of Film Dosim-eter Performance Criteria," BNWL-542(1967) Richland, Washington, 99352.
l 3
. _ _ - _. _ _ . T__ _ . _ . . - _
[7590-01]
existing standards.2 Most dosimetry processors did not fare well against any of the standards. The study recomended adoption of the draft standard being developed by the Health Physics Society Standards Committee (HPSSC). (This standard was published as a draft in 1978.)
In 1976, at the urging of the Conference of Radiation Control Program Directors (CRCPD) (representing the "'ites), the NRC, the Bureau of Radiological Health, and the Energy Researco and Development Agency jointly conducted a public, meeting to discuss personnel dosimetry problems. As a result of the recommendations made at this meeting, the NRC contracted with the University of Michigan to conduct two rounds (1977-1979) of proficiency testing of dosimetry processors against the draft HPSSC standard. Fifty-nine personnel dosimetry processors voluntarily participated in these tests. Results of the tests showed that the standard should be modified. (It was modified in June 1981 and was published as ANSI N13.11 in 1983.) The results also showed that a significant percentage of the processors were not performing to the degree of accuracy acceptable to the NRC, which indicated, in turn, that records and reportt af worker whole body and skin dose could be It became apparent considerably different from the actual dose received.
' to the NRC that the performance and competency of dosimetry processors had to be evaluated on a periodic basis and that rulemaking was reeded to ensure this periodic evaluation.
2 L. L. Nichols, "A Test of the Performance of Personnel Dosimeters,"
BMWL-2159(1977) Battelle Northwest Laboratories, Richland, Washington, 99352.
4
[7590-01]
Coordination Effort Cooperation and coordination with other interested organizations were initiated in 1977 with the formation of the Interagency Policy Comittee on Personnel Dosimetry, which included the Departnent of Defense, the Department of Energy, the Environmental Protection Agency, the NBS, the Occupational Safety and Health Administration of the Department of Labor, the Center for Devices and Radiological Fealth of the Food and Drug Administration of the Department of Health and Human Services, the CRCPD, ano the NRC. Cooperation and coordinaticn with the dosimetry processing industry were also enhanced in 1977 with the formation of the Industry Overview Comittee on Personnel Dosimetry to monitor the progress and development of the evaluation program and to ensure that any regulatory action taken would be appropriate and effective.
Advance Notice of Proposed Rulemaking On March 28, 1980, the NRC took the initial step in the rulemaking i
process with the publication in the Federal Register of an Advance Notice of Proposed Rulemaking (ANPRM) (45 FR 20493). The ANPRM discussed the results of the proficiency testing against the HPSSC standard and the need for rulemaking to improve dosimetry processing. It presented four alternatives for the operation of a proficiency testing laboratory that The ANPRM would conduct performance testing against the HPSSC standard.
specified that any proficiency testing laboratory established would be f monitored for technical competency by the NBS and that licensees would be required to use dosimetry servicas that satisfied criteria established by HRC and administered by the proficiency testing laboratory. The four 5
,. - _ . . - ~ . . . _ . . _ . . ,
[7590-01) alternatives for proficiency testing laboratory operations as describ2d i
in the ANPRM were:
- 1. Processors and licensees would establish one or more laboratories to administer proficiency testing against the HPSSC standard.
- 2. The proficiency testing laboratory would be a Federal Government l
facility managed and operated by the NRC.
- 3. The NRC would contract the services of a proficiency testing laboratory.
- 4. Another Federal agency experienced in laboratory testing would operate the proficiency testing laboratory.
1 Analysis of Coment Letters Forty-six coment letters were received in response to the ANPRM.
Twenty-one did not state a preference for which alternative should be used in establishing a proficiency testing laboratory and three felt ro Of the remaining 22, 20 proficiency testing program was necessary.
expressed a preference for laboratories controlled by the Federal govern-ment (alternatives 2, 3, or 4). Comenters also inquired and comented on control of the testing laboratory, on procedures to be used in the regulatory program, and on various other problems that could result from a processor failing to satisfy the established criteria. Several dis-cussed the importance of defining and requiring minimum elements of a generic quality assurance program that should be established as part of the dosimetry processing performance criteria. The major technical questions raised were those concerning the selection of dose conversion factors within the standard. Several of the comenting dosimetry pro-6
[7590-01]
cessors also requested a third round of performance testing to allow pro-cessors to be tested against the revised HPSSC standard before any rulemaking on dosimetry processing became effective.
National Voluntary Laboratory Accreditation Program (NVLAP) Alternative During the coment period for the ANPRM, a fifth alternative for the operation of a proficiency testing laboratory that would utilize the NVLAP of the NBS was identified by the Interagency Policy Comittee.
NBS, in accordance with NVLAP procedures specified in 15 CFR Part 7, would contract the services of a proficiency testing laboratory to admin-ister proficiency testing of dosimetry processors against a performance standard specified by the NRC (in this case ANSI N13.11).
The process of accreditation according to NVLAP procedures would require three separate actions: (1) completion of a NVLAP questiornaire and other application materials that involve documentation of responsible personnel, equipment, facilities and quality control procedures; (2) successful performance in dosimetry proficiency testing in accordance with ANSI N13.11, " Criteria for Testing Personnel Dosimetry Performance";
and (3) onsite inspection by NVLAP assessors of the processor's routine dosimetry service with respect to processing protocols and associated minimum quality assurance criteria specified in NVLAP general and specific criteria and supplied to the processor upon application for the program. NVLAP would thus offer a system of third-party accreditation by a Federal Government agency, namely, the Department of Comerce (DOC) operating through the NBS. In addition, the pass-fail criterion for 7
[7590-01]
accreditation ensures that the mean of the reported doses will be within 50% of the actual dose at the 95% confidence level, and that at leasi 90% of the individual reported doses will be within : 95% of the actual dose at the 95% confidence level.
In December 1980, the NRC asked the DOC to establish, in coordin-ation with NRC staff, an accreditation program under NVLAP for personnel dosimetry processors. In accordance with NVLAP procedures end authority (l'. CFR Part 7), the DOC published NRC's request (46 FR 9689) for development of such a Laboratory Accreditation Program (LAP) on January 29, 1981 and requested public coment. NRC sent a copy of the DOC Federal Register Notice and a description of the NVLAP to all known dosimetry processors and interested persons on February 6,1981. All 19 letters of comment received were unanimous in their approval of the NVLAP alternative. Consequently the NVLAP dosinetry LAP was started ir 1981 under an Interagency Agreement between NRC and NBS, and a proficiency testing laboratory was contracted by the NBS. Proficiency testing and NVLAP accreditation of processors began in January 1984.
Additional Performance Testing Since the original HFSSC standard was significantly revised follow-ing the two pilot tests, the NRC staff sponsored a third round of per-formance testino acainst ANSI N13.11, which was completed in 1983.3 3
Plato, P. and J. Miklos, " Performance Testing of Personrel Dosimetry Services: Final Report of Test #3," NUREG/CR 2891, February 1983.
l I
8 ON
[7590-01]
Seventy personnel dosimetry processors voluntarily participated in this round. The standard provides a total of eight radiation categories in-volving high-energy and low-energy photons, beta particles, neutrons, and mixtures of these. The procedure was for the processor to send 15 dosimeters for each test category in which it wished to be tested to the testing laboratory. These dosimeters were then irradiated with doses NBS known only to the testing laboratory and returned to the processor.
had the responsibility of verifying the accuracy of the irradiations performed by the testing laboratory. The processor then determined the dose for each dosimeter and reported the results back to the testing laboratory for evaluation against the standard. The testing laboratory evaluated the processor's performance in accordance with the performance criterion specified in ANSI N13.11. Of the category tests attempted, an average of 25% failed. This compares to failure rates of 52% for the first test and 38% for the second, as measured against the final standard.
Although the identity and individual results of the dosimeter test data were confidential to the proficiency testing laboratory, the con-tractorreportedthatthecategoriesfailedinthisthirDroundoftest-ing were evenly distributed among large and small commercial and in-house processors. In light of the results from the three pilot tests, the NRC I concluded that improvement on the part of most dosimetry processors was needed and that the regulations should be amended not only to provide for periodic evaluation but also to include checks of a processor's quality assurance program to improve the quality of personnel dosimetry processing.
9
. . . = -=
[7590-01]
II. PROPOSED RULE In view of the coments receiveo in response to the ANPRM and the ;
unanimous approval of the NVLAP alternative, the NPC published on January 10, 1984, a Notice of Proposed Rulemaking (NPRM) (49 FR 1205) that would require NRC licensees to use the services of dosimetry processors that have been ucredited by the NVLAP of NBS. Five alternatives were considered in drafting the NPRM, and an analysis of each of these is included in the Regulatory Analysis, which is available for inspection and copying for a fee at the NRC Public Document Room located at 1717 H Street NW., Washington, DC.
' III.
SUMMARY
OF PUBLIC COMMENTS The NRC received 96 coment letters on the proposed rule, some of which were duplicates, leaving a net of 93 letters, many of which
- contained more than one coment.
All of the public coments have been considered, and the staff res- i ponses to these coments are set forth in the Analysis of Comments i
document which is available for review and copying for a fee at the NRC 4
Public Document Room located at 1717 H Street NW., Washington, DC.
Forty commenters approved of the proposed rule outright, 20 comenters approved of the rule but identified suggested changes or additions, and 6 comenters approved of that part of the rule requiring 4
I 4
accreditation of processors but were opposed to requiring the licensee to retain NVLAP certification records. (This requirement has been deleted from the final rule.) Nineteen comenters were opposed to the proposed 10
, - . . - , - - - - - - . . , - . . - . - - , , , . - , , m - , . , , , - , , , - , , . , . , . - , , - - , - - - , , , , . , , _ . , . - , _ _ , _ _ - . . , , _ , - , . - - , _ _ , . . , - , - , , - . _ , . , , , , . - -
[7590-01]
rule, primarily because of the cost .and arother eight commenters provided miscellaneous coments on the rule.
A repeated coment in opposition to the rule from medical and These )
hospital licensees appears to be the result of a misunderstanding. l comenters stated that the imposition of the accreditation requirement would force them, on the basis of cost, to terminate their in-house monitoring services, which now provide supplementary or redundant do-simeters to personnel that have their primary dosimeters processed by a commercial processor, and to terminate dosimetry services not required by 10CFR20.202(a). Other commenters stated that a differential fee j structure is needed to provide relief to small processors, that the onsite assessment should be waived for snall processors as a means of reducing costs, and that the proposed section 20.202(c)(2) should be clarified by issuance of a Regulatory Guide to assist licensees to determine in which radiation categories they should be accredited.
In regard to the suggestion that onsite assessment be waived for small processors, accreditation in the testing program under appropriate categories, as emphasized in the proposed new 5 20.202(c)(2), does not in itself ensure that the processor applies the same care and attention to routine dosimetry processing as it does to test dosimeters. The onsite visits conducted by NVLAP assessors are not only a part of the mechanism for detecting sources of variability under the control of the processor, i
they also serve to check on the quality assurance program of the processor as it applies to routine dosimetry and ensure that equivalent care is given both to routine dosimetry processing and to test dosimetry processing. It is for these reasons that the onsite visits cannot be waived for the small or in-house processors.
11
~
-[7590-01]
Turning to the major coment fren r:edical and hospital licensees, it is not the intent of the NRC to discourage voluntary dosimetry or redundant dosimetry that is provided in addition to the required dosimetry. The subject regulation will not require the services of an accredited. personnel dosimetry processor for such voluntary or redundant cosimeters. It should be noted that there are also other methods of dose assessment such as surveys, time and motion studies, or use of pocket ionization chambers that do not require processing, all of which are outside the scope of this rule.
Licensees who do not make a determination as to which personnel re-quire personnel monitoring to comply with 10 CFR 20.202(a) will be required to use an accredited personnel dosimetry processor for all dosimeters that need processing. Also, licensees who use dosineters to determine whether dosimetry is routinely required under 10 CFR 20.202(a) or other relevant NRC regulations will be required to use the services of an accredited processor for those test '.e (meters. Those licensees that have made a commitment in their license application to provide personrel dosimetry to personnel for whom it is not required (under 10 CFR 20.202(a) or other applicable regulations) may apply for a license amendment to delete this requirement from the license before the effective date of the rule. Nothing in this regulation precludes a licensee from providing voluntary dosimetry services whether such The Comission, dosimetry utilizes accredited processing or not.
however, encourages the use of accredited processing for voluntary dosimetry in order to provide the desired accuracy and reliability for After the effective date of the rule, dosimetry i all dose records.
required by license conditions (which may reference commitments made in 12 1
[7590-01]
license applications) must be provided by an accredited dosimetry processor.
With respect to clarifications that would enable licensees to deter-mine which radiation categories apply to their operations, it should be pointed out that.it has always been the responsibility of the licensee to
- provide appropriate and properly calibrated personnel monitoring devices.
The rule to require NVLAP accreditation does not alter this responsibility. In view of the comments received, however, the NRC plans to issue supplementary information to help licensees to determine appropriate testing categories for their specific operations.
It is recognized that even the minimum fees charged by NVLAP can se-NRC has no authority to riously affect small dosimetry processors.
impose a differential fee structure since NES sets the NVLAP 4
accreditation fees. These processors should be aware that grants may be available from the Small Business Administration to assist small i
businesses in paying these fees. Also, licensees who believe that they should be exempted from the requirements of this rule may apply for an exemption in accordance with 10 CFR 20.501.
A number of NRC licensees have expressed concern that, should their personnel dosimetry processor lose accreditation, they could be in non-compliance with the new regulation. The NRC believes, however, that few, if any, dosiretry processors will lose their accreditatfor >.nd tnat ac-NVLAP creditation loss would be a relatively lengthy process.
accreditation is given for a two-year period; a processor would have ample warning during the retesting and renewal process that accreditation criteria were not being met. It would be prc:'ent for licensees to 13 .
[7590-01]
negotiate with their processors agreements which require current information regarding the reaccreditation process.
The NVLAP testing and accreditation progran has been in operation for more than two years, and on the basis of this operating experience it has been found that a minimum of about six months is required for
-processors to receive accreditation. Since some processors fail the first round of testing, an additional three months may be necessary. On this basis, the Commission has determined that an effective date of one year after publication of this rule in effective form would be reasonable.
ENVIRONMENTAL IMPACT: CATEGORICAL EXCLUSION The NRC has determined that this final rule is the type of action described in categorical exclusion 10 CFR 51.22(c)(3). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this final rule.
PAPERWORK REDUCTION ACT STATEMENT This final rule does not contain any new or anended information col-lection requirements subject to the Paperwork Reduction Act of 1980 (44U.S.C.3501etseq.). Existing requirements were approved by the Office of Management and Budget approval number 3150-0014.
14
(7590-01]
REGULATORY ANALYSIS The Commission has prepared a regulatory analysis on this final rule. The analysis examines the costs and benefits of the alternatives considered by the Commission. The analysis is available for inspection and copying at the NRC Public Document Room,1717 H Street NW.,
~
Washington, DC. Single copies of the analysis may be obtained from Donald O. Nellis, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Mail Stop NL-007, Washington, DC 20555, Telephone:
4 (301) 443-7989.
REGULATORY FLEXIBILITY ANALYSIS The NRC has prepared a final regulatory flexibility analysis on the i mpact of this rule on small entities as required by Section 604 of'the Regulatory Flexibility Act. The analysis indicates that although the final rule could have an economic impact of $7,000 initially, and from
$3,000 to $8,400 annually on each personnel dosimetry processor, of which about 10 are small entities, the selected alternative is the least costly alternative that provides adequate dosimetry processing for licensees and workers. A copy of the final regulatory flexibility analysis is available for inspection and copying at the NRC Public Document Room, 1717 H Street NW., Washington, DC. Single copies may be obtained from Donald O. Nellis, Office of Nuclear Regulatory Research, U.S. Nucl, ear Regulatory Commission, Mail Stop HL-007, Washington, DC 20555, Telephone:
(301)443-7989.
15
, - - - . - , -c+.ww-m--m,- q ,, y , . - - - - - . + - . .,v. , vg e*,=---p --gwy y--e rwy 7 -mv g,w-, , -r,- -w. p---*-
[7590-01]
BACKFIT ANALYSIS 1
a
.As required by 10 CFR 50.109 (50 FR 38097), the Commission has prepared a backfit analysis for the final rule. The Commission has determined, based on this analysis, that backfitt ng i to compl y with the requirements of this final rule is justified. A copy of the backfit analysis is available for inspection and copying at the NRC Public Document Room located at 1717 H Street NW., Washington, DC. Single copies may be obtained from Donald O. Nellis, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Mail Stop NL-007, Washington,DC20555, Telephone (301)443-7989.
4 LIST OF SUBJECTS IN 10 CFR PART 20 Byproduct material, Licensed material, Nuclear materials, Nuclear power plants and reactors, Occupational safety and. health, Packaging and containers, Penalty, Radiation protection, Reporting and recordkeeping requirements, Special nuclear material, Source material, and Waste treatment and disposal.
For reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 553, the NRC is adopting the following amendments to 10 CFR Part 20.
16
'< [7590-01]
PART 20 - STANDARDS FOR PROTECTION AGAINST RADIATION
- 1. The authority citation for Part 20 is revised to read as follows:
Authority: Sees. 53, 63, 65, 81,103,104,161, 68 Stat. 930, 933, 935, 936, 937, 948, as amended (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C.
2273); il 20.101, 20.102, 20.103(a), (b), and (f), 20.104(a) and (b),
20.105(b),20.106(a),20.201,20.202(a),20.205,20.207,20.301,20.303, l 20.304, and 20.305 are issued under sec.161b, 68 Stat. 948, as amended ,
I (42U.S.C.2201(b));andil 20.102,20.103(e),20.401-20.407,20.408(b),
and 20.409 are issued under sec. 161(o), 68 Stat. 950, as amended
_(42U.S.C.2201(o)).
t
- 2. In i 20.3, a new definition is added to read as follows:
{ 20.3 Definitions.
(a) As used in this part:
J-(20) "Dosinetry processor" means an individual or an organization that processes and evaluates personnel monitoring equipment in order to determine the radiation dose delivered to the equipment.
- 3. In i 20.202, a new paragraph (c) is added to read as follows:
I i 20.202 Personnel monitoring.
17
-+.r-+ ,.,--,-----,,w-- + w , .. - - , - . -, - -,-, - - , , ---,.m.-- +-m--. ., , -v- r,-,,- --,,,- --
[7590-01]
f (c) All personnel dosimeters (except for direct and indirect reading pocket ionization chambers and those dosimeters used to measure the dose to hands and forearms, feet and ankles) that require processing to determine the radiation dose and that are utilized by licensees to comply with paragraph (a) of this section, with other applicable provisions of 10 CFR Chapter I, or with conditions specified in a licensee's license must be processed and evaluated by a dosimetry processor:
(1) Holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Bureau of Standards, and (2) Approved in this accreditation process for the type of radiation or radiations included in the NVLAP program that most closely approximate the type of radiation or radiations for which the individual wearing the dosimeter is monitored.
Dated at Washington, DC, this bdayofheb ,1987.
For the Nuclear Regulatory Commission.
sN [0 m Samuel J. Cni Secretary of he Connission}.
l i
l l
I l
18 t