ML20209B861
Text
/ 19'- L 'o, UNITED STATES p I ~4 NUCLEAR REGULATORY COMMISSION d ,I WASHINGTON, D. C. 20566
- s...../
MEMORANDUM FOR: d E. Cunningham, Director 2_EC/NMDSS Themis P. dpels, virector, S000/NRR Donald A. Nussbaumer, Assistant Director, SAP /SP James G. Partlow, Director, DDEP/IE FROM: Karl R. Goller, Director, DRPES/RES
SUBJECT:
DRAFT ANNUAL RECOMMENDATIONS TO ED0 CONCERNING WHETHER TO CONTINUE WITH ONG0ING RULEMAKING SPONSORED BY RES Enclosed for your consideration is a draft anr.ual recommendation supported by a draft annual office review concerning whether to continue with the ongoing rulemaking, " Improved Personnel Dosimetry Processing - 10 CFR Part 20", sponsored by RES for which your office is identified as a user office. This memorandum constitutes my concurrence in the enclosed draft annual recomendation. I plan to dispatch this memorandum with the enclosed draft annual recommendation to the Chairman, RIRB, two weeks from the above date. Please acknowledge receipt by returning this memorandum with or without comments on the draft annual recommendation as indicated below. Karl R. Goller, Director Division of Radiation Programs and Earth Sciences, RES
Enclosures:
1. Draft Annual Recommendation 2. Draft Annual Office Review J Receipt acknowledged. No comment. Receipt acknowledged. Comments as follows: kn S Gl(lq Signature DJ /2,fA4 G A YNJS/S y Title g g fj 8704280529 870422 49 1205 PDR YlG'f2705b
ALs. o,, UNITED STATES 8 NUCLEAR REGULATORY COMMISSION 8/I; o B ,I wasmNGTON, D. C. 20555
- s.,...../
m MEMORANDUM FOR: Richard E. Cunningham, Director, FC/NMSS T emis Pj.pais,-Dkectui,5000/NRR nard'A. Nussbaumer, Assistant Director, SAP /SP ames 6. PartiMirectnr; nnrpnr FROM: Karl R. Goller, Director, DRPES/RES
SUBJECT:
DRAFT ANNUAL RECOMMENDATIONS TO EDO CONCERNING WHETHER TO CONTINUE WITH ONG0ING RULEMAKING SPONSORED BY RES Enclosed for your consideration is a draft annual recommendation supported by a draft annual office review concerning whether to continue with the ongoing rulemaking, " Improved Personnel Dosimetry Processing - 10 CFR Part 20", sponsored by RES for which your office is identified as a user office. This memorandum constitutes my concurrence in the enclosed draft annual recommendation. I plan to dispatch this memorandum with the enclosed draft annual recommendation to the Chairman, RIRB, two weeks from the above date. Please acknowledge receipt by returning this memorandum with or without coments on the draft annual recommendation as indicated below. Karl R. Goller, Director Division of Radiation Programs and Earth Sciences, RES
Enclosures:
1. Draft Annual Reco= endation 2. Draft Annual Office Review g Receipt acknowledged. No comment. Receipt acknowledged. Comments as follows: wJA
- hN n Signature Alh $
Nl Tftlev ~ &ase.ef ^;7 - O WiM4
/ UNITED STATES 8 o,'r. NUCLEAR REGULATORY COMMISSION h WASHINGYON, D. C. 20555 8 ...../ N MEMORANDUM FOR: Richard E. Cunningham, Director, FC/NMSS Themis P. Speis, Director, S0D0/NRR onaldJ._Russbaumer,_Assistat Director, SAP /SP ~Ja~Eies G. Partlow, Director, CDEPTI Q FROM: Karl R. Goller, Director, DRPES/RES
SUBJECT:
DRAFT ANNUAL RECOMMENDATIONS TO ED0 CONCERNING WHETHER TO CONTINUE WITH ONG0ING RULEMAKING SPONSORED BY RES E,nclosed for your consideration is a draft annual recommendation supported by a draft annual office review concerning whether to coritinue with the ongoing rulemaking, "imnmved Personnel Dnsimetry Processinc - 10 CFR Part 20". sponsored by RES for which your office is identifiec as a user ottice. This memorandum constitutes my concurrence in the encloseo draft annual recommendation. I plan to dispatch this memorandum with the enclosed draft annual recommendation to the Chairman, RIRB, two weeks from the above date. Please acknowledge receipt by returning this memorandum with or without comments on the draft annual recommendation as indicated below. Karl R. Goller, Director Division of Radiation Programs and Earth Sciences, RES
Enclosures:
I 1. Draft Annual Recommendation 2. Draft Annual Office Review Receipt acknowledged. No comment. Receipt acknowledged. Comments as follows: Wa Signature iD 5b d[ Title / / I i
\\- / 'o UNITED STATES g NUCLEAR REGULATORY COMMISSION o .B ,I wAsmNGTON, D. C. 20555
- s...../
MEMORANDUM FOR: Victor Stello, Jr. Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
CONTROL 0F NRC RULEMAKING: ANNUAL RES REVIEW 0F ONGOING RES-SPONSORED RULEMAKING Based on our annual review of ongoing RES-sponsored rulemaking, " Improved. Personnel Dosimetry Processing,10 CFR Part 20", RES recomends that this rulemaking be continued. This recomendation in draft form has been coordinated with the user offices (NMSS, NRR, SP and IE). The basis for our recomendation is as follows: A RES review of this ongoing rulemaking was approved by the EDO on July 24, 1985, based in part on the following facts. Most dosimetry processors have difficulty in the measurement of low doses of radiation, particularly if the measurements are made in mixed radiation fields. A 1984 personnel dosimetry intercomparison. study at ORNL showed that almost one half of all dosimeters tested did not meet regulatory guidelines for accuracy and some readings differed from the true dose by more than a factor of 20. Most discrepancies in dosimetry occur as a result of non-standard procedures, geometry, sources and readout practices. Inaccuracies in personnel dosimetry processing could result in overexposures, particularly to the fetus in the case of pregnant radiation workers. Since the last RES review of this rulemaking the following has occurred: An analysis of the coments received on the proposed rule has been completed. The analysis revealed that a majority of the comenters are in favor of the rule.
2 Of the 90 known personnel dosimetry processors, 54 have voluntarily applied for accreditation and 45 of these have already been accredited. Since the proposed rule was published in 1984 the Commission promulgated the Backfit Rule, (10 CFR 50.109). Because this rulemaking is subject to the backfit rule, a backfit analysis has been prepared which concludes that the rule would provide a substantial increase in the overall protection of the public health and safety and that the direct and indirect costs of implementation are justified in view of this increased protection. A Commission package which includes the final rule has been prepared and it is presently in the office concurrence chain. The independent review of this rulemaking indicated that nothing that has occurred in the past year that would alter the previous decision to continue the rulemaking. Additional reasons for continuing are: considerable effort has been expended on the rule in the past year and a final rule package for the Commission is now in the office concurrence chain, and comments received on the proposed rule were generally in favor of promulgating such a rule, and failure to promulgate this rule could result in the 45 dosimetry processors who are now accredited under NVLAP abandoning the accreditation program in order to compete economically with other less qualified processors, with a concomitant deterioration of the quality and accuracy of dosimetry processing. The schedule for publication of the rule has slipped, primarily because of the numerous division review comments that had to be resolved and the need to complete a backfit analysis. The new target date for submission to the E00 is July 31, 1986. The complete annual 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 - - ~ ~ -e-,-, m --e,--, ,m-,-,- , -,,-, --,,, --,,,,q -,m r ,-g---.-p w--
4 "[ hf DRAFT ANNUAL RES RECOMMENDATIONS TO THE EDO IMPROVED PERSONNEL DOSIMETRY PROCESSING (10 CFR PART 20) The current ongoing rulemaking will require NRC licensees that supply personnel dosimeters to persons in order to comply with 10 CFR 20.202(a), to have the personnel dosimeters processed by a processor which has been accredited under the National Voluntary Laboratory Accreditation Program, operated by the National Bureau of Standards A review of the ongoing rule was completed one year ago and approval to continue with the rulemaking was signed by the ED0 on July 24, 1985. Some of the arguments presented at that time to justify continuation of the rulemaking were: Most dosimetry processors have difficulty in the measurement of low doses of radiation, particularly if the measurements are made in mixed radiation fields. A 1984 personnel dosimetry intercomparison study at ORNL showed that almost one half of all dosimeters tested did not meet regulatory guidelines for accuracy and some readings differed from the true dose by more than a factor of 20. Most discrepancies in dosimetry occur as a result of non-standard procedures, geometry, sources and readout practices. Inaccuracies in personnel dosimetry processing could result in l overexposures, particularly to the fetus in the case of pregnant radiation workers. Since the RES review was completed one year ago, the following has occurred: i An analysis of the coments received on the proposed rule has been completed. The analysis revealed that a majority of the comenters are in favor of the rule. l Of the 90 known personnel dosimetry processors, 54 have voluntarily applied for accreditation and 45 of these have already been accredited. i Since the proposed rule was published in 1984 the Comission promulgated the Backfit Rule, (10 CFR 50.109). Because this rulemaking is subject to the backfit rule, a backfit analysis has been prepared which concludes that the rule provides a significant improvement in safety. A Comission package which includes the final rule has been prepared and it is presently in the office concurrence chain. An independent review of this rulemaking indicates that_nothing has occurred in the past year that would alter the previous decision to continue the rulemaking. Additional reasons for continuing with the rulemaking are, first, l l 1
i i i h fr i that a considerable effort has been expended in the past year and a final rule package for the Comission is now in the office concurrence chain, and second, failure to promulgate this rule could result in the 45 dosimetry processors who are now accredited under NVLAP abandoning the accreditation program in order to compete economically with other less qualified processors. l l i i l 2 l l
i DRAFT ANNUAL OFFICE REVIEW A Federal Register Notice ) ) Office Screening B Regulatory Analysis ) C NRC Regulatory Agenda Update D Assessment of Compliance E Backfit Analysis / l l l l I l l ENCLOSURE 2 l t -
P TITLE: + Improved Personnel Dosimeter Processing CFR CITATION: 10 CFR 20 ABSTRACT: The notice of proposed rulemaking seeks comment 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 requiring proficiency tests of dosimetry processors who perform dosimetry for NRC licensees. The proposed amendments would require NRC licensees to have personnel dosimeters (devices carried or worn by each radiation worker to measure radiation exposure received during work) processed by a dosimetry service that is accredited by NBS/NVLAP. The Commission 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 laboratory; requiring licensees to participate in performance testing conducted by an NRC-specified testing laboratory; a request from Congres.s for the. authority for NRC to license personnel dosimetry processors directly; and requiring licensees to obtain dosimetry services from an 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 S717,000. This would result in an estimated net annual increase in the cost of providing monitoring for each worker per year of S0.51, a 2.1% annual increase. The major benefit of the proposed rule would be increased accuracy and reliability of dose measurement to workers in licensed installations. Other benefits include continued assurance of personnel dosimeter processor competence with minimal NRC staff and resource allocation; formulation of a program that can easily be utilized by other agencies; value to the industrial licensee through legal credibility of a nationally-recognized accreditation program; and value to the worker through more accurate assignment of dose.. Final rulemaking is presently undergoing review prior to publication. Enclosure C --.-e. - ~-. --
4 TITLE: Improved Personnel Dosimeter Processing + TIMETABLE: ANPRM 03/28/80 45 FR 20493 ANPRM Comment Period Begin 05/12/80 45 FR 31118 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 RULE FOR DIVISION REVIEW 11/12/85 OFFICE CONCURRENCE ON FINAL RULE COMPLETED 04/15/86 FINAL RULE TO EDO 05/07/86 FINAL RULE PUBLISHED 06/30/86 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: Don Nellis Nuclear Regulatory Commission Office of Nuclear Regulatory Research Washington, DC 20555 301 427-4588 The rule is not on schedule and the above schedule is not likely to be met. Reasons for slippage include numerous division review comments that had to be resobed and the recent requirement for inclusion of a backfit analysis along with the rulemaking package. The following target date is based on an estim-ated turn-around time for Office Review of 2 weeks, revisions 1 week, CRGR and ACRS reviews of 2 weeks and ED0 concurrence of 1 week. FINAL RULE TO COMMISSION 7/31/86 l l
Assessment of Compliance by RES 1 With Procedures and Guidance for Rulemaking 10 CFR Part 20 l 1 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 have been developed through association with the Interagency Policy Committee on Personnel Dosimetry (IPCPD). The Final Regulatory Flexibility Analysis discusses the project range of accreditation fees for processors and the effect of the rule on small processors. A Backfit Analysis has been provided to comply with the recent Backfit Rule (10 CFR.50.109). To the best of our knowledge this rulemaking is in compliance with NRC procedures and guidance for rulemaking. Enclosure D
-s ) v BACKFIT ANALYSIS The NRC "backfit rule" (10 CFR 50.109) states: "Backfitting is defined as the modification of..., or procedures or organization required to design, construct or operate a facility; any of which may result from a new or amended provision in the Commission rules...." Since the rule requiring accreditation of dosim-etry processors represents a modification of procedures required in the opera-tion of a facility, it is subject to a systematic and documented analysis in conformance with S 50.109(c). The following represents a systematic and documented analysis according to the nine-factor outline considered in S 50.109(c). 1. Statement of the Specific Objectives to be Achieved The principal objective of the rule is to improve the accuracy of dosimetry processing by imposing a uniform set of procedures and performance standards on the personnel dosimetry processors, including those of nuclear utilities. All licensees will be required to obtain accreditation from the National Voluntary Laboratory Accreditation Program operated by NBS if they do their own process-ing in-house. Otherwise they will be required to use commercial processors who are accredited by NVLAP. The use of standard tests and quality control progre:s for calibration and readout procedures will ensure that all occupationally exposed workers will have their personnel dosimeters evaluated against an accept-able national standard, regardless of which processor does the work. The prin-cipal health and safety benefit that results from imposition of this rule is the increased credibility of the recorded and reported occupational dose, allow-ing the NRC, the employer, and employee to better assess and control the radia-tion hazards of the workplace. 1 Enclosure E
~ to e 2. General Description of the Activity to be Required of the Licensee or Applicant The licensee or applicant will be required to have its dosimetry processing activity accredited by NVLAP. If this activity takes place in-house, the li-censee or applicant would be required to develop an in-house quality assurance program, submit certain dosimeters to a proficiency testing laboratory (PTL) for testing, and agree to periodic inspections by NVLAP personnel. It should be noted that the in-house quality assurance program is now required under Appendix B to Part 50 and does not constitute an additional requirement. 3. Potential Change in the Risk to the Public from the Accidental Off-Site Release of Radioactive Material The dosimetry accreditation rule will have no effect on accidental off-site releases. 4. Potential Impact on Radiological Exposure of Facility Employees The dosimetry accreditation rule is expected to provide a more accurate assess-ment of individual worker radiation exposure. It will therefore result in increased safety by ensuring that those individuals whose doses are now being underestimated, will not be overexposed as a result of poor quality dosimetry processing. In addition the improved accuracy of measurements is expected to result in improved controls and in benefits under the ALARA concept. l 5. Installation and Continuing Costs, Including the Cost of Facility Downtime ( or the Cost of Construction Delays The cost of installing the required quality control system is estimated at approximately $7,000, but, since Appendix B to Part 50 requires a quality con- [ trol system, there should be little or no cost involved among licensees in com-pliance in adapting the existing system to meet NVLAP requirements. The cost of proficiency testing depends upon the number of dosimeter types used and the number of categories for which each dosimeter must be tested. For a single dosimeter tested for all eight categories in the national standard ANSI N13.11, 2 Enclosure E I
4 O the cost is $10,250 biennially. No other costs are anticipated. No facility downtime or construction delays will occur as a result of the requirements specified in this rule. 6. The Potential Safety Impact of Changes in Plant or Operational Complexity, Including Relationships to Proposed and Existing Regulatory Requirements The dosimetry accreditation rule will not require changes in plant design or operational complexity except that NVLAP procedures may require a larger area than is currently being used for dosimeter calibrations in order to reduce radiation scattering and other such effects. No other changes are anticipated and no potential safety impact is expected. 7. The Estimated Resource Burden on the NRC and the Availability of Such Resources Possible costs to the NRC are those associated with revision of the Office of Inspection and Enforcement inspection procedures to prevent duplication of in-spection in ti;ose areas where NVLAP inspections occur. Since the net effect should be a reduction in required NRC inspection time, no significant costs are anticipated. One other anticipated cost is the development of a Regulatory Guide to assist licensees to establish the required test categories for their operations. This Regulatory Guide will require an estimated 0.3 staff years. No technical support effort is anticipated. 8. The Potential Impact of Differences in Facility Type, Design, or Age on the Relevancy and Practicality of the Proposed Action The dosimetry accreditation rule is concerned with operating procedures so that differences in type, design, or age would not contribute any additional impact. 9. Whether the Proposed Backfit is Interim or Final and, if Interim, the Justification for Imposing the Proposed Backfit on an Interim Basis The backfit is intended as final. 1 3 Enclosure E i A
m
== Conclusion:== If one assumes that about one quarter, or 300 of the 1200 individuals badged at a typical nuclear reactor site have their dosimeters underestimated by a factor of 3 (a factor found to apply to most dosimetry processors in the early round of proficiency testing), and if the average recorded individual annual dose is 0.7 rem, then these 300 individuals have probably been exposed to an additional unrecorded 1.4 rem each. Adoption of the dosimetry accreditation rule would prevent this additional exposure of 420 person-rem annually, and thereby provide a substantial increase in the overall protection of the public health and safety. At an estimated cost of $1,000 per person-rem, this results in a saving of some $420,000 annually. The direct and indirect costs of imple-mentation, which average some $5,000 annually to the reactor facility are' there-fore justified in view of the increased protection provided. An additional benefit of the NVLAP program to nuclear power plant operations has been described by the American Nuclear Insurers in their Information Bulletin 85-1A. This bulletin points out that although the principal benefit of the NVLAP program is greater worker protection, the accreditation will lead to better claim defensibility because of the reduced uncertainty and increased objectivity of dosimetry methods in the event that dosimetry measurements are used in radiation claims litigation. 4 Enclosure E .. -.}}