ML20034D222
| ML20034D222 | |
| Person / Time | |
|---|---|
| Issue date: | 11/13/1991 |
| From: | Harold Denton NRC OFFICE OF GOVERNMENTAL & PUBLIC AFFAIRS (GPA) |
| To: | Heltemes C NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20034D215 | List:
|
| References | |
| FRN-57FR56287, RULE-PR-31, RULE-PR-32 AD82-1-012, AD82-1-12, AD82-1-7, NUDOCS 9112300108 | |
| Download: ML20034D222 (38) | |
Text
{{#Wiki_filter:.. 'i a-l W j 4 UNITED STATES E k NUCLEAR REGULATORY COMMISSION '[ j. WASHINGTON. D. C. 20555 i k ) 8 .....f November 13, 1991 l t i MEMORANDUM FOR: Clemens J. Heltemes Jr., Deputy Director i' for Generic Issues.and Rulemaking, RES t Harold R. Denton, Directorj[ FROM: Office of Governmental and Public Affairs
SUBJECT:
COMMISSION PAPER ON RULEMAKING CONCERNING THE ACCESSIBLE AIR GAP FOR GENERALLY LICENSED DEVICES t We.have received the draft Commission Paper on proposed rulemaking concerning [ accessible air gaps in generally licensed devices. The paper does not include a discussion of the participation of the Agreement States in the development of the proposed rule nor does it discuss the compatibility aspects of the proposed rule. Rulemakings proposed by NRC that potentially affect Agreement State regulatory programs are to include early State participation and Commission Papers are to include staff recommendations concerning compatibility. The subject proposed rulemaking will affect Agreement State programs.since they,' too, license the manufacture and distribution' of generally licensed devices. Although this particular rule is beyond early involvement by the l' States, however, we still plan to excerpt the draft rule from the Paper and distribute it to the Agreement States for review and comment as we do with other proposed NRC rulemakings affecting Agreement' State programs. We will l indicate to the States that we propose the proposed rule be considered a i Division 11 item of compatibility except those parts which are technical specifications, e.g. the maximum size of the airgap.and permitted radiation.'No levels which would be Division I. f comment. After taking into account additional time needed for reproduction t and mailing, I suggest January 2,1992 as the target for formally transmitting- [. to you the Agreement State comments and SP views. cc: DRathbun, CA } HThompson, ED0 f ~. 7, hhwo(OS 1 A it /
s A C)22-1 O O PPR ga "%g UNITED STATES fg NUCLEAR REGULATORY COMMISSION g( p, WASHING TON, D. C. 20$55 ,.,j j r,. %* G 4} November 13, 1991 ..o. MEMORANDUM FOR: Clemens J. Heltemes Jr., Deputy Director for Generic Issues.and Rulemaking, RES Harold R. Denton, Directorj[- ,{ FROM: Office of Governmental and Public Affairs
SUBJECT:
COMMISSION PAPER ON RULEMAKING CONCERNING THE ACCESSIBLE AIR GAP FOR GENERALLY LICENSED DEVICES We.have received the draft Commission Paper on proposed rulemaking concerning accessible air gaps in generally licensed devices. The paper does not include a discussion of the participation of the Agreement States in the development of the proposed rule nor does it discuss the compatibility aspects of the proposed rule. Rulemakings proposed by NRC that potentially affect Agreement State regulatory programs are to include early State participation and Commission Papers are to include staff recommendations concerning compatibility. The subject proposed rulemaking will affect Agreement State programs since they, too, license the manufacture and distribution of generally licensed devices. Although this particular rule is beyond early involvement by the States, however, we still plan to excerpt the draft rule from the Paper and 3 distribute it to the Agreement States for review and comment as we do with other proposed NRC rulemakings affecting Agreement State programs. We will indicate to the States that we propose the proposed rule be considered a Division II item of compatibility except those parts which are technical specifications, e.g. the maximum size of the airgap and permitted radiation g levels which would be Division I. Normally, we allow ine States 45 days for t comment. After taking into account additional time needed for reproduction and mailing, I suggest January 2,1992 as the target for formally transmitting i to you the Agreement State comments and SP views. cc: DRathbun, CA HThompson, EDO
r O O For: The Commissioners from: James H. Taylor Executive Director for Operations Subiect. PROPOSED AMENDMENTS TO 10 CFR PARTS 31 AND 32 CONCERNING THE ACCESSIBLE AIR GAP FOR GENERALLY-LICENSED DEVICES
Purpose:
To obtain Comission approval to publish a proposed rule that would revise 10 CFR Parts 31 and 32 to restrict the accessible air gap for generally-licensed devices in order to control radiation exposures of individuals. Cateoory: This paper covers a routine matter requiring Commission consideration. Summary: The staff seeks to reduce the frequency and likelihood of unnecessary radiation exposure from generally-licensed gauges. The staff proposes that this be accomplished by improving control over certain gauges that have both an accessible air gap and radiation level that exceed specified values. Under the provisions of the proposed rule, distributors of these devices would be prohibited'from transferring them to general licensees and general licensees would no longer be permitted to possess these devices. General licensees who currently possess these devices would have two options:
- 1) to obtain a specific license for the device and to establish a radiation safety program that, among other things, could include lock-out prbcedures, or 2) have the device physically modified to eliminate the accessible air gap and avoid obtaining a specific license.
Resources to conduct the rulemaking are included in the FY 1992-1996 Five-Year Plan (FYP). The staff estimates that 3.2 FTE would be required each year for 3 years to implement the rule, specifically to process the new applications and CONTACT: Donald R. Hopkins, RES 492-3784
p w The Comissioners 2 l a inspect those licensees who do not physically modify their. gauges. These resources are not. included in the FYP, but based on the current rulemaking schedule, the final rule will { not be issued untii FY 1993. This resource requirement will l be addressed during the next update of the Five-Year Plan. Backaround: On February 12, 1959 (24 FR 1089), The' Atomic Energy i Comission amended its regulations to provide a general i license for the use of byproduct material contained in certain luminous, measuring, gauging, and controlling a devices. The devices were designed with inherent radiation safety features so that, when installed by the distributor, they could be used by persons with little or no radiation training, experience, or equipment. This simplified the licensing process so that a case-by-case determination of the adequacy of training, experience, and radiation safety program was not necessary. In May 1990, the staff identified to the Comission certain applications involving generally-licensed devices that need i greater regulatory control (SECY-90-175). These devices are gama gauges that, of necessity, are configured with an air j gap large enough that a worker.could place his or her body i directly in the radiation beam. This could subject workers to unnecessary radiation. The staff proposed to initiate a-1 rule change to restrict'the air gap in generally-licensed devices. The Comission concurred with this recomendation and by SRM dated August 13,1990 (Enclosure A) directed the staff to proceed with the rulemaking. This rulemaking i package, including a Notice of Proposed Rulemaking (Enclosure i B), has been developed in response.to that SRM. j i Discussion: There are approximately 35,000 general licensees who possess an estimated 600,000 devices containing byproduct material ( regulated under 10 CFR Parts 31 and 32. From this group there are approximately 52,000 gauges in use.by 13,000 i general licensees. The staff has identified approximately 3,000 gama gauges from this group that may need to be better { controlled through specific licensing because of inherent radiation levels and large accessible air gaps..These gauges are sometimes mounted ' o that it is possible for a worker to s place his or her body directly in the-radiation beam. This e occurs because the gauge must have ?ome' air gap in order to measure the product as it passes through the radiation beam. 1 Although a small air gap presents little health and safety concern, a large air gap may subject improperly-trained workers to unnecessary radiation exposure. Hence, the staff is proposing to restrict possession of certain gauges with accessible air gaps to specific licensees because, as a condition of the license, specific licensees must have t i
f (vl &w The Commissioners 3 radiation safety programs that will protect individuals from unnecessary exposure to radiation. The size of the " accessible air gap" addressed by this proposed rule is a gap of 18 inches or greater between the radiation source and detector which would allow insertion of a 12 inch diameter sphere into the radiation beam of the device without the removal of a barrier. The specification is a reasonable limit to restrict access of a person's torso. An air gap which is longer than 18 inches between the source and detector but is enclosed by a wire mesh enclosure or a chemical tank with a metal lid would not be considered under this proposed rule because a 12 inch diameter sphere could not be placed in the radiation beam without the removal of a barrier. The magnitude of the radiation level of concern which would be addressed by this proposed rule is 125 millirem per hour at 18 inches from the radiation source with any shutter in the open position. This radiation level specification is based on the scenario of a worker receiving less than I hour of direct exposure in a calendar quarter at a distance of 18 inches from the radiation source as a result of normal operations and maintenance. This would result in a quarterly exposure of less than 125 millirem. This corresponds to the dose restriction for general licensees in NRC regulations [10 CFR 32.51(a)(2)(ii)]. The 18 inch specification corresponds to a guideline (Inspection Manual, Section: 10 CFR Interpretations, p. 20.203-1) set forth for NRC inspectors that a radiation level must extend 18 inches into an accessible area for it to cause whole body radiation doses. While this guideline would allow part of an individual's body to be exposed to a higher radiation level than that specified while it is within the 18 inch distance and closer to the source of the radiation, practical considerations dictate that a person would not be situated in the radiation beam next to the radiation source for long periods of time. A more likely scenario is where a worker is cleaning a vat in which a radiation source and detector are installed on opposite walls, such that the worker is out of the radiation beam most;of the time and is in the beam close to the radiation source for only short periods of time. In order to reduce the frequency and likelihood of unnecessary radiation exposure from these gauges, the staff is recommending the following approach. First, restrict distribution of this type of gauge to specific licensees. Second, require general licensees who currently possess these gauges to become specific licensees and thus require these licensees to establish radiation safety programs to assure
O O I The Commissione.rs 4 that only individuals who are properly trained are permitted access to those gauges. These general licensees would have the option of having the gauges physically modified to eliminate the " accessible air gap", and hence not be required to obtain a specific license. (This physical modification, as with all installation and servicing of the gauge, must be performed by a person authorized to perform the activities by a specific license.) If no general licensees choose the physical modification approach to solving this problem, the staff would expect approximately 525 applications for new licenses and 225 applications for amendments to existing licenses over a 3-year period. i Resources: Under the proposed amendments [l 31.5(e)], general licensees i who possess gauges with accessible air gaps and radi.ation levels in excess of specified values and are not able to have the gauges physically maodified to eliminate the accessible airgaps will be required to submit an application for a specific license. The staff estimates that of the 750 general licensees who now possess such gauges, 225 already possess a specific license. For these licensees, bringing the possession of these gauges under the provisions of their specific licenses would be done by license amendment. The remaining 525 general licensees would be required to apply for a specific license (unless they modify their gauges). The staff estimates approximately 1.5 FTEs would be needed each year for 3 years to review the applications for new and l amended licenses, assuming no licensee chooses to modify his or her gauge. Additionally, inspection resources would be needed for the 525 new licenses issued. The staff estimates that approximately 1.7 FTEs would be needed each year for 3 i years to inspect these new licensees. These resources are not included in the FY 1992-1996 FYP, but based on the current rulemaking schedule, the final rule will not be issued until FY 1993. This resource requirement will be l addressed during the next update of the Five-Year Plan. Resources to conduct the rulemaking are inclu'ded in the FYP. j The potential economic impacts on licensees are explored in the regulatory analysis (Enclosure C). Significant economic impacts on licensees are expected to be rare because of the alternatives available. Specifically, licensees may make the air gap of the gauge inaccessible by any number of means such as building an enclosure, locking the area where the air gap exists, or by interlocks where no one can enter the area while the radiation source is in the exposed position. The costs of making the air gap inaccessible are explored in the regulatory analysis (Enclosure C) and found to be relatively low, averaging about $1700 for a facility containing four of
O O l i t The Commissioners 5 these gauges. Specific licensees would be subject to a license application fee of $500, a renewal fee (each 5 years) of $500, infrequent inspection lees of $1200, and $1500 in annual fees. Enforcement: The staff proposes that the Enforcement Policy be modified to. t address violations of this rule as part of the final rulemaking. The policy would be simplified to provide fixed penalties with only the factor of identification (Section l V.B.I. of 10 CFR Part 2, Appendix C) considered in the ~ assessment process. Enforcement conferences would not normally be held. The base penalty would be established at i $1000 per source in violation 'of the rule to provide an incentive to comply with it. This should be a relatively l simple process to implement given the type of violations i involved and therefore should not require an increase in enforcement resources. The enforcement policy changes are described in the Statement of Considerations in the Federal Reaister notice. Coordination: The Office of the General Counsel has no legal objection. 1 Recommendation: That the Commission: 1. Approve the flotice of Proposed Rulemaking (Enclosure B) for publication. 2. Certify that this rule, if promulgated, will not have a significant economic impact on a substantial number e of small entities in order to satisfy requirements of i the Regulatory Flexibility Act, 5 U.S.C. 605(b). This certification is included in the enclosed Federal Reaister notice. 3. tiote: l l a. The rulemaking would be published in the Federal Reaister for a 120-day comment period; b. A draft regulatory analysis will be available in the Public Document Room (Enclosure C); c. A draft environmental assessment and a finding of no significant impact have been prepared (Enclosure D); i I
. _g. I )_ 4.u_:_..-.._._. g7_ f ()' e a The-Commiss'ioners 6 l 1 1 d. The Chief Counsel for Advocacy of. the Small Business Administration will-be informed of the: certification regarding economic 11mpact on small entities and the reasons for.it-as required by. ' the Regulatory Flexibility Act; ? e. The proposed rule contains information collection requirements that are' subject to .j review by OMB. Upon Commission ' approval. formal. request fo_r OMB review and clearance will be. initiated; f. .The appropriate congressional committees will be. informed (Enclosure E); g. A public announcement will be issued-(Enclosure F), h. Copies of the Federal Reaister notice of proposed rulemaking will be distributed Eto all -l NRC distributors of 5 31.5' generally-licensed j devices, and to all corresponding general - licensees of record;, and _. i.. ' If the rule ch~anges proposed ~ in SECY-91-275 are-made final prior to those proposed'inLthis paper, adjustments to:the. text will' be necessaryj to merge the two revisions. + i f ] -j ~N 1li 4 li 'l t i
o O i i The Commissioners 7 Schedulino: If scheduled on the Commission agenda, recommend this paper i be considered at an open meeting. No specific circumstance is known to staff which would require Commission action by any particular date in the near terni. James M. Taylor Executive Director for Operations
Enclosures:
A. Staff Requirements Memorandum Dated August 13, 1990 B. Federal Reaister Notice of l Proposed Rulemaking C. Draft Regulatory Analysis D. Draft Environmental Assessment E. Draft Congressional Letter F. Draft Public Announcement a l i h i i i i 4
.~.- .~ The Commissioners ,7 Schedulino: If scheduled on the Commission agenda,. recommend this paper be considered at an open meeting. No specific circumstance is known to staff which would require Commission action by any particular date in the near term. I James M. Taylor Executive Director for Operations l
Enclosures:
A. Staff Requirements Memorandum Dated August 13, 1990 B. Federal Reaister Notice of Proposed Rulemaking C. Draft Regulatory Analysis D. Draft Environmental Assessment r 5 E. Draft Congressional Letter F. Draft Public Announcement l i I l h i ~ i
- SEE PREV 100 ibR C
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- CHeltemes EBeckjord j
Date: 8/12/91 8/12/91 8/12/91 10/17/91 10/22/91 10/23/91 11/g7/91 Offc: D:ADM D:0E D:NMSS D:SP GC:0GC EDO Hame: *PNorry
- JLieberman *RBernero CKammerer
- WParler JMTaylor i
Date: 11/04/91 11/20/91 11/19/91 11/ /91 11/25/91 11/ /91 0FFICIAL RECORD COPY i l
2t O O The Commissic 6 i d. The proposed rule contains inf rmation collection requirements that re subject to review by OMB. Upon Commis on approval, formal request for OMB review and learance will be initiated; e. The appropriate congress nal committees will be informed (Enclosure D); f. A public announcement 11 be issued (Enclosure E); g. Copies of the Federa Reaister notice of proposed rulemakinghill be distributed to all NRC distributors o'f 6 31.5 generally-licensed devices, and to a i corresponding general licensees of rec d; and h. If the rule cha es proposed in SECY-91,275 are made final pri to those proposed in this paper, adjust nts to the text will be necessary to merge the wo revisions. Coordination: The Office of the Genera Counsel has no legal objection. [ Schedulina: If scheduled on the to ission agenda, recommend this paper be considered at an o en meeting. No spcific circumstance is known to staff wh'ch would require Comission action by any particular date 'n the near term. James M. Taylor Executive Director for Operations
Enclosures:
A. Staff Requirements Memoran m Dated August 13, 1990 B. Federal Reaister Notice Proposed Rulemaking C. Draft Regulatory Analys s D. Draft Congressional Le ter E. Draft Public Announce ent F. Draft Environmental sessment
- SEE PREVIOUS' CONCURRENCE Offc:
RDB:DRA:RES RDB:DRA:R RDB:DRA:RES DD:DRA:RES D:DRA:RES DD:GIR:RES D:RES Name:
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/91 10/17/91 10/22/91 10/23/91 11/ /91 Offc: D:ADM D: CM NMSS)- D:SP Ni C EDO Name: PNorry JLieberman RBernero CKammerer-WParler JMTaylor Date: 11/04/91 11/p/91 II/A/91 11/ /91 11/25/91 11/ /91 0FFICIAL RECORD COPY
9-9 The Commissioners 6 C_gordination: The Office of Governmental and Public Affairs concurs with the contents of this paper. The Office of the General Counsel has no legal objection. Schedulino: If scheduled on the Commission agenda, recommend this paper be considered at an open meeting. No specific circumstance is known to staff which would require Commission action by any particular date in the near term. James M. Taylor Executive Director for Operations
Enclosures:
A. Staff Requirements Memorandum Dated August 13, 1990 B. Federal Reaister Notice of Proposed Rulemaking C. Draft Regulatory Analysis D. Draft Congressional Letter E. Draft Public Announcement WParler, OGC JTaylor, ED0 HDenton, GPA RBernero, HMSS JLieberman, OE PNorry, ADM EBeckjord CHeltemes BMorris FCostanzi SBahadur MFleishman DHopkins
- SEE PREVIOUS CONCURRENCE n
D:DRA:RES[D REpD:RES Offc: RDB:DRA:RES RDB:
- RES RDB:DRA:RES DD:DRA:RES Name: *DHopkins:lc *MFleishman *SBahadur
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emes EBeckjord Date: 8/12/91 8/12/91 B/12/91 10/17/91 10/P/91 10 /91 10/ /91 Offe: D:ADM D:0E D:NMSS D:GPA EDO GC:0GC Name: PNorry JLieberman RBernero HDenton JTaylor WParler Date: 10/ /91 10/ /91 10/ /91 10/ /91 10/ /91 10/ /91 0FFICIAL RECORD COPY
. _.. _. ~. _. ~. The Commissioners 6 / request for OMB review and clearance will be' iisitiated; e. The appropriate congressional committees will be 4 informed (Enclosure / / f. A public ann uncement will be issued / (,9 closure / c L4 / g. Copier of the Federal Realiter notice of proposed rulemaking wilVbe distributed to all NRC distributors of l 31.5 generally-licensed j devices, and to all, corresponding general licensees of record 1 and / h. If the rule chan'ges proposed in SECY-91-275 are made final prfor to those proposed in this paper, adjustments to the text will be necessary to merge tfie two revisions. / Coordination: The Office of Goverdmental and Public Affairs concurs with the contents of this paper. The Offie.e of the General Counsel has no)fgal objection. / Schedulino: If scheduled /on the Commission agenda, recommend this paper s be consider d at an open meeting. No specific circumstance is known,to staff which would require Commission action by any papticular date in the near term. / James M. Taylor Executive Director for Operations
Enclosures:
A. Staff Requirements Memorandum Dated August 13, 1990 B. Fede/al Reaister Notice of P,roposed Rulemaking C. Draft. Regulatory Analysis D., Draft Regulatory tiU1de,' Task FC 404:4 ' 'E Draft Congressional Letter p,,Fi Draft Public Announcement i
- SEE PREVIOUS
- )eURRENCE Offc/RDB
- DRA:RES*RDB:DRA:RES*RDB:DRA:RES*DW RES D:DRA:RES DD/GIR:RES D:RES Name: DHopkins:lc MFleishman SBahadur FCostanzi BMorris CHeltemes EBeckjord Dite: 8/12/91 8/12/91 8/12/91 10// 7/91 10/ /91 10/ /91 10/ /91 Offc: D:ADM D:0E DNMSS D:GPA EDO GC:0GC Hame:
PNorry JLieberman RBernero HDenton JTaylor WParler Date: 10/ /91 10/ /91~ 10/ /91 10/ /91 10/ /91 10/ /91 0FFICIAL RECORD COPY
O O, i f .1 The Comissioners _ 8 j e Distribution {AIRGAP2.CP] Subj: circ:chron Reading File /Bahadur j JMTaylor, EDO r WParler, OGC CKammerer, SP RBernero, NMSS JLieberman, OE l PNorry, ADM EBeckjord t CHeltemes BMorris i FCostanzi MF1eishman DHopkins s I l i h 1 1 b 4 4 4 + 0 4
O O e h The Commissioners 9 00C. FILE NAME: AIRGAP2.CP LONG DISPLAY: COMN LTR/ACCESSBL AIR GAP CREATED: S AUTHOR: D. HOPKINS REVISED: 7/22/91 7/30/91 8/12/91 08/22/91 08/26/91 TYPIST: LCrossland MMcGill LCrossland STaylor LCrossland TIME: 2:25 p.m. 4:45 p.m. 7:30 a.m. 9:00 a.m. 11:35 a.m. ~ 08/26/91 8/27,29 08/30/91 09/03/91 09/19/91 09/26/91 STaylor LCrossland S. Taylor S. Taylor S. Taylor S. Taylor 4:45 p.m. 4:15 p.m. 12:45 p.m. 11:20 a.m. 12:45 p.m. 4:30 p.m.' 10/04/91 10/10,17,21,22/91 11/15,18,20,21,22, 25,26/91 S. Taylor LCrossland LCrossland MFleishman 10:40 a.m. 11:10 am 10:05 am 9:31 am EXCERPT: 1 For: The Commissioners From: James M. Taylor, Executive Director for Operations Subiect: PROPOSED AMENDMENTS T0 10 CFR PARTS 31 AND 32 CONCERNING THE ACCESSIBLE AIR GAP FOR GENERALLY-LICENSED DEVICES L
L.. o O. ENCLOSURE A STAFF REQUIREMENTS MEMORANDUM DATED AUGUST 13, 1990 Y r 1 1 2 5 + f
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Blaha CFF8CE OF THE Jordan, AE0D SECRET ARY Scroggins, OC SBacgett, NM55 MEMORANDUM FOR: James M. Taylor SMoore, ilMS'; Executive Director for O 5 ions ) Samuel J. Chilk, Secreta: FROM: SECY-90-175 - STAFF REQU7 NTS - OCTOBER 3,
SUBJECT:
1989, FOLI4 WING A BRIEFI O STUDY OF ADEQUACY OF REGULATORY OVERSIGHT OF MATERIALS UNDER A GENERAL LICENSE F This is to advise you that the Commission (with all Commissioners agreeing) has concurred in the staf f's recommendations.- ~The staff should proceed with the rulemaking to modify the general license in 10 CFR 31.5 and to establish a registration and response system for general licensees through the proposed rulemaking. The periodic verification letters provided for in the rule should be accompanied by a copy of the regulations from These actions should promote better tracking, time to time. improved communications, and enhanced licensee understanding of Staff should prepare the requirements and compliance with them. and submit a proposed rule for Commission review. /O/0//?O NCbch -(-EBot-(RES) (SECY Suspense: 4/1/0 W m ' The staff should also proceed with a rulemaking to modify 10 CFR 32.51 to restrict the maximum air gap between the device and the A proposed rule should product for generally licensed devices. /g be prepared and submitted for Commission review. 'Y -(EDO-)- (RES) (SECY Suspense: 3/29/91) 9000192 \\Y M As a separate but related matter, staff should proceed for certain devices. Staff should ensure that proposed g exe=ptions of certain devices that are currently used under \\ + \\ general and specific licenses are analyzed and exempted in The staff accordance with the Below Regulatory Concern policy. should integrate its proposal to consider exempting these devices // into the BRC implementation program. g k.c \\' -(EDO)- (NMSS) (SECY Suspense: 9/14/90) 9000193 't THE SUBJECT SECY PAPER, AND THE VOTE SHEETS SECY NOTE: THIS SRM, OF COMMISSIONERS ROGERS, CURTISS, AND REMICK WILL BE MADE PUBLICLY AVAILABLE IN 10 WORKING DAYS FROM THE DATE OF THIS SRM. ' 01 Gi L.0
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~ _.. L The staff should conduct reviews and analyses, as described below, and report findings to the Commission. Given the staff's belief that losses of generally licensed 1. devices are underreported, it is likely that some kinds of accidents and misuses might also be underreported. The staff's recommendation for periodic verification letters itself indicates a concern that some general licensees might not know what problems they are required to report, or even that they are required to report. The staff should present the information obtained through these periodic surveys to the Commission, with an evaluation of the need for further regulatory action. This evaluation should consider the need to require a specific license for additional types of devices or applications, to provide additional guidance to general licensees, for changes in the verification letters, and for other changes to Part 31, such as a requirement for additional training. The April 1987 report by Oak Ridge Associated Universities-2. entitled " Improper Transfer / Disposal Scenarios for Generally Licensed Devices" suggests a potential for significant doses from several types of devices. Although the staff has informally determined that this document is based on unrealistic assumptions that produce dose estimates that are too conservative, the staff currently has no documented analysis supporting its conclusions. The staff should explain why the doses estimated in the Oak Ridge report are unlikely to be experienced in practice or otherwise insufficient as a basis for rulemaking. Tc support its conclusions, the staff should obtain a peer review of the Oak Ridge report and analyze the potential doses associated with radioactive materials under a general license. Staff should use its analysis as a major part of the basis for making future improvements in regulatory oversight of general licenses and for making decisions on whether to recommend specific licensing for other generally-licensed devices. The staff's analysis could also provide a basis for gathering additional information on categories of This general licensees where survey responses are sparse. analysis should be independent of the proposed rule on the so that the registration and response system, however, rulemaking vill not be delayed. 4
A O W U 3 3. The staff should assess the design dose criteria established for generally licensed devices in 10 CFR Part 32 to ensure that members of the public are adequately protected. In the recent Commission deliberations' on fin?1 revisions to 10 CFR Part 20, Commissioner Curtiss raised a concern about adoption of 10% of the occupational limit (i.e. 500 mrem /yr) as the design criterion for generally licensed devices in 10 CFR 32.51(a) (2) (ii) and 32.51(c). Rather than delay promulgation of the final revisions to 10 CFR Part 20 and the conforming changes, this issue should be resolved as part of an integrated program to improve regulatory oversight of generally licensed material and devices. Staff should carefully consider what the design criteria should be, given that the people receiving the exposures are members of the general public rather than radiation workers, and should provide recommendations for the Commission's consideration on whether revision of the design criteria should be initiated. The staff should submit a plan with milestones for the accomplishment of these reviews and analyses. -fEDOP (NMSS) (SECY Suspense: 2/1/91) 9000194 cc: Chairman Carr Commissioner Rogers commissioner curtiss Commissioner Remick OGC GPA a ?. e
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t ? ? -{ -) e e .^t I l. h I l ENCLOSURE B ' I l EEDfBAL REGISTER NOTICE t - r i I i s - t ? I h i i i l, h I i I I i n j l i ~ v 1 + i 1 1 h
r [7590-01) { i NUCLEAR REGULATORY COMMISSION 10 CFR Parts 31 and 32 RIN 3150-AD82 l l Requirements Concerning the Accessible Air Gap for Generally Licensed Devices AGENCY: Nuclear Regulatory Commission. I ACTION: Proposed rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations governing the safe use of radioactive byproduct ' material in certain measuring, gauging, and controlling devices. The proposed rule would
[ provide for additional regulatory control over devices with both an accessible air gap and radiation levels that exceed specified values. This action is intended to make it increasingly difficult for personnel to obtain access to the gauge's radiation beam, thereby reducing the frequency and likelihood of unnecessary exposure to plant personnel. This amendment applies both to persons who distribute these special measuring, gauging, and controlling devices under the NRC general license provisions and to persons who use the i devices under the NRC's general license. 1 Enclosure B
O. O ._ t t DATES: The coment period expires [1,20 days following publication in the Federal Register). Coments received after this date will be considered if it 1 i is practicable to do so, bat assurance of consideration cannot be given except I for coments received on or before this date. l l ADDRESSES: Mail written coments to: The Secretary, U. S. Nuclear Regulatory Comission, Washington, DC 20555, Attention: Docketing and Service Branch. i Deliver comments to: One White Flint North, 11555 Rockville Pike, Rockville, MD, between 7:30 am and 4:15 pm on weekdays. Copies of the draft regulatory analysis, as well as copies of the. comments received on the proposed rule, may be examined at the NRC Public Document Room, 2120 L Street NW. (Lower Level), i Washington, DC. f FOR FURTHER INFORMATION CONTACT: Donald Hopkins, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Comission, Washington, DC 20555, telephone (301) 492-3784. SUPPLEMENTARY INFORMATION:
Background
On February 12,1959 (24 FR 1089), the predecessor to the Nuclear Regulatory Commission (The Atomic Energy' Comission) amended its regulations to establish a general license for the use of radioactive byproduct material i contained in certain luminous, measuring gauging, and controlling devices. The general license permitted the use of specially approved devices, designed 2 Enclosure B I i
~ ._.1 1 o O l for safe use by persons not trained in radiation safety, for the purpose of: detecting, measuring, gauging, or controlling thickness, density, level, interface location, radiation, leakage, or chemical composition, or for producing light or an ionized atmosphere. Those permitted to use these devices in the conduct of their business under the general license included (1) commercial and industrial firms; (2) research, educational, and medical institutions; (3) individuals; and (4) Federal, State, or local government agencies. This simplified the licensing process so that a case-by-case I determination of the adequacy of the licensee's training, experience, and radiation safety program by the regulatory authority was unnecessary.. i The practice of using a device under a general license grew over the years. There are currently some 600,000 devices in use by about 35,000 l general licensees. The gauge segment of that group constitutes about 52,000 t gauges in use by some 13,000 general licensees. As a result of a recent study f of general licensee practices, the fiRC has identified several types of gauge installations for which there should be improved regulatory control by the fiRC. Under the procedures governing the application for and issuance of a j specific license, the applicant's training, experience, and radiation safety program would all be evaluated as to their appropriateness for the types of devices possessed by the specific licensee. Thus, restricting possession of certain types of gauges to specific licensees is necessary to obtain better regulatory control over these types of gauges. ( I t 3 Enclosure B f t
9 9 Dis,cussion The gauges identified as needing improved regulatory control are those which have been installed by the distributor so that there is a large air gap between the radioactive sealed source and the gauge detector. While some air gap is almost always present in gauging devices for the placement of the material being gauged, the identified gauges have a large enough air gap so that an untrained or careless worker could place his or her body directly in l the radiation beam. Many gauges contain a small enough quantity of radioactive material so that even with a large accessible air gap no - significant radiation exposures would result. However, for those gauges that have both a large air gap and radiation levels that exceed a certain value, the NRC intends to prohibit further distribution under a general license and to convert existing general licenses to a specific license. However, current general licensees would have the option of having the gauges physically modified to eliminate the accessible air gap, and thus, not be required to become a specific licensee. The NRC estimates there may be as many as 3000 gauges, used by approximately 750 general licensees, that would be affected by this rulemaking. The size of the " accessible air gap" addressed by this proposed rule is a gap of 18 inches or greater between the radiation source and detector which would allow insertion of a 12 inch diameter sphere into the radiation beam without the removal of a barrier. The specification is a reasonable limit to restrict access of a person's torso. An air gap which is 18 inches or longer between the source and detector but is enclosed by a wire mesh enclosure or a chemical tank with a metal lid would not be considered under this proposed 4 Enclosure B
g d rule because a 12 inch diameter sphere could not be placed in the radiation beam without the removal of a barrier. The magnitude of the radiation level of concern which would be addressed by this rule change is 125 millirem per hour at 18 inches from the radiation source with any shutter in the open position. This radiation level specification is based on the scenario of a worker receiving less than I hour of direct exposure in a calendar quarter at a distance of 18 inches from the radiation source as a result of normal operations and maintenance. This would result in a quarterly exposure of less than 125 millirem. This corresponds to the dose restriction for general licensees in NRC regulations. The 18-inch specification corresponds to a guideline set forth for NRC inspectors that a radiation level must extend 18 inches into an accessible area for it to cause whole body radiation doses. WF ile this guideline would allow part of an individual's body to be exposed to a higher radiation level than that specified while the body is within the 18 inch distance and closer to the source of the radiation, practical considerations dictate that a person would not be situated in the radiation beam next to the radiation source for long periods of time. A more likely scenario is where a worker is cleaning a vat in which a radiation source and detector are installed on opposite walls, so that the worker is out of the radiation beam most of the time and is in the beam close to the radiation source for only short periods of t'ime. The NRC is proposing to modify its regulations, 9 31.5 "Certain measuring, gauging or controlling devices", to exclude those types of gauges with both an accessible air gap of 18 inches or greater and a radiation level exceeding 125 millirem per hour at a distance of 18 inches from the source from the category of generally-licensed devices. 5 Enclosure B
i O O l There are some general licensees who at present possess this type of gauge installed in such a way that unnecessary radiation exposure could occur if untrained or careless employees inadvertently placed their bodies in the gauges' radiation beams. General licensees who currently possess these gauges would be required to either obtain a specific license for the gauge and to establish a radiation safety program to assure that only individuals who are l properly trained are permitted access to those gauges, or have the gauges physically modified to eliminate the " accessible air gap", and hence not be required to obtain a specific license. This physical modification, as with l all installation and servicing of the gauge, would need to be performed by a f person with a specific license that authorizes him or her to perform this type of activity. The Commission intends to modify the Enforcement Policy,10 CFR Part 2, + Appendix C, at the time of the final rulemaking to address enforcement actions for failure to either obtain a specific license or to physically modify the devices to avoid the need to obtain a specific license. The possession of material without the required specific license is considered under Supplement VI of the Enforcement Policy to be a Severity Level III violation since it involves possession of unauthorized material. Consequently, a civil penalty will be considered for such violations. It is the Commission's intent to provide a separate assessment schema for these violations shouid the proposed rule be finalized. It is expected that each source which is possessed in violation of the rule would be subject to a separate assessment of $1000.00. Except for the identification factor in Section V.B.1. of 10 CFR Pe-t 2 Appendix C, this penalty would be assessed without regard to the normal assessment factors in Section V.B. The penalty would be assessed without 6 Enclosure B
9 Q k normally holding an enforcement confe,rence because the factors would not need f I to be considered and to simplify the process. The written response required by 10 CFR 2.201 and 2.205 should provide sufficient information for regulatory i purposes for this type of violation. The purpose of this penalty process' would be to deter violations by making noncompliance with this requirement more expensive than compliance. Invitation to Comment Comments on the criteria defining the type of gauge requiring better NRC control and the implementation of the proposed amendments are encouraged. Comments are especially solicited on: 1. The proposed use of both the 18 inch dimension and " allow insertion of a 12 inch diameter sphere into the radiation beam," as criteria for defining the maximum size of the accessible air gap; 2. The proposed use of 125 millirem per hour at 18 inches from the source as the level of radiation to which a worker could be exposed as the threshold triggering the restrictions of this proposed rule; 3. The need for a grace period between the effective date of the final rule and the date on which particular portions of the rule become' effective. While it is unlikely that distributors would need a grace period to finish installing a gauge subject to the restrictions of this rule change, it is unclear how long it will take for present users of that type of gauge to react to the restrictions and take some kind of action, either to have the device physically modified to eliminate the accessible air gap, or to apply for and obtain a specific license; and 7 Enclosure B
-O
- Ol j
l t 4. The costs that might-result from physically modifying the devices or obtaining specific licenses. Finding of no Significant Environmental Impact: Availability-1 1 The proposed amendment, if adopted, would not result in any activity that significantly affects the environment. The Commission has determined j under the National Environmental. Policy Act of 1969, as amended, and the Commission's regulations in Subpart A of 10 CFR Part 51, that this' rule is not 1 i a major Federal action significantly affecting the quality of the human l environment and, therefore, an environmental impact statement is not required. The proposed amendments, if adopted by the NRC and as implemented by l licensees, would likely result in a potential gain in radiation: protection by f i reducing the frequency'and likelihood of unnecessary radiaticn exposures. It -l l is expected there would be no additional radiation exposure to individuals or. the environment from any physical modification'of gauges to satisfy the requirements of this proposed rule..The environmental impact assessment l forming the basis for this determination is available for inspection at the NRC Public Document Roca, 2120 L Street 'NW. (Lower Level) Washington, DC. l Paperwork Reduction Act Statement ) j The proposed rule amends the information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). l This proposed rule has been submitted to the Office of Management and Budget j for review and approval of the paperwork requirements. I e I 8 Enclosure B l I
2 i O O _ The public reporting burden for this collection of information is estimated to average 24 hours per initial response by up to 750 general licensees, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Further collections of information at 5 year intervals are estimated to averzge 6 hours. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the Information and-Records Management Branch (MNBB-7714), U.S. Nuclear Regulatory Commission, Warhington, DC 20555, and to the Desk Officer, Office of Information and Regulatory Affairs, NE0B-3019, (3150-00016 and 3150-0001), Office of Management and Budget, Washington, DC 20503. Regulatory Analysis i The NRC has prepared a draft regulatory analysis for this proposed regulation. The analysis examines the cost and benefits of the alternatives considered by the NRC. The draft analysis is available for inspection in the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. Single copies of the draft analysis may be obtained from Donald R. Hopkins, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory' Commission, Washington, DC 20555, telephone: 301-492-3784. ] 9 Enclosure B
.-2.,_ .3 v w Regulatory Flexibility Certification Based on information available at this stage of the rulemaking proceeding and in accordance with the Regulatory Flexibility Act, 5 J.S.C. 605(b), the NRC certifies that, if promulgated, this rule will not have a significant economic impact on a substantial number of small entities. The NRC has adopted size standards that classify a small entity as one whose gross annual receipts do not exceed $3.5 million. The proposed rule affects about 750 persons using 3000 gauges under this general license. Many of the users would be classified as small entities. If these users vere to adopt the regulatory alternative of obtaining a specific license authorizing use of their presently held gauges, the costs, as discussed in the draft regulatory analysis " Proposed Regulations Concerning Certain Generally Licensed Devices," would be as follows: 1. Application preparation $1200 (first year only). 2. Renewal application preparation $400 (every 5 years thereafter). 3. Licensing fee $500 (first year and every 5 years thereafter). 4. Inspection fee $1200 (first year and every 5 years thereafter). 5. Annual fee $1500 (every year, includes $100 surcharge). 6. Establishing radiation safety program $7500 (first' year only). 7. Maintaining radiation safety program $2500 (every subsequent year). Total of $11,900 for first year; $6100 every subsequent fifth year; and $4000 for all other years, for an average annual cost over a 15 year period of 10 Enclosure B
$4807. The 225 licensees who are estimated to already possess a specific license (even though using gauges under a general license) would have a one-l time additional cost of $780 to add the generally-licensed gauges to their i specific license. The average cost to these licensees over a 15 year period would be $52 per year. While the nearly $5000 per year average costs would be significant for some small entities who decide to obtain a specific license, the NRC believes that the economic impact of the proposed requirements would not be significant for a substantial number of small entities because of the alternative available other than becoming a specific licensee. If a person makes the air I gap of the gauge inaccessible by any number of means, such as building a barrier around the air gap, locking the area where the air gap exists, or by i interlocks where no one can enter the area while the radiation source is in 1 the exposed position, that person would not-be required to obtain a specific license. Although thi:, alternative may be impractical in some cases because i of the nature of the gauging process, the NRC believes it will be a practical alternative in most cases. The NRC believes that this would subject affected i persons to the one-time' additional barrier construction costs estimated at $1700 per facility. Over the 15-year period this would average $113 per year. The potential gain in radiation protection by reducing the frequency and likelihood of unnecessary radiation exposure significantly outweighs the economic impact on small general licensees. i However, the NRC does not have information indicating how many of the potential 525' general licensees may be prevented from adopting the less costly -[ alternatives for technical reasons. Because of this uncertainty, the NRC is I seeking comment from small entities (i.e., small businesses, small .l l 11 Enclosure B {
organizations, and small jurisdictions under the Regulatory Flexibility Act) ~ as to how the regulations will affect them and how the regulations may be tiered or otherwise modified to impose less stringent requirements on small entities while still adequately protecting the public health and safety. Those small entities which offer comments on how the regulations could be l modified to take inte account the differing needs of small entities should specifically discuss the following: i (a) The size of their business and how the proposed regulations would i i result in a significant economic burden upon them as compared to i i larger organizations in the same business community. Commenters i should provide specific information concerning physical. barrier construction costs. Commenters should also indicate specific j i reasons why the physical protection alternative may not be [ t appropriate fo'r them. l I (b) How the proposed regulations could be modified to take into i account the differing needs or capabilities of small entities. (c) The benefits that would accrue, or the detriments that would be i avoided, if the proposed regulations were modified as suggested by the commenter. ) l (d) How the proposed regulations, as modified, would more closely i equalize the impact of NRC regulations or create more equal access F to the benefits of Federal programs as opposed to providing h special advantages to any individuals or groups. i I (e) How the proposed regulations, as modified, would still adequately l protect the public health and safety. l t 12 Enclosure B l I t
o o Backfit Analysis The NRC has determined that the backfit rule,10 CFR 50.109, does not apply to these proposed rules and therefore a backfit analysis is not required for this proposed rule because these proposed amendments do not involve any provisions that would impose backfits as defined in 10 CFR 50.109(a)(1). 1 List of Subjects in 10 CFR Parts 31 and 32 l 10 CFR Part 31 - Byproduct material, Criminal penalties, Labeling, Nuclear materials, Packaging and containers, Radiation protection, Reporting and recordkeeping requirements, and Scientific equipment. 10 CFR Part 32 - Byproduct material, Criminal penalties, Labeling, Nuclear materials, Radiation protection, Reporting and recordkeeping i requirements, and Scientific equipment. For the 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, l as amended, and 5 U.S.C. 553, the NRC is proposing to adopt the following amendments to 10 CFR Parts 31 and 32: Part 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT i4ATERIAL 1. The authority citation for Part 31 continues to read as follows: P AUTHORITY: Secs. 81, 161, 183, 68 Stat. 935, 948, 954, as amended (42 U.S.C. 2111, 2201, 2233); secs. 201, as amended, 202, 88 Stat. 1242, as amended, 1244 (42 U.S.C. 5841, 5842). 13 Enclosure B
i O O a I Section 31.6 is also issued under sec. 274, 73 Stat. 688 (42 U.S.C. 2021). i For the purposes of sec. 223, 68 Stat. 958, as amended (42.U.S.C. 2273); Il 31.5(c) (1)-(3) and (5)-(9), 31.8(c), 31.10(b), and 31.11(b), (c), and (d) are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b); and i il 31.5(c) (4), and (5), and (8), and 31.11(b) and (e) are issued under sec. i 1610, 68 Stat. 950, as amended (42 U.S.C. 2201(o)). 2. In 5 31.5, paragraph (b) is revised and paragraph (e) is added to read as follows: 5 31.5 Certain measurino. caucino or controllino devices. j l l (b) The general license in paragraph (a) of this section: (1) Applies only to byproduct material contained in devices which have j been manufactured or initially transferred and labeled in accordance with the specifications contained in a specific license issued pursuant to 132.51 of i this chapter or in accordance with the specifications contained in a specific Y license issued by an Agreement State which authorizes distribution of the devices to persons generally licensed by the Agreement State; and (2) Does not apply after (three years after the effective date of this l rule) to byproduct material contained in a device which has been manufactured i and installed so that: (i) The dose rate in the radiat' ion beam of the device at 18 inches from the radiation source with the device shutter in the open position exceeds 125 millirem per hour; and 14 Enclosure B j
--t (ii) There is an air gap of 18 inches or greater between the radiation ' f source and detector of a device which would allow insertion of a 12 inch diameter sphere into the radiation beam of the device without the removal of a barrier. '. } I (e) Any person who, under a general license, possesses byproduct material in a device of a type referred to in paragraph (b)(2) of this-section: (1) Shall submit an application to the Nuclear Regulatory Commission, as prescribed'in 130.6(b)(2) of this chapter, by '(three years after the effective date of this rule), for a specific license authorizing possession of l that device, and other activities as appropriate; and (2) Shall, if an application is submitted not later than (30 days i prior to three years from the effective date of this rule) in proper form for a specific license or amendment to a specific license, retain hi: or her l general license until a final determination _on the application has been. reached by the Commission. ? ?/j?!Mi i 3. In 6 31.6, paragraph (d) is added to read as follows: 6 31.6 seneral license to install devices cenerally licensed in f 31.5. .j l (d) The byproduct' material is not contained in a device of a type referred to in 6 31.5(b)(2). l 15' Enclosure B-l
3 (J-w PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL 4. The authority citation for Part 32 continues to read as follows: AUTHORITY: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841). For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273); il 32.13, 32.15(a), (c), and (d), 32.19, 32.25(a) and (b), 32.29(a) and (b), 32.54, 32.55(a), (b), and (d), 32.58, 32.59, 32.62, and 32.210 are issued under sec.161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b); and 5 5 32.12, 32.16, 32.20, 32.25(c), 32.29(c), 32.51a, 32.52, 32.56, and 32.210 are issued under sec. 1610, 68 stat. 950, as amended (42 U.S.C. 2201(o)). 5. In 5 32.51a, paragraph (c) is added to read as follows: 5 32.51a S_ame: Conditions of licenses. (c) Not transfer a device containing byproduct material to a person i 16 Enclosure B
... t o o. f generally licensed under 5 31.5 of t,his chapter if that device is of a type referred to in 131.5(b)(2) of this chapter. Dated at Rockville, Maryland this day of 1991. For the Nuclear Regulatory Commission. f Samuel J. Chilk, Secretary of the Commission. ? i i t } 17 Enclosure B
w D0C. FILE NAME: AIRGAP2.fRN, LONG DISPLAY: Access. Air. Gap /Prt31,32 CREATED: AUTHOR: D. HOPKINS REVISED: 8/27,29 08/30/91 09/03/91 09/19/91 09/27/91 TYPIST: LCROSSLAND S. Taylor S. Taylor S. Taylor S. Taylor TIME: 2:40 pm 12:45 p.m. 11 a.m. 2:15 p.m. 9 a.m. 10/01/91 10/10,17/91 11/15,18,20,21,22/91 S. Taylor LCrossland LCrossland Mfleishman 10:30 a.m. 3:42 pm 10:45 am 4:32 p.m. EXCERPT: [7590-01] NUCLEAR REGULATORY COMMISSION 10 CFR Parts 31 and 32 RIN 3150-AD82 Requirements Concerning the Accessible Air Gap for Generally Licensed Devices AGENCY: Nuclear Regulatory Commission. ACTION: Proposed rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations governing the safe use of radioactive byproduct material in i
18 Enclosure B
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