ML23153A061

PR-031,032 - 57FR56287 - Requirements Concerning the Accessible Air Gap for Generally Licensed Devices

ML23153A061
Person / Time
Issue date:	11/27/1992
From:	Chilk S NRC/SECY
To:
References
PR-031, 032, 57FR56287
Download: ML23153A061 (1)

Text

ADAMS Template: SECY-067 DOCUMENT DATE: 11/27/1992 TITLE: PR-031,032 - 57FR56287 - REQUIREMENTS CONCERNING THE ACCESSIBLE AIR GAP FOR GENERALLY LICENSED DEVICES CASE

REFERENCE:

PR-031,032 57FR56287 KEYWORD: RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

STATUS OF RULEMAKING PROPOSED RULE: PR-031,032 OPEN ITEM (Y/N) N RULE NAME: REQUIREMENTS CONCERNING THE ACCESSIBLE AIR GAP FOR GENERALLY LICENSED DEVICES PROPOSED RULE FED REG CITE: 57FR56287 PROPOSED RULE PUBLICATION DATE: 11/27/92 NUMBER OF COMMENTS: 5 ORIGINAL DATE FOR COMMENTS: 03/29/93 EXTENSION DATE: I I FINAL RULE FED. REG. CITE: FINAL RULE PUBLICATION DATE: I I NOTES ON: PR WITHDRAWN (64FR3052, 01/20/99). FILE IN 16G4.

STATUS OF ..RULE :

HISTORY OF THE

• RULE PART AFFECTED: PR-031,032 RULE TITLE: REQUIREMENTS CONCERNING THE ACCESSIBLE AIR GAP FOR GENERALLY LICENSED DEVICES PROPOSED RULE PROPOSED RULE DATE PROPOSED RULE SECY PAPER: 92-147 SRM DATE: 09/25/92 SIGNED BY SECRETARY: 11/20/92 FINAL RULE FINAL RULE DATE FINAL RULE SECY PAPER: SRM DATE: I I SIGNED BY SECRETARY: I I STAFF CONTACTS ON THE RULE CONTACTl: DONALD HOPKINS MAIL STOP: NLS-129 PHONE: 492-3784 CONTACT2: JAYNE MCCAUSLAND MAIL STOP: T-9F31 PHONE: 415-6219

DOCKET NO. PR-031,032 (57FR56287)

In the Matter of REQUIREMENTS CONCERNING THE ACCESSIBLE AIR GAP FOR GENERALLY LICENSED DEVICES DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT

. 11/20/92 11/20/92 FEDERAL REGISTER NOTICE - PROPOSED RULE 01/11/93 01/05/93 COMMENT OF JOHNSON WAX (GENE I . MATSUMOTO) ( 1) 03/23/93 03/22/93 COMMENT OF OHMART CORP (GEORGE W. BROWN) ( 2) 03/24/93 03/19/93 COMMENT OF BERTHOLD SYSTEMS, INC (G.M. (BUD) SMITH, JR., PRESIDENT) ( 3) 03/26/93 03/24/93 COMMENT OF APGEE CORP (WHIT LITTLE, V. P.) ( 4) 03/29/93 03/25/93 COMMENT OF AMERSHAM HOLDINGS, INC (DR. BRYAN W. BAKER) ( 5) 06/01/93 03/03/92 COPY OF COMMENT OF MEASUREX ON PRIOR PART 31 & 32 RULEMAKING PROVIDED BY MEASUREX AT THE REQUEST OF E. L. JULIAN, CHIEF, DSB, SECY 06/01/93 05/28/93 LETTER FROM CHARLES VANORDEN, GENERAL COUNSEL, MEASUREX TO THE CHAIRMAN PROVIDING CONCERNS ON PROPOSED REVISIONS OF PARTS 31 & 32 06/07/93 06/07/93 LETTER FROM KENNETH W. FARBER, COUNSEL TO MEASUREX, TO SECRETARY ADVISING THAT ADDITIONAL COMMENTS WILL BE PROVIDED BY JUNE 9, 1993 06/11/93 06/09/93 LETTER FROM CHARLES VANORDEN, GENERAL COUNSEL FOR MEASUREX TO THE CHAIRMAN, PROVIDING COMMENTS ON RULEMAKING IN RESPONSE TO 6/7/93 CONFERENCE CALL 01/13/99 01/12/99 FEDERAL REGISTER NOTICE - PROPOSED RULE :

WITHDRAWAL

DOCKET NUMBER DOCKETED US~lF\:

PROPOSED RULE 3 / ~ 3;2.,

(5 1fR 5~ ~g1) "99 JAN 13 A1fJ~9_f-0 1-PJ 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: Withdrawal.

SUMMARY

The Nuclear Regulatory Commission (NRC) is withdrawing a proposed rulemaking that would have amended the Commission's regulations to provide additional regulatory control over certain measuring, gauging, and controlling devices to prevent unnecessary radiation exposure to individuals resulting from the use of the devices that contain radioactive sources.

This proposed rule would have addressed only generally licensed devices. It did not include devices subject to specific licenses. The NRC is conducting a risk review of the current licensing and inspection programs and licensees' activities for both generally and specifically licensed devices. The risk review will determine the risk associated with licensees' activities by determining and relating the probabilities of the occurrence and consequences of events during use and likely accidents involving radioactive material. The NRC will determine from the results

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of the risk review the need to develop restructured licensing and inspection programs for material licensees and the associated rulemaking for implementing these programs.

Therefore, pending the results of the risk review and the need for a comprehensive rulemaking, and because the proposed rule did not include both generally and specifically licensed devices, the Commission is withdrawing this proposed rule.

ADDRESSES: The Commission paper, the staff requirements memoranda (SRM), and associated documents are available for public inspection and/or copying for a fee at the NRC Public Document Room located at 2120 L Street, NW. (Lower Level), Washington, DC 20003-1527, telephone: (202) 634-3273.

FOR FURTHER INFORMATION CONTACT: Jayne M. McCausland, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 ,

telephone (301) 415-6219, e-mail jmm2@nrc.gov.

SUPPLEMENTARY INFORMATION:

On November 27, 1992 (57 FR 56287), the Commission published a notice of proposed rulemaking in the Federal Register entitled "Requirements Concerning the Accessible Air Gap for Generally Licensed Devices." The proposed rule would have amended the Commission's regulations to provide additional regulatory control over certain measuring, gauging, and controlling devices distributed by manufacturers and used by persons under NRC's general license provisions. The rulemaking would have affected devices with an accessible air gap or radiation levels that exceed a specified value. This rulemaking would have made it increasingly difficult for personnel to obtain access to the device's radiation beam, thereby reducing the frequency and likelihood of unnecessary radiation exposure. The rulemaking applied to 2

persons who distribute these special measuring, gauging, and controlling devices under the NRC general license provisions, and to persons who use the devices under the general license.

The NRC received 5 comment letters on the proposed rule. Three comments were received from manufacturers and two comments were received from device users.

Development of the final rule was suspended. On July 2, 1996, the NRG/Agreement State Working Group (WG) issued a final report concerning its evaluation of current regulations on generally and specifically licensed devices and provided recommendations to increase licensees' accountability regarding these devices. The staff's evaluation of the WG recommendations was provided to the Commission. The subsequent SRM dated December 31, 1996, requested a response to specific issues raised by the Commission in SECY-96-221. On November 26, 1997, the NRC staff provided for the Commission's consideration SECY-97-273, entitled "Improving NRC's Control Over, and Licensees' Accountability for, Generally and Specifically Licensed Devices." Included as an attachment to this Commission paper was the SRM, entitled "Responses to Issues Included in the December 31, 1996, Staff Requirement Memorandum." Additional recommendations from the NRC staff that were not addressed in the WG report, such as proceeding with or dropping the air gap rule, were discussed. Subsequently, an SRM dated April 13, 1998, directed the NRC staff to terminate the proposed rulemaking.

This proposed rule addressed only generally licensed devices and has been on hold for the last five years. The NRC's current strategy for both generally and specifically licensed devices, is to perform a comprehensive risk review of the licensing and inspection programs, including licensees' activities. The results will be used to develop new risk-based licensing and inspection programs and will be approved by the Commission before they are implemented. In 3

I addition, the risk review will determine whether a similar rulemaking should be developed.

Because of these actions, the Commission is withdrawing this proposed rulemaking.

Dated at Rockville, Maryland, this 12- day of January, 1999.

For the Nuclear Regulatory Commission.

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Annette L. Vietti-Cook, Secretary of the Commission .

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• 93 J' ,J 11 ~ 9 :, 6 (Transmitted via telefax) 9 June 1993 Dr. Ivan Selin, Chairman Nuclear Regulatory Commission Washington , DC 20555

Subject:

Planned Modifications to 10 CFR 31 and 32

Dear Dr. Selin:

This letter responds to the June 7, 1993 conference call between the Nuclear Regulatory Commission's (NRC) staff (John Lubinski, Rajender Auluck, Joseph Mate, and Maria Schwartz) and Measurex Corporation regarding the NRC's proposed modifications to 10 CFR 31 and 32. Measurex appreciates this opportunity to work cooperatively with the NRC to resolve the outstanding issues associated with the proposed rule and to avoid the need for judicial Intervention.

While the NRC has made a good faith effort to address the concerns expressed in Measurex's written comments, even with the modifications to the proposed rule noted by the NRC staff, Measurex believes that portions of the rule are unmanageable and will create unnecessary administrative burdens on both the NRC and the regulated community, particularly Measurex. We believe the suggestions contained in this letter will enable the NRC to meet the objectives identified in the proposed rule cost effectively and without disrupting commerce.

Objective of the Bui~

The rule is designed to protect both workers and the public from potential radiation exposure. The NRC stated in its December 27, 1991 proposal that the rule is:

intended to ensure that general licensees are aware of and understand the requirements for the possession of devices containing byproduct material. This awareness will better assure that general licensees will comply with the reQuirements for proper handling and disposal of generally licensed devices and presumably reduce the potential for incidents that could MeA$URSX CORPORATION ON&: RESIJL'IS WAV CUPEm'INO, CAU~NIA 95014-5991 (408) 255*1100

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JUN 09 '93 04:58PM MEASUREX FIN/ADMIN 408 864 7580 P.3 measurex result in unnecessary radiation exposure to the public.

As a manufacturer and servicer of Generally Licensed devices, Measurex endorses these objectives. We agree that some of the proposed revisions to Parts 31 and 32 will help accomplish these goals. The same cannot be said for the 3-day notice provision.

3-Pa:t Notice Unmanageable and unnecessacy Even as modified, the 3-day notice requirement of 10 CFR 31.6 does not further the NRC's stated objectives and creates an unmanageable communications bureaucracy for companies Specifieally Licensed In Agreement States and operating under the General License In 10 CFR 31.8.

The December 1991 proposal states that the 3-day notice "would allow for a level of periodic Inspection of those activities that intentionally place a worker in direct contact with the device or an unshielded radiation source. " The 3-day notice requirement, however, is not needed for such inspections because the NRC currently has authority under 10 CFR 19.14 and 31.6 to inspect the service activities conducted by Agreement State licensees in Non-Agreement States under a General License. This authority is identical to the NRC's authority to inspect the service activities conducted by NRC Specific Licensees working in Non-Agreement States.

Since the NRC does not require 3-day advance notice of service activities conducted by NRC Specific Licensees working in Non-Agreement States, reQuiring such notice by 10 CFR 31.6 General Licensees working In Non-Agreement States would be both arbitrary and unnecessary. There is no rational basis to have different reQuirements for service to 10 CFR 31.5 devlces based solely on whether the person doing the work is authorized by a Specific License issued by the NRC or authorized by the General License given in 10 CFR 31,6. Furthermore, as a result of the existing reQuirements to report to the NRC the distribution of the devices, regardless of whether the manufacturer or distributor is an NRC or Agreement State Specific Licensee, the NRC has identical information on the whereabouts of the devices and the locations at which service operations must take place. Accordingly, Measurex believes that the 3-day notice provision should be deleted since the NRC already has both the authority and adequate site Information to conduct periodic inspections.

JUN 09 '93 04=59PM MEASUREX FIN/ADMIN 408 864 7580 P.4 measurex Recommendatioos if the NBC Betajns 3-0ay Notice BeaiAicernent If the NRC decides to retain some form cf notice requirement, the modified language Is still too vague. This will result in costly and administratively burdensome over-notification by companies such as Measurex for servicing activities that have no potential to expose anyone to radiation risks and that are beyond the intent of the rule. Unless the rule is clarified, Measurex will be forced to provide unnecessary notice to avoid the r'isk of significant enforcement penalties if we are wrong in concluding that notice is not required for any activities associated with the device.

Specifically, because the term "device" is used in the rule and must presently be understood to include all aspects of the eQuipment described in the Sealed Source and Device registry sheets issued by Agreement States, most device servicing activities create no radiological risks but would still be subject to notice by Measurex. While a long-term solution might be accomplished by having Measurex and other manufacturers request revisions to the descriptions of the device and service activities in the registry sheets issued by Agreement States, in the short term and for that matter, for the foreseeable future, it is essential that the rule and its preamble provide some further guidance on what activities reQuire notice.

Otherwise the NRC !ind those affected by this rule will waste an unconscionable amount of time making and answering meaningless notification phone calls.

If the NRC retains the notice requirement, Measurex requests that all of the following necessary provisions be added:

0 Modify the 3-day notice portion of the rule in 10 CFR 31.6 to state:

The person performing routine, scheduled service/installation or decommissioning of devices shall notify the appropriate NRC Regional Office listed in Appendix D of this chapter at least 3 working days prior to engaging in such activities in Non-Agreement States. Prior notification does not apply for routine, scheduled service activities that have no bearing on radiological hazard, such as service, repair, or replacement of device components other than the radiation source, its primary shielding, the on-off mechanism, or the radiation beam collimation. [Hen, add the NRC-proposed changes regarding the exemption from the notification requirement in cases where the device has or will malfunction or be damaged unless J

JUN 09 '93 04!59PM MEASUREX FIN/ADMIN 408 864 7580 P.5 measurex immediate service takes place.] Prior notification does not apply in eases where a radiological hazard due to an accident or malfunction of the device exists.

0 In addition, the following language should be added to the preamble to clarify the type of activities that are to be reported:

The NRC requires advance notice of scheduled activities that intentionally place a worker In direct contact with the unshielded radiation source or where the activity involves disassembly, removal, or modification of the radiation source's primary shielding, the on-off mechanism which controls the radiation beam, the collimation of the radiation beam, or permanent removal or change to the shielding ability of any portions of the device which, when the on-off mechanism is in the open/radiation beam on position, serve as primary shielding (beam stop). The NRC also requires notice when 10 CFR 31.5 devices are Installed or decommissioned.

The NRC need NOT be notified of routine, scheduled service operations that have no bearing on radiological hazard, such as service, repair, or replacement of device components other than the radiation source, its primary shielding, the on-off mechanism, or the radiation beam collimation. It Is not intended that the prior notification requirement apply in cases where the device has or will malfunction or be damaged unless immediate service takes place or In cases where service is required to correct or prevent a radiological hazard.

Comments on Revisions Proposed by the NBC during the June Ztb conference can During the June 7th conference call , the NRC discussed a number of possible changes to the 3-day notice rule that might address the concerns expressed by Measurex. One of these was to include wording to clarify that the notification requirement would apply only to service operations that are "scheduled" (i.e.

specifically excluding immediate service required as a result of device malfUnction or damage or to prevent malfunction or damage) . Measurex agrees that this change would be important if the notice rule is adopted and has included it In some of the wording suggested above.

JUN 09 '93 05:00PM MERSUREX FIN/RDMIN 408 864 7~80 F.6 measurex Another possible change mentioned was the NRC's acceptance of some form of "blanket" notice In cases of "continuous" service. As discussed In the conference call , such wording could be acceptable, assuming the NRC's adoption of our other requested word changes, depending on how "continuous service is defined.

Like similar companies, Measurex offers its customers many forms of continuing service contracts. Many customers have service contracts that are considered full-service, with one or more employees at the tocatlon 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> or more per week.

Many others have contracts that have a Measurex employee at the site one or more times per week or one or more times per month. Within Measurex's six United States service regions, it is estimated that there are over 250 service visits per month to sites that have less than full-time continuing service contracts. As currently proposed by the NRC, Measurex would have to provide the appropriate NRC Region with 3-day notice of each such visit and would also have to inform the NRC Region each time a visit day was rescheduled to accommodate customer or Measurex needs. Administratively, compliance would be impossible for Measurex.

Another issue is the form of "blanket notice the NRC would accept in cases of

continuous service". In the June 7th conference call, there was discussion of requiring the 10 CFR 31.6 General Licensee to provide each NRC Region with a list including: information on the types of service operations, the applicable site addresses, and, for each site, the NAME(S) of the employee(s) to carry out service.

It was noted that the 10 CFR 31.6 Licensee would be responsible for informing the appropriate NRC Region anytime the name of an employee to provide service at a site changed.

While substantial effort would be required, Measurex and similar companies could probably set up reasonable ways to generate lists of sites where there are continuing service contracts, possibly similar to the Quarterly reports presently required under regulations and license conditions equivalent to 10 CFR 32.52. In contrast, it Is not at all reasonable to require the provision of up-to-date information on which individual employee will be providing service at each site. In Measurex's case, there are about 400 badged employees working within the United States.

While our radioactive materials licenses carefully detail how these employees are to be trained and what records Measurex must maintain, the individual names are not listed on these licenses in recognition of the fact that Measurex would be submitting changes continuously, Needless to say, the enormous waste of time Involved in trying to keep the NRC notified of changes in trained service employees would be further compounded by trying to report employees by site.

5

JUN 09 '93 05:00PM MERSUREX FIN/RDMIN 408 ~b4 I~~~ P. 7 measurex If the NRC requires 10 CFR 31.6 General Licensees to provide lists of sites with continuing service contracts, Measurex suggests that a simple and reasonable alternatlve be pennitted, namely that the lists could provide the names of the regional service manager (or equivalent) responsible for each customer site.

In addltlon1 Measurex requests that the rule provide that any such information be treated as Confidential Business Information, since disclosure of the lists to competitors would adversely affect our business.

Measurex requests that adoption of the rule be delayed and reQuests a meeting with the NRC staff to resolve these issues. We request that this document, notice of the requested meeting, and a summary of the meeting be made part of -the record for the NRC's deliberations on this rule.

Please contact me or our counsel at Hogan and Hartson in Washington O.C. , Ken Farber (202/637-5618).

Sincerely, Charles Van Orden General Counsel CC: Dr. Rajender Auluck Or. Samuel Chilk Dr. John Lubinski Or. Joseph Mate Maria Schwartz, Esq.

JUN 09 '93 05:0?PM MEASUREX FIN/ADMIN 408 864 7580 P.1 measurex C0FIF'0~A T I O N To: Dr. Ivan Selin, Chairman (301) 504-1672 Nuclear Regulatory Commission Dr. Rajender Auluck (301) 492-3866 Dr. Samuel Chilk (301) 504-1672 Dr, John Lubinski (301) 504-2260 Dr. Joseph Mate (301) 492-3866 Maria Schwartz, Esq . (301) 504-3725 CC: Bob Baker (207) 854-0216 Ken Farber, Esq. (202) 637-5910 Dave Bossen Elsa Nimmo

- From: Charles Van Ord en ,

C3eneral Counsel Measurex Corporation (408) 864-7580

Subject:

Planned Modifications to 10 CFR 31 and 32

Attachment:

6-page letter McASURli)( COAF'OAATIO,.

o+iE R~ULTS WAV CUPEATINO. C,lLIFORNIA sso1**S991 (408) 255-1500

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COUN$ll WUSAW OJll!CT DIAL (20J) l>>l-.$014 MLTIMOl!, MO BiTIUSDA, MD Mtl.f.AN,VA June 7, 1993 VIA FACSIMILJ;t Samuel J. Chilk, Secretary U.S. Nuclear Regulatory Commission Docketing and Service Branch Washington, o.c. 20555

Dear Mr. Chilk:

On behalf of Measurex Corporation, I am confirming in response to today's conference call between NRC staff and Measurex Corporation regarding the proposed Byproduct rule {Part 31 and 32 of title 10, Code of Federal Regulations), that Measurex will be submitting additional comments before the close of business on June 9.

As discussed during today's call, we would appreciate a follow-up meeting and/or conference call, after NRC staff has had the opportunity to review the additional comments. We request that these materials be included in the record and that the final rule address these comments.

Sincerely, Kenneth w. Farber Counsel to Measurex Corp.

cc: Dr. Rajender Auluck Maria Schwartz, Esq.

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URGENT *93 .nJN -1 P3 :55 (Transmitted via telefax) 28 May 1993

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Dr. Ivan Selin , Chairman Nuclear Regulatory Commission Washington, OC 20555

Subject:

Planned Modifications to 10 CFR 31 and 32

Dear Dr. Selin:

As a Specifically Licensed manufacturer, distributor, and supplier of service for process control sensors used by General Licensees, Measurex Corporation is very concerned over some of the changes planned for Parts 31 and 32 of Title 10, Code of Federal Regulations. We originally commented on the changes in the Proposed Rules published in the 27 December 1991 Federal Register. Based on the presentations and discussions at the Nuclear Regulatory Com mission public meeting that took place in San Francisco on 20 May 1993, it is our understanding that regulations similar or identical to those In the 27 December 1991 Proposed Rules are soon to be reviewed and possibly adopted by the Commission. In particular, Dr. Frank Costanzi confirmed that the three-day advance notification provision is still Intact as originally proposed.

Other than some relatively minor wording changes (noted in Measurex's letter of comment dated 3 March 1992), Measurex agrees that most of the provisions outlined in the 27 December 1991 Proposed Rules are reasonable and appropriate ones. However, the section requiring three-day advance NRC notification of service/installation is unworkable.

The section of the Proposed Rule that discusses three-day notification before service states:

"The person performing routine seivice/installation or relocations of devices shall notify the appropriate NRC Regional Office ... at least 3 working days prior to engaging In such activities in Non*Agreement States. The notification shall include the date and location of the activity that shall be performed. Prior notification does not apply in cases where a radiological hazard due to an accident or malfunction of the device exists,"

Unless "routine service" means something different from our understanding of the term, this portion of the Proposed Rule is completery" impractical. impossible to comply with and impossible for the NRC to enforce. We also see no basis for such a requirement since there is no history of significant radiation safety incidents Involving Installation or service to such devices.

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measurex The process control systems Measurex ships to General Licensees typically consist of a scanner frame of 20 to 40 or more feet In length, associated computers, operator control stations, cables, actuators, and the like. Mounted on the scanner, directly opposite one another and separated by (typically) a 0.4" air gap are two sensor heads, one of which will contain the well-shielded source holder assembly.

The sensor heads will also contain other, non-nuclear types of sensors and the detectors and electronics needed for signal processing and transmission. Non-nuclear sensors may include ones that measure product moisture, temperature, caliper, color, gloss, smoothness, strength, formation, and mineral content, and ones that measure minute variations in the spacing between the source and detector sensor heads and in the temperature of the air in that gap.

Due to the nature of such systems, the Generally Licensed device is not one isolated component - working on the scanner power track or changing a light bulb in a radiation warning light assembly can be considered providing routine service to the device, although the radioactive source in its assembly may be located inside a sensor head that is 20 or 40 feet away. Providing routine service to the device also includes working on a variety of non-nuclear sensors, electronics, and mechanical components located in the sensor head that contains the radioactive source within its shielded source holder assembly.

At present, there are about 1300 radioactive sources installed in such Measurex-manufactured systems within the United States. Other manufacturers have distributed similar types of process control system throughout the United States.

Due to the complexity of these systems and the fact that they are essential to the 24-hour per day processes they are designed to control, a large percentage of the firms that possess them contract with Measurex or our competitors to have employees on site to maintain the systems on a full-time basis. These Measurex or competitor employees generally live near the customer site, report there for work each day, and have no outside office. Their working days are spent providing routine service and maintenance to process control systems: trouble-shooting electrical and software problems, doing preventive maintenance, cleaning sensor heads, replacing drive belts, cables, connectors, PC boards, air and water lines and filters, sensor windows, and verifying performance of the sensors. Measurex employs about 400 people In this capacity in the United States.

Measurex technical representatives must be able to do this type of routine service and repair on these systems on an on-going basis to prevent interruption of their function. In many instances, if a routine repair Is not made immediately, the non-nuclear electronics will be at risk of damage, including irreparable damage, For the firm in possession of the system, failure of the Measurex system means that their process must be interrupted, at a cost of hundreds of dollars per minute.

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measurex Adoption of the three-day advance notification reQuirement as previously drafted will result in a severe burden to Measurex, Including foreseeable loss due to Irreparable damage to Measurex equipment or foreseeable toss resulting from customer plant shut downs during the notification period. Thus, we urgently request a meeting with the Nuclear Regulatory Commission so we may further demonstrate our operational requirements, address questions from the Commission, and discuss altemative changes ,which would be acceptable to the Commission. In addition, we request that the public docket be re-opened and that this document as well as the notice of the requested meeting and a summary of the meeting be made part of the record for the Commission's final deliberations on this Issue.

We appreciate the Commission's willingness to consider Measurex's concerns.

Please don't hesitate to contact me or our counsel at Hogan and Hartson in Washington O.C. , Ken Farber (202/637-5618).

Sincerely1 Charles Van Orden General Counsel CC: Dr. Rajender Auluck Robert Fonner, Esq.

Or. Joseph Mate Wllllam Parler, Esq.

FACSIMILE TRANSMISSION COVER SHEET MEASUREX CORPORATION LEGAL DEPARTMENT ONE RESULTS WAY CUPERTINO, CALIFORNIA 95014 Tel: (408) 255*1500, Ext. 2094 Fax: (408) 864..7580 TOTAL NO, OF PAGES;..!.. {INCWDING THIS PAGE)

DATE: May 28, 1993 FAX: (301) 504~1672 TO: Dr. Ivan Selin, Chairman Nuclear Regulatory Commission FROM: Charles Van Orden General Counsel

SUBJECT:

Planned Modifications to 10 CFR 31 and 32 URGENT

measurex COAF10AATION 3 March 1992

• 93 JL: -1 P 3 :ss Secretary

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U.S. Nuclear Regulatory Commission Washington , D.C. 20555

Subject:

Proposed Changes to Requirements for the Possession and Distribution of Industrial Devices (10 CFR 31 and 32)"

Dear Sir or Madam:

As a Specifically Licensed manufacturer, distributor, and service organization for process control sensors used by General Licensees, Measurex is very interested in the proposed changes to Parts 31 and 32 of 10 CFR as published in the Federal Register of 27 December 1991 .

While some exceptions are discussed below, Measurex basically agrees with the proposed requirements to increase the accountability of Generally Licensed devices. It is our opinion that adopting and consistently enforcing ~ of the provisions described In this proposed rule will eliminate a significant number of problems. We believe that this can be done without undue expense or effort and that it will benefit everyone involved by making the General License program for gauging devices a safer and more stable one.

Proposed Compatibility Requirements for Agreement States Measurex strongly urges the NRC and the Agreement States to reconsider the proposed Division 2 compatibility categorization.

Because the proposed regulations directly affect firms and the customers of firms that distribute products throughout the U.S .. the variations between NRC and individual Agreement State requirements permitted by Division 2 are detrimental to effective regulation.

Conscientious firms go to great effort to comply with and assist their customers in complying with regulations. However, variations between state requirements for devices that are widely distributed are apt to lead to confusion , the expenditure of lots of time and effort, and , sadly, reduced compliance. Agreement State freedom to

• • ... adopt requirements more restrictive than the NRC ... " sounds very

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measurex Page 2 positive, but for regulation of Generally Licensed devices- it translates into something very different from the intent.

Safety and compliance will be enhanced and General Licensees.

device distributors, and regulatory agencies will all benefit if a uniform set of regulations for General Licenses is adopted and consistently enforced throughout the U.S.

Proposed Notification in Advance of Service [10 CFR 31.6(f)]

Although the intent of the 1o CFR 31.6(f) may have considerable merit, this proposed regulation is not workable as it is written. To understand why the proposed notification is impractical, it is useful to consider how such service is handled. Background information is provided In the paragraphs that follow.

The Specifically Licensed firms which provide service to large numbers of gauges may (as Measurex does) have hundreds of trained employees located throughout the U.S. Many of these employees will have full time assignments maintaining one or more process control systems at a customer site. Such employees usually live near the customer site and report there for work on a daily basis.

The Generally Licensed gauge is generally just one small, component within the large and highly complex process control system. Service or testing that involves the Generally Licensed gauge is not a scheduled activity, but one relatively minor (In terms of total time spent) part of ongoing service activity at a location.

An individual performing service or repair on a Generally Licensed gauge usually does so in response to an immediate proble111 . A typical example is the replacement of a damaged source sensor head window which has been ripped. This problem is like essentially all problems that require service by a licensed individual: it does not present any immediate radiation safety hazard. However, it must be fixed immediately. If not, and the sensor is left in use. the sensor will soon cease to function correctly. If correction is delayed for many hours, is likely that necessary repairs will require removal of E"d

~easurex Page 3 the sensor from use and shipment of major components to the manufacturer.

In many cases, the firms in possession of the sensors rely on them to the extent that they must interrupt their manufacturing process if the sensors aren't functional. If a serious safety hazard exists, it is certainly reasonable to require that process control sensors be taken out of service, even if this means that a manufacturing line must be shut down. However, it is not reasonable to require delays in routine, but critical gauge service simply to allow for an advance notification period.

There appear to be alternative ways for the NRC to accomplish its stated inspection objectives. Two possibilities are described below:

1. The NRC already has information on where Generally Licensed gauges are located and could make visits to these sites to determine who is performing service and whether they are licensed to do so. In many eases, service personnel at an inspection site selected by the NRC could arrange to take gauges off-line long enough to demonstrate how typical service operations involving the gauges are performed.

2. The NRC could have persons/firms Specifically Licensed for service provide (periodically, or upon request) up-to-date information on sites that have fuli.time service personnel assigned, or where service visits are scheduled. Again, service personnel on site could usually arrange to demonstrate how typical service operations involving the gauges are performed.

Wording of Proposed Requirements for Specifically Licensed Distributors, Installers, and Service Groups [10 CFR 31.6(d*e)]

We find the wording in proposed regulations 10 CFR 31.6(d-e) to be confusing, For example, in (d) the term "the person" refers to the specifically licensed (whether by the NRC or an Agreement State) distributor, installer, or service group, while "each person who is responsible for ensuring compliance ... " seems to refer to one or more 08SL v98 80v NIWCT~/N!j X3~ns~3W W~E0:11 E6, 10 Nnr

easurex Page 4 representatives of the General Licensee in possession of the device.

In (e). if we understand it correctly, the representative of the General Licensee in possession of the device is referred to as "the individual responsible for service of the device.

These paragraphs would be less confusing if the terms were used consistently and definitions were included in the section, e.g.:

person: the distributor, installer, and/or service organization:

authorized for distribution, installation, and/or service on generally licensed devices either by a Specific License issued by the NRC or by the General License contained in this section.

r responsible individual: representative of the person or firm authorized for possession of a device by a General License contained Part 31.5 of 10 CFR; the individual identified in 31.5(C)(11)(ili).

We are also confused by the use of the term "each person" in 10 CFR 31.6(d). for eacb device transferred, is the licensed device distributor required to provide one copy of the General License (10 CFR 31.5) to the person identified in 31.S(c)(11 )(iii), or multlpte copies to various individuals, all of whom have some responsibility for compliance involving the single generally licensed device?

Shouldn't the reference to 31.5(c)(11) in the first sentence of 31.51a(c) be replaced with 31.5(c)(11)(iii)'?

Proposed Transfer Report Format [10 CFR 32.310]

The proposed transfer report format includes a column labeled "Serial Number". The regulations should clarify whether this is intended to be a device serial number or a sealed radioactive source serial number. If this is intended as a device serial number, this Implies a new reciuirement; to the best of our knowledge, individual thickness gauges have never been required to have serial number.

Reporting the serial number of the radioactive source presents no

easurex ".'

Page 5 particular problem . However, we note that 31.5(c)(8) specifically exempts General Licensees in possession of a gauge from being reQuired to report transfers to Specific Licensees when they are conducted for the purpose of obtaining replacement devices. The regulations proposed in 31.5(11) also do not require the General Licensee to provide updated information on source serial number.

This means that the source serial number the NRC has on file will not be corrected when a particular source is retumed to the distributor and replaced with another.

While these commenta are lengthy, we do want to emphasize that in most ways, the proposed regulations are good ones. We hope the few problem areas will be reconsidered and corrected and the regulations adopted.

Sincerely, MEASUREX CORPORATION

~~/fl~

Elsa Nimmo Radiation Safety Officer CC: Robert Funderburk Thomas Hill 9"d

FACSIMILE TRANSMISSION COVER SHEET MEASUREX CORPORATION LEGAL DEPARTMENT ONE RESULTS WAY CUPERTINO, CALIFORNIA 95014 Tel: (408) 255*1500, Ext. 2094 Fax: (408) 864-7580 TOTAL NO. OF PAGES:_§_ (INCLUDING THIS PAGE)

DATE: June 1, 1993 FAX: 301-504-1672 TO: Emile Julian NUCLEAR REGULATORY COMMISSION FROM: Charles Van Orden General Counsel

SUBJECT:

Proposed Changes to Requirements for the Possession and Distribution of Industrial Devices MESSAGE: You requested another copy of our 3 March 1892 comments.

BOCKET NUMBl:ft .

Pl I

PROPOSED RULE 3~ 2.

CGj F R 56 2.h)

• 93 MAR 29 P~ :09 March 25, 1993 AmershamHoldings,lnc.

2636 S. Clearbrook Drive Arlington Heights, IL 60005 The Secretary U.S. Nuclear Regulatory Commission tel (708) 593-6300 Washington, D.C. 20555 Attention: Docketing and Service ,,.Amersham T Health Science Group Re: Requirements Concerning the Accessible Air Gap for Generally Licensed Devices RIN 3150-AD82 TR 57,229, 56287-56292

Dear Sir:

I am writing on behalf of Amersham Corporation in response to your request for comments on the above proposed rule.

Amersham supplies a wide variety of radioactive materials, including sealed sources used in industrial applications. Our product range includes static eliminators, which are generally licensed devices.

From our perspective, the proposed changes are the result of a very thorough review and are reasonable.

We do take this opportunity to urge again for the maximum compatibility possible between NRC and Agreement State regulations, since it facilitates business for companies and manufacturers like Amersham that conduct business nationwide. So we request that this proposed rule, when adopted, be one for Division I compatibility. With variation in state regulations, it becomes increasingly time-consuming to ensure compliance with all applicable regulations.

My phone number is (708) 593-6300, extension 379, should you have questions concerning my comments.

l"\L!l~ l r .r"Raker, Ph.D.

Corporate Manager Nuclear Licensing and Industrial Liaison BWB/jc Acknowledged by card ....!~. :!. :.:.:S

t'.1. tJUC'. ~)i=: r,EGULATORY COMMISSIOI".

DC(' : 1NG & SERVICE SECTION

_-,;-,-ir,E Or THE SECRETARV OF THE COMMISSION

March 25, 1993 AmershamHoldings,Inc.

2636 S. Clearbrook Drive Arlington Heights, IL 60005 The Secretary U.S. Nuclear Regulatory Commission tel (708) 593-6300 Washington, D.C. 20555 Attention: Docketing and Service rAmersham Tbe Hea/t/; Science Gro11p Re: Requirements Concerning the Accessible Air Gap for Generally Licensed Devices RIN 3150-AD82 TR 57, 229, 56287-56292

Dear Sir:

I am writing on behalf of Amersham Corporation in response to your request for comments on the above proposed rule.

Amersham supplies a wide variety of radioactive materials, including sealed sources used in industrial applications. Our product range includes static eliminators, which are generally licensed devices.

From our perspective, the proposed changes are the result of a very thorough review and are reasonable.

We do take this opportunity to urge again for the maximum compatibility possible between NRC and Agreement State regulations, since it facilitates business for companies and manufacturers like Amersham that conduct business nationwide. So we request that this proposed rule, when adopted, be one for Division I compatibility. With variation in state regulations, it becomes increasingly ti..'lle"'consuming to ensure compliance with all applicable regulations.

My phone number is (708) 593-6300, extension 379, should you have questions concerning my comments.

"\L."U:~rr. aker, Ph.D.

Corporate Manager Nuclear Licensing and Industrial Liaison BWB/jc

rT N BR Apgee Corporation lS, FR,St L::,32.

Hopewell Business & Industrial Park* 103 Corporation Drive* Aliquippa, Pennsylvania 15001

• Telephone: (412) 378-1900

• Fax: (412) 378-1926 March 24, 1993

• 93 MA 26 P3 :Q 3 The Secretary U.S. Nuclear Regulatory Commission Washington DC 20555 ,_ * ** *,t

t. Jc-Kl 'v r Attention: Docketing and Service Branch Gentlemen:

This concerns amendment of requirements for the accessible air gap for generally licensed devices (57 FR 56287, published November 27, 1992)

We are not aware of any pressing health and safety problem which the proposed amendments would remedy. Thus we endorse the three year interval for manufacturers and users to come into compliance.

We would like to see regulatory guidance, perhaps in the form of an NRC Regulatory Guide similar to R.G. 10.10, be made available early in the three year period.

We recommend that NRC and State regulations be the same and that both the NRC and the States participate in development and use of the Regulatory Guide.

Apgee also supports the positions expressed by Berthold Systems Inc, in their letter to you of March 19, 1993.

Thank you for the opportunity to comment on the proposed rule.

APGEE Whi Little Vice President cc: Richard Santorum - U.S. House of Representatives Austin Murphy - U.S. House of Representatives Ron Klink - U.S. House of Representatives Acknowledged by card .......... .t.l.~.. m*

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BERTHOLD SYSTEMS, INC.

Process Control Instrument Hopewell Business & Industrial Park 1 01 Corporation Drive Al1qu1ppa, Pennsylvania 15001-4863 March 19, 1993 ,1 .~i;ilephone : [412) 378-1900 P, . T@efax: (412) 378-1926 Telex : 988393 [BRTHLD SYST UO)

The Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555 Attention: Docketing and Service Branch Gentlemen:

SUBJECT:

Proposed Regulations Concerning Certain Generally Licensed Devices.

We offer the following comments on the proposed requirements concerning the accessible air gap of generally licensed devices (57FR 56287, published 11/27/92).

1. In the long accepted American National Standard N538, "Classification of Industrial Ionizing Radiation Gauging Devices",

most measurement distances are from the nearest accessible surface

- of the source housing to the point of interest. Consistent with this practice and your guidance for NRC inspectors, we recommend that the 45 cm distance referred to in your proposal be not from the radiation source as proposed. We recommend that the proposed section 31.5 (b)(2) be revised to read, in substance:

" .... radiation beam of the device at 45 cm (18 inches) from the radiation source housing or, if the radiation source is mounted external and adjacent to the vessel, from any inside vessel surface with the device shutter ..... " .

In addition to being consistent with ANSI N538, this change would Acknowledged by car!.!. :.~. ~:::,,..,,,..,n

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help in determining compliance with the requirement. It would be difficult to determine, in the field, the exact location of the radiation source, rende r ing the measurement difficult if not impossible. The inside surface of the vessel is a readily available end point for the 45 cm (18 inch) distance measurement.

It may be noted that ANSI N538 has long been recognized by the NRC in Draft Regulatory Guide TP 102-5, "Safety Feature s of Gauges Containing Radioactive Material", and in Regulatory Guide 10.10, "Guide for the Preparation of Applications for Radiati on Safety Evaluation and registration of Devices Containing Byproduct Material."

2. The proposed paragraph 31.5(b)(3), second provision, appa rentl y assumes that the radiation source would be shielded in all directions except for a collimated beam which is directed at the detector. This assumption is not necessarily correct in all situations. For example, a radiation source could be contained in a "dip tube" which could be 40 cm from the vessel's nearest inner wall and the detector located at the nearest outer surface of the vessel. In this situation, the wording of the proposed rule would

- place no limit on the acceptable radiation leve l within the tank.

If an individual (a) ignored caution signs at the entrance, and (b) ignored commonly followed procedures, the individual could receive unnecessary exposure.

We recommend that 31.5(b)(3) be revised to read, in substance:

" ... the vessel is prohibited; or if foreseeable circumstances suggest an occasional infrequent entry by one or more individuals, then (i) each logical access point shall norma lly be secured, shall be posted with the radiation caution symbol and the statement 'Radiation 2

Area - Check to ensure that the shutter is closed before entering', and (ii) the radiation dose rate at 45 cm from any surface within the vessel, with the device shutter, if any, in the open position, shal 1 not exceed 125 mRem/hr."

The requirement to provide a caution sign and statement at all logical access points has long been a condition of our Company's registration certificates. To the best of our knowledge, no generally 1 icensed user of any Berthold manufactured gauge has ever been over-exposed.

The above suggested posting, together with a limit on radiation levels within the vessel to restrict exposures if the posting were ignored, would allow certain users to continue operations without incurring the expenses associated with converting to a specific license.

Also, a level of 125 millirem per hour at 45 cm will encourage manufacturers to use smaller sources and more sensitive detectors.

This has always been the practice of Berthold.

3. The Statement of Considerations for the proposed rule invited comment on consistency between NRC regulations and Agreement State regulations.

As a nationwide distributor of gauges, we urge that the NRC and Agreement State regulations be exactly the same for devices used under general license. We aim to comply with all State and NRC regulations. Significant differences among the various sets of regulations would add to administrative costs and could necessitate more expensive custom installations in some jurisdictions.

3

Section 274 of the Atomic Energy Act of 1954, as amended, mentions the promotion of an orderly regulatory pattern between the Commission and State governments with r e spect to use and regulation of byproduct mat erials. Any inconsistency between NRC and State requirements for the distribution of gauges used under general l i cense would seem to depa rt from an orderly pat t ern.

4. Our careful re a ding of the Statement of Considerations, Draft Regulatory Analysis dated Feb. 1992, and Draft Environmental Assessment dated Feb. 1992, did not uncover an indication that

- users of gauges under general license are now being overexposed.

Accordingly, there does not appear to be a need for i mmed iate implementation. Appare ntly, the proposed changes are based more on "good engineering judgement" than on a pressing health and safe ty problem.

I f our a bove comments are adopted in the final rule, and in the absence of new and adverse experience, we believe that 3 years is a reasonable interval for distributors and users to come into compliance with the changes.

BERTHOLD SYSTEMS, INC. ~

//

~-P' G.M. (Bud) Smith, Jr.

President cc: Richard Santorum, House of Representatives Austin Murphy, House of Representatives Ron Klink, House o f Representatives 4

DOCKET NUMBER Pf=tO?OSED RULE PR J:j_ 32-ohmart CO RP O R AT I O N (51 F(l 56:L'iri)

March 22, 1993

• 93 HA 23 P4 :20 I ~

Secretary lJ ),; ' I I ~"

U.S. Nuclear Regulatory Commission I  ! r Washington, D.C. 20555 I"'

Attn: Docketing and Service Branch (f)

Reference:

Proposed Rule Change 10CFR Parts 31 & 32 RIN 3150-AD82 Federal Register Vol. 57, no. 249 Gentlemen:

As a small manufacturer of gauging devices distributed to General Licensees, we have a number of comments.

First, to establish a baseline for our comments, we maintain a NRC license which permits the distribution of certain products to General Licensees. We also maintain an Agreement State License for another facility which permits the distribution of certain other products to General Licensees. In addition, we maintain reciprocity agreements with most agreement states.

In general, we agree with the philosophy of the proposed rule changes. The NRC's position that general licensees need more guidance is well founded. It has always been the Ohmart Corporation's philosophy that we train the user at gauge start-up and try to maintain a relationship with them to insure that the gauge is being properly cared for; but if the licensee does not want us to maintain that contact, we have no means of tracking the continuing safety of the equipment. Regular agency contacts would remind the users that they have a responsibility to their employees for the safe use of the equipment and to that agency to safeguard the by-product material.

With regard to agreement state compatibility, we feel very strongly that this should be an area of direct compatibility. Having many sets of design criteria would only confuse the issue for manufacturers and would be a constraint of interstate trade. The real area of concern is what exposure the workers would likely receive. This area is best addressed by the sections of agreement state rules that follow 10 CFR parts 19 and 20. If you think of radiation sources as one of the many work place hazards that require documented training, and require reasonable levels of training. Then with training many of the exposure related problems will be resolved prior to the potential exposure.

MAY 11 1993~

Acknowledged by card ................."'"""'"""'

THE OHMART CORPORATION

• 4241 ALLENDORF DRIVE , CI NCINNATI , OHIO 45209 * (513) 272-013 1

• TELEX 21-2071 OHMUSA-UR

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We also feel that categorically eliminating level gauges on vessels is not being consistent with the regulations for other gauge types for several reasons. Exposures calculated for individuals who have entered a vessel with the source on, typically assume a worst case of the vessel being on consistent level of radiation. When, in fact, the radiation beam is typically very tightly collimated, so only a narrow cone or vertical plane is the beam. Since the source holder is mounted on the outside of the vessel, generally several inches from the wall, and the wall thickness shields some of the radiation beam, the potential for exposure is actually less than some other types of gauges. No special equipment is required to detect that the source has been closed because the gauge electronics will show that the radiation beam is not present when the source is closed. In addition several methods of mechanical or electrical interlocks could be used to ensure that the source is closed prior to vessel entry.

Vessel entry is very closely controlled as part of 29 CFR 1910.146. It would be consistent to consider ionizing radiation as "other recognized serious safety and health hazards".

Then the vessel entry by unauthorized and untrained personnel would be unlikely.

Written lock-out procedures that explain necessary compliance with the applicable parts of the OSHA regulation could be supplied by the manufacturers. This would give the end user one set of regulations to follow for vessel entry.

Finally, there are many applications of nuclear gauges on vessels that make measurements that improve worker and environmental safety. The NRC's position that if a general license is not available for a particular gauge, then the user can just get a specific license is not reasonable. A specific license will cost several thousand dollars a year. Many of our customers cannot afford to pay these fees. As a result they have removed gauges or refuse to buy nuclear gauges. This loss of business is of great concern to us not only for monetary reasons. We are also concerned about the potential hazard to people and the environment because a necessary measurement is not being made because regulations have made it too expensive.

Sincerely, THE OHMART CORPORATION

~~~~~

George W. Brown Radiation Safety Officer Training Manager

~~ I oocK:::T NUMBER PR 3 I J 2.

~ohnson PRCPOS£:D RULE J

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[I[fffil (51rR562rV S.C. Johnson & Son, Inc.

1525 Howe Street Racine, WI 53403-5011 Phone: (414) 631-2000

'93 JPJ 11 r~ ') :S 8 January 5, 1993 Attn: Docketing and Service Branch The Secretary U.S. Nuclear Regulatory Commission 9 Washington, D.C. 20555 RE: RIN 3150-AD82 - "Requirements Concerning the Accessible Air Gap f or Generally Licensed Devices". dated November 27. 1992 at 57 FR 56287-92 Sir:

Enclosed are our comments regarding NRC's proposal to provide for control over radioactive byproduct material in certain measuring, gauging, and controlling devices with both an accessible air gap and radiation levels that exceed specified values. This proposed rule was published on November 27, 1992 at 57 FR 56287-92 under:

RIN 3150-AD82 - "Requirements Concerning the Accessible Air Gap for Generally Licensed Devices".

S. c. Johnson and Son, Inc. (SC J ohnson) wishes to than NRC for providing us this opportunity to submit comments on its proposal.

We hope that our limited comments assists NRC in its development of a cost-effective and reasonable rule.

If you would like to discuss these comments further, please f~el free to contact me at 414/ 631-3570.

Sincerely yours, I~

Gene I. Matsumoto Consulting Engineer u.s. Safety and Environmental Affairs GIM/goa 3093G JAN 2 1 1993 Enclosures Acknowledged by card ..................................

c G. A. Krieger

c. M. Richards T. T. Stocksdale

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SPECIFIC COMMENTS 31.5 Certain Measuring. Gauging or Controlling Devices

1. Part 31.S(b) (2) does not "tie" source strength to the air gap together.

Part 31.S(b) (2) states that a "device which has been manufactured and installed:

i. So that the air gap between the radiation source and detector of the device is less than 45 cm (18 in.)

ii. So that the air gap of the device would not allow the insertion of a 30 cm (12 in.) diameter sphere into the radiation beam of the the device without removal of a barrier, m;: (emphasis added) iii. So that the radiation dose rate in the radiation beam of the device at 45 cm (18 in.) from the radiation source with the device shutters , if any, in the open position does not exceed 125 millirem per hour" may receive a general license 3 years after the effective date of the final rule. As written, (i), (ii), and (iii) are independent conditions for receipt of a general license. Thus, condition (i)

[or (ii) or (iii)] alone would be sufficient to receive a general license.

Under one scenario, this means that a device having a 18 inch air gap but failing to meet condition (ii) and/or (iii), could still receive a general license. This, however, was not NRC's intent.

[A variation of this scenario, would consist of a device meeting condition (i) and (ii) but not (iii) of this Part. As currently written, such a device could still receive a general license no matter how "hot" the source.]

We suggest NRC rewrite this part by replacing the word "or" that is now between condition (ii) and (iii) with the word "and". By so doing, the revised wording will meet NRC's intent by "moving" all devices of concern to require a specific license.

2. The 30 cm (12 in.) diameter sphere criteria in condition (ii) of 51.5(b) (2) is redundant.

Part 31.5(B) (2) proposes three conditions for a device to still receive a general license. Condition (ii) requires the air gap to be designed "not allow insertion of a 30 cm (12 in.) diameter sphere into the radiation beam of the the device without removal of a barrier: condition (i), requires the device's air gap to be less than 45 cm (18 in.).

Page 2 These two conditions can readily be reduced to a single condition by "reducing" the air gap under condition (i) to 30 cm (12 in.).

This change will make condition (ii) redundant. Unless there is an unstated reason for maintaining two separate conditions under this proposal, we suggest that NRC modify condition (i) along the above and eliminate condition (ii).

3. The term "entry" in Part 31.SCb>P> is should be defined.

Part 31.S(b) (3) covers devices installed on vessels (e.g., pipes, tanks, etc.) if the vessel does not need to be entered under any foreseeable circumstances and casual vessel "entry" is prohibited. NRC's stated intent is to eliminate "the potential for radiation exposure of major parts of the body, not extremities." (emphasis added)

Under the proposed Occupational Safety and Health Administration

[OSHA] standard on confined space e ntry, "entry" has been defined as "any action resulting in any part of the employee's face break-ing the plane of any opening of the confined space and includes any ensuing work activities inside the space". Therefore, under OSHA's definition, a worker can "enter" a vessel by just putting his head inside of the tank; he does not need to place his entire body into the tank.

This means that a vessel less than 30 cm (12 in.) in diameter can be entered under the OSHA definition; the NRC, however, requires that the vessel be at least 45 cm (18 in.) in diameter before it can be entered. This discrepancy needs to be addressed.

We recommend that NRC clarify what is meant by the term "entry" under Part 31.S(b) (3). Specifically, we suggest that NRC "tie" its definition of "entry" to the potential for a worker placing his body between the source and detector of the device. Because the NRC's definition of "entry" will differ from that under OSHA, we would suggest that it be explicitly defined rather than allow the OSHA definition to be applied.

4. Part 31.S(e) (1) and (2) should have the same date for the submission of an application for a specific license.

Part 31.4(e) (1) requires the submission of an application for a specific license "3 years after the effective date of the final rule". Part 31.4(e) (2) allows for the continuation of a general license if the application for specific license is submitted no later than 11 30 days prior to 3 years after the effective date of the final rule" (emphasis added). We see no reason for the two dates to be different.

Page 3 Nothing in the proposal indicates why there is this difference.

Unless NRC has a "reasonable" explanation for such a difference, we suggest that both dates should be the same. We would prefer, however, 11 30 days prior to 3 years after the effective date of the final rule" in order to assure continuation of the general license until a final determination on the application has been reached by the Commission.

5. Physical modification of the "accessible air gap" should not be the only option to maintain a general license.

The NRC would allow general licensees to either obtain a specific license for the device or have the area surrounding the device to be physical ly modified to eliminate the " accessible air gap". We urge NRC to consider alternatives to this requirement.

A device may be "guarded by location" to limit routine access to the air gap. Such "guarding by locat ion" would include placement of the device 10 or more feet off the floor or into a corner of a room. In both cases, access to the device is restricted causing the air gap to be less "accessible".

For devices "guarded by location", there is no need to construct a barrier (e.g., 6 foot high chain link fence) or interlocks to make the air gap "inaccessible" simply because its very location does this. We urge NRC to consider this as an alternative means to maintaining a general license when it is appropriate to do so.

Chi.. ED USN[<J:590-0 l]

• 92 NOV 20 P3 :59 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 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 devices under the NRC's general license.

1

3~~

DATES: The comment period expires [120 days following publication in the Federal Register]. Comments received after this date will be considered if it is practicable to do so, but assurance of consideration cannot be given except for comments received on or before this date.

ADDRESSES: Mail written comments to: The Secretary, U. S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docketing and Service Branch.

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 exami ned at the NRC Public Document Room, 2120 L Street NW. (Lower Level),

Washington, DC.

FOR FURTHER INFORMATION CONTACT: Donald Hopkins, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, 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 Commission) amended its regulations to establish a general license for the use of radioactive byproduct material contained in certain luminous, measuring, gauging, and controlling devices.

The general license permitted the use of specially approved devices, designed 2

V 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 I

devices in the conduct of their business under the general license included (1) connnercial 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 determination of the adequacy of the licensee's training, experience, and radiation safety program by the regulatory authority was unnecessary.

The practice of using a device under a general license grew over the years. There are currently some 450,000 devices in use by about 35,000 general licensees in non-Agreement States where the NRC licenses and otherwise controls the use of these devices. In Agreement States, where State regulatory agencies control the use of the devices, there are about twice this number of generally licensed devices. In 1989, there were 54 vendors of generally licensed devices licensed by the NRC. There were 76 vendors licensed by Agreement States. The regulatory framework and process have changed little over the past three decades.

Studies conducted by the NRC in 1984, 1985, and 1986 revealed several areas of safety concern about the use of some sealed source devices under general license. Investigators observed that accountability for some devices was inadequate and that users were frequently unaware of regulations which applied to them. Furthermore, some devices could not be located and final disposition of some devices could not be determined by the user or the NRC.

3

A follow-up survey of a sample of general licensees possessing gauging devices, laboratory analytic devices, and tritium-activated exit lights containing radioactive byproduct material was completed in 1990. The survey was designed to obtain information about the respondents' knowledge of the regulatory requirements for general licensees, and their practices and procedures concerning maintenance, testing, and disposition of the generally licensed devices. Although a high proportion of the general licensees, particularly gauge licensees, displayed knowledge of the regulatory requirements and compliance with them, the survey indicated the possible need for further regulatory attention in some areas, most notably the possession and use of tritium-activated exit lights.

Based on the results of the earlier studies and the recent survey, the NRC concluded that the general license program should be continued, but with some modification. The possibilities considered included the following:

1. Quality assurance program for vendors;

2. Third-party testing of generally licensed devices;

3. Ultimate disposition of byproduct sources;

4. Upper bound on source size permitted under general license; and 5 Responsibilities and communications.

From these choices, a decision was made in 1990 to proceed by rulemaking with an NRC program for corresponding by mail with general licensees. This program of correspondence by mail is being developed to ensure that the general licensees are aware of and understand the requirements attendant to possession of these devices. This will be accomplished through (1) an initial verification by the NRC of the information regarding the identification of the device and people responsible for the device collected at the time at which 4

the general licensee takes possession of the device, and (2) periodic follow-up by the NRC to remind general licensees of their regulatory responsibilities and to verify the currency of the information on possession and use of these devices. This communication program will affect approximately 35,000 general licensees who possess an estimated 450,000 devices containing byproduct material. The Notice of Proposed Rulemaking to implement this p.rogram was published in the Federal Register on December 27, 1991 (56 FR 67011).

The rulemaking presented in this Notice of Proposed Rulemaking, viz., to place an upper bound on the radioactive source size permitted under general license in a gauge devi~e which has an accessible air gap between the source and detector of the device, is another action proceeding from the results of the above studies. The 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 radiation exposure to plant personnel. The NRC estimates that there are some 3000 gauges which use a large enough radiation source to be a potential problem. The gauges are in the possession of about 750 general licensees. This action and the program of e corresponding with licensees provide the minimum cost-effective improvements needed to respond to the problems identified in the general license program.

Discussion The gauges identified as needing improved regulatory control are those which both have a somewhat higher radiation level and have been installed so that there is a sufficiently large air gap between the radioactive sealed source and the gauge detector such that an untrained or careless worker could 5

place his or her body directly in the radiation beam. Many gauges contain a small enough quantity of radioactive material so that even with a large 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 specific licenses.

Notwithstanding, general licensees who currently possess such gauges would have the option of having the area around those gauges physically modified to eliminate the accessible air gap. General licensees who exercise this option would not be required to become specific licensees. The NRC estimates that the 3000 or so gauges that are the subject of this rulemaking (one-half percent of the general licensed devices) are used by approximately 750 general licensees (2 percent of the total number of general licensees). The NRC is not considering specifically licensing over 97% of the general licensees and over 99% of the devices. Further, the lower cost option to provide passive controls in lieu of specific licensing, where feasible, is also provided in this proposed rule.

The size of the air gap addressed by this proposed rule is a gap of 45 cm (18 in.) or greater between the radiation source and detector, shaped in such a way so as to allow insertion of a 30 cm (12 in.) diameter sphere into the radiation beam without the removal of any barrier. The proposed rule would define such a gap as an 11 accessible air gap." The specification is a reasonable limit to restrict access of a person's torso. An air gap which is 45 cm (18 in.) or greater between the source and detector but is enclosed by a wire mesh or other barrier would not be considered an 11 accessible air gap 11 under this proposed rule provided the barrier is configured so that a 30 cm 6

(12 in.) diameter sphere could not be placed in the radiation beam without the removal of the barrier.

The magnitude of the radiation level of concern which would be addressed by this rule change is 125 millirem per hour or greater at 45 cm (18 in.) 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 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> of direct radiation exposure in a calendar quarter at a distance of 45 cm (18 in.) from the radiation source as a result of unlikely and careless practices. This would result in a quarterly exposure of less than 125 millirem, which is one-tenth the radiation exposure limit for occupationally exposed workers. This corresponds to the dose restriction for general licensees in NRC regulations (10 CFR 32.51 (a)(2)(ii)). The 45 cm (18 in.) specification corresponds to a guideline set forth for NRC inspectors that a radiation level must extend 45 cm (18 in.) 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 the body is within the 45 cm (18 in.) 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. An exception to this "practical consideration

statement is a situation where individuals enter for cleaning, maintenance, or any other reason, a vessel on which a radioactive gauge has been installed.

If it is possible that the gauge shutter could be left open, exposing the individual who entered the tank, greater radiation exposures could result than are thought reasonable for generally licensed operations. General licensees are not generally trained or equipped to quickly discover a radiation problem 7

which is causing undue radiation exposure of plant workers. That is why the proposed rule in § 31.5 (b)(2) would prohibit the use of vessel gauges under general license.

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 restrict and control access to those gauges, or have the area around the gauges physically modified to eliminate the 11 accessible air gap," and hence not be required to obtain a specific license. Although this physical modification, as with all installation and servicing of the gauge, would need to be performed by a person with a specific license that authorizes him or her to perform this type of activity, the Commission views it as a lower cost alternative to obtaining a specific license.

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 violation. It is the Commission's intent to provide a separate assessment scheme for these violations should the proposed rule be finalized. It is expected that each source which is 8

possessed in violation of the rule would be subject to a separate assessment of $600. Except for the identification factor in Section VI.8.2.(a) of 10 CFR Part 2, Appendix C, this penalty would be assessed without regard to the normal assessment factors in Section VI.B.2. The penalty would be assessed without normally holding an enforcement conference. The written response required by 10 CFR 2.201 and 2.205 should provide sufficient information for regulatory 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.

Connnents From Agreement States A draft of this proposed rulemaking was provided to the Agreement States for their review and comment. Agreement States are those States which have entered into an agreement with the NRC or its predecessor Atomic Energy Connnission to regulate persons within their States who have in their possession byproduct, source, and special nuclear material. This allows NRC to discontinue exercising most regulatory control over radioactive materials used in the State. However, NRC is required to assure that the State program is compatible with the NRC program and is adequate to protect the public health and safety. The Atomic Energy Act of 1954, as amended, authorizes and directs the NRC to cooperate with the States in the formulation of standards for protection against hazards of radiation to assure that State and NRC programs for protection against hazards of radiation will be coordinated and compatible.

9

Of the 23 Agreement States that acknowledged their receipt of the draft rule for comment, 17 offered specific comments. Those comments have all been considered. None of the States objected to the publication of the proposed rule. Nine of the States agreed that the draft rule treated at least part of the generally-licensed device problem and should be proposed. Five States asked what help would be available to them to identify the gauge installations which require corrective action. The NRC is prepared to share with them the information and search techniques to identify gauge installations in need of corrective action. On the issue of the period of time over which the corrective action on the gauges would be implemented, all the Agreement States commenting urged a shorter time period than the 3 years in the draft NRC notice. Because the time period proposed in the draft notice is based on the licensing/inspection resources available to the NRC for this project, no changes have been made in that schedule. The NRC plans to work with the States, encouraging them to provide advance notice to their licensees of this upcoming action, in order that the Agreement States implementation of compatible new rules restricting accessible air gaps on generally licensed devices could be completed at the same time as the NRC implementation of its rules.

While the c-0mments of five States supported the criteria for defining "accessible air gap 11 in the draft rule, seven States commented that further consideration should be given to a more conservative approach in two areas.

First, it was suggested that the rule eliminate large tanks with level gauges from the generally licensed device category. The NRC agrees that gauges on large tanks which are manually cleaned from the inside should be specifically licensed and has clarified that position. Second, the suggestion was made to 10

extend the rule to protect body extremities. Based on its decision to effect the minimum cost-effective improvements needed to respond to the problems identified with the general license program, the NRC believes this rule change should be limited to eliminating the potential for radiation exposure of major parts of the body, not extremities. As an example, even assuming a radiation dose rate inside an air gap of 250 mrem/hour, an individual would have to keep a hand in the beam more than 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> per year to exceed a dose to the extremities of 5000 mrem per year, one-tenth the dose limit now imposed by 10 CFR Part 20 for occupationally exposed individuals. Based on this consideration, the NRC demurs with regard to extending the rule to protect body extremities.

Of the seven States submitting specific comments on the proposed radiation level in an accessible air gap below which no action would be required, only two States supported the 125 mrem/hr at 45 cm (18 in.) in the draft rule. Several States questioned the NRC's estimate that persons exposed to radiation in an accessible air gap of a gauge would not be so exposed for as much as 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> per calendar quarter but provided no rationale for that contrary view. Nonetheless, in the NRC's view, all the characteristics of a gauge serve to limit the time a person could be exposed in an accessible air gap. During normal gauging, the material being gauged is flowing through the air gap, preventing the presence there of any individual. When not operating, the normal condition of the gauge is to have the source shutter closed, shielding any significant radiation from the air gap. Most generally, licensed gauges utilizing radioactive material are designed with a "fail-safe" shutter mechanism which automatically shields most of the radiation when the gauge is not being operated. If the shutter were left open (or if there were 11

no shutter), warnings from the operator and from the warning labels on the gauge would normally deter any individual from positioning his/her body so as to expose it to radiation. There is little reason to believe that even an untrained worker could easily find a way to expose his/her body to significant radiation levels (except perhaps in conducting normal maintenance inside a large tank) for any significant time.

Two States commented that the radiation level limits should be related to permitted exposures of members of the general public on the basis that individuals who are untrained in radiation safety, even though occupationally exposed, should be considered members of the general public. Other States suggested that the radiation level limits should be related to the definitions of "radiation area" (5 mrem/hr at 30 cm (12 in.)), or "high radiation area" (100 mrem/hr at 30 cm (12 in.)), or to other doses or dose rates which are lower than those proposed in the draft rule on the basis of making the gauge restriction equal to one of the many existing limits in the NRC's radiation safety standards in 10 CFR 20, "Standards for Protection Against Radiation."

These suggestions relating to consistency with Part 20 standards were

• seriously considered by the NRC and thought to have merit. In the final analysis, however, the NRC has given greater weight to the following practical considerations in reconunending that the accessible air gap rule be proposed using the original criterion of 125 mrem per hr at 45 cm (18 in.) from the radioactive source:

1. Based on discussions with manufacturers and users of these gauges, it is the NRC's understanding that most general licensees possess radiation profiles of their gauge environs, provided to them by the gauge installer, which characterizes the gauges in terms of radiation levels produced by the 12

gauge at 45 cm (18 in.). In the NRC's opinion, using a criterion related to the way in which a gauge is characterized is a practical means of distinguishing those gauges that should be specifically licensed from those that can remain generally licensed. If we were to change the distance at which the radiation level criterion is measured so that the relationship between the radiation profile and criteria of this rule is not readily discernable to the general licensee, the radiation profile would lose its value and the general licensee would become more dependent on outside expertise in deciding whether a particular gauge falls within the criteria of this rule.

2. The criterion of 125 mrem per hour at 45 cm (18 in.) from the gauge's radiation source was chosen as a reasonable specification related to a radiation exposure of 500 mrem in 1 year, and to actual gauges which have been distributed under general licenses. The NRC recognizes, however, that other radiation level and other radiation exposure standards could be chosen which are also acceptable. The NRC sees no substantial improvement in changing the criterion from 125 mrem per hour at 45 cm (18 in.) to 100 mrem per hour at 45 cm (18 in.) or to 100 mrem per hour at 30 cm (12 in.) as have been suggested, although these criteria would be acceptable. On the other hand, the other suggestions of radiation level criteria of 5 mrem per hour at 30 cm (12 in.), 2 mrem per hour, and radiation exposure criteria of 50 mrem per year are extremely low for purposes of this rulemaking. However, for the purpose of allowing Agreement States to impose more stringent criteria in their jurisdictions should they wish to do so, the NRC supports Compatibility Division II for this rule.

13

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 45 cm (18 in.) dimension and allowing insertion of a 30 cm (12 in.) 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 45 cm (18 in.) 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.

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;

4. The costs that might result from physically modifying the areas around the devices or obtaining specific licenses; and

5. The specification of Compatibility Division II for Agreement State compatibility, which will allow States to set different, more restrictive limits for this rule when it is finalized and subsequently adopted in State regulations. NRC is particularly interested in comments from manufacturers and distributors on the impacts associated with this level of Agreement State compatibility, and whether this involves matters of interstate commerce.

14

Finding of No Significant Environmental Impact: Availability The proposed amendment, if adopted, would not result in any activity that significantly affects the environment. The Commission has determined 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 a major Federal action significantly affecting the quality of the human environment and, therefore, an environmental impact statement is not required.

The proposed amendments, if adopted by the NRC and as implemented by licensees, would likely result in a potential gain in radiation protection by reducing the frequency and likelihood of unnecessary radiation exposures. It is expected there would be no additional radiation exposure to individuals or the environment f~om any physical modification of gauges to satisfy the requirements of this proposed rule. The environmental impact assessment forming the basis for this determination is available for inspection at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.

Paperwork Reduction Act Statement 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.).

This proposed rule has been submitted to the Office of Management and Budget for review and approval of the paperwork requirements.

The public reporting burden for this collection of information is estimated to average 14 hours1.62037e-4 days <br />0.00389 hours <br />2.314815e-5 weeks <br />5.327e-6 months <br /> per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the 15

data needed, and completing and reviewing the collection of information.

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, Washington, DC 20555, and to the Desk Officer, Office of Information and Regulatory Affairs (3150-0120, 3150-0028 and 3150-0017),

NEOB-3019, Office of Management and Budget, Washington, DC 20503.

Regulatory Analysis 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.

Regulatory Flexibility Certification Based on information available at this stage of the rulemaking proceeding and in accordance with the Regulatory Flexibility Act, 5 U.S.C. 605(b), the NRC certifies that, if promulgateda this rule will not have a significant economic impact on a substantial number of small entities.

The NRC has adopted size standards that cl,assify a small entity as one whose gross annual receipts do not exceed $3.5 million. The proposed rule affects 16

about 750 persons using 3000 gauges under this general license. Many of the users would be classified as small entities. If these users were 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; $6,100 every subsequent fifth year; and

$4,000 for all other years, for an average annual cost over a 15-year period of $4,807. The 225 licensees who are estimated to already possess a specific license (even though using gauges under a general license) would have a one-time additional cost of $780 to add the generally-licensed gauges to their 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 gap of the gauge inaccessible by any number of means, such as building a 17

barrier around the air gap, locking the area where the air gap exists, or by interlocks where no one can enter the area while the radiation source 1s in the exposed position, that person would not be required to obtain a specific license. Although this alternative may be impractical in some cases because 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 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.

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 seeking comment from small entities (i.e., small businesses, small 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 modified to take into account the differing needs of small entities should specifically discuss the following:

(a) The size of their business and how the proposed regulations would result in a significant economic burden upon them as compared to larger organizations in the same business community. Commenters should provide specific information concerning physical barrier construction costs.

18

Commenters should also indicate specific reasons why the physical protection alternative may not be appropriate for them.

(b) How the proposed regulations could be modified to take into account the differing needs or capabilities of small entities.

(c) The benefits that would accrue, or the detriments that would be avoided, if the proposed regulations were modified as suggested by the connnenter.

(d) How the proposed regulations, as modified, would more closely equalize the impact of NRC regulations or create more equal access to the benefits of Federal programs as opposed to providing special advantages to any individuals or groups.

(e) How the proposed regulations, as modified, would still adequately protect the public health and safety.

Backfit Analysis The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply to this proposed rule, and therefore, a backfit analysis is not required I

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)(l).

19

List of Subjects in 10 CFR Parts 31 and 32 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 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, 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 MATERIAL

1. The authority citation for Part 31 continues to read as follows:

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).

Section 31.6 is also issued under sec. 274, 73 Stat. 688 (42 U.S.C.

2021).

For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273);

§§ 31.5(b) and (c) (1)-(3) and (5)-(9), 31.8(c), 31.lO(b), and 31.ll(b), (c),

and (d) are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C.

220l(b); and §§ 31.5(c) (4), and (5), and (8), and 31.ll(b) and (e) are issued under sec. 1610, 68 Stat. 950, as amended (42 U.S.C. 2201(0)).

20

2. In § 31.5, paragraph (b) is revised and paragraph (e) is added to read as follows:

§ 31.5 Certain measuring, gauging or controlling devices.

(b) The general license in paragraph (a) of this section:

(1) Applies only to byproduct material contained in devices which have been manufactured or initially transferred and labeled in accordance with the specifications contained in a specific license issued pursuant to § 32.51 of this chapter or in accordance with the specifications contained in a specific license issued by an Agreement State which authorizes distribution of the devices to persons generally licensed by the Agreement State; (2) Applies after (3 years after the effective date of this rule) only to byproduct material contained in a device which has been manufactured and installed (1) so that the air gap between the radiation source and detector of the device is less than 45 cm (18 in.), (2) so that the air gap of the device would not allow insertion of a 30 cm (12 in.) diameter sphere into the radiation beam of the device without removal of a barrier, or (3) so that the radiation dose rate in the radiation beam of the device at 45 cm (18 in.) from the radiation source with the device shutters, if any, in the open position does not exceed 125 millirem per hour; and (3) In the case of byproduct material in a device which has been installed on a vessel such as a pipe or a tank, applies after (3 years after the effective date of this rule) only if the inside of the vessel does not need to be entered under any foreseeable circumstance by one or more individuals and a casual entry to the vessel is prohibited, or if the air gap 21

between the radiation source and detector of the device is less than 45 cm (18 in.).

(e) Any person who, under a general license, possesses byproduct material in a device which does not qualify after (3 years after the effective date of this rule) under paragraphs (b)(2) and (b)(3) of this section:

,(1) Shall submit an application to the Nuclear Regulatory Commission, as prescribed in § 30.6(b)(2) of this chapter, by (3 years after the effective date of this rule), for a specific license authorizing possession of that device, and other activities as appropriate; and (2) Shall, if an application is submitted not later than (30 days prior to 3 years from the effective date of this rule) in proper form for a specific license or amendment to a specific license, retain his or her general license until a final determination on the application has been reached by the Commission.

3. In § 31.6, paragraph (d) is added to read as follows:

- § 31.5.

§ 31.6 General license to install deyices generally licensed in (d) The byproduct material is contained in a device which qualifies after (3 years after the effective date of this rule) under paragraphs (b)(2) and (b)(3) of§ 31.5.

PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL 22

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);

§§ 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. 220l(b); and §§ 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(0)).

5. In § 32.51a, paragraph (c) is added to read as follows:

§ 32.51a Same: Conditions of licenses.

(c) Transfer a device containing byproduct material to a person generally licensed under § 31.5 of this chapter only if that device qualifies after (3 years after the effective date of this rule) under paragraphs (b)(2) and (b}(3) of § 31.5 of this chapter.  ! I Dated at Rockville, Maryland this J,O day of 11.._ol._e.u.,..py..,,_ 1992.

For the Nuclear Regulatory Commission.

retary oft 23