ML23153A041

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PR-030, 040, 070 - 60FR46784 - One-Time Extension of Certain Byproduct, Source, and Special Nuclear Materials Licenses
ML23153A041
Person / Time
Issue date: 09/08/1995
From: Taylor J
NRC/EDO
To:
References
60FR46784, PR-030, PR-040, PR-070
Download: ML23153A041 (1)


Text

ADAMS Template: SECY-067 DOCUMENT DATE: 09/08/1995 TITLE: PR-030,040,070 - 60FR46784 - ONE-TIME EXTENSION OF CERTAIN BYPRODUCT, SOURCE, AND SPECIAL NUCLEAR MATE RIALS LICENSES CASE

REFERENCE:

PR-030,040,070 60FR46784 KEYWORD: RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

STATUS OF RULEMAKING PROPOSED RULE: PR-030,040,070 OPEN ITEM (Y/N) N RULE NAME: ONE-TIME EXTENSION OF CERTAIN BYPRODUCT, SOURCE, AND SPECIAL NUCLEAR MATERIALS LICENSES PROPOSED RULE FED REG CITE: 60FR46784 PROPOSED RULE PUBLICATION DATE: 09 / 08 / 95 NUMBER OF COMMENTS: 28 ORIGINAL DATE FOR COMMENTS: 10 / 10 / 95 EXTENSION DATE: I I FINAL RULE FED. REG . CITE: 61FR01109 FINAL RULE PUBLICATION DATE: 01/16 / 96 NOTES ON: PROPOSED RULE SIGNED BY EDO . FINAL RULE SIGNED BY EDO; EFFECTIVE STATUS : FEBRUARY 15 , 1996. FILE LOCATED ON Pl .

OF RULE:

HISTORY OF THE RULE PART AFFECTED : PR-030 , 040,070 RULE TITLE: ONE-TIME EXTENSION OF CERTAIN BYPRODUCT , SOURCE ,

AND SPECIAL NUCLEAR MATERIALS LICENSES PROPOSED RULE PROPOSED RULE DATE PROPOSED RULE SECY PAPER: SRM DATE : I I SIGNED BY SECRETARY: 08 /2 9/95 FINAL RULE FINAL RULE DATE FINAL RULE SECY PAPER: SRM DATE: I I SIGNED BY SECRETARY: 01/17/96 STAFF CONTACTS ON THE RULE CONTACTl: JOHN PELCHAT MAIL STOP: RII/NMS PHONE: 331-50 83 CONTACT2: CHARLES NILSEN, RES MAIL STOP: T9-F31 PHONE: 415-6209

DOCKET NO. PR-030,040,070 (60FR46784}

In the Matter of ONE-TIME EXTENSION OF CERTAIN BYPRODUCT, SOURCE, AND SPECIAL NUCLEAR MATERIALS LICENSES DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT

- 09/11/95 08/29/95 FEDERAL REGISTER NOTICE - PROPOSED RULE 09/21/95 09/19/95 COMMENT OF UNITED REFINING COMPANY (MICHAEL J. SHANSHALA} ( l}

09/25/95 09/21/95 COMMENT OF CHICAGO BRIDGE & IRON CO (P. BRAD SHAW} ( 2) 09/25/95 09/21/95 COMMENT OF SAM-SON INSPECTION & TECHNICAL SERVICES, INC (S.M. HOPKINS, EXECUTIVE VICE PRES.} ( 3) 09/25/95 09/20/95 COMMENT OF CENTER FOR MOLECULAR MEDICINE & IMMUNOLOGY (STEPHEN M. ROSE} ( 4) 09/25/95 09/20/95 COMMENT OF MORRISTOWN MEMORIAL HOSPITAL (SIMON C.P. LAM} ( 5)

- 09/25/95 09/18/95 COMMENT OF CONAM INSPECTION, INC (ROBERT J. SLACK} ( 6) 09/25/95 09/19/95 COMMENT OF SMITHKLINE BEECHAM (RICHARDS. BAK} ( 7) 09/25/95 09/21/95 COMMENT OF HWS CONSULTING GROUP, INC (RAYMOND DELKA} ( 8) 09/27/95 09/22/95 COMMENT OF WRIGHT STATE UNIVERSITY (THOMAS MOHAUPT) ( 9) 09/28/95 09/21/95 COMMENT OF RADIATION ONCOLOGISTS OF NORTHWEST NEW JERSEY (ALLAN J. SCHER) ( 10}

09/28/95 09/23/95 COMMENT OF ROBERT M. BOYD ( 11) 09/29/95 09/25/95 COMMENT OF OMNIGENE, INC (ROGERS YOCUM} ( 12}

10/02/95 09/29/95 COMMENT OF BILL VERMEERE ( 13}

10/02/95 09/28/95 COMMENT OF COMMUNICATIONS & POWER INDUSTRIES (MIKE GRABKO} ( 14}

10/04/95 09/29/95 COMMENT OF ALLIANCE OF ARCHITECTS AND ENGINEERS (GARY NORTON} ( 15}

DOCKET NO. PR-030,040,070 (60FR46784)

DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 10/04/95 10/03/95 COMMENT OF TSI, INC (GILMORE SEM) ( 16) 10/06/95 09/28/95 COMMENT OF MAYO CLINIC (RICHARD J . VETTER) ( 17) 10/10/95 10/04/95 COMMENT OF COUNCIL ON RADIONUCLIDES & RADIOPHARMACEUTICALS (LEONARD R. SMITH) ( 18) 10/10/95 10/04/95 COMMENT OF ILLINOIS DEPARTMENT OF NUCLEAR SAFETY (STEVEN C. COLLINS) ( 19)

- 10/10/95 10/06/95 COMMENT OF THE FORSCHNER GROUP , INC (JAYE. SILBERG) ( 20) 10/10/95 10/06/95 COMMENT OF SOUTH DAKOTA STATE UNIVERSITY (LEO H. SPINAR) ( 21) 10/10/95 10/06/95 COMMENT OF RADIATION TECHNOLOGY , INC (DORIS C. BRYAN) ( 22) 10/10/95 10/10/95 COMMENT OF NUCLEAR ENERGY INSTITUTE (FELIX M. KILLAR, JR.) ( 23) 10/16/95 10/04/95 COMMENT OF SOUTHWEST MEDICAL CENTER OF OKLAHOMA (JAMES HENDRIX AND CHRIS HAMMES) ( 24) 10/18/95 09/28/95 COMMENT OF MET-CHEM TESTING LABORATORIES (DOUGLAS R. JOHNSTON) ( 25)

- 10/18/95 09/21/95 COMMENT OF NATIONAL INSTITUTE OF STANDARDS & TECHNOLOGY (L.E. PEVEY) ( 26) 10/18/95 09/26/95 COMMENT OF SAINT JOHN 'S REGIONAL HEALTH CENTER (CHARLES R. NICOLOSI) ( 27) 10/18/95 10/15/95 COMMENT OF MARVIN I . LEWIS ( 28) 01/11/96 12/20/95 FEDERAL REGISTER NOTICE - FINAL RULE

DOCK ET ED US NRC

[7590 P]

.96 JAN 11 A9 :11 NUCLEAR REGULATORY COMMISSION OFF ICE OF SECRETAR Y DOCKET ING & SERVIC E 10 CFR Parts 30, 40 , and 70 BRANCH RIN 3150-AF38 DOCKET NUMBER PROPOSED RULE PR AA, 4:9 . . .

( ~\-=R...'-\-b, ,a+)

,ti One-Time Extension of Certain Byproduct , Source ,

and Special Nuclear Materials Licenses AGENCY : Nuclear Regulatory Commiss ion .

ACTION : Final rule .

SUMMARY

The Nuclear Regulatory Commission (NRC) is amending its regulat ions to iaple111ent, on a one-time basis, a five-year extension of certain byproduct, source, and special nuclear materials licenses . The provisions of the licenses under extension provide the same authorizations and limits on licensee act1v1t1es as they do now. The final ru, ~ specifies the licenses that are not extended .

~ \5, \91:\lc .

EFFECTIVE DATE: ( ~ the date of the pubHeation i n the Federal R.,ister}

FOR FURTHER INFORMATION, CONTACT: John M. Pelchat, NRC , Region II, 101 Marietta Street, N.W., Suite 2900, Atlanta, GA 30323, telephone (404) 331-5083; or C. W. Nilsen, Office of Nuclear Regulatory Research , NRC, Washington, DC 20555, telephone (301) 415-6209.

~~ ,\ \lc:,\9to (lo\ r~ \ \ DC\J

2 SUPPLEMENTARY INFORMATION:

Background

The NRC has completed the preliminary phases of an effort to redesign the process for licensing medical, academic, and industrial users of byproduct materials as well as some small scope users of source and special nuclear materials. To make resources available to expedite the development, design, and testing of the new materials licensing process, the Commission is extending certain specific materials licenses {"licenses") by five years from the current expiration dates of those licenses. Resources that would have otherwise been used to renew these licenses will be devoted to the redesign project. The extension will be a one-time occurrence. The Commission does not envision that any similar extensions will be granted in the future.

The extension granted by this rulemaking does not apply to the licenses for power and non-power reactors, uranium milling and pro~essing facilities, or fuel production facilities. The extended licenses are not considered to be the equivalent of a renewed license because they provide the same authorizations and limits on licensee activities as are currently applicable to each licensee. Accordingly, the extended licenses will not be based on nor reference pending renewal applications, including requests, if any, in those renewal applications, for NRC approval of changes in current operations. The frequency of licensee inspections will not change as a result of this final rule.

3 The C01111ission concludes that it may take this action because no legislative mandate requires that aterials licenses have a five-year term.

Many years ago, materials licenses were issued for two-year periods. As the uses of radioactive materials becilWle more stable and predictable, the typical duration of licenses was changed to five years. The Convnission has concluded that certain specific materials licenses may be extended once by rule for an additional five years beyond their stated expiration date without the normal renewal review and without adverse effect on public health and safety. The COllllission's conclusion is based upon three factors. First, certain specific licenses for which the Co11111ission believes that a renewal review should not be delayed five years will not be affected by this rule. Licenses that may present, in the C011111ission's view, a greater potential risk from a health and safety standpoint will not be generically extended by this rulemaking.

Second, the extended licenses will not change the authorized activities nor regulatory requirements. Third, the NRC will continue its normal inspection progra111 of licensed activities, including inspections of those licenses that will be extended by this final rule. Significant inspection findings will be resolved through the issuance of Notices of Violations that require written responses describing corrective actions, Confin1atory Action Letters (CALs),

or Orders that would 110dify, suspend, or revoke the license and that would ilRl)Ose civil penalties, as appropriate. Accordingly, the Comniss1on has concluded that there would be reasonable assurance of public health and safety under this rule.

4 SU11111ary of Require111ents and Analysis of Public Conments The NRC is amending Parts 30, 40, and 70 of its regulations to extend, on a one-time basis, certain byproduct, source, and special nuclear materials licenses. These regulations specify the licenses that are not extended by this rule11aking. The NRC received 28 letters of public convnent: twenty-one from licensees; one from an Agreement State; none from non-Agreement States; two fro consulting firms; two from private citizens; and two from trade associations. Eighteen connenters supported the proposed rule and one was opposed. Eight c01111enters supported the rulemaking to varying degrees, but offered suggestions for modification of the rules. One conment addressed issues to be considered by the NRC should the rulemaking be implemented, without stating support or opposition for the proposed rule.

Conaenters supporting the proposed rule cited the cost savings to taxpayers, affected licensees, and the general public. Some of these c01111enters also supported the redesign effort of the materials licensing process.

One coaenter supported the proposed rule and suggested that the rulemaking be amended to include the Quality Assurance program requireinents in 10 CFR Part 71. The suggested amend1nent is outside of the scope of the proposed rulemaking.

Another cOIIB8nter supported the proposed rule but noted there was no mention of specific cost reductions to the licensee as a result of this

5 extension and stated that this point should be addressed. The NRC recognizes that, on a one-tinte basis, many licensees will save the renewal fee required by 10 CFR 170.31 as well as the costs associated with the preparation of the renewal application. The NRC staff did not attempt to quantify these costs, recognizing the significant variability among licensees as to the effort required to prepare license renewal applications. In addition, the NRC staff

  • believes these savings will be offset to s0111e extent by the need for those

-licensees to prepare and submit license amendment requests {and associated fees) to request necessary changes in their programs that may have been included 1n the license renewal application.

Another co1111enter supported the* proposed rulemaking but also suggested that the NRC reevaluate its fee structure. The fees structure and questions rel~ting to the assessaent of fees are outside the scope of this rulemaking.

4t Another cOlllllenter expressed gener~l support for the effort to redesign the licensing process and stated that t~e renewai ~rocess was redundant, and served no useful purpose that could not otherwise be achieved more effectively through the license amendment and inspection processes. The connenter urged the NRC to reconsider the proposed rule and remove the license renewal process fro11 the regulations. The issue of deleting the license renewal process from the *regulations is beyond the scope of this rulemaking. However, this comnent will be considered as part of the Office of Nuclear Material Safety and Safeguards' (fllSS') initiative to review the appropriate duration of the -

licenses and the certificates that it issues. In addition, for uranium recovery facilities, the Coanission staff is currently analyzing the

6 possibility of extending the duration of licenses for that class of licensees.

Once the staff has completed its analysis and consulted with the Commission, the NRC will determine what, if any action it will take in extending the duration of uraniuM recovery facility licenses. This final rule extends certain materials licenses on a one-time basis and NMSS' consideration of the appropriate duration of materials licenses is a separate issue being considered by the NRC.

A connenter who objected to the proposed rulemaking stated that the renewal process is valuable because it forces licensees to examine their programs and bring records up to date. The commenter also noted that the proposed rulemaking was indicative of the NRC's * ... arrogant, deficient attitude toward safety." In response to the comment, the NRC staff notes that 10 CFR 20.1101 requires all specific licensees to develop, document, and iFRl)leaent a radiation protection program co11111ensurate with the scope and extent of licensed activities. The regulation further requires that licensees periodically (at least annually) review thP. content arid the implementation of the radiation protection program. The Co11111ission believes that this requirement, the criteria set out in this rulemaking, and the NRC's ongoing inspection prograa are sufficient to ensure that licensees develop and implement radiation programs and periodically review them to assess the progrm's effectiveness. It must also be recognized that the NRC is not eliminating the need to file for a renewal but is only changing the time frame for renewal of licenses affected by this rulemaking.

7 An Agreement State submitted a comment concerning provisions that the NRC should have available to ensure that persons could detennine that a specific license was extended as a result of this rulemaking. The NRC staff is developing procedures to implement this rule, including providing prompt notification to licensees whose licenses have been extended by the final rule.

The Conmi~sion also sought public convnents on the issue of license duration. Ten of the persons who commented on the one-time extension also provided specific comments regarding the appr~priate duration of material licenses. Several commenters suggested that a license term of ten years would be appropriate. One co11111enter specifically suggested that medical licenses be issued for seven years. Three commenters suggested licenses have a term of twenty years. Another commenter suggested that a license be initially issued for two to four years, to allow a new licensee to demonstrate its stability.

The*tenns of subsequent *license renewals could then be extended for up to e twenty years. The NRC will consider these conments in the development of its policy concerning the duration of material licenses.

Other comments addressed specific components of the proposed rule.

Those coment~ and their resoluttons are disc~ssed below and, to the extent p~ssible, are arranged under the identified section of the rule to which they are related. For the purpose of clarity, the co111110n elements of the comment discussion will be grouped by the nature of the requirements, because the new

  • regulatory. requ1reaents in 10 CFR Parts 30, 40, and 70 closely parallel each other.

8 Description of Rulemaking and Analysis of Specific Public Co11111ents The final rule was based on and mainly derived from the current provisions 1n 10 CFR Parts 30, 40, and 70. Parts 30, 40, and 70 contain the general requirements used by the Coanission to license the possession and use of byproduct, source, and special nuclear materials. Specific sections being added or aaended by this final rulemaking include the following:

IQ CFR 3Q.36Cal(2l, 40.42Cal(2l, and 70.38Cal{2l These paragraphs s~ate that each specific license that has an expiration date after July 1, 1995, has an expiration date that is 5 years after the expiration date stated in the current license, unless it is specifically excluded by the final amendments contained in this rule. This extends all licenses, that are not otherwise disqualified by the regulations, by five 411 years without the requirement for the licensee to prepare and submit a license renewal application 30 days before the expiration date in th~ current license.

Licensees holding licenses that are extended by this rule would not be required to take any action to renew the license until 30 days before the end of the extension which will end five years after the date currently specified on the license.

Licensees who hold licenses that are not extended by this rule will continue to be required to either file for license renewal 30 days before the expiration date currently specified in the license or comply with th~

9 applicable license termination requirements specified in 10 CFR 30.36, 40.42, and 70.38.

No specific c0111R1ents were received on these paragraphs.

Paragraphs 3Q.36la)l3llil, 40.42lalC3lljl, and 70.38lal<3llil These paragraphs delineate the specific licenses that are not extended by the final rule because an evaluation or an emergency plan is required in accordance with 10 CFR 30.32(i}, 40.3l(j}, or 70.22(i), respectively. This excludes those licenses that require an evaluation or an emergency plan, because these licenses authorize activities involving large quantities of unsealed licensed aater1als that the Connission believes may pose a significant potential for release of radioactive materials that may result in potential exposure to the public and contamination of the environment.

4t Therefore, the COfllllission believes that it would be prudent to review these licenses individually during the renewal process u~fore making a determination to extend these licenses.

One c~nter took exception to the NRC's statements, in the proposed rule, which it believed implied that its member organizations, many of whom are ineligible for the one-time extension based on the size and the scope of their licensed progrlllS and the regulatory requirement for an emergency plan, pose relatively greater safety risks. The connenter indicated that it did not believe these licensees have a significant potential for release of licensed material and public exposure. The conrnenter further noted that there have

10 been no incidents where members of the public received significant exposures from licensed materials, that the licensees' controls were sufficient to contain licensed materials, and that maximum credible release scenarios showed insignificant offsite impacts.

In developing its criteria to disqualify certain material licenses from the extension, the NRC staff considered its licensees' operations on a scale of relative hazard. The NRC used previously-established criteria (i.e., the need to have emergency plans, the need to have adequate financial assurance to fund decOR11issioning, etc.) to determine which licensed operations were relatjye]y 110re hazardous, thus deserving closer NRC oversight. The NRC believes that licenses authorizing possession and use of large quantities of unsealed high-activity radionuclides pose a greater potential for hazard than do licenses authorizing use of sealed sources with engineered safety features or licenses authorizing smaller quantities of lower activity radionuclides.

The NRC did not state or suggest that this group of licensees has released l1c~~sed materials, exposed the public, or contaminaieJ the environment. The NRC only indicated that the scope of activities carried out by this group of licensees, using previously established standards, has the potential for such releases and, accordingly, should not be generically extended by this rule.

The NRC believes that a licensee possessing sufficient quantities of licensed materials to be subject to the requirements of 10 CFR 30.32(1), 40.3l(j), or 70.22(1) should file renewal applications so the NRC staff can review the licensee's overall operations before granting an extended license term.

11 Another connenter objected to the disqualification for an extension based on need for an evaluation or an emergency plan as required in 10 CFR 30.32(1), 40.3l(j),*or 70.22(i). The conunenter suggested that the disqualifier for extension based on the need for contingency planning be structured similarly to the disqualifier basea on the need for financial assurance. In other words, amend the rule to not extend any license whose

  • holder is required to provide an evaluation or an emergency plan" . . . and who has not submitted such a plan.~ The co11111enter indicated that the NRC acceptance of the required evaluation or emergency plan should be sufficient to allow a license to be eligible for extension. The commenter alternatively suggested that its particular situation be evaluated on a case-by-case basis.

The NRC has concluded that licensees required to submit either an evaluation or an emergency plan are authorized to possess and use sufficient quantities of licensed materials to warrant closer NRC oversight to ensure that conditions related to the evaluation have not changed or that the emergency plan continues to be appropriate and adequate with regard to the scope of the licensee's activities. The NRC believes that holders of this type of license should continue to suhllit this type of information in renewal applications and that these licenses should not be subject to the one-time license extension. The one-time extension of licenses is being pursued through rulemaking, rather than on a case-by-case basis, so as to free the maxillUII amount of NRC resources to revise the current materials licensing process. The NRC is in the process of reviewing the appropriate duration for materials licensees. After completing the case-by-case review that will take

12 place during the renewal process for those licenses not extended by this rulemaking, the NRC may decide to grant license renewals for periods exceeding the five-year duration typical under current practice depending on the results of the ongoing review of license duration.

Paragraphs 30,36lall3lliil, 40,42lal{3lliil, and 70.38(a)(3l(iil These paragraphs delineate the specific licenses that are not extended under the final rule because the licenses are subject to the financial assurance requirements specified in 10 CFR 30.35, 40.36, or 70.25; and either:

(a) have not submitted a deco11111issioning funding plan or certification of financial assurance for deco11111issioning; or (b) have not received written notice as of (INSERT EFFECTIVE DATE OF FINAL RULE) that the deco11111issioning funding plan or certification of financial assurance for deco11111issioning is acceptable. These licenses authorize possession of quantities and forms of licensed aaterials that the Connission believes pose a potential need for extensive decontamination before tenaination of the license and release of dec011111issioned facilities. Therefore, the Convnission believes that renewals of these licenses should continue to be reviewed under existing procedures to ensure that appropriate r~sources are available to support deco11111issioning

  • activity.

No specific COIIIA8nts were received on these paragraphs.

13 Paragraphs 30,36Ca}C31Ci11l, 4Q,42Ca}C3lC1iil, and 70.38la}l3lliiil These paragraphs delineate the specific licenses that are not extended under the final rule because the licenses are listed in the Site Deconaissioning Management Plan (SDMP). Generally, licenses on the SDMP list are no longer actively using licensed materials. The Commission believes that

  • it is necessary in the interest of public health and safety to review the licensee's procedures to ensure proper evaluation of site remediation activities at facilities where the licensee's radiation safety program may be inactive or scaled back.

No specific c0111Dents were received on these paragraphs.

Paragraphs 30.36(alC3}Civl, 40,42Cal(3l{iv}, and 70.38{a){3l{ivl These paragraphs delineate the specific licenses that are not extended because the issuance, amendment, or renewal of th1~ type of license is not a categorical exclusion under 10 CFR 51.22(c)(l4). This excludes.licenses that include activities requiring the preparation of an environmental assessment or environmental i11pact statetnent, before the C011111ission's specific authorization of that activity, from the five year extension. Generally, these licenses authorize the release of licensed materials to the environment under highly controlled conditions in conjunction with scientific research activities. The C0111nission has concluded that it is important to continue reviewing licenses that may have a greater potential for adversely impacting the environ111ent

14 before aaking decisions on to whether to grant these licensees licenses with longer durations.

No specific connents were received on these paragraphs.

Paragraphs 3Q.36CalC3lCYl, 40.42Ca}C3l<v>, and 70.38Cal<3lCvl

  • These paragraphs delineate the specific licenses that are not extended under the final rule because the holders of these specific licenses have not had a prior NRC inspection as of (INSERT EFFECTIVE DATE OF FINAL RULE). This ensures that the Connission has verified the effectiveness of the licensees' radiation safety programs by onsite inspections of the licensees' equipment and procedures used to safely possess and use licensed materials, as a precondition to allowing five-year extensions of licenses, under these aaendments to the regulations.

No specific connents were received o~ these parQgraphs.

Paragraphs 30.36CalC3lCv1l, 4Q.42CalC3lCY1l, and 70.38CalC3lCvil These paragraphs delineate the specific licenses that are not extended under the final rule if, as the result of the most recent inspections, the holders of these specific licenses have been:

(a) Cited for a Severity Level I, II, or III violation;

15 (b) Subject to an Order issued by the NRC; or (c) Subject to a Confirmatory Action Letter (CAL) issued by the NRC.

This excludes licenses from the five-ye~~ extensions, after the NRC has identified significant safety concerns or other regulatory issues. Typically, these licensees are reinspected within six months, to verify that effective corrective actions have been taken and to ensure that the licensees' facilities, equipment, and procedures have been adequately modified to prevent a recurrence of*the identified violations. The Commission expects its licensees to operate in strict compliance with its regulatory requirements.

Therefore, the Commission believes that it is prudent to review license renewal applications of licensees with recent safety-significant findings so that the NRC can verify that the licensees have adequate personnel, facilities, and procedures to enable them to operate at the expected level of

- compliance.

A commenter objected to use of the issuance ~fa CAL as a disqualifier from the one-time license extension. The NRC chose to disqualify from the one-time extension those licenses that have exhibited significantly declining or poor performance with regard to compliance with the NRC regulations as documented at the time of the most recent NRC inspection. One such indicator of significantly declining or poor performance is the issuance of a CAL*. NRC recognizes that licensees receiving a CAL usually take the necessary corrective actions. The NRC expects that licensees will take timely and effective corrective actions. CALs specifically state that the failure to do

16 so may result in the NRC's issuance of an order modifying, suspending, or revoking the subject license. The NRC does not believe that it should extend these licenses without having first verified, by direct observation as well as other evaluations, during follow-up inspections, that the licensees' corrective actions were, in fact, effective.

Another connenter noted that a modest improvement in program safety can be expected as a result of this rulemaking because the rule bestows a tangible, public, and previously unexpected reward on those licensees that have maintained programs free of significant violations.

Paragraphs 30.36{a){3){yjj), 40.42{a){3){vii}, and 70.JB(a}(J)(vii}

These paragraphs delineate the specific licenses that are not extended under the final rule because the Connission intends to continue to review the submissions of these licensees who have already submitted applications and paid fees for timely license renewal. Renewal requests will be granted after the NRC c0111pletes its review of those applications and determines that the applications satisfy NRC requirements. The July 1, 1995, expiration date was chosen based on resource considerations. The NRC staff has begun the review of 11any applications for renewal of licenses with expiration dates before July 1, 1995, and believes that it is not appropriate to waste the resources already expended in that effort. However, the NRC has not begun the review of 1110st of the applications for renewal of licenses with expiration dates after July I, 1995, and resources will be conserved by extending those licenses.

17 No specific connents were received on these paragraphs.

Paragraph 70.38CalC3lCvii1l This paragraph delineates the specific licenses that are not extended under the final rule because the licenses authorize possession of sufficient quantities of special nuclear material to be subject to the criticality accident requirements of 10 CFR 70.24. This excludes those licenses from the five-year extension because the CoDll'lission believes that it is prudent to continue reviewing the licensees' existing programs before granting licenses for longer durations to ensure the adequacy of the licensees' criticality safety procedures.

No specific c0111Dents were received on this paragraph.

Paragraphs 3Q.37Cbl, 4Q.43{bl, and 7Q.33Cbl These paragraphs specify that any pending license renewal applications for specific licenses that are extended under the final rule are automatically withdrawn. Any paid license renewal fees for withdrawn applications will be refunded.

Two COlllll&nts generally supportive of the rule expressed concern about licensees who had already prepared license renewal applications for submission to the NRC. One conaenter suggested that licensees whose licenses expired after July 1, 1995, and who have prepared complete renewal applications

18 without reference to previously submitted documents should have the option of:

(1) having their new renewal application reviewed and the license renewed; or (2) having the existing license extended. The other commenter had prepared complete license renewal applications, for its clients, that included descriptions of the radiation safety programs updated to reflect the revisions to 10 CFR Part 20 that became effective January 1, 1994. The commenter suggested that these applications be reviewed and the licenses renewed, rather than extended.

The NRC believes that as many eligible licenses as possible should be extended, to achieve the maximum resource savings possible for use in redesigning the materials licensing process. However, the NRC also recognizes that some licensees may want the NRC to review part or all of their license renewal applications. Licensees whose license renewal applications are automatically withdrawn by this rulemaking but whose renewal applications

- contain revisions that they need to have incorporated in their licenses,

~:.~*.!ld submit those changes as an amendraent requesL a.:".:'ompanied *by the appropriate amendment fees.

Environmental Impact: Categorical Exclusion The NRC has determined that these regulations are the type of actions described in the categorical exclusion in 10 CFR 51.22(c)(3). Therefore, neither an environaental impact statement nor an environmental assessment has been prepared for this regulation.

19 Paperwork Reduction Act This final rule does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1995 {44 U.S.C. 3501, et seq.). Existing requirements were approved by the Office of Management and Budget (0MB) approval number 3150-0009 (Part 70) and 3150-0120 (Parts 30 and 40). The NRC may not conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid 0MB control number.

Regulatory Analysis A regulatory analysis has not been prepared for this rule because it is not expected to have any adverse impact on licensees subject to the final rule. These licensees will be postponing the submission of license renewal

- applications and the associated fees for five years.

Regulatory Flexibility Analysis As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b),

the C011111ssion certifies that these rules will not have a significant economic i11pact on a substantial number of small entities. These rules merely extend, on a one-time basis, certain existing byproduct, source, and special-nuclear aater1als licenses that meet specified criteria by five years and therefore, will not result in any adverse impact.

20 Backfit Analysis The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply to this final rule and, therefore, that a backfit analysis is not required for this rulemaking because these amendments do not involve any provisions that would impose backf1ts as defined 1n 10 CFR 50.109(a)(l).

List of Subject Index Terms 10 CFR Part 30 Byproduct material, Criminal penalties, Government contracts, Intergovernmental relations, Isotopes, Nuclear materials, Radiation protection, Reporting and recordkeeping requirements.

- 10 CFR Part 40 Criminal penalties, Government contracts, Hazardous materials transportation, Nuclear materials, Reporting and recordkeeping requirements, Source material, Uranium.

10 CFR Part 70 Criminal penalties, Hazardous materials transportation, Material ~uutrol and accounting, Nuclear materials, Packaging and containers, Radiation

21 protection, Reporting and recordkeeping requirements, Scientific equipment, Security measures, Special nuclear material.

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. 552 and 553; the Nuclear Regulatory Commission is adopting the following amendments to 10 CFR Parts 30, 40, and 70.

PART 30 - RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL

1. The authority citation for 10 CFR Part 30 continues to read as follows:

AUTHORITY: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 953,

- 954, 955, as a11ended, sec. 234, 83 Stat. 444, as amended {42 U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); sers. 201, 4~ amended, 202, 206, 88 Stat.

1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).

Section 30.7 also issued under Pub. L.95-601, sec. 10, 92 Stat. 2951 as uaended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123 {42 U.S.C. 5851}.

Section 30.34(b) also issued under sec. 184, 68 Stat. 954, as amended {42 U.S.C. 2234). Section 30.61 also issued under sec. 187, 68 Stat. 955 {42 u.s.c. 2237).

2. In 10 CFR 30.36, paragraph (a) is revised to read as follows:

22

§ 30.36 Expiration and ter11in1tion of licenses and deconnissioning of sites and separate buildings or outdoor areas.

(a)(l) Except as provided in paragraph (a)(2) of this section, each specific license expires at the end of the day on the expiration date stated in the license unless the licensee has filed an application for renewal under

§ 30.37 not less than 30 days before the expiration date stated in the existing license (or, for those licenses subject to paragraph (a)(2) of this section, 30 days before the deemed expiration date in that paragraph). If an application for renewal has been filed at least 30 days before the expiration date stated in the existing license (or, for those licenses subject to paragraph (a)(2) of this section, 30 days before the deemed expiration date in that paragraph), the existing license expires at the end of the day on which the C011111ission makes a final detennination to deny the renewal application or, if the determination states an expiration date, the expiration date stated in the deteraination.

(2) Each specific license that has an expiration date after July I, 1995, and is not one of the licenses described in paragraph (a)(3) of this section, shall be deellled to have an expiration date that is five years after the expiration date stated in the current license.

(3) The following specific licenses are not subject to, or otherwise affected by, the provisions of paragraph (a)(2) of this section:

23 (1) Specific licenses for which, on [INSERT EFFECTIVE DATE OF FINAL RULE], an evaluation or an emergency plan is required in accordance with

§ 30.32(1);

(11) Specific licenses whose holders are subject to the financial assurance requirements specified in 10 CFR 30.35, and on [INSERT EFFECTIVE DATE OF THE FINAL RULE], the holders either:

(A) Have not submitted a decommissioning funding plan or certification of financial assurance for deconaissioning; or (B) Have not received written notice that the deconunissioning funding plan or certification of financial assurance for decommissioning is acceptable; (111) Specific licenses whose holders are listed in the SDMP List published in NUREG 1444, Supplement 1 (November 1995);

(1v) Specific licenses whose issuance, amendment, or renewal, as of

[INSERT EFFECTIVE DATE OF THE FINAL RULE], is*not a categorical exclusion under 10 CFR 51.22(c)(l4) and, therefore, need an environmental assessment or environmental impact statement pursuant to Subpart A of Part 51 of this chapter;

24 (v) Specific licenses whose holders have not had at least one NRC inspection of licensed activities before [INSERT EFFECTIVE DATE OF THE FINAL RULE];

(vi) Specific licenses whose holders, as the result of the most recent NRC inspection of licensed activities conducted before [INSERT EFFECTIVE DATE OF THE FINAL RULE], have been:

(A) Cited for a Severity Level I, II, or III violation in a Notice of Violation; (B) Subject to an Order issued by the NRC; or (C) Subject to a Confirmatory Action Letter issued by the NRC.

(vii) Specific licenses with expiration dates before July 1, 1995, for which the holders have submitted applications for renewal under 10 CFR 30.37 of this part.

3. In 10 CFR 30.37, a new paragraph (b) is added to read as follows:

§ 30.37 Application for renewal of licenses.

25 (b) If any licensee granted the extension described in 10 CFR 30.36(a)(2) has a currently pending renewal application for the extended license, that application will be considered withdrawn* by the licensee and any renewal fees paid by the licensee for that application will be refunded.

PART 40 - DOMESTIC LICENSING OF SOURCE MATERIAL

4. The authority citation for 10 CFR Part 40 continues to read as follows:

AUTHORITY: Secs. 62, 63, 64, 65, 81, 161, 182, 183, 186, 68 Stat. 932, 933, 935, 948, 953, 954, 955, as amended, secs. lle(2), 83, 84, Pub. L.95-604, 92 Stat. 3033, as amended, 3039, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2014(e)(2), 2092, 2093, 2094, 2095, 2111, 2113, 2114, 2201, 2232, 2233, 2236, 2282); sec. 274, Pub. L.86-373, 73 Stat. 688 (42 U.S.C. 2021);

secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846); sec. 275, 92 Stat. 3021, as amended by Pub. L.97-415, 96 Stat. 2067 (42 U.S.C. 2022).

Section 40.7 also issued under Pub. L.95-601, sec. 10, 92 Stat. 2951 as aaended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123, (42 U.S.C. 5851).

Section 40.3l(g) also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152).

Section 40.46 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C.

2234). Section 40.71 also issued under sec. 187, 68 Stat. 955 (42 U.S.C.

2237).

26

5. In§ 40.42, paragraph (a) is revised to read as follows:

10 CFR 40.42 Expiration and ter111ination of licenses and deco111Bissioning of sites and separate buildings or outdoor areas.

(a)(l) Except as provided in paragraph (a)(2) of this section, each specific license expires at the end of the day on the expiration date stated in the license unless the licensee has filed an application for renewal under

§ 40.43 not less than 30 days before the expiration date stated in the existing license (or, for those licenses subject to paragraph (a){2) of this section, 30 days before the deemed expiration date in that paragraph). If an application for renewal has been filed at least 30 days before the expiration date stated in the existing license (or, for those licenses subject to paragraph (a)(2) of this section, 30 days before the deemed expiration date in that paragraph), the existing license expires at the end of the day on which the C011111ission makes a final determination to deny the renewal application or, if the determination states an expiration date, the exµiration date stated in the detenn1nat1on.

(2) Each specific license that has an expiration date after July 1, 1995, and is not one of the licenses described in paragraph (a)(3) of this section, shall be deetned to have an expiration date that is five years after the expiration date stated in the current license.

(3) The following specific licenses are not subject to, or otherwise affected by, the provisions of paragraph {a)(2) of this section:

27 (1) Specific licenses for which, on [INSERT EFFECTIVE DATE OF THE FINAL RULE], an evaluation or an eMergency plan is required in accordance with

§ 40.3l(j);

(11) Specific licenses whose holders are subject to the financial assurance require11ents specified in 10 CFR 40.36, and on [INSERT EFFECTIVE DATE OF THE FINAL RULE], the holders either:

(A) Have not submitted a deco11111issioning funding plan nor certification of financial assurance for decomissioning; or (B) Have not received written notice that the decommissioning funding plan or certification of financial assurance for deco11111issioning is acceptable; (iii) Specific licenses whose holders are listed in the SDMP List published in NUREG 1444, Suppleaent I (November 1995);

(iv) Specific licenses whose issuance, amendment, or renewal, as of

[INSERT EFFECTIVE DATE OF THE FINAL RULE], is not a categorical exclusion under 10 CFR 51.22(c)(l4) and, therefore, need an environmental assessment or environaental impact stateaent pursuant to Subpart A of Part 51 of this chapter;

28 (v) Specific licenses whose holders have not had at least one NRC inspection of licensed activities before [INSERT EFFECTIVE DATE OF THE FINAL RULE];

(vi) Specific licenses whose holders, as the result of the most recent NRC inspection of licensed activities conducted before [INSERT EFFECTIVE DATE OF THE FINAL RULE], have been:

(A) Cited for a Severity Level I, II, or III violation in a Notice of Violation; (B) Subject to an Order issued by the NRC; or (C) Subject to a CAL issued by the NRC.

- (vii) Specific licenses with expiration dates before July 1, 1995, for which the holders have submitted applications for renewal under 10 CFR 40.43 of this part.

6. In 10 CFR 40.43, a new paragraph (b) is added to read as follows:

§ 40.43 Renewal of licenses.

29 (b) If any licensee granted the extension described in 10 CFR 40.42(a)(2) has a currently pending renewal application for the extended license, that application will be considered to be withdrawn by the licensee and any renewal fees paid by the licensee for that application will be refunded.

PART 70 - DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL

7. The authority citation for 10 CFR Part 70 continues to read as follows:

AUTHORITY: Secs. 51, 53, 161, 182, 183, 68 Stat. 929, 930, 948, 953, 954, as amended, sec. 234, 83 Stat. 444, as amended, sec. 1701, 106 Stat.

2951, 2952, 2953 (42 U.S.C. 2071, 2073, 2201, 2232, 2233, 2282, 2297f); secs. 201, as amended, 202, 204, 206, 88 Stat. 1242, as amended, 1244, 1245, 1246 (42 u.s.c. 5841, 5842, 5845, 5846).

Sections 70.l(c) and 70.20a(b) also issued under secs. 135, 141, Pub. L.97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161). Section 70.7 also issued under Pub. L.95-601, sec. 10, 92 Stat. 2~51 (42 U.S.C. 5851). Section 70.2l(g) also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152). Section 70.31 also issued under sec. 57d, Pub. L.93-377, 88 Stat. 475 (42 U.S.C.

2077). Sections 70.36 and 70.44 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Section 70.61 also issued under secs. 186, 187, 68 Stat. 955 (42 U.S.C. 2236, 2237). Section 70.62 also issued under sec. 108, 68 Stat. 939, as 8118nded (42 U.S.C. 2138).

30

8. In 10 CFR 70.38, paragraph (a) is revised to read as follows:

§ 70.38 Expiration and ter11ination of licenses and decoTB111issioning of sites and separate buildings or outdoor areas.

(a)(l) Except as provided in paragraph (a)(2) of this section, each specific license expires at the end of the day on the expiration date stated in the license unless the licensee has'filed an application for renewal under

§ 70.33 not less than 30 days before the expiration date stated in the existing license (or, for those licenses subject to paragraph (a}(2) of this section, 30 days before the deemed expiration date in that paragraph}. If an application for renewal has been filed at least 30 days before the expiration date stated in the existing license (or, for those licenses subject to paragraph (a)(2) of this section, 30 days before the deemed expiration date in that paragraph), the existing license expires at the end of the day on which .

the C01111ission makes a final determination to deny the renewal application or, 1f the determination states an expiration ~ate, the eApiration date stated in the determination.

(2) Each specific license that has an expiration date after July 1, 1995, and is not one of the licenses described in paragraph (a)(3) of this section, shall be deemed to have an expiration date that is five years after the expiration date stated in the current license.

(3) The following specific licenses are not subject to, nor otherwise affected by, the provisions of paragraph (a)(2) of this section:

31 (1) Specific licenses for which, on [INSERT EFFECTIVE DATE OF THE FINAL RULE], an evaluation or an emergency plan is required in accordance with

§ 70.22(1);

(11) Specific licenses whose holders a,*e subject to the financial assurance requirements specified in 10 CFR 70.25, and on [INSERT EFFECTIVE DATE OF THE FINAL RULE], the holders either:

(A) Have not submitted a decon111issioning funding plan or certification of financial assurance for decommissioning; or (8) Have not received written notice that the decommissioning funding plan or certification of financial assurance for decolllllissioning is acceptable; (111) Specific licenses whose holders are listed in the SDMP List published in NUREG 1444, Supplement 1 {Nove~ber 1995);

{iv) Specific licenses whose issuance, amendment or renewal, as of

[INSERT EFFECTIVE DATE OF THE FINAL RULE], is not a categorical exclusion under 10 CFR 51.22{c)(l4) and, therefore, need an environmental assessment or environmental impact statement pursuant to Subpart A of Part 51 of this chapter;

32 (v) Specific licenses whose holders have not had at least one NRC inspection of licensed activities before [INSERT EFFECTIVE DATE OF FINAL RULE];

(vi) Specific licenses whose holders, as the result of the most recent NRC inspection of licensed activities conducted before [INSERT EFFECTIVE DATE OF FINAL RULE], have been:

(A) Cited for a Severity Level I, II, or Ill violation in a Notice of Violation:

(8) Subject to an Order issued by the NRC; or (C) Subject to a CAL issued by the NRC.

(vii) Specific licenses with expiration dates before July 1, 1995, for which the holders have sublllitted applications for renewal under 10 CFR 70.33 of this part.

(viii) Specific licenses issued pursuant to 10 CFR 70.31 that, as of

[INSERT EFFECTIVE DATE OF FINAL RULE], are also subject to the requirements in

§ 70.24.

33

9. In 10 CFR 70.33, a new paragraph (b) is added to read as follows:

§ 70.33 Renewal of licenses.

(b) If any licensee granted the extension described in 10 CFR 70.38(a)(2) has a currently pending renewal application for that extended license, that application will be considered withdrawn by the licensee and any renewal fees paid by the licensee for that application will be refunded.

Dated at Rockville, Maryland, this ,:2,0 ~day of ~~ , 1995.

For the Nuclear Regulatory Co11111ission.

s

  • Taylor ve Director for Operations

DOCKETED USt-iRC Marvin I . l ew is

'95 OCT 18 P3 :36 3133 Fdirfield Stre~t Philridelphia, PA 191~6 OFFICE OF SECPETARY (215)676 1291 COCKE i, -. q* . E BRANCH In the matter of

1. HPalth F-ffFct~ Valuation, Letter frnm T. S. Kress, Chairman ACRS, to Jdmt::c>s R. Taylor, EDD NRC, dated Sept. 13, 1995.
2. N11c- }p.,u* f-nE->r9y In~ti tute petitions NRC far "reduction in commitmttnt" F~deral Regio:;ter Notir.e dated Sept. 14, 1995.
. Petition for* Rulemaking to AmPnd 10 CF-R !'10.48 from W. Rasin, NEI, to J.C. Hoyl~, Secretary NRC, dr.1ted Feb. 2, 1995.
4. NRC considers cinE' time~ year Automatic extension of rertain mdlP.ridl~ license~. NUREG/BR 0032 Vol 15 No. 33 News Release~

d a tE. *d Rei It e>mt:H:,.* r 1 ~, 1 99~ *

~1. NRC Staff .;.~k~ pultl ic comment on proposal to reduce c'lmount of operatiundl ddtd reported by nuclear power plant licen~ees.

NURF-8/RR 0082 Vu). 15 No. 31, dated Septemher 1, 1995.

6. Cumpdtibility with the Interndtional Atomic Energy Agenr.y, Final RulP, FR dated Sept. ?8, 1995 at Page 50?48, and Re1J11ldtion.,; on tht:? l" r ensportation ot* Radioactive Material pub l i !"-heel in t.hP FedM a J Register Ser,t.* 28, 1995.

'J. rlire~ relatP.u NUREG..,; were i<;sued together for comment in l\uyu~t 1995:

NURE-G 150~ {\ Nonpar~metric- Statistical Me>thndology for the Design dnd Analyc;.is of Final Stdtus DP.commissioning Survt:?ys.

Nl~~G 1~06 MPa5urement Methods for Radiological Surveys *.*

NIJRF.l:i 1 '.J07 Minimum De tee tab le Concentrations with Typ ica 1 fiadiation SurvPy Jn'-"truments ***

DQal Commis~ioner~:

Tl1i!:"", c-omm~nt le:>ttPr c-ontains comm@nts on an entire group c1f rer.~nt rulemakin1J-,; -'ind other actions for which the NRC hd-;

invited or al)ow~d comment. I cho$e thi~ unusual style for

~everdl ~pecific r~dson-;. The most important redson for which I chose this stylF is to demonstrate a pattern in the recent rulMmdking~ and uthur actions which places the public in a very un,;;.afE:' rPgulatory milieu.

1. Herllth ~ffects Valudtion:

PrPsPntly thp NRC Staff is reronsidering the ancient

$ 1000/p~.-r,.;un rem ~voided health effects valudtiun used in the HDC~ and PlsewhE>r&.*. $ 1000/per'hon rem Avoided calculates in-to a hum,*m life being wor*th about $ 1 . 5 million dollars. The ACRS has

~ugg~slE:.>d that $3 million/human life would he more consistent with lh~ valuation uf human life in other Federal ayenc:ies . The Staff ha~ suyy£>stE>d reduc-ing the- valuation of human lifP by disco1mtintJ th~ $1000/person rem. This attitude on the Staff's c1nd NRC' s part t.o di ~.count human 1 if e is part uf the NfiC

  • s dr1uyd1\t, deficient dttitude toward Sdfety CACRS Letter to James laylor dated 7-20-95.>

U.S. NUCLEAR REGULA10RY COMMISSIO DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMIS ION Docvm nt Statistics Postmart< Dare Copl s Recei Ad<fl Copies

~~ *. .~Ck~)

2.

2. NF.:I Petitions for "Reduction In Commitment."

What an amazing concept! Hey, if the nuc-lear industry makes a

<: ontr* rlr.t and if they don't want to fulfill that contract, they t.an give th~-ms.Plvel:. a "reduction in rommitment." I wish that I c.:uuhJ tJive myself rl "reduction in commitment" from my mortgage by

~elf determination.

This is a r ompletely parallel situation:

1. The nucl~a r indu~t r y makes a commitment,

?. llie- NRC "would pe=-rmit a license=-e (nuc-lear industry) to c- hange

( r ~duc.:t.ion in c ommitmQnt) its quality control program if it could i:.how by analys.i<; (esoteric. paperwork) that the-- change does not invulv~ ~n unreviewwd safety question (Safety questions remain after thPy are- ,- ev i ewE>d ! ) "

Aqain th~ puhli r. safety ic; subjected to an arrogant, clefi ci E:>nt. attitucJP, laut this time tliP attitude arises from the nucl~a r* indust r y 1 n petitioning for these changes.

3. Hu** lhermolag Debac lea> c ontinues:

A f ire ret..-u-rl~nt material failerl to ~rovide fire protection again and c1grdn in testing. UnE? pers.on went to jail, fines were levied, rlnd thH ThermoLay remains in place performing most UE:dic.ie,,ntly. lhE:- re-~.ult is the nuclear industry petitions for a " r ~ductiun in c ommitment" and other relief thru rulemaking o f 10 C:f-R ~0.4H.

Again, the> nuclea r industry shows its arrogant, deficient attitudH where safely is concerned.

4. ~n r yet safety; just c hange the r ules.

Wi th 10 CFR :-30, 40, and 70, the NRC plans to extend lir:enses for ~ year&. Many small users bring their records up to date anrl du ~~~Hntidl mdintenan~e at license renewal time like many peuplP c hange t.lu-d r ~mnkP alarm hatteries on their birthday ~.

  • Sm~ll users need the shock of filling out a license and paying a f~p to gpt thea>ir attention on their radioactive sources. This is onw ~mall wdy that the NRC ~hows its arrogant, deficient attitude towa r d !:,cc'\f ety.

~l. *1 h r ow away the data lief ore somebody t j nds it.

fhe NRC i s proposing to reduce the amount o*f operational data rE*po , lPd lty nuc]ec-1 r plant lict?nsees. "fMJ #2 would have liked this r uli.1. fhink how little nf the shoddy workmanship and arrogant attitude would have bePn rermrted during the acc-ident if t.he li c ,.,,.nse~-, did nut have to n :.? port hi~ operational dcita.

Wit.h nuc-}E,!a r* µJnnt& aging, riefi c- iencies will he hidclen by th i ~ l t l l Y . E rr o r ~ o f judgement and ~ins of commission need nev~r reach the light of rlay. Hy reduriny the amuunt of data reported suffi c iently, tht> uyin<J need never know where the radiation which c ausPd their c- anc r>r c- amt:.*.

3.

6. l.ow~sl common denominntor: domesti r.: and foreign.
  • 1 he Uruguay Round of C:iATT requi rc>s, "E-:ach member sha 11 e:ansure tht> 1~onfnrmity of it-,. laws, reguldtion-,. and admini-;trative proceriurec; wi ti, it~. oli ligation!::, as provided in the annex Pd

/\gr~1~m1:?nts."<GAfT WfO MarrakC?sh, Morrocco, dated 4/15/94.)

lh* AnnPx~d AgrPem~nts are tens of thousands of pages. The NHC rP.~ponded to thes1-::1 annexed Agreements by a rule which prnmot£:*!:> thP t.r*.;1n~partation hy air of plutonium and oth~r rddionuclirl~s. fhff NRC c:39ain presents its arrogant, deficient attitude toward sat*ety L,y promoting the air transportation of pl11toni11m and othP.r rarlionuclides while the country is in thE:?

throes of a "unabomPr" sc:are.

'l. n,~ Devi l is in th~ de ta i ls.

C.:ommis~ianPr F::. tiai 1 Depl anquE:-* said in a spPech on Nnvembe*r 29, 1 '-t94," n,~ Devi l i-:; in the rleta i 1 s. " fhe Comm i -,..,,. i oner* i o:;

c-01-rect. By manipulating details a!::> d~scrihed in NlJRE-C:is 150~,

1~306, .ind l'.50'7 ~n investicJator could r.ome up with any intPrp r etation wtdch he wishe*d. The rerent lhermol ag criminal c a*;H r.t'.),iin-;;t a rl1t>rmoLacJ principle demonstrr1ted that manipulation ut b-*t:hnic_al data is impossible for a jury of goocl c i tj zens to UVliH C UIJH~.

H1f-' <:-amp might he said for NRC staff or just ahout anyone.

Ou r Nation ha-;; entt>r~d on era of technology where a h.,_lf ciozen reµrnbatP5 can cierail a train with crowbars, where a "unahuml~r" Crill k i 1 l for two dt-?cades, where a former foe sel 1 s l10111li g, .;u:le- matt->r i al on the black market. lhe NRC mu~t wake up to thF~ n~~litiHs of le>day and understand that its primary a<_;Jt:?nda is

~af~ty inht~arl of JicPnsing at any cost.

SuygM~tion, requH~t, plea for help.

Htora prnduc-inq more and more radioactive wa~tes. WP will have

~ lul. of Wd"ilc:! and losP. uur* Country. Stop prouuction now.

lf tlic> NRC is really ~Prious about safE:>ty, c:all me at P1~ 676 1291 .tnu [ will -;how you how to inc:rease ,;afety.

Respectfully ~uhmitted,

~~,/~~

10-15-9~

DOCKETED USNRC 1407 West Fourth Street

  • Red Wing, Minnesota 55066-2198 * (612) 388-6721

°95 0C 18 All :2a September 26, 1995 DOCKET NUMBE OFFICE OF SECRETARY DOCKETI NG & ERVICE P OPOS Rl'1.. BRANCH

((c,()~~ ~7't'\1 Donald Cool, Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Washington D.C.

20555 ATTENTION: Docketing and Service Branch

Dear Mr. Kuhl:

The purpose of this communication is to respond to the letter we received about a proposed rule to extend certain material licenses by five years. I think our Nuclear Medicine Service at St. John's Hospital would qualify for this proposed extension, and I fully support this proposed plan. This one-time five-year extension would be welcome news indeed.

!Ii:J.~

Charles R. Nicolosi, M.D.

Radiation Safety Officer License No. 22-16550-01, Expiration date 1-31-96 Reference No. 030-11228 OCT 2 3 199fl Ael<no .ed dby ea d..................................

A member of RIVER REGION HEALTH SERVICES

u UNITED STATES DEPARTMENT OF COMMERCE National Institute of Standards and Technology Gaithersburg , Maryland 29m,~O USNRC September 21, 1995

  • 95 OCT 18 A11 :2 8 Donald A. Cool, Director Division of Industrial and OF FIC E OF SECRETAR Y Medical Nuclear Safety DOCKETING & SERVI CE Office of Nuclear Material BRAN CH Safety and Safeguards U. S. Nuclear Regulatory Commission DOCKET NUMBER Washington, D.C. 20555-0001 p OP ~ LE 'i ~ :J O

((oo~ >\-(o, ~ +)

Dear Dr. Cool:

We wish to comment on the August 31, 1995 Proposed Rule to Extend Certain Material Licenses by Five Years. Our materials license, SNM-362, is due to expire on July 31, 1996. We interpret the proposal to exclude our license from an automatic extension because we were required to submit an accident evaluation. That evaluation was submitted and accepted by the USNRC (see NRC letter dated Dec. 6, 1994,

Subject:

Possession Limit Changes (fAC No. L30660)).

Given that the evaluation was submitted and accepted, we feel that License No. SNM-362 should be a candidate for consideration for the automatic extension. We propose that you consider one of the following two options for the final ruling:

1. The disqualification from extension category for " ..... any license whose holder is required to provide an evaluation or emergency plan for responding to the release of radioactive materials; OR. .. .. " might be changed to read ".... .any license whose holder is required to provide an evaluation or emergency plan for responding to the release of radioactive materials and who has not submitted such a plan; OR..... ". The added portion might be changed to grant extensions on NRC review and approval of such a plan, rather than simple plan submission.
2. The license limits on material quantities at NIST that forced the generation of the accident evaluation are, in a sense, "dummy" limits. The limits provide for the temporary possession and use of customer provided radioactive materials that we measure to quantify and qualify material activities and emission field intensities. The overlapping of customer sources at NIST does happen, but a single source is in use at one time; others awaiting action are kept in secured storage. Also, the radioactive materials at NIST are used by a quite stable, technically competent staff, because establishment and maintenance of radioactivity and radiation standards is such a demanding arena. We feel that NIST could be granted the extension, with periodic reviews, perhaps annually or biennially, to guarantee the continuing efficacy of license condition compliance.

Thank you for your consideration of these comments. Should you wish to communicate with us about this matter, please contact Mr. Thomas Hobbs, Chief of the Health Physics Group, telephone:

301-975-5800.

Sincerely, c?g@'l l'~

L. E. Pevey Occupation th and Safety Division (Materials Li - e Manager)

OCT 2 3 1995t-Acknow edg dby card ..........................,.,....,.

NISI

OFFI OFTH Postmark Da Copies R~DJ Add'I Copies 8 Special [)i (2..

MET *CHEM TEST ING LABORATOR I ES I N C.

369 W. Gregson Ave.

  • Salt Lake City, Utah 84115 - 3 4 4 ~ (l:j..Q. ) jl-~7-0;01

~ ut.; It, At :17 OFFI CE Or SECRtTARY September 28, 1995 DOCKE l Ii 3 i ~~ ('{V!CE BRANt.:H Mr. Donald A. Cool Director U.S. Nuclear Regulatory Commission Division of Industrial & Medical Nuclear Safety Office of Nuclear Material Washington, D. c. 20555-0001

Subject:

Extension of certain material licenses by five years

Dear Mr. Cool:

Met-Chem Testing Laboratories (license# 43-27362-01) feels giving this one-time extension to licensees who qualify is a good idea. It will not only help the NRC, but also the licensees.

ety Officer sh OCT 2 3 1995"'.r--

Acknowled ed by card .......................... .,,..,1

9\~:\\~ (~ f'r\~

I -

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United States Nuclear Regulatory Commission ~

Washington, D .C. 20555-0001

Dear Sir or Madam:

We at Integris Southwest Medical Center support the proposed change that would allow materials license renewals to be extended to 5 years. Changes that need to be made to a radioactive materials license during the interim 5 year period can be done by amendment on an as needed basis. This change will increase the number of man hours available both to the license holders and the regulatory agency and should improve the overall safe use of radioactive materials.

We appreciate your consideration of our support in implementing this change.

Sincerely,

r. James Hendrix Chris Hammes Radiation Safety Officer Director of Radiology/Cardiology/Oncology 4401 South Western Oklahoma City, OK 73109 405/636-7000

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  • 95 OCT J-5 A10 :79 Felix M. Killar, Jr., DIRECTOR MATERIAL LICENSEES PROGRAMS r TECHNICAL/REGULATORY DIVISION DOCKET NUMBER PR PROPOSED RULE ~ o, d-9 -r 70

( (oo rR. % ~ 4)

October 10, 1995 Mr. John C. Hoyle Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 ATTENTION: Docketing and Service Branch

SUBJECT:

One-Time Extension of Certain Byproduct, Source, and Special Nuclear Materials Licenses (60 FR 46784 -- 9/8/95)

Request for Comments

Dear Mr. Hoyle:

The Nuclear Energy Institute (NEl) 1 offers the following comments on behalf of the commercial nuclear energy industry on the subject license extension. We support the extension, but more important, we support the impetus for the proposed extension - the redesign of the materials licensing process. We also completely support the Commission's four goals for the licensing redesign process.

We agree that it is timely for the Commission to consider the appropriate duration of materials licenses. The Commission recognizes some types of industry licensed activities have matured and they may, therefore, be considered for longer duration licenses, perhaps to 20 years. We strongly support this concept for all 10 CFR Parts 30-40 and 70 licenses because we believe that the maturation process has been uniformly beneficial in maintaining or increasing industry safety margins.

1 NEI is the organization responsible for establishing unified nuclear industry policy on matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEI's members include all utilities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect/engineering firms, fuel fabrication facilities, materials licensees, and other organizations and individuals involved in the * ~

nuclear energy industry. d OCT 1 3 1995 Ae!tnowl8dged by car ......................m, ::~

1776 I ,TREET NW ., J TE 4v0 WASHINGTON DC 20006 3708 PHONE 202 39 8000 FAX 202 785 4019

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Mr. John C. Hoyle October 10, 1995 Page 2 We look forward to interacting with the staff as they pursue the redesign of the materials licensing process and its four important goals.

Sincerely,

<r/~I ~ 3/4<-

elix M. Killar, Jr. F'°vrz.

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~ radiation DOCKETED 11 1 technology, inc. USNRC

  • 95 OCT 10 P2 :44 October 6, 1995 OF FICE O SE CRETARY DOCKET! 'G ?.: SERVICF BRANCH Secretary Attn: Docketing and Service Branch U. S. Nuclear Regulatory Commission DOCKET NUMBER PR C, PROPOSED RULE ~ ....

Washington, D. C. 20555 (bo~1/47<t..\- @

Reference:

Proposed Rule RIN 3130-AF38 Gentlemen:

I have reviewed with great interest your proposed rule to grant a one-time five-year extension to certain byproduct, source, and special nuclear material licenses with a renewal date after July 1, 1995. This concept is very good for many licensees with small programs and minimal operational or personnel changes. However, I would urge you not to unilaterally apply the automatic extension across-the-board.

Since January 1, 1994, when major changes to 10 CFR Part 20 became effective, many licensees have been working diligently to enhance their radiation safety programs and bring them into total compliance with these new requirements. Some of these existing licenses have not been renewed in their entirety since the early 1980s and, in fact, have a long list of cited references as far back as the late 1970s. They no longer accurately reflect operational needs or current regulatory requirements. Automatic renewal potentially places these licensees in a conflicting situation.

We are currently working with several clients whose licenses are due to be renewed in late 1995 and early 1996. These clients have already made inordinate efforts to update procedures and radiation safety programs in order for their license renewal submissions to be current and operationally accurate. To unilaterally deny review of these renewals would be punitive to these licensees, would result in the licensees having to operate by antiquated license conditions for another five years, and certainly would not be in the best interest of public health and safety.

We propose that if a licensee requests renewal of their license in its entirety, and provides a complete submission including updated procedures and radiation safety program, that the NRC honor that request. We understand that the NRC needs to "make resources available to expedite the development, design, and testing of the proposed new materials licensing process", and we agree that this is a worthwhile endeavor. However, resources should not be diverted to such an extent that it would be detrimental to those existi~

  • uCT 1 3 1995 ,

Ac1fflowt9dged by card ..........111,:::*:;;::*;; ;:::.

P.O. Box 27637

  • Austin, Texas 78755 * (512) 346-7608
  • Fax (512) 795-8718 8407 Skyline Avenue
  • Odessa, Texas 79764 * (915) 550-9701

U.S. NUCLEAR RE:Gu.Y.1 uA, COMMISSIO~

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U. S. Nuclear Regulatory Commission October 6, 1995 Page Two licensees who have already spent time and resources preparing comprehensive renewal submissions in order to comply with current requirements.

As a final comment, your proposal to write licenses for longer periods of time is a good one. Once a license is current and accurate in compliance with the new requirements of 10 CFR Part 20, then a ten-year interval seems reasonable.

We appreciate your consideration.

Sincerely, Radiation Technology, Inc.

~~ ~. ~~o-->

Doris C. Bryan, Manager Licensing & Regulatory Affairs

Environmental Regulatory South Dakota DOCKETED Compliance Office Radiation Safety Chemical Hygiene State University USNRC Laboratory Safety Box 2202, Shepard Hall 153

'95 OCT 10 P2 :4 4 Brookings, SD 57007-0896 Phone 605-688-4264 FAX 605-688-6364 SDSU OF FICE OF SECRETARY Email: ERCO@mg.sdstate.edu DOCKETING & SERVICE BRANCH October 6, 1995 Secretary of the Commission US Nuclear Regulatory Commission Attn: Docketing and Service Branch Washington, DC 20555 Comments: RIN 3150-AF38 Sir/Madam:

South Dakota State University supports the proposed five-year extension of by-product, source, and special nuclear materials licenses. Use of radioactive materials in educational institutions changes slowly. Underlying management program seldom changes. Any changes can be accommodated easily and readily by amendment. The proposed extension would result in significant budgetary savings to the licensees as well as the NRC.

Ineffective uses and inappropriate control of radioactive materials are more likely to be detected during an inspection than in the license renewal. Serious deficiencies can be addressed by requiring a modified renewal application as a part of the resolution of the Notice of Violation.

For South Dakota State University ,

~

Leo H. S Radiation LHS:klg NRCFEES.COM cc: President Robert Wagner Vice President Michael Reger Dean Christopher Sword rocr 1 3 1995 Acknowledged by card .............................. ,

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SHAW, PITTMAN, POTTS & TROWBRIDGE A PARTNERSHIP INCLUDING PROFESSIONAL CORPORATIONS DOCKETED 2300 N STREET. N.W.

USNRC WASHINGTON, D.C. 20037-1128 (202) 663-8000 FACSIMILE (202) 883-8007

'95 OCT 10 AB :27 JAY E . SILBERG, P.C.

(202) 683-8063 OFFICE OF SECRETARY DOCKETING &. ;:E RVI CE BRAHC i--l October 6, 1995 DOCKET NUMBER R PROPOSED RULE --oQ, P ~Jo Secretary (bo ~Fii!..'+b7~'-\)@

U.S. Nuclear Regulatory Commission Washington, D.C. 20555 ATIN: Docketing and Service Branch Re: Proposed Rulemaking, "One-Time Extension of Certain Byproduct, Source, and Special Nuclear Materials Licenses"

Dear Mr. Secretary:

On behalf of The Forschner Group, Inc. (Forschner"), we are pleased to submit comments on the proposed rule published by the NRC on September 8, 1995, regarding a "One-Time Extension of Certain Byproduct, Source, and Special Nuclear Materials Licenses." ~ 60 Fed. Reg. 46784 (1995). The proposed rule, if adopted, would extend for five years most materials licenses with expiration dates after July 1, 1995, in order "to make resources available to expedite the development, design, and testing of the proposed new materials licensing process .... " Id. This letter also responds to the NRC's solicitation of comments on the general topic of the appropriate duration of materials licenses.

Forschner holds two NRC materials licenses which respectively authorize the possession and use, and distribution to persons exempt from licensing under 10 C.F .R.

§30.15, of tritiated luminous painted subcomponents contained in previously assembled watches. ~ NRC License Nos. 06-28699-01 , 06-28699-02E. Forschner's licenses expire on October 31, 1996, and therefore come within the general scope of licenses which the proposed rule would extend. With one possible exception relevant to the "possession and use" license only (discussed below), Forschner's licenses would qualify for an automatic extension.

I. ONE-TIME AUTOMATIC EXTENSION We believe that an automatic one-time, five-year extension of most materials licenses is sound and worthwhile. Such an extension would largely relieve the NRC of the burden of rocr 1 3 1995 Acknow!edgsd by card ................................

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SHAW, PITTMAN , POTTS & TROWBRIDGE A PARTNERSHIP INCLUDING PROFESSIONAL CORPORATIONS Secretary U.S. Nuclear Regulatory Commission October 6, 1995 Page2 making individualized extension determinations for numerous materials licenses now scheduled to expire after July 1, 1995. The proposed extension therefore would greatly facilitate the NRC's objective of redirecting its resources "into the detailed design and testing of the proposed new materials licensing process." 60 Fed. Reg. at 46785. Moreover, at least for materials licenses of the kind possessed by Forschner, an automatic five-year extension beyond the five years now authorized would in no way endanger the public health or safety.

Indeed, such materials licenses should have a normal duration of 10-20 years in any event, as we will discuss below.

The proposed rule would not extend materials licenses whose holders have been subject to a Confirmatory Action Letter ("CAL") "as the result of the most recent NRC inspection of licensed activities conducted before the effective date of the final rule."

Proposed 10 C.F.R. § 30.36(a)(3)(vi), at 60 Fed. Reg. 46787. We believe that the proposed rule's denial of an automatic extension to all licensees recently subject to a CAL is unnecessary. At least where the licensee has (like Forschner) promptly implemented corrective steps, the issuance of a CAL without any finding of a Severity Level I, II or III violation does not raise significant safety or other regulatory issues warranting heightened NRC scrutiny of the licensee's operations.11 In such a situation, there is no "relatively greater risk to public health and safety" that would justify requiring the standard 5-year renewal review. 60 Fed. Reg. at 46785. The final rule should, at the very least, authorize the one-time five-year extension for those licensees who may have received CAL's for unintentional and safety-insignificant violations, such as the CAL issued to Forschner with respect to its "possession and use" license.

JL With respect to Forschner's "possession and use" license, a CAL was issued on May 4, 1995 as the result of an NRC inspection on April 27, 1995. The CAL arose from Forschner's having engaged in watch repair activities without having modified its license, based upon the incorrect assumption that the repair activity was exempt from licensing under 10 C.F.R. § 30.15(a). In response to the CAL, Forschner promptly took the corrective steps of: (1) taking comprehensive radiological analyses to assure that no individuals had received significant radiation doses from the watch repair operations; and (2) transferring those operations to a wholly-owned subsidiary which is separate and distinct from Forschner and qualifies for the § 30.15(a) licensing exemption. ~ Letter to NRC from Stephen J. Zazuri, dated June 26, 1995; Letter to Charles W.

Hehl (NRC) from James W. Kennedy, dated June 5, 1995.

Of course, if the NRC again were to inspect Forschner before the final rule's adoption, the April 27, 1995 inspection would cease to be the "most recent" inspection of licensed activities. In that situation, the proposed rule's exclusion would not apply to Forschner's "possession and use" license in any event. Nor does the exclusion apply to Forschner's distribution license, which has never been the subject of a CAL.

SHAW, PITTMAN , POTTS & TROWBRIDGE A PARTNERSHIP INCLUDING PROFESSIONAL CORPORATIONS Secretary U.S. Nuclear Regulatory Commission October 6, 1995 Page 3

11. APPROPRIATE DURATION OF MATERIALS LICENSES We strongly endorse the NRC's planned reassessment of the appropriate duration of materials licenses generally. As the NRC has recognized, "for some types of licensed activities the industry has matured and it may be appropriate to consider issuing licenses for

[periods longer than five years], perhaps 10-20 years." 60 Fed. Reg. at 46786. We submit that materials licenses of the kind held by Forschner -- authorizing the possession, use and distribution of tritiated luminous painted subcomponents contained in previously assembled watches -- are in fact suitable and appropriate for durations ofup to 20 years. For these kinds of licenses, the current 5-year tenure is unnecessarily short in light of the maturation of the luminous watch distribution industry and the minuscule amounts of radioactive material involved, as well as the NRC's financial restrictions in this era of tight budgets. The NRC has ample authority and ability to oversee licensees' handling of the minute quantities of tritium contained in luminous watches, without imposing at 5-year intervals the burdensome paperwork and expenditure of resources incident to license renewal. At this stage, such frequent renewals are needless and redundant. Extending to 20 years the duration of materials licenses for tritiated watches would conserve scarce resources of both the NRC and licensees, with no adverse effect on public safety.

For the reasons set forth above, the NRC should effectuate the automatic five-year extension of certain materials licenses which it is now considering, but should not exclude those licensees in receipt of CAL's arising from inadvertent and safety-insignificant violations. The NRC should also extend to up to 20 years the normal duration of materials licenses for the possession, use and distribution of tritiated subcomponents in luminous watches.

ilberg

. Wendtland

October 4, 1995 DOCKET NUMBER p PROPOSED RULE~~ ~----

Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D. C. 20555 (fooR. % 7 '6~ \G\

Attention: Docketing and Seivice Branch Re: 10 CFR Parts 30, 40 and 70 Proposed Rule, "One-Time Extension of Certain Byproduct, Source and Special Nuclear Materials Licensees. "

Gentlemen:

The Illinois Department of Nuclear Safety (Department) hereby submits its comments on the referenced proposed rule. The proposed rule represents changes to 10 CFR Parts 30, 40 and 70 that would automatically grant a five-year extension of certain licensees.

Our comment concerns the implementation of this rule. Will the NRC provide any documentation to licensees to indicate that they qualify for the exemption, or that their license has been automatically extended? Agreement States and distributors rely on the expiration date specified on the license document to verify that a licensee can use and receive radioactive material. When granting reciprocity to an NRC licensee, for example, will Agreement States have any documentation to assure that a particular licensee has been granted the extension? Agreement States do not have immediate access to the NRC's license files to know whether or not the licensee meets the criteria for extension of the expiration date.

The Department considers it crucial that the NRC provide some type of correspondence to the licensee indicating the licensee's qualification for the exemption, or modifying the first page of the license to indicate the extension of the expiration date. If you have any questions regarding these comments, do not hesitate to call me or Kathy Allen at (217) 785-9947.

Sincerely, J~~.~

Steven C. Collins, Chief Division of Radioactive Materials SCC:KAA:ka rocr 1 3 1995~

~ cc: Jim Lynch, State Agreements Officer ard ............ ................. 'wtflld

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  • 95 OCT 10 A9 :07 510/283-1850 Fax:510/283-1850 October 4, 1995 Henry H. Kramer, Ph.D., FACNP OF FICE OF SECRETARY Executive Director DOCKETING & SERVICE BRANCH DOCKET NUMBER PROPOSED RULE PR Sc .., c lldJ~%"1"6 @

Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555 Attn. : Docket and Service Branch

Reference:

Proposed Rule. "One-Time Extension of Certain By-product, Source, and Special Nuclear Materials Licenses". Federal Register Vol. 60, No. 174, September 8, 1995.

Notice to all Material Licensees. "Proposed Rule to Extend Certain Material Licenses by Five Years" . August 31, 1995.

These comments are submitted on behalf of the Council on Radionuclides and Radiopharmaceuticals (CORAR). CORAR members include the major manufacturers and distributors of radiopharmaceuticals, radioactive sources and research radionuclides used in the USA for therapeutic and diagnostic medical applications and for industrial, environmental and biomedical research and quality control. CORAR members are NRC or Agreement State Licensees and are therefore affected by this proposed rule to extend certain material licenses.

In general CORAR supports the proposed rule's objective to free NRC staff resources to design and test a new materials licensing process. On previous occasions CORAR has communicated the need to modernize the licensing process. While we recognize that the proposed rule could be beneficial, we believe that the NRC has even a greater opportunity to make further improvements in the licensing process. These improvements are discussed in the attached detailed comments.

CORAR believes that the license renewal process is redundant and serves no useful purpose that cannot be achieved more effectively through license amendment and inspection processes. Consequently, even though we support this proposed rule, we urge the NRC to reconsider this proposed rule and instead remove the license renewal process from the regulations. The NRC should also encourage Agreement States to make similar changes.

rocr 1 3 1995

  • Acknow edged by card ........................<<-..,-

U.S. NUCLEAR REGULATORY COMMISSIO"1 DOCKETING & SE, V,CE SECTIO OFFICE OF 1HE SECRET ARY OF THE COMMISSION DocuMPnt S a+istics Postmark Date ,i Copies Received_ \_ _

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4

We appreciate the opportunity to comment and would be glad to provide additional information to substantiate our position or further clarification.

Sincerely yours, Leonard R. Smith, CHP CORAR Subcommittee on Regulating Major Materials Licensees 2

COMMENTS ON US NRC PROPOSED RULE TO EXTEND CERTAIN MATERIAL LICENSES BY FIVE YEARS.

Page and paragraph numbers refer to the cover note and text of the notice to material licensees dated August 31, 1995.

Cover Note

1. Page 1, paragraph 2.

"NRC expects that about 80 percent of its 6550 materials licenses would be extended by five years, temporarily relieving those licensees of the requirement to renew their licenses."

Most CORAR members are major licensees who possess broad scope license that would not be affected by the proposed rule. However, CORAR supports the proposed NRC rule to extend applicable licenses by five years. We recognize that such action would be a significant relief to applicable licensees with no adverse consequences to radiation protection performance.

2. Page 1, paragraph 3.

"The selective extension of ... material licenses will result in the freeing of staff resource that would otherwise be used in the renewal of these licenses. These resources will then be redirected ... into detailed design and testing of a new materials licensing process."

CORAR is encouraged that the NRC is freeing staff to design and test a new materials licensing process. We believe that the modernization of the licensing process should be a high priority, There is an opportunity here to reduce regulatory burden and permit both NRC and licensee resources to be redirected to activities that promote radiaJion protection.

3. Page 1, paragraph 4.

"Licenses with operations that pose relatively greater safety risks and licenses with poor performance would not be eligible for this one-time extension."

Most CORAR members are major licensees that would not qualify for license extension as proposed. The above statement implies that we pose a relatively greater safety risk than other licensees. We object strongly to this characterization and believe this to be very misleading to the general public.

3

Licensees typically apply safety controls that are commensurate with the quantity and type of radioactive material in possession. For this reason major licensees are unlikely to pose risks that are greater than other licensees.

CORAR members have had the opportunity to bench mark their radiation protection performance against other licensees and DOE facilities and usually compare favorably with these other facilities. We recommend that the NRC delete "Licenses with operations that pose relatively greater safety risks and ...,, to retract any implication that major manufacturing licensees pose a greater safety risk or otherwise provide quantitative data to substantiate this opinion.

4. Page 2, paragraph 2.
  • " *** it can extend qualified licenses by five years without reducing the level of protection of the public health and safety."
a. While we agree with the above statement we note that the NRC has not explained why the process of license renewal improves the level of protection of the public health and safety. CORAR believes that license renewal has very little beneficial effect on licensee performance.
b. In our experience, license renewal involves one of the following processes:
1. no change to the license.
11. a license amendment which could be effected by the license amendment process.

111. removal of obsolete material from the license.

c. It is clearly redundant iflicense renewal results in no change to the license.
d. Changes are likely to be more* pertinent and timely if changes to the license are effected by license amendment rather than license renewal.
e. The current practice of accumulating obsolete material in a license is counterproductive. Instead, obsolete material should be removed whenever a license amendment is implemented. The license will then be current, easier to review and easier to use.
f. Current renewal practice requires that licensees review their radiation protection program. However, this requirement is now redundant since the revised IO CFR 20 requires annual review of the licensees program.

4

g. To summarize, timely license amendment and regulatory inspection of facilities are both sufficient and superior methods to enhance licensee performance. License renewal is redundant.

Proposed Rule

5. Page 5, paragraph 2.

"The Commission believes that these licenses [with emergency plans] authorize activities that may pose a significant potential for release of radioactive materials and may result in potential exposure to the public and contamination of the environment."

  • a. CORAR disagrees that licensees that are required by 10 CFR 30.32(i) to maintain an emergency plan have significant potential for release and public exposure. The NRC's own cost-benefit analysis showed maintenance of emergency plans to be unjustified.
b. The possession limits for requiring an emergency plan have been set by the NRC to be at least a factor of twenty too low. Again this was clearly indicated by the NRCs own cost benefit analysis.
c. CORAR is unaware of any incidents involving major material licensees where members of the public received significant exposures from released radioactive materials.
d. Major material licensees maintain controls that are more than sufficient to contain the quantities of licensed material in possession. Even hypothetical maximum credible release scenarios show insignificant off-site impact.
e. Further more the NRC has not explained, nor is it evident, that license renewal has any effect on performance.  ;
6. Page 8, paragraph 4.

Page 9, paragraph 1.

" ... each license be considered separately in determining whether its expiration date should be extended under this rule."

CORAR agrees that a temporary expedient might be to consider each license separately in determining whether to extend its expiration date. However, we believe that a better approach would be to extend all licenses and eliminate the renewal process.

5

7. Page 10, paragraph 1.

"The Commission is aware that for some type of licensed activities the industry has matured and it may be appropriate to consider issuing licenses for longer times, perhaps 10-20 years. the Commission is also aware that some Agreement States routinely issue licenses for periods longer than 5 years."

a. Radionuclides and radiopharmaceutical manufacturers have been practicing for about 40 years. The financial community classifies these businesses as a mature industry.
b. The manufacture and supply of radioactive materials for essential nuclear medicine and biomedical research requires a very high level of commitment and reliability in areas including production, distribution, product safety, quality and radiation protection. This industry needs stable regulations and stable license conditions.

Frequent license renewal is unnecessary and unwanted.

c. Minor changes in licensee practice to accommodate new or increased use of radionuclides and personnel changes are adequately addressed by the license amendment process.
d. Some CORAR members process both by-product material and accelerator produced materials. Typically these accelerator operations are simply registered with state authorities. However, CORAR members establish similar safety practices for both by-product and accelerator material.
e. The NRC should be aware that other developed countries do not have licensing programs and do maintain safety and protection standards that are considered by many to be more realistic than those in the USA.
f. There is clearly ample evidence that the license renewal process does not make a significant contribution to safety and protection. We therefore recommend that the NRC eliminates the license renewal program and eliminate license expiration dates.
g. If instead the NRC believes that the license renewal process makes a substantive benefit to safety and protection, the NRC should provide quantitative evidence to justify its cost to society for each applicable class of license.

6

DOCKETED Mayo Clinic Rochester, Minnesota 5590 SN RC Radiation Safety Telephone 507 2~-3~ - 6 p J :Q 4 September 28, 1995 OFFICE OF SE CRE TARY DOCK ETING & SERVICE Secretary, U.S. Nuclear Regulatory Commission BRANCH Docketing and Service Branch DOCKET NUMBER PR Washington, DC 20555 PROPOSED RULE..!.!!~~~a~ -

( <oc~~1-=t-0 @

RE: Proposed Rule Extending Certain Materials Licenses By 5 Years

\1 RJN 3150-AF38 Thank you for this opportunity to comment on the proposal to allow certain materials licenses to be extended five years without submission of a new application. We are supportive of this proposal in situations where the licensee has had very good previous performance as documented in inspection findings and is in compliance with required submittals (e.g. decommissioning fimding plan, quality management plan, emergency plan, etc.).

For many licensees, radioactive material operations do not change substantially over a short period of time (5-y) and, therefore, do not warrant submission of a new license application which requires a significant investment of time on the part of Radiation Safety and NRC Staff. License changes can be made simply by submitting an amendment. Also, by continuing the same inspection schedule over this extended time, safety infractions can be addressed quickly.

However, we suggest that licensees who have submitted a license renewal after July 1, 1995, and whose applications would now fall under this proposal and be extended without reference to the new application, should have the option of having their application reviewed or having the "old" license extended. While we agree with your statement that since NRC review of the new application has not yet begun so resources can be conserved, some institutions submitting renewals have spent numerous hours on a document under which they would prefer to operate.

Regarding your request for comments on license duration, we agree that under certain circumstances it would be appropriate for licenses to be approved for ten years. These circumstances include the items listed that would prevent automatic extension for 5 y: emergency plan, decommissioning fimding plan, etc ..

It is our opinion that the inspection process should fill the role of determining whether a licensee is maintaining a program that assures the health and safety of employees and members of the public and that the inspection program should replace the largely paperwork (license renewal application) process.

If you have any questions regarding these comments, please call me (507) 284-4408.

Sincerely, Richard J. Vetter, Ph.D.

Radiation Safety Officer OCT 1 3 1QQ,..

Mayo Clinic Acl{now\edged by card ...........................,....~

200 First Street Southwest Rochester, Minnesota 55905

U.S. NU,,..LEAR REGULATORY COMMISSIOt-.

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\(p US NRC From: "Gilmore Sem" ("GSEM@TSII . COM")

To: secy@nrc.gov, Date: Tuesday, October 3, 1995 5:43 pm *95 OCT -4 A9 :42

Subject:

Proposed rule to extend certain material licenses by 5 years (SMTP Id#: 60525)

OFFICE OF SECRETARY Dear NRC DOCKET ING & ERVICE BRANCH I like this proposed rule very much. I believe it protects the interests of the citizens of our country while relieving both licensees and the NRC of unnecessary work. With the exceptions listed in the proposed rule dated August 31, 1995, I heartily endorse this plan.

Sincerely, Gilmore Sem TSI Incorporated PO Box 64394 St Paul, MN 55113 Phone: 612 490 2729 FAX: 612 490 3860

U.S. NUCLEAR REGULATORY COMMISSIOt--.

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September 29, 1995 *95 OCT :fr"" P4 :32 ARC HI TEC TS a n d ENG INEERS Secretary OFF' -- . ,=CRETARY 1107 M t. Rushmore Road U.S. Nuclear Regulatory Commission OOC1 '. l SERv ICE Suite 3 Washington, DC 20555 t ti I Rapid City, SD 57701 Attn: Docketing and Service Branch 605-342-9470 FAX 605-342-2377

Dear Mr./Ms. Secretary:

As a small company of approximately 20 employees and only 2 Nuclear Density/Moisture Gauges, we feel that the proposed 5 year automatic extension of certain material licenses is a great idea However, we also feel that the Nuclear Regulatory Commission (NRC) can take further steps to reduce the burden on small companies like ours as well as reduce the work load of NRC licensing personnel.

The current schedule for licensing fees creates an undue hardship on small companies like ours.

The Nuclear Density/Moisture Gauges like the Troxler 3411-B have been proven to create virtually no threat to public safety, when handled properly. Therefore, it is our opinion that licensing for Nuclear Density/Moisture Gauges should be done on a IO year increment with an inspection by the NRC every five years, unless violations are encountered within this period. We further feel that the yearly fees should be tiered. For example, a company such as ours that has only two nuclear devices should not be required to pay the same yearly fee as a larger company that may have 5 or more machines. The current fee schedule is a major burden on small companies. We would propose that the fees be based on a per machine basis for all companies and that this fee should be in the range of $250. 00 per device per year.

Another requirement that the NRC has that puts an undue burden on smaller companies is the NRC's inspection policies. To require a small company to pay for inspections at any time and as many times as the NRC determines can present undue hardship on a small company. As stated above we feel that the Nuclear Density/Moisture Gauges have limited risk to public health and safety and an inspection every 5 years would more than adequately serve the health and safety needs of the public. We understand that additional inspections should be allowed if the company has a history of noncompliance with NRC regulations or if an "incident" with the device has recently occurred. The suggestions mentioned would not only relieve unnecessary burden on small companies, it would also free up NRC staff to pursue entities that pose greater risk to public health and safety.

We hope that the NRC will take a serious look at its current license and fee policies and realize that some of them place undue hardship on small companies such as ours. With an extension of the license from 5 years to IO years and a re-evaluation of current fee and inspection schedules, both small companies and the NRC would greatly benefit without creating any greater risk to the public health or safety.

rocr 1 s 191_ --

Ae1':nowtooged y ea ........................... --....a

U.S. NUCLE/1t .,* w;T(;RY COMMISSIOt-.

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Thank you for your time and consideration of the matters outlined in this letter. We hope that the NRC will take a serious look into these issues and create a better method that will benefit all of the entities involved.

If you have any further questions please contact our office.

ALLIANCE OF ARCJilTECTS AND ENGINEERS Gary A. Norton, E.I.T Radiation Safety Officer cc: Senator Larry Pressler Senator Tom Daschle Representative Tim Johnson

DOCKETED USNRC

..... =

Communicalions & Power lndusJries '95 OCT -2 A10 :11 beverly microwave division Secretary, U. S. Nuclear Regulatory Commission OFFI CE OF SECRETARY DOCKETING & SE VICE Washington, DC 20555 BRANCH ATTN: Docketing and Service Branch

Dear Ladies and Gentlemen:

Communications and Power Industries mmiufacturers microwave devices for the Radar and Electronics Wufare Markets. Some of these devices, Receiver Protectors, contain a small amount of byproduct material to serve as a free electron source, necessary for the proper function of the device. As a small mmiufacturer of a mature product, we support the Commissions recent proposal to extend license duration beyond the current five year term. We believe the proposal will reduce administrative effort for the Commission and licensees while enhancing the integrity of efforts to ensure public health and safety by freeing resources for these efforts.

Many of the industries using byproduct material have matured over the past 25 years, thus the current five year license duration has little to do with the rate of technological change.

Our own experience has shown that changes to license conditions are small over the five year license duration. In fact, most changes do not coincide with the timing of license renewal and are handled through the amendment process. This would continue under the proposed extension without the administrative detail of license renewal in the shorter term.

Technological changes require a license amendment under the current license cycle as well as the proposed cycle, thus there is no change here. Licensees with a solid record of strong support for adherence to regulation, sound inspection experiences, and highly developed technologies would be well served by the license duration extension. Licensees with a history of inattention to safety and regulatory compliance would be subject to the sanctions embodied within the current regulatory framework. Therefore, the extension contains adequate measures to ensure the continued protection of public health and safety.

In summary, we see two major advantages to extended license duration. Longer license duration would eliminate a bureaucratic burden for the licensee and the Commission.

Efforts to insure public health and safety would be enhanced by freeing limited resources for these efforts. We view these as important ways for the Commission to continue improving the quality of service it provides the public and licensees.

Sin: rel~ ~

~ abko Radiation Safety Officer ISO Sohier Road, Beverly, Massachusetts 01915-5595 (508) 922-6000 *oCT '::' 3 199S-fonnerly a division of Varian Associates, Inc. Ae1':now'edged by card ........................... ..

U.S. NUCLEAR REGULATORY COMMISSIO DOCKETING & SERVICE ~ECTION OFFICE OF THE SEC ETARV OF THE COMMISSION Document Sta~stics POSlfflar1( Date _._...........Y-'"-. . . __ _ __

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((po'f'~4-lc,7"b~@) *95 OCT -2 A9 :01 From: Bill Vermeere ("VERMEERE@SNOWHITE.ARC.NASA.GOVOf FICE OF SECRETARY To: SECY@nrc.gov DOCKET! ~G & SERVICE Date: Friday, September 29, 1995 1:31 pm BRANCH

Subject:

Extension of NRC licenses (SMTP Id#: 54845)

The NASA Ames,Moffett Field, CA, Radiation Safety Committee fully endorses the concept of extending certain materials licenses by five years. We are very interested in acquiring information regarding the redesign of the materials licensing process.

Name: Bill Vermeere E-mail: Bill Vermeere <Vermeere@snowhite.arc.nasa.gov>

Date: 09/29/95 Time: 09:52:04 This message was sent by Chameleon Acknowledged by Cl * -~ ~

U.S. NUCLEAR REGULATORY COMMISSIO~

DOCKETING ERVICE SECT ION OHICE OF THE SECRETARY 0 THE CO 1* MlSSION Postmar1( Date l),Q.,r~.._:. 1~.,Q Coples Rece1verl_L-_ _ _ _ __

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DOCKETED USNRC September 25, 1995

  • 95 SEP 29 A9 :50 OFFI CE F S CRETARY DOCKETltb & c ~RVI CE BRANCH Secretary DOCKET NUMBER PR PROPOSED RULE__:_-:.:.~-2>o~ ~ .,.,,.

US Nuclear Regulatory Commission ( CcDF"R-4-lo7 -S '-\-)

Washington, DC 20555 ATTN: Docketing and Service Branch

Dear Secretary,

This letter is a response to your request for comments on the proposed 5 year extension on certain material licenses.

OmniGene, Inc. is of course strongly in favor of this proposal to extend the term of licenses for licensees that have a good record of safety and compliance. The savings of time and expense for a renewal application would be highly significant for a small business such as ours.

Thanks.

Sincerely,

~~

Rogers Yocum, Ph.D.

Radiation Safety Officer 763D Concord Avenue, P.O. Box 9002, Cambridge, MA 02139-9002 Tel 617-576-1966 Fax 617-547-9256

U.S. NL;C!..EA L*.:, LATORY COMMISSIOI\

DOCKET ~(, & SERVICE SECTION OFFICE OF Tf-<E SECRETARY Of THE COMM1SSION Doc *rr1:nt Statistics Postman< Date __._,= "'-14.....__ _ __

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  • Stone Mountain, GA 30083

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NUREG/BR-0032

- INTERNET:OPA@NRC.GOV 301-415-8200 Vol. 15, No. 33 Week Ending September 15, 1995 NEWS RELEASES

-/20 95-112 September 11, 1995 NRC CONSIDERS ONE-TIME FIVE-YEAR categories of materials licenses that would not be eligible for the extension.

The Commission estimates that AUTOMATIC EXTENSION OF CERTAIN more than 80 percent of its 6,500 MATERIALS LICENSES materials licenses would be extended under the proposed rule, including, The Nuclear Regulatory for example, many hospitals that use Commission is considering a one-time radioactive materials for patient automatic extension of certain treatment and diagnosis, nuclear materials licenses for five universities that use radioactive years from their current expiration material in research, and industrial dates. The extension would provide users.

time a~d resources for the NRC to develop a new nucl~ar materials The Commission believes that licensing process that would be most materials licenses may be faster than the current process, use automatically extended once for five modern information technology, and years without adverse effect on the reduce personnel resources needed public health and safety because:

for the licensing program to meet the agency's projected lower

  • Licenses that could present a staffing levels. The aim is to greater potential health and maintain or raise the level of safety risk would continue to public safety achieved by the be reviewed and renewed in current licensing process. accordance with existing procedures.

The proposed one-time five-

  • The extended licenses would year automatic license extension and provide the same the new licensing process under authorizations and limits on development would not apply to licensee activities as the nuclear reactors, uranium milling current ones.

and processing facilities, or

  • NRC will continue to inspect nuclear fuel pr?duction facilities. licensees with the same frequency as now and, if In addition, those materials violations of NRC requirements licenses that the Commission are found, require corrective believes could present a relatively actions or issue orders that greater potential risk from a health would modify, suspend or and safety standpoint would not be revoke the license.

automatically extended. A Federal Register notice published on The extended license would be September 8 identifies the different from a "renewed" license,

which involves an NRC technical publication of the Federal Register review and can include changes in notice). The comments should be current operations if requested by addressed to the Secretary, U.S.

the licensee in its renewal Nuclear Regulatory Commission, application and approved by the NRC. Washington, DC 20555, Attention:

Materials licenses are currently Docketing and Servlc Branch.

issued for five years, with an Comments may alau *-~itted opportunity for renewals for five- through the Internet ~ressing year periods, upon licensee electronic mail to application and NRC approval. If a INTERNET:SECY@NRC.GOV or th~ the licensee applies for renewal before NRC Electronic Rulemaking Bull the license expires, the license Board on FEDWORLD, as describec remains in effect until the NRC the Federal Register notice.

acts--by approval or disapproval.

The proposed rule would automatically egtend eligible No.95-113 September 14, 1995 licenses with expiration dates after July l, provided a timely renewal application is received, and the NRC 23RD WATER REACTOR SAFETY would refund any renewal fees INFORMATION MEETING SET FOR submitted. The NRC staff will OCT. 23-25 IN BETHESDA, MARYLAND continue process for renewal, rather than automatic extension, the time applications received for The Nuclear Regulatory l .ases with expiration dates Commission will hold its 23rd Water

~fore July 1. Licensees whose Reactor Safety Information Meeting license term expires soon and who October 23-25 at the Bethesda have not yet submitted an Marriott Hotel, 5151 Pooks Hill application for renewal will need to Road, Bethesda, Maryland.

submit such an application if their license expiration date occurs NRC Chairman Shirley Ann before the Commission issues a new Jackson will open the meeting at the rule. plenary session starting at 8:30 a.

m. on the first day. Her remarks The NRC is seeking public will be followed by a panel comment on the proposed five-year discussion on "Current Industry automatic license extension and also Issues and Their Relation to NRC on the appropriate duration for Research." Participating will be materials licenses. The NRC will Dr. David L. Morrison, director of consider whether the current five- the NRC Office of Nuclear Reactor year duration of materials licenses Research; William T. Russell, is appropriate, whether various director of the Office of Nuclear durations should be used depending Reactor Regulation; and senior on the nature of the activities utility executives. James M.

permitted under the license, and Taylor, NRC executive director for whether, in view of the fact that pperations, will speak at the for some types of licensed general luncheon on the final day of activities the industry has matured, the conference.

licenses might be issued for longer periods. If the Commission decides During the three-day meeting, to revise its policy on materials sessions will feature presentation license duration, licensees with on Human Factors Research, pending renewal applications that Structural and Seismic Engineering, fulfill all regulatory requirements Advanced Hardware and Software for would be granted licenses for Instrumentation and Control, High periods consistent with that Burnup Fuel Behavior, Severe decision. Accident Research, Primary Systema Integrity, Equipment Operability and Interested persons are invited Aging, Thermal Hydraulic Research, to submit written comments by Probabilistic Risk Assessment, October 10 (30 days after Individual Plant Examination, and 2

Radiation Oncologi_sts DOCKETED ofNorthwest New Jersey, P.A. USNRC ROBERT J. COLE, M.D. "9'J SfP 28 A10 :1 5 REVA OREN , M.D.

ALLAN J . SCHER, M.D.

OFFICE OF SECRETARY DOCKETING & SERVICE September 21, 1995 BRA CH Secretary US Nuclear Regulatory Commission Washington, D.C. 20555 Attn: Docketing and Service Branch Re: Proposed One Time Five-Year Extension for 6550 Materials Licenses As long as inspections continue, as before, in the interest in public safety, I believe that the license extension would be of benefit to both the NRC and the licensees. The exceptions to this five year extension grant, as listed, are quite reasonable.

Perhaps, on the basis of experience gathered with this experiment, relicensing intervals might be extended in the future.

Sincerely, AJS:srd Allan ~6, D.A.B.R., F.A.C.R.

cc: Simon c. P. Lam Radiation Safety Officer OCT -= 3 1995"'

Actmowtadged by card .......-"..__............,.

100 Madison Avenue

  • Morristown, New Jersey 07962-1956 Telephone: (201) 971-5329 Emergency: (201) 971-5448 FAX: (201) 984-1712

U.S. NUCLEAR . 0 MlSSIOt-.

DOCKETIN ECTION oc:FICE TAR OF N

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Department of Environmental Wright State DOCKETED Health and Safety University USNRC Dayton, Ohio 45435 513/873-2215

'95 SEP 27 P3 :Q3 September 22, 1995 OFFI CE OF SEC RETA RY DOCK ETl tG & SER VICE DOCKET NUMBER BRANCH PROPOSED RULE..:..::.:..s~ PR "'".,o

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;;
..:...::.;;;:;.

Secretary [ATTN: Docketing and Service Branch] ( (gc ~~ 4(;.1 '?> ~CS)

U.S. Nuclear Regulatory Commission Washington, DC 20555 Re: Five-Year Extension of Byproduct Nuclear Materials Licenses The Commission's proposal to extend certain radioactive material licenses for a period of 5 years is a sound approach to cost savings. I agree that the level of protection of public health and safety will not be compromised. The list of factors that would disqualify licenses from this program appears comprehensive. We support this approach as an effective means to do more with less.

. Sincerely, v l/l'/M-Thomas Mohaupt, M.S., CHP

- University Radiation Safety Officer OCT :: 3 1995~

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

U.S. NUCLEAG 81:::(;ii..1 , A' .;H ' COMMISSIOI\

DOCKErn~G & SEF;iCE SECTION OFFICE OF THE SCCRET ARY OF THE: COMMISSION Document Statistics Postmark Date 3 ~.....__ __

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HWS..,

Consulting Group Inc. . . .

DOCKETED USNRC LINCOLN OFFICE 825 J Street, Box 80358 Lincoln, NE 68501-0358 402/479-2200 FAX 402/479-2276

  • 93 SEP 25 P4 :u 3Solutions Through Service OFFICE OF SECRETARY September 21, 1995 DOC KETI NG & SERVICE BRANCH Secretary, U.S. Nuclear Regulatory Commission DOCKET NUMBER*

Washington, DC 20555 PROPOSED RULE rR ~ D

( (c()~ L\ '9"1 ~ if)

REFERENCE:

Docketing and Service Branch © Extention of Materials license by Five Years

Dear Secretary:

I believe this would be a good for the Commission and for the Licensees. It would save a great deal of time, effort and money for both parties.

Thank You for the opportunity to express our opinion.

Sincerely HWS CONSULTING GROUP INC.

RD/cac 52-86-0086 GEOTECH\NRC

  • .1 b Acknowledgw ... Qf'.ul'T"..~~~

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LINCOLN DENVER

  • WICHITA OMAHA CHICAGO

. NUCLEAR REGUu, rr' R: "OMMISSIOt-.

DOCKETING & SfR 'ii' E SECTION OFFICE OF THE: s~CRETAAY Of THE COMMISSION Document Stansb llffllrt{ Date 9 \.

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Sm1thKl1ne Beecham SD DOCKETED USNR C Clinical Laboratories

  • 95 SEP 25 P4 :Q3 September 19, 1995 OFF ICE OF SECRETAR Y OOCK ET l1 1G & SERV ICE BRAH CH Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555

Dear Secretary:

We support the proposed rule, as written, for a one-time five-year extension of certain byproduct, source, and special nuclear materials licenses.

Sincerely, Richard S. Bak, Ph.D.

Radiation Safety Officer RSB/cqg OCT -= 3 l99S: __

Acknow19dged by eard ...""'"""'"""'"""'"'~

38700 Country Club Drive, Farmington Hills, Ml 48331, (810) 488-2300 c:\opertns\tech\corres\secynrc.9/19/95

NUCLEAR REGULA t-l lO OOCKETING & SER OFFICE OF THE C OF THE COMMISSION Document Start tics arttDate 5\&o~qS:: - - =

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STAVELEY

., NOT TECHNOLOGIES Conam Inspection Inc 1245 Norwood Avenue Itasca, IL 60143 DOCK ET ED Telephone +I 708-773-9400 USNRC Facsimile +I 708-773-9285

  • 95 SEP 25 P4 :03 DOCKET NlNBERPI September 18, 1995 PROPOSED RULE..:...:.:.~ '--"=-

OFFICE OF SECRETARY DOCKETI NG & SERV ICE ( ~Fg. 4,~'1~~ © BRANCH CONAM===

U. S. Nuclear Regulatory Commission Washington , D.C. 20555-0001 RE: .PROPOSED RULE TO EXTEND CERTAIN MATERIAL LICENSES BY FIVE YEARS Gentlemen:

CONAM INSPECTION INC wishes to cast a positive vote for a one-time license extension of five years. We agree with the "cost saving" argument and point out that licensees also will save costs by being freed up to pursue our safety programs without the interruption of assembling and submitting a renewal package.

There was no mention of specific cost reductions to the licensee as regards this extension and is a point which merits addressing .

In closing , I believe there should be a ten (10) year licensing period instead of the current five (5) year period .

S~ n j [._______

RobertJ . ~~

Radiation Safety Officer RJS.jjh :ss.132 Ae ,edg by card .._ OCT _- 3 _1995" ..,.,.,.

A subsidiary of Scaveley NOT Technologies Inc

U.S. NUCLEAR REGULATORY COMMISSIOI'.

DOCKETING & SERVICE SECTION OFFICE OF THE SECPETARY Of THE COMMISSION DoQJment Statistics Postmartt Date ~ .\_~,.-19._.._<.__

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DOCKETED Morristown Memorial Hospital USNRC Radiation Safely Office . SEP 25 P3 :19 100, Madison Ave.

  • Morristown, NJ 07960
  • Phone (201)-971-5675
  • Fax: (2~ -326-1721 September 20, I 995 OFFICE OF/&.

oocKET~*RtHcH Cf[R't,~l Secretary, USNRC Docket and Service Branch, Hand deliver comment to:

11555 Rockville Pike, Rockville, MD 20852.

Dear Sir/Madame:

I am a practicing medical physicist, involve in the licensing process for more than 20 years. I am very much in favor of your one time rule change to extend some of less critical licensee for 5 more years, while you are reorganizing and streamlining your review procedures. It may be worthwhile even to extend the 5 year renewal review time to 7 years for medical licenses. Your past tum-around review time is undesirable.

Continue your reengineering, make best use of your resources.

Sincerel ",e!P e ~..s--,,--b_

Simon C. P. Um Radiation Safety Officer

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~--.--, ___, .,. _ ___________,- ,,.

Simon C.P. Lam, MSE, DABR, DABMP, Morristown Memorial Hospital 34, Lord Wtlliam Penn Drive, Morris Township, NJ, 07960.

Secretary, USNRC Docket and Service Branch, Hand deliver comment to: OCT ':." 3 1995:U.

11555 Rockville Pike, Ae,mow\edged by card ..................-.~-

  • Rockville, MD 20852.

. ___,,,..._ ____________________________ ~--- --- -- .

U.S. NUCLEAR t--.t.*.,,,...-, UHY COMMISSIC DOCKETING & SERVICE SECTION OFFICE Of* THE SECRETARY OF THE COM ISSION Document Statistics Postmani: Date .9. \ot\\,--'=S:,,_____

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Center for 111111 Molecular Medicine and Immunology DOCKETED USNRC A Specialized Cancer Research & Treatment Center One Bruce Street Newark, New Jersey 07103-2763 September 20, 1995 *95 SEP 25 A10 :06 201-982-4600 FAX: 201-982-7047

~ ,f, lr - OF SECRETARY TO: Secretary, U.S . Nuclear Regul1)1)CKE . . s OISE.RV ICE DOCKET NUMBER BKAHCH PR PROPOSED RULE...:;...;:.;:~ .i.:::;.~. .-,.__c:>___

FROM: Stephen M. Rose, RSO ~

( looF~ 4-<o7 ~ ~

RE: Materials License# 29-28554-01 Comment on "Proposed Role to Extend Certain Materials Licenses by Five Years" In regard to this proposal to extend certain materials licenses by 5 years: This proposal has a number of merits. One is relieving the NRC of the paperwork burden of these renewals so that it can modify the licensing process to more appropriately reflect current governmental, business and information technology practices. The current licensing system was developed piecemeal over the previous working life of the NRC; as a result, certain inefficiencies were unavoidable. Additionally, many new information handling techniques which would benefit the licensing system cannot be implemented piecemeal and therefore the NRC must now totally revise the system or be content with less than state-of-the-art processing of licensing actions . Finally, suspending the majority of renewals by this one-time license extension will allow the NRC to completely develop the new system and test it before using it. This will avoid delays in developing the new system and will avoid the inevitable problem of piecemeal application of the new system as it is developed, which will surely cause confusion to the licensees.

With regard to the appropriate length for license issuance, it is my opinion that a seven-to-ten year period may prove to be more reasonable than the current 5-year period. Several reasons for this may be seen. On initial licensing of a new entity, the most volatile years are more likely to be the first 2-4 years (i.e., business failures, expansion, etc.). The current regulatory structure has shown that the changing needs of a young business can be accommodated by license amendments in the first few years.

Therefore, this practice should be continued. Once a business (licensee) has passed these first years, it usually would become rather stable, therefore requiring only changes in its radiation safety program due to changes in regulations. Since these licensees would be relatively stable over many years, the licensing period should reflect that relative stability by being relatively long (i.e. , 10 years). Any needed changes, such as changes in location, etc., could be handled effectively by the amendment process, as they are currently. This would alleviate the NRC from reviewing materials except on an as-needed basis and relieve licensees from the burden of generating a renewal every 5 years as is currently done. Even longer licensing times of 20 years are appropriate in many instances, so long as the license is kept current through appropriate amendments and the inspection process continues. The time saved in not needing to renew every 5 years could be spent more profitably in day-to-day radiation safety concerns with no loss of either safety or control by the NRC.

SMR:lg OCT :: 3 1995-Ae"'1,ow18dged by card .......................,-....uu-

U.S. NUCLEAr, F*.::..,vw* 1Ofi \' CG,v* i. :::

DOCKGli 'G & SERVICE ECTION OFFICE OF THE SECRET.AR OF THE COMMISSION Document Statistics Postmark Date - - \~ ~,.z__ _ __

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  • S£ 2S A10 :08 "A SOUND PATH TO QUALITY" 95 P.O. Box 80570
  • Canton, Ohio 44708 September 21 , 1995 F sE-RET}{R' 453-13 13 FAX: (21s) 453-2505 g~~~lr?NG &\ERV ICE BRAHCH DOCKET NUMBER PROPOSED RULE Pl ~o U.S.N.R.C.

(<"oorR-4Co7~~ G)

Secretary of the U.S.N.R.C .

Docketing & Service Branch Washington, D .C. 20555

Subject:

One-time extension of certain by-product source and special nuclear material licenses (10-CFR - Parts 30, 40 & 70 - RIN 3150-AF-38)

Reference:

SAM-SON INSPECTION & TECHNICAL SERVICES, INC.

U .S.N.R.C. LICENSE #34-25898-01 Gentlemen:

Concerning the proposed rule, SAM-SON INSPECTION & TECHNICAL SERVICES , INC ., as a licensee, would consider this "very cost effective" to our Company; in that we would not have to accumulate many unprofitable man hours in creating a wheel that is already round and turning.

We would further suggest that this one-time extension be extended to cover 10-CFR Part 71 for D. 0 .T.

- and Quality Assurance packaging of radioactive shipments.

We feel that the Quality Assurance permit issued under Part 71 is synonymous with the U. S.N.R.C .

license issued under Parts 30 thru 40 inclusive.

Respectfully submitted, SAM-SON INSPECTION & TECHNICAL SERVICES , INC .

~o~

Corporate Radiation Safety Officer Executive Vice President SMH:jh

._., 1'18~

OCT -=3 199S-UJ \,ClfU**...**.......

u;s, NUCLEAR REG Lr. uR COMMISSIO~

COCK TING & SERVICE SECTION 0 FICE OF THE SEC ETARY OF THE CO ISSION Document Sta .sties Postmar1t Date Coples Recei

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DOCKETED Chicago Bridge & Iron l1$NBC 8900 Fairbanks North Houston Road Houston. Texas 77064 September 21, 1995 *95 SE . 25 A9 33 Address Reply To: P.O. Box 41146 Secretary U.S. ~uclear Regul 111 *

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-~r. ETARY 5s _ .VI CE Houston. Texas 7724 1- 1146 713 466 7581 Telecopler: 713 466 4259 Washington, D.C. BRAN CH Attention: Docketing and Service Branch DOCKET NUMBER Pl PROPOSED RULE..:..;.:~ ~- -

(.(oOF~ ~to1~

Subject:

Federal Register Notice; One-Time Extension of Certain Byproduct, Source, and Special Nuclear Materials Licenses.

Reference:

10 CFR Parts 30, 40, and 70.

RIN 3150-AF38 I am writing to endorse the Proposed Rule to Extend Certain Material Licenses by Five Years.

This proposed rule offers advantages to the taxpayer, to the affected licensees, and to the general public. These advantages can be expected to lead to lower government operating costs, lower costs to licensees and a modest improvement in radiation safety among licensees. These advantages include:

1. A savings in effort and expense to the affected licensees, savings which ultimately accrue to the public.
2. A modest improvement in program safety can be expected. The proposed rule bestows a tangible, public, and previously unexpected reward to those licensee's that have maintained violation free programs {no Severity Level I, II, or Ill violations). Although other motives for remaining violation free are financially more significant, the public and unexpected nature of this reward can be expected to make it a positive reinforcement with an effect that is disproportionately greater than the direct monetary value. This effect can only act to improve safety, thus benefiting all parties.
3. This proposed rule will utilize USNRC resources in an effective manner. The Commission's savings will ultimately accrue to the benefit of the taxpayer.

Please, enact the proposed rule.

Sincerely yours, 11,BJ~

P. Brad Shaw Assistant Corporate Radiation Safety Officer Chicago Bridge and Iron Company OCT -= 3 1995 Ac~ow18dged by card ..- ..................... -. ... ,

U.S. NUCLt:Al1 H:. ._, "' L ,:; : CO' IM18Sl0t\

DOCKE1 IN(, & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COM 1... SiON Document Stat.sties Postmark Date --+-I-""-'+"'.....,__ _ __

Co~es Received_-£-_ _ _ _ __

Actd'I Copies Reproduced ___ _ __

Special Distribution ':£,S>,.~ ,'5:)f1M.,._.,)

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United Refining Company* Petroleum Products DOCKETED US 'R C

  • 95 SE 21 PJ :32 OFF/Cf. er q. "RE TA September 19, 1995 DOCKETIN.~ &:ER V RY BRA NCH I ICE Secretary, U.S. Nuclear Regulatory Commission Docketing & Service Branch DOCKET NUMBER p PROPOSED RULE Washington, DC 20555 ( ~ Fte 461 '9 i-t)

Gentlemen:

CD I examined the proposed rule to extend certain nuclear material licenses by five years and concur that the licensing process for industrial users, such as United Refining Company, will benefit from all four goals, in particular the economic impact relating to NRC staffing levels.

If the proposed rule is adopted we expect to take full advantage of the one time license extension which precludes the need to submit a license renewal application and associated fees during that time period.

Thank you for the opportunity to comment on this proposal.

Very truly yours, UNITED REFINING COMPANY

~R~J Michael J. Shanshala Radiation Safety Officer MJS/kw pc: T. E. Skarada T. C. Covert OCT -= 3 1995-Acknow\edged by card ........................"-~...-

Box 780

  • 814-723-1500
  • FAX 814-726-4603
  • 814-726-4602

'.S. NUCLEAR REGULATORY COMMISS!Ot'-.

DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY Of THE COMMISSION Document Statistics Postmark Date __._~--t->--- - - -

Coples Recei Add'l Copes R 1

Copy to SECY. DOCKET NUMBER" -.___

Origina, lent to lhe PROPOSED RULE ..so DOCKETED Of1ice Of lhe Feae,BI Reoilter l '-'o ~(e_ ~b'1~~ [7590-tUS C NUCLEAR REGULATORY COMMISSION

  • 93 SEP 11 P4 :36 10 CFR Parts 30, 40, and 70 RIN 3150-AF38 OFFICE OF SECRETARY DOCKETING SERVICE BRANCH One-Time Extension of Certain Byproduct, Source, and Special Nuclear Materials Licenses AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

SUMMARY

The Nuclear Regulatory Commission (NRC} is proposing, on a one-time basis, a five-year extension of certain byproduct, source, and special nuclear materials licenses. The provisions of the licenses under extension would provide the same authorizations and limits on licensee activities as they do now. The proposed rule specifies the licenses whose expiration dates would not be extended. On a separate but related matter, the Commission is considering the appropriate duration of materials licenses and seeks comments on this topic.

0~ \0) \C\C\5 DATES: Submit comments by (iRsert date 38 days after the date of pabl icatio1r in tha Federal Register). Comments received after this date will be considered if it is practical to do so, but the Commission is able to assure consideration only for comments received on or before this date.

ADDRESSES: Mail written comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555. ATTN: Docketing and Service Branch.Hand deliver conments to: 11555 Rockville Pike, Rockville, MD, 20852, between 7:45 am and 4:15 pm Federal workdays. Copies of convnents received may be examined at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. For infonnation on submitting conunents electronically, see the discussion under Electronic Access in the Supplementary Infonnation Section.

FOR FURTHER INFORMATION CONTACT: John Pelchat, NRC, Region II, 101 Marietta Street, N.W., Suite 2900, Atlanta, GA 30323, telephone (404) 331-5083; or C. W. Nilsen, Office of Nuclear Regulatory Research, NRC, Washington, DC 20555, telephone (301) 415-6209.

SUPPLEMENTARY INFORMATION:

Background

The materials licensing ("licensing") process sets out provisions for licensing medical, academic, and industrial users of byproduct materials as well as some small scope users of source and special nuclear materials. This process does not apply to the licensing of power and non-power reactors, uranium milling and processing facilities, or fuel production facilities.

Recent NRC internal reviews and regulatory impact surveys of materials licensees ("licensees") have highlighted areas in which the current materials licensing process can be improved. The NRC has completed the preliminary phases of an effort to redesign this process. The goals of the licensing

process redesign project are (1) to maintain or raise the level of public safety achieved by the current process; (2) to perform licensing reviews and associated tasks an order of magnitude faster than the current process; (3) to utilize modern infonnation technology as a fundamental part of the new process; and, (4) to reduce the resources needed to carry out the licensing program to meet the projected 1998-1999 staffing levels.

In order to make resources available to expedite the development, design, and testing of the proposed new materials licensing process, the Corrmission proposes to extend, by rulemaking, certain specific materials licenses

("licenses") by five years from the current expiration dates shown on those licenses. Resources that would have otherwise been used to renew these licenses would be devoted to the redesign project. The extension would be a one-time occurrence and the Corrmission does not envision that any similar extensions would be granted in any future rulemaking. The extended licenses are not considered to be the equivalent of a renewed license because they would provide the same authorizations and limits on licensee activities as they do now. Accordingly, the extended licenses would not be based on or reference pending renewal applications, including requests, if any, in those renewal applications for NRC approval of changes in current operations. The frequency at which the licensee is inspected would not change. The Commission estimates that more than 80 percent of its 6,500 materials licenses would be extended by this proposed rulemaking.

The Commission believes that it may take this action because no legislative mandate requires that materials licenses have a five-year term.

Many years ago, materials licenses were issued for two-year periods. As the uses of radioactive materials became more stable and predictable, the typical duration of licenses was changed to the current five years. The Commission believes that certain specific materials licenses may be extended once by rule for an additional five years beyond their stated expiration date without the nonnal renewal review and without adverse effect on public health and safety.

The Comission's belief is based upon three factors. First, certain specific licenses for which the Connnission believes that a renewal review should not be delayed five years would .not be affected by this rule. Licenses that may present, in the Commission's view, a greater potential risk from a health and safety standpoint would not be extended by this rulemaking. These licenses are discussed in greater detail below and these licenses would be renewed in accordance with current schedules. Second, the extended licenses would not change the authorized activities or the regulatory requirements with which the licensees must comply. Third, the NRC will continue to inspect licenses that would be extended by this proposed rule. Significant inspection findings would be resolved through the issuance of Notices of Violations that require written responses describing corrective actions or Orders that would modify, suspend, or revoke the license. Accordingly, the Commission believes that there would be reasonable assurance of public health and safety under this rule.

The Commission believes that certain licenses, specified below, should be subject to the health and safety review currently required as part of the 5-year renewal review. These licenses would not have their license terms extended by this proposed rule. The criteria listed below would be applied as

of the effective date of the final rule so as to assure that any extensions are based on the most current information available.

o Any specific license that, on the effective date of the final rule, must have prepared an evaluation or an emergency plan for responding to the release of radioactive materials as required by 10 CFR 30.32(1),

40.ll(j), or 70.22(i). The Cofflllission believes that these licenses authorize activities that may pose a significant potential for release of radioactive materials and may result in potential exposure to the public and contamination of the environment. Therefore, renewals of these licenses should continue to be reviewed under existing procedures.

0 Any specific licenses whose holders are subject to the financial assurance requirements specified in 10 CFR 30.35, 40.36, or 70.25; and on the effective date of the final rule the holders either (a) have not submitted a decont11issioning funding plan or certification of financial assurance for decommissioning, or (b) have not received written notice that the deco11111issioning funding plan or certification of financial assurance for decommissioning is acceptable. These licenses authorize possession of quantities and forms of licensed materials that pose a potential need for extensive decontamination before termination of the license and release of decont11issioned facilities. The Commission believes that renewals of these licenses should continue to be reviewed under existing procedures to ensure that the process of obtaining sufficient funding continues so that appropriate resources are available to support decommissioning activity.

o Any license, as of the effective date of the final rule, that is on the Site Dec011111issioning Management Plan (SDMP) list. Generally, licenses on the SDMP list are no longer actively using licensed materials. The C0111Rission believes that these licenses should continue to be reviewed under existing procedures to ensure proper evaluation of site remediation activities at facilities where the licensee's radiation safety program l1aY be inactive or scaled back.

o Any specific license whose issuance, amendment, or renewal, as of the effective date of the final rule, is not a categorical exclusion under 10 CFR 51.22(c)(l4) and therefore needs an environmental assessment or environmental impact statement pursuant to Subpart A of Part 51 of this chapter. The Co11111ission believes that these licenses authorize activities that ay have a potential for impacting the environment.

Therefore, renewals of these licenses should continue to be reviewed under existing procedures.

o Any specific license issued pursuant to 10 CFR Part 70 for which, as of the effective date of the final rule, the license holder is authorized to possess sufficient quantities of special nuclear material to be subject to the criticality accident requirements of 10 CFR 70.24. The Commission believes that renewals of these licenses should continue to be reviewed under existing procedures to ensure the adequacy of the licensees' important criticality safety procedures.

o Specific licenses whose holders have not had at least one prior NRC

inspection of licensed activities as of the effective date of the final rule. The C011111ission believes that it is inappropriate to extend these licenses when it has not verified the effectiveness of the licensees' radiation safety prograas by inspection. This verification is part of the safety basis upon which the NRC is relying. NRC inspection procedures require that all new licensees be inspected within six months of the issue date of their license. A few new licenses that might otherwise be extended 111ay not be extended because they have not been inspected. Because the NRC is continually issuing new licenses, it is not practical to innediately inspect all new licensees to determine whether they satisfy the other criteria for the extension of their license expiration dates.

o Specific licenses whose holders, as the result of the most recent NRC inspection of licensed activities conducted before the effective date of the final rule, have either been (a) cited for a Severity Level I, II, or III violation in a Notice of Violation, (b) subject to an Order issued by the NRC, or (c) subject

\

to a Confirmatory. Action Letter issued by the NRC. The NRC has identified significant safety or other regulatory issues in these programs as a result of their most recent NRC inspection.

The Commission believes that applications for renewal of these licenses should continue to be reviewed under existing procedures.

Apart from these licenses that the Comnission has determined may pose a relatively greater risk to public health and safety, the Comission recognizes that there is another set of licenses that will not be extended by this rule.

This set includes those licenses with expiration dates before July 1, 1995, whose holders have submitted applications for renewal pursuant to the renewal provisions specified in 10 CFR Parts 30, 40, or 70. The Corrmission intends to continue to review the submissions of these licensees who have already subaitted applications and fees for the renewal of their licenses and are deemed as being in timely renewal. Renewal requests will be granted as the NRC completes its review of those applications that satisfy the requirements specified in the regulations.

The proposed rule will extend the expiration date of those licenses with expiration dates after July 1, 1995, that are in a timely renewal status. As specified in the proposed rule, NRC will consider that these licensees have withdrawn their requests for renewal. Renewal fees paid by these licensees will be refunded.

The July 1, 1995, expiration date was chosen based on resource considerations. The NRC staff has begun the review of many applications for renewal of licenses with expiration dates before July 1, 1995, and it is not appropriate to waste the resources already expended in that effort. On the other hand, 1ROst of the applications for renewal of licenses with expiration dates after July 1,1995, have been received only recently, their review has not begun, and resources will be conserved by extending those licenses.

The C011111ission recognizes that an entity may hold more than one materials license issued under one or more parts of Title 10 of the Code of Federal Regulations. It is the CoR111ission's intent that each license be considered

separately in deternining whether its expiration date should be extended under this rule. For example, assume that an entity holds two licenses, A and B, and License A is of the type listed in paragraph (a}(3} of§§ 30.36, 40.42, and 70.38 of this proposed rule, but License Bis not. In this situation, the expiration date of License A would not be affected by the rule, but the expiration date of License B would be extended by a period of five years from the expiration date stated in the license.

The selective extension of byproduct, source, and special nuclear materials licenses would result in the freeing of Conmission resources that would otherwise be used in the review of these renewal applications. These resources will then be redirected, in part, into the detailed design and testing of the proposed new materials licensing process.

Nothing in this rule relieves licensees from the requirements to file for appropriate amendments to their licenses, when changes in licensed activities occur.

If a licensee should elect not to take full advantage of the license extension, the licensee may request tennination of its license in accordance with the applicable requirements of 10 CFR Parts 30, 40, or 70.

The Connission seeks convnents on the issue of license duration. In conjunction with the licensing process redesign effort, the Conmission also intends to consider the appropriate duration of materials licenses, including whether the duration should differ depending on the nature of the activities

peraitted under the license. The Coamission is aware that for some types of licensed activities the industry has matured and it may be appropriate to consider issuing licenses for longer times, perhaps 10-20 years. The Connission is also aware that some Agreement States routinely issue licenses for periods longer than 5 years. The Convnission seeks convnents at this time on the general topic of the appropriate duration of licenses. If the C011111ission ultimately revises its policy on materials license duration, licensees with pending renewal applications that fulfill all regulatory require1A0nts would be granted licenses consistent with the Co11111ission's resolution of the license duration issue.

Agreement State Compatibility The C011111ission has determined that the amended provisions of 10 CFR Parts 30, 40, and 70 are not matters of compatibility for evaluating the regulations of States that have entered into agreements (Agreement States) with the Comission pursuant to Section 274.b of the Atomic Energy Act, as amended.

Therefore, the States are not required to amend their regulations or licensing practices as a result of this rulemaking. However, the Commission is interested in receiving comments from the Agreement States on the regulatory implications of this proposed rule.

Electronic Access Co11111ents may be submitted through the Internet by addressing electronic mail to INTERNET:SECY@NRC.GOV. Comments may also be submitted electronically,

in either ASCII text or WordPerfect fonaat (version 5.1 or later), by calling the NRC Electronic Ruleaaking Bulletin Board (BBS) on FEDWORLD.

The BBS is an electronic information system operated by the National Technical Infonnation Service of the Department of Contnerce. The purpose of this bulletin board BBS is to facilitate public participation in the NRC regulatory process, particularly rulemakings. With publication of this notice, proposed rulemakings and appropriate supporting documents will be available for review and convnent on the BBS. These same documents are also available for review and comment at the NRC's Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. The BBS may be accessed using a personal computer, a modem, and one of the comnonly available conununications software packages, or directly via Internet.

The NRC rulemaking bulletin board (rulemaking subsystem) on FEDWORLD can be accessed directly by using a personal computer and modem, dialing the toll free number 1-800-303-9672. Communication software parameters should be set as follows: parity to none, data bits to 8, and stop bits to 1 (N,8,1).

Using ANSI or VT-100 terminal emulation, the NRC rulemaking subsystem can then be accessed by selecting the "Rules Menun option from the *NRC Main Menu.*

For further information about options available for NRC at FEDWORLD consult the "Help/lnfonnation Center* from the "NRC Main Menu." Users will find the

  • FEDWORLD Online User's Guides" particularly helpful. Many NRC subsystems and databases also have a "Help/Information Center* option that is tailored to the particular subsystem.

The NRC subsystem on FEDWORLD also can be accessed by a direct dial phone nuaber for the main FEDWORLD BBS at 703-321-3339, or by using Telnet via Internet: fedworld.gov. Using the 703 number to contact FEDWORLD, the NRC subsystea will be accessed froa the main FEDWORLD menu by selecting the

  • Regulatory, Government Administration and State Systems," then selecting
  • Regulatory Information Mall.* At that point, a menu will be displayed that has the option *u.s. Nuclear Regulatory Commission* that will take you to the NRC Online main 110nu. The NRC Online area also can be accessed directly by typing "/go nrc" at a FEDWORLD command line. If you access NRC from FEDWORLD's main menu, you may return to FEDWORLD by selecting the "Return to FEDWORLD* option fro the NRC Online Main Menu. However, if you access NRC at FEDWORLD by using NRC's toll-free number, you will have full access to all NRC systems, but you will not have access to the main FEDWORLD system.

If you contact FEDWORLD using Telnet, you will see the NRC area and menus, including the *Rules Menu.* Although you will be able to download documents and leave messages, you will not be able to write co11111ents or upload files. If you contact FEDWORLD using File Transfer Program (FTP}, all files can be accessed and downloaded, but uploads are not allowed, and all you will see is a list of files without descriptions (normal Gopher look). An index file listing all files within a subdirectory, with descriptions, is available.

There is a IS-minute time limit for FTP access.

Although FEDWORLD can be accessed through the World Wide Web as well, like FTP, that IIOde only provides access for downloading files and does not display the NRC *Rules Menu.*

For 1110re infon11ation on NRC bulletin boards call Mr. Arthur Davis, Systems Integration and Development Branch, U.S. Nuclear Regulatory Comission, Washington, DC 20555, telephone (301) 415-5780; e-mail AXD3@nrc.gov.

Environmental llftl)act: Categorical Exclusion The NRC has detennined that these regulations are the type of actions described in categorical exclusion 10 CFR 51.22(c)(3). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this regulation.

Paperwork Reduction Act This proposed rule does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). Existing requirements were approved by the Office of Manage1Rent and Budget approval number 3150-0009 (Part 70} and 3150-0120 (Parts 30 and 40).

Regulatory Analysis A regulatory analysis has not been prepared for this rule because it is not expected to have any adverse impact on licensees subject to the proposed rule. These licensees will be postponing, for five years, submission of license renewal applications and the associated fees.

Regulatory Flexibility Analysis The NRC is seeking public coaaents on the potential impact of the proposed rule on small entities. The NRC particularly desires coinments froa 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 that offer conrnents 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 saae business conununity.

(b) How the proposed regulations could be modified to take into account their needs or capabilities.

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

(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

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

Backfit Analysis The NRC has determined that the backf1t rule, 10 CFR 50.109, does not apply to this proposed rule and, therefore, that a backfit analysis is not required for this proposed rule because these amendments do not involve any provisions that would impose backfits as defined in 10 CFR 50.109(a)(l).

list of Subject Index Terms 10 CFR Part 30 Byproduct material, Criminal penalties, Government contracts, Intergovernmental relations, Isotopes, Nuclear materials, Radiation protection, Reporting and recordkeeping requirements.

10 CFR Part 40 Criminal penalties, Government contracts, Hazardous materials transportation, Nuclear materials, Reporting and recordkeeping requirements, Source material, Uranium.

10 CFR Part 70 Criminal penalties, Hazardous materials transportation, Material control

and accounting, Nuclear materials, Packaging and containers, Radiation protection, Reporting and recordkeeping requirements, Scientific equipment, Security measures, Special nuclear material.

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. 552 and 553; the Nuclear Regulatory Comission is adopting the following amendments to 10 CFR Parts 30, 40, and 70.

PART 30 - RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL

1. The authority citation for Part 30 continues to read as follows:

AUTHORITY: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 953, 954, 955,as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).

Section 30.7 also issued under Pub. L.95-601, sec. 10, 92 Stat. 2951 as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123 (42 U.S.C. 5851).

Section 30.34(b) also issued under sec. ,184, 68 Stat. 954, as amended (42 U.S.C. 2234). Section 30.61 also issued under sec. 187, 68 Stat. 955 (42

u.s.c. 2237).

2. In§ 30.36, paragraph {a) is revised to read as follows:

§ 30.36 Expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas,

{a){l) Except as provided in paragraph {a){2) of this section, each specific license expires at the end of the day on the expiration date stated in the license unless the licensee has filed an application for renewal under

§ 30.37 not less than 30 days before the expiration date stated in the existing license (or, for those licenses subject to paragraph (a)(2) of this section, 30 days before the deemed expiration date in that paragraph). If an application for renewal has been filed at least 30 days prior to the expiration date stated in the existing license (or, for those licenses subject to paragraph {a){2) of this section, 30 days before the deemed expiration date in that paragraph), the existing license expires at the end of the day on which the Comission makes a final determination to deny the renewal application or, if the determination states an expiration date, the expiration date stated in the determination.

(2) Each specific license which has an expiration date after July 1, 1995, and is not one of the licenses described in paragraph {a){3) of this section, shall be deemed to have an expiration date which is 5 years after the expiration date stated in the current license.

(3) The following specific licenses are not subject to, or otherwise affected by, the provisions of paragraph (a)(2) of this section:

(i) Specific licenses for which, on the [INSERT EFFECTIVE DATE OF THE FINAL RULE], an evaluation or an emergency plan is required in accordance with

§ 30.32(1);

(ii) Specific licenses whose holders are subject to the financial assurance requirements specified in§ 30.35, and on [INSERT EFFECTIVE DATE OF THE FINAL RULE], the holders either:

(A) Have not submitted a deconvn1ss1on1ng funding plan or certification of financial assurance for decolllllissioning; or (B) Have not received written notice that the deconunissioning funding plan or certification of financial assurance for decon111issioning is acceptable; (iii) Specific licenses whose holders are listed in the Site Decoaaissioning Management Plan List published in the Federal Register at

(___ , 1995);

(iv) Specific licenses whose issuance, amendment, or renewal, as of

[INSERT EFFECTIVE DATE OF THE FINAL RULE], is not a categorical exclusion under 10 CFR 51.22(c)(l4) and, therefore, need an environmental assessment or

environmental impact statement pursuant to Subpart A of Part 51 of this chapter; (v) Specific licenses whose holders have not had at least one NRC inspection of licensed activities before [INSERT EFFECTIVE DATE OF THE FINAL RULE];

(vi) Specific licenses whose holders, as the result of the most recent NRC inspection of licensed activities conducted before [INSERT EFFECTIVE DATE OF THE FINAL RULE], have been:

(A) Cited for a Severity Level I, II, or III violation in a Notice of Violation; (B) Subject to an Order issued by the NRC; or (C) Subject to a Confirmatory Action Letter issued by the NRC.

(vii) Specific licenses with expiration dates before July 1, 1995, for which the holders have submitted applications for renewal under§ 30.37 of this part.

3. In§ 30.37, a new paragraph (b) is added to read as follows:

20

§ 30.37 Application for renewal of lsicenses.

(b) If any licensee granted the extension described in§ 30.36(a)(2) has a currently pending renewal application for the extended license, that application will be considered withdrawn by the licensee and any renewal fees paid by the licensee for that application will be refunded.

PART 40 - DOMESTIC LICENSING OF SOURCE MATERIAL

4. The authority citation for Part 40 continues to read as follows:

AUTHORITY: Secs. 62, 63, 64, 65, 81, 161, 182, 183, 186, 68 Stat. 932, 933, 935, 948, 953, 954, 955, as amended, secs. lle(2), 83, 84, Pub. L.95-604, 92 Stat. 3033, as amended, 3039, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2014(e)(2), 2092, 2093, 2094, 2095, 2111, 2113, 2114, 2201, 2232, 2233, 2236, 2282); sec. 274, Pub. L.86-373, 73 Stat. 688 (42 U.S.C. 2021); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C.

5841, 5842, 5846); sec. 275, 92 Stat. 3021, as amended by Pub. L.97-415, 96 Stat. 2067 (42 U.S.C. 2022).

Section 40.7 also issued under Pub. L.95-601, sec. 10, 92 Stat. 2951 as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123, (42 U.S.C. 5851).

Section 40.3l(g) also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152).

Section 40.46 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C.

Section 40.46 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C.

2234). Section 40.71 also issued under sec. 187, 68 Stat. 955 (42 U.S.C.

2237).

  • 5. In§ 40.42, paragraph {a) is revised to read as follows:

§ 40,42 Expiration and termination of licenses and decorrmissioning of sites and separate buildings or outdoor areas.

{a){l) Except as provided in paragraph {a){2) of this section, each specific license expires at the end of the day on the expiration date stated in the license unless the licensee has filed an application for renewal under

§ 40.43 not less than 30 days before the expiration date stated in the existing license {or, for those licenses subject to paragraph {a){2) of this section, 30 days before the deemed expiration date in that paragraph). If an application for renewal has been filed at least 30 days prior to the expiration date stated in the existing license {or, for those licenses subject to paragraph {a)(2) of this section, 30 days before the deemed expiration date in that paragraph), the existing license expires at the end of the day on which the C011111ission makes a final determination to deny the renewal application or, if the determination states an expiration date, the expiration date stated in the determination.

(2) Each specific license which has an expiration date after July 1, 1995, and is not one of the licenses described in paragraph (a)(3) of this section, shall be deemed to have an expiration date which is 5 years after the

expiration date stated in the current license.

(3) The following specific licenses are not subject to, or otherwise affected by, the provisions of paragraph (a)(2) of this section:

(i) Specific licenses for which, on [INSERT EFFECTIVE DATE OF THE FINAL RULE], an evaluation or an emergency plan is required in accordance with

§ 40.3l(j);

(ii) Specific licenses whose holders are subject to the financial assurance requirements specified in§ 40.36, and on [INSERT EFFECTIVE DATE OF THE FINAL RULE], the holders either:

(A) Have not submitted a deconvnissioning funding plan or certification of financial assurance for deco1m1issioning; or (8) Have not received written notice that the decommissioning funding plan or certification of financial assurance for decommissioning is acceptable; (iii) Specific licenses whose holders are listed in the Site Dec011111issioning Management Plan List published in the Federal Register at

(____ , 1995);

(iv) Specific licenses whose issuance, amendment or renewal, as of

[INSERT EFFECTIVE DATE OF THE FINAL RULE], is not a categorical exclusion

under 10 CFR 51.22(c)(l4) and, therefore, need an environmental assessment or environmental impact statement pursuant to Subpart A of Part 51 of this chapter; (v) Specific licenses whose holders have not had at least one NRC inspection of licensed activities before [INSERT EFFECTIVE DATE OF THE FINAL RULE];

(vi) Specific licenses whose holders, as the result of the most recent NRC inspection of licensed activities conducted before [INSERT EFFECTIVE DATE OF THE FINAL RULE], have been:

(A) Cited for a Severity Level I, II, or III violation in a Notice of Violation; (B) Subject to an Order issued by the NRC; or (C) Subject to a Confirmatory Action Letter issued by the NRC.

(vii) Specific licenses with expiration dates before July 1, 1995, for which the holders have submitted applications for renewal under§ 40.43 of this part.

6. In§ 40.43, a new paragraph (b) is added to read as follows:

24

§ 40.43 Renewal of licenses.

(b) If any licensee granted the extension described in§ 40.42(a)(2) has a currently pending renewal application for the extended license, that application will be considered to be withdrawn by the licensee and any renewal fees paid by the licensee for that application will be refunded.

PART 70 - DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL

7. The authority citation for Part 70 continues to read as follows:

AUTHORITY: Secs. 51, 53, 161, 182, 183, 68 Stat. 929, 930, 948, 953, 954, as amended, sec. 234, 83 Stat. 444, as amended, sec. 1701, 106 Stat.

2951, 2952, 2953 (42 U.S.C. 2071, 2073, 2201, 2232, 2233, 2282, 2297f); secs. 201, as amended, 202, 204, 206, 88 Stat. 1242, as amended, 1244, 1245, 1246 (42 u.s.c. 5841, 5842, 5845, 5846).

Sections 70.l(c) and 70.20a(b) also issued under secs. 135, 141, Pub. L.97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161). Section 70.7 also issued under Pub. L.95-601, sec. 10, 92 Stat. 2951 (42 U.S.C. 5851). Section 70.21(g) also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152). Section 70.31 also issued under sec. 57d, Pub. L.93-377, 88 Stat. 475 (42 U.S.C.

2077). Sections 70.36 and 70.44 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Section 70.61 also issued under secs. 186, 187, 68 Stat. 955 (42 U.S.C. 2236, 2237). Section 70.62 also issued under sec. 108,

68 Stat. 939, as amended (42 U.S.C. 2138).

8. In§ 70.38, paragraph (a) is revised to read as follows:

§ 70.38 Expiratjon and tennination of licenses and deconmissioning of sites and separate buildings or outdoor areas, (a)(l) Except as provided in paragraph (a)(2) of this section, each specific license expires at the end of the day on the expiration date stated in the license unless the licensee has filed an application for renewal under

§ 70.33 not less than 30 days before the expiration date stated in the existing license (or, for those licenses subject to paragraph (a)(2) of this section, 30 days before the deemed expiration date in that paragraph). If an application for renewal has been filed at least 30 days prior to the expiration date stated in the existing license (or, for those licenses subject to paragraph (a)(2) of this section, 30 days before the deemed expiration date in that paragraph), the existing license expires at the end of the day on which the COD111ission makes a final determination to deny the renewal application or, if the determination states an expiration date, the expiration date stated in the determination.

(2) Each specific license which has an expiration date after July 1, 1995, and is not one of the licenses described in paragraph (a)(3) of this section, shall be deemed to have an expiration date which is 5 years after the expiration date stated in the current license.

(3) The following specific licenses are not subject to, or otherwise affected by, the provisions of paragraph (a)(2) of this section:

(i) Specific licenses for which, on [INSERT EFFECTIVE DATE OF THE FINAL RULE], an evaluation or an emergency plan is required in accordance with

§ 70.22{1};

{11) Specific licenses whose holders are subject to the financial assurance requirements specified in§ 70.25, and on [INSERT EFFECTIVE DATE OF THE FINAL RULE], the holders either:

(A) Have not submitted a deco11111issioning funding plan or certification of financial assurance for decommissioning; or (B) Have not received written notice that the deco11111issioning funding plan or certification of financial assurance for decon111issioning is acceptable; (111) Specific licenses whose holders are listed in the Site Deconnissioning Management Plan List published in the Federal Register at

(.____ , 1995);

(iv) Specific licenses whose issuance, amendment or renewal, as of

[INSERT EFFECTIVE DATE OF THE FINAL RULE], is not a categorical exclusion under 10 CFR 51.22{c)(l4) and, therefore, need an environmental assessment or

environSRental impact statement pursuant to Subpart A of Part 51 of this chapter; (v) Specific licenses whose holders have not had at least one NRC inspection of licensed activities before [INSERT EFFECTIVE DATE OF THE FINAL RULE];

(vi) Specific licenses whose holders, as the result of the most recent NRC inspection of licensed activities conducted before [INSERT EFFECTIVE DATE OF THE FINAL RULE], have been:

(A) Cited for a Severity Level I, II, or III violation in a Notice of Violation:

(8) Subject to an Order issued by the NRC; or (C) Subject to a Confirmatory Action Letter issued by the NRC.

(vii) Specific licenses with expiration dates before July 1, 1995, for which the holders have submitted applications for renewal under§ 70.33 of this part.

(viii) Specific licenses issued pursuant to§ 70.31 that, as of [INSERT EFFECTIVE DATE OF THE FINAL RULE], are also subject to the requirements in

§ 70.24.

9. In§ 70.33, a new paragraph (b} is added to read as follows:

§ 70.33 Renewal of licenses.

(b} If any licensee granted the extension described in§ 70.38(a}(2} has a currently pending renewal application for that extended license, that application will be considered withdrawn by the licensee and any renewal fees

  • paid by the licensee for that application will be refunded.

-t,/

a. . ""'_,<_/""----'

Dated at Rockville, Maryland, this./(9- day of _ .... 1995.

7 For the Nuclear Regulatory Conmission .

. Taylor Executive Director for Operations

United States Nuclear Regulatory Commission Office of Public Affairs Washington, DC 20555 Phone 301-415-8200 Fax 301-415-2234 Internet:opa@nrc.gov No. 96-08 FOR IMMEDIATE RELEASE (Wednesday, January 17, 1996)

NRC EXTENDS -CERTAIN MATERIALS LICENSES BY FIVE YEARS ON A ONE-TIME BASIS The Nuclear Regulatory Commission is revising its

, regulations to extend certain nuclear materials licenses

=*, * * .. *"automatically for five years.

  • * ~,.J l

, , ,. " , , . . The* one*-time extension will provide time and resources for the NRC to develop a new nuclear materials licensing process that will be faster than the current one, that will use modern inrormation technology, and that will reduce personnel resources needed for the licensing program to meet the agency's projected lower staffing levels. The objective is to maintain or raise the level of public safety achieved by the current licensing process.

The one-time, five-year automatic license extension and the new licensing process under development will not apply to nuclear reactors, uranium milling and processing facilities, or nuclear fuel production facilities.

In addition, those materials licensees that the Commission

    • ,,believes could present a relatively gneater potential risk from a health and safety standpoint will not be automatically extended.

A Federal Register notice published *on January 16 identifies the categories of materials licenses ._,t..***

inelJg-ible for the extension .

The Commission estimates that more than 80 percent of its 6,500 materials licenses will be extended under the rule, including, for example, many hospitals that use radioactive materials for patient treatment and diagnosis, universities that use radioactive material in research, and industrial users.

The Commission believes that the one-time extensions may be granted without adverse effect on the public health and safety because:

  • Licenses that could present a greater potential health and safety risk will continue to be reviewed and renewed in accordance with existing procedures.
  • The extended licenses will provide the same authorizations and impose the same limits on licensee activities as the current ones.
  • NRC will continue to inspect licensees with the same frequency as now and, if violations of NRC requirements are found, require corrective actions or issue orders that would modify, suspend or revoke the license.

The extended license will be different from a "renewed" license, which involves an NRC technical review and can include changes in current operations if requested and approved.

' Materials licenses are currently issued for five years, with an opportunity for renewal for five-year periods, upon licensee application and NRC approval. If a licensee applies for renewal before the license expires, the license remains in effect until the NRC acts.

  • The new rule w-ill automatically extend eligible licenses with expiration dates after last July 1, provided a timely renewal application has been received. The NRC will refund any renewal fees submitted. The NRC staff will continue to process for renewal, rather than automatic extension, the timely applications received for licenses with expiration dates before July 1.

The NRC issued a proposed rule on this subject on September

8. No substantive changes were made as a result of the comments received.

2