ML20206E817

EDO Control of Rulemaking Package Re 10CFR30,32,40 & 70, Licenses of Sources & Devices. Continuation of Rulemaking & Extension of Completion Date to Dec 1987 Approved

ML20206E817
Person / Time
Issue date:	11/29/1985
From:	Dircks W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:	Jennifer Davis NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
References
NUDOCS 8606240015
Download: ML20206E817 (75)

Text

Vbb NOV 2 91985 MEMORANDUM FOR: John G. Davis, Director Office of Nuclear Material Safety and Safeguards FROM: William J. Dircks Executive Director for Operations

SUBJECT:

TRANSFERRING AND CONTINUING A RULEMAKING (REVISION OF 10 CFR PARTS 30, 32, 40 and 70) TO IMPROVE THE REGULATION OF SEALED SOURCES AND DEVICES In a RES memorandum dated October 1, 1985 concerning the above subject, R. Minogue reconinended that NMSS rather than RES continue the subject rulemaking which is responsive to the Coninission's Planning and Policy Guidance and my Program Guidance. My understanding is that you agree with the RES recommendation provided that the rulemaking scheduled completion date will be extended from June 1987 to December 1987.

I approve continuation of the rulemaking by NMSS and extension of the rulemaking completion date to December 1987.

As a related matter, I am concerned that the rulemaking was allowed to progress for an extended period of time without sufficient NMSS or RES management attention to ensure it was proceeding in the appropriate direction on a timely basis. Please let me know if you have any other rulemaking in '

this situation.

(SipedWilliam J.Dircks William J. Dircks Executive Director for Operations cc: V. Stello Distribution:

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- +p # "*% t /2Lb NUCLEAR nEGULATORY COMMISSION h WASHINGTON, D. C. 20555 OCT 1 1985 MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research

SUBJECT:

DRAFT RECOMMENDATIONS TO EDO CONCERNING THE CONTINUANCE OF ONG0ING RULEMAKING SPONSORED BY RES: REVISION TO 10 CFR 30, 32, 40 and 70--LICENSING OF SOURCES AND DEVICES On May 28, 1985, RES transmitted a memorandum soliciting NMSS' comments /

concurrence on our reevaluation of the subject rulemaking package (Attachment 1). This reevaluation was conducted in accordance with the procedures set forth in your memorandum of February 13, 1984. In substance, my staff recommended termination of this rulemaking action in its present fonn, but noted that there was a genuine need to improve the regulation of sealed i sources and devices and, further, that a request to reinitiate this rule-

, making action would be resubmitted in the future.

The staff recommendation to terminate this rule was based on three principal considerations. The first was that this rule was principally administrative j in nature, i.e., it did not directly affect the public health and was, there-I fore, of low relative priority within the Office. Second, in our judgment, the specifics of the rule and supporting documentation required substantial modification and restructuring in order to adequately support the proposed action. Third, current RES manpower limitations . made it impossible to reactivate the effort and complete action on this rule within the foreseeable future. Thus, it was felt that this rulemaking should be terminated and deleted from the Regulatory Agenda until such time as adequate resources became available.

In follow-up discussions NMSS indicated that they would be willing to assume responsibility for completion of this rule and felt they could complete the effort with presently available resources.

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William J. Dircks 2 OCT 1 1985 Accordingly, I am recomending this rulemaking be continued and advise you that NMSS is assuming responsibility for the further development of this rule.

The complete RES review package has been sent to ED0 (Attn: DEDR0GR) and to the Director, NMSS. ,

/ 0 Robert B. Minogue, Director Office of Nuclear Regulatory Research Attachments:

1. Memo, Gillespie to Cunningham dtd 5/28/85

2. Memo, Cunningham to Gillespie dtd 6/10/85 1

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t l 1 OCT 1 1985

. MEMORANDUM FOR

William J. Dircks

% Executive Directer for Operations FROM: Robert B. Minogue Director p Office of Nuclear Regulatory Research V .

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SUBJECT:

DRAFT RECOMENDATIONS TO EDO CONCERNING THE CONTINUANCE hL

/ OF ONGOING RULEMAKING SPONSORED BY RES: REVISION TO 10 CFR 30, 32, 40 and 70--LICENSING OF SOURCES AND DEVICES y; -

[ On May 28, '1985, RES transmitted a memorandum soliciting NMSS' comments /  !

y concurrence on our reevaluation of the subject rulemaking package (Attachment l h 1). This reevaluation was conducted in accordance with the procedures set  !

%. forth in your memorandum of February 13, 1984. In substance, my staff .

h. recommended temination of this rulemaking action in its present form, but E noted that there was a genuine need to improve the regulation of sealed 4 sources and devices and, further, that a request to reinitiate this rule-7 making action would be resubmitted in the future. 4 M- l t The staff reconnendation to terminate this rule was based on three principal E considerations. The first was that this rule was principally adninistrativo fj g in nature, i.e., it did not directly affect the public health and was, there-

,t. fore, of low relative priority within the Office. Second, in our judgment. .

. ' the specifics of the rule and supporting documentation required substantial l4 modification and restructuring in order to adequately support the proposed action. Third, current RES manpower limitations made it impossible to M

a reactivate the effort and complete action on this rule within the foreseeable future. Thus, it was felt that this rulemaking should be teminated and 4[. deleted from the Regulatory Agenda until such time as adequate resources g: became available.

f' In follow-up discussions NMSS indicated that they would be willing to assume

[h responsibility for completion of this rule and felt they could complete the effort with presently available resources.

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William J. Dircks 2 007 1 1985 Accordinglv. I an recomending this rulemaking be continued and advise you that N'4SS is assuming responsibility for the further development of this rule.

The cc,mplete RES review package has been sent to ED0 (Attn: DEDROGR) and to the Director, N:tSS.

Wisinalafaned by ROBERTB,urggg :

9 Robert B. Minogue, Director d

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50 30 1935 RES INDEPENDErd LIVIEW BOARD h j f ( v(f VOTING SEEE1 l TO: F. P. GILLESP]E CHAIRMAN, RlRB FROM: G. A. Arlotto, Member, RIRB TITLE OF RULEMAKING:

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RES INDEPENDEta ilVIEk' BOARD VOTING SHEET TO: F. P. GILLESPIE, CHAIRMAN, RIRB FROM: K. R. Goller, Member, RIRB TITLE OF RULEMAKING: - b \C Cf-R 36,32 i % M ~lO -

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COMENTS AND SUGGESTIONS:

An important precedent is about to be set here and RIRB should consider carefully what this is.

Essentially the only reason given for recomending terminating this rulemaking is inadequate RES resources. In any case, terminating a rulemaking for this reason alone should be very carefully considered, including the possibility of transferring lead responsibility to another office. In this case, however, the " user" office has indicated willingness to assume such responsibility.

Therefore, it would be very bureaucratic to follow through with this independent review and terminate this rulemaking and then perform another review to initiate the same rulemaking by another office. Instead, why not set a precedent tnat the consideration of the transfer of lead responsibility for a rulemaking (for any reason and at any time) is part of an independent review of a rulemaking and that such a transfer and approval of continuing the rulemaking can result directly from a recomendation to this effect coming out of an independent review.

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RE5 INDEPENDEtd Lti1Ek' BOARD VOTING SEEET 10- F. P. GILLESPIE, CHAIRMAN, RIRB FROM: W. M. Morrison, Member, RIRB TITLE OF RULEMAKING: h \D CM '20 youMO-5 c . .w w te.Ac s REQUEST RIRB AGREE WITH REC 0!EENDATIONS MEETING.

IN RES RULEMAKING REVIEW

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- PACKAGE AS INDICATED BELOW COMMENTS AND SUGGESTIONS:

It is not possible to conduct an independent review of this rulemaking, as requested by the RAMRB Staff, because insufficient information is provided. Missing information, most of which is required to be included in the package by the May 1984 Procedures for Conducting RES Independent Review, includes the following:

(1) The NRC Regulatory Agenda entry; (2) The rulemaking as currently proposed; (3) The items listed in I.E.1.d. of the Procedures for Conducting RES Independent Review; (4) The regulatory analysis; (5) The memorandum identified as " Attachment 1" in the draf t Minogue to Dircks memorandum, subject " Draft Recommendations to EDO Concerning ...". (It is not clear why the " draft" is in the subject.)

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- sheets indicating their positions on the rulemaking..

Responses by c.o.b. SegNer 3 BB5 will be appreciated. RAMRB will usd the voting

. . . . . sheets to. assemble the complete RES review package ,

for eventual transmittal to the OEDO and the Director of the user office.

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RESEARCH OFFICE REVIEW 0F PROPOSED REVISIONS TO COW 11SSION RULES GOVERNING THE LICENSING 0F SOURCES AND DEVICES (10 CFR 30, 32, 40 and 70)

The subject rulemaking package has been reviewed in accordance with the guid-ance provided in R. 8. Minogue's memorandum to staff dated May 10 1984.

Basically, this rulemaking proposes that manufacturers and distributors of sedled sources or devices containing sealed sources be required, as a condi-tion of licensi.ng, to submit information on the characteristics and proposed uses of their products. NRC and the Agreement states would, in procedures not fully documented, review and " approve" such devices for the uses proposed in the license' application. Currently, product information of this type has been provided by manufacturers on a voluntary basis since it facilitates the subsequent licensing of the users (purchasers) of their products. Such product information is catalogued and published by NRC and distributed to the Agreement States for their use in licensing reviews of applicants proposing to use a given product. Where no prior product review has been made or where no product data is on hand, information is obtained from the user-applicant as part of his ,,

licensing review.

In addition, this proposed rulemaking would establish a system which classifies sources and devices according to end-use and source characteristics. Further, the rule would also permit licensee-users of such products to employ any one of a number of sources or devices which have previously been " reviewed" by NRC or the Agreement States without the need for a specific amendment to their license as is currently the case under existing regulations.

i After considering the information provided in this rulemaking package (State-l ment of Considerations, Regulatory Analysis, etc) we are of the opinion that.

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in its present form, this rulemaking action should be tenninated. This judge-ment is based on the following:

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(a) the health and safety of the public is not affected by the imposition of these proposed changes. Current regulatory requirements and procedures are adequate to ensure public and occupational safety in this activity..

(b) No abuses of'the voluntary system having an impact on public safety have been cited to support the, need for improved regulatory control in this area . .

(c) The principal benefits cited in support of this rule are administrative in nature. These benefits flow principally to the subsequent user of these devices rather than to the manufacturer or distributor upon whom these new licensing requirements are being imposed. The administrative burden appears to be a small reduction for the user and a small increase to the supplier.'

(d) Legal redress is currently available to NRC (under 10 CFR 2.200) in situations where it ca'n be shown that manufacturers or distributors have, through negligence, or fraud, adversely impacted on licensees' compliance with NRC regulations and, indirectly, on public health and safety.

(e) The net cost impact of these proposed changes is small; a slight increase Cost in manufacturers costs and reduction in users costs could occur.

and other impact estimates provided in the Regulatory Analysis are incon-clusive. It would seem that the manufacturers / distributors would be required to apply for a license amendment .for each new or unique product they produce. No assessment of this impact is given.

These opinions are, we believe, consistent with those of ELD and ADMIN who provided extensive and substantive connents on the draft rulemaking package.

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_ _ _ _ _ _ _ _ _ _ _ . _ . - , -- . . . . _ _ _ , , , , , , . . . ~ . ,

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MEMORANDUM FOR: William J. Dircks Dross Executive Director for Operations RMinogue ,

l FROM: Robert B. Minogue, Director  :

r Office of Nuclear Regulatory Research )

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SUBJECT:

CONTROL OF NRC RULEMAKING: RES REVIEW 0F ONGOING f RES-SPONSORED RULEMAKING: REVISIONS TO 10 CFR 30, 32, T 40 and 70: LICENSING OF SOURCES AND DEVICES-M -

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f. Based on our reassessment of the subject rulemaking. RES recomunends that b; further work on this rule, in its present form, be terminated. This review has t, been coordinated with the Office of Nuclear Material Safety and Safeguards, who U concurs with this recommendation.  !

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The basis for this recommendation is as follows: [

'f, o The proposed rulemaking would propose to replace a voluntary system. l i No abuses of the voluntary system (which has been in effect for many k years). have been cited to support the need for this proposed action. .

5 I, o The principal benefits of rulemaking are administrative in i nature and do not flow to the licensees impacted by this proposed

p. rule; this action would seem to increase the regulatory burden  :

q by requiring both the manufacturer and the user of the sealed sources k or devices to be licensed rather than the present method of just ,

licensing the user.

l o Ba' sed on the draft Regulatory Analysis, the net cost impact

( of these proposed rule changes are inconclusive, but appears

( to be modest.

I f .. o NMSS is presently pursuing the development of an alternative

'. approach to modifying the licensing process for sealed sources and

devices which would be less onerous on the industry and more

!' effective in reducing the NRC workload. We anticipate that a new i rulemaking action will be proposed by NMSS in the near ,

- future. -

The complete RES review package has been sent to OEDO (Attn: DEDROGR) and to

, the Director, NMSS Robert B. Minogue, Director Office of Nuclear Regulatory Research

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NIC FORM 318 (10-80) NRCM 0240 FICIAL RECORD COPY '

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& J. A Y TITLE:

Licensing of Sources and Devices

/UM S 5 /0/ 2/8 6.

CFR CITATION:

10 CFR 30; 10 CFR 32; 10 CFR 40; 10 CFR 70 ABSTRACT:

The proposed rule would require manufacturers or distributors of sealed sources or devices containing sealed sources to obtain a license from the NRC prior to the initial transfer of the sealed sources or devices to specific licensees. The rule would also require manufacturers or distributors of sealed sources or .

devices to provide the NRC with information on such products relating to design, manufacture, testing, operation, safety and hazards as a condition for obtaining a license. If the proposed requirements were applied to the 800 material license i applications and amendments reviewed in 1982 as a statistical l base, total ' costs to suppliers would rise f rom $148,025 under the current voluntary program to $152,950. At the same time, the proposed rule would eliminate the $48,000 cost to material licensees of preparing 800 license amendments.

NRC plans to 1__l.___: i t = M M_ing &4 develop an alternative means to modify the licensing process for sealed sources and devices that would be less costly to the industry and .

more offective in reducing the NRC workload.

TIMETABLE: Of f[ .

Final Action GF/00 K c(,[oo /P7 LEGAL AUTHORITY:

42 USC 2111; 42 USC 2201; 42 USC 2071; 42 USC 2092 EFFECTS ON SMALL BUSINESS AND OTHER ENTITIES: Yes AGENCY CONTACT:

• Donald R. Hopkins Nuclear Regulatory Commission Office of Nuclear Regulatory Research Washington, DC 20555 301 443-7878 I

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EP- T [7590-01]

4 NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30, 32, 40, and 70 Licensing of Sources and Devices AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

SUMMARY

The Nuclear Regulatory Commission is considering amending its

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regulations to require suppliers of sources containing radioactive

/

material or devices which contain sources as part of the device to submit design, construction, kuality control, and other information to enable the Commission to conduct generic safety reviews of these sources and devices. The proposed amendments would require generic safety reviews (as opposed to custom review for specific applications) for all sources and devices which will be distributed to specific licensees. The proposed amendments will create a formal source and device safety review process in place of the current voluntary program thereby providing a well defined regulatory authority applicable to both supplier and license applicant.

DATES: Comments should be submitted on or before .

Comments received after this date will be considered if it is practicable to do so, but assurance of consideration cannot be given except as to comments received on or before that date.

ADDRESSES: Submit comments on the proposed rule or the supporting regulatory analysis to the Secretary of the Commission, Nuclear Regula-04/11/84 1 FRN 10 CFR 30 32 40 70 l

.- --_- ~,.__ _. _

~ ^ ~~ ~

, , [7590-01]

tory Commission, Washington, DC 20555, Attention: Docketing and Service Branch. Single copies of the regulatory analysis may be obtained on request from the contact identified below. Copies of the regulatory analysis and of comments received by the Commission may be examined in the Commission's Public Document Room at 1717 H Street NW., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Donald O. Nellis, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC

< 20555,tilephone(301)443-7891.

SUPPLE $ENTARYINFORMATION:

Background

Applicants for specific material licenses submitte'd under 10 CFR Parts 30, 40, and 70 for use of sources containing radioactive material or devices containing such sources, must specify in the license appli-cation the manufacturer and the model number of the source or device to be used. Approval of such license applications is given only after a safety evaluation of the source or device has been performed by the NRC or Agreement States' licensing staffs.

In the absence of specific regulatory requirements applicable to f both the supplier and the licensee applicant, the licensing staffs, in an effort to expedite the application review process, have encouraged suppliers of such' sources and devices to provide design, construction, quality control, and other information needed to perform the safety evalu-ations before the customer (licensee applicant) has a need for these items.

04/11/84 2 FRN 10 CFR 30 32 40 70

i '. [7590-01]

This voluntary program, which has been in use for a number of years, was intended to develop a list of "off-the-shelf" sources and devices for which generic safety reviews had been completed before the customer had a need for them.

Because there is no regulatory requirement, a number of problems exist with the present voluntary system. These include misunderstanding by suppliers of the requirements of the voluntary system, failure to submit all the information needed for generic safety reviews, and sub-mission of-inadequate quality assurance programs. These cause unneces-sary burdens and delays for the licensee applicant who is often forced to act as,a conduit funneling the required information from the supplier to the-NRC or to the Agreement States.

Somet.luies suppliers provide only ::ncugh infor=: tion for : "cu:ter.

review" for a specific application of a specific customer. One result of these nongeneric (custom or specific) reviews is that subsequent users of the same item (which would be an "off-the-shelf" item if a generic safety review had been performed) often suffer licensing delays and additional costs for additional safety reviews required to assess the safety of the item for.their particular operation. In addition, costs and delays are often suffered by current users of such items when they wish to change from one model source or device to accommodate changes in their opera-tions. The additional safety reviews resulting from current practices require some 800 amendments to NRC licenses annually, and constitute a considerable burden to the materials licensing staffs and to the licensees themselves.

In addition, although 99% of all suppliers of sources and devices are NRC licensees, the present voluntary program allows the NRC no 04/11/84 3 FRN 10 CFR 30 32 40 70

[7590-01]

authority over the quality assurance program of the supplier. The pro-posed rule however would provide a specific regulatory requirement for the submission of such a quality assurance program as part of the license _

application to distribute sources and devices. Such a regulatory require-ment should provide a mechanism for alerting the licensing staffs of possible safety problems associated with the sources or devices.

The NRC feels that replacement of the current voluntary program with well defined regulatory requirements will not place any additional burden on suppliers of sources and devices since they'are already providing certain /information directly or through their customers (licensee

~

applicants). The institution of a regulatory basis for providing this information will allow increased flexibility in the types of sources and devices which licensees may possess and use, will eliminate the necessity for licensee applicants having to provide complete information on each source and device they plan to use, and will eliminate the need for 800 license amendments per year.

The NRC is proposing to amend its regulations by adding new sections to 10 CFR Parts 30, 32, 40, and 70 to require suppliers of sources and devices containing sources which will be distributed to specific licensees to submit design, construction, prototype testing, quality control, and other information as needed for review of such sources and devices.

The establishment of the proposed amendments would also provide for classification of devices containing sources according to the uses intended for the devices. A licensee would be permitted to possess and use any approved device containing a source within a specific category without the need for a license amendment.

04/11/84 4 FRN 10 CFR 30 32 40 70 t . ,.

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NO ENVIRONMENTAL IMPACT This proposed rule is non-substantive and insignificant from the standpoint of environmental impact. Therefore, neither an environmental impact statement nor an environmental impact appraisal and negative declaration are required for this proposed rule (10 CFR 51.5(d)(3)).

PAPERWORK REDUCTION ACT STATEMENT This proposed rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). This rule has been submitted to the Office of Management and Budget for review and approval of the paperwork requirements.

i REGULATORY ANALYSIS The Commission has prepared a draft regulatory analysis on this proposed regulation. The analysis examines the costs and benefits of the alternatives considered by the Commission. The draft analysis is avail-able for inspection in the NRC Pubite Document Room,1717 H Street NW.,

Washington, DC. Single copies of the analysis may be obtained from Donald O. Nellis, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC, telephone (301) 443-7891.

The Commission requests public comment on the draft regulatory analysis. Comments on the draft analysis may be submitted to the NRC as indicated under the ADDRESSES heading.

04/11/84 5 FRN 10 CFR 30 32 40 70

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REGULATORY FLEXIBILITY CERTIFICATION On the basis of information available to it at this stage of the rulemaking proceeding and in accordance with the Regulatory Flexibility I Act of 1980, 5 U.S.C. 605(b), the Commission hereby certifies that this rule will not, if promulgated, have a significant economic impact on a significant number of small entities. The proposed rule affects about 290 suppliers of sources and devices, most of whom qualify as small business entities. In order to obtain a safe'ty evaluation of their

/

products prior to distribution to their customers (NRC and Agreement State licensees), thes'e suppliers are required to submit design and other required information to the licensing staffs and are assessed fees for safety reviews as provided in 10 CFR 170.31.

The approximately 290 suppliers are assessed fees of $350 for a

- generic source safety review and 5175 for a custom source safety review,

$1600 for a generic device safety review and 5800 for a custom device safety review. In addition, up to 5 drawings and 10 pages of text are required, adding an additional 5240 for supplier staff time in assembling watev M the{foreachofthereviews. The resulting costs are then $590 and $415 for source reviews and $1840 and $1040 for device reviews.

During 1982 there were 50 generic source safety reviews performed at a cost of $29,500 and 19 custom source reviews performed at a cost of

$7885. During this same period there were 59 generic device safety reviews performed at a cost of $108,560 and 2 custom device reviews per-formed at a cost of $2080. The total costs to the 290 suppliers during this period were $148,025. Also during 1982 there were some 800 license 04/11/84 6 FRN 10 CFR 30 32 40 70

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amendments at $60 per amendment, resulting in costs to licensees of

$48,000 and an overall cost of $196,025.

The proposed rule would eliminate custom reviews and require source and device suppliers to obtain generic safety reviews for all of their products prior to distribution to their customers. If this rule were appited to the 1982 reviews, the total costs to' suppliers would rise to

$152,950, an increase of 3%. At the same time the proposed rule would eliminate the need for the 800 license amendments costing $48,000, resulting in an overall cost reduction of some'25%. The costs to individual suppliers would depend upon the_ number of items submitted for safety review.

The proposed rule should have only a minor economic impact on the majority of suppliers since, although the fees are made mandatory under the rule, most suppliers have been paying these fees under the voluntary program. The small increase in fees to the suppliers, as indicated above, will be offset by a larger decrease in fees to licensees due to the reduction in the number of license amendments required annually.

l LIST OF SUBJECTS IN 10 CFR PART 30, 32, 40 AND 70 PART 30 Byproduct material, Government contracts, Intergovernmental relations, Isotopes, Nuclear materials, Penalty, Radiation protection, Reporting and Recordkeeping requirements.

04/11/84 7 FRN 10 CFR 30 32 40 70

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PART 32 Byproduct material, Labeling, Nuclear materials, Penalty, Radiation protection, Reporting and Recordkeeping requirements.

PART 40 Government contracts, Hazardous materials-transportation, Nuclear materials,-Penalty, Reporting and Recordkeeping requirements, Source material, Uranium.

4 PART 70 Hazardous materials-transportation, Nuclear materials, Packaging and containers, Penalty, 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 i

of 1974, as amended, and 5 U.S.C. 553, the NRC is proposing to adopt the following amendments to 10 CFR Parts 30, 32, 40, and 70.

I 04/11/84 8 FRN 10 CFR 30 32 40 70

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[7590-01]

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

1. The authority citation for Part 30 is revised to read as follows: j 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).

Sec. 30.7 also issued under Pub. L. 95-60'1, sec. 10, 92 Stat.

2951 (42 U.S.C. 5851). Sec. 30.34(b) also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Sec. 30.61 also issued under sec. 187, 68 Stat. 955 (42 U.S.C. 2237).

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

$5 30.3, 30.34(b) and (c), 30.41(a) and (c) and 30.53 are issued under sec. 161b. 68 Stat. 948, as amended (42 U.S.C. 2201(b)); and SS 30.36, 30.51, 30.52, 30.55 and 30.56(b) and (c) are issued under sec. 1610, 68 Stat. 950, as amended (42 U.S.C. 2201(o)).

2. Section 5 30.35 is added to read as follows:

S 30.35 Sources and devices.

(a) Subject to the provisions of paragraph (c) of this section, an application for a specific license to use any type of source or any device containing sources for use or uses specified in groups I to VI inclusive of 5 30.72, will be approved for all the uses specified in the application if --

4 (1) The applicant satisfies the general requirements of 5 30.33; i

04/11/84 9 FRN 10 CFR 30 32 40 70 l

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(2) The applicant has adequate experience in the use or uses of byproduct material specified in the groups listed in 5 30.72; (3) The appitcant's radiation detection and measuring instrumenta-

- tion is adequate for the specific uses applied for from the list of uses described in 5 30.72; and i

(4) The applicant's radiation safety procedures are adequate for the specific uses applied for from the list of uses described in 5 30.72.

(b) An application for a specific license to possess and use a

~

device containing a source which has not been specifically approved for

/

inclusion in one of the groups in Section 30.72 Schedule C will be approved if the applica'nt satisfies the general requirements in Section 30.33 of this chapter and satisfies the requirements in Section 32.120 or i equivalent regulations of an Agreement State.

(c) The source or device has been approved under,10 CFR 32.120 or the equivalent regulations of an Agreement State.

3. A new $ 30.72 is added to read as follows:

$ 30.72 Schedule C - Groups of devices containing sources of byproduct material and maximum allowed activities per device.

(a) GROUP I - Fixed (permanently mounted) cauces.

i (1) Tyne 1 - Density Measurement, The use of sources contained in gauging devices manufactured and distributed in accordance with a specific license issued according to the provisions of 10 CFR 32.120. These devices are designed to measure density of materials in fixed installations.

l l

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J Isotope Maximum Activity Cs-137 10 curies Co-60 1 curie Am-241 1 curie (2) Type 2 - Level measurement.

The use of sources contained in gauging devices manufactured and distributed in accordance with a specific license issued according to the provisions of 10 CFR 32.120. These devices ar'e designed to measure

, / .

height 'of fill or interface location of materials in fixed installations.

Isotope Maximum Activity Cs-137 10 curies Co-60 250 mil 11 curies (3) Type 3 - Thickness measurement and control.

The use of sources contained in gauging devices manufactured and distributed in accordance with a specific license issued according to the provisions of 10 CFR 32.120. These devices are designed for use in fixed installations to measure or control thickness of materials.

Isotope Maximum Activity Sr-90 300 mil 11 curies Cs-137 10 curies Kr-85 1500 m1111 curies Co-60 1 militcurie Pm-147 5 mil 11 curies T1-204 250 mil 11 curies Ru-106 30 mil 11 curies 04/11/84 11 FRN 10 CFR 30 32 40 70

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(4) Type 4 - Moisture measurement.

The use of sources contained in gauging devices manufactured and distributed in accordance with a specific license issued according to the provisions of 10 CFR 32.120. These devices are designed to measure moisture content of materials in fixed industrial installations.

Isotope Maximum Activity Am-241:Be 1 curie (b) GROUP II - Analytical instruments.

/

(1) Type 1 - Gas chromatographs and aerosol detectors.

The use of sources contained in gauging devices manufactured and distributed in accordance with a specific license issued according to the provisions of 10 CFR 32.120. These devices are designed to determine quantitative and qualitative chemical composition of materials by gas chromatography in laboratory or industrial environments.

Isotope Maximum Activity H-3 300 mil 11 curies Ni-63 40 mil 11 curies Am-241 60 microcuries (2) Type 2 - X-ray fluorescence analysis devices.

The use of sources contained in gauging devices manufactured and distributed in accordance with a specific license issued according to the provisions of $ 32.120. These devices are designed to determine elemental composition of materials using the X-ray fluorescence technique in both laboratory and field conditions.

04/11/84 12 FRN 10 CFR 30 32 40 70

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Isotope Maximum Activity Cd-109 100 mil 11 curies Fe-55 125 mil 11 curies Cm-244 200 mil 11 curies Am-241 100 millicuries Pu-238 100 mil 11 curies Pm-147 1 curie (c)/ Group III - Portable gauges.

(1) Type 1 - Moisture and density cauges Use of sources contained in gauging devices manufactured and distri-buted in accordance with a specific license issued according to the provisions of 10 CFR 32.120. These devices are designed for field measurement of both moisture and density of materials. Each device con-tains two isotopes which may be encapsulated as one source or two. During measurements the source (s) may remain in the device or be moved at the end of a rod from the device into a prepared hole in the material being sampled. Following the measurement the source (s) is retracted inside the device.

i' Isotope Maximum Activity l, Cs-137 45 mil 11 curies Am-241:Be 100 millicuries (2) Type 2 - Moisture cauges.

Use of sources contained in gauging devices manufactured and distri-l l

buted in accordance with a specific license issued according to the 04/11/84 13 FRN 10 CFR 30 32 40 70 f

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1 provisions of 10 CFR 32.120. These devices are portable and are designed to measure the surface moisture of materials. l Isotope Maximum Activity Am-241:Be 100 millicuries (3) Type 3 - Density gauges.

Use of sources contained in gauging devices manufactured and distri-

' buted in accordance with a specific license issued according to the pro-visions of 10 CFR 32.120. These devices are portable and are designed to

/

measure density of material under field conditions.

, Isotope Maximum Activity j Cs-137 200 mil 11 curies

(d) Group IV - Irradiators.

(1) Type 1 - Self contained dry storage irradiators, i Use of sources contained in devices manufactured and distributed in accordance with a specific license issued according to the provisions of 10 CFR 32.120. These devices are designed for irradiation of small 4

samples for research and commercial purposes. The sources are dry shielded and stationary.

Isotope Maximum Activity Co-60 26400 curies 4200 curies Cs-137 (e) Group V - Calibrators.

(1) Type 1 - Gamma-ray calibration devices.

Use of sources in devices manufactured and distributed in accordance with a specific license issued according to the provisions of 10 CFR 04/11/84 14 FRN 10 CFR 30 32 40 70 3--_r-. p ,, . . - - - _ . _ , , y--, - --- - - . , _ . _ . - _ _ - - _ - - - - . . . , _ - - - _ . _ _ . _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _

o. . [7590-01]

32.120. These devices are designed for use in fixed facilities for calibration of portable gamma-ray survey meters or dosimetry devices such as thermoluminescent dosimeters (TLD).

Isotope Maximum Activity Cs-137 200 millicuries (f) Group VI - Radiography exposure devices.

(1) Type 1 - Panoramic (crankout).

f Use of sources contained in devices manufactured and distributed in accordancIwithaspecificlicenseissuedaccordingtotheprovisionsof 10 CFR 32.120. These devices are designed to perform industrial radiog-raphy in both fixed and field locations. During use, the source is moved from its shielded storage position to a fully exposed position outside the exposure device (panoramic exposure). After exposures are complete, the source is restricted to a shielded position.

Isotope Maximum Activity Ir-192(portable) 200 curies Co-60 (fixed) installation 200 curies Co-60 (portable) 100 curies (2) Type 2 - Beam (pipeliner).

Use of sources contained in devices manufactured and distributed in accordance with a specific license issued according to the provisions of 10 CFR 32.120. These are portable devices which are designed for use in field industrial radiography. These devices (often referred to as a pipeliner) are placed in position on a pipe and the source "on-off" 04/11/84 15 FRN 10 CFR 30 32 40 70

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mechanism operated to allow radiation to be beamed as required. The source remains inside the device during exposure.

Isotope Maximum Activity Ir-192 200 curies PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL

4. TheauthoritycitationforPart32isrevisedtoreadasfollows:

AUTHORITY: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 211i, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).

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

2273); SS 32.13, 32.15 (a), (c), and (d), 32.19, 32.25(a) and (b),

32.29(a) and (b), 32.54, 32.55(a), (b), and (d), 32.58, 32.59, and 32.62 are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b));

and SS 32.12, 32.16, 32.20, 32.25(c), 32.29(c), 32.51a, 32.52 and 32.56 are issued under sec. 1610, 68 Stat. 950, as amended (42 U.S.C. 2201(o)).

5. A new Subpart D is added to Part 32 to read as follows:

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t 04/11/84 16 FRN 10 CFR 30 32 40 70

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SUBPART D - SPECIFICALLY LICENSED SOURCES AND DEVICES S 32.120 Byproduct inaterial contained in sources or in devices contain ing sources for use under S 30.35: requirements for license to manu facture or initially transfer.

An appitcation for a specific license to manufacture or initially transfer sources containing byproduct material or devices containing such as those listed in 10 CFR 30.72 of this chapter to persons specifically licensed ,under S 30.35 of this chapter or equivalent regulations of an Agreement State will be approved if --

(1) The applicant satisfies the general requirements of S 30.33 of this chapter; (2) The applicant submits the following information to the NRC i (1) Sources (A) Model number and type; (B) Isotope, chemical and physical form and maximum activity; (C) Leak test frequency. The NRC normally requires a six month interval. In the event the source manufacturer desires a longer leak test interval, the application shall contain sufficient information to demon-strate that such longer interval is justified by the performance charac-teristics of the source, or request that the NRC determine an acceptable i

leak test interval based on information which includes but is not limited to: .

(1) The ANSI classification of the source; (2) The radiotoxicity of the contained radioisotope (s);

(3) Operating experience with identical or similarly designed and constructed sources (s);

04/11/84 17 FRN 10 CFR 30 32 40 70

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(D) A precise, concise description of the source including construc-tion materials, dimensions, fabrication and sealing methods and chemical and physical form of the radioisotope (s). The description should include a package of engineering drawings that identify construction methods, dimensions and procedures for sealing.

(E) A description of the information to be engraved, etched or imprinted on the source and a description of the type and location of warning labels to be used. The label for a source should include the words " CAUTION-RADI0 ACTIVE MATERIAL", the manufacturer's name or trade-

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, mark, the model number or unique serial number, radioisotope (s),

activity, assay date, and the radiation trefoil symbol. Where labelling is impracticable, a tag containing the above information should be attached to the source, unless the attachment of such a tag is also impracticable. When a source is permanently mounted in a device, source labelling is not required provided the device is labelled.

(F) A description of the planned use(s) of the source and the i

expected environment and operating conditions during normal use. Describe type of users, locations of use, circumstances of normal use and possibil-ities of use as a component in other products. Indicate the expected l ,

useful life and describe probable effects of severe conditions, including ,

i accidents and fires and possible diversion from intended use.

(G) Prototype testing and evaluation information as follows:

. (1) Maximum radiation levels at 5 and 30 centimeters from any external surface of the source averaged over an area not to exceed 100 square centimeters, giving the method of measurement or calculation.

(2) The results of tests performed on prototype sources that establish the integrity of source construction and seal under the most 04/11/84 18 FRN 10 CFR 30 32 40 70

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adverse conditions of use to which the source is likely to be subjected.

These prototype tests should, insofar as possible, reflect the actual con-ditions of use and, as a minimum, shall meet the designated usage classif-ication of the current ANSI Standard N542 entitled " Sealed Radioactive Sources, Classification" (see accompanying tables), provided the means for assigning such a classification is described.

(H) Describe the quality control program that will be used by the source manufacturer to identify any mechanical material discrepancy that would be allowed between units and the manufacturing specifications.

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Table 1 Classification of Sealed Source Performance Tests cl.a.

7"' r I a 4 6 e Temperttune No Test -de*C(90 min) -44*C(30 miel -44*C -de* Cite saia). Speelal

+se C (Iki +180 C (th) . +400 dse ada) -44*C(Se ilh) and +4ee C(th) ada)d an see Calbi 7..t thermal sheek thesimiel sheek runal ahmk 400*C te se*C Sce*C la te*C Ses*ClaSe*C Ext;rml No Test as kN/m' eks. 35 kN/m' aba. 24 kN/su' abe. 25 kN/m' aba. 26 kN/m' aba. Special prewrre (3.6 lb.lin') to 3 MN/en* ta 7 MN/ses' to 70 klN/m' to 170 MN/m' Test te stamaaphere (290 blin') (I 016li / (le 163 El (21ti&4lb./

eins. la'l abe. hi'l abs, ini') aba.

Impact No Test 60 z (1.8es) See a (7 es) 2 kr (4.4 lbl & kg (11 ab) tokm(44lb) Special fruniI as(3.se from I at fasen I en . fruen I as frunen I as Test I

ft.) and free drop ten names to a eteel (4.b Lt .

Vibratium No Test 30 min 30 mais se asia Net Used Not Used

• Special 25 te see Hs 25 to 58 Hs at 25 t. 80 Ils Test at 5 g peak 5 e punk asas. at 1.6 aus amp, ashp. men 4 fee to et pusik to punk lis at 0.435 unme aand as I 2000 am peak Hs at 3D r m H.at ie r Puestirs No Test I a (15.4 eri ler (154 ar) Ser (1.14es) Seet (14.4 sal I kg (2.3 lb) . Spaial from I sa(3.2 eft) freas i en frein I as fe an I as faveu I am Ts*L I

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l 04/11/84 19 FRN 10 CFR 30 32 40 70 l

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Table 4 Sealed Source Performance Requirements for Typical Usage

• Sealed Souwe Test and Class Sealed Source Usage Tempera- Pree- Vibra. Func.

ture sure Impact tion ture Unprotseted source 4 3 5 1 5 Radiography-Industrial

• 3 1 3 Source in device 4 3 Radiography 3 2 3 1 2 Medical 5 2 4

• Camma telethersey 5 3 Camma gauges (medium and Unprotected source 4 3 3 3 3 Source in device 4 3 2 3 2 high energy)

Beta saures and sources for low energy gamma zauses 3 3 2 2 2 or X Ray ouorescence analysis (excluding gas Alled sources)

Oil Well logging 5 6 5 2 2 Portable moisture and density gauge (including hand held 4 .3 3 3 '

3 or dolly transported)

General neutron source application (excluding reactor 4 3 3 2 3 start.up)

Calibration source.--Activity greater than 30 pCi 2 2 2 1 2 Categorise II. III. IV 4 3 4 2 4 Camrna lrradiators' 3 2 3 Category I 4 3 Chromatography 3 2 2 1 1*

fon generators' 2 Static Eliminators 2 2 2 2 Srnoke Detectors 3 2 2 2 2

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(ii) Devices

{A) Model number and type; (B) The source model designation and source manufacturer / distributor.

Unless the source has been previously evaluated, provide the information required for sources in (i) above. Include the maximum activity and iso-tope to be used in device.

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(C) Leak test frequency. The NRC normally requires a six month interval. In the event the manufacturer or initial distributor desires a longer leak test interval, the application shall contain sufficient infor-mation to demonstrate that a longer interval is justified on the basis of operating experience with an identical device or one of similar design and construction used under similar conditions. (The leak test should consist of swiping of all, if practical, external surfaces of the device.

Particular attention should be given to areas where the device has been bolted or welded together to form a seal. In most cases, the NRC does

/

not require that the device be disassembled and the sources smear tested for removable contamirIation.)

(D) A precise, concise description of the device including construc-tion materials, dimensions, design, shielding, fabrication, "on-off" mechanisms and indicators and methods of securing the source (s) in the device. Provide a brief statement that will provide the reviewer an understanding of the capabilities of the device. The description should be accompanied by a package of engineering drawings that identify construc-1 tion methods, dimensions, safety components and descriptions of typical device installations. A copy of the operation and service manual on the l

device should be included.

I (E) A description of the label to be affixed to the device and its location. As a minimum the label should contain the manufacturer or distributor's name or trademark, model number or unique serial number, f

i radioisotope (s), activity, assay date, the radiation trefoil symbol and the words, " CAUTION RADIOACTIVE-MATERIAL."

(F) A description of the planned normal use. A range of operating l

conditions for each environmental condition should be specified for the .

04/11/84 21 FRN 10 CFR 30 32 40 70 I

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device except in the case of custom devices. The range of operating conditions should include, as a minimum, temperature, vibration, impact, puncture, compression loadings, corrosive nature of the atmosphere, and potential for fire or flooding in the area in which the device is to be used. Include descriptions of the types of users, locations of use, possibilities of use as a component in other products and the circum-i stances of normal use. Specifically indicate whether the device will be moved during normal use; for example -- whether it will slide on a track, rotate, swing on and off line and whether it is portable. Indicate the expected useful life of the device.

(G) Indicate whether or not the device is a custom device. Devices manufactured per the unique specification of and for use by a single appli-cant are considered custom devices. Devices designed and constructed as off-the-shelf items or for use by more than a single applicant are not deemed to be custom devices and should'not be so registered. If the e

device is a custom device the name and address of the company planning to use the device must be given as well as the name and telephone number of the cognizant individual who will use the device at the company facility.

(H) Prototype testing and evaluation information as follows:

(1) Radiation dose rates in millirems per-hour at the surface, at 5, 30, and 100 centimeters from the surface for the device with the shutter (s) in closed position and in the open position. As a minimum i

these readings should be taken at four equally spaced points in both the ,

longitudinal and transverse planes. A description of the method used to make the measurements and a description of the measurement locations should be included.

J

, 04/11/84 22 FRN 10 CFR 30 32 40 70 i

[7590-01]

(2) The results of tests performed on prototype devices. The tests and/or engineering analysis should, insofar as possible, reflect the actual conditions of use. The tests shall be performed on a device that is of the same design and fabricated in a manner that can be duplicated in production units, especially in regard to materials, tolerances and methods of construction. In the event that the device is a custom device, engineering analysis may be used in lieu of test data or as a minimum an operational test of the device should be made and the device swipe tested

~

for removable contamination. Historical data or engineering analysis

/

data on the units or similar units should also be submitted to reinforce any statements made.

(I) Describe the quality control program that will be used by the -

i device manufacturer to identify any mechanical or material discrepancy that would be allowed between units and the manufacturing specifications.

PART 40 - DOMESTIC LICENSING OF SOURCE MATERIAL

! 6. AUTHORITY: Secs. 62, 63, 64, 65, 81, 161, 182, 183, 186, 68 Stat. 932, 933, 935, 948, 953, 954, 955, as amended, secs. 11e(2) 83, 84, Pub. L.95-604, 92 Stat. 3033 n a:n ,ded, 3039, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2014( Q ;2), A 2, 2093, 2094, 2095, 2111, 2113, 2114, 2201, 2232, 2233, 2236, 2282); secs. 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. 40.7 also issued under Pub. L.95-601, sec. 10, 92 Stat.

2951 (42 U.S.C. 5851). Sec. 40.31(g) also issued under sec. 122, 68 04/11/84 23 FRN 10 CFR 30 32 40 70

[7590-01]

Stat. 939 (42 U.S.C 2152). Sec. 40.46 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Sec. 40.71 also issued under sec. 187, 68 Stat. 955 (42 U.S.C. 2237).

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

2273);SS40.3,40.25(d)(1)-(3),40.35(a)-(d),40.41(b)and(c),40.46, 40.51(a) and (c), and 40.63 are issued under sec. 161b, 68 Stat. 948, as amended, (42 U.S.C. 2201(b)); and SS 40.25(c) and (d)(3) and (4),

40.26(c)(2), 40.35(e), 40.42, 40.61, 40.62, 40.64 and 40.65 are issued under sec. 161o, 68 Stat. 950, as amended (42'U.S.C. 2201(o)).

/

7. Section 40.33 is added to read as follows:

1 S 40.33 Sources and devices.

(a) Subject to the provisions of paragraph (b) of this section, an application for a specific license to use sources containing source material or devices containing sources will be approved for the uses e

specified in the application if --

(1) The applicant satisfies the general requirements of 5 40.32.

(2) The applicant's radiation detection and measuring instrumenta-tion is adequate for conducting the procedures involved in the uses specified in the application; and (3) The applicant's radiation safety procedures are adequate for the uses proposed in the application.

(b) The sources or devices applied for must be approved under S 40.36 ,

or equivalent regulations of an Agreement State before a license application to use them may be approved.

04/11/84 24 FRN 10 CFR 30 32 40 70 e

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-wr +=w we-=w, -es ---g -

[7590-01]

8. Section 40.36 is added to read as follows:

$ 40.36 Source material contained in sources or in devices containing sources for use under S 40.33 requirements for license to manufacture or initially transfer. ,

(a) An application for a specific license to manufacture or initially transfer sources containing source material or devices containing such sources to persons specifically licensed under S 40.33 of this chapter or equivalent regulations of an Agreement State will be approved if --

(1) The applicant satisfies the general " requirements of S 40.32 of

/

this chapter; (2) The applicant' submits the following information to the NRC (1) Sources (A) Model number and type; (B) Isotope, chemical and physical form and maximum activity; (C) Leak test frequency. The NRC normally requires a six month interval. In the event the source manufacturer desires a longer leak test interval, the appitcation shall contain sufficient information to demon-strate that such longer interval is justified by the performance charac-teristics of the source, or request that the NRC determine an acceptable i

leak test interval based on information which includes but is not limited l

to:

( ?.) The ANSI classification of the source; (2) The radiotoxicity of the contained radioisotope (s);

(3) Operating experience with identical or similarly designed and constructed sources (s);

(D) A precise, concise descripton of the source including construc-tion materials, dimensions, fabrication and sealing methods and chemical l

04/11/84 25 FRN 10 CFR 30 32 40 70

• - =,aw mwsm.,---e.pwam. . g

[7590-01]

and physical form of the radioisotope (s). The description should include a package of engineering drawings that identify construction methods, dimensions and procedures for sealing.

(E) A description of the information to be engraved, etched or imprinted on the source and a description of the type and location of wart.?ng labels to be used. The label for a source should include the words " CAUTION-RADI0 ACTIVE MATERIAL", the manufacturer's name or trade-mark, the model number or unique serial number, radioisotope (s),

activity, assay date, and the radiation trefo'11 syrnbol. Where labelling

/

is impracticable, a tag containing the above information should be attached to the source', unless the attachment of such a tag is also impracticable. When a source is permanently mounted in a device, source labelling is not required provided the device is labelled.

(F) A description of the planned use(s) of the source and the expected environment and operating conditions during normal use.

Describe type of users, locations of use, circumstances of normal use and i i

possibilities of use as a component in other products. Indicate the expected useful life and describe probable effects of severe conditions, including accidents and fires and possible diversion from intended use.

! (G) Prototype testing and evaluation information as follows:

. (1) Maximum radiation levels at 5 and 30 centimeters from any

{

external surface of the source avertjed over an area not to exceed I~

! 100 square centimeters, giving the method of measurement or calculation.

(2) The results of tests performed on prototype sources that establish the integrity of source construction and seal under the most adverse conditions of use to which the source is likely to be subjected.

I i

04/11/84 26 FRN 10 CFR 30 32 40 70 l

'TU~ _ J Z '._i T Z_~Z:Z.l~_ ~______

[7590-01]

These prototype tests should, insofar as possible, reflect the actual conditions of use and, as a minimum, shall meet the designated usage classification of the current ANSI Standard N542 entitled " Sealed Radio-acsive Sources, Classification" (see accompanying tables), provided the means for assigning such a classification is described.

(H) Describe the quality control program that will be used by the source manufacturer to identify any mechanical material discrepancy that would be allowed between units and the manufacturing specifications.

/

e 04/11/84 27 FRN 10 CFR 30 32 40 70

- w __g-- , ,i.,., -- - - -

[7590-01]

Table 1 Classification of Sealed Source Performance Tests csau 7"'  : a 4 s s x t

40 c -40 c(30 mi.) 40 c(30 mi.) special Tam orat. w. Test -40 ciso al.) -40 ci30 maini -

T..e

+so c (Ik) +1 0 c (th) +400 d20 mi.)ishiand +s00 clin) a .ts00 ctlhi

. therusal aliack thermal shock thermal sl.=k 400 c to 20 c S00 c to 20 c 000 c to 20 c 25 kN/m' aba. 15 kN/m' aba. 25 LN/m' aba. Special i hhtienal No Tant as kN/sn* ahe. 25 kN/en' aba. Tsat (3.6 lb,lin') to 2 LIN/en' to1 hlH/m' la 10 LIN/m' to 170 EIN/m' preuurs (1 015 18 / (10153 lb./ GIsiS4lb./

te stanneepl.ere (ISO lb./in')

aba. Im') La. hi'l alt In') eles.

2 kg (4.4 lbl 5 kg (Il IL) 20 kg (44 lb) Special Impact No Test 50 g (1.8 es) 200 m (7 es) Test frusu I m(3.28 from I ne feem I mi fruin I ni freni i no it.) and free -

drop tan tantes to a Leel -

- surface fausa 1.5 n (4.92 fil .

30 mia 90 nda Not Used No.t Und

• Special Vike: tion No Test 30 min T=st 25 to 500 Ils 25 to 50 Hs at 25 ta 80 lis at5 g peak 5 e p.isk simp. at 1.5 snia amp.

. anip. swl f 0 to be psak to swak Ils at 0.625 sans asul su to 2000 amo. peak to 11s at '4D g peak and 90 to

• sou lls at 10 a 10g (154 arl 50g (1.14 es) 300g (10.6 aan I kg (2.2 lb) , Span:ial Punct1rs Na Test I a (15.4 rr) tavai i sa Tsat from I mI3.28ft) fram I mi freniI m faam I si l

l l

04/11/84 28 FRN 10 CFR 30 32 40 70 l

m.ooe,. - - , ,wm--

m- a+we mm m

o . .

[7590-01]

Table 4 Sealed Source Performance Requirements for Typical Usage Sealed Source Test and Class Sealed Source Usage Tempera- Pres. Vibra- Pune-ture aur, Impact tion ture Radiography-Industrial ' Unprotmeted source 4 3 5 1 5 Source in device 4 3 3 1 3 Medical Radiography 3 2 3 1 2 Gamma teletherapy 5 3 5 2 4 Gamma gauges (medium and Unprotected source 4 3 3 3 3 high energy) Source in device 4 3 2 3 2 Beta gauges and sources for low energy ramras raures 3 3 2 2 2 or X-Ray fluorescence analysis (excluding gas Alled sources)

Oil Well logging 5 6 5 2 2 Portable moisture and density gauge (including hand held 4 .3 3 3 2 or dolly transported)

General neutron source application (excludina reactor 4 3 3 2 3 start up)

Calibration sources-Activity greater than 30 pCl 2 2 2 1 2 Gamma Irradiators' Categories II. III, IV 4 3 4 2 4 Catesory I 4 3 3 2 3 Ion generators

• Chromatok r a ,hy 3 2 2 1 1 .

Static Elimiutors 2 2 2 2 2 Smoke Detacurs 3 2 2 2 2 heYrsea"sUSNam"eleN.

c'*O I: T"., se.".'o'r,'Ceb'terediate,e '

• ae"n". been been dieteed sene teme descieet seteseries.

=: w-::=c s:.es s.e.::: - -

(ii) Devices (A) Model number and type; (B) The source model designation and source manufacturer / distributor.

Unless the source has been previously evaluated, provide the information required for sources in (1) above. Include the maximum activity and iso-tope to be used in device, t

1 04/11/84 29 FRN 10 CFR 30 32 40 70 l

l -

[7590-01]

(C) Leak test frequency. The NRC normally requires a six month interval. In the event the manufacturer or initial distributor desires a longer leak test interval, the application shall contain sufficient infor-mation to demonstrate that a longer interval is justified on the basis of operating experience with an identical device or one of similar design and construction used under similar conditions. (The leak test should consist of swiping of all, if practical, external surfaces of the device.

Particular attention should be given to areas where the device has been c

bolted or-welded together to form a seal. In most cases, the NRC does not require that the device be disassembled and the sources smear tested for removable contamination.)

(D) A precise, concise description of the device including construc-tion materials, dimensions, design, shielding, fabrication, "on-off" mechanisms and indicators and methods of securing the source (s) in the device. Provide a brief statement that will provide the reviewer an understanding of the capabilities of the device. The description should be accompanied by a package of engineering drawings that identify con-struction methods, dimensions, safety components and descriptions of typical device installations. A copy of the operation and service manual on the device should be included.

(E) A description of the label to be affixed to the device and its location. As a minimum the label should contain the manufacturer or distributor's name or trademark, model number or unique serial number, radioisotope (s), activity, assay date, the radiation trefoil symbol and the words, " CAUTION-RADIOACTIVE MATERIAL."

(F) A description of the planned use of the device and the expected environment and operating conditions during normal use. A range of 04/11/84 30 FRN 10 CFR 30 32 40 70

_ _ ... _ _ _ , _ . _ -._ .~ _ . . _ . .

[7590-01]

operating conditions for each environmental condition should be specified for the device except in the case of custom devices. The range of operat-ing conditions should include, as a minimum, temperature, vibration, impact, puncture, compression loadings, corrosive nature of the atmosphere and potential for fire or flooding in the area in which the device is to be used. Include descriptions of the types of users, locations of use, possibilities of use as a component in other products and the circumstances of normal use. Specifically indicate whether the device will be moved during normal use; for example -- whether it will slide on a track, rotate, swing on and off line and whether it is portable. Indicate the expected useful life of the device.

(G) Indicate whether or not the device is a custom device. Devices manufactured per the unique specification of and for use by a single appli-cant are considered custom devices. Devices designed and constructed as off-the-shelf items or for use by more than a single applicant are not l

deemed to be custom devices and should not be so registered. If the device is a custom device the name and address of the company planning to use the device must be given as well as the name and telephone number of the I cognizant individual who will use the device at the company facility.

(H) Prototype testing and evaluation information as follows:

(I) Radiation dose rates in millirems per-hour at the surface, at l

5, 30, and 100 centimeters from the surface for the device with the i shutter (s) in closed position and in the open position. As a minimum i

these readings should be taken at four equally spaced points in both the longitudinal and transverse planes. A description of the method used to make the measurements and a description of the measurement locations should be included.

04/11/84 31 FRN 10 CFR 30 32 40 70

---

e.,- - - - - - - -w ,- - --,,

---

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[7590-01]

(2) The results of tests performed on prototype devices. The tests and/or engineering analysis should, insofar as possible, reflect the actual conditions of use. The tests shall be performed on a device that is of the same design and fabricated in a manner that can be duplicated in production units, especially in regard to materials, tolerances and methods of construction. In the event that the device is a custom device, engineering analysis may be used in lieu of test data or as a minimum an operational test of the device should be made and the device swipe tested for removable contamination. Historical data or engineering analysis

/

data on the units or similar units should also be submitted to reinforce any statements made.

(I) Describe the quality control program that will be used by the device manufacturer to identify any mechanical or material discrepancy that would be allowed between units and the manufacturing specifications.

PART 70 - DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL .

9. The authority citation for Part 70 is revised 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 (42 U.S.C. 2071, 1073, 2201, 2232, 2233, 2282); secs. 201, as amended, 202, 204, 206, 88 Stat. 1242, as amended, 1244, 1245, 1246 (42 U.S.C. 5841, 5842, 5845, 5846).

Sec. 70.7 also issued under Pub. L.95-601, sec.10, 92 Stat.

2951 (42 U.S.C. 5851). Sec. 70.21(g) also issued under sec. 122, 68 tat. 939 (42 U.S.C. 2152). Sec. 70.31 also issued under sec. 57d, Pub. L.93-377, 88 Stat. 475 (42 U.S.C. 2077). Secs. 70.36 and 70.44 04/11/84 32 FRN 10 CFR 30 32 40 70

- _ _ _ - - - - _ - ~

=

[7590-01]

i also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234).

Sec. 70.61 also issued under secs. 186, 187, 68 Stat. 955 (42 U.S.C.

I 2236,2237). Sec. 70.62 also issued under sec. 108, 68 Stat. 939, as amended (42 U.S.C. 2138).

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

2273); $$ 70.3, 70.19(c), 70.21(c), 70.22(a), (b), (d)-(k), 70.24(a) (b) 70.32(a)(3), (5), (6), (d), and (1) 70.36, 70.39(b) and (c), 70.41(a),

70.42(a),and(c),70.56,70.57(b),(c),and(d),70.58(a)-(g)(3),and (h)-(j)/are issued'under sec. 161b, 68 Stat. 948, as amended (42 U.S.C.

, 2201(b)); SS 70.7, 70.20a(a), and (d) 70.20b (c), and (e) 70.21(c),

j 70.24(b),70.32(a)(6),(c),(d),(e),and(g), 70.36,70.51(c)-(g),70.56, 70.57(b) and (d), 70.58(a)-(g)(3) and (h-j) are issued under sec. 1611, d 68 Stat. 949, as amended (42 U.S.C. 2201(1)); and SS 70.20b(d) and (e),

~

70.51(b) and (1), 70.52, 70.53, 70.54, 70.55, 70.58(g)(4), (k), and (1),

70.59, and 70.60(b) and (c) are issued under sec.161o, 68 Stat. 950, as l amended (42 U.S.C. 2201(o)).

10. Section 70.43 is added to read as follows:

$ 70.43 Sources and devices.

(a) Subject to the provisions of paragraph (b) of this section, an application for a specific license to use sources containing special l

nuclear material or devices containing sources will be approved for the use(s) specified in the application if --

(1) The applicant satisfies the general requirements of 5 70.23; l (2) The applicant's radiation detection and measuring instrumenta-tion is adequate for conducting the procedures involved in the uses specified in the application; and i

i i 04/11/84 33 FRN 10 CFR 30 32 40 70 l

'Z_-___.__ ._ i _ _ _ _ . _ _ . _ _ . . _ _ .

[7590-01]

(3) The applicant's radiation safety procedures are adequate for the uses proposed in the application.

(b) The sources or devices applied for must be approved under S 70.45 or the equivalent regulations of an Agreement State before a license appli-cation to use them may be approved.

11. Section 70.45 is added to read as follows:

$ 70.45 Special nuclear material contained in sources or in devices containina sources for use under S 70.43$ requirements for license to

/

manufacture or initially transfer.

i (a) An application for a specific license to manufacture or initially transfer sources containing special nuclear material or devices containing such sources to persons specifically licensed under S 70.43 of this chapter or equivalent regulations of an Agreement State will be approved if -

(1) The applicant satisfies the general requirements of 5 70.23 of 4 this chapter; (2) The applicant submits the following information to the NRC (1) Sources i

) (A) Model number and type; (B) Isotope, chemical and physical form, and maximum activity; (C) Leak test frequency. The NRC normally requires a six month interval. In the event the source manufacturer desires a longer leak test interval, the application shall contain sufficient information to demonstrate that such longer interval is justified by the performance

\

i 04/11/84 - 34 FRN 10 CFR 30 32 40 70 l . ,

..-- - ~ _._. .

[7590-01]

characteristics of the source, or request that the NRC determine an acceptable leak test interval based on information which includes but is not limited to:

(1) The ANSI classification of the source; (2) The radiotoxicity of the contained radioisotope (s);

(3) Operating experience with identical or similarly designed and constructed sources (s);

(D) A precise, concise description of the source including construc-tion mate, rials, dimensions, fabrication and sealing methods, and chemical

/

and physical form of the radioisotope (s). The description should include a package of engineering drawings that identify construction methods, dimensions and procedures for sealing.

(E) A description of the information to be engraved, etched or imprinted on the source and a description of the type and location of warning labels to be used. The label for a source should include the words " CAUTION-RADI0 ACTIVE MATERIAL", the manufacturer's name or trade-mark, the model number or unique serial number, radioisotope (s),

activity, assay date, and the radiation trefoil symbol. Where labelling is impracticable, a tag containing the above information should be attached to the source, unless the attachment of such a tag is also impracticable. When a source is permanently mounted in a device, source labelling is not required provided the device is labelled. I 1

(F) A description of the planned use(s) of the source and the l expected environment and operating conditions during normal use. Describe type of users, locations of use, circumstances of normal use and possibil-ities of use as a component in other products. Indicate the expected l l

04/11/84 35 FRN 10 CFR 30 32 40 70

[7590-01]

useful life and describe probable effects of severe conditions, including accidents and fires and possible diversion from intended use.

(G) Prototype testing and evaluation information as follows:

(1) Maximum radiation levels at 5 and 30 centimeters from any external surface of the source averaged over an area not to exceed 100 square centimeters, giving the method of measurement or calculation.

(2) The results of tests performed on prototype sources that establish the integrity of source construction and seal under the most adverse conditions of use to which the source is likely to be subjected.

/

These prototype tests should, insofar as possible, reflect the actual condit, ions of use and,'as a minimum, shall meet the designated usage classification of the current ANSI Standard N542 entitled " Sealed Radio-active Sources, Classification" (see accompanying tables), provided the means for assigning such a classification is described.

(H) Describe the quality control program that will be used by the source manufacturer to identify any mechanical material discrepancy that

! would be allowed between units and the manufacturing specifications.

04/11/84 36 FRN 10 CFR 30 32 40 70

_ _ _ . ; ;= _ ___;_;_-______ _ _ _ _ _

[7590-01]

Table 1 Classification of Sealed Source Performance Tests a.s.

T 4 s s x I e T.m er.t.,. N. T t -se- c(se mi .) -se c(no mini -4e ca l s in .i) -4e cise mi.) special Ts t

+eo c (th) +las c (th) -escdsemis.)

+ 400- (th) and +so0cgik) a +se0 cane) threi at al.erk thermal e6ck thersmalskak 400 C to 20*c 400 Cto to C 800 C to 30 c 25 kN/m' aba. 25 kN/m' aba. 15 kN/sn'she. 26 kN/n.'abe. Special Ettrtrcl No Test 25 kN/m' abe. Test (3.5 lb,/in') to 2 M Nien* Le1 EIN/m' to 70 nIN/m' to I'lo SIN /m' pas re (10153lb./

le staneespliere (tb0 blin') (I ell 11../ (2 8 ai&4 s' u ./

abs. in'l ab in') ab., in') .bs.

2 kg (4.4 lb) & Le (Il ibn to kg (44 lb) Special Imiput No Test to a (1.4 est too a (7 es) Test frwu 1 m(8.28 from I m fivisi 1 en fruem 1 m frwa 1 m it.) and free drop ten unies la a eteel .

. surface fnesa '

1.5m (4.92 ft) .

No Test 30 min 30 mia to niin Not Uncd Ni.4 Used Special ynkerti 25 to 500 Ils 25 to la Hs at 25 6 so 11: Tt at5 g peak 5 g peak sees. at 3.6 ease emp.

anip. acid fee to De punk to peak lls at U 635 sani as I hu to 2000 amis. peak te ils at 20 g k and Dete ifa at to a No Test I a (15.4 arrl lee (154 arl Een (1.14 a s) soog (10.4 os) i kg (2.11b) . Spatal riensters in.ui i see Ts.t freou i en(3.28ft) from i m fessu I su faeni I ai l

r 04/11/84 37 FRN 10 CFR 30 32 40 70

---4---r----..%-p--. _ _may.-*_---v- ,,yae7cm-,.m-----wp---w _

-m .- -p-. ,we.w--, - - ------e.---- - - - - , . -

r- ,

[7590-01]

Table 4 Sealed Source Performance Requirements for Typical Usage Sealed Soum Test and Class Sealed Scuree Usage Tempers. Pres- Vibra. Pune.

ture sure Impact tion ture Radiography-Industrial ' Unprotected source 4 3 5 1 5 Source in device 4 3 3 1 8 Medical Radiography 3 2 3 1 2 Gamma teletherapy 5 3 5 2 4 Gamma gauges (medium and Unprotected source 4 3 3 3 3 bish energy) Source in device 4 3 2 3 2 Beta gauges and sources for low energy samma rauses 3 3 2 2 2 or X-Ray fluorescence analysis (excluding gas Alled sources)

Oil Welllogsing 5 '6 5 2 2 Portable moisture and density gauge (including hand held 4 .3 3 3 ,

3 or dolly transported)

General neutron source application (excluding reactor 4 3 3 2 3 start up)

Calibration soureco-Activity greater than 3o pCl 2 2 2 1 2 Gamma Irradiators' Categoriee II. III. IV 4 3 4 2 4 Category I 4 3 3 2 3 Ion generators' Chromatorra.hy 3 2 2 1 1 Static Eliminators 2 2 2 2 2 Smoke Detectors 3 2 2 2 2

~

, ,,, . e. - a..e.< r- , . .e., -

1. R.':::,;li c';; ~s. t:"3.:1..'J r 3 ~a M .:::.n.' E E -

2::::;; iti:".2='"# ."4,t.".*.,*r (ii) Devices (A) Model number and type; i (B) The source model designation and source manufacturer / distributor.

Unless the source has been previously evaluated, provide the information required for sources in (1) above. Include the maximum activity and iso-tope to be used in device.

04/11/84 38 FRN 10 CFR 30 32 40 70

- - - - _ _ = _ _ . - _ - _ _ _ _ _

[7590-01]

(C) Leak test frequency. The NRC normally requires a six month )

interval. In the event the manufacturer or initial distributor desires a I

longer leak test interval, the application shall contain sufficient infor-mation to demonstrate that a longer interval is justified on the basis of operating experience with an identical device or one of similar design and construction used under similar conditions. (The leak test should l consist of swiping of all, if practical, external surfaces of the device.

Particular attention should be given to areas where the device has been

! bolted or welded together to form a seal. In most cases, the NRC does

, /

! not req'uire that the device be disassembled and the sources smear tested i

for removable contamination.)

(D) A precise, concise description of the device including construc-i tion materials, dimensions, design, snielding, fabrication, "on-off" mechanisms and indicators and methods of securing the source (s) in the l

{ device. Provide a brief statement that will provide the reviewer an understanding of the capabilities of the device. The description should be accompanied by a package of engineering drawings that identify con-struction methods, dimensions, safety components and descriptions of i

typical device installations. A copy of the operation and service manual on the device should be included.

(E) A description of the label to be affixed to the device and its location. As a minimum the label should contain the manufacturer or 1

distributor's name or trademark, model number or unique serial number, I radioisotope (s), activity, assay date, the radiation trefoil symbol and

the words, " CAUTION-RADIOACTIVE MATERIAL."

j (F) A description of the planned normal use. A range of operating

! conditions for each environmental condition should be specified for the i 04/11/84 39 FRN 10 CFR 30 32 40 70 4

h l

t .

- - - - - - - - . . . . , . , - - . . .. ~ +- ~ . - - . n-- w.. -- = = : - - - - , - -

E"' )

[7590-01]

l i

device except in the case of custom devices. The range of operating conditions should include as a minimum, temperature, vibration, impact, puncture, compression loadings, corrosive nature of the atmosphere and ,

potential for fire or flooding in the area in which the device is to be used. Include descriptions of the types of users, locations of use, possibilities of use as a component in other products and the circum-stances of normal use. Specifically indicate whether the device will be moved during normal use; for example -- whether it will slide on a track, rotate, swing on and off line and whether it is portable. Indicate the expected useful life of the device.

(G) Indicatewhetherornotthedeviceisacustomdevice. Devices manufactured per the unique specification of and for use by a single applicant are considered custom devices. Devices designed and con-structed as off-the-shelf items or for'use by more than a single appli-

! cant are not deemed to be custom devices and should not be so registered.

If the device is a custom device the name and address of the company planning to use the device must be given as well as the name and tele-phone number of the cognizant individual who will use the device at the company facility.

(H) Prototype testing and evaluation information as follows:

(I) Radiation dose rates in millirems per-hour at the surface, at 5, 30, and 100 centimeters from the surface for the device with the shutter (s) in closed position and in the open position. As a minimum these readings should be taken at four equally spaced points in both the longitudinal and transverse planes. A description of the method used to make the measurements and a description of the measurement locations should be included.

04/11/84 40 FRN 10 CFR 30 32 40 70

...-,.m-. _ . ~ - .

(.,

[7590-01]

(2) The results of tests performed on prototype devices. The tests and/or engineering analysis should, insofar as possible, reflect the actual conditions of use. The tests shall be performed on a device that is of the same design and fabricated in a manner that can be duplicated in production units, especially in regard to materials, tolerances and methods of construction. In the event that the device is a custom device, engineering analysis may be used in lieu of test data or as a minimum an operational test of the device should be made and the device swipe tested for removable contamination. Historical data or engineering analysis

/

data on the units or similar units should also be submitted to reinforce any statements made.

(I) Describe the quality control program that will be used by the device manufacturer to identify any mechanical or material discrepancy that would be allowed between units and the manufacturing specifications.

Dated at Bethesda, Maryland this day of 1984.

For the Nuclear Regulatory Commission.

William J. Dircks, Executive Director for Operations.

04/11/84 41 FRN 10 CFR 30 32 40 70

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1 DRAFT REGULATORY ANALYSIS AMENDMENTS TO 10 CFR PARTS 30, 32, 40, AND 70 -

LICENSING OF SOURCES AND DEVICES

1. STATEMENT OF THE PROBLEM The material license application review process for applications submitted unde'r 10 CFR PA'rts 30, 40, and 70 includes evaluation of the radiation safety adequacy of sources and devices containing sources which incorporate radioactive material. The responsibility for the safety evaluation review of these sources and devices is shared by the NRC and the Agreement States.

In order to expedite the application review process, the NRC licensing staff has encouraged manufacturers, distributors and importers of such sources and devices containing radioactive material to submit information to the NRC or Agreement States licensing staffs concerning these products prior to the need for a license to use the products by their customers (license applicants). For the past 35 years this process has been carried out as a voluntary program without specific and well defined regulatory authority applicable to both the supplier and the licensee.

The primary incentive or driving force for the supplier to furnish information is the desire to accommodate its customer, the license applicant.

One result of this is that the evaluation of sources and devices is frequently

, accomplished under considerable pressure on the NRC or Agreement State staffs since the supplier often waits until a sale of the source or device has been made before applying for a safety review. Another result is that the supplier often fails to supply all the needed information so that the ultimate user, the licensee, suffers delays in obtaining license approval and is often forced to I

i I

1 Enclosure B

a act as a conduit, funneling the required information from the supplier to the NRC or the Agreement States.

An additional problem associated with the present system is the practice

]

of suppliers of requesting a " custom" review of a sealed source or device for a specific customer, with the result that subsequent users of the same item (which should be an off-the-shelf item if a complete generic review had been performed) often suffer licensing delays and additional costs for subsequent 3

safety reviews required to assess the item safety for their particular operation.

2 One result of the current practices is the need for some 800 amendments to

/

NRC licenses annually by users wishing to change from one model of a device containing a source to another to accommodate changes in their operations.

These licensing actions constitute a considerable burden to the materials I licensing staff and to the licensees themselves.

1 4

Clearly, a generic safety review process is needed for all specifically licensed sources and devices. A classification system which groups devices according to their intended uses could lead to a licensing system which provides for flexibility and would enable licensees to possess and use approved devices containing sources without the need for license amendments.

2. OBJECTIVES l

! A. Establish a regulatory requirement for suppliers (manufacturers,

! distributors or importers) of sources or devices which contain radioactive j material which will be possessed and used by specific licensees to submit suffi-cient information concerning the devices and sources to the NRC or Agreement States to permit a generic safety review of the sources and devices prior to l their distribution to specific licensees. This a requirement would provide a consistent regulatory base for the sources and devices.

B. Reduce the number of amendments required annually to authorize the use l of devices containing sources by specific licensees.

l l

2 Enclosure B

- - - _ - . - - - - - - - . - -- - _. _ - _ - =_ .-.... _ - - - - - - - . . _ -

C. Minimize the overall regulatory burden on specific licensees using devices containing sources.

D. Provide a classification system which groups source-device combinations into various use categories to provide flexibility for their possession and use by specific licensees.

3. ALTERNATIVES The regulatory alternatives which could be considered include:

A. Maintal'n the status quo which relies on the voluntary submission of information on sources and devices by the supplier.

B. End the current voluntary program and require each applicant to submit design and construction data on sources and devices containing sources it wishes to possess and use.

C. Amend the regulations to require suppliers of sources or devices which incorporate sources, to submit design, construction, quality control and other information required to conduct a generic safety review on the sources and devices.

4. CONSEQUENCES A. Maintain the status quo: The present program of voluntary submission of information lacks regulatory consistency. Regulations are in place which require suppliers of sources or devices which will be distributed to general licensees or persons exempt from licensing to provide adequate information on ,

i the sources and devices as needed to perform generic safety evaluations. For consistency similar regulations are needed to require suppliers to provide j

adequate information on sources and devices containing sources which will be distributed to specific licensees.

Continuation of the voluntary program would have little effect on the suppliers of sources and devices. The approximately 290 suppliers are 3 Enclosure B L

l l

l assessed fees of $350 for a generic source safety review and $175 for a custom source safety review, $1600 for a generic device safety review and $800 for a custom device safety review as provided in 10 CFR 170.31. In addition, up to j 5 drawings and 10 pages of text are required, adding an additional $240 for 4 supplier staff time in assembling the material for each of the reviews. The resulting costs are then $590 and $415 for source reviews and $1840 and $1040 for device reviews. The 10 or so suppliers who fail to participate in the voluntary program are unaffected but the licensees who choose to use their products are required to pay the fees assessed under 10 CFR 170.31 and their additional costs will be greater in that they will be acting as a conduit to funnel the required information between the supplier and the licensing staffs.

Additional costs are also incurred under the current system in that some

]

800 licensing amendments are required annually because of the lack of a system which would provide flexibility for the devices containing sources which specific licensees may possess and use. At an estimated $60/hr and I hour per amendment, this adds some $48,000 annually to the costs imurred by licensees.

B. End current voluntary registry: The abolishment of the present i

voluntary system of registry would change little except to transfer the responsibility for transmitting design and other safety information to the

]

NRC or Agreement States from the manufacturer or supplier to the licensee-user. Although.the suppliers would be relieved the burden of data submittal and licensing, identical information would be required from each licensee-user. The overall costs may be expected to increase some since the licensee-user would incur the same fees as those of the supplier (estimated in A above), plus the additional staff costs incurred in relaying the needed information to the licensing staffs.

j C. Amend the regulations to require submission of information concerning i sources and devices by suppliers: Replacing the current voluntary registration i program with a well defined regulatory requirement for licensing information j submission maintains the advantages of the current voluntary program and I eliminates the disadvantages. The requirement would apply to all suppliers, j would eliminate custom reviews, and would reduce the costs to both the licensee l

4 Enclosure B

=-_=_____ -_1--_. _ u =u_ _ _ __ . . _ _ _ _ _ _ _ . . , . . _ _ _ _ . _ . _

\

users and the NRC and Agreement State li. censing staffs by requiring generic safety reviews and eliminating the 800 amendments now required annually.

The additional burden to suppliers required by this alternative needs to j be considered. Although the approximately 290 suppliers have been assessed fees under the existing voluntary program, this is the first time the program would be imposed by regulation or made mandatory. A list of fees assessed is described in A above and an analysis of the costs for safety reviews during 1982 is found in the Regulatory Flexibility Certification of the proposed rule. This analysis shows that costs to suppliers during 1982 were $148,000 and costs to licensee users for license amendments were $48,000. Under the proposed rule t5tal costs to suppliers would be increased to $153,000 (based on 1982 safety reviews) and costs to licensee users would be essentially zero due to elimination of the need for license amendments. Costs to individual suppliers would be determined by the number of items submitted for safety review and can be calculated from the fee schedule given in the above analysis.

The establishment of a generic safety review requirement coupled with a generic classification of devices, which includes the maximum quantity of each specific isotope to be used in the sources contained in the devices, will serve to provide increased flexibility for the devices which specific licensees may possess and use. The licensee-users would be the beneficiaries of the generic review by eliminating the need for the 800 license amendments now required annually and the costs of some $48,000 described in A above.

5. DECISION RATIONALE Based on the discussion in (4), the staff recommends that alternative C be adopted. Alternative A lacks regulatory consistency and imposes unnecessary burdens in terms of license amendments on both licensee user and on the NRC and Agreement State licensing staffs. Alternative B would impose all of the burden on the licensee user with the supplier being relieved of all needs for voluntary submittal and would probably increase costs since the licensee user would be acting as an intermediary in the data submittal process. Alternative C would 5 Enclosure B

considerably reduce costs and delays to licensee users, reduce much of the burden on licensing staffs and at the same time impose minimal burdens on the suppliers.

! 6. IMPLEMENTATION 1

l Rulemaking of minor or non policy nature may be approved by the Executive Director for Operations under authority delegated in 10 CFR 1.40(d). The proposed rulemaking is of a non policy nature in that it merely formalizes the existing voluntary policy of having suppliers of sealed sources and devices

! submit design and safety information concerning such sources and devices to the

NRC and Agreement State licensing staffs.

The rulemaking would be undertaken in two stages: publication of a proposed rule in the Federal Register; and, following consideration of public comments on the proposed rule, a final rule would be published in the Federal Register.

I 7. NATIONAL ENVIRONMENTAL POLICY ACT (NEPA)

Since the proposed rulemaking would have no effect on currently used [

i procedures, no change in environmental impact will result. As a result, under

the criteria of 10 CFR Part 51 no Environmental Impact Statement is required.

1 l 8. PAPERWORK REDUCTION ACT

, The Paperwork Reduction Act of 1980 (Pub. L.69-511) requires that approval 3 of the information gathering requirements of the proposed rulemaking be sought from the Office of Management and Budget. It should be noted that the informa-tion gathering requirements are, in effect, now required under the voluntary registration system so that if the supplier fails to provide the required information, the licensee user must provide it in order to obtain license ,

approval to use the sealed source or device. Since more than 10 persons are affected by this rulemaking, approval will be sought from OMB.

6 Enclosure B l

=. =_=.=-__; _=______:._._=_._-._-----.--

9. REGULATORY FLEXIBILITY ACT As indicated previously, the proposed rule would have an economic impact on suppliers of sources and devices amounting to approximately $153,000 annually. Costs to individual suppliers would be determined by the number of items submitted. Of the approximately 290 suppliers, approximately 70% are estimated to be small entities as defined by the Small Business Administration in 13 CFR Part 121. On the other hand the proposed rule would benefit some 8,000 NRC licensee users, 90% of whom are considered to be small antities. On balance of tradeoff it is considered that the net effect of the proposed rule-making will not have a significant effect on a significant number of small entities.

/

10. RELATIONSHIP TO EXISTING OR PROPOSED REGULATIONS OR POLICIES The proposed rulemaking is generically related to the existing regulations in 10 CFR 32.22,10 CFR 32.26, and 10 CFR 32.51 which apply to distribution to general licensees and persons exempt from licensing of radioactive material introduced into sources and devices. There are no known proposed regulations or policies that could have an adverse impact on this action. The present voluntary program supports the concept of the proposed change since its exist-ence has helped to minimize the potential impact on suppliers.

7 Enclosure B

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9 9

SUPPORTING DOCUMENTS

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? I Barbara J. Sabol, Secretary Topeka, Kannes 06620 91H62-0300 June 6,1984 Lloyd Bolling U.S. Nuclear Regulatory Commission Washington, D.C. 20555 -

Dear Mr. Bolling:

This refers to the request dated May 3,1934, for comments on the proposed changes to 10 CFR Parts 30, 40 and 70 relating to devices and sources in devices.

It is not possible to support the proposal as presented. The basic difficulty has to do with the language in 30.35 which essentially removes the . agencies authority to review an amendment request by the ultimate. user of a device. It is our feeling that the argument for such general approval is inadequate. The number of amendments whether 80,800, or 8,000 is not a reason for a change in regulations. Our experience has been that the required amendment request has been very useful and on some occasions may have prevented some devices from -

simply disappearing.

It is recommended that the following changes to the proposal be made unless a more direct argument for eliminating the required case by case review of changes at a licensee's facility can be provided.

5 30.35(a) Subject to the provisions of this section, an application for a specific license for a source or device shall only be approved if the applicant satisfies the general requirements of 5 30.33 and the source or device has been approved for the use requested under 10 CFR 32.120 or the equivalent regulations of an Agreement State.

5 30.72 no change from proposal.

I 32.120 no change from proposal.

5 40.33 Subject to the provisions of this section an application for a specific license to use sources containing source matmerial or devices containing source material shall only be approved if the applicant satisfies the general requirements of 5 40.32 and the sources or devices applied for have been approved for the use requested under i 40.36 or equivalent regulations of an Agreement State.

t Lloyd Bolling Page 2 June 6, 1984 5 40.36 no change from proposal.

I 70.43(a) Subject to the provisions of this section an application for a specific license to use sources containing special nuclear material or devices containing sources shall only be approved if the applicant satisfies the general requirements of 5 70.23 and the sources or devices have been approved for the use requested under i 70.45 or equivalent regulations of

. an Agreement State.

It is hoped the above has been helpful and that you will not hesitate to contact this office if you have further questions. .

/ Sincerely, ,

- DIVI 0F ENVIR0fMENT E d W. Allen '

Bureau of Air Quality and .- .

Radiation Control I

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,F4*b NORTH DAKOTA bb #D .E l' # ~

. [ STATE DEPARTMENT OF HEALTH [//5 Sete Capit:1 M. A. K. Lemmen, M.D., R.P.E.

" Bismarck, North Dakota 58505 State Health Officer Environmental Health Section Missouri Office Building June 11, 1984 1200 Missouri Avenue Bismarck, North Dakota 58501 Mr. Lloyd Bolling Office of State Programs U.S. Nuclear Regulatory Commission Washington, DC 20555

Dear Mr. Bolling:

This Department would like to indicate its support for amending of the regulations to require submission of in-formation concerning sources and devices by suppliers. This Department concurs that this requirement would eliminate custom reviews and should reduce costs to both the licensee and to the agreement state and/or the NRC staffs by elimina-ting the many amendments that are now required annually.' .

Therefore, this Department does support the amendment which would facilitate the changes as outlined in Alternative C of the Draft Regulatory Analysis, therer7 amending 10 CRF Parts 30, 32, 40, and 70.

Should you have any questions, please cont'act my office at 224-2348.

cerely, f .  %

Dana K. Mount, P.E.

Director, Division of Environmental Engineering DKM/DPP:pkm Envir:nmental Environmental Environmental Environmental Waste Water Supply &

Ent;rcement Engineering Sanitation Management & Research Pollution Control aa. --.--a. - . . . . . . . . . . _ . . . . . .... .......... . . . . . . . . .

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i OFFICE OF ENVIRONMENTAL PROGRAMS DEPARTMENT OF HEALTH AND MENTAL HYGIENE 201 WEST PRESTON STREET

• BALTIMCRE. MARYLAND 21201

• AREA CODE 301

• 3832744

. TTY FOR DEAF: Balto. Area 383 7555 0 C. Metro 565m51 June 15,1984 Adele Witzack, R.N., M.S., Secretary William M. Eichbaum. Assistant Secretary State Agreements Program .

Office of State Programs ~

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

a Attn: Lloyd Bolling Dear Sirs This Division has. reviewed the proposed rule which would require suppliers of sources or devices containing radioactive material to submit certain information to enable the Commission to conduct generic safety reviews."

We believe that the proposed regulations offer a greatly improved approach to the current system and highly favor their adoption.

Although you did not indicate whether or not the adoption of these l regulations would be a me,tter of compatibility for Agreement States, our feeling is that we would want to adopt similar regulations in Maryland as soon as

practicable after NRC adopts them.

i on page 7 of the proposed rule document number (7590-01), and on page 4 of the " Draft Regulatory Analysis" are statements to the effect that the proposed i rule would eliminate custom reviews. Yet in the proposed rule on pages 22, 31, and 40, in Parts 30.120(ii)G, 40.33(ii)G, and 70.43(ii)G, respectively, the subject of custca devices is addressed in some detail.

We have appreciated the opportunity to cosament on this proposed rule.

Sincerely, b

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",1U s e c- w a Robert E. Corcoran, Chief Division of Radiation Control REC /ame cc: Mr. David L. Resh, Jr.

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• tGn y/is N delaeuas DEPARTMENT OF HEALTH

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• 4815 WEST MARKHAM STREET

• UTTLE ROCK. ARKANSAS 72201 TELEPHONE AC 501661-2000 1  ?

C U. CUNTON D R CToR GOVERNOR June 7, 1984 Lloyd Bolling Office of State Programs U.S.N.R.C.

W:shington, D. C. 20555

Dear Mr. Bolling:

t This letter concerns the proposed rule which would require suppliers of sources or devices containing radioactive material to submit information to the NRC for evaluation of the source or device prior to marketing and the' proposed rule to c11ow group licensing of various gauges, analytical instruments, irradiators and -

rediography devices.

This Agency supports the adoption of the rule change requiring source and device evaluations prior to marketing. We also agree with the Commission that. Alt'ernative C is the regulation of choice.

However, we have significant reservations regarding group 1h ensing of gauges, c:rtain irradiators and radiography devices. Source / device accountability may b come a problem and regulatory personnel may not be able to determine if all mate-rial can be accounted for by the licensee. We gen'erally do not write "open-ended",

("no single source to exceed...." with no maximum limit stated), licenses for new licensees or for licensees with poor compliance histories. .Only after a licensee hss demonstrated the ability to maintain an adequate radiation safety program, in-cluding acceptable record keeping and source accountability, are "open-ended" li-ccnses written.

Therefore, it is recommended that the Commission reconsider the group licensing proposed rule. If the rule is adopted however, it is suggested that the Commission consider requiring manufacturers to submit Quarterly reports of these source / device distributions, similiar to the reports required for generally licensed sources and devices, to facilitate source accountability.

Also, it is noted that Well Logging sources were not included in the rule. If ra-diography sources and devices are included, it seems that Well Logging sources chould also be a licensed group.

S cerely, eta cus Ch

. adioac ve Materials Program GJD:mm

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Texas Department of Hea t1

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Robert A. MacLean, M.D.

Robert Bernstein, M.D., F.A.C.P. 1100 West 49th Street Austin, Texas 78756-3189 Deputy Commissioner Commissioner Professional Services (512) 458-7111 Hermas L Miller Radiation Control Deputy Commissioner Managementand Administration (512)835-7000 June 18, 1984 Mr. Lloyd Bolling <

State Agreements Program ,

Office of State Programs -

U.S. Nuclear Regulatory Commission Washington, DC 20555

Dear Mr. Bolling:

Thank you for the opportunity to comment on proposed changes to 10 CI'R Pa'r'ts 30, 32, 40, and 70 regarding licensing of sources and devices. Staff members of the Bureau of Radiation Control have reviewed the document and offer the following comments for consideration:

1) The basic concept and objectives of the proposed rules are desirable, especially the development of a consistent system for the review and regulation of sources and devices. Rules regarding safety reviews would be less subjective than existing regulatory guides.

2) Information in the Background Section (page 3) indicates that

".. 99% of all suppliers of sources and devices are NRC licensees..."

The Registry of Sealed Sources and Devices lists 140 companies as NRC licensees, ac opposed to 111 companies licensed by Agreement States for manufacture and/or distribution of sources and devices.

These figures would suggest that only 56 percent of all suppliers of sources and devices are NRC licensees. This might cause a difference in the monetary figures expressed in the Regulatory

. Flexibility Certification section.

3) We disagree with the use of Schedule C in 530.72 in that it is too specific and limiting to be included as part of the regulation.

Several categories of sources and devices are not included, such as well logging sources, static elimination devices, and spinning pipe gauges.

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Mr. Lloyd Bolling Page Two -

June 18, 1984 It was noted that prototype testing of sources would be required to 4) meet the current ANSI Standard N542. However, no equivalent requirements l were made for devices. The regulations for prototype testing of j

devices should, as a minimum, reference ANSI Standard N432 for '

ganuma radiography devices, N538 for gauging devices, N433.1 for self-contained, dry source storage irradiators, and N540 for self-luminous light sources. .

If you have any questions regarding these consments, please contact us.

Yours truly, ,

id K ker, Chie -

bureauo.L f Radiation on ol o

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, MEMORANDUM FOR: Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety e

Office of Nuclear Material Safety and Safeguards i

E FROM: Frank P. Gillespie, Director Division of Risk Analysis and Operations

/ Office of Nuclear Regulatory Research

h.

SUBJECT:

' DRAFT RECOMMENDATIONS TO EDO CONCERNING THE CONTINUANCE

,- 0F ONGOING RULEMAKING SPONSORED BY RES: REVISIONS TO 10 CFR 30, 32, 40 AND 70--l.ICENSING OF SOURCES AND DEVICES

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E- Enclosed for your concurrence are draft reconnendations to the EDO and a t supporting Staff Analysis concerning the continuation of the subject b rulemaking action for which your Division is identified as the User Office.

I' In summary, we are reconmending that the subject rulemaking, in its present I'

form, be teminated.

This recommendation was discussed with members of your staff at a meeting

9[ March 19, 1985. At that meeting it was generally agreed that improvements in i the procedures for licensing sealed sources and devices were indicated. It was also agreed that there were alternatives to the subject rulemaking which

.; might be more effective in achieving these improvements and that these

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alternatives should be investigated further.

E This memorandum constitutes my concurrence with these draft reconnendations.

b I plan to dispatch this package to the Director, RES, two weeks from the above date for subsequent transmittal to the EDO.

t-i;; I would appreciate it if you would provide your concurrence with or comments

on these reconmendations by signing and returning the enclosed concurrence

/ sheet.

i

) Frank P. Gillespie, Director Division of Risk Analysis and Operations Office of Nuclear Regulatory Research 1

Enclosures:

As stated -

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USER OFFICE CONCURRENCE SHEET RECOMENDATIONS TO EDO 9

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Receipt acknowledged. No Comument. -l Receipt acknowledged. Comments as follows:

,/

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Richard E. Cunningham, Director Division of Fuel Cycle and Naterial Safety Office of Nuclear Material Safety and Safeguards OF FICE ) ............ ............. ............. ...........,.. ............. ............. .............

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,ma tz W85 05 #*% UNITED STATES NUCLEAR REGULATORY COMMISSION g g W ASHINGTON, D. C. 20555 y g

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\...**/ JUN 101985 MEMORANDUM FOR:

Frank P. Gillespie, Director Division of Risk Analysis and Operations, NRR ato

[f FROM:

Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety, NMSS h,t

SUBJECT:

DRAFT RECOMMENDATIONS TO EDO CONCERNING THE CONTINUANCE OF ONG0ING RULEMAKING SPONSORED BY RES: REVISIONS CFR 30, 32, 40 and 70 - LICENSING 0F SOURCES AND DEVICES

{ TO 10 f\ J We do not concur with the termination of the rulemaking action. We are in agreement with you that the draft rule, as prepared by the Office of Nuclear Regulatory Research (RES) does not address adequately our regulatory needs. In our meeting with Charles Barlett on March 19, 1985, we indicated how important the rule is to our regulatory program and suggested that the proposed rule be improved, not cancelled.

Mr. Bartlett agreed that RES would review the task, including consideration of whether alternatives to rulemaking could be identified. RES has not identified any alternatives, and our own review indicates that there are no legal alternatives to rulemaking.

In view of the above, we urge that the rulemaking go forward. We will be happy to meet with your staff to explain how the rule can be developed -

and modified to meet our needs.

f h ,

Richard E. Cunningham,. Director Division of Fuel Cycle and Material Safety l

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