ML20216H242

Concurs on Proposed Rule Entitled, Generally Licensed Industrial Devices Containing Byproduct Matl; Registration & Reporting Requirements

ML20216H242
Person / Time
Issue date:	01/11/1999
From:	Veronica Wilson NRC OFFICE OF ADMINISTRATION (ADM)
To:	Cool D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
Shared Package
ML20216H047	List: ML20216H041 ML20216H121 ML20216H151 ML20216H176 ML20216H242 ML20216H283 ML20216H390 ML20216H486 ML20216H506 ML20216H694
References
FRN-64FR40295, RULE-PR-170, RULE-PR-171, RULE-PR-30, RULE-PR-31, RULE-PR-32 AG03-1-006, NUDOCS 9910010331
Download: ML20216H242 (106)

Text

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If""%ka UNITED STATES PDR g j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 30006 4001 I

.g January 11, 1999 MEMORANDUM TO: Donald A. Cool, Director }

Division of Industrial and Medical Nuclear Safety Offi of Nuclear Material Safety and Safeguards FROM: a l

Division of Administrative Services Office of Administration

SUBJECT:

OFFICE CONT 3RRENCE ON THE PROPOSED RULE ENTITLED i

" GENERALLY < i ENSED INDUSTRIAL DEVICES CONTAINING .

BYPRODUCT MATERIAL; REGISTRATION AND REPORTING l REQUIREMENTS" The Office of Administration (ADM) concurs on the proposed rule that would establish explicit requirements for a registration process that would apply to certain generally licensed industrial devices containing byproduct material. We have attached a marked copy of the proposed rule package rule that presents our comments.

The Regulatory Flexibility Certification Statement must provide sufficient information to support the contention that the proposed rule would not have a significant economic impact on a substantial number of small entities. The information should identify the types of businesses that would most likely use a generally licensed device covered by the proposed rule, the estimated gross annualincome of these businesses, and an estimated percentage of each type of business that would qualify as small entities. Similar information should be included for distributers. We have provided suggested language that specifically requests comment from affected businesses and small entities on the economic impact of the proposed rule.

We have provided a rewritten Summary statement that more clearly meets the requirements of the Office of the Federal Register (OFR) in 1 CFR 18.12. We have adjusted the presentation of regulatory text as necessary to meet OFR requirements. We have also presented a revised subject heading for the proposed rule that more clearly describes the action taken in this proposed rule.

We have made a number of editorial changes to the proposed rule in keeping with the President's June 1,1998, memorandum on plain language. We have inserted a standard statement in the proposed rule that requests public comment on the clarity and effectiveness of the language used.

If y' ou have any questions concerning this matter, please have a member of your staff contact David L. Meyer, Chief, Rules and Directives Branch, at 415-7162 (DLM1) or Michael T. Lesar, ADM, at 415-7163 (MTL).

Attachment:

As stated 9910010331 990928 PDR PR 30 64FR40295 PDR MI@

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FOR: The Commissioners FROM: William D. Travers, Executive Director for Operations

SUBJECT:

PROPOSED RULE: 10 CFR PARTS 30,31,32,170, and 171 -

REQUIREMENTS FOR CERTAIN GENERALLY LICENSED INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL" PURPOSE:

S V To request Commission approval of a proposed rule that would ask explicitWrequire~ '~ B -

general licensees who possess certain devices contaiging byproduct material to register their devices, and dd other provisions improve /seco'Untability of generally licensed devices.

BACKGROUND: * "> b" Devices containing radioactive material nanamil

~aed eder 10 CCA45 have not always been disposed of, or handled properl his ha dn a number of occasions,fresulted in unnecessary radiation exposure to the pu ic and' contamination of property. The staff concluded that more frequent and timely contact between the generallicensee and NRC could remedy these problems. On December 27,1991 (56 FR 67011), NRC published a proposed rule addressing this issue. The proposed rule would have required generallicensees under 10 CFR 31.5 to provide information at NRC's request. This provision would have provided the regulatory basis for the registration of devices. The proposed rule also included additional requirements in 10 CFR 32.51a and 32.52 for the specific licensees who manufacture or initially transfer these devices to the generallicensees. A final rule was not implemented because the resources needed to properly implement the proposed rule were lacking.

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In July 1995, with assistance from the Organization of Agreement States, NRC formed a working group to evaluate the issues related to the loss of control of generally and specifically licensed sources of radioactivity. This NRC/ Agreement State Working Group submitted a final report to NRC concerning its evaluation. On October 18,1996, the staff provided its evaluation of the working group recommendations in SECY 96-221. This report was published as NUREG-1551 in October 1996. On November 13,1996, the staff briefed the Commission on its preliminary views of the NRC/ Agreement State Working Group's recommendations.

CONTACT:

Catherine R. Mattsen, NMSS/IMNS (301) 415-6264 I

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' i[-y ,g/ fh" The Commissioners 2 in an AviM 100R %" icqun eiiWnts Memorandum (dmvy, responuing iu CECV-57-273, "hnpruvrrig NCC'e Cred Ovei and Luensees' Accvuidausiy ivi Generaiiy unu Specically Lw.mvJ Devn,en"Fe Commission directed the staff to terminate the 1991 rulemaking except for the provisions that would enable NRC to request information from certain general licensees to provide the regulatory basis for a registration program and to renotice those nn+nne d *g,

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1991 proposed ruTeior puanc commerih Th2t proposed rule /is4se was p " *^ +^ -

Com.ame,vo in SECY4aMoo eppreved by an OnY d Mcbr 22, "", and published on i December 2,1998 (63 FR 66492). The Sf%hf April 13,1998,gso directed the staff to o" o

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develop, in a subsequent rulemaking, a registration and follow-up program for generally licensed sources / devices identified by the NRC/ Agreement State Working Group in fP NUREG-1551, to assess fees to these generailice tsues, and to incorporate requirements for y the permanent labeling of sources / devices. The staff was also directed to explore the ,

possibilities, advantages, and disadvantages of various fee approaches such as pro-rating the {

fees, e.g., per device (fixed or sliding scale) or per license and provide recommendations to the Commission and to determine the extent to which application of the small business rule will affect the fees. The analysis of fee options (Attachment 1) and this proposed rule (Attachment 2) respond to those directives.

DISCUSSION: dh#

l' 0'; f 5 The proposed pre &!c= del,cann registration requirement a essentially consistent with the plans for the registration process discussed in the first of these proposed rules. The criteria for determining which devices would be included in the registration program are those m recommended by the working group. As part of the registration program, t#e hcensees will be asked to verify information concerning the identification of devices, accountability for the devices, the persons responsible for compliance with the regulations, and the disposition of the i devices. The staff estimates that approximately 6000 general licensees would be required to l provide registration information. As directed by the Commission, ttQrule would also add a i

' registration fee. fg gggom/

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The proposed rule would require that general licensees under 9 31.5 appoint an individual to be '

responsible for ensuring day-t> day compliance with the regulations. The distributorgwould g  ?

l have to obtain the name and phone number of this person from the genera l Eccn;Oc h 9 U '

s customers, rather than simply a contact, and provide this information to the NRC or the P h, ',r . ' ' !

Agreement State in quarterly transfer reports. Fee-ihuwe regmenny aeu,Mformation onQ responsible individual would be updated through the registration process. The serial number of M}{ devices';:"' dec be added to the information reported in quarterly transfer re M '

reports of transfers by generallicensees so that individual devices can be tracked. Additional labeling would be required to better ensure that devices can be identified as containing radioactivity and can also be traced back to the responsible party after loss of control. There are some additional provisions, not addressed in the NRC-Agreement State recommendations, also intended to improve the accountability of devices generally licensed under 31.5 and to clarify the regulations pertaining to all generally licensed devices containing byproduct material.

The proposed rule is intended to better ensure that certain general licensees are aware of and understand the requirements for possession of devices containing byproduct material and can account for their devices. This communication, accomplished primarily through registration, would provide NRC assurance of licensee accountability. The staff believes that if general licensees were more aware of their responsibilities, they would be more likely to comply with the u

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requirements for proper handling and disposal of generally licensed devices. This would reduce the potential for incidents that could result in unnecessary radiation exposure to the public and the contamination of property.

The proposed rule is also intended to better allow the NRC and the Agreement States to keep  !

track of generallicensees, including tracking of specific devices. Tracking the general

' licensees is important so that they can be contacted and inspected as appropriate. Tracking  ;

will also allow devices to be traced back to the owner in the event that they have been found in  ;

inappropriate locations. J

'l RESOURCES:

The resources needed to complete this action are in the current budget, j COORDINATION: i The Office of the General Counsel h'as no legal objection to the proposed rulemaking. The Office of the Chief Financial Officer has reviewed this paper for resource implications and has l no objections. The Office of the Chief information Officer has reviewed the proposed rule for nformation technology and information management implications and concurs in it. However.

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the rule amend 9 information collection requirement the must bc 02 t;d !c nd6ceived by '

the Offic e of Management and Budget no later than he iate the rule is published in the j Federal Reoister.

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RECOMMENDATIONS: oppsnaf ,/ 1Ar ameo#d j idbnm/kn o A*t /i.,n That the Commission: m.g ,g

1. Acorove the notice of proposed rulemaking (Attachment 2).

2. Certify that this rule, if adopted, will not have a significant impact on a substantial number of small entities, to satisfy the requirements of the Regulatory Flexibility Act, 5 U.S.C. 605(b).

3. Note:

a. The rulemaking will be published in the Federal Reoister for a 75-day public i comment period,

b. - This' rule has been reviewed by the Agreement States.

c. - Neither an environmental impact statement nor an environmental assessment has been prepared because the provisions in this proposed rule are the type of actions described in the categorical exclusions 10 CFR 51.22(c)(1) through (3). l d.' A draft regulatory analysis has been prepared and will be available in the Public  ;

. Document Room (Attachment 3).

.e. The appropriate Congressional committees will be informed (Attachment 4).

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The Commissioners 4 l f. The Chief Counsel for Advocacy of the Small Busir'ess Administration will be

! informed of the certification regarding economic impact on small entities and the l reasons for it as required by the Regulatory Flexibility Act.

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g. The proposed rule would amend information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These 1 requirements will be forwarded to the Office of Management and Budget for approval,

h. A draft press release will be issued by the Office of Public Affairs when the proposed rulemaking is filed with the Office of the Federal Register (Attachment 5).

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1. An optional Form XXX will be made available for distributors' quarterly transfer reports. (Attachment 6)

j. Draft guidance for licenses for distribution to general licensees will be published for I comment. A brief appendix for use in providing guidance to 10 CFR 31.5 general licensees is included. (Attachment 7) l William D. Travers Executive Director for Operations Attachments: 1. Analysis of Fee Structure Options

2. Draft Federal Reaister Notice

3. Draft Regulatory Analysis

4. Draft Congressional Letters

5. Draft Press Release ,

, 6. Draft Form XXX - Transfers of Industrial Devices Report

7. Draft NUREG-1556, Vol.16, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About General License Distribution Licenses I

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, 1 The Commissioners 4

f. The Chief Counsel for Advocacy of the Small Business Administration will be informed of the certification regarding economic impact on small entities and the reasons for it as required by the Regulatory Flexibility Act.

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g. The proposed rule would amend information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These requirements will be forwarded to the Office of Management and Budget for approval.

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h. A draft press release will be issued by the Office of Public Affairs when the proposed rulemaking is filed with the Office of the Federal Register (Attachment 5).

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1. An optional Form XXX will be made available for distributors' quarterly transfer reports. (Attachment 6)

J. Draft guidance for licenses for distribution to general licensees will be published for comment. A brief appendix for use in providir g guidance to 10 CFR 31.5 general licensees is included. (Attachment 7) i William D. Travers  !

Executive Director i for Operations Attachments: 1. Analysis of Fee Structure Options l

2. Draft Federal Reaister Notice

3. Draft Regulatory Analysis

4. Draft Congressional Letters

5. Draft Press Release

6. Draft Form XXX - Transfers of industrial Devices Report

7. Draft NUREG-1556, Vol.16, Consolidated Guidance About Materials Licenses: Program. Specific Guidance About General License Distribution Licenses E .","'"'"*"r'i, Tl'"#3f,9 ~ .. .....,,-.ny.-im.... w . . . . . . , -, .m .s . . v...

OFFICE: RGB RGB MSB IMNS ARDB/ADM NAME: CRMattson JPiccone LCamper DCool DMeyer DATE: / SB / /98 / /98 / G8 / S9 OFFICE: CIO OGC D/OE CFO NAME: AJGalante JGray JLieberman JFunches DATE: / /99 / 19 9 / /99 / /99 mm m m - . .r . m m m .:: r- r-...- -,

OFFICE: D/OsP Tech Ed D/NMss DEDR EDO l

NAME: RBangart EKraus (e-mail) CPapenello FMiragha WTravers DATE: / G9 / M8 / S9 / M9 / S9 OFFICIAL RECORD COPY NMSS FILE CODE NO.:---

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i ATTACHMENT 1  !

-t Analysis of Fee Structure Options' l

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To be provided by OCFO ,

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ATTACHMENT 2 Federal Register Notice I

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[7590-01)

NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30,31,32,170, and 171 RIN 3150- AG03 R ; .:;. mnio 'vi Ce,;oin Generally Licensed Industrial Devices Containing Byproduct Materialj Affd/n/hn -ad Arpon/i4) Aepwgemen/1 AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

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N rhe Nuclear Regulatory Commission (NRC) is proposing to arnend its regulations governing the use of byproduct material in certain measuring, gauging, or controlling devices.

tre/c nov/l The proposed reWba McWs-the ad xplicit requirements for a registration process j hat the NRC plans to initiate through cr. :2r!!:: pr^p^rd ru! This a  ; d .

I th e specific criteria for inclusion in the registration program andbetails aboutte 7}e pme, sed xalc f f/"90m/ H/c information require ould also add a registration fee. The :=t...us would also modify I

the quarterly transfer reporting, recordkeeping, and labeling requirements for specific licensees l who distribute certain generally licensed devices and clarify which provisions of the regulations apply to all general licenses for byproduct material. The proposed rule is intended to allow the I NRC to better track certain general licensees so that they can be contacted or inspected track generally licensed devices so that the devices can be identified even if lost or damagep j j '

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INSERT A

SUMMARY

The Nuclear Regulatory Commission is proposing explicit requirements for a registration process that would apply to certain generally licensed industrial devices containing l byproduct material. The proposed rule would also amend reporting and labeling requirements for manufacturers licensed to distribute these products. The proposed rule is intended to improve the NRC's ability to track and contact certain general licensees and to track generally licensed devices. l f

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[Jx p<,op,,m/guk wll N0 N ead b N +f... ensure that generallicensees are aware of and understand the ad the possession of devices containing byproduct materialr9 a-+- halos to ensure

--anace uso. ,omo,a son. y ke-will properly handle and dispose of genom::, S r.xu devicetand- 744 w acw/c/

reduce the potential for incidents that could result in unnecessary radiation exposure to the public and contamination of property.

DATES: Submit comments by (insert date 75 days ;fter publication date). Comments received after this date will be considered if it is practical to do so, but the Cornmission is able to ensure consideration only for comments received on or before this date.

ADDRESSES: Send comments by mail to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Attention: Rulemakings and Adjudications Staff.

Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland, between 7:30 am and 4:15 pm on Federal workdays.

You rnay also provide comments via the NRC's interactive rulemaking web site through the NRC home page (http://www.nrc. gov). This site provides the availability to upload comments as files (any format), if your web browser supports that function. For information about the interactive rulemaking site, contact Ms. Carol Gallagher (301) 415-5905; e-mail CAG O nrc. gov.

Certain documents related to this rulemaking, including comments received and the regulatory analysis, may be examined at the NRC Public Document Room,2120 L Street NW.

(Lower Level), Washington, DC. These same documents also may be viewed and downloaded electronically via the interactive rulemaking website established by NRC for this rulemaking.

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FOR FURTHER INFORMATION CONTACT: Catherine R. Mattsen, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6264, or e-mail at CRM@nrc. gov.

l g SUPPLEMENTARY INFORMATION:

Background

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On February 12,1959 (24 FR 1089), the Atomic Energy Commission (AEC) amended  ;

its regulations to provide a generallicense (10 CFR 30.21(c)) for the use of byproduct material l contained in certain measuring, gauging, or controlling devices. Under current regulations in 10 CFR 31l5, certain persons may receive and use a device containing byproduct material under this generallicense if the device has been manufactured and distributed according to a

' specific license issued by the NRC or by an Agreement State. A specific license authorizing i distribution of g6nerally licensed devices is issued if a regulatory authority determines that the safety features of the device and the instructions for safe operation of that device are adequate i and meet regulatory requirements hese generallicensees are subject to requirements for  !

' maintaining labels following instructions for safe use, proper storage or disposition of the s ,

device and reporting transfers and failure of or damage to the device. For some devices, the h

general licensee must also comply with testing requirements for leakage and for proper i operation of on-off mechanisms. Generallicensees are also subject to the terms and conditions in 10 CFR 31.2 concerning general license requirements, transfer of byproduct material, reporting and recordkeeping, and inspection. General licensees must comply with the safety instructions contained in or referenced on the label of the device and must have the

&f rbotel ** N e ceOJ rak q C )9t'ntos) og f4em $beh L harc herom a p mea,/ %ece J

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I testing or servicing of the device performed by an individual who is authorized to manufacture, install, or service these devices.

A generally licensed device usually consists of radioactive material, contained in a sealed source, within a shielded housing. The device is designed with inherent radiation safety features so that it can be used by persons with no radiation training or experience. T%

generallicense k maant implifft licensing process so that a case-by-case determination cM [

of the adequacy of the radiation training or experience o each user is [l>r/'

n,ot nerg'ssary.

/h" ista tha /pvrism

• livefa There are about 45,000 generallicenseg under/io CFR 31.5 t*r Pe A 600,000 devices that contain byproduct material. The NRC has not contacted or inspected generallicensees on a regular basis because of the relatively small radiation risk posed by these devices. Sm$w/a(J n /Jo possacr ol evied CNd ONI

• P!'l T license are not always aware of applicable requirements and S= c ne OM'#'

co fje 4sc 3 may nd h acessarily complying with all of th epp"~ ~ requirements. [most concern gg occurrences where generally licensed devices have not been handled or disposed of properly.

In some cases, this.has resulted in radiation exposure to the public and contamination of

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p u ua//7 //rened o'edre.g been accidentally melted in steel mills causing ruch er considerable contamination of the mill, the steel product, and the wastes from the process e slag and the baghouse dust. Although known exposures have generally not exceeded the public dose limits, there is a potential for significant exposures.

Because of these incidents, the NRC conducted a 3-year sampling (1984 through 1986) of generallicensees to assess the effectiveness of the generallicense program to determine whether there was an accounting problem with generally licensed device users. The sampling revealed several areas of concern regarding the use of generallicensed devices. The NRC I

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, [f dnke concluded that - '(1) Many general licensees are unaware of the ep;S9!c regulation and; (2)

Many general licensees are unable to account for their devices.

Approximately 15 percent of the general licensees sampled could not account for all of their generally licensed devices. The NRC concluded that these problems could be resolved by more frequent and timely contact between the general licensee and the NRC.

On December 27,1991 (56 FR 67011), the NRC published a notice of proposed

. rulemaking concoming the accountability of generally licensed devices. The proposed rule contained a number of provisions, including a requirement under 10 CFR 31.5 for general licensees to provide information to the NRC upon request, through which a device registry could be developed. The proposed rule also included requirements in 10 CFR 32.51a and

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32.52 for specific licensees who manufacture or initially transfer generally licensed devices.

Although the public comments received were reviewed and a final rule develo d, a final rule

>Vr e, was not issued because the resources to fully implement the praa^ rule were not available.

The NRC has continued to consider the issues related to the loss of control of generally licensed, as well as specifically licensed, devices. In July 1995, the NRC, with assistance from m - the Organization of A0reement States, formed a working g oup to evaluate these issues. The working group consisted of both NRC and Agreement State regulatory personnel and encouraged the involvement of all persons having a stake in the process and its final recommendations. All working group meetings.were open to the public. A final report was published in. October 1996 as NUREG-1551, " Final Report of the NRC-Agreement State Working Group to Evaluate Control and Accountability of Licensed Devices."

Iln considering the recommendations of this working group, the NRC has decided,

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- among other things, to initiate an annual registratio imilar to the program originally proposed in the 1991 proposed ru f devices generaHy licensed under 10 CFR 31.5 However, the Tdir xcynhaum 5

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', , NRC has decided to do so only for those devices considered to present a higher risk of potential exposure of the public or property loss in the case of loss of control (compared to i . other generally licensed devices). Initially, the NRC will use the criteria developed by the working group for determining which sources should be subject to the registration program.

CA//cA/A L  : Thesebre based on considerations of relative risk and were limited to radionuclides

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I in use in these types of devices, if quantities of other radionuclides that would present a similar these.

- risk are used in a devices in the future, '.h ^;;;f 5 : .r 8 Yde M C nrv W cw rik k evising the criteria to I [bei" include [ additional radionuclides. The Commission may n future rulemaki also consider revising the criteria to include a larger number of ' devices in the registration requirement for.

other reasong The Atomic Energy Act of 1954 (AEA), as amended, provides the NRC with the j

authority tb request information from its licensees concerning licensed activities. A uno - m'

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QO CFR 31.5 general licensed kwever, the Commission had not included an e licit' provision 4 43- m/of Afresn e.

6 fo pode in enweMa u nyj 2- thi ..,..u ni its regulations l n December 2,1998 (63 R 66492), the Commission

~ published a proposed rule that would explicitly require general licensees who possess ce'rtain measunng, gauging, or controlling devices to provide the NRC with information about the .

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' devices. . The NRC intends to use that brovision primarily to institute a registration and

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accounting system for the devices containing certain quantities of specific radionuclides that present a higher risk of exposure to the public or property damage if a device were lost. That Ae/c w Mt iffreel l 4ldgghmmasnetpr s a matter of compatibility for Agreement States.

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y^Apen l2 ' Thiskule would add specific requirements coriceming the registration of devices and lo(/vI(4 additional provisions of an enhanced regulatory oversight program for all general licensees in c Th moom/ sa/c this category. It would also establish levels of compatibility for Agreement State regulations so that'an increased level of oversight for general licensees in Agreement States would also be 6

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required. Some States haveStates alreadyher instituted inr/ihtecsome form of enh]need oversight fo generallicenseeh a few casesb regis'tration program. A few States have a higher level of control on these devices through requiring specific licenses. Under the proposed level of compatibility for @ 31.5, the essential objectives of the regulation should be adopted by the State to avoid conflicts, duplicationgor gaph manner in which the essential objective addressed need not be the same as NRC. Strict compatibility would only be required for M1 revisions to{tributo equirements because of interjurisdictional distribution.

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Discussion i

7 f Th D posed rule PAN:d e tecember 2,1 > cr pd'!r mmm=1 would provide x one of the key elements in improving the accountability and control over devices of particular concem through the institution of a registration proces wever, re inadequate

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g provisionskh; rg.;; allow e NRC to k nerallylicense devices.

g NRC needs to d^ ra :a ed that the eneral licensees can be contacted ituations arise

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A'eh --n=eh c%t and 6 ,;,,; Men purps;,y. As noted, it would not require a .ro f}c Nec cur asyc/ S*

compatibil Agreement State regulations /~ ,# ;)Q ff7,.,, ,cf j/ g /f,.a/AavA/A/e er perenasyQ In addition, there are other means for reducing the likelihood of incidents of lost sources.

The Commission has reconsidered the provisions in its 1991 proposed rule, evaluated the recommendations of the NRC Agreement State Working Group, and identified additionalissues l concerning these devices in developing this proposed rule.  ;

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Summary and Discussion of Proposed Requirements Revisions to the Requirements for General Licensees under 9 31.g ThepmTctpattange R *e genere!!!::n:;; that c;;uld L inaue umkr s proposed rule would d explicit provisions delineating an annual registration requirement. The registration process irrspcted k#d/M Jbnpned fir.tl (c) le be initiated under $ 31.5(c)(11), proposed on December 2,1998, would require

}f NxNepieemraf ir ochs/cr licensees to respond to requests for information frem NRC within 30 days or as otherwise #4 fike/ a/c in thh t/ewme,t specified. The specific provisions proposed (a new 6 31.5(c)(13 pare essentially consistent with the Commission's plans for the registration process discussed in that scr!!:r '

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proposed rule. This proposed rule would specifically require that the information about devices be verified through a physicalinventory and he king labelinformation. The advantage of including more explicit requirements in the regulation is that information about the registration process will be more clearly defined and move available. When the distributor of a device supplies opies of 31.5 to its customers (under 9 32.51a(a)), the potential general licensees wod A w[be made aware of the registration requirement, mcludm[ the devices to which it applies, w info mation.w r q e ed, and ye f achn' th::; ml: L; egistration fee. The proposed rule would add a fee of $370 to 170.31 to be assessed in conjunction with the Aefi7/u//n fee registration proceshsCwould be for each general licensee possessing devices req ne registered regardless of the number of devices.(NRC is required by law to recover all costs 7/>e peopcyce) p wuehl  ;

from licensees' fees.

egistration fees are gnnned in ~ der M recover the cost of the gene .

license program associated with this group of general licensees in hin equitable way q, /o a- Q 4rombose who are allowed to use devices under the general licens :th:r 'h2n ' ;- . Oth::;-

who hold specific licenses. gg fen Nu

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,jh f The first registration carried out under 10 CFR 31.5(c)(11) would depend on the NRC's

! N f Arrueur f)e Ng marfsemrj Abe 1 l ability to contact generallicensees ad informatiorge raquer+" ^a'y

• N raq"ad This l proposed ruley teft:d, !

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ecifies that the generallicensee w omplete registration by verifying, correcting, and/or adding to the information in a request for registration received from the Commission. It is silent on when or how general licensees should re.gister if the l

Commission fails to contact the generallicensee. The Commission seeks comment on whether the registration requirement should include a provision koch /tepioc thatbe allicensee f

gener!

M r@es to complete registration b any a a certain time, such as 15 months after the date of the previous registration certificate, the receipt of a device subject to registration, or the effective

-fon date of this rule, H s ^^ e $n unregistered device possessed at the time of the effective ft /k/ \

date of the rule This would put the burden of registering on general licensees who have not l

c'rfor!<</ h Aespm h nsAc /s.ywrc/ /W/eQ l been notified by NRC of the requirement.

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1. j l The time of year of registration wift vary for licenseedowever, requests for renewal of uul  :-

registration wif[ijedema/ approximately one year after the previous registration request for that betGac Tb t licensee. Although registration would not be requiredgMreceipt ct.

of deviceg, the Commission plans to sen'drequests for registration to new general licensees identified in L }nf

/ et e distributors' quarterly transfer reports submitted under 9 32.52 shortly after re:@! :nd ir xeceived and neccx/egn ren.J.,4 c4 this informationfFor generallicenseeph: h v previously registered devices L .ff 9 L bes  ;'

and receiv dditional devices requiring registration, the adSn s? new devices teihe "#"

ened when regist 4 uun 6 um Lc.: e he annual reregistration The Commission requests haveen}ien L it 70Jaiyedg comment on whether the NRC should contact previous registrants who receive additional J

. Lm;fa l devices-- r- 'h-a " either by an acknowledgment by NRC to the user or by a required )

response accountdo the additional device (s% e general f u nj y,M J 9

7_

1. 1. j ,,jfr k t'id Ibw /soposc/ ensor p/09 "" #

M* A're.rsis (,<

eb 5jfb/ith Arin ou af fr4%gg

/dditional graneced equirements for all general licensees under 31.glr.iid1) an L The fsopus .

explicit requirement for the general licensee to appoint an individual to carrv out the general A/< ass / l QThraf,% /r/o f es/o2/3 h \

ensee's responsibilities to comply with the applicable regulations (new @ 31.5(c)(12)g2) I nrnvicina t:t limity the amount of time a generallicensee can keep an unused device n

'[

j storage and allowg the deferment of testing during the period of storage (new 6 31.5(c)(15)pM

] (3)y /he twpsrce' n/r Jnc/ vat [a provision gallow transfers n to spe

/Jef nodd g//o g ff j, v

State regulations, as waste collectors, in addition to currently allowed transfers to Part 32 (and 7twould Agreement State) licenseeganA[also alinw transfers to other specific licensees but only with nr*=1 M3 P 4 A /Arpcd itde noatt/

prior written NRC approval (rev the recipient's license 31.5(c)(8)g 4)/5ehdd i number, the serial number of the device, and the date of transfer to the information required to 1 Jni r .3 ,9 ... neur i re p tG P be provided to NRC upon a transfer of a device (revision of @ 31.5(c)(8) , ) a provision to - ; h,pc8" ,

Qsm/

• 4 M %

notify NRC of address changes (new s m.5(c)(14) evice *rmliailu. ;%,at ae ar) 'pk res j/ad h"' h ely to or are known to have resulted A in contaminatiog be oJ/tpl e W= J. a plan fo l premises and envirnns ara mitable for unrestricted accessh the information that must be sent b w n. ,,, .,a ss -y a,s to NRC b -- re- a' - '" -- -" -bhange to the, addressee for reporting inform n 1W 6 4 'a' M A h concerning aka ure /ct. .

(revision to 9 31.,5(c)(5)y (7) revisqme reporting requirement, c pscipned p/t l'ed(/

in the case of a transfer to a general licensee taking ov ossession of a device at the same location, to provide the name and phone number for the person designated to be responsible for ensuring compliance with the appropriate regulations and requirements, rather than simply a contact name, and the serial number of the ' device (revision to S 31.5(9)(i)). )AOo1W /Y I

7tpfatie-de hn o h Jiiiesepreancad e amare..Ji.

F -

g The " person" who holds a general license is usually a corporation, or public or private institution, rather than an individual. In practice, in order for the general licensee to comply with existing regulations, some individual must be aware of the requirements and take the required g

~ hrex/ h _

10

l p- ~

l _-

kctions. Appointing a specific individual to be responsible for ensuring compliance with 10 }hof iS

[g# i regulations is an appropriate operational practiceph!ch ![, unfortunately,{ riot always followed.

f/ a E[deviceg not subject to testing under Q 31.5(c)(2), there are no routine actions require taken the requirements are generally restrictions on actions, such as not abandoning the k 6 eave device, or actions to be taken only in the case of particular, non-routine events, such as E-. derenje g- JY h notification of NRC of the transfer or failure of the device. M thigsituation, itic p2&u!2r!y "hcP; klex < fyfe of hknowledge of the nature of the device, the general license, and the associated regulations 4e it not be maintained and passed on to individuals using the device. nc#,;; tjssignmerIcf the responsibility for compliance with regulations to a specific individual would improve the probability that the general licensees will do what they are already required to do. The impact of this should be minimal, somewhat limiting operational flexibility with regard to the assignment of duties. This individual would not necessarily be someone who works on site at the place of use of the device and would not necessarily be conducting all required actions, but would be responsible to ensure that required actions are taken.

(2) When a device is not in use for a prolonged time, it is particularly susceptible to eing forgotten and ultimmely disposed of or transferred inappropriately. Generallicensees are f"l#

f p unlikely to keep a device unuced for more than two years and subsequently reuse it. If a rievice f6*

is being held in storage indefinitely, it is likely that it is being stored to avoid the costs of p oper l disposa!. If a generallicensee does want to reuse a device after a period of more than two I

years O! MUL, the device could be sent back to the supplier to be held under the distributor's specific license until later use or the general licensee could request an exemption from 1

31.5(c)(15) indicating the reason (s) why the licensee intends to use the device after two years and prefers to keep it on site in the interim.

I1

}

0109 t

.jp if a period of storage exceeds the interval for testing, testing need not be done until the device is to be put back into use again. This would relieve the burden of unnecessary testing j during the period of storage as well as eliminating any exposure that may occur during testing for that period.

y wroksf-(3) Thiproposed r:/Yr M $ 3*.5(:)(Chould provide some flexibility to the general

[ N licensee in transferring a device while assuring that it is transferred appropriately. It would h% allow a general licensee to transfer a device directly to a waste collector for disposal, rather than going through a distributor. It would also allow the transfer of a device to other specific licensees, but would require NRC approval in these cases so that NRC can ensure that the recipient is authorized to receive it.

(4) The inclusion of a recipient's license number in the report of transfer would better j& ensure that the general licensee has verified that the recipient is a Part 32 licensee or a specific

)l

'[g licensee under equivalent Agreement State regulations authorized to receive it. It would also j

} supply an additional means for NRC to identify the recipient, as'g-and bmu e company names addresses i

sometimes change. The addition of the date of transfer will make the transfer easier to track j and help to ensure that the general licensee. makes the report in a timeiy manner (required

' thin 30 days of the transfer).

g(/ (5) The quarterly reports required of distributors under $9 32.52(a) and (b) are intended

'h

?

3/ to provide NRC and the Agreement State regulatory agencies with the identity cf general licensees in their jurisdictions and addresses at which these general licensees can De contacted (which is usually the location of use of the generally licensed devices). These generallicensees can then be contacted or inspected. If generallicensees move their operations without notifying the NRC, or appropriate Agreement State agency, they may be difficult to locate. This proposed requirement to report address changes would only apply to mailing addresses and, f 12 t

g L

1 for portable devices, the address of the primary place of storage, although they may be used at

.f I + multiple field sites. For those registering devices, changes in the address of use, if different f from the mailing address, will be provided at the time of the next registration.

This simple change of address notification is intended to cover moves into and within NRC jurisdiction. The generallicense in 10 CFR 31.5 only applies within NRC jurisdiction. If a general licensee intends to move from one jurisdiction to another, they should contact the bdoes applicable regulatory authority, NRC or the particular Agreement State, pddoing so is 4Nier to determine the applicable, current regulations in that jurisdiction. All jurisdictions do not have a comparable generallicense and specific provisions of the generallicense may vary among jurisdictions. ha generallicensee obtained a portable device in an Agreement State and wishes to use the device within NRC jurisdiction, they must do so under i 10 CFR 31'.5[ s no reciprocity provision applicable to generallicenses. In this case, they would be subject to the provisions of 10 CFR 31.5.

(6) Generallicensees are not subject to decommissioning requirement 1$ a,, general s- ,

cense is granted by regulation and, under normal circumstances, does not involve any b

termination of license process. If a generally licensed device fails or is seriously damaged so

[ as to cause significant contamination of the premises or environs, the NRC may need to M respond to the notification of an incident made under 9 31.5(c)(5) to ensure that a facility is property decontaminated if necessary. Following such an incident, the NRC would determine what actions are necessary on a case-by-case basis and could apply the requirements set out in $ 20.1402, " Radiological criteria for unrestricted use." The general licensee is exempt from this section of Part 20 when only in possession of an intact generally licensed device. However, when a device has been damaged, the material in the device may no longer be only.in the j device, i.e., it may also be unsealed radioactive material. Such an action can be taken under l

13 l .

4 J

JUh

,eg..

/ 30.61, "Modificatio,'. and revocation of licenses," which is applicable to general licensees. The provision proposed in this action would require that the' general licensee _ propose to the Commission how it will be shown that the premises are or will be adequately cleaned up.

Depending on the nature of the event, the remedial action taken (and reported under existing requirements) along with any confirmatory surveys may be sufficient to complete action on the event.

The addressee for submitting information under Q 31.5(c)(5) would be changed from Regional' Administrator to Director of Nuclear Material Safety and Safeguards so that all NRC addressees specified in % 31.5 for reports by these licensees are the same nnd to eliminate the need for the general licensee to refer to 10 CFR Part 20 to determine the appropriate

- addressee. The addressee and address for registration will be specified in the registration request.

(7) Consistent with the provision for appointing an individual to act for the general

[f licensee to ensure compliance with the applicable regulations and requirements and other reporting requirements being proposed, it is more effective for the general licensee to provide the name of the new responsible individual when another general licensee takes over the facility and res sibility for the device, pe[p r ould clarify the status of a person 1 9 31.5 !: ti{

who receives a device mrough an unauthorized transfer. Paragraph (b) would be revised to

. limit the applicability of the generallicense to those who receive a device through an authorized transfer. has generally, although not consistently, interpreted the general li6ense to apply ,

I to a recipient meeting the criteria for general licensee, i.e., ".. commercial and industrial firms and research, educational and medical institutions, individuals in the conduct of their business, and Federal, State or local govemment agencies.." , even if the device is received through an -

t 14

e .

~

N \

~

i f})elgetJa n

9yuY unauthorized transfer. TNe =.ish, would clearly provide that the general license only applies A i' .

1. pu,V if the device is obtained through an authorized transfer. othd l cho'*YS -

in addition to the proposed to 31.5, e nuWr of :: ! !c}..I are bemg;t ,

. ; f- HsF uuW .

proposed Wclarify,which sections of the regulations in Part 30 apply to all of the general licensees under Part 31.; Section 31.1, " Purpose and scope," would be amended to clarify that only those paragraphs in Part 30 specified in 6 31.2 or the particular general license pply to Part 31 general licensees. Section 31.2, " Terms and conditions," would be amended to b:'M reference sections of Part 30 that are applicable to all of the Part 31 generallicensees, including $ 30.7, " Employee protection," $ 30.9, " Completeness and accuracy of information,"

k -

make i)-

andb.10, " Deliberate misconduct." qke proposed clarificationgwould ide~asier general licensees to be aware of applicable regulations. In addition, future o Part 30

that would" apply to Part 31 generallicensees would include a conforming amendment to Part 31 Note, however, that while $ 31.2 would specify applicable sections of Part 30, it would not eliminate the applicability of other Parts of the Commission's regulations that may appl %  !

e pie,P " Rules e fo mesti roc ings an f 4

'd* , .E j The applicability of .34(h) on bankruptcy notification to general licensees also needs to be clarified.' Under the existing regulations, this requirement applies to all licenseeg  !

hver, it's application to general licensees is not clear because it is not referenced in 6 31.2

$ 31.5.! This proposed rule would makh the bankruptcy notification requirement l

applicable only to those general licensees subject to the registration requirement. These L .

g ' licensees possess devices for which the Commission believes a higher level of oversight is l- . appropriate.: Thus, notification that a gencral licensee is filing for bankruptcy may be important j 15 a *

,;- , i i

'h

to allow the Commission to intervene to ensure that the financial status of the licensee does not lead to the improper disposal or abandonment of a device.

Requirements for Manufacturers and initial Distributors of Devices The proposed would modify the quarterly transfer reporting, recordkeeping, and labeling requirements for specific licensees who distribute these generally licensed devices OMI

.7AF' ) @ trP o.ral o m e the requirement for providing information to users.jR,ege/ requirements f4 .'

matter of strict lot pom/ w// b e compatibility ofAgreement Statehge'Pae ead - nmnosed 'a n.u.,ub ;e be gnakh

' equivalent revisions to Agreement State regulations necessary. The basis of this compatibility requirement is significant direct transboundary implications.

Reoortin existing quarterly transfer reporting reauiremekh following information would be added serial number and model number of the device; the date of transfer; indication if device is a replacement, and if so, the type, model number, and serial number of the one returned; name and license number of reporting company; and the specific reporting period. he model number of the device is already required in reports to Agreement States. The name and phone number of the person designated by the generallicensee to be responsible for the device and for ensuring compliance with the appropriate regulations M WW/

replace the name and/or position of a simple contact between the Commission and the general licensee. Also, a form will be provided for use in making these reportg wever, the use of the form would not be required as long as the report is clear and legible and includes all of the required information. .".:W}... lbewouldadebetom/Mopox/ omem6ned).

9 32.52(a) and (b The existing reporting requirement is intended to provide NRC and the Agreement State regulatory agencies with the identity of general licensees in their jurisdictions, addresses at which the generallicensees can be contacted (which are usually the location of use of the 16

. A

(L , 1 j

l devices), the particulars of the type of device possessed, and the name (or position) of an individual who constitutes a point of contact between the NRC and the generallicensee. These i woulel l

. generallicensees can then be contacted or inspected. M&She serial number w[ allow the NRC and Agreement States to track individual devices. The existing reporting requirementh h1.5(c)kdoes not require the general licensee to report a transfer if it is for the purpose u 3 i

obtaining a replacemen . This is consistent with the original intent of this regulation in that the status of the generallicensee is unchanged ly tha specific device is changed. In order for individual devices to be tracked, the NRC or Agreement State needs to be informed of such a

- transfer. The proposed rule would require ihnmf the distributorlr~ / M vi/c //* 4fm*//enQ

~

Under existing requirements, ecifics on any new device transferred but not on the devices quarterly 7/xreports

1. 4 4e include sp// wor ease sW' iO cciu/c/

returned. "'c;dd .d MQumcanthu4= ' M4idtributor include this additional f A//4c.<

' informatiod in the quarterly reportsland {he distributor is likely to be more reliable than the

~lb9 general licensee in providing this information. FThe name and license number of the reporting company and the specific reporting period are typicall included in the reports in order to show wp Abir 476Anaf4po jf compliance with the reporting requiremen , not always r,eadily identifiable k

b d, fhh individual 44 ac s contact with the NRC conceming the generallicense,

=

La '" "t?! should have knowledge of the device, the general license, and the regulations pertaining to the generallicense. This is the intent of the existing requiremen owever, in practice, the name given to the distributor and reported to the NRC (and the Agreement State r- /h is / p c d agencies) trequently is not an individual with swen knowledge. The proposed rule would specify that the contact designated be the person responsible for ensuring compliance with the regulations. gpp #

Recordkeeoina The e would add to the recordkeeping requirements information on e

final disposition of devices. The recordkeeping requirements concerning transfers would have \

l

, l l

L

the period of retention extended from 5 years from the date of the recorded event to 3 years after the expected usefullife of the device or the final disposition,if known. Imm. ywou

})ld bef esc / l made to @ 32.52(c).

M.,uiiani4.athormation about the general licensees and the specific devices in yd their possession (be available until the device is disposed of permanently. Requiring t ,

distributor to keep these records for an extended time provides a useful backup to the recordkeeping of NRC and State regulatory agenciega records include information on final distribution that may not have been included in reports to NRC and the Agreement States.

7essuolly It is NRC's understanding that it 6 - ~r=~nt nractica M these distributors Eeep these records indefinitel us, this regulatory requirement should have( little, y.oa/if any, impact.) }je Reygjo

[ additio requirement would be added for the distribu it vailable to the various regulatory agencies rds nf finai w=posmon of device 3in the case of bankruptcy or termination of license ew paragraph @ 32.51a(d))ffeu!d bc edd& .Jhe dNbih When a distributor goes out of business and terminates ic nse, can no longer be required to retain these records. This requirement would give NRC, as well as State regulatory agencies, the opportunity to obtain and retain records of this type previously kept by the distributo These records could be helpfulin verifying information used to keep track of devices relative to the final disposition of devices. This provision would not

' require distributors to automatically provide these records unless the NRC or the Agreement State in which the device was distributed makes a request for these records. In the case of bankruptcy, NRC or the Agreement State may want to secure these records early in the l 1

process, in case financial difficulties interfere with the licensee fulfilling its responsibilities.

f5*rosto % h n eW a m / fo e9ein e Labelina %ehxisting labeling requirementsg^"W d ditionallabel on 4

any separable source housing and a permanent label on devices meeting the criteria for )

18 I

r registratior}. The NRC would consider a label" permanent,"if, for example, it were embossed, etched, stamped, or engraved in metal ew paragraphs Q 32.51(a)(4) and (5) and Q 32.51a(c))

l hqW6be N Under these requirements, new distributors would have labels approved as part of obtaining a license; distributors including existing licensees would have the new labeling requirements as conditions of license in 32.51(a)(4) and (5). Approval of the new labels by NRC for existing distributors would not be require owever, distributors may voluntarily submit information for NRC review on how they plan to cornply with the new labeling requirements. In any case, labeling is subject to inspection. To the extent necessary, the new labeling requirements would supercede anything contradictory in individual license conditions. The individual license conditions would be updated to include specifics related to the new requirements during the first license renewal or amendment following the effective date of those {

paragraphs of the rule.

The first cf P.: hangeQs simply he existing requiremen carries out the initial intent\ in 'ha arre q devices where the source may be separable in a housing that L (vA does not include the label. It is important that this housing, if separated from the remainder of xeyvi

l

Public Protection Notification if an information collection does not display a currently valid OMB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

Regulatory Analysis The NRC has prepared a draft regulatory analysis for this proposed regulation. The analysis examines the cost and benefits of the alternatives considered by the NRC. The comments received on the draft regulatory analysis associated with the proposed rule of December 27,199ghave been considered to the extent that they apply to this action. The regulatory analysis is available for inspectinn in the NRC Public Document Room,2120 L Street NW. (Lower Level), Washington, DC. Single copies of the analysis may be obtained by calling Catherine R. Mattsan, U.S. Nuclear Regulatory Commission, Office of Nuclear rAaterial Safety and Safeguards, Washington, DC,20555-0001; telephone (301) 415-6264; or e-mail at CRM@ nrc. gov, Regulatory Flexibility .^ ='yaia [r4//[/M/dn

)

l As required by the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commission has evaluated the impact of this rule on small entities. The Commission certifies that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The most significant cost of this proposed rule would be the registration fee of $370.

26

fj y,,y,,/, essesefj u /> <?  ?

s "/(3 w . / bu swr ,#/n, yr', esf/wie a

T Jege on ja f4e /CS, b/l*lWil lb*{ " Yrtl d '< < Inhom efio<> fht ,

sj s'u(ficiea,/ to i n /te IAO r"/ll"Y'*O- Id' jdsn,~//w w/sist/6 \

l

\

tja /y/es o f hsin esses lA'Y #^~ '

" 9f / l Z. . p

..k:pa o e/ onn wn/ sdront* of f&s " "*e fy",, 'M/4, f j u f f ,, , , ,'" N,,' /, p ea u, u e would apply to the annmvt.cicly 45,00m,mang oc (Canf/g/fr W NRC generallicense, many of whom may be classified as small entities. However, the r/Ae// cefg/ r, l

\

osc/ .rikim '

registration requirement and associated fee would apply.to about 6000 of these genert I fo /,, pe,f/f,,

k'd /*n disfsiAf, licensees. The NRC believes that the fees fnot present a significant economic impa on,f,j, 4 these licensees and that the economic impact of the additional proposed requirements o any/#"'"'"/ "

cl4l" f \

generallicensee would be a negligible increase in administrative burden. The proposed ru ggyo yfff,, l cce would also revise requirements for specifically licersed distributors of certain generally license fe,/

devices. Mos,t of these licensees are not small entities and the impact to any of these distributors would not be significant in any case. '

jI Backfit Analysis

' 3]h

• The NRC has determined that the backfit rule,10 CFR 50.109, does not apply to this proposed rule and, therefore, a backfit analysis is not required because these amendments would not involve any provisions that would impose backfits as defined in 10 CFR 50.109(a)(1).

List of Subjects 10 CFR Part 30 - Byproduct material, Crirninal penalties, Government contracts, Intergovernmental relations, Isotopes, Nuclear materials, Radiation protection, Reporting and recordkeeping requirements, l

27

)

l ,

l INSERT 27A

.The NRC is seeking public comment on the potentialimpact of the proposed rule on )

small entities.' The NRC particularly desires comment from small businesses, small 7 organizations, and smalljurisdictions under the Regulatory Flexibility Act as to how the regulations will affect them and how the regulations may be tiered or modified to impose less stringent requirements on small entities while still adequately protecting the public health and safety and complying'with other legislative requirements. Those small entities that offer comments on how the regulations could be modified to take into account the diff ring needs of L small entities should specsfically discuss-(a)iThe type a' nd' size'of their business and how the proposed regulations would result in

a significant economic burden upon them as compared to larger organizations in the same

- business community;

,(b) How the proposed regulations could be modified to take into account their differing needs or capabilities; 1

= (c) The benefits that would accrue, or the detriments that would be avoided, if the proposed regulations were modified as suggested by the commenter; i l

(d) How the p e-;-:rd regulations, as modified, would more closely equalize the impact of NRC regulations or cre'ate more equal access to the benefits of Federal programs as opposed 1

to providing special advantages to any individuals or groups; and .

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

The comments should be sent to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attn: Rulemakings and Adjudications i Staff,-

m 3

j

m

(' -

g-t 10 CFP. Part 31 - Byproduct material, Criminal penalties, Labeling, Nuclear materials, Packaging and containers, Radiation protection, Reporting and recordkeeping requirements, Scientific equipment.

10 CFR Part 32 - Byproduct material, Criminal penalties, Labeling, Nuclear materials, l i

- Radiation protection, Reporting and recordkeeping requirements.

to CFR Part 170 - Byproduct material, import and export licenses, intergovernmental relations, Non-payment penalties, Nuclear materials, Nuclear power plants and reactors, Source material, Special nuclear material.' I i

10 CFR Part 171 - Annual charges, Byproduct material, Holders of certificates, i registrations, approvals, Intergovernmental relations, Non-payment penalties, Nuclear materials, Nuclear power plants and reactors, Source material, Special nuclear material.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C.

O

- .a _cd 553, the NRC is proposing to adopt the following amendments to 10 CFR Parts 30,31,

- 32,170, and 171, i

4 L ,

i,:

28 i

i i-

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

1. The authority citation for Part 30 continues to read as follows-Authority: Secs. 81, 82,161,182,183,186, 68 Stat. 935, 948, 953, 954, 955, as amended, sec. 234,83, Stat. 444, as amended, (42 U.S.C. 2111,2112,2201,2232,2233, 2236,2282); secs. 41, 5842, 5846).

Sec. 30.7 also issued under Pub. L.95-601, sec.10,92 Stat. 2951 as amended by Pub.

L.102-486; sec. 2902,106 Stat. 3123, (42 U.S.C. 5851). Section 30.34(b) also issued under sec.184,68 Stat. 954, as amended (42 U.S.C. 2234). Section 30.61 also issued under sec. 187,68 Stht. 955 (42 U.S.C. 2237).

2. Section 30.31 is revised to read as follows:

6 30.31 Types of[icenses g N ' nses for b oduct material are of two types: ueneral and specific. Spect i enses are issued to n ed persons upon applications filed pursuant to the regulations in thi part and Parts 32-36, and 39, eneral licenses are effective without the filing of applications I with the Commission or the issuance o ocuments to particular persons, although registration with ission may be required by t icular generallicense, s

29

INSERT 29 A The Commission issues two types of licenses for byproduct material: specific licenses and general licenses.-

(a) The Commission issues a specific license to a named person who ha> f%d an application for the license under the provisions of this part or 10 CFR Parts 32 through 39.

(b) The Commission grants a general license to authorize a person to receive and use certain dehicos that contain byproduct material if the device has been manufactured and

' distributed according to a spe,cific license. The Commission considers the general license to be effective even though an application is not submitted and licensing documents are not issued to a particular person.

A l

t

r_

prV O

3. Sect $130.34 ic =manH hu ravieig paragraph (h)(1) o read as follows:

7 js jo h  !

p N

f *toit M

6 30.34 tTerms +and conditions t of licenses @ r L )Ugp e (h)(1) Each generallicensee phjed tn the rnmictratinn ranniro ;'.' iN 6 31.5(c)(13) and l

each specifiu licensee shall notify the appropriate NRC Regional Administrator, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy under any chapter of title 11 (Bankruptcy) of the United States Code by or against:

(i) The licensee; (ii) An entity (as that term is defined in 11 U.S.C.101(14)) controlling the licensee or listing the license or licensee as property of the estate; or (iii) Ana ' ffiliate (as that term is defined in 11 U.S.C.101(2)) of the licensee.

PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL l

I

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

Authority: Secs. 81,161,183, 68 Stat. 935, 948, 954, as amended (42 U.S.C. 2111, 2201,2233); secs. 201, as amended,202,88 Stat.1242, as amended, 1244 (42 U.S.C. 5841, 5842).

Section 31.6 also issued under sec. 274,73 Stat. 688 (42 U.S.C. 2021).

i

'30

_ )

i

5. Section 31.1 is revised to read as follows:

, f 31.1 Purpose and scope This part establishes generallicenses for the possession and use of byproduct material .

he<ifc l'A,,.p contained in certain items and a general license for ownership of byproduct A !r che;":: ; :: ou,uains provimunges ed in 6 31.2 or the particular genera f g pe a 4 pplicable to 2: =.bic.i www, v' t';; 72-* G Jrnep/ hoste issard wbd fjig paf; There j9soulimt ose

6. Section 31.2 is revised to read as follows:

g/,,,. /k pesca,/ /iusu in kra/es 4 E Ye n Nyg .

( 31.2 Terms and conditions. - (d h's general licenses provided in this part are su ect to e general provisions of b

Part 30 of this chapter (9$ 30.1 through 30.10);ade pro (v)isions of 6

( (C t)

(e),30.41,30.50 to 30.53,30.61 to 30.63?andlParts 19,20, and 21, of this chapteg%

" .iai#ar- :. ni um ':7'J ;. vi ma 9m m..l :::'ca-1 f/ea.r pay (lst c tiention !: 9:::;d pir' "; to the provisions e' 'ha rac"latinne 4 Part 20 of this chapter 1 th" -dt: :: I 5; labeling +nntai- .

e ,an,,ois, ns.e~

31 l

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7. Seeteer,31.5 it rm=dd by efir5;; paragraphs (b) and (c)(5)(8), andh)Md addag paragraphs (c)(12), (13), (14), and (15) to read as follows:

oxe ude'rel

$ 31.5 Certain measuring, gauging, or controlling devices.2 f'(0 (b)fThe general license in paragraph (a) of this section applies only to byproduct material contained in devices which have been manufactured or initially transferred and labeled

-~ (1) in accordance with the specifications contained in specific license issued pursuant to 32.51 ID of this chapter,'or H =ar~9~ "tS 1; ;-m-='ene mnt*M bh(pecific license issue

=

an Agreement State which authorizes distribution of the devices to persons generally licensed (2) The c/euw snw 4 ,<<

by the Agreement Stat a wiueMwwe been received from one of thepe specific licensees or

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through a transfer pe curn' t paragraph (c)(9) of this section.

L nsede un/rx s,,,fe,fn (c)

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. . . . . M'I

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( (h;.. C; :re rrn a failure of, or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the on-off mechanism or indicator, or upon the detection of ~0.005 Th c. microcurie device mey m/- or more be opeu removable c ra; shallimmeoiately suspend operation of the devic untilit has been repaired by the  !

N manufacturer or other person holding a specific licens p"rreent har)ts 30 and 32 of i bY Tbe divire pey du j

-chapter or f an Agreement Stat pair such device eksposed of by transfer to a i person authorized by a specific license to receive the byproduct material contained in the devicp "'* M dayabumish to the Director of Nuclear Material Safety and Safeguard  ;

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1. Persons possessing byproduct material in devices under a general license in 6 31.5 before January 15,1975, may continue to possess, use, or transfer that material in accordance with

- the labeling requirements of 6 31.5 in effect on January 14,1975.

32' F  !

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-k U.S. Nuclear Regulatory Commission, Washington, DC 2055 report containing a brief i

- =

description of the event and the remedial action taken; and, in the case of detection of 0.005 l

' microcurie or more removable radioactive material or failure of or damage to a source likely to result in contamination of the premises or the environs, a plan for ensuring that the premises

.l and environs are acceptable for unrestricted usy jng / 4e A_ _ fg,, / JJ -D

,(l f]iy oph/6M y&/ galer' es - MM) ! A (8) in paragraph (c)(9) of this sectioMhall transfer or dispose of the

, w.ra u 1 C-device containi byproduct material only by transfer tc, grso thorized rc device by a specific noe issued under parts 30 and 32 of this chapter 7 cific license issued underpart 30 of chapter that authorizes waste collec ' , 'fic license issued (I CD under equivalent regulations o n Agreement State' days after transfer of a devi

/  %

" 0;i m,i-ct (m -

specific licens% hall furni n.,

t Nuclear Material Safety ano safeguards, 4 C U.S. Nuclear Regulatory Commission,

' gton, DC 205554reportponh[C.C.;&vn Hc

% L myJ of the device by manufacturer' ame, model nu r, and serial number and the name, '

address, license num of the person receiving the devi and the date of the transfer. No g p' oY .

reportisCrequir if the device is transferred to the specific licen in order to obtain a 1 '.

replace Ph t device. iDevicehm be transferred to other specific licen s only with written bdee R approvalMtransfer; >

N. . . . . .

~~~~. _ _ ~

(9) Shall transfer the device to another generallicensee only(~~ 'f . ,

l g>>5 (i) Wherske device remains in use at a particular location. In sue (case, the transferor i shall give the transferee a copy of this section and any safety { documents identified Jk rion nos shell -

of the devigj.4 thin 30 days of the transfe io um Dhactor of Nuclear Material Safe

,ds, u.S. Nucieaseguiaiory Commission, washingt e gnd Safe aa i

7: . , .

INSERT 33 A f

l c (8)(i) Shall transfer or dispose of the device containing byproduct material only by

' transfer to -

=

- (A) A person authorized to receive the device by a specific license issued under parts 30 and 32 of this chapter; (B) A person authonzed to receive the device by a specific license issued under part 30 of this chapter that authorizes waste collection; (C) A person authorized to receive the device by a specific license issued under

- equivalent regulations of an Agreement State; or -

(D) To another general licensee as authorized in paragraph (c)(9) of this section.

(ii) Shall furnish a report to the Director of Nuclear Materials safety and Safeguards, U.S.

Nuclear Regulatory Commission, Wasnington, dc 20555-0001 within 30 days after the transfer i

of a device to a specific licensee. A report is not required if the device is transferred to the ,

l specific licensee in order to obtain a replacement device. The report must contain -

(A) The identification of the device by manufacturer's name, model number, and serial number;-

(B) The name, address, and license number of the person receiving the devbe; and

_ (C) The date of the transfer.

'(iii) Shall obtain written NRC approval before transferring a device to another specific

licensee.

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y - manufacturer's name and model' number and serial number of the device transferred, the name L

and address of the transferee, and the name and phone number of the individual designated by

/ , pnew g{jarears e re 4

' the transferee in accordance with ?tHe)(12 nsible for ensuring compliance with

- the appropriate regulations and requirement _

p))

(ii) WhsfeIe device is held in storage by an intermediate person in the original shippin container at its intended location of use prior to initial use by a general licensee.

' (12) Shall appoint an individual to act for the general licensee as responsible for

, y Lensuring the day to-day compliance with the appropriate regulations and requirements. This a

t appointment does'not relieve the general licensee of responsibility in this regard.

F J(13)(i) Shall register devices containing at least 370 MBq (10 mci) of cesium 137, 3.7 MBq (0.1 mCl) of strontium-90,37 MBq (1 mci) of cobalt-60, or 37 MBq (1 mCl) of i

americium-241 or any other transuranic in accordance with paragraphs (c)(13)(ii) and (iii) of this section.

- (ii) It in possession of a device %^ meeting the criteria of paragraph (c)(13)(i) of this jfg ga ro<l lhuice .

section,fshall register these devices annually with the Commission and shall pay the fee r- /cM/4*//N -

frequired by 6170.31 of this chapter, Tid must be done by verifying, correcting, and/or adding

.q-$Aovfded to the informationlin a request for registr'ation received from the Commission. The registration

' linfortnation must be submitted to the NRC within 30 days of the date of the request for 6Itsi ist//hrkr e/4ne417e registration c n :t:ri: Mf'::2:I[the requestbn addition, generallicensee{ holding u

devices meetirig the criteria of paragraph (c)(13)(i) of this section subject to the bankruptcy riotification requirement in 5 30.34(h) of this chapter. #f (iii) in registering devices, the general licensee shall fumish the following information

- and any other information specifically requested by the Commission:

34 T l

F i

(A) Name and mailing address of the generallicensee.

' (B) Information about each device: the manufacturer, model number, serial number, the radioisotope and activity (as indicated on the label).

(C) Name and telephone number of the responsible person designated as a s representative of the generallicensee under 31.5(c)(12).

(D) Address at which the device (s) are used and/or stored. For portable devices, the address of the primary place of storage.

(E) Certification by the' responsible representative of the general licensee that the information concoming the device (s) has been verified through a physical inventory and checking oflabelinformation.

3 . (F) Certification by the responsible representative of the generallicensee that they are aware of the requirements of the generallicense.

(14) Shall report changes of address ithin 30 days after the moving of a devic o the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555 portable devices, ly applies tothe device's primary place of

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(15) not hold devices that are not in use for longer that two years. if devices are not being used, the shutter must be locked in the closed position. The testing required by paragraph (c)(2) of this section need not be performed during the period of storage only.

However, when devices are put back into service or transferred to another person, and have not been tested within the required test interval, they must be tested for leakage before use or transfer and the shutter tested before use.

5

,g .g' $ >$ 8 35 m ,

V

I l

PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR ,

lae

~ TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL l l

8. The authority citation for Part 32 continues to read as follows:

1 Authority: Secs. 81,161,182,183,68 Stat. 935,948,953,954, as amended (42

. U.S.C. 2111,2201,2232,2233); sec. 201,88 Stat.1242, as amended (42 U.S.C. 5841).

0 gge ad'Y 9.Mi 32.51 h; r"M '; - *g paragraphs (a)(4) and (5 o read as follows:

.97

$ 32.51 Byproduct material contained in devices for use under 6 31.5; requirements for license to bnufacture, or initially transfer. ,

(a)

Q f{ (L hef

_ (4) ddevicog !- -At9 e ds a separable source housing that provides the primary

- shielding for the source, the source housing must also bear a durable label containing the device model number and serial number, the isotope and quantity, the words, " Caution-Radioactive Material," the radiation symbol described in 9 20.1901 of this chapter, and the name of the mangfacturer or initial distributor. / /y;g cWYM  ;

fr a s I (5) Fddevice( that mee[the criteria of 9 31.5(c)(13)(i a permanent (e.g., embossed, etched, stamped, or engraved) label must be affixed to the source housing if separable, or the device if the source housing is not separable, that includes the words," Caution-Radioactive Material," and, if practicable, the radiation symbol described in 9 20.1901 of this chapter.

f Y W Y f 36 c >

, j),,ffa N MnJrd fo' /rd W N0 ,' 5 g ge vUr0 P g/l 1

10. 3 t :.T.;r9My rht ga agraphs (a) and (b nd r.dd 7.- -

$ 32.51a Same: conditions of licenses a) Prior to aMieTofTdeVice to a general IIc'e'Rsee7fmnT5trcopres of tne gone cense contained in 6 .5 of this chapter and of 6 31.2,30.51,20.2201, and 20.2202 of this chapter, a list of the service that can only be performed by a specific licensee, and information on acceptable disposal options a luding estimated costs of disposal to each person to whom he directly or through an intermediat erson transfers byproduct materialin a device for under the general license contained in 6 .5 of this chapter.

(b) Prior to transfer of a device to a g erallicens ish a copy of the Agreement State's regulations equivalent to 66 31.5,31. .1,20.2201, and 20.2202 of this chapter, or altematively, fumish a copy d [31.2, 30.51, 2 201, and 20.2202 of this chapter, to each person to who irectly or through an intermediate rson transfers byproduct materiali evice for use pursuant to the generallicense of an eement State. Also furnish name, address, and phone number of the contact at the Agreement to regulatory agency from which additionalinformation may be obtained. If a copy of the generallic e in 6 31.5 of this chapter is furnished to such person, it shall be accompanied by a note explaining that use e device is renoiH by er A;; eemem Ste.

(c) kalpel eacn devicekra/hef is (insert date one year after the effective date of nsferred after E

this rule) le c::-cd .- ;;;;( the labeling requirements in 6 32.51(a)(3) through (5).

Inud 37 l

INSERT 37A

- (a) If a device is to be transferred to .) 9eneral licensee under NRC jurisdiction, each person that is licensed under 6 32.51 shall provide the information specified in this paragraph to each person, either directly or through an intermediary, to whom a device containing byproduct material is transferred. The information must be provided before the device may be transferred.

The requir'e d information includes -

(1) A copy.of the general license contained in 9 31.5 of this chapter;

. (2) A copy.of $$ 31.2,30.51,20.2201, and 20.2202 of this chapter; (3) A list of the services that can only be performed by a specific licensee; and (4) Information on acceptable disposal options including estimated costs of disposal.

(b) L If a device is to be transferred to a general licensee underjurisdiction of an Agreement State, each person that is licensed under 9 32.51 shall prnvide the information specdied in this paragraph to each person, either directly or through an intermediary, to whom a -

. device containing byproduct materialis transferred. The'information must be provided before the device may be transferred.

(1) The required information includes -

(i) A copy of the Agreement State's regulations equivalent to $9 31.5,31.2,30.51, 20.2201, and 20.2202 of this chapter; or

- (ii) A copy of $$ 31.5,31.2,30.51. 20.2201, and 20.2202 of this chapter.

. (2) in addition, the information must include the name, address, and telephone number

of the contact at the Agreement State regulatory agency from which additional information may be obtained.

(3) If a copy of the general license in 6 31.5 of this Chapter is provided to a prospective general licensee, the information must include a note explaining that the device is regulated by an Agreement State. '

(d) If a notification of bankruptcy has been made under G 30.34(h) or the license is to be c'ae}; A*co,j /icene/ ewho fA7* S/ rha #

terminated,hrovide, upon request, to the NRC and to any appropriate Agreement State,, /

r- M/ 9<c (

records of final dispositionhequired under Q 32.52(c).

11. Section 32.52 is revised to read as follows:

$ 32.52 Same: material transfer reports and records.

Each person licensed under 9 32.51 to initially transfer devices to generally licensed persons shalib $ y N d'"dd O ## ".

C The pedoe rhao .

(a)peportyr-'.crpirector of the Office of Nuclear Material Safety an  ;

s  !

Qguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-000 11 transfers f /) e M l of devices'to persons for use under the generallicense in S 31.5 of this chapte @'bmitme g be leg os e Prek esport on Form XXX " Transfers of Industrial Dev s Report," or on a clear and legible ;port Ja.rir er; l

'containing all of the data required by the form.3Th e ired information includeshfe identity of

{

each generallicensee by name and address;b name and phone number of the person designated by the general licensee to be resp i i for ensurin liance with the appropriate regulations and requirements;[he date of transfer; fe type, model number, and l

serial number of the device transferred; quantity andandhe#n) type of byproduct material i

( PM (2) l contained in the device. if one or more intermpdiate persons will temporarily possess the p efer e device at the intended place of use pMts possession by the user, the report must include l the same information for each intermediate person, and clearly designate that person as an

. If (3.)

intermediate person.bf the device transferred replaced another returned by the general (y) licensee, report also the type, model number, and serial number of the one returned. no transfers have been made to persons generally licensed under 9 31.5 of this chapter during the 38 m _o

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L ,

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! reporting period, the report must so indicate. lThe report must cover each calendar quarter, a

e L must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the

. $063-period covered by the report. hhe report must clearly identify the specific licensee submittin the report and include the license number of the specific licensee,

~ T4e /psm Jbe// _

(b)/epoQresponsible Agreement State agen, 11 transfers of devices to N

persons for use under a general license in an Agreement State's regulations that are equivalent to 6 31.5 of this chapte 7kbm(p a w onw*Form m r/ 4XXX " Transfers of Industrial Devices $0

' Report," or on a clear and legible report containing all of the data required by the form. he I' 9'd) required information include e identity of each general licensee by name and address e E 3.

name and phone number of the person designated by the general licensee to be re nsible for ensuring compliance with the appropriate regulations and requirements; e date of transfer;

, #(It)- 69 b type, model number, and serial number of the device transferred; and e quantity and type

% p 90) E-of byproduct material contained in the device.j If one or more intermediate persons will 4 do.e

-. temporarily possess the device at the intended place of use pmpdits possession by the user, the report must include the same information for each in ermediate person, and clearly designate that individual as an intermediate person. 3 The report must be submitted within 30 days after the end of each calendar quarter in which such a device is transferred to the IPf'O generally licensed person and clearly indicate the period covered by the report.hthe device in##

' . transferred replaced another retumed by the general licensee, report isofhe type, model

-r a)  ;-w.

number, and serial number of the one retumed. The report must clearly identify the specific

' licensee submitting the report and must include the license number of th'e specific licensee. If no transfers have been made to a particular Agreement State during the reporting period, this -

information shall be reported to the responsible Agreement State agency upon request of the agency.

E 39

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( i (c)Meep records of all transfers of devices for each generallicensee including all the information in the reports required by this section and records of final disposition. Records required by this paragraph must be maintained for a period of three years following the estimated usefullife of the device or the date of final disposition, if known.

PART 170 - FEES FOR F.ACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED

12. The authority citation for Part 170 continues to read as follows:

. Authority: 31 U.S.C. 9701; sec. 301, Pub. L. 92 - 314,86 Stat. 222 (42 U.S.C. 2201w);

sec. 201,88 Stat.1242, as amended (42 U.S.C. 5841); sec. 205, Pub. L.101 - 576,104 Stat.

2842, (31 U.S.C. 902).

13. Section 170.2 is amended by adding a paragraph (r) to read as follows:

$ 170.2 Scope.

' (r) A holder of a generallicense granted by 10 CFR Part 31 who is required to register a device (s).

. t 40 I-

1 l

(c) Keep records of all transfers of devices for each gen 3ral licensee including the inform ion in the reports required by this section and records of final disposition. ecords required b this paragraph must be maintained for a period of three years fo wing the estimated use Ilife of the device or the date of final disposition,if kno .

I

' PART 170 - FEE OR FACILITIES, MATERIALS, IMPO AND EXPORT LICENSES, ,

. AND OTHER REGU ORY SERVICES UNDED T ATOMIC ENERGY ACT OF 1954, AS AMEN D I

12. The authority citation for P continues to read as follows:

Authority: 31 U.S.C. 9701; se . 30 Pub. L. 92 - 314, 86 Stat. 222 (42 U.S.C. 2201w);

sec. 201, 88 Stat.1242, as amen d (42 U.S. 5841); sec. 205, Pub. L.101 - 576,104 Stat.

2842, (31 U.S.C. 902).

l

13. Section 1 .2 is amended by adding a paragrap (r) to read as follows:

$ 170.2 Scope. ,

(r) holder of a generallicense granted by 10 CFR Part 31 who required to register a device .

41 1

['

14. In 170.3, the definition of Materials License is revised to read as follows:

9170.3 Definitions.

F Y F Y W .

Materials License means a license, certificate, approval, registration, or other form of permission issued or granted by the NRC pursuant to the regulations in 10 CFR parts 30,31 through 36,39,40,61,70,71 and 72.

Y f h f f

.1v j.

15. Section 170.31 is amended by adding a fee category,3. O. to the schedule of -

materials fees an[ ootnote 1 [ad a paragraph (f).

an><nJh) 9 170.31 Schedule of fees for materials licenses and other regulatory services, including inspections, and import and export licenses.

Schedule of Materials Fees f Category of materials licenses and types of fees Fee28

3. l O. Registration of a device (s) generally licensed pursuant to Part 31........ ....................$370

' Types of fees (f) Generallylicensed device registrations under 10 CFR 31.5. Submittals of registration information must be accompanied by the prescribed fee.

V f Y Y .,X. --

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g.  ;

Part 171 - ANNUAL FEES FOR REACTOR OPERATING LICENSES, AND FUEL CYCLE LICENSES AND MATERIALS LICENSES, INCLUDING HOLDERS OF CERTIFICATES OF COMPLIANCE, REGISTRATIONS, AND QUALITV ASSURANCE PROGRAM APPROVALS AND GOVERNMENT AGENCIES LICENSED BY THE NRC

16. The authority citation for Part 171 continues to read as follows:

{

Authority: Sec. 7601, Pub. L.99-272,100 Stat.146, as amended by sec. 5601, Pub. L.

100-203,101 Stat.1330, as amended by sec. 3201, Pub. L.101-239,103 Stat. 2106 as amended by sec. 6101, Pub. L.101-508,104 Stat.1388 (42 U.S.C. 2213); sec. 301, Pub. L.92-314,86 Stat. 222 (42 U.S.C. 2201(w)); sec. 201,88 Stat.1242 as amended (42 U.S.C.

5841; sec. 2903, Pub. L.102-486,106 Stat. 3125 (42 U.S.C. 2214 note).

17. In Section 171.5, the definition of Materials License is revised to read as follows:

l 9171.5 Definitions.

W Y W I y y Materials License means a license, certificate, approval, registration, or other form of l

permission issued or granted by the NRC pursuant to the regulations in 10 CFR Parts 30,31 '

through 36,39,40,61,70,71, and 72.

% b  % M y i

18. In Section 171.16, paragraph (d) is revised by adding a fee category,3. Q. to the schedule of annualfees.

43

P i v

$ 171.16 Annual fees: Material Licensees, Holders of Certificates of Compliance, Holders of Sealed Source and Device Registrations, Holders of Quality Assurance Program Approvals and Government Agencies Licensed by the NRC Schedule of Materials Annual Fees and Fees for Government Agencies Licensed by NRC

. Category of materials licenses Annual fees'28 3.

O. Registration of devices generally licensed pursuant to Part 31............................."N/A "No annual fee is charged for this category since the cost of the general license registration program will be recovered through 10 CFR Part 170 fees, l Dated at Rockville, Maryland, this day of 1999.

1 l

For the Nuclear Regulatory Commission. 1 Annette Vietti-Cook, Secretary of the Commission.

]

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(

)

ATTACHMENT 3 ,

l Regulatory Analysis l

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\

REGULATORY ANALYSIS:

REQUIREMENTS FOR THE POSSESSION OF INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL I

l l

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1 STATEMENT OF THE PROBLEM . . . . . . . . . . . . . . ... . . .. .. . . .1 1.1 BAC KG R OU ND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1.2 NRC Study of Conformity with General License Conditions . . ... . 1 1.,2.1 Part l Results . . . . . . . . . . . . . . . . . . .... ..... ... .2

'1.2.2 Part il Results . . . .. .. .. . . . .. . .2 1.3 Subsequent Actions . . . . . . . . . . . . . . . . . . . . .. ... ....... .3 2 OBJECTIVES . . . . . . . . . . . . . . . . . . . ........ . . .... ... . . . . . . .5 3 ALTERNATIVES . . . . . . . . . . . . . . . . . . . .......... .. . . . . . . .. . . ,. .. 5 3.1 No a ction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 3.2 Non-rulemaking alternatives . . . . . . . . . . . . . . . . . . . . .. ..... . .6 3.3 Rulemaking to modify distributors labeling, reporting, and record keeping requirements and add additional provisions to the 31.5 generallicense . . 7 4 DESCRIPTION AND DISCUSSION OF PROVISIONS AND COST ESTIMATES . ...... 7 4.1 Revisions to the Requirements for General Licensees in Q 31.5 . . ........ 7 A. Registration: Certain measuring, gauging or controlling devices

( 31.5(c)(13)) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .......... .7 B. Responsible Individual: Certain measuring gauging or controlling devices (Q 31.5(c)(12)) ...... ...... ......... .

... .. .8 C. Storage: Certain measuring, gauging or controlling devices

( 31.5(c)(15)) . .............. . ...... .... ... . . . .. 9 D. Transfers of Devices: Certain measuring, gauging or controlling devices

. (Revision to 31.5(c)(8)) . ... .. . ... .............. . .9 E. Notification Requirements: Certain measuring, gauging or controlling devices (Q 31.5(c)(14)) .................. ......... ... . 10 F. Decommissioning Requiroments: Certain measuring, gauging or controlling devices (Revision to Q 31.5(c)(5)) . . . . . . . . . . . . . . . . . . . 11  !

G. Reports of Transfer to another generallicensee at same premises )

(Revision to 31.5(c)(9)(i)) . . . . . . . . . . . . . . . . . . . ..... .. . 12 H. Limitation of Applicability of General License (Revision to 31.5(b)) . 12

1. Bankruptcy: Terms and conditions of licenses (Revision to 30.34(h)) . . . . . . . . . . . . . . . . . . . . ................ .....,. 12 J. Schedule of fees for matefalc licenses and other regulatory services, including inspections, and import and export licenses (Revision to 170.31 ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............... .12 )

K. Impact to General Licensees in Agreemant States due to Compatibility l Requirements for Q 31.5 . .. . . . . ...................... .. .. 13 l

- 4.2 Requirements for Manufacturers and initial Distributors of Devices ....... 13  !

A. Quarterly Reports: Material transfer reports and records (Q 32.52(a) and (b)) .......................... .......... ......... .

.14 '

B. Retention: Material transfer reports and records (9 32.52(c)) . . .... 15 i C. Records: Conditions of licenses ( 32.51a(d)) . . . . . . . ... ...... 15 ,

l , D. Labeling: Byproduct material contained in devices for use under Q 31.5; I requirements for license to manufacture, or initially transfer (Q 32.51(a)(4) and (5) and 32.51a(c)) . . . . . . ........ ............. ..... 16 i

r k j

6 E. Information provided to general licensees: Conditions of licenses (6 32.51a(a) and (b)) . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . 17 4.3 Clarifying and Conforming Amendments . . . . . . . . . . . . . . . . . . . . . . . 18 A. Types of licenses ( 30.31) . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 B. Fees for facilities, materials, import and export licenses, and other regulatory services under the Atomic Energy Act of 1954, as amended (Part 170) ... . ............ . . . .. . . . . . . . . . . . . . . . 18 C. Annual Fees for reactor operating licenses, and fuel cycle licenses and materials licenses, including holders of certificates of compliance, registrations, and quality assurance program approvals and government

- agencies licensed by NRC (Part 171) . . . . . . . . . . . . . . . . . . . 18 4.4 . Summary of Estimated Annual Costs of Proposed Rule . . . . . . . . . . . . . . 18 4.5 Annual Costs to Agreement States of Compatible Regulations . . . . . . . . . . 19

' 5 BENEFITS OF PROPOSED RULE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 5.1 i Summary of Benefits of Proposed Alternative . . . . . . . . . . . . . . . . . . . . . . 21 5.2 Summary of Radiation Exposure Averted Benefit . . . . . . . . . . . . . . . . . . . . . 22 5.3 Summary of Economic Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

- 6 DECISION RATIONALE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 7 IMPLEMENTATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 8 EFFECT ON SMALL ENTITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 h

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1 STATEMENT OF THE PROBLEM

1.1 BACKGROUND

On February 12,1959 (24 FR 1089), the U.S. Atomic Energy Commission (AEC) amended its regulations to provide a general license to possess and use byproduct material in certain devices designed and manufactured for the purpose of detecting, measuring, gauging, or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition or for producing light or an ionized atmosphere. The devices had to be manufactured in accordance with the specifications contained in a specific license issued either by the Commission under 10 CFR Parts 30 and 32, or by an Agreement State.

Today, there are approximately 45,000 "geperal lic:asees," i.e., persons possessing and using such devices under the generallicense (9 31.5). These generallicensees possess an estimated 600,000 devices.

A generallicensee under the jurisdiction of the Commission is required to follow safety instructions on device labels and to test or service a device (with some exceptions) or to have the testing or servicing performed by the supplier or other specific licensee authorized to manufacture,' install, or service the devices. Additionally, general licensees may not abandon devices, and must maintain records concerning the testing and servicing of these devices.

Further, 31.5(c)(8) requires generallicensees to transfer or dispose of the generally licensed devices only to the holder of a specific license under Parts 30 and 32 or to the holder of a specific license issued by an Agreement State. SJction 31.5(c)(9) provides a limited exception to this requirement that allows general licensees to transfer the devices to other general licensees, but only if the device remains in use at a particular location or the device is held in storage in the original shipping container before initial use. In either case, transfers of devices  ;

by generallicensees must be reported to the NRC within 30 days of the transfer. No report of a transfer is required if a generally licensed device is transferred to a specific licensee in order to {

l obtain a replacement device. Generallicensees must also report damage to or loss of devices.

Specific licensees making the transfer of generally licensed devices are requiredjs part of its f f specific license togmaintain records of the transfer and to be accountable for all radioactive materialin its #6ssession. The NRC is notified by specific licensees when these licensees transfer devices containing byproduct material to general licensees through quarterly reports submitted under $ 32.52(a). These reports identify each general licensee by name and address (including, for an organization, the name or position of a person who may act as a point of l contact between the NRC and the generallicensee); the type of device transferred; and the quantity and type of byproduct material contained in the device. Under compatible Agreement State regulations, similar information is obtained from suppliers in Agreement States on j transfers to NRC generallicensees. j l 1 1.2 NRC Study of Conformity with General License Conditions ,

I The NRC traditionally has had little contact with generallicensees. The NRC staff believes that l this may account for why many generallicensees are not aware of their responsibilities under a l general licensymd that this results in incidents of mishandling and improper disposition of  !

generally licensed c'evices. Mishandling and improper disposition of generally I! censed devices 7)y N/K WrS1 AS T i e

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. . ...m, has resulted in radiation exposure to the public and, in some cases, has entailed

. expensive investigation, cleanup, and disposal activities; in most instances, exposures to the J public have not been significant. However, these exposures would probably not have occurred if the devices had been properly handled and disposed of.

The Commission conducted a study from 1984 through 1986 (General License Study) to ascertain the extent of compliance with generallicense conditions after it became aware of a few incidents where control over generally licensed devices was lost. The results of the study

. were discussed in SECY 87-167, dated July 9,1987, and in SECY-89-289, dated September 14,1989. Although current regulations ( 30.52) allow for the inspection of

, licensees possessing byproduct material, the Commission does not inspect general licensees

- on a regular basis primarily because of the large number of these licensees and the low risk presented by most of these devices; The Commiwion's knowledge of whether general licensees are complying with the regulations for the proper use and disposal of generally licensed devices is limited.

Because of the broad range of devices co' v ered under 31.5, the study was divided into two parts. The .first part covered industrial gauging and measuring devices, such as large-scale

. level, density, and thickness monitors. There were then approximately 10,000 Commission licensed devices in this category containing sources with activities in the 0.5 to 1 curie range.

The second part of the study covered devices which greatly varied in design and use, such as self-luminous signs, analytical instruments such as x ray fluorescence spectrometers or liquid scintillation spectrometers and smaller scale thickness, density, and level gauges. . A summary of the results of the study presented below is based on an unpublished NRC report entitled

" General License Study Report."

L1.2.1 : Part i Results

! The Part I study included 228 site surveys of general licensees by the study task force and 132 inspections conducted by NRC regional offices. Some Agreement States also contributed data

~ to the " General License Study." The information gathered by the study, although from a small

{

sample of generallicensees possessing large scale gauges, clearly established that there is a compliance problem. Amongilie findings of Part ! ;;n N 2"a;Mg: 4 #4>44 A /t o' Approximately 16 percent of these generallicensees could not account for all of their gauges; A majority of these generallicensees either did not notify the NRC of transfers of

their gauges or improperly transferred their gauges.

>' At least 25 percent of these general licensees were not performing required leak

tests or maintaining leak-test records, or they were not inspecting a gauge's on/off shielding mechanisms or not inspecting them as required.

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' Agreement States reported incidents of thickness gauges being found in landfills and, in one case, even in an abandoned paper milli

' 1.2.2 ~ Part il Results '

Although Pa 1 ll of the study covere' d devices that vary greatly in design and use, the range of problems encountered in Part ll is exemplified by the problem relating to self-luminous exit

.., .. . signs and beta backscatter gauges. Exit signs, which are one of the most common devices 2

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covered by a generallicense, contain tritium gas that excites phosphorous-coated glass tubes to give off light. They are used in places where wiring of electrical signs would be difficult or j expensive to do. Beta backscatter gauges contain a small sealed source and a radiation detector that measures hcw much radiation is reflected back from a material sample. The concern about these devices is the accountability of the removable source which is about one inch in diameter. Ninety-eight interviews were conducted of persons who possess these types of devices. The findings of Part il are summarized below:

Nonconformity with general license conditions was very widespread.

Only 16 percent of the generallicensees for exit signs were aware of the regulatory requirements.

Manufacturers and distributors frequently under reported the number of exit signs sold to general licensees. General licensees (electrical distributors and contractors) reported having about a0 percent more signs than were listed in quarterly reports of the manufacturers.

Three cases involved missing sources from beta backscatter gauges.

Only 45 percent of those surveyed for backscatter gauges were aware of the

- generallicense conditions.

Vendor reports did not accurately reflect the number of radioactive sources in the possession of generallicensees. When sources were returned by general licensees to the manufacturer for disposal, the NRC was not always notified.

Hence, NRC records were not always accurate.

1.3 Su'bsequent Actions On December 27,1991 (56 FR 67011), the NRC published a notice of proposed rulemaking regarding the accountability of generallicensees under 31.5. It proposed a number of provisions, including a requirement for these licensees to provide information at the request of the NRC in order to provide the regulatory basis for the registration of these devices. The proposed rule also would have added requirements in 32.51a and 32.52 for specific licensees who manufacture or initially transfer these devices to the generallicensees. Although the public comments received were reviewed and a final rule developed, that rule was not issued becausie resources to implement the proposed rule properly were not available.

The NRC has continued to consider the issues related to the loss of control of generally licensed, as well as specifically licensed, sources of radioactivity. In July 1995, the NRC, with assistance from the Organization of Agreement States, formed a working group to evaluate these issues. The working group consisted of both NRC and Agreement State personnel and encouraged the involvement of all persons having a stake in the process and its final recommendations. All working group meetings were open to the public. A final report was

. completed in July of 1996 and published in October of 1996 as NUREG 1551, " Final Report of the NRC-Agreement State Working Group to Evaluate Control and Accountability of Licensed Devices."

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One of the conclusions f the wo ing group is that generallicensees possessing certain identified devices shout report nnually to their regulatory authority a listing of their current inventory of devices so s to all w the regulator to independently verify that the licensee has maintained accountabilitt and ontrol of the devices. This was the basis for the recent rule proposed on (L a.1 dd)( )(Rule 1) which would revise Part 31 to add an explicit requirement that generallicensees under @ 31.5 respond to requests from NRC for information.

The intent is to use that provision to institute a registration program for devices recommended by the Working Group for enhanced regulatory oversight.

The additional recommendations of the working group provide the major basis for this rulemaking, which, among other things, would provide more explicit provisions with regard to a registration program. For general licensees us.ng devices containing at least 10 mci of cesium-137,0.1 mci of strontium-90,1 mci of cobalt-60, or 1 mci of any transuranic, the 3 working group recommended the following:

j Licensees must assign a Responsible Individual (RI) and a Backup Responsible j Individual (BRl). The RI and BRl must each be an individual that has the j authority and responsibility for compliance.

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Licensees must perform, at intervals not to exceed six months and maintain

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records of; (1) physicalinventories of devices including reconciliation of any l discrepancies with previous inventories, and (2) inspections of each device for

, proper labeling including correction of any deficiencies. '

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Licensees must keep current inventory records.

Licensees must report changes concerning the RI and BRI and transfers or disposalof devices.

Licensees must report immediately following the filing of a voluntary or l

involuntary petition for bankruptcy. i For vendors of the same devices, the working group recommended the following:

Vendors must report transfers quarterly and the report must include the name, i telephone number, and mailing address of the recipient, the address of use of I the device, the model number and serial number of the device, the isotope and activity, any intermediate holders of the device, including the function of the intermediate holders, the specific reporting period covered by the report, and the name and license number of the repo-ting company.

Vendors must maintain records of transfer for all devices they have distributed, including final disposition, if known. The records must be maintained for three years after final disposition of the device.

• Vendors must provide recipients with disposal information prior to transfer of the device.

• Vendors must ensure each device, or separable source housing, is labeled with the model number and serial number, the isotope and activity, the trefoil symbol, the words " Caution - Radioactive Material," and the name of the device vendor.

• Vendors must ensure that source housings are permanently marked (e.g.,

engraved or embossed) with the trefoil symbol and the words " Caution -

Radioactive Material," as practicable.

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! For both NRC and Agreement States, the working group recommended the following:

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F NRC and Agreement States must verify that all transfers by their users are in accordance with their regulations and license conditions.

NRC and Agreement States must compare the annualinventories reported by their users against previous inventories and against transfer reports from vendors and other users. This provides an independent verification that licensees have maintained accountability and control of the devices.

NRC and Agreement States must resolve any discrepancies in the information with the assistance of the licensees.

NRC and Agwement States must acknowledge to their licensees that the transfers and inventories have been reviewed.

2 OBJECTIVES The objectives _of the amendments to Parts 31 and 32 of the Commission's regulations are to ensure that certain generallicensees are aware of and understand the requirements attendant to the possession of generally licensed devices containing byproduct material and to better enable the NRC to verify the location, use, and disposition of such devices. The intent is to reduce the possibility of the devices being improperly transferred or inadvertently discarded and, ultimately, to avoid unnecessary radiation exposure to the public and unnecessary expense involved in retrieving the items, particularly in the scrap metal stream, as well as to avoid the contamination of steel mills, metals, and waste products.

In addition, the objective of the revision of Part 170 to add a registration fee for certain generally licensed devices is equity of fee recovery for the costs of the generallicense program.

3 ALTERNATIVES 3.1 No action.

This alternative is to continue the status quo. As costs and benefits are evaluated in terms of changes from the status quo, there are no costs or benefits associated with this alternative. In this case, it is assumed for the purpose of analysis, that Rule 1 is made effective and costs and benefits are evaluated as changes from a base case of having that rule in place and implementing a registration program under that provision.

No action, of course, does not address identified concerns. In the past, the only communication between a general licensee and the NRC was through the requirement that the NRC be notified when a device containing byproduct material was transferred. Information notices have been sent and inspections have been made but only rarely.

As discussed in Section 1.2 of this analysis, generallicerisees have a lack of awareness of their responsibilitiet under a generallicense. The NRC staff believes that this lack of awareness is a major contributor to the occurrence of incidents of mishandling and improper disposition of l

generally licensed devices. This, in tum, has resulted in radiation exposure to the public and, in some cases, entailed expensive investigation, cleanup, and disposal activities. Rule 1 would l begin to address this problem, but in a limited way. It does not require compatibility of Agreement State regulations, so only approximately one third of generally licensed devices meeting the criteria for enhanced oversight will be covered. It was estimated in the regulatory 5

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analysis for that action that it wo ld affect about 20hof the devices presenting a s ificant risk in the case of loss (the other 80 being generally licensed under Agreement State re lations or held by specific licensees). It was also assumed that it would conceivably cut the rate f loss within this population by roughly one half, thus reducing the impacts from lost sources by 1 3  ;

Also, Rule 1 will not completely address the factors discussed in the next section concerning )

knowledge of the regulations reaching the appropriate persons.

No action would not be appropriate because the factors listed in the preceding paragraph ,

should be addressed.

3.2 Non-rulemaking alternatives With respect to the problem of lack of awareness 01 regulatory requirements on the part of generallicensees, there are a number of approaches that could be considered. Guidance could be provided in a number of formpwever, periodic contact with the general licensees would be expected to have the most significant impact on the level of awareness of requirements. The most appropriate means to remind users of their responsibilities would be periodic issuance of information noticergliowever, these informa' ion notices may not reach all l users. While 6 32.52 requires that specific licensee distributors report to the NRC or the I

Agreement State agency the name and/or title of the individual who constitutes the point of I contact between the generallicensee and the NRC, or the Agreement State agency, the l General License Study indicated that this individual, who is frequently in the purchasing

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I department, often did not inform the individual who uses the device of the general license I conditions. Moreover, the study indicated that personnel turnover frequently destroyed the i organization's knowledge of the license conditions. For similar reasons, information notices i may also not reach the appropriate person within the organization of a generallicensee since the contacts provided in the specific licensees' quarterly reports are frequently not the individuals responsible for, or knowledgeable of, the devices after they have been received and j are being used. In this case, the initial contact name received from a distributor would continue  ;

to not be the person responsible for the compliance with regulations and would present {

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problems with the implementation of a registration program in Rule 1. The process will be more l efficient if more appropriate contact information is received initially from the distributor.

Even when generallicensees are aware of their basic responsibilities concerning the devices, l there may be other factors contributing to noncompliance with requiremen.ts. For example, the '

cost of disposal may cause some generallicensees to dispose of devices improperly. It is important that the general licensees understand that the Commission will hold them responsible for these devices. Increased inspection of generallicensees and enforcement of the requirements may improve compliance. .However, without a registration system to verify compliance as well as additional requirements for generallicensees such as, appointing a i responsible individual, performing inventories, reporting of bankruptcy, time limit on storage of devices, and without additional requirements for vendors such as reporting Ris and serial numbers of devices transferred, providing recipients of disposal costs and maintaining transfer records including final disposition of devices as well as additional labeling requirements, there would not be sufficient regulatory requirements for general licensees to be responsible and accountable for their devices. Also, there would not be a large enough number of inspections and these inspections would be on a random basis and vould not be very efficient.

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' None of these actions would result in a high degree of accountability for these devices.

Additional regulatory requirements would be more effective in terms of accountability, and

. would provide c basis for more efficient use of inspection and enforcement efforts.

1 3.3 _ Rulemaking to modify distributors labeling, reporting, and record keeping

- requirements and add additional provisions to the 6 31.5 general license This alternative would amend 10 CFR Parts 31 and 32 to help ensure that devices containing

, byproduct material are maintained and transferred properly and are not inadvertently discarded.

The general mechanism to be used would be to add explicit provisions delineating the registration requirement so that general licensees verify compliance with certain conditions imposed by the generallicense.

In addition, the amendments to 10 CFR Parts 31 and 32 would require a general licensee to appoint a responsible individual, perform inventories, report bankruptcy, limit the time on )

storage of devices, and would require vendors to report responsible individuals and serial numbers of devices transferred, provide recipients of disposal costs, and maintain transfer l records including final disposition of devices as well as additional labeling requirements.

The NRC envisions that these are elements of a well defined registration program. They offer I greater assurance that a generallicensee is informed of its regulatory responsibilities and will {

assign a knowledgeable individual who will provide information to assist with verifying I accountability for devices. The NRC would make periodic requests for verification to remind generallicensees of their regulatory responsibilities and to reduce the likelihood that devices f' containing byproduct material are illegally transferred or inadvertently discarded. In addition. for specific licensees who distribute these generally licensed devices, there would be changes in the reporting, record keeping, and labeling requirements. 1

.4 DESCRIPTION AND DISCUSSION OF PROVISIONS AND COST ESTIMATES 4.1 Revisions to the Requirements for General Licensees in 9 31.5 A. - Registration: Certain measuring, gauging or controlling devices ($ 31.5(c)(13))

- Section 31.5 currently grants a general license to certain individuals and contains the requirements under that license. The principal change to the general license in 6 31.5 that would be made under this proposed rule would be to add explicit provisions delineating a registration requirement. This addition would provide generallicensees with the details of the registration requirement including which devices are subject to registration and the kinds of inform 8 tion that will be required to be submitted by this process. Specific provisions proposed here are essentially consistent with the Commission's plans for the registration process

. discussed in Rule 1. Annual registration is required for devices containing at least 370 MBq

- (10 mci) of cesium 137. 3.7 MBq (0.1 mci) of strontium-90,37 MBq (1 mci) of cobalt-60, or 37 MBq (1 mci) of any transuranic. This provision would specifically require that the information about devices be verified through a physical inventory. The registration information that would be required is as follows:

.- Name and mailing address of the generallicensee.

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r Information about each device: the manufacturer, model number, serial number, radioisotope, and activity.

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Name and telephone number of the responsible person designated as a representative of the generallicensee under 31.5(c)(12).

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Address at which the device (s) are used and/or stored. For portable devices, the address of the primary place of storage, Certification by the responsible representative of the generallicensee that the information concerning the device (s) has been verified through a physical inventory and checking of label information.

Certification by the responsible representative of the generallicensee that they are aware of the requirements of the generallicense.

Cost Imoacts:

None anticipated.

The cost to industry and to the NRC of the registration process were addressed in Rule 1 and are not a result of this action. Rule 1 would require generallicensees to respond to requests from the NRC to verify information related to their generallicensed devices. Specifically, it accounted for the costs associated with locating and verifying license conditions for all devices in the possession of generallicensees. This rule describes the information that will be required by registrants and would not require more than verification of the current location of all devices and verification of the information as is planned to be requested under the Rule 1.

The advantage of including more explicit requirements in the regulation is that information about the registration process will be more clearly defined and more available. When the distributor of a device supplies copies of 31.5 to its customers (under 32.51a(a)), the potential general licensees will be made aware of the registration requirement, including to which devices it applies, what information will be requested, and also the fact that there will be a fee.

Having more explicit requirements would, if anything, simplify inspection and enforcement.

B. _ Responsible Individual: Certain measuring, gauging or controlling devices

($ 31.5(c)(12))

The proposed rule would add an explicit requirement, @ 31.5(c)(12), for the general licensee to appoint an individual to carry out the general licensee's responsibilities to comply with the applicable regulations.

Cost imoacts:

None anticipated.

While apponting a person to be responsible for performing required actions should already be occurring in practice, this action would make that responsibility explicit. In other words, there must already be a person who performs shutter tests, leak tests, and compliance with regulations. This proposed rule would require generallicensees to designate the person who 8

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ensures the performance of shutter tests, leak tests, and compliance with regulations as the

" " responsible individual."

No significant effect on inspection and enforcement is anticipated.

. C. - Storage: Certain measuring, gauging or controlling devices ($ 31.5(c)(15))

The proposed rule would add a provision that limits the amount of time a generallicensee can keep a device' unused and would eliminate leak testing and shutter testing while a device is in L i storage.

Cost impacts:

There are potential cost impacts to general licensees in limiting the length of time they can l- , store devices, but these are highly uncertain and difficult to quantify. The vast majority of

generallicensees,have devices in storage because they are no longer in use due to L

, replacement of such devices. Almost all devices that would be in storage for as long as two

years are destined for disposal, however many in storage less that two years are put back into service. ' Licensees are storing devices to avoid disposal costs, however, disposal costs are -

inevitable. The actual difference in cost for any particular general licensee will depend on actual discount rates and the change in disposal costs between the time this provision leads to disposal and when it might have been disposed of absent this provision, whether there is significant decay of the radioactivity in that time, what arrangement the general licensee has with the distributor for returning the device, and the annual costs of keeping the device.. For registered devices, the annual costs of keeping the device could include the registration fees

' which are to be imposed by this rule.

l , ..There would be a cost savings'for general licensees with the provision of 6 31.5(c)(15) allowing testing to be deferred during storage. These cost savings would result from no longer requiring the' performance of leak tests and shutter tests during storage and are estimated in section 5 on r . benefits.-

No'significant effect on inspection and enforcement is anticipated.

. D. Transfers of Devices: Certain measuring, gauging or controlling devices (Revision to 5 31.5(c)(8))

The proposed rule would add a provision to allow transfers to specific licensees other than Part 32 licensees. This would add waste collectors specifically licensed under Part 30. It would 1 also allow transfers to other specific licensees but only with prior written NRC approval. Also, it Lwould add the recipient's license number, the serital number of the device, and the date of

- 7.  ; transfer to the information required to be provided to NRC upon a transfer of a device.

, ; This'would provide some flexibility to licensees. The addition of the license number to the

' reporting'_ requirement increases assurance that the general licensee will transfer devices only

- to appropriate recipients.1The addition of the serial number of the device will allow tracking of i-

- the indmdual device. The date of transfer will make the transfer easier to track and help to

ensure that th's general licensee makes the report in a timely way (required in 30 days).

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Cost imoacts:

No anticipated costs to licensees since this proposed rule provides for an alterroe method of transfer which avoids licensees having to request exemptions to regulations. Currently licensees must transfer devices only to Part 32 licensees so they must verify that the recipient is a Part 32 licensee. The additionalinformation in the report will have no significant impact.

Assumptions:

Cost to NRC:

Number of requests for approval per year: 100 Staff hours per submittal: 0.5 hr Professional staff hourly rate: S70/hr Total cost per year: $3,500 No significant effect on inspection and enforcement is anticipated.

E. Notification Requirements: Certain measuring, gauging or controlling devices

($ 31.5(c)(14))

The proposed rule would contain a provision that generallicensees notify NRC in the event of a change of address. This requirement is a necessary element of the registration program.

Without a current mailing address, the NRC would not be able to mail out the registrations.

This applies to all 9 31.5 generallicensees, because it is important for NRC to keep track of all general licensees so that they can be contacted whenever the need arises and inspected.

Cost Impacts:

Assumptions:

General Licensees:

Number changing address per year: 100 Time spent: 0.10 Technical staff hourly rate $50/hr Totallicensee cost per year: $500 NRC (recordina information):

Number changing address per year: 100 Staff hrs per submittal: 0.10 hrs Staff hourly rate: S70/hr j Total NRC cost per year: S700 '

Total cost per year: 51,200 No significant effect on inspection and enforcement is anticipated.

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4 F. Decommissioning Requirements: Certain measuring, gauging or controlling devices (Revision to 6 31.5(c)(5))

l The proposed rule would add, to the information that must be sent to NRC in the case of i

detection of 0.005 microcurie or more removable radioactive material or failure of or damage to l

a source likely to result in contamination of the premises or the environs, a plan for ensuring that premises are suitable for unrestricted access. It would also change addressee / address from appropriate Regional Administrator to Director, NMSS.

If contamination occurs at a facility, unrestricted areas must be cleaned up to a point where public health and safety is ensured. Generallicensees may not have adequate knowledge to evaluate the extent of decontamination activities needed due to a leaking or damaged source.

The NRC needs to evaluate, on a case by case basis, a decontamination plan to ensure facilities are suitable for unrestricted use. Generallicensee's submittals of information pertaining to cleanup of facilities will allow the NRC to carry out its mission. The intent is to provide additional assurance of the adequacy of decontamination of facilities for gen' eral licensees.

The change to addressee will make all reports required under 31.5 to be sent to the same address and eliminate the need to reference Part 20 in this regard.

Cost imoa' cts:

Assumptions:

General Licensees:

Number reporting (one third of total number reporting under 31.5(c)(5) per year): 7 Time spent: _ 8 hrs Technical staff hourly rate $50/hr Total licensee cost per year: $2,800 j NRQ:

Number reporting: 7  !

Staff hrs per submittal: 2 hrs Staff hourly rate: $70/hr  !

Total NRC cost per year: 5980 Total cost per year: S3,780 This is only the cost of reviewing this additional submittal of information from the eneral license; additional effort may be involved in resolving the contamination proble wever, this is not an impact of this revision. In fact, having the generallicensee include this a itional information may reduce the overall cost of intervention for incidents of this type. The change in addressee / address will simplify reporting requirements for the general licensees, i

i No significant effect on inspection and enforcement is anticipated.

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G. Reports of Transfer to another general licensee at same premises (Revision to l 31.5(c)(9)(l))

This revision would replace the name or position of a contact with the name and phone number of the transferee's responsible person,in reports of transfer to another generallicensee at the same location; it would also add the serial number of the device.

This would provide a more appropriate contact to the NRC in this instance; the serial number would make tracking of individual devices easier.

Cost Imoacts:

No anticipated costs to generallicensees. This is a minor revision to a reporting requirement which is applicable under very limited circumstances.

No significant effect on inspection ~and enforcement is anticipated.

H. Limitation of Applicability of General License (Revision to i 31.5(b))

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The applicability of the general license to those who come into possession by an unauthorized means would be clarified such that they would not be considered general licensees.

Cost Imoacts:

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~ This would have no impact on authorized users, but would clarify enforcement issues with

' respect to unauthorized users and those who inadvertently come into possession of a generally licensed device. This should somewhat simplify enforcement actions involving unauthorized recipients on the part of NRC.

l. , BankrQtcy: Terms, and conditions of licenses (Revision to i 30.34(h))

N (The appl'icability of b30.34(h) on bankruptcy notification to general licensees needs to be clarified. This proposed rule would clarify that this requirement is applicable only to those generallicensees subject to the registration requirement.

Cost Imoacts: i l

None anticipated. These generallicensees are currently subject to 30.34(h); however, this is not clear because of the lack of a reference in $ 31.2.

' No significant effect on inspection and enforcement is anticipated.

'J. Schedule of fees for materials licenses and other regulatory services, including

. Inspections, and import and export licenses (Revision to i 170.31)

The proposeil rule would add a fee required in conjunction with the registration process. Fees are proposed to be required in order to recover the cost of the general license program associated with this category of general license in an equitable way; that is, from those who are 12 l

allowed to use devices under the general license rather that from others who hold specific licenses. - NRC is required by law to recover all costs from licensees' fees.

Cost imoacts:

Assumptions:

General Licensees:

. Number of registrants: 6000 Annual fee: S370 Totallicensee cost per year: S2,220,000 The cost being recovered from the general licensees is t limited to those for implementing these revisions to the general license prograripmstenA e cost to generallicensees consists of the cost of that fraction of the overall generallicense gram associated with the devices subject to the registration requirement. Since the requirement for full cost recovery was enacted, all costs of the general license program have been recovered from specific licensees.

These cost estimates include an estimate of increased inspection and follow up efforts expected to be made as a result of the registration process identifying noncompliance with existing regulations. That cost will now be passed on tv > generallicensees associated with the registration requirement. It is also expected that this cost will decline after the initial implemen,tation of the registration procesgin - m .. this fee might be reduced in the future.

y4gg 4/jg NRC (for collection of fees and associated followuo):

Total NRC cost per year: S100,000 Total cost per year: $2,320,000 K. . Impact to General Licensees in Agreement States due to Compatibility Requirements for i 31.5 This rule would make all of 6 31.5 a Category C level of compatibility. Many of the Agreement States already have similar or identical provisions in their regulations to the existing Q 31.5.

Regulations that differ are generally more stringent, e.g., a few jurisdictions require a specific license for these types of devices. The most significant impact to Agreement State general licensees would be the change of the registration requirement, proposed in Rule 1, from j Category D to Category C. The impact to Agreement State generallicensees WW depend on

~

the approach used to achieve a Category C compatibility. Some States have already instituted a registration requirement or some other type of enhanced oversight program. The largest cost to NRC generallicensees under this rule would be the payment of feep]his provision would be Category D, no compatibility required. E 13 1

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4.2 Requirements for Manufacturers and initial Distributors of Devices i

The proposed regulation would modify the quarterly transfer reporting, recordkeeping, and labeling requirements for specific heensees who distribute these generally licensed devices.

These cost estimates include costs'to distributors in Agreement States under compatible Agreement State regulations. These provisions would be a compatibility Category B.

A.- -Quarterly Reports: Material transfer reports and records (9 32.52(a) and (b))

i The proposed rule would add the following information to the existing quarterly transfer reporting requirement: the serial number and model number of the device; the date of transfer; indication if device is a replacement, and if so, the type, model number (Agreement States already require the model number), and serial number of the one returned; name and license number of reporting company, and the specific reporting period; the name and phone number of the person designated by the generallicensee to be responsible for the device and for ensuring compliance with the appropriate regulations (which will replace that of a simple contact between the Commission and the generallicensee). Also, a form will be provided for use in making these reports; however, the use of the form would not be required as long as the report is clear and legible and includes all of the required information. Revisions would be made to

@ 32.52(a) and (b).

This provision would provide a mechanism for tracking of individual devices. It would also clarify that the contact name to be obtained from the general licensee (and reported to NRC and the Agreement State regulatory bodies)is that of the individual who will be responsible for compliance with the regulations regarding generally licensed devices. The provision should improve NRC's ability to contact the appropriate person and to provide information to those actually knowledgeable of the device and the requirements for possession, improving general licensees knowledge of the regulations and thus their compliance with the regulations.

Cost Imoacts:

Most of the additionalinformation that would be provided under this proposed rule is information

. that vendors currently track and maintain records on. However, additional time may need to be

. spent to keep track of replacement devices.

Assumptions:

Distributer (NRC and Aareement State) reports to NRC:

Number of submittals per year: 356

((28 NRC+61 AS) licensees x 4 reports /yr)

Additional time spent: 0.2 hr Technical staff hourly rate $50/hr Totallicensee cost per year: S3,560

- NRC (recordina information):

Number of submittals per year: 356 l Staff hrs per submittal: 0.1 hrs L Staff hourly rate: $70/hr Total NRC cost per year: $2,492 14 l

T.

1 Distributor (NRC and Aareement State) reports to Aareement States:

Number of submittals: 1780 (assuming an average of 5 States per distributor)

Staff hrs per submittal: 0.1 hrs Staff hourly rate: S50/hr Total cost per year for reports to States: S8,900 Total cost per year: $14,952 No significant effect on inspection and enforcement is anticipated.

B. Retention: Material transfer reports and records ($ 32.52(c))

The proposed rule alters the records retention so that records of transfers would have the period of retention extended from 5 years after a recorded event to 3 years after the expected usefullife of the device or the final disposition, if known. The proposed rule also adds a requirement for records on final disposition of devices.

This improves the ability to track individual devices. Further, these revisions will better enable the NRC to verify the location, and disposition of these devices, and thereby confirm the efficacy of the generallicense regulatory program.

Cost imoacts:

This section of the proposed rule would create small incremental costs (i.e. <S1,000) for licensees as a result of the increase in the length of the records retention period and recording of the final disposition of devices. Most manufacturers record this information on a database and currently retain this information indefinitely. In addition, the time spent for data entry into a database for recording final disposition of devices is small making the corresponding costs small.

No significant effect on inspection and enforcement is anticipated.

C. Records: Conditions of licenses ($ 32.51a(d))

The proposed rule would add a requirement for the distributors to provide upon request to the NRC and Agreement States, records of final disposition of devices in the case of bankruptcy or termination of license. This information must be available upon request.

This will assist the NRC and the Agreement State agencies in tracking individual devices.

Further, these revisions will better enable the NRC to verify the location, and disposition of these devices, and thereby confirm the efficacy of the generallicense regulatory program.

Cost Imoacts:

This section of the proposed rule would create small incremental costs (i.e. <$1,000) for licensees as a result of making available to various regulatory agencies records of final disposition of devices in the case of bankruptcy or termination of license. Most manufacturers 15

l i

i l record this information on a databa refore, the time spent to transfer this information to regulatory agencies is small. % Iso, e number of manufacturers going bankrupt or requesting license termination is small, making the corresponding costs small. In addition, this information unty needs to be provided upon request making the number of times the information needs to be provided even smaller.- {

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. No significant effect on inspection and enforcement is anticipated.

D. Labeling: Byproduct material contained in devices for use under 6 31.5; requirements for license to manufacture, or initially transfer (9 32.51(a)(4) and (5) and $ 32.51a(c))

The proposed rule would revise 32.51(a)(4) and (5) and 9 32.51a(c) to add requirements for a t

label on any separable source housing, and a permanent label on devices meeting the criteria j

for registration, j

I The first of these changes is simply an extension of the existing requirement and carries out the j initialintent of the current reguiations in the case of devices where the source may be separable in a housing that does not include the label. It is important that this housing, if j

separated from the remainder of_ the device, can also be identified. Labels are approved by the NRC as part of the licensing process. Labels are generally put on separable housings under present practice; however, this should be clearly required. Also, many existing labels would 4 already meet the " permanent" requirement. ,

This part of the proposed rule would increase the likelihood that devices, including any \

l separable source hesings, include labels that stay intact even in non-routine circumstances I (such as theft, loss, damage), and as a result, would increase the likelihood that the device could be identified as containing radioactive material, thereby reducing the likelihood of incidents resulting in unnecessary exposures to the public and contamination of property.

Cost imoacts:

Assumptions:

Distributors:

Total NRC licensee cost per year:

' Number of devices with separable source housings manufactured per year (5% of 9351 devices): 468 Price of additionallabel: $4 ,

Number of devices requiring registration 305 j manufactured per year:

Price of permanentlabel: $13 Total NRC licensee cost per year: SS,837 l

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.a Estimated Agreement State licensee cost per year:

Number of devices with separable source housings

. manufactured per year 1300 Price of additionallabel: $4 Number of devices requiring registration .

manufactured per year: 800 Price of permanent label: $13 Estimated Agreement State licensee cost per year: $15,600

Total cost per year: $21,437 This provision would not be expected to result in a significant impact to the NRC licensing staff for additional reviews of labels.

' No significant effect on inspection and enforcement is anticipated.

' E. Information provided to general licensees: Conditions of licenses ($ 32.51a(a)

' and.(b))

The proposed rule'would revise $ 32.51a(a) and (b) requirements pertaining to information distributors would be required to provide to the generallicensee. .They are now required to provide generallicensees with a copy of 31.5 at the time of transfer of the device. The proposed rule would require that 6 31.5 be provided prior to transfer. The distributor would also be required to provide copies of additional applicable sections of the regulations, a listing of services that can only be performed by a specific licensee, and information regarding disposal options for the devices being transferred. The disposat options would include the cost of disposing of the device at the end of its useful life to the extent that the cost information is

- available to the specific licensee distributor at the time of the sale of the device. This is to provide general licensees with information needed concerning the applicable requirements as

- well as some idea of the additional costs for disposal of the device before making a decision to buy a device.

Cost Imoacts:

Assumptions:

. Distributers (NRC and Aareement State):

Number of NRC generallicensees who are shipped generally licensed devices per year: 4,277 Time spent to provide additional information: 0.03 hr Technical staff hourly rate $50/hr Total licensee cost per year for distribution to NRC generallicensees: 56,415 17

.m i . . .. .. .

Estimated number of Agreement State general licensees

, shipped generally licensed devices per year: 12,000 i

Time spent to provide additional information: 0.03 hr i Technical staff hourly rate $50/hr

.Totallicensee cost per year for distribution to l

Agreement State generallicensees: $18,000 Totallicensee cost: S24,415 No significant effect on inspection and enforcement is anticipated.

4.3 Clarifying and Conforming Amendments A. Types of licenses ($ 30.31)-  !

. The proposed rule would add a clarifying amendment in @ 30.31.

{

- Cost imoacts:

None i B. Fees for facilities, materials, import and export licenses, and other regulatory services under the Atomic Energy Act of 1954, as amended (Part 170)

The proposed rule would make minor conforming amendments to 170.2 and 170.3.

C. Annual Fees for reactor operating licenses, and fuel cycle licenses and materials licenses, including holders of certificates of compliance, registrations, and quality assurance program approvals and government agencies licensed by NRC (Part 171)

The proposed rule would also make nmior conforming amendments to g 171.5 and 171.16.

4.4 . Summary of Estimated Annual Costs of Proposed Rule Table 4-1 presents a summary of the estimated costs of the revisions to Parts 30,31,32,170 and 171. For each regulatory change described above, Table 4-1 lists the total costs estimated for that section, f

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Table 4-1 Summary of the Proposed Rule's Annual Cost Effects Subpart Section Licensee Costs NRC Costs Total Costs 4.1 A 31.5 (c)(13) 0 0 0 4.1 B 31.5 (c)(12) 0 0 0 4.1 C 31.5 (c)(15) variable. O variable, unquantified unquantified 4.1 D 31.5 (c)(8) 0 3,500 3,500 4.1 E 31.5 (c)(14) 500 700 1,200 4.1 F 31.5 (c)(5) 2,800 980 3,780 4.1 G 31.5(c)(9)(i) 0 0 0 4.1 H 31.5(b) 0 0 0 4.11 30.34(h) 0 0 0 4.1 J 170.31 2,220,000 100,000 2,320,000 4.2 A 31.52 (a) and (b) 12,460 2,492 14,952 4.2 B 32.52 (c) 0 0 0 4.2 C 32.51a (d) 0 0 0 4.2 D 31.51 (a)(4) and (5) 21,437 0 21,437 and 32.51a (c) 4.2 E 32.51a (a) and (b) 24,415 0 24,415 4.3 A 30.31 0 0 0 4.3 B 170 0 0 0 4.3 C 171 0 0 0 4.5 . Annual Costs to Agreement States of Compatible Regulations l l

Assuming that the Agreement States have jurisdiction over roughly twice as many devices as )

the NRC in total, and assuming the same average cost / licensee, approximate costs to Agreement States for carrying out a comparable oversight program would be estimated as

$83,000/ year after the first year or two. The first year costs would be higher, roughly $190,000.

However, the smaller number of generallicensees and specifically licensed distributors in individual States relative to the total number of NRC licensees may result in higher average

, costs / licensee. This cost is the administrative cost of exercising a similar level of control as the registration requirement initiated in Rule 1, which would now be a Compatibility Category C and for the additional requirements that would be placed on distributors, which would be 19 l l

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Compatibility Category B. This does not include the cost of collection of fees, as this is Compatibility Category D. Also, the registration process or other oversight program will likely uncover noncompliance with existing rules leading to a significant cost of followup, especially in the early years of implementat;on; this is also not included in this estimate as it is not a direct cost of compatibility with this rule, rather an enforcement of existing rules. The actual cost of achieving Compatibility level C for general licensees will depend on the approach taken by the various States and how much change this requires from existing requirements. In some cases, l

Agreement States have already instituted a registration system or other enhanced oversight program, in these cases, little or no additional action may be needed.

4.6 Development and implementation Costs NRC development costs are the costs of preparat,on of a regulation prior to its promulgation and implementation. Such costs may include expenditures for research in support of this regulatory action, publishing notices of rulemaking, holding public meetings, responding to public comments, and issuing a final rule. NRC implementation cost are those " front-end" costs necessary to effectuate the action; they may arise from the necessity of developing procedures and guidance to assist licensees in complying with the final action. The Working Group's recommendations, published as NUREG 1551 in October of 1996, which is the research in support of this regulatory action, has already been performed and is therefore outside the scope of this analysis. Developmental costs and implementation costs within the scope of this analysis are the costs of proceeding with a rulemaking. These are mainly costs of the effort of NRC professional staff members in the Office of Nuclear Materials Safety and Safeguards expended in developing the rule.

S The actic s preparation cost to the NRC is estimated to require a total of 4 professional staff-yeal. The estimated cost of one NRC professional staff member is S126,000/ staff-yr. The component of NRC's development cost due to staff effort, then, would be $504,000.

Registration will require a more efficient computer data base. A computerized directory has been previously used by the Commission. However, it is outdated and will require improvement or replacement; this would be the case if it is to be adequate for carrying out the Commission's mission in the area of general licenses. This computer system upgrade cost was addressed in the previous proposed rule, which is to be used as a basis for initiating a registration, and, ,

therefore, no additional cost is provided in this analysis.

Additional costs will be incurred by the Agreement States for development and implementation ,

of compatible regulations, including the change to Compatibility Category C for all of 9 31.5.  !

The costs will vary significantly by State because of differences in intemal procedures for developing regulations and in the state of existing regulations in each State, some States

- having already instituted an enhanced oversight program, in some cases, specifically a registration program. Even in these cases, some rule change will be required to meet compatibility Category B for requirements for distributors. As these need to be essentially word-for-word compatibility, the process should be relatively simple for this part. If we assume an average of 1 FTE at $105,000/FTE for 30 States, the cost would be $3,150,000. In addition, the NRC/ Agreement State Working Group estimated that the cost of each State setting up a database for use in implementing such a program would be $20,000. Although some progress 20 l

c has been made by some States, we assume the same amount for all 30 States for a total of

$600,000. Thus total front end costs to Agreement States would be in the area of S3,750,000.

Revision of distributors' manufacturing process to include additionallabels would result in small incremental costs (i.e. <$1,000).

5 BENEFITS OF PROPOSED RULE

- 5.1 Summary of Benefits of Proposed Alternative

-The revisions are intended to better ensure understanding of and compliance with the general license requirements, and thereby reduce the likelihood of incidents resulting in unnecessary exposures to the public and contamination of property. These revisions will better enable the NRC to track the location, and disposition of these devices, and thereby confirm the efficacy of the generallicense regulatory program. NRC needs to keep track of the generallicensees so that they can be contacted or inspected. Further, the revisions would improve the likelihood that labels on devices will be retained under most circumstances so that devices can be identified and appropriate actions can be taken. A number of the proposed provisions work together to achieve these benefits. Thus, the benefits of these provisions cannot be accounted separately. The basic rationale for each provision is discussed in section 4; the overall benefits are discussed below.

The primary benefits of this proposed rule can be categorized into economic benefits and exposure aversion benefits. In addition, there are less tangible benefits to improving accoun.tibility for generally licensed devices. Many incidents involving generally licensed devices occur in the public domain. As a result, incidents to be averted by this rule have a significant impact on the public's perception of risks associated with the use of radioactive

~ material. This, in turn, can affect the credibility of NRC in other areas. Therefore, this rulemaking could contribute to the alleviation of inappropriate public fear and improvement of NRC credibility in the future.

All of these benefits are very difficult to quantify. Although ranges of potential exposures have been calculated and ranges of costs from individual incidents have been recorded, the working group concluded that none of the studies conducted are adequate to quantify an overall net cost of improperly disposed or lost devices. An admittedly uncertain estimate was made of the current economic costs and exposures resulting from improper disposition of both specifically and generally licensed devices meeting the proposed criteria for increased oversight. Tne degree of effectiveness of a particular process is also uncertain and would depend on the level of effort used in enforcement of the provision.

The estimate of economic costs made by the working group and adjusted here for the number of devices covered by this proposed action is based on experience (as reported by the steel industry).

- Uncertainty in these estimates comes from a nurnber of factors including:

The number of incidents of meltings reported is small overal[ughere is considerable statistical uncertainty in how representative the costs are of future costs averted.

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i g/d JL The likelihoo of loss may be different for s ecifi lly and generally licensed devices and f r different categories of devi e e experience cannot be separated Qnce_a melting has occurr it usoMlv c determined whether a generally or $65ifically licensed device was involve The cost of a cleanup depends on the type of steel milp,gxperience reported did not include incidents at large integrated steel mills and the resultant costs of such an incident are expected to be much greater than those experienced to date, as much as S100 million for a single incident.

The likelihood of meltings depends on the level of effort on the part of metal j

manufacturers and recyclers in monitoring for radioactive sources in scrap, which has generally increased over time, particularly at larger mills.

5.2 Summary of Radiation Exposure Avertt J 6enefit This rule should avert radiation exposure to the publipkhough it is reasonable to assume that a member of the public would not deliberately expose himself or herself or i someone else to radiation, in some cases, these individuals might not understand that a gamma gauge is a potential source of radiation. When a gamma gauge is distributed to a '

general licensee, the gauge must bear durable, legible labels which include a caution that the gauge contains radioactive material. The generallicense in 31.5 requires that the general licensee maintain those labels. In the absence of such maintenance, however, the csuiionary language can become corroded and unreadable or painted over. An individual who finds the gauge without this labeling in an uncontrolled situation would have no reason to suspect tha the gauge contains radioactive material.

If a generally licensed gauge were improperly transferred or disposed of such that it became available to a member of the general public, provided the radioactive material sealed source j remained in the gauge and ;ne shutter mechanism remained closed, no significant radiation

]

exposure harm could result. Moreover, the gauge may be too heavy for anyone to casually relocate so as to cause long-term exposure. In addition, temporary exposure to an intact gauge should not cause a significant radiation dose. Also, the intact gauge would normally include a warning label with a radiation symbol and cautionary words. I If a gauge with a significant source of activity were to end up in the public domain, the labeling  !

were to be destroyed, and a person somehow exposed the source, a significant exposure could I result. Radiation exposure due to impr per control could conceivably result in doses of a few i rem to doses that are life threatening the highest doses is extremely small.g wever, incidents to datethe likelihood in the U. S. haveofresulted situations in the which could re upper range of these potential doses.

Based on a June 1994 PNL report, " Peer Review of improper Transfer / Disposal Scenarios for l Generally Licensed Devices," the working group (WG) estimated the average dose received

! from incidents of lost devices involving cesium-137 (the most common nuclide involved in incidents historically) could be 7 rem (70 mSv) and the maximum dose that might be received i

could be somewhat over 1000 rem (10 Sv). The PNL study considered gamma gauges containing 20 mci or greater of cesium-137. The analysis was based on the average activity of 883 mci of cesium-137 within this category using data from the General License Data Base on devices registered in the Sealed Source Device Registry (SSDR) during the period 1987-1992. j i

j J7 '

The activities listed in the SSDR are the maximum allowed in a model and thus overestimate the average for the devices actually distributed. Gamma gauges were chosen for the example analysis as representative of relatively high risk sources amongst generally licensed devices.

These were very rough estimates. The data has known errors and the average activity per device being distributed has declined.

5.3 Summary of Economic Benefits There is a cost savings to industries which might inadvertently come into possession of an improperly disposed device. The most significant of these would be the avoidance of a melting of a source and resulting contamination of a steel mill and its products and wastes.

Based on the known incidents in the period 1983 .995 involving the nuclides for which registration would be required, the cost of decontamination and clean-up of these incidents I

(using the average clehn-up costs) is about $12 million per year. This cost can be considered f((

as a societal cost which may be mitigated or possibly averted in the future if the rule is im lamantad The regulatory analysis for the previous proposed rule (Rule 1) estimated that it ould cover 2Mof the devices contributing to the melting experience to date (since that rule addressed only devices in NRC-regulated States and some of the melted devices may have been specifically licensed) and might reduce the rate of incidence involving those devices by half, and estimated that the average annual cleanup cost of $12 M would be reduced by about

$1.2 M per year.

This rule would require Agreement State Compatibility Category C for the regulations governing general licensees, so that generally licensed devices in Agreement States would be similarly controlled. Based on the estimates of the WG, this would involve approximately half of the devices considered by the WG as likely contributors to smelting incidents and as presenting a risk of significant exposure to the public If we again estimate that the increased oversight of these devices reduces smelting incidents by one half amongst this population of devices, a potential savings of S3 M per year could result. It is recognized, however, that some States have already implemented increased oversight programs for generally licensed devices.

1 Improved tracking for devices distributed in the future, as well as improved awareness by I generallicensees of their responsibilities, expected to result from this rulemaking, will also help l te reduce future smelting incidents.

There are other costs, though less significant, associated with lost sources which could be e

reduced by this rulemaking.

In addition to registration, or comparable controls implemented under Agreement State regulations for certain devices, there are additional provisions in this rule that are expected to improve accountability and compliance with existing regulations for all devices generally J

. licensed under 31.5 and equivalent regulations of the Agreement States, particularly those distributed in the future. Although the criteria chosen for determining which devices should be subject to a registration requirernent are intended to include those devices that present the most risk of significant costs or significant exposures to the public if lost or improperly disposed of, other generally licen.ced devices present similar though lesser risks.

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The proposed revisions that are intended to allow NRC and the Agreement States to better track the location of generally licensed devices would maintain the regulatory bodies' ability to contact and inspect the general icensees. The proposed provisions would also allow the tracking of individual device is will aid the enforcement of regulations and the identification ,

of the persons responsible f devices that are found in inappropriate places. '

The rulemaking should thus reduce the number of orphaned sources. The cost of disposalin the case of orphaned sources falls on parties other than the user of the device, such as government agencies, e. g., EPA or DOE, or individuals or organizations who inadvertently come into possession of a device. {

j

These projected savings would not be entirely attributable to implementation of the rule, but also to the planned increase in inspection and enforcement efforts.

Additional Benefits from 9 31.5(c)(15):

The ALARA principal is one basis for alleviating the need for leak testing and shutter testing while a device is in storage. Indeed, it is an unnecessary exposure to personnel who perform I such tests since, prior to removing the device from storage, the device must be checked. '

Reduced burden on generallicensees to perform activities while a device is in storage, resulting {

in exposure benefit and cost savings. Also, decreases the likelihood of loss of control of a

~ device due to a fixed time period of stcrage of such devices. Devices that are in storage for long periods of time (i.e. greater than two years) are more likely to be forgotten and end up being improperly transferred or inadvertently discarded.

Assumptions:

General Licensees:

(

' Number of 9 31.5 GL devices: 600,000 l Percentage of devices requiring leak tests and shutter tests every 6 months: 10% ,

Percentage of devices in long term storage: 3%

Time per year to perform leak test and shutter test .

- per device (assuming 15 minutes every 6 months): 0.5 hrs l Technical staff hourly rate: $50/hr j I

Total Cost Savings (per year): $45,000 l

. Note that there is not strict compatibility of this requirement for Agreement States, however if there are similar changes made to an Agreement State's regulations, similar savings would result, potentially for a larger number of devices. )

i 1

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6 DECISION RATIONALE lt is recommended that this action be adopted because it represents a reasonable means for the Commission to fulfill its obligation to protect pub!ic health and safety, property, and the environment. It would be implemented to better ensure that certain generallicensees are aware of those requirements with which they must comply, and to provide a more complete system for NRC and the Agreement States regulatory bodies to keep track of the location of their generallicensees as well as track individual devices. The rationale for this recommendation follows, it is estimated that adoption of this regulatory action would result in up-frcot development and implementation costs to the Commission and to Agreement States of $504,000 and $3,750,000 respectively. Also, estimated annual costs would oe $2,282,000 to industry, $107,700 to the Commission and $83,000 to Agreement States. These costs are appropriate considering; 1) the nominal cost per device and full cost recovery requirement,2) the averted radiation exposure, 3) savings in cleanup costs, and 4) increased confidence in the efficacy of the generallicense program.

First, almost the entire cost to licensees is the imposition of fees. This is being done as a matter of equity and is shifting a portion of the overall costs of implementing and enforcing the generallicense requirements from specific licensees to some of the generallicensees who benefit from the general license program. The cost being recovered from the general licensees is not limited to those for implernenting these revisions to the general license program; instead, the cost to generallicensees consists of the cost of that fraction of the overall generallicense program associated with the devices subject to the registration requirement. Since the requirement for full cost recovery was enacted, all costs of the general license program have been recovered from specific licensees. The cost estimate used to develop the amount of the fee includes an estimate of increased inspection and follow up efforts expected to be made as a result of the registration process identifying noncompliance with existing regulations. That cost will now be passed on to the generallicensees associated with the registration requirement. It is also expected that this cost will decline after the initialimplementation of the registration process, in which case, this fee might be reduced in the future.

Although the total cost to general licensees of $2,200,000 is significant, the fee per general licensee is $370, which amounts to an average of $92 per device. The economic impact of this fee is not believed to be significant, especially in comparison to the fees placed upon specific licensees.

Second, the results of the General License Study conducted by the NRC indicated that there is noncompliance with the generallicense requirements contained in 6 31.5(c). The Study revealed that a major reason for noncompliance is that users of the generally licensed devices are unaware that there are regulatory requirements associated with the possession and use of these devices that must be met. Such noncompliance presents a risk of low but avoidable exposure of the public to radiation plus a low probability of significant exposure as a consequence of improper handling or disposal of the devices generally licensed.

Third, this regulatory action will establish a reasonable procedure to ensure that general licensees are aware of the provisions associated with the general license and comply with the 25 l

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applicable regulatory requirements. It is believed that increased awareness and understanding of the NRC's requirements on the part of the generallicensees willincrease the likelihood that general licensees will comply with those requirements and thereby prevent costs to industry, and to State government agencies, from improper handling or disposal of generally licensed devices. The benefit to be realized even further overshadows the small costs when considered in light of the contribution of this action to the possible avoidance of the substantial cleanup costs which have occurred because of past improper disposition of generally licensed devices.

And finally, promulgation of this rule should result in improvement in the accountability for devices and would provide confidence that the use of generally licensed devices is being regulated in an appropriate manner.

7 IMPLEMENTATION The regulatory action is not expected to present any significant implementation problems. The revised computer database system which willinclude the capability of processing registrations is already being developed. General licensees will be sent a copy of the final Federal Reaister notice.

8 EFFECT ON SMALL ENTITIES The action would have an economic impact on general licensees of devices containing byproduct material. There are up to 45,000 generallicensees under @ 31.5 of which 6000 would be required to register devices and pay a fee, some of whom may be "small entities" within the meaning of the Regulatory Flexibility Act (P.L.96-534). The specific provisions proposed here are essentially consistent with the Commission's plans for the registration process discussed in the earlier proposed rule. With the exception of the fee, the provisions would add no further, or minimal impact than that already planned and accounted for under the previous proposed rule. Therefore the economic impact on small entities would be the incurrence of the fee, in the proposed amount of $370, about $92 per device on average. The economic impact on the small entities are not believed to be significant. Most of the distributors of generally licensed devices are not small entities and the impact to any of these distributors l would not be significant in any case. l 26 L

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l ATTACHMENT 4 Congressional Letters b

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i p[" N, .& UNITED STATES g

o j

d NUCLEAR REGULATORY COMMISSION WASHINGTON, D.c. 20065 4001 s...../

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l The Honorable James M. Inhofe, Chairman Subcommittee on Clean Air, Wetlands, i Private Property and Nuclear Safety I

Committee on Environment and Public Works j

~ United States Senate Washington, DC 20510 i

Dear Mr.' Chairman:

)

Enclosed for the information of the Subcommittee is a copy of a Notice of Proposed Rulemaking to be published in the Federal Reoister soon. The U.S. Nuclear Regulatory Commission (NRC) is propcsing to amend 10 CFR Parts 30,31,32,170, and 171 to explicitly requ;re that certain generallicensees register certain devices that they have received for use under a general license and add a registration fee. The NRC plans to institute this registration system for devices using certain quantities of specific radionuclides that are primarily used in commercial and industrial applications under an earlier proposed rule. The enclosed rule would also revise requirements for transfers, storage, reporting, recordkeeping, labeling pertaining to these generally licensed devices.

NRC has observed a number of instances in the past where generally licensed devices nave not j been properly handled or disposed of. This amendmerit would allow NRC to better account for devices that have been distributed for use under the generallicense and thereby reduce the

_ potential for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property.' This change will have no adverse impact on the health and safety of workers or the public and is not expected to impose a significant burden on licensees.

Sincerefy, I

Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosure:

Federal Register Notice cc:~ Senator Bob Graham c

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~ The Honorable Dan Oci Chairman Subcommittee on Energy and Power Committee on Commerce United States House of Representatives Washington, DC 20515

Dear Mr. Chairman:

Enclosed for the information of the Subcommittee ic, a copy of a Notice of Proposed Rulemaking to be published in the Federal Reaister soon. The U.S. Nuclear Regulatory Commission (NRC) ,

is proposing to amend 10 CFR Parts 30,31,32,170, and 171 to explicitly require that certain l general licensees register certain devices that they have received for use under a general license and add a registration fee. The NRC plans to institute this registration system for devices using certain qur.Laed w.' *necific radionuclides that are primarily used in commercial and industrial appliW.,ns under an earlier proposed rule. The enclosed rule would Ao revise requirements for dansfers, storage, reporting, recordkeeping, labeling pertaining to these generally licensed devices.

NRC has observed a number of instances in the past where generally licensed devices have not been properly handled or disposed of. This amendment would allow NRC to better account for devi.:es that have been distributed for use under the generallicense and thereby reduce the pote itial lor incidents that could result in unnecessary radiation exposure to the public as well as

-containint tion of property. This change will have no adverse impact on the health and safety of workers or the public and is not expected to impose a significant burden on licensees.

Sincerely, l

Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosure:

Federal Register Notice cc: ." .cp.e;cnt:'jve Pth N=

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' The Honorable James M. Inhofe, Chairman Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety Committee on Environment and Public Works United States Senate Washington, DC 20510

Dear Mr. Chairman:

Enclosed for the information of the Subcommittee is a copy of a Notice of Proposed Rulemaking to be published in the Federal Reoister soon. The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend 10 CFR Parts 30,31,32,170, and 171 to explicitly require that certain general licensees register certain devices that they i de received for use under a general license and add a registration fee, The NRC plans to institute this registration system for

' devic'es using certain quantities of specific radionuclides that are primarily used in commercial and industrial applications under an earlier proposed rule. The enclosed rule would also revise requirements for transfers, storage, reporting, recordkeeping, labeling pertaining to these generallylicensed devices.

, NRC has observed a number of instances in the past where generally license'd devices have not be'en properly handled or disposed of. This amendment would allow NRC to better account for devices that,have been distributed for use under the generallicense and thereby reduce the potential for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property. This change will have no adverse impact on the health and safety of

~

workers or the public and is not expected to impose a significant burden on licensees.

Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs '

Enclosure:

Identicalletter sent to: The Honorable Dan Schaeffer Federal Register Notice Chairman, Subcommittee on Energy and Power cc: Senator Bob Graham -

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ATTACHMENT 5 i

Draft Press Release )

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NRC PROPOSES ADDITIONAL REQUIREMENTS

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FOR CERTAIN DEVICES CONTAINING RADIOACTIVE MATERIAL The Nuclear Regulatory Commission is proposing to amend its regulations to

? establish additional requirements for users and distributors of radioactive material in certain measuring, gauging and controlling devices.

4 The revisions are aimed at providing greater assurance that users of the devices will properly handle and dispose of them, thus reducing tha mtential for unnecessary radiation exposure' to the public or contamination of property.

The proposed revisions would provide the details of an annual registration 1

program that the NRC plans to initiate. The changes would also require that distributors

. provide additional information to users to provide further assurance that they -

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undeistand the requirements for possession of the devices.

Companies and individuals are permitted to use the devices under an NRC

" general lioense," which means that they need not have a specific license issued to a

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I named individual or organization with specific license conditions and requirements. A '

generally licensed device usually consists of radioactive material contained in a sealed source within a shleided container. A common exampie is a fixed gauge used in a factory to monitor a production process and ensure quality control.

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..x Such a device is designed with inherent radiation safety features so that it can be used by persons with no radiation training or experience. The general license is meant to simplify the licensing process so that a case-by-case determination of the adequacy of radiation training or experience of each user is not necessary.

In the past, NRC has not regularly contacted general licensees because of the relatively small radiation risk posed by the devices. However, there have been a number of instances in which generally licensed devices have not been properly handled or property disposed of. -

The proposed registration requirement would apply to generally licensed measuring, gauging and controlling devices with quantities of certain radioactive

-c  ;. materials posing a higher risk to public safety or of property damage if the device were 1

lost than would other generally licensed devices.

The majority of the devices meeting these criteria are used in commercial and industrial applications measuring thickness, density or chemical composition in industries such as petrochemical and steel manufacturing. About 6,000 general

' licensees possessing about 24,000 devices would come under the registration requirement.

General licensees affected by the registration requirement would have to pay the NRC an annual registration fee of $370.

Specific licensees who distribute the measuring, gauging and controlling devices would be required to provide-before transferring a device to a general licensee-copies of additional applicable sections of the NRC regulations, a listing of the types of service to the devloe that can only be performed by a specific licensee, and info'rmation 2

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l regarding disposal options, including the cost for disposal. The amendments would also modify the reporting, recordkeeping and labeling requirements for distributors.

The Commission has established an interim enforcement policy for violations of NRC regulations that general licensees discover and report during the initial cycle of the registration program. The interim po! icy provides that enforcement action normally will not be taken for violations so identified and reported, provided appropriate corrective action has been taken. This amnesty period, which will remain in effect through one complete cycle of the registration program, should encourage general licensees to search their facilities to ensure that sources are located, to determine if applicable requirements have been met, and to develop appropriate corrective actions when deficiencies are found.

The Commission also plans to increase the civil penalty amounts that would be imposed for violations involving lost or improperly disposed-of devices or radioactive

. material from them. This increase would be to ensure that, after the amnesty period ends, civil penalties for lost sources will be significantly higher than the disposal costs.

Additional details of the proposed revisions to the regulations are contained in a Federal Register notice to be published shortly. Interested persons are invited to submit written comments'within 75 days of the Federal Register notice to the Secretary, U.S.

Nuclear Regulatory Commission, Washington, D.C. 20555-0001, Attention: Rulemakings

~ and Adjudications Staff. Comments may also be submitted via the NRC's interactive rulemaking web site through the NRC home page at http://www.nrc.nov, Information on this site is available from Carol Gallagher,301/415-5905; e-mail CAG@nrcs 3

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i ATTACHMENT 6 i 1

Form XXX - Transfers of Industrial Devices Report i

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Form XXX - Transf:rs of Industrial DsviceS Report Page of _

Name cf Vendor: Reporting Period:

License Number: From: To:

For each " person" to whom a device (s) has been transferred dunng the reporting period, supply the following:

Intermediate Person (if any) j Name:

1. cnd Street: i City, State, and Zip Code:

N:me of Responsible Individual: Telephone number:

General Licensee User Information Name:

Depart,aent:

1. cnd Street:

City, State, and Zip Code:

Name of Responsible Individual: l Telephone number:

Information on Device (s) Transferred:

Dat:< of Transfer: /d Type of Device: Model Number:

replacement Serial number: Isotope: Activity and Units:

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In the case of replacements provide foliowing for device (s)

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received:

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N::me:

1. cnd Street:

City, State, and Zip Code:

Name of Responsible Individual: Telephone number:

General Licensee User Information Name:

Department:

1. cnd Street:

City, State, and Zip Code:

N:.me of Responsible Individual: Telephone number:

Information on Device (s) Transferred:

Dato of Transfer: /d Type of Device: Model Number: Sena! number: Isotope: l Activity and Units:

replacement l

In the case of replacements, M93 provide folk, wing for device (s)  %,

received:

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. ATTACHMENT 7 Draft NUREG-1556, Vol.16, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Gerieral License Distribution Licenses j i

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