ML20216H694

Forwards Updated Versions of Proposed Rule Revs to Parts 30,31,32,170 & 171 Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct Matl & FRN Showing Commission-requested & Other Changes

ML20216H694
Person / Time
Issue date:	07/02/1999
From:	Patricia Holahan NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Meyer D NRC OFFICE OF ADMINISTRATION (ADM)
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 AG03-1-021, NUDOCS 9910010446
Download: ML20216H694 (175)

Text

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' F'DR July 2, 1999 MEMORANDUM TO: David L. Meyer, Chief Rules and Directives Branch Division of Administrative Services l Office of Administration FROM: Patricia K. Holahan, Acting Chief Rulemaking and Guidance Branch %! s'en.f '- )

Division of Industrial and I Medical Nuclear Safety, NMSS l

SUBJECT:

IMPLEMENTATION OF JUNE 15,1999, SRM: PROPOSED  !'

RULE: REVISIONS TO PARTS 30,31,32,170, AND 171, REQUIREMENTS FOR CERTAIN GENERALLY LICENSED INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL 4

On June 15,1999 the Commission approved the proposed rule on the above subject as set out in SECY-99-108 with minor changes and the addition of questions for comment. The staff has informed the Commission that additional changes are needed to update the number of affected j licensees and revise the fee to reflect that change. Some minor corrections and clarifications have also been made.

Please implement the Commission's action by arranging for publication of the attached I proposed rule in the Federal Reoister allowing 75 days for public comment.

Attached is a marked-up copy of the Federal Register notice showing Commission-requested and other changes for transmittal to the Office of the Secretary.

Also attached is the Draft Regulatory Analysis for forwarding to the PDR, a Congressional l Letter package, and a Draft Press Release. l Attachments:

1. Federal Register Notice of Proposed Rulc I

+ 2 Copies and Diskette i

2. Marked-up copy of FR notice

3. Draft Regulatory Analysis

4. Congressional Letters

5. Draft Press Release Distribution: NMSS Ticket No. 199900306/ WITS No. 199600071 RGordon/RF LRiani SWoods Meridgers, EDo IMNS/ Central File DMendiola DBroaddus NMSS R/F CGallagher JMcCausland NRC Central File PHolahan CPoland (o:\MATTSEN\GL2P\ ADMIN.MEM) to receive a copv Of tM11 flocument, trdficate in the tm 'C'

• copy without attacftwnt/ent101 pre. *8*

• c0Dy with attachltrit/ enc 105ure. *N*

• 400 Copy j OFFICE: RGB/IMNS O RGS/_IMMS NAME: CMattsent.b. o hn .

DATE: 4 / 3 0/99 7 / A /99 0FFICIAL RECORD COPY 9910010446 990928 POR PR 30 64FR40295 PDR

, C{6f p0l 6LlL(6

F f? 4 UNITED STATES jo,* )If j

. NUCLEAR REGULATORY COMMISSION

• WASHINGTON. D.C. 20555-0001

1. July 2, 1999 MEMORANDUM TO: David L. Meyer, Chief Rules and Directives Branch Division of Administrative Services Office of Administration FROM: J, dtr cla K. Holahan, Acting Chief Rulemaking and Guidance Branch

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Division of Industrial and

's Medical Nuclear Safety, NMSS

SUBJECT:

IMPLEMENTATION OF JUNE 15,1999, SRM: PROPOSED RULE: REVISIONS TO PARTS 30,31,32,170, AND 171, REQUIREMENTS FOR CERTAIN GENERALLY LICENSED INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL On June 15,1999 the Commission approved the proposed rule on the above subject as set out in SECY-99-108 with minor changes and the addition of questions for com-ment. The staff has informed the Commission that additional changes are needed to update the number of affected licensees and revise the fee to reflect that change. Some minor corrections and clarifications have also been made.

Please implement the Commissi6n's action by arranging for publication of the attached proposed rule in the Federal Reaister allowing 75 days for public comment.

Attached is a marked-up copy of the Federal Register notice showing Commission-requested and other changes for transmittal to the Office of the Gecretary.

Also attached is the Draft Regulatory Analysis for forwarding to the PDR, a Congressional )

Letter package, and a Draft Press Release. i Attachments:

1. Federal Register Notice of Proposed Rule

+ 2 Copies and Diskette

2. Marked-up copy of FR notice

3. Draft Regulatory Analysis -

4. Congressional Letters

5. Draft Press Release l

CONTACT: Catherine R. Mattsen, NMSS/IMNS l (301) 415-6264 l

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i ATTACHMENT 1 Federal Register Notice of Pr'oposed Rule

+ 2 Copies and Diskette 9

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NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30,31,' 32,170, and 171 RIN 3150 - AG03 Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct Material

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' AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

SUMMARY

The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations governing the use of byproduct materialin certain measuring, gauging, or controlling devices. )

The proposed amendments would include adding explicit requirements for a registration process that the NRC plans to initiate through a related rulemaking, would add a registration fee, and would clarify which provisions of the regulations apply to all general licenses for byproduct material. The proposed rule would also modify the reporting, recordkeeping, and labeling requirements for specific licensees who distribute these generally licensed devices.

The proposed rule is intended to allow the NRC to better track certain general licensees and the

' devices they possess and to further ensure that generallicensees are aware of and understand the requirements for the possession of devices containing byproduct material.

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

1 l

' 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 may 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 @ nrc. gov.

Certain documents related to this rulemaking, including commenis 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 rulemakirig.

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.

2 r ,

i 4 SUPPLEMENTARY INFORMATIONi

Background

On February 12,19S9 (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 contained in certain measuring, gauging, or controlling devices. Under current regulations in 10 CFR 31.5, 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 distribution of generally licensed devices is issued if a regulatory authority determines that the safety feat'ures of the device and the instructions for its safe operation are adequate and meet regulatory requirements.

The person or firm who receives such a device is a general licensee. These general licensees are subject to requirements for maintaining labels, following instructions for safe use, storing or disposing of the device properly, and reporting transfers and failure of or damage to the device. For some devices, the general licensee must also comply with testing requirements for leakage and for proper operation of on-off mechanisms. Generallicensees are also subject to the terms and conditions in @ 31.2 concerning general license requirements, transfer of byproduct material, reporting and recordkeeping, and inspection. Generallicensees must comply with the safety instructions contained in or referenced on the label of the device and must have the testing or servicing of the device performed by an individual who is authorized to manufacture, install, or service these devices except as indicated on the label.

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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. The general license simplifies the licensing process so that a case-by-case determination of the adequacy of the radiation training or experience of each user is not necessary.

1 There are about 45,000 gererallicensees authorized by 31.5 to possess about 600,000 devices that contain byproduct material. The NRC has not contacted or inspected ,

these general licensees on a regular basis because of the relatively small radiation risk posed I

by these devices.

Individuals who possess devices under this general license are not always aware of applicable requirements and thus are not necessarily complying with all of these requirements.

The NRC is most concerned about 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 property. Some generally licensed devices have been accidentally melted in steel mills causing considerable contamination of the mill, the steel product, and the wastes from the process, the slag and the baghouse dust. A!though known exposures have generally not exceeded the public dose limits, there is a potential for significant exposures.

The NRC conducted a 3-year sampling (1984 through 1986) of generallicensees to assess the effectiveness of the generallicense program. The sampling revealed several areas of concern regarding the use of generally licensed devices. In particular, the NRC concluded 3

that --

(1) Many generallicensees are unaware of the regulations that apply to the possession of a generally licensed device; and 4 l 4

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(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 j their generally licensed devices. The NRC concluded that these problems could be resolved by

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more frequent and timely contact between general licensees and the NRC.

On December 27,1991 (56 FR 67011), the NRC published a notice of proposed rulemaking concerning the' accountability of generally licensed devices. The proposed rule contained a number of provisions, including a requirement under 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 Q& 32.51a and 32.52 for specific licensees who manufacture or initially transfer generally licensed devices. Although the public comments received were reviewed and a final rule developed, a final rule was not issued because the resources to fully implement the 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 the Organization of Agreement States, formed a working group to evaluate these issues. The j 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 I published in October 1996 as NUREG 1551," Final Report of the NRC-Agreement State Working Group to Evaluate Control and Accountability of Licensed Devices."

In considering the recomrnendations of this working group, the NRC decided, among other things, to again initiate rulemaking to establish an annual registration of devices generally licensed under 6 31.5. This registration program would be similar to the program originally proposed in the 1991 proposed rule. However, it would apply only to those devices considered 5

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to present a higher risk of potential exposure of the public or property loss in the case of loss of control (compared to other generally licensed devices). Initially, the NRC has been using the criteria developed by the working group for determining which sources should be subject to the registration program. Using these criteria, it is now estimated that the registration requirement would apply to about 5100 general licensees possessing about 20,000 devices. These criteria were based on considerations of relative risk and are limited to radionuclides currently in use in these types of devices. If quantities of other radionuclides that would present a similar risk are used in these devices in the future, the criteria may be revised to include additional radionuclides. The Commission may also consider revising the criteria to include a larger number of devices in the registration requirement for other reasons in future rulemaking.

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. The Atomic Energy Act of 1954 (AEA), as amended, provides the NRC with the authority to request information from its licensees conceming licensed activities. However,' the l

Commission had not included an explicit provision in its regulations that would require 6 31.5 l l

general licensees to provide information on request. On December 2,1998 (63 FR 66492), the

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- Commission published a' proposed rule that would explicitly require general licensees who possess certain measuring, gauging, or controlling devices to provide the NRC with infomiation about the devices. Assuming it becomes'a final rule, the NRC intends to use that provision primarily to institute a registration and 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 rulemaking was not proposed as a matter of compatibility for Agreement States. That proposed rule presented an estimate of 6000 general licensees, based on the estimates made in the working group report. However, this had not accounted for the fact that, in the interim, Massachusetts had become an Agreement State.

[ Using the same criteria, and removing the previously NRC general licensees in Massachusetts, 6

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results in an estimate of 5100 NRC generallicensees that would be subject to the registration requirement.

This proposed rule would ' add specific requirements concerning the registration of devices and additional provisions of an enhanced regulatory oversight program for all gene'ral

' licensees to be registered. The proposed rule 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 required.. Some States have already instituted some form of enhanced oversight for these general licensees. In a few cases, States have instituted a registration 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, duplications, or gaps. However, the manner in which the essential objectives of the regulation are addressed ,

need not be the same as NRC. Strict compatibility would only be required for revisions to the requirements applicable to distributors because of interjurisdictional distribution.

Discussion i

The December 2, '1998, proposed rule would provide one of the key elements in improving the accountability and control over devices of particular concern through the institution of a registration process. However, current regulatory provisions are inadequate'to allow for the NRC to track general licensees and the specific devices they possess. The NRC needs to track these general licensees in order that they can be contacted or inspected when appropriate.1 The NRC also needs to track individual generally licensed devices, so that the responsible party can be identified when a device is found in an inappropriate situation.

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l Tracking devices would also allow th'e NRG to contact the appropriate general licensees if a generic defect in a group of devices is identified. As noted, that proposed rule would not l

require Agreement State regulations to be compatible. I 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 l recommendations of the NRC-Agreement State Working Group, and identified additionalissues  !

concerning these devices in developing this proposed rule.

G Summary and Discussion of Proposed Requirements Revisions to the Requirements for General Licensees under 9 31.5.

Reaistration. This proposed. rule would add explicit provisions delineating an annual registration requirement, as well as a registration fee. The registration process would be initiated under 31.5(c)(11), proposed on December 2,1998, if that requirement is adopted in a final rule. Proposed % 31.5(c)(11) would require licensees to respond to requests for -

information frorn NRC within 30 days or as otherwise specified. The provisions proposed in this document (new 31.5(c)(13)) are essentially consistent with the Commission's plans for the registration process discussed in the December 2,1998, proposed rule. This proposed rule would specifically require that the information about devices be verified by the licensee through

' a physical inventory and by checking labelinformation. The advantage of including more explicit requirements in the regulation is that information about the registration process will be

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- more clearly defined and more available. When the distributor of a device supplies copies of 31.5 to its customers (under 9 32.51a(a)), the potential general licensees would be made h

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PROPOSED RULE PR soa, 3x <2o <,2, czSg001.Pj

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NUCLEAR REGULATORY COMMISSION g.

10 CFR Parts 30,31,32,170, and 171 K RIN 3150 - AG03 i

Requirements for Certain Generally Licensed lodustrial Devices Containing Byproduct Material I

AGENCY: Nuclear Regulatory Commission.

-- ACTION: Proposed rule.

SUMMARY

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

The proposed amendments would include adding explicit requirements for a registration I process that the NRC plans to initiate through a related rulemaking, would add a registration fee, and would clarify which provisions of the regulations apply to all generallicenses for byproduct material. The proposed rule would also modify the reporting, recordkeeping, and labeling requirements for specific licensees who distribute these generally licensed devices.

The proposed rule is intended to allow the NRC to better track certain general licensees and the devices they possess and to further ensure that generallicensees are aware of and understand the' requirements for the possession of devices containing byproduct material. I f 7oulI

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f& on v/a4/99 b

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C W 42,1999 l DATES: Submit comments by (!=cd it 75 ii .L rn_Sr 6M). Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.

l i.

i l ' 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 l

l and 4i15 pm on Federal workdays.

.You may 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 j 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 @nrc. gov.  ;

I 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.

- 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.

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' SUPPLEMENTARY INFORMATION:

Background

. On February 12,1959 (24 FR 1089), the Atomic Energy Commission (AEC) amended its regulations to provide a general license (10 CFR 30.21(c)) for the use of byproduct ma contained in certain measuring, gauging, or conuolling devices. Under current regulations in 10 CFR 31.5, 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 authorizi distribution of generally licensed devices is issued if a regulatory authority determines that the safety features of the device and the instructions for its safe operation are adequate and regulatory requirements.

The person or firm who receives such a device is a generallicensee. These general licensees are subject to requirements for maintaining labels, following instructions for safe use

' storing or disposing of the device properly, and reporting transfers and failure of or dama the device.' For some devices, the generallicensee must also comply with testing requirement for leakage and for proper operation of on-off mechanisms. Generallicensees are also to the terms and conditions in %'31.2 concerning general license requirements, transfer of

- byproduct material, reporting and recordkeeping. and inspection. Generallicensees m i d

.. comply with the safety instructions contained in or referenced on the label of the dev must have the testing or servicing of the device performed by an individual who is authoi l

manuf acture, install, or service these devices except as indicated on the label. i y

3

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. The general license simplifies the licensing process so that a case-by-case determination of the adequacy of the radiation training or experience of each user is not necessary.

There are about 45,000 generallicensees authorized by 6 31.5 to possess about 600,000 devices that contain byproduct material. The NRC has not contacted or inspected these generallicensees on a regular basis because of the relatively small radiation risk posed by these devices.

Individuals who possess devices under this general license are not always aware of applicable requirements and thus are not necessarily complying with all of these requirements.

The NRC is most concerned about 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 property. Some generally licensed devices have been accidentally melted in steel mills causing considerable contamination of the mill, the steel product, and the wastes from the process, the slag and the baghouse dust. Although known exposures have generally not exceeded the public dose limits, there is a potential for significant exposures.

The NRC conducted a 3-year sampling (1984 through 1986) of general licensees to assess the effectiveness of the generallicense praccam. The sampling revealed several areas of concern regarding the use of generally licensed devices. In particular, the NRC concluded that -- '

(1) 6.9.iy general licensees are unaware of the regulations that apply to the possession of a generally licensed device; and 4

(2) Many general licensees are unable to account for their devices.

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

On December 27,1991 (56 FR 67011), the NRC published a notice of proposed rulemaking conceming the accountability of generally licensed devices. The proposed rule contained a number of provisions, including a requirement under @ 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 66 32.51a and 32.52 for specific

licensees who manufacture or initially transfer generally licensed devices. Although the public comments received were reviewed arid a final rule developed, a final rule was not issued because the resources to fully implement the 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 the Organization of Agreement States, formed a working group 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 s Working Group to Evaluate Control and Accountability of Licensed Devices."

In considering the recommenda: ions of this working group, the NRC decided, among

. other things, to again initiate rulemaking to establish an annual registration of devices generally licensed under 6 31.5. This registration program would be similar to the program originally 1

proposed in the 1991 proposed rule.- However, it would apply only to those devices considered i

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to present a higher risk of potential exposure of the public or property loss in the case of loss of control (compared to other generally licensed devices). Initially, the NRC has been using the l

criteria developed by the working group for determining which sources should be subject to the l

' registration program. Using these criteria, it is now estimated that the registration requirement i

would apply to about 5100 generallicensees possessing about 20,000 devices. These criteria were based on considerations of relative risk and are limited to radionuclides currently in use in these types of devices. If quantities of other radionuclides that w auld present a similar risk are used in these devices in the future, the criteria may be revised to include additional radionuclides. The Commission may also consider revising the criteria to include a larger number of devices in the registration requirement for other reasons in future rulemaking.

The Atomic Energy Act of 1954 (AEA), as amended, provides the NRC with the authority to request information from its licensees concerning licensed activities. However, the Commission had not included an explicit provision in its regulations that would require 31.5 generallicensees to provide information on request. On December 2,1998 (63 FR 66492), the Commission published a proposed rule that would explicitly require general licensees who possess certain measuring, gauging, or controlling devicas to provide the NRC with information about the devices. Assuming it becomes a final rule, the NRC intends to use that provision primarily to institute a registration and 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 lott . That rulemaking was not proposed as a matter of compatibility for Agreement States. That proposed rule presented an estimate of 6000 general licensees, based on the estimates made in the working group report. However, this had not accounted for the fact that, in the interim, Massachusetts had become an Agreement State.

Using the same criteria, and removing the previously NRC general licensees in Massachusetts, 6

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results in an estimate of 5100 NRC general licensees that would be subject to the registration requirr, ment.

l This proposed rule would add specific requirements concerning the registration of devices and additional provisions of an enhanced regulatory oversight program for all general licensees to be registered. The proposed rule 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 required. Some States have already instituted some form of enhanced oversight for these generallicensees. In a few cases, States have instituted a registration 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, duplications, or gaps. However, the manner in which the essential objectives of the regulation are addressed need not be the same as NRC. Strict compatibility would only be required for revisions to the requirements applicable to distributors because of interjurisdictional distribution.

Discussion 4 i

The December 2,1998, proposed rule would provide one of the key elements in improving the accountability and control over devices of particular concern through the institution of a registration process. However, current regulatory provisions are inadequate to allow for the NRC to track general licensees and the specific devices they possess. The NRC needs to track these general licensees in order that they can be contacted or inspected when appropriate. The NRC also needs to track individual generally licensed devices, so that the responsible party can be identified when a device is found in an inappropriate situation.

7

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Tracking devices would also allow the NRC to contact the appropriate general licensees if a generic defect in a group of devices is identified. As noted, that proposed rule would not require Agreement State regulations to be compatible.

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 concerning these devices in developing this proposed rule. l Summary and Discussion of Proposed Requirements i

Revisions to the Requirements for General Licensees under 9 31.5.

. Reaistration. This proposed rule would add explicit provisions delineating an annual j registration requirement, as well as a registration fee. The registration process would be J

initiated under 31.5(c)(11), proposed on December 2,1998, if that requirement is adopted in a final rule. Proposed 6 31.5(c)(11) would require licensees to respond to requests for  ;

i information from NRC within 30 days or as otherwise specified. The provisions proposed in this

, document (new 6 31.5(c)(13)) are essentially consistent with the Commission's plans for the registration process discussed in the December 2,1998, proposed rule. This proposed rule would specifically require that the information about devices be verified by the licensee through a physical inventory and by checking label information. The advantage of inclu' ding more I

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 l 31.5 to its customers (under 9 32.51a(a)), the potential general licensees would be made I-I l 8

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aware of the registration requirement, the devices to which it applies, the nature of the registration information, and the registration fee.

An organization which uses generally licensed devices at numerous locations is considered a separate general licensee at each location. Different facilities at the same complex or campus are not, however, considered separate locations. In the case of portable i 1

devices that are routinely used at multiple field sites, there is one general licensee for each primary place of storage, not for each place of use. Thus, an organization would be required to complete more than one registration, if it possess devices subject to registration at multiple distinct locations.

The proposed rule would add a fee to 9170.31 to be assessed in conjunction with the '

annual registration process. This registration fee would be for each generallicensee filing a registration under $ 31.5(c)(13) regardless of the number of devices. As noted above, an organization is considered to be a separate general licensee at each separate address at which devices are used, and would be assessed a registration fee for each location of use.

The NRC is required by the Omnibus Budget Reconciliation Act of 1990, as amended  ;

(OBRA-90), to recover approximately 100 percent of its budget through fees. Since OBRA-90 was enacted, all costs of the generallicense program have been recovered through annual fees paid by specific licensees. The proposed registration fees would recover the cost of the general license program associated with this group of general licensees in an equitable way, as required by law. Those who are allowed to use devices under the general license would now bear the operational cost of the program instead of those who hold specific licenses. However, it should be noted that the initial program startup costs would be recovered from the annual fee

. paid by current holders of specific licenses.

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1 The costs to be recovered through the registration fee include the costs for obtaining and maintaining information associated with the devices subject to the registration requirement, the costs of processing and reviewing the registrations, and the costs for inspections and follow-up efforts expected to be made as a result of the registration process identifying noncompliance ivith existing rogulations. The fee would be based on the average cost of the program for each of the licensees registering devices. Some of the gerallicensees, such as non-profit educational institutions, will be exempt from the fee under 170.11. Costs not I

recovered from this small segment of the generallicensees registering devices would continue to be recovered from annual fees paid by current holders of specific licenses.

It is expected that the overall cost will decline after the initial years of implementation of the registration process, due to increased compliance leading to reduced inspection and follow-up. However, the number of generally licensed devices in NRC jurisdiction is reduced when a l State becomes an Agreement State and takes over responsibility for the general licensees in that State. Although a large part of the cost of the program is proportional to the number of  ;

generallicensees, a portion of the cost is fixed. Thus, the cost per generallicensee could increase if the number of generallicensees subject to registration decreases. The proposed registration fee is $420 based on the current estimated cost of the program and the current number of generallicensees with devices that would be subject to registration. If additional States become Agreement States before this rule is made final, the fee could be somewhat higher in the final rule.

The Commission considered other approaches to the proposed fee structure, such as a fee per device or a sliding scale, i. e., fees set for a few ranges of numbers of devices.

However, basing fees on the number of devices or a sliding scale would not necessarily meet the intent of the Independent Offices Appropriation Act of 1952 (IOAA), which is the authority 10

under which 10 CFR part 170 fees are established. The IOAA provides that fees recover ,the agency's cost in providing the service. The agency's costs to register generally licens i

devices at each location is projected to be nearly the same regardless of the nurnber of l j

sources / devices possessed by the licensee. Costs of follow-up and inspection do not go up f

substantially with increased numbers of devices. In addition, these alternative methoI complicate the determination of the proper fee and the fee recovery process, noti but for the registrants as well. With the uncertainty of the licensees' status from one ye iext, the additional administrative effort related to the reconciliation of the fee based on th number of devices possessed from year to year, would not be cost effective; considering total amount projected to be recovered for the registration program. Additionally, under th attemative methods a large diversified firm that owns one device would pay a reduced fee ,

while a small entity whose business may depend solely on the use of the devices might pa disproportionate fee because it has more than one device. The NRC believes fee on a per device basis or a sliding scale would not result in a fair and equita its regulatory costs, and would not achieve the goal of the Regulatory Flexibility the impact of fees on small entities. The NRC believes that the proposed approac assessing a fee for each licensee subject to registration --

(1) Better reflects the costs to administer the program, (2) is most consistent with existing NRC fee assessment practices, (3) Would simplify fee collection,

. (4) Would be fair'and equitable, and (5) Would minimize impacts to small entities.

The planned registration process will be somewhat different from that used i Commission's other registration programs, in which blank forms are filled out by re 11 i

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_ instead, it is planned to send a registration request containing the information recorded in the Commission's database, which would ask the general licensee to verify, correct, and/or add to the information provided. This would be similar to the approach typically used by States for the renewal of automobile' registrations. This is intended to be more efficient for the general licensees and the Commission.

The first registration that would be carried out under 9 31.5(c)(11) would depend on the NRC's ability to contact general licensees because the NRC must request the information. This proposed rule also specifies that the general licensee would complete registration by verifying, correcting, and/or adding to the information in a reouest for registration received from the I i

' Commission. It is silent on when or how general licensees should register if the Commission fails to contact the generallicensee. Thus, it might be interpreted that, if the Commission fails to contact a general licensee, the registration requirement would not apply. The Commission i seeks comment on whether the registration requirement should include a provision that would require the general licensee to complete registration by a certain time, such as 15 months 6 after -

1 (1) The date of the previous registration certificate; . i (2) The receipt of a device subject to registration; or -

(3) The effective date of this rule for an unregistered device pcssessed at the time of the l effective date of a final rule' enacted in response to this proposed rule.

This would put the burden of regie 9 g on general licensees who have not been notified by the NRC of the requirement. The intent would be for general licensees who find out about the new 1

requirements, for example', from a distributor, to contact the NRC to begin the registration process. If this. approach were taken, the Commission would likely exercise enforcement y 12

discretion in cases where the Commission locates a general licensee who has not previously '

registered devices,if the generallicenste was unaware of the requirement. It is recognized l

that some general licensees who have received devices in the past may never be located.

The time of year for registration would vary for licensees. However, requests for renewal of registration would be made approximately 1 year after the previous registration request for that licensee. Although registration would not be required before the receipt of a device, the Commission plans to send requests for registration to new general licensees subject to registration that are identified in distributors' quarterly transfer reports submitted under

$ 32.52 shortly after this information is received and recorded. If a general licensee has previously registered devices and receives addibonal devices requiring registration, the new devices would be registered when the annual reregistration is carried out. The Commission requests comment on whether the NRC should have earlier contact with previous registrants who receive additional devices, either by an acknowledgment by NRC to the user or by a 1

required response from the general licensee that accounts for the additional device (s). The effective date of the registration fee will be set to apply after the initial registration requests have been sent for response under @ 31.5(c)(11) so that the first round of annual registration will be ~ complete prior to this effective date and the fee will be imposed with the first reregistration for all devices currently in use.

Other revidons for G 31.5 aeneral licensees. Thu proposed rule would establish additional requirements for all general licensees under Q 31.5. These proposed requirements include --

(1) An explicit requirement for the generallicensee to appoint an individual assigned responsibility'for knowing what regulatory requirements are applicable and having authority to

- take required actions to comply witie she applicable regulations and through whom the general 13

f 4

4 liGrisee carries out its responsibilities to comply with the applicable regulations (new 9 31.5(c)(12));

_ (2) A provision that limits the amount of time a general licensee can keep an unused device in storage and allows the deferment of testing during the period of storage (new

$ 31.5(c)(15));

(3) A provision to allow transfers to specific licensees authorized under part 30, or equivalent Agreement State regulations, as waste collectors, in addition to currently allowed transfers to part 32 (and Agreement State) licensees; to allow transfers to other specific licensees but only with prior written NRC approval; and to add the recipient's license number, the serial number of the device, and the date of transfer to the information required to be provided to NRC upon transfer of a device (revision of 31.5(c)(8));

_ (4) A provision to .iotify NRC of address changes, including name changes (new Q 31.5(c)(14));

(5) Far device damage or failures that are likely to or are known to have resulted in contamination, the addition of a plan for ensuring that premises and environs are suitable for unrestricted access, to the information that must be sent to NRC in the case of a failure; a change to the addressee for reporting information concerning a failure; and a note that the

- criteria in 6 20.1402, " Radiological criteria for unrestricted use," may be applied by the Commission in the case of contamination in spite of the exemption in 31.5(c)(10) (revision to j

$ 31.5(c)(5)); and

- (6) A revision of the reporting requirement, in the case of a transfer to a general licensee l taking over possession of a device at the same location, to provide the serial number of the j device and the name and phone number for the person designated as the responsible i i

individual, rather than simply a contact name (revision to Q 31.5(c)(9)(i)).

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p- 1 The rationale for each of these proposed amendments is:

(1) New 31.5(c)(12) - Responsible person. 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, an individual in the co@ ration or institution must be aware of the requireraents and be authorized to take the required actions. Appointing a specific individual to be responsible for knowing about and taking actions to comply with regulations is an appropriate operatic.;a, practice, which, unfortunately, is not always followed. If a device is net subject to testing under 9 31.5(c)(2),

there are no routine actions required to be taken, because the requirements are generally restrictions on actions, such as not abandoning the device, or actions to be taken only in the case of particular, non-routine events, such as notification of NRC of the transfer or failure of the device. It is this type of situation, where knowledge of the nature of the device, the general license, and the associated regulations is unlikely to be maintained and passed on to individuals using the device. Requiring the assignment of the responsibility for knowing and having authority to take required actions for complying 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 does not have to work on site at the place of use of the device and does not have to conduct all required actions, but would be responsible to ensure that the generallicensee is aware of required actions to be taken. This assignment does not relieve the generallicensee of responsibility.

The NRC/ Agreement State Working Group recommended that general licensees assign a backup responsible individual (BRI) as well. The proposed rule does not include this requirement, but the Commission solicits comment on this issue and will consider adding it to 15 L

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the final rule. A BRI would add some assurance that there is a continuation of knowledge of the requirements in the event of the person assigned to be the responsible individual leaves his assigned duties. However, even without a BRI, the generallicensee would have the responsibility under the proposed rule to replace the responsible individual to maintain compliance with proposed @ 31.5(c)(12).

(2) New $ 31.5(c)(15) - Timeliness of disposition and deferral of testing while in storage.

When a device is not in use for a prolonged time, it is particularly susceptible to being forgotten and ultimately disposed of or transferred inappropriately. General licensees are unlikely to keep a device unused for more than 2 years and subsequently use it. If a device is being held in storage indefinitely, it is likely that it is being stored to avoid the costs of proper disposal. If a generallicensee intends to use a device after a period of more than 2 years of nonuse, 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 9 31.5(c)(15) indicating the reason (s) why the licensee intends to use the device after 2 years and prefers to keep it on site in the interim.

If a period of storage exceeds the normalinterval for testing, testing would not need to I

be done until the device is to be put back into use again. This would relieve the burden of )

I unnecessary testing during the period of storage as well as eliminate any unnecessary exposure that could occur during testing for that period.

(3) Revision to 31.5(c)(8) - Provisions for transfers to specific licensees. This proposed revision would provide some flexibility to the generallicensee in transferring a device while ensuring that it is transferred appropriately. It would allow a generallicensee to transfer a device directly to a waste collector for disposal, rather than going through a distributor. It would 16

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 the device.

The inclusion of a recipient's license number in the report of transfer would better ensure that the generallicensee has verified that the recipient is a part 32 licensee, a part 30 waste collection licensee, or a specific licensee under equivalent Agreement State regulations authorized to receive it. It would also supply an additional means for NRC to identify the recipient, because company names and addresses sometimes change. The addition of the date of transfer will make the transfer easier to track and help to ensure that the general ,

licensee makes the report in a timely manner (required within 30 days of transfer).

(4) New 31.5(c)(14) - Change of address notification (including change in name of I

generallicensee). The quarterly reports required of distributors under 32.52(a) and (b) are i intended to provide NRC and the Agreement State regulatory agencies with the identity of general licensees in their jurisdictions and addresses at which these general licensees can be contacted (proposed to now be specifically the mailing address for the location of use of the generally licensed device). These general licensees can then be contacted or inspected. If generallicensees move their operations without not;fying the NRC, or appropriate Agreement State agency, they may be difficult to locate. Even a change of name can cause mail to be returned. This proposed requirement to report address changes would only apply to previously supplied mailing addresses and, for portable devices, the mailing address for the primary place of storage, although the devices may be used at multiple field sites. For those registering devices, other changes in addresses, if different from the mailing address for the location of use, will be provided at the time of the next registration. Note: changes to the general licensee, other than a simple name change, such as in the case of a sale of a company, require reporting of additionalinformation under Q 31.5(c)(9)(i).

17

4 This simple change of address notification is intended to track moves into and within NRC jurisdiction and to maintain current mailing address information. The general license in

$ 31.5 only applies to persons within NRC jurisdiction. If a general licensee intends to move from one jurisdiction to another, it should contact the applicable regulatory authority, NRC or the particular Agreement State, before doing so to determine the applicable, current regulations in that jurisdiction. All jurisdictions do not have a comparable general license and specific provisions of the generallicense may vary among jurisdictions. If a generallicensee has obtained a portable device in an Agreement State and wishes to use the device within NRC jurisdiction, it must do so under $ 31.5, because there is no reciprocity provision applicable to generallicenses. In this case, they would be subject to the provisions of 31.5.

(5) Revision to 6 31.5(c)(5)- Reports of device failures. Generallicensees are not subject to decommissioning requirements. A general license is granted by regulation and, under normal circumstances, does not involve any 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 respond to the notification of an incident made under 6 31.5(c)(5) to ensure that a facility is properly decontaminated. Following such an incident, the NRC would determine what actinns are necessary on a case-by-case basis and, if necessary, would apply the criteria set out in 9 20.1402, " Radiological criteria for unrestricted i

use." The generallicensee is exempt from this sect;on of part 20 when in possession of an intact generally licensed device. However, when a device has been damaged, the material in the device may no longer be fully contained within the device, i.e., it may also be unsealed radioactive material. Action can be taken by the NRC under 9 30.61, " Modification 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 18

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t. hat 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 G 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 and to eliminate the need for the general licensee to refer to part 20 to determine the appropriate addressee. The addressee and address for registration will be specified in tha registration request. Adding a note concerning the possible applicability of 9 20.1402 is a clarification.

(6) Revision to S 31.5(c)(9)(i) - Reporting new general licensee's responsible individual.

Consistent with the provision for appointing an individual through whom the generallicensee will 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 responsibility for the device.

An additional proposed amendment to 6 31.5 would clarify the status of a person who receives a device through an unauthorized transfer and would remove a restriction on devices.

Paragraph (b) would be revised to (1) limit the applicability of the general license to those who receive a device through an authorized transfer and (2) expand the applicability of the general license to devices authorized for distribution by an Agreement State that has no generallicense covering the use of such devices within that State.

Concerning the first of these issues, the NRC has generally, although not consistently, interpreted the generallicense to apply to any recipient within the group identified in 31.5(a),

i.e., ".. commercial and industrial firms and research, educational and medical institutions, 19

- individuals in the conduct of their business, and Federal, State or local government agencies.." ,

. even if the device is received through an unauthorized transfer. The proposed language would clearly provide that the generallicense does not apply J the device is obtained through an unauthorized transfer. In the case of an unauthorized transfer, the recipient would possess the device without a license.

Paragraph 31.5(b) currently restricts applicability of the generallicense in the case of devices from distributors in Agreement States, to those devices from Agreement States that authorize the devices to be used under a general license within their respective States.

However, the NRC practice is to allow a device to be used under the general license in 31.5, that is distributed in accordance with a license issued under equivalent regulations to Q 32.51 by an Agreement State that does not authorize devices to be used under a general license within j their State. This approach reserved for NRC the right to require distributors in this situation to obtain an NRC distribution license in order to transfer devices into NRC jurisdiction, but did not 4

require them to do so as long as the State issued acceptably equivalent licenses. Through l

NRC's oversight of Agreement State programs, NRC ensures the safety of these devices.

Given this fact and the experience to date with these few States, the Commission believes that this restriction is no longer necessary, in addition to the proposed changes to Q 31.5, other amendments are proposed that would clarify which sections of the regulations in part 30 apply to all of the generallicensees 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 apply to part 31 generallicensees. Section 31.2," Terms and conditions," would be amended to reference the l

sections of part 30 that are applicable to all of the part 31 generallicensees, including Q 30.7, l

30.10,

" Employee protection," 9 30.9," Completeness and accuracy of information," and f

i 20 l c j

" Deliberate misconduct." The proposed clarification would make it easier for general licensees to be aware of applicable regulations. In addition, future amendments to part 30 that would I l

apply to part 31 general licensees would include a conforming amendment to part 31. Note, however, that whilc s 31.2 would specify sections of part 30 generally applicable to general licenses, it would not eliminate the applicability of other parts of the Commission's regulations that may apply.

The applicability of 30.34(h) on bankruptcy notification to generallicensees also needs to be clarified. Under the existing regulations, this requirement appears to apply to all licensees. However, its application to general licensees is not clear because it is not i

referenced in $ 31.2 or Q 31.5. This proposed rule would make the bankruptcy notification i requirement applicable only to those general licensees subject to the registration requirement.

These licensees possess devices for which the Commission believes a higher level of oversight is appropriate. Thus, notification that such a general licensee is filing for bankruptcy may be important to allow the Commission to intervene to ensure that the financial status of the I licensee does not lead to the improper disposal or abandonment of a device.

Requirements for Manufacturers and initial Distributors of Devices. The proposed rule would modify the quarterly transfer reporting, recordkeeping, and labeling requirements for specific licensees who distribute these generally licensed devices, and the requirement for providing information to users. The existing requirements in these areas are a matter of strict compatibility of Agreement State regulation, that is, the State regulations are essentially identical.' The proposed amendments would also be a matter of strict compatibility so that ,

I revisions to Agreement State regulations would be necessary and distributors in Agreement States would be affected. The basis of this compatibility requirement is significant direct 21

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l transboundary implications. This results from the fact that devices are distributed under various

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Agreement State and NRC authorities into other jurisdictions where different regulatory agencies regulate the possession and use of the devices. Currently, there are 28 NRC licensed distributors and approximately 61 licensed distributors in Agreement States.

Reportina. The following information would be added to the existing quarterly transfer reporting requirement: the serial number and model number of the device; the date of transfer; indication if the 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. The model number of the device is already required in reports to Agreement States.

The generallicensee address would be specified as the mailing address for the location of use of the generallylicensed device.

The name and phone number of the person identified by the generallicensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements would replace the name and/or position of a simple contact

. between the Commission and the general licensee.

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. Proposed amendments would be made to Q 32.52(a) and (b).

The existing reporting requirement is intended to provide NRC and the Agreement State regulatory agencies with the identity of gererallicensees in their jurisdictions, addresses at which the generallicensees can be contacted (which are usually the location of use of the 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 or the Agreement State and the generallicensee. These generallicensees can then be contacted or inspected. Including the 22

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serial number would allow the NRC and Agreement States to track individual devices.

existing reporting requirement in 9 31.5(c)(8) does not require the general license

. transfer if it is for the purpose of obtaining a replacement. This is consistent with t intent of this regulation in that the status of the generallicensee is unchanged, o device is changed. In order for individual devices to be tracked, the NRC or Agreemen needs to be informed of such a transfer. The proposed rule would require that the distributor provide this information either to NRC or the appropriate Agreement State. Under e requirements, quarterly reports are required to include specifics on any new device transfe but not on the devices returned. The NRC believes that the distributor co additionalinformation in the quarterly reports without a significant burden and that the distributor is likely to be more reliable than the general licensee in providing this informatio Thi name and license number of the reporting company and the specific reporting pe typically included in the reports in order to show compliance with the reporting requireme However, this information is not always readily identifiable.

The individual who acts as contact with the NRC or the Agreement State concerni generallicense should have knowledge of the device, the generallicense, and the regulatio

. pertaining to the general license, or at least know who in the organization does. This is the intent of the existing requirement. However, in practice, the name given to the distributor and I reported to the NRC (or the Agreement State) frequently is not an individual with this type o knowledge. The proposed rule would specify that the contact designated be the person

- (1) assigned responsibility for ensuring that the general licensee is aware of its regulato '

resp 6" nsibilities and (2) who has authority to take required actions for complying with th applicable regulations.

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, Recordkeepina. The proposed rule would add to the recordkeeping requirements information on final disposition of devices. The recordkeeping requirements conceming

, transfers would have the period of retention extended from 5 years from the date of the j recorded event, to 3 years after the expected useful life of the device or the final disposition, if known. Proposed amendments would be made to @ 32.52(c).

It is important that information about the general licensees and the specific devices in their possession be available until the device is disposed of permanently. Requiring the distributor to keep tnese records for an extended time provides a backup to the recordkeeping of NRC and State regulatory agencies. The records include information on final disposition that L

may not have been included in reports to NRC and the Agreement States. It is NRC's understanding that these distributors generally keep these records indefinitely. Thus, this regulatory requirement should have little, if any, impact.

In addition, distributors would be required to make available records of final disposition of devices to the various regulatory agencies in the case of bankruptcy or termination of license (new paragraph 9 32.51a(d)). When a distributor goes out of business and terminates its license, the distrib'utor can no longer be required to retain these records. This requirement I

would give NRC, as well as State regulatory agencies, the opportunity to obtain and retain records of this type previously kept by the distributor. These records could be helpfulin I

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 j I

NRC or the Agreement State in which the d,evice 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 process, in case financial difficulties interfere with the licensee fulfilling its responsibilities.

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s Labelina. The proposed rule would amend the existing labeling requirements to require an additionallabel'on any separable source housing and a permanent label on devices meeting the criteria for registration (new paragraphs 6 32.51(a)(4) and (5) and 32.51a(c)). The NRC would consider a label " permanent," if, for example, it were embossed, etched, stamped, or engraved in metal. Under these requirements, new distributors would have labels approved 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 required. However, distributors may l b li

' voluntarily submit information for NRC review on how they plan to comply with the riew a e ng requirements. In any case, labeling is subject to inspection. To the extent necessary, the new labeling requirements would supercede anything contradictory in individual license condition The individuallicense conditions would be updated to include specifics related to the new requirements during the first license renewal or amendment following the effective date paragraphs of the rule.

The first change simply carries out the initial intent of the existing requirement for devices where the source may be separable in a housing that does not include the label. It is important that this housing, if separated from the remainder of the device, can also be identified. The impact of this requirement should be minimal. The permanent label for devi requiring registration would provide better assurance that even when a device has been exposed to other than normal use conditions, for example, when a building has been refurbished or demolished with the device in place, the label will be intact and the device m

, be identified and proper actions can be taken. This may result .in a more significant chang the production of devices. Distributors would have 1 year after the effective date 25

m irnplement these changes to minimize any impact to the manufacturing and distributing

- process Information to be orovided to aenerallicensees. The proposed rule would amend the requirements pertaining to the information distributors must provide to the general licensee

( 32.51a(a) and (b)). Distributors are now required to provide generallicensees with a copy of 9 31.5 when the device is transferred. The proposed rule would require that a copy of @ 31.5 be provided before transfer. The distributor would also be required to provide copies of additional applicable sections of the regulations, a listing of the services that can only be performed by a specific licensee, and information regarding disposal options for the devices being transferred. The disposal options would include the estimated cost for disposal of the device at the end of its useful life to the extent that the cost information is available to the distributor at the time of the sale of the device. For transfers to generallicensees in Agreement States, the distributor may furnish either the applicable NRC regulations or the comparable ones of the Agreement State. In addition, the distributor would furnish the name, address, and phone number of the contact at the Agreement State regulatory agency from which additional information may be obtained.

The generallicensee should be aware of the specific requirements before purchasing a generally licensed device, rather than afterward. While the Commission does not want to get involved with details of licensees' business practices, it is the Commission's intent that " prior to transfer" would be before a final decision to purchase so that the information can be considered in making that decision. The Commission seeks comment on how best to achieve and enforce this intent. For example: What are the advantages / disadvantages of using the words," prior to purchase"in the regulatory text?

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While f 31.5 contains the primary requirements related to the general license, it does not reference the applicable sections of part 30. The generallicensee should have copies of at least those regulations that may require an action on his part. The sections of the regulation that would be included in this requirement are believed to be the most important for the general licensee to be aware of. The inclusion of a listing of services that can only be performed by a specific licensee would clarify the services that can and cannot be performed by the general licensee. These services vary depending on the nature and design of the particular device and so are not specified in the regulations. Information on the estimated cost for disposal of the device at the end of its useful life may be a significant factor in a decision to purchase a device because of the high costs of disposing of radioactive materials. In some cases, the cost of disposal could exceed the purchase price of the device.

Additional clarifying amendments would be made in &9 30.31,30.34(h), and 31.5(c)(9)(ii). The wording of 30.31 would provide a similar clarification as that in the Suggested State Regulations with respect to generallicenses. The amendment to 6 30.34(h) would be consistent with the previou's ly discussed change concerning reporting bankruptcy.

The revision of 9 31.5(c)(9)(ii) to include the term, " intermediate person," is intended to provide clarification about intermediate persons holding devices. Specifically, intermediate persons holding devices in their original shipping containers at their intended location of use are geneieilicensees. Distributors licensed under $ 32.51, or equivalent Agreement State regulations, must provide information about both intermediate persons and intended users in i

their quarterly reports submitted under 32.52(a). Transfers from intermediate persons to intended users under G 31.5(c)(9)(ii) do not need to be reported to NRC because information about the intended user must be reported by the distributor under Q 32.52(a).

27

n Minor conforming amendments would also be made to @ 170.2,170.3,171'.5, and 171.16.

Public Comments on the Original Proposed Rule The NRC reviewed the comments received on the December 27,1991, proposed rule in developing both the proposed rule published on December 2,1998 (63 FR 66492), and this proposed rule. There were 26 comment letters received from a variety of sources including private and publicly held corporations, private citizens, citizens groups, the Armed Forces, and State governments. These comments have been considered to the extent applicable to each rule. A detailed analysis of the comments received on the December 27,1991, proposed rule, which was withdrawn by the notice of proposed rulemaking on December 2,1998, is not resented in either of the subsequent proposed rules because many of the specific comments pertain to specific provisions that have been withdrawn, a great deal of time has passed since these' comments were made, and additional opportunity for comment is being provided.

Early State and Public Input These proposed amendments were provided to the Agreement States twice during its development via the use of the NRC Technical Conference Website and notification to the States of its availability. Input was received following the first posting through discussions at an All Agreement State meeting in October of 1998. The second posting was also available to the public. A notice of availability was published December 31,1998 (63 FR 72216). The States and the distributors were notified of its availability directly, as well. Two comments were 28

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received. One from a State and one from industry. They.were generally supportive and indicated points needmg clarification; Summary of Proposed Provisions by Paragraph

- Section 30.31 - Revision would reconcile the apparent conflict between the description -

' of a generallicense and a registration requirement.

Section 30.34, paragraph (h)(1)_-' Revision would make the bankruptcy notification -

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

Section 31.1 - Revision would clarify that only those paragraphs in part 30 specified in f 31.2 or the particular general license apply to part 31 general licensees.

Section 31.2 - Revision would clarify references to the sections of part 30 that are applicable to all of the part 31 generallicensees.

? Section 31.5, paragraph'(b) .- Revision would clarify the status of a person who receives a device through an unauthorized transfer by limiting the applicability of the general license to those who receive a device through an authorized transfer; and would remove the restriction on

' devices ' distributed by Agreement State licensees in Agreement States without a general

- license.-

Section 31.5, paragraph (c)(5) - Revision would add a plan for ensuring that premises and environs are suitable for unrestricted access, to the information that must be sent to NRC

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in the case of a failure, when device damage or failure is likely to or known to have resulted in contamination; .would change the addressee for reporting information concerning a failure; and D would clanfy that the criteria in 6 20.'1402 may be applied in spite of the exemption in 6 31.5(c)(10).

'29 b e.

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. Section 31.5, paragraph (c)(8) - Revision would allow transfers to specific licensees authorized under part 30, or equivalent Agreement State regulations, as waste collectors, in addition to currently allowed transfers to part 32 (and Agreement State) licensees; would allow transfers to other specific licensees but only with prior written NRC approval; and would add the

' recipient's license number, the serial number of the device, and the date of transfer to the information required to be provided to NRC upon transfer of a device.

Section 31.5, paragraph (c)(9)(i) - Revision would add to the reporting requirement, in the case of a transfer to a general licensee taking over possession of a device at the same location, to provide the serial number of the device and the name and phone number of the person identified as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements, rather than simply a contact name.

Section 31.5, paragraph (c)(9)(ii) - Revision would add the term, " intermediate person,"

to clarify that a report of transfer is not required only when the information on both an intermediate person and an intended user was provided through the distributor in a quarterly material transfer report.

Section 31.5, paragraph (c)(12) - Would add an explicit requirement for the general licensee to appoint an individual assigned responsibility for knowing what regulatory requirements are applicable to the general licensee and having authority to take required actions to comply with the applicable regvations.

Section 31.5, paragraph (c)(13)- Would add an explicit requirement for the general licensee to register devices meeting certain criteria, which specifies the information to be provided and references the fee requirement in @ 170.31.

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I Section 31.5, paragraph (c)(14) - Would add requirement for general licensees to notify l NRC of eddress changes.

Section 31.5, paragraph (c)(15) - Would limit to 2 years the amount of time a general licensee can keep an unused device in storage and allow the deferment of testing during the period of storage, j

Section 32.51, paragraphs (a)(4) and (5) _ Would add requirement for an additional label on any separable source housing and a permanent label on devices meeting the criteria for /

registration.

Section 32.51a, paragraphs (a) and (b) - Revision would amend the requirements pertaining to the information distributors must p.rovide to the generallicensee. Distributors are now required to provide general licensees with a copy of 6 31.5 when the device is transferred.

The proposed rule would require that 31.5 be provided before to Jesfer. The distributor would also be required to provide copies of additional applicable sections of the regulations, a ficting of the services that can only be performed by a specific licensee, and information regarding disposal options for the devices being transferred, including estimated costs of disposal. For transfers to general licensees in Agreement States, the distributor may furnish either the l

applicable NRC regulations or the comparable ones of the Agreement State. In addition, the distributor would furnish the name, address, and phone number of the contact at the Agreement State regulatory agency from which additional information may be obtained.

Section 32.51a, paragraph (c) - Would make labeling requirements a condition of license 1 year after effective date of rule.

Section 32.51a, paragraph (d) - Would add requirement for distributors to make available records of final disposition of devices to the various regulatory agencies in the case of bankruptcy or termination of the distributor's license.

31

Section 32.52, paragraphs (a) and (b) - Revision 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, and serial number of the one returned; name and license number of reporting company; and the specific reporting period. Also, the generallicensee address would be specified as the mailing address for the location of use of the generally licensed device.

The name and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements would 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 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.

Section 32.52, paragraph (c)- Revision would add to the recordkeeping requirements information on final disposition of devices. The recordkeeping requirements concerning transfers would have the period of refention extended from 5 years from the date of the recorded event to 3 years after the expected useful life of the device or the final disposition, if known.

Section 170.2 - Would conform the scope of part 170 to include a general licensee registrant.

Section 170.3 - Would revise definition of " Materials License" to include part 31 and the words, "or granted" as general licenses are granted by regulation rather than individually issued to licensees.

Section 170.31 - Revision would add $420 registration fee for general licensees subject to 31.5(c)(13).

32

I Section 171.5 - Would revise definition of " Materials License" to include part 31 and the l words, "or granted" as general licenses are granted by regulation rather than individually issued I to licensees.

Section 171.16 - Would add category for part 31 general license registration foi  !

I consistency with the Table in 170.31. l National Database The Commission is in the process of developing a new computer database to handle j information about general licensees and generally licensed devices. Among other improvements from the currently used system, it will be designed to handle the registration process efficiently with automated features. In doing so, the Commission has given some consideration to whether a national database should be established in which information on the identity of generallicensees and device information for all jurisdictions would be maintained, making this information accessible to all Agreement States and the NRC. There are variations on the exact approach that might be taken particularly with respect to access and update authority. At this time, the Commission has not yet found it practical to resolve all the issues related to having broad access to the database.

The Commission would like to give further consideration to establishing such a database. It would not require rulemaking. However, if it were to be established, one option would be to change the material transfer reporting requirements so that distributors would report all transfers to the NRC rather than reporting to all jurisdictions into which transfers of devices are made.

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A' primary advantage of a national database would be the ease of tracing a "found" device back to the general licensee owner responsible for the device. A "found" generally licensed device would be conside'r ed an orphan source until such time as the responsible general licensee is identified and it is returned to the licensee. The Commission is in the l

process of modifying the Nuclear Materials Events Database (NMED) to accept and track information on orphan sources nationally (i.e. all States). Access to the NMED will be available to the NRC and all.the States. The Commission will encourage the States to use NMED for this purpose so that this category of information will be shared nationally. However, NMED would

' rely on reporting of events for its data, in order for a device to be traced back to the responsible generallicensee, each jurisdiction would need to search its own files. In addition, information in a riatienal general license database would be immediately available, and would contain the most complete information about general licensees and generally licensed devices.

The primary disadvantage to a national database would be the difficulty of maintaining

. the security of the data, which is primarily_made up of proprietary information. A national database would also present more risk to the integrity of the data, because there would be a higher potential for illicit corruption of data.

In considering 'whether or not to implement a national database and, if so, what the

particular approach would be used,- there are a number of aspects to be considered including --

\

k (1) Who will maintain the database (the NRC, an independent third party, or each

- agency maintaining its own data)? '

(2) How access to the data would be controlled.

(3) Potential changes to the reporting requirements for transfers. l i

l(4) The ability for the NRC and the Agreement States to protect information of other q agencies.

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(5) Costs to implement and maintain the system or systems (including training).

The Commission seeks comment on the advantages and disadvantages of implementing a national database and on these related issues.

Specific Questions for Public Comment The Commission welcomes comments on all aspects of this proposed rule, and is especially interested in receiving comments on the specific questions summarized here:

1. The Commission seeks comment on whether the registration requirement should include a provision that would require the generallicensee to complete registration by a certain time, whether or not the NRC requests registration.

2. The Commission requests comment on whether it is appropriate for new devices obtained by registrants to be registered when the annual reregistration is carried out without the NRC having earlier contact after additional devices are received. Earlier contact could be made either by an acknowledgment by NRC to the user or by a required response from the general licensee to account for the additional device (s).

3. The Commission solicits comment on whether general licensees should be required to assign a backup responsible individual (BRI).

4. The Commission seeks comment on how best to achieve and enforce the intent that full disclosure of information required to be provided to general licensee customers by distributors be made early enough to be considered in a decision to purchase. For example:

Would it be better to use the words, " prior to purchase" in the regulatory text?

5. The Commission seeks comment on the advantages and disadvantages of implementing a national database of general licensees and their devices.

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W Enforcement On March 9,1999 (64 FR 11508), the Commission established an interim enforcement policy for violations of 31.5 that licensees discover and report during the initial cycle of the registration program. This policy supplements the normal NRC Enforcement Policy in NUREG-1600, Rev.1. It will remain in effect through one complete cycle of the registration program.

Under this interim enforcement policy, enforcement action normally will not be taken for violations of 31.5 that are identified by the general licensee, and reported to the NRC if reporting is required, provided that the generallicensee takes appropriate corrective action to address the specific violations and prevent recurrence of similar problems and otherwise has undertaken good faith efforts to respond to NRC notices and provide requested information.

This change from the Commission's normal enforcement policy is to remove the potential for the threat of enforcement action to be a disincentive for the licensee to identify deficiencies.

This approach is warranted given the limited NRC inspections of generallicensees. This approach is intended to encourage general licensees to determine if applicable requirements l

have been met, to search their facilities to ensure sources are located, and to develop '

appropriate corrective action when deficiencies are found. Under the interim enforcement i policy, er.forcement action, including issuance of civil penalties and Orders, may be taken where there is --

(a) Failure to take appropriate corrective action to prevent recurrence of similar violations; I

(b) Failure to respond and provide the information required by regulation;

)

(c) Willful failure to provide complete and accurate information to the NRC; or 36

. (d) Othrd willful. violations, such as willfully disposing of generally licensed material in an unauthorized manner.

As noted in the December 2,1998, proposed rule, the Commission also plans to increase the civil penalty amounts specified in its Enforcement Policy in NUREG-1600, Rev.1, for violations involving lost or improperly disposed sources or devices. This increase will better relate the ' civil penalty amount to the costs avoided by the failure to properly dispose of the

' source or device. Due to the diversity of the types of sources and devices, the Commission is considering the establishment of three levels of base civil penalty for loss or improper disposal.

The three levels of base civil penalty would be $5500, $15,000, and $45,000. The higher tiers

.. would be for sources that are relatively costly to dispose of and would be based on approximately three times the average cost of proper transfer or disposal of the source or

' device; Agreement State Compatibility Under the " Policy Statement on Adequacy and Compatibility of Agreement State Programs

• published on September 3,1997 (62 FR 46517), the proposed rule would be a matter of compatibility.between the NRC and the Agreement States, thereby providing consistency among Agreement State and NRC requirements. The revisions to part 32 would A

be classified as Category B and the revisions to Q 31.5 would be classified as Category C.

-ThrougMhis action, existing provisions of. 31.5 would also be reclassified from Category D to Category C J Although changes are being made to l 30.31,30.34(h)(1),31.1, and 31.2, and parts'170 and 171 as part of this rulemaking, the existing compatibility designations for these regulations will not be affected.'

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. Category B means the provisions affect a program element with significant direct a transboundary implications.' The State program element should be essentially identical to that of NRC. Category C means the provisions affect a program element, the est.ential objectives of

which should be adopted by the State to avoid conflicts, duplications,' or gaps in the national programJ The manner in which the essential objectives are addressed need not be the same P

as NRC provided the essential objective's are met.

Specific information about the compatibility or health and safety components assigned p to this rule may be found at Office of State Programs website, http1/www.hsrd.ornl. gov /ntc/home.html.  ;

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' As discussed above, revised 6 32.52(a) and (b) would add the following information to I

the existing distributors' quarterly transfer repoding requirements: the serial number and model number of the device, the date of transfer, indication if the device is a replacement (e id d io, the type, model numNr, and serial number of the device returned), the name and licem >

number of the reporting company, and the specific reporting period. The proposed revisions would also require the name and phone number of a general licensee's " responsible individual" lrather than simply a contact and would specify that the address of the general licensee be the mailing address for the location of use. ' According to NRC Management Directive (MD) 5.9,

" Adequacy and Compatibility of Agreement State Programs," NRC regulations that should be

' adopted by an Agreement State for purposes of compatibility should be' adopted in a time frame such that the effective date'of the State requirement is no later than 3 yer.rs after the effective date of NRC's final rule. MD 5.9 also provides that some circumstances may warrant that the

,, . States ' adopt certain regulations in less than the recommended 3-year time frame or that the

' effective date's for both N'RC licensees and Agreement State licensees be the same. The 4

Commission believes it is important to the implementation of this program, and to Agreement e ,

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3, State programs, to begin receiving the additional information in the distributors' quarterly transfer reports as soon as possible. The Commission requests comments on whether NRC and the Agreement States should establish a single implementation date. for this provision l

. which would be earlier thari is usually allowed for revision of Agreement State rules for compatibility. One approach would be to request Agreement States' to require distributors to

' provide all[the information consistent with this rule (proposed $ 32.52(a) and (b)) either

'i; . . . .. . .

-- coincident with the effective date of the Commission's final action on this rulemaking or within 1 year of that effective date. Agreement States would have the flexibility to adopt this provision through rulemaking, license conditions, or other legally binding requirements.

Plain Language Jhe Presidential Memorandum dated June 1,1998, entitled, " Plain Language in

- Government Writing," directed that the government's writing be in plain language. This .

. memorandum was published June 10,1998 (63 FR 31883). In complying with this directive, L editorial changes have been made in the proposed revisions to improve the organization and

. readability of the existing language of paragraphs being revised. These types of changes are

~ 'not discussed further in this notice The NRC requests comments on this proposed rule

, 'specifically with respect to the clarity and effectiveness of the language used. Comments should be~sent to the address listed under the heading: " ADDRESSES" above.

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l Environmental Impact: Categorical Exclusion l The NRC has determined that the revisions proposed in this rule aie the types of actions described in the categorical exclusions in 5 51.22(c)(1) through (3). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this regulation.

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Paperwork Reduction Act Statement

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1 This proposed rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq). This rule has been submitted to the Office of Management and Budget for review and approval of the information collection I

requirements.

The public reporting burden for this information collection is estimated to average 2 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the information collection. The time involved is small because most of the proposals are minor revisions to existing information collection requirements. The U.S. Nuclear Regulatory Commission is seeking public comment on the potential impact of the information collections I

contained in the proposed rule and on the following issues:

1. Is the proposed information collection necessary for the proper performance of the functions of the NRC, including whether the information will have practical utility?

2. Is the estimate of burden accurate? ,

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3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?-

L 4. How'can the burden of the information collection be minimized, including the use of automated collection techniques?

Send comments on any aspect of this proposed information co!!ection, including suggestions for reducing the burden, to the Records Management Branch (T-6F33), U.S.

Nuclear Regulatory Commission, Washington, DC 20555-0001, or by internet electronic mail at BJS10NRC. GOV; and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202 (3150-0016), Office of Management and Budget, Washington, DC 20503.

Comments to OMB on the information collections or on the above issues should be submitted by (insert date 30 days after publication in the Federal Register). Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given to comments received after this date.

Public Protection Notification if a means used to impose 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. l 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 41 k

comments received on the draft regulatory analysic associated with the proposed rule of December 27,1991~ have been considered to the extent that they apply to this action. The regulatory analysis is available for inspection 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. Mattsen,' U.S. Nuclear Regulatory Commission, Office of Nuclear Material Safety and Safeguards, Washington, DC,20555-0001; telephone (301) 415-6264; or e-mail at CRMenrc. gov.

Regulatory Flexibility . Certification 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 NRC has established standards for determining which NRC licensees qualify as small entities (10 CFR 2.810). 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 proposed $420 fee to be assessed for each registration. Portions of the proposed rule

would apply to the 'approximately 45,000 persons possessing products under an NRC general license, many of whom may be classified as small entities. However, the annual registration

. requirement and associated fee would apply to about 5100 of these general licensees. Based -

l on input received previously from small entities who hold specific materials licenses, the NRC - I believes that the proposed $420 part 170 registration fee would not have a significant economic o

. impact on a substantial number of small entities. The NRC believes that the economic impact

' of the other proposed requirements on any general licensee would be a negligible increase in y

administrative burden. The NRC is' soliciting comment from the general licensees who meet the

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NRC's small entity size standards and would be required to register their devices pursuant to

_ part 31 on whether the proposed part 170 fee for their annual registration would have a signifbant economic impact on their business.

The proposed rule would also revise requirements for specifically licensed distributors of

.certain generally licensed devices. Currently, there are 28 NRC licensed distributors and approximately 61 Agreement State licensed distributors. Many of these licensees are not small entities and the impact to any of these distributors is not expected to be significant in any case.

Distributors who are small entities are also invited to comment on whether they believe the economic impact would be significant.

Those small entities that offer comments on the potential impact on small entities and how that might be minimized should specifically include information on the type and size of their business and how the proposed regulations would result in a significant economic impact on them as compared to larger organizations in the same business community. To the extent possible, the commenter should provide relevant economic data, such as the licensee's gross annual receipts, as well as number of employees.

Backfit Analysis The NRC has determined that the backfit rule, 9 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 50.109(a)(1).

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List of Subjects l

10 CFR Part 30 - Byproduct material, Criminal penalties, Government contracts, )

Intergovernmental relations, Isotopes, Nuclear materials, Radiation protection, Reporting and recordkeeping requirements.

I 10 CFR Part 31 - Byproduct material, Criminal penalties, Labeling, Nuclear materials, ,

1 Packaging and containers, Radiation protection, Reporting and recordkeeping requirements, Scientific equipment.

10 CFR Part 32 - Pyproduct material, Criminal penalties, Labeling, Nuclear materials, Radiation protection, Reporting and recordkeeping requirements.

10 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.

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

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I For the reasons set out above and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 553, the NRC is proposing to adopt the following amendments to 10 CFR Parts 30,31,32,170, and 171.

1 44

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

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

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

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 Stat. 955 (42 U.S.C. 2237).

2. Section 30.31 is revised to read as follows:

9 30.31 Types of Licenses.

Licenses for byproduct material are of two types: General and specific.  !

(a) The Commission issues a specific license to a named person who has filed an application for the license under the provisions of this part and Parts 32-36, and 39.

(b) A general license is provided by regulation, grants authority to a person for certain activities involving byproduct material, and is effective without the filing of an application with the Commission or the issuance of a licensing document to a particular person. However, registration with the Commission may be required by the particular general license. >

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3. In 6 30.34, paragraph (h)(1) is revised to read as follows:

i 30.34 Terms and conditions of licenses.

(h)(1) Each generallicensee that is required to register by 31.5(c)(13) of this chapter and each specific licensee shall notify the appropriate NRC Regional Administrator, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy unde' 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) An affiliate (as that term is defined in 11 U.S.C.101(2)) of the licensee.

i PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL i

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

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Authority: Secs. 81,161, k 1, 6t. Stat. 935, 948, 954, as amended (42 U.S.C. 2111, 2201,2233); secs. 201, as amended,20i 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).

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5. Section 31.1 is revised to read as follows:

9 31.1 Purpose and scope.

This part establishes general licenses for the possession and use of byproduct material and a generallicense for ownership of byproduct material. Specific provisions of 10 CFR Part 30 are applicable to general licenses established by this part. These provisions are specified in f 31.2 or in the particular general license.

6. Section 31.2 is revised to read as follows:

5 31.2 -Terms and conditions. l The general licenses provided in this part are subject to the general provisions of Part 30 of this chapter ( 30.1 through 30.10), the provisions of Q 30.14(d),30.34(a) to (e),

30.41,30.50 to 30.53,30.61 to 30.63, and Parts 19,20, and 21, of this chapter' unless indicated otherwise in the specific provision of the generallicense.

l 1

7.In 31.5, paragraphs (b), (c)(5),(c)(8), and (c)(9) are revised and paragraphs (c)(12),

. (13), (14), and (15) are added to read as follows:

i

! Attention is directed particularly to the provisions of Part 20 of this chapter concerning labeling of containers.

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$ 31.5 Certain measuring, gauging, or controlling devices.2 (b)(1) The 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 in accordance with the specifications contained in --

(i) A specific license issued under @ 32.51 of this chapter; or

'(ii) An equivalent specific license issued by an Agreement State.

(2) The devices must have been received from one of the specific licensees described in paragraph (b)(1) of this section or through a transfer .made under paragraph (c)(9) of this section.

(c)

(5) Shall immediately suspend operation of the device if there is a failure of, or damage fo, 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 microcurie or more removable radioactive material. The device may not be operated untilit has been repaired by the manufacturer or other person holding a specific license to repair such devices that was issued under parts 30 and 32 of this chapter or by an Agreement State. The device I

may be disposed of by transfer to a person authorized by a specific license to receive the byproduct material contained in the device. A report containing a brief description of the event )

l and the remedial action taken; and,in the case of detection of 0.005 microcurie or more removable radioactive material or failure of or damage to a source likely to result in 2

Persons possessing byproduct material in devices under a general license in Q 31.5 before January 15,1975, may continue to possess, use, or transfer that material in accordance with l the labeling requirements of Q 31.5 in effect on January 14,1975. 1 48 i

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contamination of the premises or the environs, a plan for ensuring that the premises and environs are acceptable for unrestricted use, must be furnished to the Director of Nuclear

. Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC

'20555-0001 within 30 days. Under these circumstances, the criteria set out in @ 20.1402,

" Radiological criteria for unrestricted use." may be applicable, as determined by the

' Commission on a case-by-case basis;

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

- transfer to another general licensee as authorized in paragraph (c)(9) of this section or to a person authorized to receive the device by a specific license issued under parts 30 and 32 of this chapter, part 30 of th'is chapter that authorizes waste collection, or equivalent regulations of an Agreement State, or as approved under paragraph (c)(8)(iii) of this section.

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

Nuclear Regulatory Commission, Washington, DC 20555-0001 within 30 days after the transfer

-.of a device to a specific licensee. A report is not required if the device is transferred to the specific licensee in order to obtain a replacement device from the same specific licensee. The report must contain --

(A) The identification of the device by manufacturer's name, model number, and serial number; (B) Th'e name, address, and license number of the person receiving the device; and I

(C) The date of the transfer.

(iii) Shall obtain written NRC approval before transferring the device to any other specific j licensee.

(9) Shall transfer the device to another general licensee only if --

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(i) The device remains in use at a particular location. In this case, the transferor shall give the transferee a copy of this section and any safety documents identified in the label of the device. Within 30 days of the transfer, the transferor shall report the manufacturer's name and the model number and the serial number of the device transferred, the name and address of the transferee, and the name and phone number of the responsible individualidentified by the transferee in accordance with paragraph (c)(12) of this section to have knowledge of and authority to take actions to ensure compliance with the appropriate regulations and requirements to the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-000.1; or (ii) The device is held in storage by an intermediate person in the original shipping container at its intended location of use prior to initial use by a general licensee.

(12) Shall appoint an individual responsible for having knowledge of the appropriate regulations and requirements and the authority for taking required actions to comply with appropriate regulations and requirements. The general licensee, through this individual, shall ensure the day-to-day compliance with appropriate regulations and requirements. This appointment does not relieve the generallicensee of responsibility in this regard.

(13)(i) Shall register, in accordance with paragraphs (c)(13)(ii) and (iii) of this section, 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 americium-241 or any other transuranic, i.e., element with atomic number greater than uranium (92), based on the activity indicated on the label.

(ii) If in possession of a device meeting the criteria of paragraph (c)(13)(i) of this section, j shall register these devices annually with the Commission and shall pay the fee required by 50 i

$ 170.31 of this chapter. Registration must be done by verifying, correcting, and/or adding to the information provided in a request for registration received from the Commission. The registration information must be submitted to the NRC within 30 days of the date of the request for registration or as otherwise indicated in the request. In addition, a general licensee holding devices meeting the criteria of paragraph (c)(13)(i) of this section is subject to the bankruptcy

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notification requirement in 30.34(h) of this chapter.

(iii) In registering devices, the general licensee shall furnish the following information and any other information specifically requested by the Commission --

(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) Narne and telephone number of the responsible person designated as a i

representative of the generallicensee under paragraph (c)(12) of this section.

(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 generallicensee that the information concerning the device (s) has been verified through a physicalinventory and checking of labelinformation.

(F) Certification by the responsible representative of the generallicensee that they are I

aware of the requirements of the generallicense.

(14) Shall report changes of address (including change in name of generallicensee) to the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, )

Washington, DC 20555-0001 within 30 days of the effective date of the change. If it is a l

l 51 l

l l

)

i portable device, a report of address change is only required for a change in the device's primary place of storage.

i (15) May not hold devices that are not in use for longer than 2 years. If devices with shutters 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.

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

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

Authority: Secs. 81,161,182,183,68 Stat. 935,948,953,954, as amended (42 U.S.C. 2111,2201,2232,2233); sec. 201,88 Stat.1242, as amended (42 U.S.C. 5841).

9.In 32.51, paragraphs (a)(4) and (5) are added to read as follows:

1 l

1

$ 32.51 Byproduct material contained in devices for use under 9 31.5; requirements for license to manufacture, or initially transfer. I 52

M (a)

(4) Each device having a separable source housing that provides the primary shielding

. for the source also bears, on the source housing, 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 20.1901 of this chapter, and the name of the manufacturer or initial distributor.-

(5) Each device meeting the criteria of $ 31.5(c)(13)(i) of this chapter, bears a permanent (e.g., embossed, etched, stamped, or engraved) label 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 20.1901 of this chapter.

10. Section 32.51a is revised to read as follows:

$ 32.51a Same: Conditions of licenses.

(a) If a device containing byproduct material is to be transferred for use under the generallicense contained in 31.5 of this chapter, each person that is licensed under @ 32.51 shall provide the information specified in this paragraph to each person to whom a device is to be transferred.' This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes --

(1) A copy of the generallicense contained in @ 31.5 of this chapter; 53

=

(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) If byproduct material is to be transferred in a device for use under an equivalent generallicense of an Agreement State, each person that is licensed under 32.51 shall provide the information specified in this paragraph to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes --

(1) A copy of the Agreement State's regulations equivalent to @ 31.5,31.2,30.51, 20.2201, and 20.2202 of this chapter or a copy of 31.5,31.2,30.51,20.2201, and 20.2202 of this chapter. If a copy of the NRC regulations is provided to a prospective generallicensee, it shall be accompanied by a note explaining that use of the device is regulated by the Agreement State; (2) A list of the services that can only be performed by a specific licensee; (3) bformation on acceptable disposal options including estimated costs of disposal; and (4) The name, address, and phone number of the contact at the Agreement State regulatory agency from which additional inf armation may be obtained.

(c) Each device that is transferred after (insert date 1 year after the effective date of this rule) must meet the labeling requirements in 32.51(a)(3) through (5).

54

(d) If a notification of bankruptcy has been made under 9 30.34(h) or the license is to be terminated, each person licensed under 32.51 shall provide, upon request, to the NRC and to any appropriate Agreement State, records of final disposition required under 32.52(c).

11. Section 32.52 is revised to read as follows:

9 32.52 Same: material transfer reports and records.

Each person licensed under 32.51 to initially transfer devices to generally licensed persons shall comply with the requirements of this section.

(a) The person shall report all transfers of devices to persons for use under the general license in 9 31.5 of this chapter to the Director of the Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The report must be submitted on a quarterly basis on Form 653 " Transfers of Industrial Devices Report" l j

or in a clear and legible report containing all of the data required by the form.

(y The required information includes --

(i) The identity of each general licensee by name and mailing address for the location of use;-

(ii) The name and phone number of the person identified by the generallicensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements; (iii) The date of transfer;

- (iv) The type, model number, and serial number of the device transferred; and (v) The quantity and type of byproduct material contained in the device.

55

(2) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person (s).

(3) If a device transferred replaced another returned by the general licensee, the report must also include the type, model number, and serial number of the one returned.

(4) The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report.

(5) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.

(6) If no transfers have been made to persons generally licensed under S 31.5 of this chapter during the reporting period, the report must so indicate.

(b) The person shall report all transfers of devices to persons for use under a general license in an Agreement State's regulations that are equivalent to S 31.5 of this chapter to the 1 l

I respor...ble Agreement State agency. The report must be submitted on Form 653 " Transfers of Industrial Devices Report" or in a clear and legible report containing all of the data required by the form. i

. (1) The required information includes --

l (i) The identity of each general licensee by name and mailing address for the location of j l

use; I l

(ii) The name and phone number of the person identified by the generallicensee as 1

having knowledge of and authority to take required actions to ensure compliance with the l

appropriate regulations and requirements; )

. l (iii) The date of transfer; 56 l l

l j

(iv) The type, model number, and serial number of the device transferred; and

' (v) The quantity and type of byproduct material contained in the device.

. (2) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person (s).

(3) If a device transferred replaced another returned by the general licensee, the report L

must also include the type, model number, and serial number of the one retumed.

(4) The report must be submitted within 30 days after the end of each calendar quarter in which such a device is transferred to the generally licensed person and clearly indicate the

period covered by the report.

(5) The report must clearly identify the specific licensee submitting the report and must include the license number of the specific licensee.

(6)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.

(c) The person shall keep records of all transfers of devices for each general licensee 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 3 years

~

z following the estimated usefullife of the device or the date of final disposition, if known.

J 57 m

PART 170 - FEES FOR FACILITIES, 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:

3 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. 9012).

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

9170.2 Scope.

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

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

l 9170.3 Definitions.

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.

58 i

I

15. Section 170.31 is amended by adding a fee category,3. O. to the schedule of materials fees and amending footnote 1 to add a paragraph (f).

$ 170.31 Schedule of fees for materials licenses and other regulatory services, including inspections, and import and export licenses.

Schedule of Materials Fees (See footnotes at end of table]

2 Category of materials licenses and type.of fees' Fee.a l

3.

O. Registration of a device (s) generally licensed pursuant to Part 31... ... .... ...............$420 l

l I

' Types of fees

)

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

h-59

Part 171 - 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 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.101239,103 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 @ 171.5, the definition of Materials License is revised to read as follows:

$ 171.5 Definitions.

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 Per:s 30,31

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

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

60 4

$ 171.16 Annual fees: Material Licensees, Holders of Certificates of Compliance, Holdere -

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

[See footnotes at end of table]

Category of materials licenses i Annual fees .2.3 3.

Q. 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.

A Dated at Rockville, Maryland, this d day of July,1999.

i For the Nuclear Regulatory Commission.

n.5 A W L Samuel Walker Acting Secretary of the Commission.

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' 0 03-\

40295 PM Proposed Rules r+<in i-r s Vol. 64. No.142 Monday, July 26.1999 This section of the FEDERAL REGISTER between 7:30 am and 4:15 pm on also comply with testing requirements contains notices to the pubhc of the proposed Federal workdays. for leakage and for proper operation of issuance of ruies and regulations. The You may also provide comments via purpose of these notices is to give interested on-off mechanisms. Generallicensees the NRC's interactive rulemaking web are also subject to the terms and p:rsons an opportunity to participate in the e making prior to the adoption of the final site through the NRC home page conditions in S 31.2 concerning general (http://www.ntc. gov). This site provides license requirements. transfer of the availability to upload comments as byproduct material, reporting and files (any format), if your web browser recordkeeping, and inspection. General NUCLEAR REGULATORY supports that function. For information licensees must comply with the safety COMMISSION about the interactive rulemaking site. instructions contained in or referenced contact Ms. Carol Gallagher (301) 415- on the label of the device and must have 10 CFR Parts 30,31,32,170, anr5171 5905: e mail CAC@nrc. gov. the testing or servicing of the device Certain documents related to this performed by an individual who is RIN 3150-AG03 rulemaking, including comments authorized to manufacture, install, or received and the regulatory analysis, service these devices except as Requirements for Certain Generally may be examined at the NRC Public indicated on the label.

Licensed Industrial Devices Containing Document Room. 2120 L Street NW. A generally licensed device usually Byproduct Material (Lower Level), Washington. DC. These consists of radioactive material.

same documents also may be viewed contained in a sealed source, within a AGENCY: Nuclear Regulatory and downloaded electronically via the Commission. shielded housing. The device is interactive rulemaking website designed with inherent radiation safety ACTION: Proposed rule. established by NRC for this rulemaking. features so that it can be used by F R FURTHER INFORMATION CONTACT: persons with no radiation training or

SUMMARY

The Nuclear ReEulato7 Catherine R. Mattsen. Office Nuclear experience. The general license C n ission ( RC s pro s gi Material Safety and Safeguards. U.S. simplifies the licensing process so that 8 B E Nuclear Regulatory Commission, a case-by-case determination of the j neas r g ga ging r o troll ng Washington, DC 20555-0001, telephone adequacy of the radiation training or (301) 415-6264, or e-mail at experience of each user is not necessary, devices. The proposed amendments would include adding explicit CRM@nrc. gov. There are about 45.000 general requirements for a registration process SUPPLEMENTARY INFORMATION* - licensees authorized by S 31.5 to possess  !

about 600,000 devices that contain i that the NRC plans to initiate through a Background related rulemaking, would add a byproduct material. The NRC has not i On February 12,1959 (24 FR 1089), contacted or inspected these general j registration fee, and would clarify the Atomic Energy Commission (AEC) licensees on a regular basis because of I which provisions of the regulations apply to all generallicenses for amended its regulations to provide a the relatively small radiation risk posed bypr duct general license (10 CFR 30.21(c)) for the by these devices.

erial The proposed rule fy p use of byproduct material contained in Individuals who possess devices B.

T p 8and g certain measuring, gauging, or under this general license are not

,, {g , e ntrolling devices. Under

{ icensees who regulati ns in 10 UR 31.5, cenain current always aware of applicable distribute these generally licensed mquimments and ums am not pers ns may receive and use a device necessarily complying with all of these devices. The proposed rule is intended l to allow the NRC to better track certain containing byproduct material under requirements. The NRC is most this general license if the device has nneerned about occurrences where generallicensees and the devices they ,

possess and to further ensure that been manufactured and distributed generally licensed devices hase r at general licensees are aware of and according to a specific license issued by been handled or disposed of properly.

the NRC or by an Agreement State. A In some cases, this has resulted in understand the requirements for the possession of devices containing specific license authorizing distribution radiation exposure to the public and byproduct material, of generally licensed devices is issued if contamination of property. Some a regulatory authority determines that generally licensed devices have been DATES: Submit comments by October 12, the safety features of the device and the accidentally melted in steel mills i 1999. Comments received after this date instructions for its safe operation are causing considerable contamination of I will be considered if it is practical to do adequate and meet regulatory the mill, the steel product, and the so, but the Commission is able to ensure requirements, wastes from the process. the slag and consideration only for comments The person or firm who receives such the baghouse dust. Although known rrceived on or before this date. a device is a general licensee. These exposures have generally not exceeded ADDRESSES: Send comments by mail to general licensees are subject to the public dose limits, there is a the Secretary. U.S. Nuclear Regulatory requirements for maintaining labels, potential for significant exposures.

Commission, Washington, DC 20555- following instructions for safe use, The NRC conducted a 3-year sampling 0001, Attention: Rulemakings and storing or disposing of the device (1984 through 1986) of general licensees  ;

Adjudications Staff. properly, and reporting transfers and to assess the effectiveness of the general

- Hand deliver comments to: 11555 failure of or damage to the device. For license pmgram. The sampling revealed Rockville Pike, Rockville, Maryland, some devices, the general licensee must several areas of concern regarding the

]

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40296 Feder:tl Register /Vol. 64, No.142/ Monday, July 26,1999/ Proposed Rules use of generally licensed devices. In for determining which sources should instituted some form of enhanced particular, the NRC concluded that- be subject to the registration program. oversight for these general licensees. In (1) Many general licensees are Using these criteria, it is now estimated a few cases, States have instituted a i

unaware of the regulations that apply to that the registration requirement would registration program. A few States have the possession of a generally licensed apply to about 5100 general licensees a higher level of control on these device; and possessing about 20,000 devices. These devices through requiring specific (2) Many general licensees are unable criteria were based on considerations of licenses. Under the proposed level of to account for their devices. relative risk and are limited to compatibility for S 31.5, the essential Approximately 15 percent of the radionuclides currently in use in these objectives of the regulation should be general licensees sampled could not types of devices. If quantities of other adopted by the State to avoid conflicts.

account for all of their generally radionuclides that would present a duplications, or gaps. However, the licensed devices. The NRC concluded similar risk are used in these devices in manner in which the essential i

l l that these problems could be resolved the future, the criteria may be revised to objectives of the regulation are by more frequent and timely contact include additional radionuclides. The addressed need not be the same as NRC.

' between general licensees and the NRC. Commission may also consider revising Strict compatibility would only be On December 27,1991 (56 FR 67011)- the criteria to include a larger number requPed for revisions to the the NRC published a notice of proposed of devices in the registration requirements applicable to distributors rulemaking concerning the requirement for other reasons in future because of interjurisdictional accountability of generally licensed rulemaking. distribution.

devices. The proposed rule contained a The Atomic Energy Act of 1954 I

number of provisions, including a (AEA), as amended, provides the NRC Discussion requirement under S 31.5 for general with the authority to request licensees to provide information to the The December 2.1998, proposed rule l information from its licensees would provide one of the key elements NRC upon request, through which a concerning licensed activities. However, in improving the accountability and device registry could be developcd. The the Commission had not included an proposed rule also included control over devices of'particular {

explicit provision in its regulations that concern through the institution of a requirements in SS 32.51a and 32.52 for would require S 31.5 general licensees to registration process. However, current specific licensees who manufacture or provide information on request. On initially transfer generally licensed regulatory provisions are inadequate to December 2,1998 (63 FR 66492), the allow for the NRC to track general devices. Although the public comments Commission published a proposed rule licensees imd the specific devices they '

received were reviewed and a final rule that would explicitly require general '

developed, a final rule was not issued possess. The NRC needs to track these licensees who possess certain generallicensees in order that they can because the resources to fully measuring, gauging, or controlling im lement the rule were not available. be contacted or inspected when devices to provide the NRC with appropriate. The NRC also needs to he NRC has continued to consider information about the devices.

the issues related to the loss of control track individual generally licensed Assuming it becomes a final rule, the devices, so that the responsible party of generally licensed, as well as NRC intends to use that provision specifically licensed, devices. In July can be identified wnen a device is found primarily to institute a registration and in an inappropriate situation.

1995, the NRC. with assistance from the accounting system for the devices Organization of Agreement States, containing certain riuantities of specific Trackin8 devices would also allow the formed a working group to evaluate R " P 8" radionuclides that present a higher risk these issues. The working group of exposure to the public or property es ge c f gr consisted of both NRC and Agreement of devices is identified. As noted, that damage if a device were lost. That State regulatory personnel and rulemaking was not proposed as a proposed rule would not require encouraged the involvement of all matter of compatibility for Agreement Agreement State regulations to be persons having a stake in the process States. That proposed rule presented an c mpatible.

and its final recommendations. All estimate of 6000 general licensees. There are other means for reducing working group meetings were open to based on the estimates made in the the likelihood of incidents of lost the public. A final report was published working group report. However, this sources. 'I be Commission has in October 1996 as NUREG-1551, " Final had not accounted for the fact that, in reconsidered the provisions in its 1991 Report of the NRC Agreement State the interim. Massachusetts had become proposed rule, evaluated the Working Group to Evaluate Control and an Agreement State. Using the same recommendations of the NRC-Accountability of Licensed Devices.' criteria, and removing the previously Agreement State Working Group, and in considering the recommendations NRC general licensees in Massachusetts, identified additional issues concerning of this working group, the NRC decided, results in an estimate of 5100 NRC these devices in developing this among other things, to again initiate general licensees that would be subject Pmposed rule.

rulemaking to establish an annual to the registration requirement. Summary and Discussion of Proposed registration of devices generally This proposed rule would add Requirements licensed under S 31.5. This registration specific requirements concerning the program would be similar to the - registration of devices and additional Revisions to the Requirements for program originally proposed in the 1991 provisions of an enhanced regulatory GeneralLicensees Under S 31.5 proposed rule. However, it would apply oversight program for all general Registration only to those devices considered to licensees to be registered. The proposed present a higher risk of potential rule would also establish levels of This proposed rule would add exposure of the public or property loss compatibility for Agreement State explicit provisions delineating an in the case of loss of control (compared regulations so that an increased level of annual registration requirement, as well to other generally licensed devices). oversight for generallicensees in as a registration fee. The registration Initially, the NRC has been using the Agreement States would also be process would be initiated under criteria developed by the working group required. Some States have already S 31.5(c)(ll), proposed on December 2.

J

Federal Register /Vol. G4 No.142/ Monday, July 26.1999/ Proposed Rules 40297 1998,if that requirement is adopted in would now bear the operational cost of costs to register generally licensed a final rule. Proposed S 31.5(c)(ll) the program instead of those who hold devices at each location is projected to would require licensees to respond to specific licenses. However, it should be be nearly the same regardless of the requests for information from NRC noted that the initial program startup number of sources / devices possessed by within 30 days or as otherwise costs would be recovered from the the licensee. Costs of follow.up and specified. The provisions proposed in annual fee paid by current holders of inspection do not go up substantially th.a document (new S 31.5(c)(13)) are specific licenses. with increased numbers of devices. In essentially consistent with the The costs to be recovered through the addition, these alternative methods Commission's plans for the registration registration fee include the costs for would complicate the determination of process discussed in the December 2, obtaining and maintaining information the proper fee and the fee recovery 1998, proposed rule. This proposed rule associated with the devices subject to process, not only for NRC but for the would specifically require that the the registration requirement, the costs of registrants as well. With the uncertainty information about devices be verified by processing and reviewing the of the licensees' status from one year to the licensee through a physical registrations, and the costs for the next, the additional administrative inventory and by checking label inspections and follow-up efforts effort related to the reconciliation of the information. The advantage ofincluding expected to be made as a result of the fee based on the number of devices more explicit requirements in the registration process identifying possessed from year to year, would not regulation is that information about the noncompliance with existing be cost effective, considering the total registration process will be more clearly regulations. The fee would be based on amount projected to be recovered for the defined and more available. When the the average cost of the program for each registration program. Additionally, distributor of a device supplies copies of of the licensees registering devices. under these alternative methods a large S 31.5 to its customers (under Some of the general licensees, such as diversified firm that owns one device S 32.51a(a)), the potential general non-profit educational in: itutions, will would pay a reduced fee, while a small licensees would be made aware of the be exempt from the fee under S 170.11. entity whose business may depend registration requirement, the devices to Costs not recovered from this small solely on the use of the devices might wh;ch it applies, the nature of the segment of the generallicensees pay a disproportionate fee because it has registration information, and the registering devices would continue to be more than one device. The NRC believes registration fee. recovered from annual fees paid by that basing the fee on a per device basis An organization which uses generally current holders of specific licenses. or a sliding scale would not result in a licensed devices at numerous locations it is expected that the overall cost will fair and equitable allocation of its is considered a separate general licensee decline after the initial years of regulatory costs, and would not achieve at each location. Different facilities at implementation of the registration the goal of the Regulatory Flexibility Act the same complex or campus are not, process, due to increased compliance to reduce the impact of fees on small however, considered separate locations. leading to reduced inspection and entitles. The NRC believes that the in the case of portable devices that are follow-up. However, the number of proposed approach of assessing a fee for routinely used at multiple field sites, generally licensed devices in NRC each licensee subject to registration-there is one general licensee for each jurisdiction is reduced when a State (1) Better reflects the costs to primary place of storage, not for each becomes an Agreement State and takes administer the program, place of use. Thus, an organization over responsibility for the general (2) Is most consistent with existing would be required to complete more licensees in that State. Although a large NRC fee assessment practices.

than one registration, if it possess part of the cost of the program is (3) Would simplify fee collection, devices subject to registration at proportional to the number of general (4) Would be fair and eq sitable, and multiple distinct locations, licensees, a portion of the cost is fixed. (5) Would minimize impacts to small The proposed rule would add a fee to Thus, the cost per general licensee entities.

$ 170.31 to be assessed in conjunction could increase if the number of general The planned registration process will with the annual registration process. licensees subject to registration be somewhat different from that used in This registration fee would be for each decreases. The proposed registration fee the Commission's other registration general licensee filing a registration is $420 based on the current estimated programs, in which blank forms are under S 31.5(c)(13) regardless of the cost of the program and the current filled out by registrants. Instead, it is number of devices. As noted above, an number of general licensees with planned to send a registration request organization is considered to be a devices that would be subject to containing the information recorded in separate generallicensee at each registration. If additional States become the Commission's database, which separate address at which devices are Agreement States before this rule is would ask the general licensee to verify, used, and would be assessed a made final, the fee could be somewhat correct, and/or add to the information registration fee for each location of use. higher in the final rule. provided. This would be similar to the The NRC is required by the Omnibus The Commission considered other approach typically used by States for Budget Reconciliation Act of 1990, as approaches to the proposed fee the tenewal of automobile registrations.

amended (OBRA-90), to recover structure, such as a fee per device or a This is intended to be more efficient for approximately 100 percent ofits budget sliding scale,1. e., fees set for a few the general licensees and the through fees. Since OBRA-90 was ranges of numbers of devices. However, Commission.

enacted, all costs of the general license basing fees on the number of devices or The first registration that would be program have been recovered through a sliding scale would not necessarily carried out under S 31.5(c)(ll) would ennual fees paid by specific licensees, meet the intent of the Independent depend on the NRC's ability to contact The proposed registration fees would Offices Appropriation Act of 1952 general licensees because the NRC must recover the cost of the general license (IOAA), which is the authority under request the information. This proposed program associated with this group of which 10 CFR part 170 fees are rule also specifies that the general general licensees in an equitable way, as established. The IOAA provides that licensee would complete registration by required by law, Those who are allowed fees recover the agency's cost in verifying, correcting, and/or adding to to use devices under the general license providing the servicc, The agency's the information in a request for

.40298 Federal Register /Vol. 64. No.142/ Monday, July 26,1999/ Proposed Rules registration received from the registration fee will be set to apply after location, to provide the serial number of Commission. It is silent on when or how the initial registration requests have the device and the name and phone general licensees should register if the been sent for response under number for the person designated as the Commission fails to contact the general S 31.5(c)(ll) so that the first round of. responsible individual, rather than

. licensee. Thus, it might be interpreted annual registration will be complete simply a contact name (revision to that, if the Commission falls to contact prior to this effective date and the fee S 31.5(c)(9)(i)),

a general licensee, the registration . will be imposed with the first The rationale for each of these requirement would not apply.The

. Commission seeks comment on whether use. reregistration for all devices currently in(1 prop)osed amendments is:

New S31.5(c)(12)-Responsible the registration requirement should Person. The " person" w i 1 olds a

' include a provision that would require Other Revisions for S 31.5 General general license is usuall; :orporation, 1,1censees.

the generallicensee to complete or public or private institution, rather registration by a certain time, such as 15 The proposed rule would establish than an individual. In practice, in order months after- - additional requirements for all general for the general licensee to comply with (1) The date of the previous licensees under S 31,5. These proposed existing regulations, an individual in registration certificate: requirements include- the corporation or institution must be (2) The receipt of a device subject to (1) An explicit requirement for the aware of the requirements and be istration; or general licensee to appoint an authorized to take the required actions.

reg (3) The effective date of this rule for - individual assigned responsibility for Appointing a specific individual to be an unregistered device possessed at the knowing what regulatory requirements responsible for knowing about and time of the effective date of a final rule . are applicable and having authority to taking actions to comply with enacted in response to this proposed - take required actions to comply with the regulations is an appropriate operational rule, applicable regulations and through practice, which. unfortunately, is not

- This would put the burden of whom the general licensee carries out always followed. If a device is not registering on general licensees who its responsibilities to comply with the subject to testing under S 31.5(c)(2),

have not been notified by the NRC of the' applicable regulations (new there are no routine actions required to requirement. The intent would be for S 31.5(c)(12)); be taken, because the requirements are general licensees who find out about the (2) A provision that limits the amount generally restrictions on actions, such as new requirements, for example, from a of time a general licensee can keep an not abandoning the device, or actions to distributor, to contact the NRC to begin unused device in storage and allows the be taken only in the case of particular, .

the registration processilf this approach deferment of testing during the period of non-routine events, such as notification I wer taken, the Commission would storage (new S 31.5(c)(15)); of NRC of the transfer or failure of the likely exercise enforcement discretion (3) A provision to allow transfers to device. It is this type of situation, where in cases where the Commission locates specific licensees authorized under part knowledge of the nature of the device.

a general licensee who has not 30, or equivalent Agreement State the general license, and the associated previously registered devices, if the regulations, as waste collectr rs, in regulations is unlikely to be maintained general licensee was unaware of the addition to currently allowed transfers and passed on to individuals using the requirement. It is recognized that some to part 32 (and Agreement State) device. Requiring the assignment of the general licensees who have received licensees; to allow transfers to other responsibility for knowng and having devices in the past may never be specific licensees but only with prior authority to take required actions for located. written NRC approval; and to add the complying with regulations to a specific The time of year for registration recipient's license number, the serial individual would improve the

. would vary for licensees. However, number of the device, and the date of probability that the general licensees requests for renewal of registration transfer to the information required to will do what they are already required would be made approximately 1 year be provided to NRC upon transfer of a to do. The impact of this should be sfter the previous registration request device (revision of S 31.5(c)(8)); minimal, somewhat limiting operational for that licensee. Although registration (4) A provision to notify NRC of flexibility with regard to the assignment would not be required before the receipt address changes, including name of duties. This individual does not have

. of a device, the Commission plans to changes (new S 31.5(c)(14)); to work on site at the place of use of the send requests for registration to new (5) For device damage or failures that device and does not have to conduct all general licensees subject to registration are likely to or are known to have required actions, but would be that are identified in distributors

• resulted in contamination, the addition responsible to ensure that the general quarterly transfer reports submitted of a plan for ensuring that premises and licensee is aware of required actions to under S 32.52 shortly after this environs are suitable for unrestricted be taken. This assignment does not information is received and recorded. If . access, to the information that must be relieve the generallicensee of a generallicensee has previously sent to NRC in the case of a failure; a responsibility.

registered devices and receives change to the addressee for reporting The NRC/ Agreement State Working tdditional devices requiring ' information concerning a failure; and a Group recommended that general registration, the new devices would be note that the criteria in S 20.1402, licensees assign a backup responsible registered when the annual " Radiological criteria for unrestricted individual (BRI) as well. The proposed reregistration is carried out. The use," may be applied by the rule does not include this requirement.

Commission requests comment on Commission in the case of but the Commission solicits comment  !

whether the NRC should have earlier contamination in spite of the exemption on this issue and will consider adding I contact with previous registrants who in S 31.5(c)(10) (revision to S 31.5(c)(5)); it to the final rule. A BRI would add receive additional devices, either by an and- some assurance that there is a teknowledgment by NRC to the user or . . (6) A revision of the reporting continuation of knowledge of the by a required response from the general requirement,in the case of a transfer to requirements in the event of the person

' licensee that accounts for the additional a general licensee taking over assigned to be the responsible device (s). The effective date of the possession of a device at the same individual leaves his assigned duties.

l

Federal Register /Vol. 64, No.142/ Monday, July 26,1999/ Proposed Rules 40299 However, even without a BRI the (4) New S 31.5(c)(14)-Change of generally licensed device fails or is gererallicensee would have the address notification (including change seriously damaged so as to cause roponsibility under the proposed rule in name of generallicensee). The significant contamination of the to replace the responsible individual to quarterly reports required of distributors premises or environs. the NRC may maintain compliance with proposed under S 32.52(a) and (b) are intended to need to respond to the notification of an S 31.5(c)(12). provide NRC and the Agreement State incident made under S 31.5(c)(5) to (2) New S 31.5(c)(15)-Timeliness of regulatory agencies with the identity of ensure that a facility is properly disposition and deferral of testing while general licensees in their jurisdictions decontaminated. Following such an in storage When a device is not in use and addresses at which these general incident, the NRC would determine for a prolonged time, it is particularly licensees can be contacted (proposed to what actions are necessary on a case-by-

' susceptible to being forgotten and now be specifically the malling address case basis and, if necessary, would ultimately disposed of or transferred for the location of use of the generally apply the criteria set out in 4 20.1402, inappropriately. General licensees are licensed device). These general

" Radiological criteria for unrestricted unlikely to keep a device unused for licensees can then be contacted or use." The general licensee is exempt more than 2 years and subsequently use inspected. If general licensees move from this section of part 20 when in it. If a device is being held in storage their operations without notifying the possession of an intact generally indefinitely, it is likely that it is being NRC, or appropriate Agreement State licensed device. However,. when a stored to avoid the costs of proper agency, they may be difficult to locate. device has been damaged, the material disposal. If a general licensee intends to Even a change of name can cause mail in the device may no longer be fully 1 use a device after a period of more than to be returned. This proposed contained within the device, i.e.. it may l 2 years of nonuse, the device could be requirement to report address changes also be unsealed radioactive material.

sent back to the supplier to be held would only apply to previously Action can be taken by the NRC under under the distributor's specific license supplied mailing addresses and for S 30.61, Modification and revocation of until later use, or the general licensee portable devices, the mailing address for licenses," which is applicable to general could request an exemption from the primary place of storage, although licensees. The provision proposed in S 31.5(c)(15) indicating the reason (s) the devices may be used at multiple this action would require that the why the licensee intends to use the field sites. For those registertng devices, general licensee propose to the device after 2 years and prefers to keep other changes in addresses, if different Commission how it will be shown that ,

it on site in the interim- from the malling address for the the premises are or will be adequately j If a period of storage exceeds the cleaned up. Depending on the nature of location of use, will be provided at the normal interval for testing. testing time of the next registration, the event, the remedial action taken vould not need to be done until the (and reported under existing

- de cM is to be put back into use again. Note: Changes to the general licensee. other requirements) along with any This would relieve the burden of . nas n e

{ me c9 cp ang , sucj q in t ng confirmatory surveys may be sufficient as,ppo l unnecessary testing during the period of to complete action on the event.

of additionalinformation under storage as well as eliminate any The addressee for submitting 5 31.5(c)(9)(t).

unnecessary exposure that could occur information under S 31.5(c)(5) would be

. during testing for that period. This simple change of address changed from Regional Administrator to (3) Revision to S 31.5(c)(8) notification is intended to track moves Director of Nuclear Material Safety and Provisions for transfers to specific into and within NRCjurisdiction and to Safeguards so that all NRC addressees i' licensees. This proposed revision would ma. itain current mailing address specified in S 31.5 for reports by these provide some flexibility to the general information. The generallicense in licensees are the same and to eliminate licensee in transferring a device while S 31.5 only applies to persons within the need for the general licensee to refer ensuring that it is transferred NRCjurisdiction. If a general licensee to part 20 to determine the appropriate appropriately. It would allow a general intends to move from onejurisdiction to addressee. The addressee and address I licensee to transfer a device directly to another, it should contact the applicable for registration will be specified in the I a waste collector for disposal, rather regulatory authority, NRC or the registration request. Adding a note l than going through a distributur. It particular Agreement State, before doing concerning the possible applicability of I would also allow the transfer of a device so to determine the applicable. current S 20.1402 is a clarification.

to other specific licensees. but would regulations in thatjurisdiction. All (6) Revision to S 31.5(c)(9)(1)-

require NRC approval in these cases so jurisdictions do not have a comparable Reporting new generallicensee*s that NRC can ensure that the recipient generallicense and specific provisions responsible individual. Consistent with is authorized to receive the device, of the generallicense may vary among the provision for appointing an The inclusion of a recipient's license jurisdictions. If a general licensee has individual through whom the general number in the report of transfer would obtained a portable device in an licensee will ensure compliance with better ensure that the general licensee Agreement State and wishes to use the the applicable regulations and has verified that the recipient is a part device within NRCjurisdiction, it must requirements, and other reporting 32 licensee, a part 30 waste collection do so under S 31.5, because there is no requirements being proposed, it is more licersee, or a specific licensee under reciprocity provision applicable to effective for the general licensee to equivalent Agreement State regulations generallicenses. In this case, they provide the name of the new l tuthorized to raceive it. It would also would be subject to the provisions of responsible individual when another supply an additional means for NRC to 5 31.5. general licensee takes over the facility identify the recipient, because company . (5) Revision to S 31.5(c)(5)-Reports of and responsibility for the device.

names and addresses sometimes change. device failures. General licensees are An additional proposed amendment The addition of the date of transfer will ' not subject to decommissioning to S 31.5 would clarify the status of a make the transfer easier to track and requirernents. A general license is person who receives a device through j help to ensure that the general licensee granted by regulation and, under normal an unauthorized transfer and would makes the report in a timely manner circumstances, does not involve any remove a restriction on devices.

. (required within 30 days of transfer). termination of license process. If a Paragraph (b) would be revised to (1) l

40300 Federal Register /Vol. 64, No. I42/ Monday, July 26,1999/ Proposed Rules i

limit the applicability of the general S 30.7, " Employee protection." S 30.9, 61 licensed distributors in Agreement license to those who receive a device " Completeness and accuracy of States, through an authorized transfer and (2) information," and S 30.10. " Deliberate expand the applicability of the general ePorung misconduct." The proposed clarification license to devices authorized for would make it easier for general The following information would be distribution by an Agreement State that licensees to be aware of applicable added to the existing quarterly transfer j has no general license covering the use regulations. In addition, future reporting requirement: The serial I of such devices within that State. amendments to part 30 that would number and model number of the Concerning the first of these issues, apply to part 31 general licensees would device: the date of transfer; indication if l the NRC has generally, although not include a conforming amendment to the device is a replacement, and if so, consistently, interpreted the general part 31. Note, however, that while S 31.2 the type, model number, and serial l license to apply to any recipient within would specify sections of part 30 number of the one returned; name and '

the group identified in S 31.5(a). i.e., generally applicable to general licenses, license number of reporting company: )

"* *

• commercial and industrial firms it would not eliminate the applicability and the specific reporting period. The and research, educational and medical of other parts of the Commission's model number of the device is atraady institutions, individuals in the conduct regulations that may apply. required in reports to Agreement States.

of their business, and Federal, State or The general licensee address would be The applicability of S 30.34(h) on local government agencies * * ? even bankruptcy notification to general specified as the mailing address for the if the device is received through an I cation of use of the generally licensed licensees also needs to be clarified. device, unauthorized transfer. The proposed Under the existing regulations, this language would clearly provide that the The name and phone number of the requirement appears to apply to all Person identified by the general licensee generallicense does not apply if the licensees. However its application to device is obtained through an -

general licensees is not clear because it ** * "E "

• E' " " " " N*

- unauthorized transfer. In the case of an take required actions to ensure unauthorized transfer, the recipient is not referenced in S 31.2 or S 31.5' This c mP ilance with the appropriate proposed rule would make the would possess the device without a bankruptcy notification requtrement "E""""'*""9"***""*"

license. replace the name and/or position of a Section 31.5(b) currently restricts applicable only to those general simple contact between the Commission I licensees subject to the registration applicability of the general license in requirement. These licensees possess and the general licensee. )

the case of devices from distributors in A form will be provided for use in Agreement States, to those devices from devices for which the Commission making these reports. However, the use l Agreement States that authorize the ' believes a higher level of oversight is of the form would not be required as  !

devices to be used under a general appropriate. Thus. notification that such long as the report is clear and legible ,

license within their respective States, a general licensee is filing for and includes all of the required j However, the NRC practice is to allow bankruptcy may be important to allow information. Proposed amendments i a device to be used under the general the Commission to intervene to ensure would be made to S 32.52(a) and (b).  ;

that the financial status of the licensee The existing reporting requirement is license in S 31.5, that is distributed in does not lead to the improper disposal intended to provide NRC and the

)

accordance with a license issued under equivalent regulations to S 32.51 by an or abandonment of a device. Agreement State regulatory agencies Agreement State that does not authorize Requirements for Manu/acturers and with the identity of general licensees in devices to be used under a general Initia1 Distributors otDevices theirjurisdictions, addresses at which license within their State. This the general licensees can be contacted approach reserved for NRC the right to The proposed rule would modify the (which are usually the location of use of require distributors in this situation to quarterly transfer reporting. the devices), the particulars of the type

~obtain an NRC distribution license in recordkeeping. and labeling of device possessed, and the name (or order to transfer devices into NRC requirements for specific licensees who position) of an individual who jurisdiction but did not require them to distribute these generally licensed constitutes a point of contact between j do so as long as the State issued devices, and the requirement for the NRC or the Agreement State and the acceptably equivalent licenses. Through Providing information to users. The general licensee. These general licensees NRC's oversight of Agreement State existing requirements in these areas are can then be contacted or inspected.

programs. NRC ensures the safety of a matter of strict compatibility of Including the serial number would these devices. Given this fact and the Agreement State regulation that is, the allow the NRC and Agreement States to ,

experience to date with these few States, State regulations are essentially track individual devices. The existing l the Commisalon believes that this identical. The proposed amendments reporting requirement in S 31.5(c)(8) i restriction is no longer necessary. would also be a matter of strict does not require the general licensee to 4 in addition to the proposed changes to compatibility so that revisions to report a transfer ifit is for the purpose  !

S 31.5, other amendments are proposed Agreement State regulations would be of obtaining a replacement.This is that would clarify which sections of the necessary and distributors in Agreement consistent with the original intent of ,

- regulations in part 30 apply to all of the States would be affected. The basis of this regulation in that the status of the j

- general licensees under part 31. Section this compatibility requirement is general licensee is unchanged, only the

, 31.1, " Purpose and scope." would be significant direct transboundary specific device is changed. In order for

-tmended to clarify that only those implications. This results from the fact individual devices to be tracked, the paragraphs in part 30 specified in S 31.2 that devices are distributed under NRC or Agreement State needs to be

or the particular general license apply to various Agreement State and NRC informed of such a transfer. The part 31 general licensees, Section 31.2, authorities into otherjurisdictions proposed rule would require that the

" Terms and conditions." would be where different regulatory agencies distributor provide this information amended to reference the sections of regulate the possession and use of the either to NRC or the appropriate  ;

part 30 that are applicable to all of the ' devices. Currently, there are 28 NRC Agreement State. Under existing part 31 generallicensees, including ' licensed distributors and approximately requirements quarterly reports are l m _ .

Fed:rtl Regist:r/Vol. 64. No.- 142/ Monday, July 26.1999/ Proposed Rules 40301 r: quired to include specifics on any final disposition of devices to the requirement should be minimal. The new device transferred but not on the various regulatory agencies in the case permanent label for devices requiring devices retumed. The NRC believes that of bankruptcy or termination oflicense registration would provide better the distributor could include this (new S 32.51a(d)). When a distributor assurance that even when a device has additional information in the quarterly goes out of business and terminates its been exposed to other than normal use reports without a significant burden and license, the distributor can no longer be conditions, for example, when a that the distributor is likely to be more required to retain these records. This building has been refurbished or reliable than the generallicensee in requirement would give NRC, as well as demolished with the device in place, providing this information. The name State regulatory agencies, the the label will be intact and the device and license number of the reporting opportunity to obtain and retain records may be identified and proper actions company and the specific reporting of this type previously kept by the can be taken. This may result in a more period are typically included in the distributor. These records could be significant change to the production of reports in order to show compliance helpful in verifying information used to devices. Distributors would have 1 year with the reporting requirement, keep track of devices relative to the final after the effective date of the rule to However, this information is not always disposition of devices. This provision implement these changes to minimize r:adily identifiable. would not require distributors to any impact to the manufacturing and The individual who acts as contact automatically provide these records distributing process.

with the NRC or the Agreement State unless the NRC or the Agreement State concerning the general license should in which the device was distributed Information To Be Provided to General have knowledge of the device, the - makes a request for these records. In the Licensees general license, and the regulations case of bankruptcy, NRC or the The proposed rule would amend the pertaining to the general license, or at Agreement State may want to secure least know who in the organization requirements pertaining to the these records early in the process. In information distributors must provide to does. This is the intent of the existing case financial difficulties interfere with the general licensee (S 32.51a(a) and (b)).

rzquirement. llowever, in practice, the the licensee fulfilling its n me given to the distributor and Distributors are now required to provide responsibilities. general licensees with a copy of S 31.5 rrported to the NRC (or the Agreement State) frequently is not an individual Labelin8 when the device is transferred. The with this type of knowledge. The The proposed rule would amend the proposed rule would require that a copy existing labeling requirements to require of S 31.5 be provided before transfer. l proposed rule would specify that the '

contact designated be the person (1) an additionallabel on any separable The distributor would also be required cssigned responsibility for ensuring that source housing and a permanent label to provide copies of additional the generallicensee is aware of its on devices meeting the criteria for applicable sections of the regulations, a rzgulatory responsibilities and (2) who registration (new S 32.51(a)(4) and (5) listing of the services that can only be i . has authority to take required actions for and S 32.51a(c)). The NRC would performed by a specific licensee, and complying with the applicable consider a label permanent, if, for information regarding disposal options regulations, example, it were embossed. etched, for the devices being transferred. The

' "du disposal options would include the Recordkeeping $',[,Pr ui en ent ne istrib os estimated cost for disposal of the device The proposed rule would add to the would have labels approved as part of at the end of its useful life to the extent rzcordkeeping requirements information obtaining a license: distributors, that the cost information is available to on final disposition of devices. The including existing licensees, would the distributor at the time of the sale of ricordkeeping requirements concerning have the new labeling requirements as the device. For transfers to general tiansfers would have the period of conditions of license in S 32.51(a)(4) and licensees in Agreement States, the retention extended from 5 years from (5). Approval of the new labels by NRC distributor may furnish either the ,

the date of the recorded event, to 3 years for existing distributors would not be applicable N (C regulations or the '

after the expected usefullife of the required. However, distributors may comparable ones of the Agreement i device or the final disposition,if voluntarily submit information for NRC State. In addition, the distributor would .

known. Proposed amendments would . review on how they plan to comply furnish the name, address. and phone ,

be made to S 32.52(c). with the new labeling requirements. In number of the contact at the Agreement State regulatory agency from which l

It is important that information about any case, labeling is subject to the general licensees and the specific inspection. To the extent necessary, the additional information may be obtained.

. devices in their possession be available new labeling requirements would The general licensee should be aware

.until the device is disposed of of the specific requirements before ]

supercede anything contradictory in l permanently. Requiring the distributor individual license conditions. The purchasing a generally licensed device, j to keep these records for an extended individual license conditions would be rather than aftenvard. While the {

time provides a backup to the updated to include specifics related to Commission does not want to get j recordkeeping of NRC and State . the new requirements during the first involved with details of licensees' regulatory agencies. The records include license renewal or amendment business practices, it is the information on final disposition that following the effective date of those Commission's intent that " prior to may not have been included in reports paragraphs of the rule. transfer" would be before a final to NRC and the Agreement States. it is The first change simply carries out the decision to purchase so that the NRC's understanding that these initialintent of the existing requirement information can be considered in distributors generally keep these records for devices where the source may be making that decision. The Commission indefinitely. Thus, this regulatory . separable in a housing that does not seeks comment on how best to achieve requirement should have little, if any, include the label. It is important that and enforce this intent. For example:

Impact. this housing. if separated from the What are the advantages / disadvantages In addition, distributors would ' e - remainder of the device, can also be of using the words, " prior to purchase" required to make available recors of identified. The impact of this in the regulatory text?

u-

40302 Federal Rrgist:r/Vol. 64 No.142/ Monday, July 26,1999/ Proposed Rules While S 31.5 contains the primary rule. There were 26 comment letters Agreement State licensees in Agreement requirements related to the general received from a variety of sources States without a general license.

license, it does not reference the including private and publicly held Section 31.5, paragraph (c)(5)-

applicable sections of part 30.The corporations. private citizens. citizens Revision would add a plan for ensuring general licensee should have copies of groups, the Armed Forces, and State that premises and environs are suitable at least those regulations that may governments. These comments have for unrestricted access. to the require an action on his part. The been considered to the extent applicable information that must be sent to NRC in sections of the regulation that would be to each rule. A detailed analysis of the the case of a failure, when device included in this requirement are comments received on the December 27, damage or failure is likely to or known believed to be the most important for 1991, proposed rule, which was the general licensee to be aware of, The to have resulted in contamination:

withdrawn by the notice of proposed would change the addressee for inclusion of a listing of services that can rulemaking on December 2.1998, is not reporting information concerning a only be performed by a specific licensee presented in either of the subsequent failure; and would clarify that the would clarify the services that can and proposed rules because many of the criteria in S 20.1402 may be applied in cannot be performed by the general specific comments pertain to specific spite of the exemption in $ 31.5(c)(10),

licensee. These services vary depending provisions that have been withdrawn, a Section 31.5 paragraph (c)(8)-

on the nature and design of the great deal of time has passed since these Revision would allow transfers to particular device and so are not comments were made . and additional specific licensees authorized under part specified in the regulations. Information opportunity for comment is being 30, or equivalent Agreement State on the estimated cost for disposal of the provided. regulations, as waste collectors. in device at the end of its useful life may be a significant factor in a decision to Early State and Public Input addition to currently allowed transfers to part 32 (and Agreement State) purchase a device because of the high These proposed amendments were licensees; would allow transfers to other costs of disposing of radioactive provided to the Agreement States twice materials. In some cases the cost of specific licensees but only with prior during its development via the use of written NRC approval; and would add disposal could exceed the purchase the NRC Technical Conference Website price of the device, the recipient's license number, the serial and notification to the States of its number of the device, and the date of Additional clarifying amendments availability. Input was received would be made in SS 30.31. 30.34(h), transfer to the information required to following the first posting through be provided to NRC upon transfer of a and 31.5(c)(9)(li). The wording of discussions at an All Agreement State S 30.31 would provide a similar device.

meeting in October of 1998. The second clarification as that in the Suggested Section 31.5, paragraph (c)(9)(i)-

posting was also available to the public. Revision would add to the reporting State Regulations with respect to general A notice of availability was published '

licenses. The amendment to S 30.34(h) requirement, in the case of a transfer to December 31,1998 (63 FR 72216). The would be consistent with the previously States and the distributors were notified a general licensee taking over discussed change concerning reporting possession of a device at the same of its availability directly, as well. Tw location, to provide the serial number of bankruptcy. comments were received. One from a The revision of 5 31.5(c)(9)(ii) to the device and the name and phone State and one from industry. They were number of the person identified as include,the term, intermediate generally supportive and indicated person, is intended to provide having knowledge of and authority to points needing clarification- take required actions to ensure Pe m ns ol ng ie. fi al Summary of Proposed Provisions by compliance with the appropriate intermediate persons holding devices in Paragraph regulations and requirements, rather their original shipping containers at Section 30.31-Revision would than s a contact "

their intended location of use are reconcile the apparent conflict between 5 ,gm 9Wib general licensees. Distributors licensed the description of a general license and under S 32.51, or equivalent Agreement a registration requirement.

Revision

" intermediate would add person," the term'rlfy to cla that a State regulations, must provide Section 30.34, paragraph (h)(1)- report of transfer is not required only information about both intermediate Revision would make the bankruptcy when the information on both an persons and intended users in their notif! cation requirement applicable only intermediate person and an intended quarterly reports submitted under to those general licensees subject to the u

{ r was provid d t S 32.52(a). Transfers from intermediate registration requirement.

persons to intended users under Section 31.1-Revision would clarify transfer report.

S 31.5(c)(9)(li) do not need to be that only those paragraphs in part 30 Section 31.5, paragraph (c)(12)-

reported to NRC because information specified in 5 31.2 or the particular Would add an explicit requirement for about the intended user must be general license apply to part 31 general the general c nsee to a point an re o e by the distributor under liegnsees

~

ents M'inor conforming amendments references to the sections of part 30 that are applicable to the general licensee would also be made to SS 170.2,170.3, are applicable to all of the part 31 and having authority to take required 171.5, and 171.16. general licensees. actions to comply with the applicable Section 31.5, paragraph (b)-Revision regulations.

Public Comments on the Original would clarify the status of a person who Section 31.5. paragraph (c)(13)-

Proposed Rule receives a device through an Would add an explicit requirement for The NRC reviewed the comments unauthorized transfer by limiting the the general licensee to register devices received on the December 27,1991, applicability of the general license to meeting certain criteria, which specifies proposed rule in developing both the those who receive a device through an the information to be provided and proposed rule published on December 2, authorized transfer; and would remove references the fee requirement in 1998 (63 FR 66492), and this proposed the restriction on devices distributed by S 170.31.

L_

Federa1 Register /Vol. 64, No.142/ Monday, July 26.1999/ Proposed Rules 40303 Section 31.5, paragraph (c)(14)- The name and phone number of the Commission has not yet found it Would add requirement for general person identified by the general licensee practical to resolve all the issues related licensees to notify NRC of address as having knowledge of and authority to to having broad access to the database.

changes. take required actions to ensure The Commission would like to give Section 31.5. paragraph (c)(15)- compliance with the appropriate further consideration to establishing Would limit to 2 years the amount of regulations and requirements would such a database. It would not require time a general licensee can keep an replace the name and/or position of a rulemaking. However, if it were to be unused device in storage and allow the simple contact between the Commission established. one option would be to deferment of testing during the period of and the general licensee. Also, a form change the material transfer reporting I storage, will be provided for use in making these requirements so that distributors would Section 32.51, paragraphs (a)(4) and reports. However, the use of the form report all transfers to the NRC rather (5)-Would add requirement for an would not be required as long as the than reporting to alljurisdictions into additional label on any separable source report is clear and legible and includes which transfers of devices are made.

housing and a permanent label on all of the re uired information. A primary advantage of a national devices meeting the criteria for Section 3 .52, paragraph (c)- l Revision would add to the database would be the ease of tracing a registration.

Section 32.51a, paragraphs (a) and recordkeeping requirements information "found" device back to the general on final disposition of devices. The licensee owner responsible for the (b)-Revision would amend the requirements pertaining to the recordkeeping requirements concerning device. A "found" generally licensed device would be considered an orphan information distributors must provide to transfers would have the period of source until such time as the the general licensee. Distributors are retention extended from 5 years from now required to provide general the date of the recorded event to 3 years responsible generallicensee is identified and it is returned to the licensees with a copy of S 31.5 when the after the expected useful life of the licensee. The Commission is in the device is transferred. The proposed rule device or the final disposition, if process of modifying the Nuclear would require that 5 31.5 be provided known.

Section 170.2-W,ould conform the Materials Events Database (NMED) to before transfer. The distributor would accept and track information on orphan also be required to provide copies of SC Pe of part 170 to include a general

,9 , 9 g3 additional applicable sections of the lic see re str3 "\Vould revise Access to the NMED will be available to i regulations, a listing of the services that the NRC and all the States. The can only be performed by a specific definition of " Materials License" to include part 31 and the words. "or Commission will encourage the States to licensee, and information regarding disposal options for the devices being granted" as general licenses are granted use NMED for this purpose so that this category of information will be shared transferred, including estimated costs of by regulation rather than individually nationally. However, NMED would rely disposal, For transfers to general issued to licensees.

Section 170.31-Revision would add on reporting of events for its data. In licensees in Agreement States, the order for a device to be traced back to

$420 registration fee for general distributor may furnish either the the responsible general licensee, each licensees subject to S 31.5(c)(13).

applicable NRC regulations or the Section 171.5-Would revise Jurisdiction would need to search its comparable ones of the Agreement own files. In addition. information in a State. In addition, the distributor would definition of " Materials License" to national general license database would include part 31 and the words, "or furnish the name, address, and phone granted" as general licenses are granted be immediately available, and would number of the contact at the Agreement by regulation rather than individually contain the most complete information State regulatory agency from which issued to licensees. about general licensees and generally additional information may be obtained. Section 171.16-Would add category licensed devices.

Section 32.51a, paragraph (c)-Would for part 31 general license registration The primary disadvantage to a make labeling requirements a condition for consistency with the Table in national database would be the of license 1 year after effective date of S 170.31. difficulty of maintaining the security of

rule, the data, which is primarily made up of Section 32.51a, paragraph (d)- m aid National Database proprietaryinformation. A national add requirement for distributors t, .nake The Commission is in the process of database would also present more risk available records of final disposition of developing a new computer database to to the integrity of the data, because there devices to the various regulatory handle information about general would be a higher potential for illicit agencies in the case of bankruptcy or licensees and g,enerally licensed corruption of data, termination of the distributor's license. devices. Among other improvements In considering whether or not to Section 32.52, paragraphs (a) and from the currently used system, it will implement a national database and, if (b)-Revision would add the following be designed to handle the registration so, what the particular approach would infonnation to the existing quarterly process efficiently with automated be used, there are a number of aspects transfer reporting requirement: the serial features. In doing so, the Commission to be considered including- l number and model number of the has given some consideration t I device: the date of transfer indication if whether a national database should be (1) Who will maintain the database device is a replacement, and if so, the established in which information on the (the NRC, an independent third party, or type, model number, and serial number identity of general licensees and device each agency maintaining its own data)?

of the one retumed: name and license information for alljurisdictions would (2) How access to the data would be number of reporting company; and the be maintained, making this information controlled, specific reporting period. Also, the accessible to all Agreement States and (3) Potential changes to the reporting generallicensee address would be the NRC. There are variations on the requirements for transfers.

specified as the mailing address for the exact approach that might be taken (4) The ability for the NRC and the location of use of the generally licensed particularly with respect to access and Agreement States to protect information device, update authority At this time, the of other agencies.

40304 Federal Register /Vol. 64 No.142/ Monday, July 26.1999/ Proposed Rules (5) Costs to implement and maintain general licensee takes appropriate and the revisions to 9 31.5 would be the system or systems (including corrective action to address the specific classified as Category C. Through this training). violations and prevent recurrence of action, existing provisions of $ 31.5 i The Commission seeks comment on similar problems and otherwise has would also be reclassified from Category the advantages and disadvantages of undertaken good faith efforts to respond D to Category C. Although changes are implementing a national database and to NRC notices and provide requested being made to 55 30.31,30.34(h)(1),

on these related issues. Information. This change from the 31.1, and 31.2, and parts 170 and 171 Specific Questions for Public Comment Commission's normal enforcement as part of this rulemaking, the existing policy is to remove the potential for the compatibility designations for these The Commission welcomes comments threat of enforcement action to be a regulations will not be affected.

on all aspects of this proposed rule, and disincentive for the licensee to identify Category B means the provisions is especially interested in receiving deficiencies. This approach is warranted affect a program element with comments on the specific questions given the limited NRC inspections of significant direct transboundary summarized here: general licensees. This approach is implications. The State program

1. The Commission seeks comment on intended to encourage general licensees element should be essentially identical whether the registration requirement to determine if applicable requirements to that of NRC. Category C means the should include a provision that would have been met, to search their facilities provisions affect a program element. the require the general licensee to complete to ensure sources are located, and to essential objectives of which should be registration by a certain time, whether develop appropriate corrective action adopted by the State to avoid conflicts, or not the NRC requests registration. when deficiencies are found. Under the duplications, or gaps in the national

2. The Commission requests comment interim enforcement policy, program. The manner in which the on whether it is appropriate for new enforcement action, including issuance essential objectives are addressed need devices obtained by registrants to be of civil penalties and Orders, may be not be the same as NRC provided the registered when the annual taken where there is- essential objectives are met. I reregistration is carried out without the (a) Failure to take appropriate Specific information about the '

NRC having earlier contact after corrective action to prevent recurrence compatibility or health and safety additional devices are received. Earlier of similar violations; components assigned to this rule may be ,

contact could be made either by an (b) Failure to respond and provide the found at Office of State Programs I acknowledgment by NRC to the user or information required by regulation: website, http://www.hsrd.ornl. gov /nrc/

by a required response from the general (c) Willful failure to provide complete home.html.

licensee to account for the additional and accurate information to the NRC; or As discussed above, revised S 32.52(a) device (s), (d) Other willful violations, such as and (b) would add the following

3. The Commission solicits comment willfully disposing of generally licensed information to the existing distributors' on whether general licensees should be material in an unauthorized manner, quarterly transfer reporting required to assign a backup responsible As noted in the December 2,1998, requirements: the serial number and individual (BRI), proposed rule, the Commission also model number of the device, the date d 4.The Commission seeks comment on plans to increase the civil penalty transfer, indication if the device is a how best to achieve and enforce the amounts specified in its Enforcement replacement (and if so the type, model intent that full disclosure ofinformation Policy in NUREG-1600 Rev.1, for number, and serial number of the dulce required to be provided to general violations involving lost or improperly returned), the name and license nun ber licensee customers by distributors be disposed sources or devices. This of the reporting company, and the made early enough to be considered in increase will better relate the civil specific reporting period. The proposed a decision to purchase. For example: pnalty amount to the costs avoided by revisions would also require the rame Would it be better to use the words, the failure to properly dispose of the and phone number of a general

" prior to purchase" in the regulatory source or device. Due to the diversity of licensee's " responsible individual" text? the types of sources and devices, the rather than simply a contact and would

5. The Commission seeks comment on Commission is considering the specify that the address of the general the advantages and disadvantages of establishment of three levels of base licensee be the mailing address for the implementing a national database of civil penalty for loss or improper location of use. According to NRC general licensees and their devices. disposal. The three levels of base civil Management Directive (MD) 5.9, penalty would be $5500, $15,000, and " Adequacy and Compatibility of nfwcement Agreement State Programs," NRC

$45.000. The higher tiers would be for On March 9,1999 (64 FR 11508), the sources that are relatively costly to regulations that should be adopted by Commission established an interim dispose of and would be based on an Agreement State for purposes of enforcement policy for violations of approximately three times the average compatibility should be adopted in a S 31.5 that licensees discover and report cost of proper transfer or disposal of the time frame such that the effective date during the initial cycle of the scurce or device, of the State requirement is no later than registration program. This policy 3 years after the effective date of NRC's supplements the normal NRC Agreement State Compatibility final rule. MD 5.9 also provides that Enforcement Policy in NUREG-1600, Under the " Policy Statement on some circumstances may warrant that Rev.1, It will remain in effect through Adequacy and Compatibility of the States adopt certain regulations in one complete cycle of the registration Agreement State Programs" published less than the recommended 3-year time program. or' September 3.1997 (62 FR 46517), the frame or that the effective dates for both Under this interim enforcement prc , sed rule would be a matter of NRC licensees and Agreement State policy, enforcement action normally corvatibility between the NRC and the licensees be the same. The Commission will not be taken for violations of S 31.5 Agreement States, thereby providing believes it is important to the that are identified by the general consistency among Agreement State and implementation of this program, and to licensee, and reported to the NRC if NRC requirements. The revisions to part Agreement State programs, to begin reporting is required, provided that the 32 would be classified as Category B receiving the additional information in

E t

i Fzderal R: gist:r/Vol. 64, No.142/ Monday, July 26.1999/ Proposed Rules 40305 I the distributors' quarterly transfer data needed, and completing and obtained by calling Catherine R.

rIports as soon as possible. The reviewing the information collectien. Mattsen. U.S. Nuclear Regulatory Commission requests comments on The time involved is small because most Commission, Office of Nuclear Material whether NRC and the Agreement States of the proposals are minor revisions to Safety and Safeguards, Washington, DC should establish a single existing information collection 20555-0001

telephone (301) 415-6264:

implementation date for this provision requirements. The U.S. Nuclear or e-mail at CRM@nrc. gov.

which would be earlier than is usually Regulatory Commission is seeking Regulatory Flexibility Certification allowed for revision of Agreement State public comment on the potential impact rules for compatibility. One approach of the information collections contained As required by the Regulatory would be to request Agreement States to in the proposed rule and on the Flexibility Act (5 U.S.C. 605(b)), the require distributors to provide all the following issues: Commission has evaluated the impact of information consistent with this rule 1. Is the proposed information this rule on small entities. The NRC has (proposed S 32.52(a) and (b)) either collection necessary for the proper established standards for determining I coincident with the effective date of the performance of the functions of the which NRC licensees qualify as small )

Commission's final action on this NRC, including whether the information entitles (10 CFR 2.810). The rulemaking or within 1 year of that will have practical utility 7 Commission certifies that this proposed effective date. Agreement States would 2. Is the estimate of burden accurate? rule, if adopted, would not have a have the flexibility to adopt this 3. Is there a way to enhance the significant economic impact on a provision through rulemaking. license quality, utility, and clarity of the substantial number of small entitles.

conditions, or other legally binding information to be collected? The most significant cost of this r:quirements. 4, How can the burden of the proposed rule would be the proposed information collection be minimized, $420 fee to be assessed for each Plain Language including the use of automated registration. Portions of the proposed The Presidential Memorandum dated collection techniques? rule would apply to the approximately June 1,1998, entitled, " Plain Language Send comments on any aspect of this 45,000 persons possessing products in Government Writing," directed that proposed information collection, under an NRC general license, many of the government's writing be in plain including suggestions for reducing the whom may be classified as small language. This memorandum was burden, to the Records Management entities. However, the annual  !

published June 10,1998 (63 FR 31883). Branch (T-6F33), U.S. Nuclear registration requirement and associated j In complying with this directive, Regulatory Commission, Washington, fee would apply to about 5100 of these l editorial changes have been made in the DC 20555-0001, or by Internet generallicensees. Based on input '

proposed revisions to improve the electronic mail at BJSl@NRC. GOV; and received previously from small entitles organization and readability of the to the Desk Officer, Office of who hold specific materials licenses, the existing language of paragraphs being Information and Regulatory Affairs, NRC believes that the proposed $420 revised. These types of changes are not NEOB-10202 (3150-0016), Office of part 170 registration fee would not have discussed further in this notice. The Management and Budget, Washington, a significant economic impact on a  ;

NRC requests comments on this DC 20503. substantial number of small entities.

proposed rule specifically with respect Comments to OMB on the information The NRC believes that the economic to the clarity and effectiveness of the collections or on the above issues impact of the other proposed linguage used. Comments should be should be submitted by August 25, requirements on any general licensee sent to the address listed under the 1999. Comments received after this date would be a negligible increase in heading: ADDRESSES above, will be considered if it is practical to do administrative burden. The NRC is j so, but assurance of consideration soliciting comment from the general Environmental Impact: Categorical . cannot be given to comments received licensees who meet the NRC's small Exclusion after this date, entity size standards and would be The NRC has determined that the p p , gg required to register their devices revisions proposed in this rule are the pursuant to part 31 on whether the types of actions described in the If a means used to impose an proposed part 170 fee for their annual

- categorical exclusions in S S t.22(c)(1) information collection does not display registration would have a significant through (3). Therefore, neither an a currently valid OMB control number, economic impact on their business.

environmental impact statement nor an the NRC may not conduct or sponsor, The proposed rule would also revise environmental assessment has been L and a person is not required to respond requirements for specifically licensed prepared for this regulation. to, the information collection. distributors of certain generally licensed devices. Currently, there are 28 NRC P;perwork Reduction Act Statement Regulatory Analysis licensed distributors and approximately This proposed rule amends The NRC has prepared a draft 61 Agreement State licensed information collection requirements that regulatory analysis for this proposed distributors. Many of these licensees are are subject to the Paperwork Reduction regulation. The analysis examines the not small entities and the impact to any

- Act of 1995 (44 U.S.C. 3501 et seq). This cost and benefits of the alternatives of these distributors is not expected to rule has been submitted to the Office of considered by the NRC.The comments be significant in any case. Distributors Management and Budget for review and received on the draft regulatory analysis who are small entities are also invited t

rpproval of the information collection associated with the proposed rule of - to comment on whether they believe the requirements. December 27,1991, have been economic impact would be significant.

The public reporting burden for this considered to the extent that they apply Those small entities that offer j, information collection is estimated to to this action. The regulatory analysis is comments on the potentialimpact on cverage 2 minutes per response, available for inspection in the NRC small entitles and how that might be including the time for reviewing Public Document Room,2120 L Street minimized should specifically include instructions, searching existing data NW. (Lower Level), Washington, DC. information on the type and size of their sources, gathering and maintaining the Single copies of the analysis may be business and how the proposed L..

3 40306 Federzl Register /Vol. 64, No.142/ Monday, July 26,1999/ Proposed Rules regulations would result in a significant PART 30--RULES OF GENERAL PART 31-GENERAL DOMESTIC economic impact on them as compared APPLICABILITY TO DOMESTIC LICENSES FOR BYPRODUCT to larger organizations in the same LICENSING OF BYPRODUCT MATERIAL business community. To the extent MATERIAL possible, the commenter should provide 4. The authority citation for part 31 relevant economic data, such as the 1. The authority citation for part 30 e ntinues to read as follows:

licensee's gross annual receipts, as well continues to read as follows: Authority: Secs. 81.161.183. 68 Stat. 935.

as number of employees. Authority: Secs. 81,82,161.182,183.186. 948. 954, as amended (42 U.S C. 2111. 2201.

68 Stat. 935,948. 953,954' 955. as amended- 2233): secs. 201 as amended. 202. 88 Stat.

Backfit Analysis as amended. 1244 (42 U.S C. 5841.

sec. 234, 83. Stat. 444, as amended. (42 The NRC has determined that the U S.C. 2111,2112. 2201. 2232,2233,2236 2 ' ' Section 31.6 also issued under sec. 274. 73 backfit rule, S 50.109, does not apply to hai 24 am nd d,"1245,12d6 4 U S C. Stat. 688 92 RS C. 2021L this proposed rule and, therefore, a 5841.5842.5846). 5. Section 31.1 is revised to read as backfit analysis is not required because Sec. 30.7 also issued under Pub. L.95-601, follows:

these amendments would not involve sec.10. 92 Stat. 2951 as amended by Pub. L.

any provisions that would impose 102-486: sec. 2002,106 Stat. 3123. (42 U.S C. $ 31.1 Purpose and scope.

backfits as defined in S 50.109(a)(1). 5851). Section 30.34(b) also issued under sec. This part establishes general licenses 184. 68 Stat. 954 as amended (42 U.S C. for the possession and use of byproduct List of Subjects 2234). Section 30 61 also issued under sec. 187,68 Stat. 955 (42 U.S.C. 2237).

material and a general license for cwnership of byproduct material.

2. Section 30.31 is revised to read as Specific provisions of 10 CFR part 30 Byproduct material Criminal follows: are applicable to general licenses penalties, Government contracts, established by this part. These Intergovernmental relations. Isotopes, $ 30.31 Types of licenses. provisions are specified in S 31.2 or in  ;

Nuclear materials, Radiation protection. Licenses for byproduct material are of the particular general license.

Reporting and recordkeeping 6. Secti n 31.2 is revised to read as two types: General and specific. ,

requirements. folloWS (a) The Commission issues a specific '

10 CFR Part 31 license to a named person who has filed $ 31.2 Terms and conditions.

an application for the license under the The general licenses provided in this Byproduct material. Crbninal provisions of this part and parts 32-36, part are subject to the general provisions penalties, Labeling. Nuclear materials. and 39 of this chapter. of Part 30 of this chapter (SS 30.1 Packaging and containers. Radiation through 30.10), the provisions of protection, Reporting and recordkeeping (b) A general license is provicled by regulation, grants authority to a person SS 30.14 (d), 30.34 (a) to (e), 30.41, 30.50 requirements. Scientific equipment. to 30.53,30.61 to 30.63, and parts 19, for certain activities involving 4 10 CFR Part 32 byproduct material, and is effective 20. and 21, of this chapter 8 unless without the filing of an application with indicated otherwise in the specific Byproduct material, Criminal the Commission or the issuance of a Provision of the generallicense.

penalties. Labeling. Nuclear materials, licensing document to a particular 7. In S 31.5, paragraphs (b), (c)(5),

Radiation protection. Reporting and person. However, registration with the (c)(8), and (c)(9) are revised and recordkeeping requirements. Commission may be required by the Paragraphs (c)(12), (13). (14), and (15) particular general license, are added to read as follows:

10 CFR Part i70

3. In S 30.34, paragraph (h)(1) is $ 31.5 Certain measuring, gauging, or Byproduct material, Import and revised to read as follows: controlling devices.2 l

exportlicenses Intergovernmental * * * *

• j relations. Non-payment penalties. $ 30.34 Terms and conditions of licenses. (b)(1) The general license in l

Nuclear materials Nuclear power plants paragraph (a) of this section applies and reactors. Source material. Special (h)(1) Each general licensee that is only to byproduct material contained in nuclear material. required to register by S 31.5(c)(13) of devices which have been manufactured this chapter and each specific licensee or initially transferred and labeled in 10 Nart 171 shall notify the appropriate NRC accordance with the specifications contained in-

)

Annual charges, Byproduct material. Regional Administrator,in writing, )

Holders of certificates, registrations. immediately following the filing of a (i) A specific license issued under 1 spprovals, Intergovernmental relations, voluntary or involuntary petition for S 32.51 of this chapter; or Non-Payment Penalties Nuclear bankruptcy under any chapter of title 11 (ii) An equivalent specific license (Bankruptcy) of the United States Code issued by an Agreement State.

materials. Nuclear power plants and by or against: (2) The devices must have been r: actors. Source material. Special (1) The licensee; received from one of the specific nuclear material.

licensees described in paragraph (b)(1)

For the reasons set out above and (11) An entity (as that term is defined under the authority of the Atomic in 11 U.S.C.101(14)) controlling the i Attention is directed particularly to the i 20 of the chapter cweming Energy Act of 1954, as amended; the licensee r listing the license or licensee {r a5 Property of the estate; or gf ,,

Energy Reorganization Act of 1974, as 2 Persons possessing bypmduct material in amended; and 5 U.S.C. 553 the NRC is (iii) An affiliate (as that term is devices under a general hcense in 5 31.5 before PtoPosing to adopt the followin8 defined in 11 U.S.C.101(2)) of the January 15.1975. may continue to possess, use, or amendments to 10 CFR parts 30,31,32, licensee, transfer that inaierial an accordance with the labehng requirements of 5 31.5 in errect on January 170, and 171. * * * *

• 14.1975-

Fzdtral R:glster/Vol. 64, No.142/ Monday. July 26,1999/ Proposed Rules 40307 of this section or through a transfer (A) The identification of the device by Commission and shall pay the fee made under paragraph (c)(9) of this manufacturer's name. model number, required by S 170.31 of this chapter.

section. and serial number; Registration must be done by verifying. i (c) * * * (B) The name, address and license correcting, and/or adding to the  !

. . . . . number of the person receiving the information provided in a request for device; and registration received from the (5) Shall immediately suspend -

operation of the device if there is a (C) The date of the transfer. Commission. The registration (111) Shall obtain written NRC information must be submitted to the failure of, or damage to, or any  :

approval before transferring the device NRC within 30 days of the date of the I indication of a possible failure of or to any other specific licensee, request for registration or as otherwise damage to, the shielding of the radioactive material or the on-off (9) Shall transfer the device to another indicated in the request. In addition, a general licensee only if- general licensee holding devices mechanism or indicator, or upon the (i) The device remains in use at a meeting the criteria of paragraph detection of 0.005 microcurie or more particular location. In this case, the removable radioactive material. The (c)(13)(1) of this section is subject to the transferor shall give the transferee a bankruptcy notification requirement in device may not be operated until it has been repaired by the manufacturer or copy of this section and any safety S 30.34(h) of this chapter.

documents identified in the label of the (111) In registering devices, the general other person holding a specific license device. Within 30 days of the transfer, to repair such devices that was issued licensee shall furnish the following the transferor shall report the information and any other information under parts 30 and 32 of this chapter or manufacturer's name and the model specifically requested by the by an Agreement State. The device may number and the serial number of the Commission- I be disposed of by transfer to a person device transferred, the name and authorized by a specific license t (A) Name and malling address of the I address of the transferee, and the name general licensee.

receive the byproduct material and phone number of the responsible (B) Information about each device:

contained in the device. A report individual identified by the transferee containing a brief description of the The manufacturer, model number, serial  !

event and the remedial action taken; in accordance with paragraph (c)(12) of number, the radioisotope and activity and, in the case of detection of 0.005 the section to have knowledge of and (as indicated on the label),

authority to take actions to ensure (C) Name and telephone number of I microcurie or more removable compliance with the appropriate the responsible person designated as a radioactive material or failure of or regulations and requirements to the representative of the generallicensee damage to a source likely to result in i Director of Nuclear Material Safety and under paragraph (c)(12) of this section.  !

contamination of the premises or the Safeguards, U.S. Nuclear Regulatory (D) Address at which the device (s) are l environs, a plan for ensuring that the Commission Washington, DC 20555-premises and environs are acceptable used and/or stored. For portable 0001; or devices, the address of the primary for unrestricted use, must be furnished to the Director of Nuclear Material (11) The device is held in storage by an place of storage.

intermediate person in the original (E) Certification by the responsible Safety and Safeguards, U.S. Nuclear Reg atory mmt ion shipping container at its intended representative of the generallicensee Vashin o"g I cation of use prior to initial use by a that the information concerning the i Y3 d these circumstances, the criteria set out generallicensee. device (s) has been verified through a in S 20.1402. Radiological criteria for physical inventory and checking of label (12) Shall appoint an individual information.

ter ed by e i in a responsible for having knowledge of the (F) Certification by the responsible appropriate regulations and representative of the generallicensee f' ,pcase basis.

, requirements and the authority for that they are aware of the requirements taking r quired actions to comply with of the generallicense.

(8)(1) Shall transfer or dispose of the appropriate regulations and (14) Shall report changes of address

. device containing byproduct material requirements. The general licensee, (including change in name of general only by transfer to another general through this individual, shall ensure the licensee) to the Director of Nuclear licensee as authorized in paragraph day-to-day compliance with appropriate Material Safety and Safeguards, U.S.

(c)(9) of this section or to a person regulations and requirements. This Nuclear Regulatory Commission, authorized to receive the device by a appointment does not relieve the Washington, DC 20555-0001 within 30 specific license issued under parts 30 general licensee of responsibility in this days of the effective date of the change.

and 32 of this chapter, part 30 of this regard, if it is a portable device, a report of

- chapter that authorizes waste collection, (13)(1) Shall register, in accordance address change is only required for a or equivalent regulations of an with paragraphs (c)(13)(ii) and (111) of change in the device's primary place of  ;

Agreement State, or as approved under this section. devices containing at least storage.

paragraph (c)(8)(lii) of this section. 370 MBq (10 mCl) of cesium-137,3,7 (15) May not hold devices that are not (ii) Shall furnish a report to the - MBq (0.1 mC1) of strontium-90,37 MBq in use for longer than 2 years. If devices Director of Nuclear Material Safety and (1 mC1) of cobalt-60, or 37 MBq (1 mCl) with shutters are not being used, the Safeguards, U.S. Nuclear Regulatory of americium-241 or any other shutter must be locked in the closed Commission, Washington, DC 20555- transuranic, i.e., element with atomic position. The testing required by 0001 within 30 days after the transfer of number greater than uranium (92), paragraph (c)(2) of this section need not a device to a specific licensee A report based on the activity indicated on the be performed during the period of is not required if the device is label. storage only. However, when devices transferred to the specific licensee in (ii)Ifin possession of a device are put back into service or transferred order to obtain a replacement device meeting the criteria of paragraph to another person, and have not been from the same specific licensee, The (c)(13)(1) of this section, shall register tested within the required test interval, report must contain- these devices annually with the they must be tested for leakage before u

7 40308 Fed:rni Register /Vol. G4, No.142/ Monday, July 26,1999/ Proposed Rules L' ust Hransfer and the shutter tested (3) A list of the services that can only a quarterly basis on Form 653-

.beiste use. ' be performed by a specific licensee; and " Transfers of Industrial Devices Report" t . * *

(4) Information on acceptable disposal or in a clear and legible report options including estimated costs of containing all of the data required by PART 32-SPECIFIC DOMESTIC disposal. the form.

LICENSES TO MANUFACTURE OR (b) If byproduct material is to be (1) The required information TRANSFER CERTAIN ITEMS transferred in a device for use under an includes- {

CONTAINING BYPRODUCT MATERIAL equivalent generallicense of an (1) The identity of each general i 8'Th a Agreement State, each person that is licensee by name and malling address  !

yci n for part 32 '

nd f,, licensed under S 32.51 shall provide the for the location of use; (11) The name and phone number of information specified in this paragraph Authority: Secs. 81,161,182,183,68 Stat.

to each person to whom a device is to the person identified by the general l 935. 948. 953,954, as amended (42 U.S.C. be transferred. This information must be licensee as having knowledge of and 2111,2201,2232,2233); sec. 201,88 Stat.

provided before the device may be authority to take required actions to 1242, as amended (42 U.S.C. 5841).

transferred. In the case of a transfer ensure compliance with the appropriate

9. In S 32.51, paragraphs (a)(4) and (5) through an intermediate person, the regulations and requirements; are added to read as follows: information must also be provided to (111) The date of transfer; the intended user prior to initial transfer (iv) The type, model number, rad ic f r e underi 15; req m ents to the intermediate person. The required . serial number of the device transferred:

se to manufacture, or initimpy in e and njation inct I") , ,' , . regulations equivalent to S$ 31.5,31.2, byproduct material contained in the 30.51,20.2201, and 20.2202 of this device-(4) Each device having a separable chapter or a copy of SS 31.5, 31.2,30 51* (2) If one or more intermediate source housing that provides the persons will temporarily possess the Primary shielding for the source als 20.2201, and 20.2202 of this chapter. lf a copy of the NRC regulations is device at the intended place of use Provided to a prospective general before its possession by the user, the I conta nin8 t vic r de report must include the same

, number and serial number, the isotope licensee, at shall be accompanied by a and quantity, the words, Caution- note explaining that use of the device is information for both the Intended user Radioactive Material,, the radiation regulated by the Agreement State. and each intermediate person, and symbol described in S 20.1901 of this (2) A list of the services that can only clearly designate the intermediate be performed by a r.pecific licensee: Person (s). j chapter, and the name of the (3) If a device transferred replaced manufacturer or initial distributor, (3) Information on acceptable disposal J options including estimated costs of another returned by the general (5) Each device meeting the criteria of licensee, the report must also include disposal; and W The name, address, S 31.5(c)(13)(1) of this chapter, bears a the type, model number, and serial and phone number of the contact at the permanent (e.g., embossed, etched, stamped, or engraved) label affixed t Agreement State regulatory agency from number of the one returned.

which additionalinformation may be (4) The report must cover each the source housing if separable, or the calendar quarter, must be filed withm device if the source housing is not obtained'h device that is transferred after 30 days of the end of the calendar (c) Eac separable, that includes the words, (insert date 1 year after the effective date quarter, and must clearly indicate tSe

, Caution-Radioactive Material, and, Pedod covered by the report.

of this rule) must meet the labeling i if practicable, the radiation symbol L5) The report must clearly identify described in S 20.1901 of this chapter.

requirements in S 32.51(a)(3) through )

(5). the specific licensee submitting the (d) If a notification of bankruptcy has report and include the license number

10. Section 32.51a is revised to read been made under S 30.34(h) or the of the specific licensee.

as follows: license is to be terminated, each person (6) If no transfers have been made to licensed under S 32.51 shall provide' Persons generally licensed under S 31.5 532.51a Sans CondWons @comies. upon request, to the NRC and to any of this chapter during the reporting (a) If a device containing byproduct appropriate Agreement State, records of ' period. the report must so indicate.

materialis to be transferred for use (b) The person shall report all final disposition required under under the general license contained in transfers of devices to persons for use S 32.52(c)'

S 31.5 of this chapter, each person that 11. Section 32.52 is revised to read as under a general license in an Agreement is licensed under S 32.51 shall provide follows: State's regulations that are equivalent to the information specified in this S 31.5 of this chapter to the responsible paragraph to each person to whom a 5 32.52 Same: Material transfer reports Agreement State agency. The report device is to be transferred. This and records, must be submitted on Form 653-information must be provided before the Each person licensed under S 32.51 to - " Transfers of Industrial Devices Report" device may b0 transferred. In the case of ' initially transfer devices to generally or in a clear and legible report a transfer through an intermediate licensed persons shall comply with the containing all of the data required by person, the information must also be requirements of this section. the form.

provided to the intended user prior to (a) The person shall report a.. (1) The required information initial transfer to the intermediate transfers of devices to persons for use includes-

person. The required information under the generallicense in S 31.5 of (1) The identity of each general includes- this chapter to the Director of the Office licensee by name and malling address (1) A copy of the general license of Nuclear Material Safety and for the location of use; contained in S 31.5 of this chapter; Safeguards, U.S. Nuclear Regulatory (11) The name and phone number of (2) A copy of SS 31.2,30.51,20.2201. Commission, Washington, DC 20555- the person identified by the general cnd 20.2202 of this chapter; 0001. The report must be submitted on licensee as having knowledge of and

Feder:1 Itgistir/Vol. 64, No.142/ Monday, July 26,1999/ Proposed Rules 40309 authority to take required actions to report and must include the license 13. Section 170.2 is amended by ensure compliance with the appropriate number of the specific licensee. adding a paragraph (r) to read as

. regulations and requirements; (6) If no transfers have been made to follows:

(iii) The date of transfer; a particular Agreement State during the (iv) The type, model number, and reporting period, this information shall $ 170.2 Scope, serial number of the device transferred; be reported to the responsible * * *

• and Agreement State agency upon request of (r) A holder of a general license I (v) The quantity and type of the agency, granted by 10 CFR patt 31 who is byproduct material contained in the (c) The person shall keep records of required to register a device (s).

devtce. all transfers of devices for each general 14. In S 170.3, the definition of (2) If one or more intermediate licensee including all the information in Materials License is revised to read as persons will temporarily possess the the reports required by this section and follows:

device at the intended place of use records of final disposition. Records before its possession by the user, the required by this paragraph must be 5170.3 Definitions. J j

report must include the same maintained for a period of 3 years * * * *

• information for both the intended user following the estimated useful life of the Mater als License means a license, ,

and each intermediate person, and device or the date of final disposition, certificate, approval, registration. or l clearly designate the intermediate if known. other form of permission issued or

• " granted by the NRC pursuant to the (3) If a device transferred replaced PART 170--FEES FOR FACILITIES MATERIALS, IMPORT AND EXPOR'T regulations in 10 CFR parts 30. 31 another returned by the general through 36,39. 40,61,70,71 and 72.

licensee, the report must also include LICENSES, AND OTHER REGULATORY SERVICES UNDER THE nut r o the ne tric ATOMIC ENERGY ACT OF 1954, AS 15. Section 170.31 is amended by (4) The report must be submitted AMENDED adding a fee category,3. Q. to the l within 30 days after the end of each 12. The authority citation for part 170

" "8 calendar quarter in which such a device continues to read as follows: o t o e I to a i a ag ap is transferred to the generally licensed $ 170.31 Schedule of fees for materials Authority 31 U.S.C. 9701; sec. 301. Pub.

person and clearly indicate the period L.92-314,86 Stat. 222 (42 U.S C. 220lw); licenses and other regulatory services, covered by the report. sec. 201, 88 Stat.1242. as amended (42 including inspections, and import and j (5) The report must clearly identify U.S.C. 5841); sec. 205, Pub. L 101-576,104 exp rtlicenses, the specific licensee submitting the Stat. 2842, (31 U.S.C. 9012), * * * *

• SCHEDULE OF MATERIALS FEES )

[See footnotes at end of table]

Category of materials licenses and type of n ~s1 Fee u I

. . , . . t

3. * *

• Q. Registration of a device (s) generally licensed pursuant to Part 31 $420 1 Types of fees.

Authority: Sec. 7601. Pub. L.99-272,100 other form of permission issued or (O Generally licensed device registrations Stat.146, as amended by sec. 5601 Pub. L. granted by the NRC pursuant to the under 10 CFR 31.5. Submittals of registration 100-203,101 Stat.1330, as amended by sec. regulations in 10 CFR parts 30,31 Information must be accompanied by the 3201, Pub. L 101-239,103 Stat. 2106 as through 36,39,40,61,70,71, and 72.

prescribed fee, 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. I8. In S 171.16, paragraph (d) is l 201,88 Stat.1242 as amended (42 U.S.C. amended by adding a fee category,3. Q.

PART 171-ANNUAL FEES FOR

' REACTOR OPERATING LICENSES, 5841; sec. 2903. Pub. L.102-486,106 Stat.

to the schedule of annual fees.

AND FUEL CYCLE LICENSES AND 3125 H2 ESA 22H note).

MATERIALS LICENSES, INCLUDING 17. In S 171.5, the definition of $ 171.16 Annual fees: Material Licensees, e o* '"

• HOLDERS OF CERTIFICATES OF Materials License is revised to read as Hjder o ., ur n ce' l COMPLIANCE, REGISTRATIONS, AND follows: Registrations, Holders of Quality Assurance QUALITY ASSURANCE PROGRAM Program Approvals and Government APPROVALS AND GOVERNMENT $17ts Dennitions. Agencies Licensed by the NRC, AGENCIES LICENSED BY THE NRC . . . . .

Materials License means a license, ]

16. The authority citation for part 171 certificate, approval, registration, or (d) * *

• continues to read as follows:

1

'40310' Fed;rtl Regist:r/Vol. 64. No.' 142/ Monday July 26,1999/ Proposed Rules SCHEDUt.E OF MATERIALS ANNUAL FEES AND FEES FOR GOVERNMENT AGENCIES LICENSED BY NRC

[See footnotes at end of table]

Category of materials license 9, N

3. * *

• Q. Registration of devices generally licensed pursuant to part 31. . .

18N/A

.17018fees.

No annual fee is charged for this category since the cost of the general license registration program will be recovered through 10 CFR part Dated at Rockville, MD., this 19th day of July,1999.-

For the Nuclear Regulatory Camission.

' J. Samuel Walker.

ActirgSecretaryofthe Commission.

[FR Doc. 99-18981 Filed 7-23-99,8 45 am]

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