ML20217M908

Requests Concurrence on Encl FRN for Pr to Amend 10CFR31.5, Requirements for Possession of Industrial Devices Containing Byproduct Matl

ML20217M908
Person / Time
Issue date:	07/14/1998
From:	Combs F NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Bangart R, Funches J, Gray J NRC OFFICE OF STATE PROGRAMS (OSP), NRC OFFICE OF THE CONTROLLER, NRC OFFICE OF THE GENERAL COUNSEL (OGC)
Shared Package
ML20217M898	List: ML20217M893 ML20217M908 ML20217M912 ML20217M920 ML20217M925 ML20217M941 ML20217N003 ML20217N009 ML20217N016 ML20217N039 ML20217N046 ML20217N060 ML20217N068 ML20217N089 ML20217N104 ML20217N111
References
FRN-63FR66492, RULE-PR-31 AG06-1-004, NUDOCS 9910280076
Download: ML20217M908 (64)

Text

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% UNITED STATES l' .;<)- j NUCLEAR REGULATORY COMMISSION  ;

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• 2 WASHINGTON, D.C. 2055541001 j s.,,,l July 14, 1998 l

l l MEMORANDUM TO: Richard L. Bangart, Director, OSP i

Jesse L. Funches, CFO l

Joseph R. Gray, Associate General Counsel for Licensing and Regulation, OGC James Lieberman, Director, OE i

David L. Meyer, Chief, RDB, ADM Brenda Jo Shelton, Chief, IRM , Cl

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FROM: Frederick C. Combs, ActingM dtor. -

Division of Industrial ang:a Nu(ear ety, NMSS

SUBJECT:

OFFICE REVIEW AND CONC 'RRENCE: PROPOSED RULE TO '

AMEND 10 CFR 31.5, " REQUIREMENTS FOR THE POSSESSION OF INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL" Your concurrence is requested on the attached Federal Register notice for the subject 4 proposed rule.

1. TAla: Requirements for the Possession of Industrit Devices Containing Byproduct Material- 10 CFR Part 31  !

2. Reauested Action: Office concurrence.

3. NMSS Task Leader: Catherine R. Mattsen,415-6264

4. Coanizant Individuals: Maria Schwartz, OGC - 415-1888 L. Rakovan, OSP 415-2539 M. Lesar, ADM 415-7163 '

J. DelMedico, OE 415-2739 l

l l

CONTACT: Catherine R. Mattsen, NMSS/IMNS ,

301-415-6264 Jayne McCausland, NMSS/IMNS 301-415-6219 l

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P R. L. Bangart et al. 2

- 5. Backoround: Under the general license provisions of 10 CFR 31.5, certain persons may receive and use a device containing byproduct material under a generallicense if certain conditions are met. A generally licensed device usually consists of radioactive material, contained in a sealed source, within a shielded device, and it is designed with inherent radiation safety features so that it can be used by persons with no radiation training or experience.

There have been a number of occurrences where generally licensed devices containing radioactive material have not been properly disposed of or properly handled resulting in radiation exposure to the public and contamination of property. The NRC concluded that more frequent and timely contact between the general licensee and the NRC could remedy these problems.

On December 27,1991 (56 FR 67011), the NRC published a proposed rule concerning this issue. The proposed rule included a requirement for general licensees un+r 10 CFR 31.5 to provide information at the request of the NRC that would form uiu regulatory basis for the registration of devices as well as additional requirements in 10 CFR 32.51a and 32.52 for the specific licensees who manufacture or initially transfer these devices to the generallicensees.

A final rule was not issued because of lack of resources to properly implement the provisions of the rule as proposed. In July 1995, with assistance from the Organization of Agreement States, NRC formed a worl:Mg group to evaluate these issues. The recomrnendations of the working group were published in NUREG-1551, " Final Report of the NRC-Agreeement State Working Group to Evaluate Control and Accountability of Licensed Devices," (Oct 1996). After evaluating the working group's recommendations, the staff requested, in SECY-97-273, Commission approval to develop and implement a registration program for certain 10 CFR 31.5 general licensees.

In an 3RM dated April 13,1998, the Commission disapproved the staff's recommendation in SECY-97-273 and directed the staff to terminate the rulemaking on 10 CFR 31.5 that was initiated in 1991, except for those provisions that would enable NRC to request information from certain general licensees to provide the regulatory basis for initiation of a registration program. Also in that SRM, the Commitsion directed the staff to develop, in a subsequent rulemaking, a registration and followup program for generally licensed sources / devices identified by the NRC/ Agreement States Working Group in NUREG-1551, apply fees to these general licensees, and incorporate requirements for permanent labeling of sources /devicesc Another item in the SRM was the development of an enforcement policy with a short amnesty program followed by increased civil penalties for lost or improperly disposed sources.

This proposed rule would present, for a second round of comment, the proposed addition of an explicit requirement for general licensees who possess these devices to provide information to the NRC, as requested, concerning products that they have received for use under the generallicense. This provision would be used primarily to institute a registration and accounting system for devices containing certain quantities of specific radionuclides. The licensees will be asked to verify information concerning the

July 14, 1998 9D(/ 1 M@Ob-/

R. L. Bangart et al. 3 identification of devices, accountability for the devices, the persons responsible for compliance with the regulations, and the disposition of the devices. This is intended to ensure that generallicensees are aware of and underst:sd the requirements for the possession of devices containing byproduct material and to assure accountability for devices which have been distributed for use under the generallicense, thus reducing the potential for incidents that could result in unnecessary radiation exposure to the public and contamination of property.

6. Reauested Co : oletion Date: Fifteen working days from date of memorandum. To meet the EDO deadline, a meeting will be scheduled during the week of July 27,1998, to

- discuss and resolve any remaining issues / concerns that are delaying concurrence.

Please plan on having an official who can concur for your office available for this meeting. If no issues are identified and all concurrences received, this meeting will be cancelled.

7. . Steerino Grouo: None

8. Enhanced Public Particioation: No

9. Comoatibility for Aareement States: No; as directed by the SRM, the Agreement State compatibilty issue will be addressed in the second, more comprehensive rule also

' dealing with this issue.

10. Resources and Coordination: A copy of this concurrence package has been forwarded to the IG for information.

Attachment:

Commission Paper w/ attachments cc w/att:

H. T. Bell,' OlG H. Miller, Rl/ ORA

- L. Reyes, Ril/ ORA C. Paperiello, Rlll/ ORA E. W. Merschoff, RIV/ ORA M. Knapp, NMSS W. Kane. NMSS~

W. Beecher, OPA Cognizant Individuals Distribution: (0:WIATTsEN\GL1 P5 rop _31.off)

RGordon/RF - LRiani (WITS No. 9800070)

IMNs/ Central File DMendiola NMss R/F CGallagher NRC Central File JMMcCausland LCarnper LLubinski SBaggett to rreiv, . emy of this onn-e inown, in tw m c m enov .itwout ttvwntiencinw, v/ hn, ith ete,-venciowe. v . % con OFFICE: RGB/IMNS h MSB/l f / RQQ(IMNS ,

N63 NAME: CMattsentb LC hK lahan CCo f/

DATE: 7/ l /98 / 3 4/h/98

, OFFICIAL RECORD COPY' NMSS FILE CODE NO.

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R. L. Bangart et al. 3 identification of devices, accountability for the devices, the persons responsible for compliance with the regulations, and the disposition of the devices. This is intended to ensure that generallicensees are aware of and understand the requirements for the -

possession of oevices containing byproduct material and to assure accountability for devices which have been distributed for use under the general license, thus reducing the potential for incidents that could result in unnecessary radiation exposure to the public and contamination of property.

5

6. Reauested Comoletion Date: Fifteen working days from date of memorandum. To meet the EDO deadline, a meeting will be scheduled during the week of July 27,1998, to discuss and r? solve any remaining issues / concerns that are delaying concurrence.

Please plan on having an official who can concur for your office available for this meeting. If no issues are identified and all concurrences received, this meeting will be cancelled.

7. Steerino Grouo: None

8. Enhanced Public Particioation: No

9. Comoatibility for Aoreement States: No, as directed by the SRM, the Agreement State compatibilty issue wiil be addressed in the second, more comprehensive rule also dealing v/ith this issue.

10. Epiqurces and Coordination: A copy of this concurrence package has been forwarded to the IG for information.

Attachment:

Commission Paper w/ attachments

EDE: The Commissioners FROM L. Joseph Callan, Executive Director for Operations SUBJECI: PROPOSED RULE: .10 CFR PART 31 " REQUIREMENTS FOR THE POSSESSION OF INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL" PURPOSE:

To inform the Commission that the EDO intends to pubriS, as directed by the Commission, a proposed rule that would explicitly require general licensees, who possess certain devices containing byproduct material, to provide the Nuclear Regulatory Commission (NRC) with infnrmation concerning devices that they have received for use under a general license. This provision would be used primarily to institute a 'egistration and accounting system for devices using certain quantities of specific radionuclides.

BACKGROUND There have been a number of occurrences where generally licensed devices containing radioactive material issued under 10 CFR 31.5 have not been properly disposed of, or properly handled, resulting in radiation exposure to the public and contamination of property. The staff concluded that more frequent and timely contact between the general licensee and the NRC

could remedy these problems. On December 27,1991 (56 FR 67011), the NRC published a proposed rule conceming this issue. The proposed rule included a requirement for general licensees under 10 CFR 31.5 to provide information at the request of the NRC that would form the regulatory basis for the registration of devices as well as additional requirements in 10 CFR 32.51a and 32.52 for the specific licensees who manufacture or initially transfer these devices to the general licensees. A final rule was not imphmented because of lack of resources to properly implement the provisions of the rule as proposed.

CONTACT:

Catherine R. Mattsen, NMSS/IMNS (301) 415-6264 Jayne M. McCausland, NMSS/IMNS (301) 415-6219'

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J

The Commissioners! 2

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. In July 1995, with assistance from the Organization of Agreement States, NRC formed a working group to evaluate the issues related to the loss of control of generally licensed as well as

. specifically licensed sources of radioactivity. The working group submitted a final report to NRC conceming its evaluation, and on October 18,1996, the staff provided its evaluation of the l

working group recommendations in SECY-96-221. 4This report was published as NUREG-1551

- in October of 1996.1 On November 13,1996, the staff briefed the Commission on its preliminary views of the working group's recommendations.-

-On November 26, '1997, SECY-97-273 requested Commission approval of the staff's recommendation to develop and_ implement a regirtration program for certain 10 CFR 31.5 genera! licensees. The staffs recommendation was based, in part, on its evaluation of the recommendations of the NRC/ Agreement State Working Group. In an SRM dated April 13, 1998, the Commission disapproved the staffs recommendation in SECY-97-273 and directed the staff to terminate the rulemaking on 10 CFR 31.5 that was initiated ir; 1091, except for those

. provisions that would enable NRC to request information from certain general licensees'to provide the regulatory basis for initiation of a registration program. The subject proposed rule responds to that directive. - Also, in that SRM, the Commission directed the staff to develop, in a

-subsequent rulemaking, a registration and followup program for generally licensed sources / devices identified by the NRC/ Agreement State Working Group in NUREG-1551, apply fees to these general licensees, and incorporate requirements for permanent labeling of sources / devices. In addition, the Commission directed the staff to provide a set of milestones for implementing the second rulemaking described above. These milestones are included in Attachment 1.

' Another item in the SRM was the development of an enforcement policy with a short amnesty program followed by increased civil penalties for lost or improperly disposed sources. The

. Federal Register notice for the proposed rule includes notification of the Commission's intent to

- make these changes to the enforcement policy. The interim policy will be provided to the Commission with the final rule and would be issued concurrently with the final rule.

DISCUSSION The NRC has authority under the Atomic Energy 'Act of 1954 to request appropriate information from its licensees conceming licensed activitiesc However, in the case of 10 CFR 31.5

. licensees, no explicit provision to this effect has been included in Part 31. This proposed rule would add an explicit requirement to 10 CFR 31.5 that general licensees respond in a timely way to written requests from the NRC for information conceming devices that they have received for use under the general license. This provision will be primarily used to institute a registration and accounting system for devices using certain quantities of specific radionuclides. The criteria for determining which devices would be included in the registration program are those  ;

recommended by the working group. . The licensees will be asked to verify information

conceming the identification of devices, accountability for the devices, the persons acting as contact with the NRC, and the disposition of the devices. It is estimated that approximately 6000 )

- general licensees would be required to provide registration information to the NRC. I

- The proposed rule is intended to ensure that certain general licensees are aware of and

' understand the requirements for the possession of devices containing byproduct material and i 1

i The Commissioners 3 l

can account for their devices. This communication would provide NRC assurance of 1 accountajility on the part of these licensees. Better awareness on the part of generallicensees I of their responsibilities would help to ensure that the general licensees comply with the requirements for proper handling and disposal of generally licensed devices and should help )

reduce the potential for incidents that could result in unnecessary radiation exposure to the {

public, as well as contamination of property.

t COORDINATION: j i

The Office of the General Counsel has no legal objection to the proposed rulemaking. The i Office of the Chief Financial Officer has reviewed this paper fer resource implications and has no objections. The Office of the Chief Information Officer has reviewed the proposed rule for information technology and management implicstions and concurs with it. j 1

RECOMMENDATIONS:

That the Commission:

1. Acorove a notice of proposed rulemaking (Attachment 2) that would explicitly require j general licensees who possess devices containing byproduct n.aterial to provide the NRC i with information concerning devices that they have received for use under the general '

license as requested by the NRC.

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

3. Mate: j

a. It is my intention to sign the draft Federal Register notice in 10 days from the date of this paper unless directed otherwise by the Commission;

b. The rulemaking will be published in the Federal Reaister for a 75-day public comment period;

c. There has been no coordination of this rulemaking with the Agreement States; as directed by the SRM of April 13,1998, no compatibility of Agreement State regulations is required; the Agreement State compatibility issue will be addressed in the second, more comprehensive rule also dealing with this issue.

d. Neither an environmentalimpact statement nor an environnu 7tal assessment has been prepared for this regulation because it does not have a significant effect on the environment;

e. A dreft regulatory analysis has been prepared and will be available in the Public Document Room (Attachment 3);

The Commissioners 4

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

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

h. The proposed rule would amend information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). These requirements have bet.1 forwarded to the Office of Management and Budget for approval;

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

L. Joseph Callan Executive Director for Operations i

Attachments: 1. Milestones for Registration Program

2. Draft Federal Register Notice

3. Draft Regulatory Analysis

4. Congre6:,ional Letters  !

5. Draft Press Release

6. Approval fer Publication -  ;

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The Commissioners 4

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

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

h. The proposed rule would amend information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). These requirements have been forwarded to the Office of Management and Budget for approval;

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

]

1 l

L. Joseph Callan '

Executive Director for Operations Attachments: 1. Milestones for Registration Program l

2. Draft Federal Register Notice

3. Draft Regulatory Analysis

4. Congressional Letters '

5. Draft Press Release

6. Approval for Publication l

I DOCUMENT NAME: o:\mattsen\glip\ prop _31.cp to ry,i., a enny ne inn onn nt u.o,c.e, in en, em r - em .ieno,,e net an- no-ime. n . ran, ien .e tret - %re. v.ecm OFFICE: RGB RGB IMNS RRDB/ADM NAME: CRMattsen PKHolahan FCCombs DMeyer DATE: / /98 / /98 / /98 / /98 OFFICE: OClO OGC D/OE CFO NAME: BJShelton JGray JLieberman JFunches DATE: / 19 8 / /98 / /98 / /98 OFFICE: D/OSP Tech D/NMSS DEDR EDO Ed l NAME: RBangart EKraus MKnapp HThompson LJCallan DATE: / /98 / /98 / /98 / /98 / /98 I 1

( OFFICIAL RECORD COPY NMSS FILE CODE NO.:-

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l ATTACHMENT 1 MILESTONES FOR REGISTRATION PROGRAM I

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I Milestones for registration program for generally licensed devices Final rule package for this rule To EDO four months after the end I of public comment period Effective - Approximately 7/99 l

The second comprehensive rule I Develop initial draft package 9/8/98 OMB package to IRM for review 10/6/98 issued for Office concurrence and to Agreement States 10/27/98 Discuss at OAS meeting 10/98 To EDO 12/24/98 To Commission 12/31/98 Fublish in Federal Register and transmit OMB package to OMB (3/9/99)

End of public comment period 75 days after publication Develop draft final rule package 13 weeks after end of comment period To Agreement States for review 18 weeks after end of comment period To Office review- 20 weeks after end of comment period l

To EDO - 25 weeks after end of comment period To Commission. 28 weeks after end of comment period I

Automated Registration System i Begin Registrations 2/2000 i

p Bua i ATTACHMENT 2 FEDERAL REGISTER NOTICE

[7590-01-P]

NUCLEAR REGULATORY COMMISSION 10 CFR Part 31 RIN 3150 - XXXX Requirements for the Possession of Industrial Devices Containing Byproduct Material AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule. ,

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SUMMARY

The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations j

. governing the use of byproduct materialin certain measuring, gauging, or controlling devices to j i

explicitly require general licensees who possess these devices to provide the NRC with information concerning the devices. The NRC intends to use this provision to provide legal basis to request information from licensees regarding accountability of devices containing certain quantities of specific radionuclides that present a higher risk (compared to other generally licensed devices) of exposure to the public or property damage if a device were lost and initiate an annual registration program. The rule, as proposed, is intended to ensure that

. generallicensees are aware of and understand.the requirements for the possession of devices L containing byproduct material and can account for their devices. Better awareness on the part u

of these licensees of their responsibilities would help to ensure that they comply with the '

requirements for proper handling and disposal of generally licensed devices and should help I

f l.

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l reduce the potential for incidents that could result in unnecessary radiation exposure to the j i

public as well as contamination of property.

I DATES: Submit comments by (Insert date 75 days after publication date). Comments received i

l after this date will be considered if it is practicable to do so, but the Commission is able to assure consideration only for comments received on or before this date.

I ADDRESSES: Send comments by mail or addressed to the Secretary, U.S. Nuclear Regulatory I

Commission, Washington, DC 20555-0001. Attention: Rulemakings and Adjudications Staff. i l

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 infohn7aion about the

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interactive rulemaking site, contact Ms. Carol Gallagher, (301) 4 624&,p mail CAG@nrc. gov.

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

(i.ower 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; or Jayne McCausland, Office of Nuclear 2

E 1 Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6219, or e-mail at JMM2@nrc. gov.

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SUPPLEMENTARY INFORMATION:

Background

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On February 12,1959 (24 FR 1089), the Atomic Energy Commission (AEC) amended its regulations to provide a general license (originally in 10 CFR 30.21(c)) for the use of byproduct material contained in certain measuring, gauging, or controlling devices.- Under current regulations, now contained in 10 CFR 31.5, certain persons may receive and use a device containing byproduct material under this general license if the device has been manufactured I and distributed in accordance with the specifications contained in a specific license issued by the NRC or by an Agreement State. A specific license authorizing distribution of generally licensed devices is issued based upon a determination by a' regulatory authority that the safety i

features of the device and the instructions for safe operation of that device are adequate and '

meet regulatory requirements. The general licensee must comply with requirements for labeling, instructions for use, proper storage or disposition of the device, and for some of these devices, I leak testing. The licensee is also subject to terms and conditions set forth in 10 CFR ,31.2 dealing with general license requirements, transfer of byproduct material, reporting and record

- keeping, and inspectiori The general licensee is also required to comply with the safety instructions contained in or referenced on the label of the device and to have the testing or servicing of the device performed by an individual authorized to manufacture, install, or service these devices.

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A generally licensed device usually consists of radioactive material, contained in a sealed source, within a shielded device. The device is designed with inherent radiation ssfety features so that it can be used by persons with no radiation training or experience. Thus, the general license is meant to simplify 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 general licensees under the Commission's general license in 10 CFR 31.5 who possess about 600,000 devices that contain byproduct material. In the past, generallicensees have not been contacted by NRC on a regular basis because of the relatively small radiation risk posed by these devices and the very large number of general licensees.

However, there have been a number of occurrences where generally licensed devices containing radioactive material have not been properly handled or properly disposed of which has resulted in radiation exposure to the public and contamination of property, e. g., when a source is accidentally melted in a steel mill, considerable contamination of the mill, the steel product, and the wastes from the process, the slag, and the baghouse dust, can result. As a result of some of these incidents and in order to assess the effectiveness of the general license program, the NRC conducted a 3-year sampling (1984 through 1986) of generallicensees to determine whether there was an accounting problem with generally licensed device users and, if so, what action could be taken. The sampling revealeo several areas of concern regarding the use of radioactive material under the generallicense provisions of 10 CFR 31.5. The NRC concluded that there is: (1) lack of awareness of appropriate regulations on the part of the generallicensee; and (2) inadequate handling and accounting for these generally licensed devices. Approximately 15 oercent of all generallicensees sampled could not account for all of 1

l their generally licensed devices. As a result of the sampling, the NRC concluded that these  !

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i problems could be remedied by more frequent and timely contact between the generallicensee 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 for generallicensees under 10 CFR 31.5 to provide information to the NRC upon request, through which a device registry could be developed. The proposed rule also included requirements in 10 CFR 32.51a and 32.52 for the 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 of lack of available resources to properly implement the provisions of the rule as proposed.

l The NRC has continued to consider the issues related to the loss of control of generally licensed, as well as specifically licensed, sources of radioactivity. In July 1995, the NRC, with assistance from the Orgt lization of Agreement States, formed a working group to evaluate these issues. The working group consisted of both NRC and Agreement State personnel and encouraged the involvement of all persons having a stake in the process and its final l recommendations. All working group meetings were open to the public. A final report was completed in July 1996 and 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 these recommendations, the NRC has decided, among other things, to initiate an annual registration, similar to the program originally proposed in the December 27, 1991 proposed rule, of devices generally licensed under 10 CFR 31.5. However, the NRC has l decided to do so only for those devices considered to present a higher risk (compared to other 5 l l

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l generally licensed devices) of potential exposure of the public and property loss in the case of l

l loss of control. Initially at least, the NRC will use the criteria developed by the working group for determining which sources should be subject to the registration program.

l' This proposed rule would present for a second round of comment the proposed addition of an explicit requirement to provide information in response to requests made by the NRC.

While the proposed rule would apply to all 10 CFR 31.5 general licensees, the NRC plans to only contact generallicensees identified by the working group for the purpose of the registration program.

l NRC, as part of this notice, is withdrawing the December 27,1991 proposed rule. NRC i plans to review the other provisions contained in the December 27,1991 proposed rule and the i recommendations of the working group and develop additional requirements in a separate l

proposed rule to be issued in the near future.

Discussion The Atomic Energy Act of 1954 (AEA), as amended, provides the NRC with the authority to request appropriate information from its licensees concerning licensed activities. In the case of 10 CFR 31.5 general licensees, however, the Commission has not included an explicit provicion in this regard in its regulations in Part 31. While 10 CFR 2.204,30.34(e), and 30.61(a) require information from licensees by order or demand, these provisions are not considered appropriate for the initiation of a routine registration program. Also, in a previous rulemaking, the Commission (then AEC) had proposed the inclusion of a registration requirement for generally licensed devices (February 5,1974; 39 FR 4583). The proposal was for registration prior to receipt of devices. In response to comment on that proposal, the Commission decided not to 6

institute a registration requirement at that time as part of the final rulemaking on that action (December 16,1974; 39 FR 43531). Given this history, establishing a device registration program without a rulemaking process is also considered inappropriate.

This proposed rule would add an explicit requirement to section 31.5 that general licensees respond in a timely way to written requests from the NRC for information concerning products that they have received for use under a general license. The NRC intends to use this provision primarily to institute an annual registration program for devices using certain quantities of specific radionuclides.

The proposed rule would require a response to requests within 30 days or such other time as specified in the request. For routine registration information,30 days should be adequate in most instances, and an extension can be obtained for good cause. If more complicated requests are made or circumstances recognized that may require a longer time, the Commission may provide a longer insial time in some instances. In the unusual circumstance of a significant safety concern, the Commission could demand information in a shorter time if appropriate, but would not do so for routine requests for information. The appropriate address and phone number for making a request for extension will be provided in the request for information. The NRC is specifically soliciting comments on this time period.

The proposed rule is primarily intended to ensure that general licensees covered by the registration program are aware of and understand the requirements for the possession of devices containing byproduct material and allow NRC to account for devices that have been distributed for use under the cenerallicense. Better awareness on the part of general licensees of their responsibilities would help to ensure that the general licensees comply with the requirements for proper handling and disposal of generally licensed devices and should help 7

[-

reduce the potential for incidents that could result in unnecessary radiation exposure to the

. public as well as contamination of property.

The licensees will be asked to verify, as well as certify, information concerning: l l

1. the identification of devices, such as the manufacturer, model and serial numbers;

2. accountability of devices;

3. the persons responsible for compliance with the regulations; and

4. the disposition of the devices.

While the proposed rule would apply to all 10 CFR 31.5 general licensees (about 45,000), the NRC will only contact approximately 6000 general licensees, possessing about 1,000 such devices. This estimate is based on the use of the criteria recommended by the working group for determining which sources should have increased oversight. Requests for i l information would be sent to general licensees who are expected, based on current NRC l

l records, to be in possession of devices containing at least 370 MBq (10 mci) of cesium-137, 3.7 MBq (0.1 mci) of strontium-90,37 MBq (1 mci) of cobalt-60, or 37 MBq (1 mci) of any l transuranic (at this time, the only generally licensed devices meeting this criterion contain l americium-241). The majority of the devices meeting these criteria are used in commercial and industrial apolications measuring thickness, density, or chemical composition in industries such as petrochemical and steel manufacturing. The requests will include the information contained l

l in NRC records concerning the possession of these devices. The licensees will be asked to verify, correct, and add to that information. The NRC records are based on information provided to NRC by distributors under 10 CFR 32.52(a) and from general licensees as required by 10 CFR 31.5(c)(8) or (9). If a generallicensee no longer possesses a device meeting the criteria ,

to register, they would still be expected to provide information about the disposition of such  !

l devices previously possessed. Errors in current NRC records concerning these general -

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( licensees could be the result of: (1) errors made in the quarterly reports of manufacturers or

. initial distributors,'(2) general licensees not reporting transfers, or (3) errors in recording transfer F information made by NRC or its contractors. {

in addition to the 6000 general licensees identified for registration, NRC may q occasionally request information from other general licensees as considered necessary or

. appropriate on a case-by-case basis. This might involve, for example, investigating the extent i

l that other users have experienced a problem that has been identified with the design of a '

l particular device model. However, if significant modifications to the registration program to -

include a larger class of licensees were envisioned, the Commission would not do so'using this

. provision; rather, it would expect to do so through rulemaking.

j Although the proposed amendment would impose some additional costs on licensees,

. the NRC has estimated these costs to be minimal. This cost is the estimated administrative cost I

1 expended by general licensees to v'erify the information requested by the NRC regarding j licensed devices. The NRC believes that the rule's intended effect of increased compliance by J

. generallicensees with regulatory requirements and resulting NRC and public confidence in the i i

! general license program potentially afforded by these new requirements outweigh this nominal administrative cost. I The NRC is currently considering additional'rulemaking concerning the control and

' accountability of devices generally licensed under 10 CFR 31.5 and is planning to add to the provisions of this rule in a separate rulemaking in the near future. The recommendations made in NUREG-1551 will be considered. That anticipated rule will address fees for registration, additional labeling requirements for 10 CFR 32.51 licensees, and compatibility of Agreement

( State regulations in this area. Public comments on this proposed rule should only address the 9

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requirements proposed in this action. Comments concerning possible future rulemaking and the

'possible imposition of fees will not be addressed in the finalization of this rule.

Public Comments on the Original Proposed Rule l

I The NRC reviewed the comments received on the December 27,1991 proposed rule. l i

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 govemments.

They have been considered to the extent applicable to this more limited proposed rule and will-be considered in the development of a subsequent rulemaking, planned to deal with the iscue of j i

' accountability of devices generally licensed under 10 CFR 31.5. A detailed analysis of the l 4

. comments received on the December 27,1991 proposed rule will not be presented in either action as many of the specific comments pertain to specific provisions that have been withdrawn, much time has passed since these comments were made, and additional opportunity l for comment is being provided.

Comments received on the December 27,1991 proposed rule demonstrated that there was considerable opposition to the rule as proposed, some of it specifically concerning a registration requirement. ~ Most of'this opposition was related to the breadth of the proposal which would have made the registration program applicable to all of the 10 CFR 31.5 general licensees, accounting for as many as 600,000 devices. Some raspondents questioned whether this was justified or cost effective. Some thought the impacts were underestimated, particularly for general licensees possessing many devices, and that the provision would have serious impacts on certain industries. Registration was specifically opposed for devices used by the 10

airline industry, self-luminous signs, static eliminators, and some other devices which present relatively low risks.

! The NRC believes that the working group process has been valuable in identifying criteria for use in categorizing devices which are more likely to present a significant risk of i

exposure of the public or contamination of property. Therefore, the registration of devices under )

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this proposed rulemaking would be limited to those devices meeting the criteria recommended a

by the working group. For the most part, general licensees using devices meeting these criteria have a limited number of such devices that would require registration. The NRC is exploring approaches to minimize the adininistrative effort for both general licensees and the NRC in implementing this requirement.

This proposal includes a provision to request an extension to the time interval to provide l a complete response to requests for information, if the general licensee is having difficulty in meeting the time limit. This provision was ircluded in response to comments on the December 27,1991 proposed rule. Although this difficulty is much less likely to arise within the limited population of general licensees covered by the current proposal, the Commission agreed that the additional flexibility is desirable.

Interim Enforcement Policy As had been planned at the time of the 1991 proposed rule, the Commission intends to establish an interim enforcement policy for violations of 10 CFR 31.5 for licensees who discover and report during the initial cycle of the registration program. This policy will supplement the normal NRC Enforcement Policy in NUREG-1600, Rev.1. It will be issued concurrent with the 11

final rulemaking, and will remain in effect through one complete cycle of the registration program.

Under the current NRC Enforcement Policy, significant violations such as those involving lost sources may result in escalated enforcement action including civil per alties. The interim policy would provide that enforcement action normally will not be taken for violations identified by a licensee and reported to the NRC, provided that appropriate corrective action is taken. For the time period that the interim policy is in effect, it would also apply to general licensees not subject to the registration requirement, if they identify and report violations and take appropriate corrective action. This change from the current NRC Enforcement Policy is to remove any disincentive to identify deficiencies that might be caused by a concern over potential enforcement action. This action would be taken to encourage general licensees to search their facilities to assure sources are located, to determine if applicable requirements have been met, and to develop appropriate corrective action when deficiencies are found. However, where the issuance of a Notice of Violation (NOV) without a civil penalty falls within the definition of

" escalated enforcement action", an NOV still may be issued if the staff believes that taking this action is justified by the safety significance of the violation or the need to record and document the generallicensee's corrective action in the forrnal manner required in a response to an NOV.

Escalated enforcement action will be considered for violations involving failure to provide the information requested, failure to take appropriate corrective action, or for willful violations including the submittal of false information. Sanctions in those situations may include significant civil penalties as well as orders to limit or revoke the authority to possess radioactive sources under a generallicense.

At the same time, the Commission intends to increase the civil penalty amounts specified in its current Enforcement Policy in NUREG-1600, Rev.1 for violations involving lost or 12

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improperly disposed sources or devices. This is to ensure that such civil penalties are significantly higher than the costs avoided by the failure to properly dispose of the source or device.

Agreement State Compatibility Under the " Policy Statement on Adequacy and Compatibility of Agreement State Programs" approved by the Commission on June 30,1997 (62 FR 46517), this rule is classified as Compatibility Category D. Category D means the provisions are not required for purposes of compatibility; however, if adopted by the State, the provisions shbuld not create any conflicts, duplications, or gaps in the regulation of AEA material. Ultimately an enhanced oversight program is expected to include provirions that will require a higher degree of compatibility. This will be considered in a subsequent rulemaking to add more explicit requirements for the registration program and additional provisions conceming accountability of generally licensed devices.- i Environmental Impact: Categorical Exclusion I

The NRC has determined that this proposed rule is the type of action described in the categorical exclusion 10 CFR 51.22(c)(3)(iii). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this regulation.

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Paperwork Reduction Act Statement This proposed rule would amend the information collection requirements that are subject -

l to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). These requirements have  !

been forwarded to the Office of Management and Budget for approval. I i

Public reporting burden for this collection of information is estimated to average about 20 I l

minutes per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of i information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the information and Records Management Branch (MNBB-7714), U.S. Nuclear Regulatory Commission, Washington, DC 20555, and to the Desk Officer, Office of information and Regulatory Affairs, NEOB-3019, (3150-0016 and 3150-0001), Office of Management and Budget, Washington, DC 20503.

Putilic Protection Notification i

if a document 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 i

respond to, the information collection.

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Regulatory Analysis l

The NRC has prepared a draft regulatory analysis for this proposed regulation. The analysis examines the cost and benefits of the alternatives considered by the NRC. The comments received on the earlier draft regulatory analysis have been cor,sidered to the extent that they apply to this more limited 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 Jayne McCausland, U.S. Nuclear Regulatory l Commission, Office of Nuclear Material Safety and Safeguards, Washington, DC,20555-0001; telephone (301) 415-6219; or e-mail at JMM2@nrc. gov. l Regulatory Flexibility Certification As required by the Reg * :*my Flexibility Act (5 U.S.C. 605(b)), the Commis on certifies that this rule will not have a significant economic impact on a substantial number of small entities. This rule would require generallicensees who have received these devices to respond to requests for information from NRC. The proposed rule applies to the approximately 45,000 persons using products under an NRC generallicense, many of whom may be classified as

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~small entities. However, the NRC intends to use this requirement to request registration i l I information from only approximately 6000 of these generallicensees; this would include information about the identification of the devices, accountability for the devices, the persons responsible for compliance with the regulations, and the disposition of the devices. The NRC also believes that the economic impact of the requirements on any generallicensee would be a j 15 l

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negligible increase in administrative burden. The rule is being proposed to better ensure that

. general licensees understand and comply with regulatory responsibilities regarding the generally

- licensed radioactive devices in their possession.

Backfit Analysis The NRC has determined that the backfit rule,10 CFR 50.109, does not apply to this proposed rule and, therefore, a backfit analysis is not required because these amendments would not involve any provisions that would impose backfits as defined in 10 CFR 50,109(a)(1).

List of Subjects 10 CFR Part 31 - Byproduct material, Criminal penalties, Labeling, Nuclear materials, Packaging and containers, Radiation protection, Reporting and recordkeeping requirements, Scientific equipment.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954,'as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR Part 31,

PART 31 -' GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL

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

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

5842).

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

l 2.' Section 31.5 is amended by adding paragraph (c)(11) to read as follows:

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! 10 CFR 31.5 Certain measuring, gauging, or controlling devices.2 j

! (c)

(11) Shall respond to written requests from the Nuclear Resulatory Commission to provide information relating to the generallicense within 30 calendar days of the date of the request, or other time specified in the request. If the generallicensee cannot provide the .

requested information within the allotted time, it must, within that same time period, request a longer penDd to supply the information and provide a justification as to why it cannot comply.

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2 Persons possessing byproduct material in devices under a generallicense in 10 CFR 31.5 before January 15,1975, may continue to possess, use, or transfer that material in accordance with the labeling requirements of 10 CFR 31.5 in effect on January 14,1975.  !

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Subject:

Requirements for the Possession of Industrial Devices Containing Byproduct I

Material (RIN 3150-XXXX).l

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- Dated at Rockville,' Maryland, this -day of - 1998.

For the Nuclear Regulatory Commission.

L. Joseph Callan,.

I Executive Director for Operations.

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1 ATTACHMENT 3 REGULATORY ANALYSIS

REGULATORY ANALYSIS:

REQUIREMENTS FOR THE POSSESSION OF INDUSTRIAL i DEVICES CONTAINING BYPRODUCT MATERIAL 1 STATEMENT OF THE PROBLEM

1.1 BACKGROUND

On February 12,1959 (24 FR 1089), the U.S. Atomic Energy Commission (AEC) amended its regulations to provide a generallicense to possess and use byproduct material in certain devices designed and manufactured for the purpose of detecting, measuring, gauging, or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or c,uantitative chemical composition or for producing light or an ionized atmosphere. The devices must be manufactured in accordance with the specifications contained in a specific license issued either by the Commission pursuant to 10 CFR Parts 30 and 32, or by an Agreement State. There are approximately 45,00010 CFP. 31.5 " general licensees,"i.e., persons possessing and using such devices under the generallicense. These generallicensees possess an estimated 600,000 devices under this provision.

A general licensee under the jurisdiction of the Commission is required to follow safety instructions on device labels, to test or service a device (with some exceptions), or to have such testing or servicing performed by the supplier or other specific licensee authorized to manufacture, install, or service such devices. General licensees may not abandon devices and 1

l must maintain records of testing and servicing of the device.' Generallicensees must also l

i: report damage or loss of devices.

The NRC is notified when specific licensees transfer devices containing byproduct material to general licensees through quarterly reports submitted purst' ant to 10 CFR 32.52(a).

These reports identify each general licensee by name and address (including, for an organization, the name or position of a person who may act as a point of contact between the

' NRC and the general licensee); the type of device transferred; and the quantity and type of f j l

' byproduct material contained in the device. Under compatible Agreement State regulations, similar information is obtained from suppliers in Agreement States on transfers to NRC general licensees. Further,10 CFR 31.5(c)(8) requires the general licensees to transfer or dispose of l

the generally' licensed devices only 'a the holder of a specific license pursuant to Parts 30 and 1 32 or to the holder of a specific license issued by an Agreement State. Section 31.5(c)(9) provides a limited exception to this requirement allowing general licensees to transfer such l

i devices to other generallicensees, but only if the device remains in use at a particular location j i

or the device is held in storage in the original shipping container prior to initial use. In either I l case, transfers of devices by general licensees must be reported to the NRC within 30 days of l the transfer. No report of a transfer is required if a generally licensed device is transferred to a specific licensee in order to obtain a replacement device. The specific licensee making the l

transfer is required as part of its specific license to maintain records of the transfer and to be accountable for all radioactive material in its possession.  ;

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1.2 NitC Study of Conformity with Geners.1 License Conditions The NRC traditionally has had little contact with general licensees. The NRC staff believes that this is why many generallicensees have a lack of awareness of their responsibilities under a general license resulting in incidents of mishandling and improper  !

disposition of generally licensed devices. This, in turn, has resulted in radiation exposure to the public and, in some cases, has entailed expensive investigation, cleanup, and disposal activities. Although, in most instances, exposures to the public have not been significant, the exposures would not have occurred had there been proper handling and disposal of devices.

The Commission conducted a study from 1984 through 1986 (General License Study) to ascertain the extent of compliance with general license conditions, when it became aware of a few incidents where control over generally licensed devices was lost. The results of the study were discussed in SECY-87-167, dated July 9,1987, and in SECY-89-289, dated September 14,1989. While current regulations (10 CFR 30.52) allow for the inspection of licensees possessing byproduct material, the Commission has, in the past, not inspected generallicensees on a regular basis. This is primarily because of the large number of such licensees and the low risk presented by most of these devices. The Commission has very limited knowledge as to whether the general licensees are complying with the rules and regulations pertaining to the proper use and disposal of generally licensed devices.

Because of the broad range of devices covered under 10 CFR 31.5, the study was

' divided into two parts. The first part covered industrial gauging and measuring devices, such as Liarge-scale level, density, and thickness monitors. There were then approximately 10,000 g

' Commission licensed devices in this category containing sources with activities in the 0.5 to 1

, curie range. The second part of the study covered devices which greatly varied in design and 3

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r l - use, such as self-luminous signs, analytical instruments such as x ray fluorescence

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spectrometers or liquid scintillation spectrometers, and smaller-scale thickness, density, and l-level gauges. A summary of the results of the study presented below is based on an 1

unpublished NRC report entitled " General License Study Report."

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' 1.2.1 Part i Results 3

The Part I study included 228' site surveys of generallicenseed oy the study task force an'd 132 inspections conducted by NRC regional offices. Some of the Agreement States also contributed data to the " General License Study," The information cathered by the study, although from a small sample of general licensees possessing large-scale gauges, clearly I

established that there is a compliance problem. Among the findings of Part I were the following: 1 Approximately 16% of these generallicensees could not account fur all of their gauges.

1 A majority of these generallicensees either did not notify the NRC of transfers of i 1 . their gauges or improperly transferred their gauges.

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At least 25% of these generallicensees were not performing required leak tests or maintaining leak-test records, or they were not inspecting a gauge's on/off shielding mechanisms or not inspecting them as required.

Agreement States reported incidents of thickness gauges being found ir, landfills and, in one case, even in an abandoned paper mill.

1.2.2 Part il Results Although Part ll of the study covered devices that vary greatly in design and use, the range of problems encountered in Part 11 is exemplified by the problem relating to self-luminous 4

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

Nonconformity with the general license conditions was very widespread.

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

Manufacturers and distributors frequently underreported the number of exit signs sold to general licensees. General licensees (electrical distributors and contractors) reported having about 30% more signs than were listed in quarterly reports of the manufacturers.

Three cases involved missing sources from beta backscatter gauges.

Only 45% of those surveyed for backscatter gauges were aware of the general license conditions.

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

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

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rulemaking regarding the accountability of generallicensees under 10 CFR 31.5. It proposed a number of provisions, including'a requirement for these licensees to provide information at the request of the NRC in order to provide the regulatory basis for the registration of these devices.

The proposed rule also would have added requirements in 10 CFR 32.51a and 32.52 for specific licensees who manufacture or initially transfer these devices to the general licensees.

Although the public comments received were reviewed and a final rule developed, that rule was not issued because of lack of available resources to properly implement the provisions of the rule as proposed.

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

1 completed in July of 1996 and published in October of 1996 as NUREG-1551, " Final Report of the NRC-Agreement State Working Group to Evaluate Control and Accountability of Licensed 4

Devices." The recommendations of the working group provide a major basis for this rulemaking.

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Some of the relevant conclusions of the working group are:

• Lack of adequate oversight by regulatory authorities is a major contributing factor to licensees losing control and accountability over their devices.

- Due to the large population of devices and the low risk associated with the design of many of the devices, an increased oversight program should only be implemented for certain devices.

General licensees possessing the identified devices should report annually to their regulatory authority with a listing of their current inventory of devices so as to allow the regulator to independently verify that the licensee has maintained accountability and control of the devices.

NRC also plans to develop a more comprehensive rulemaking to more completely address issaes concerning generally licensed devices. Other recommendations of the working group are to be considered in that action.

2 OBJECTIVES l The objectives of the amendments to Part 31 are to ensure that certain general licensees are aware of and understand the requirements for possession of generally licensed devices containing byproduct material and to better enable the NRC to verify the location, use, l

l and disposition of such devices. The intent is to reduce the possibility of the devices being improperly transferred or inadvertently discarded. This may reduce unnecessary radiation exposure to the public and unnecessary expense involved in retrieving the items, particularlv in the scrap metal stream, as well as to avoid the contamination of steel mills, metals, r -

products.

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3 ALTERNATIVES 3.1 No action.

This alternative would be to continue the status quo. As costs and benefits are evaluated in terms of changes from the status quo, there are no costs or benefits associated.

l with this alternative. No action, of course, does nothing to address identified concerns.

Often the only communication between a general licensee and the NRC is through the

. requirement that the NRC be notified when a device containing byproduct material is transferred. Information notices have been sent and inspections have been made but only l rarely..

As discussed in Section 1.2 of this analysis, generallicensees have a lack of awareness of their responsibilities under a generallicense. The NRC staff believes that this lack of awareness is a major contributor to the occurrence of incidents of mishandling and improper disposition of generally licensed devices. This, in turn, has resulted in radiation exposure to the 1 .,

i public and, in some cases, entailed expensive investigation, cleanup, and disposal activities. In j light of this, no action would not be appropriate.1 3.2 Non-rulemaking alternatives

There are a number of ways that the potential problems of lack of awareness of i regulatory requirements on the part of generallicensees could be addressed. Guidance tould l

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be provided in a number of forms; however, only periodic contact with the generallicensees  :

1 l would be expected to have a significant impact on the level of awareness of requirements. The i

) most appropriate means to remind users of their responsibilities would be periodic issuance of I 1' . 8 l information notices; however, these information notices may not reach all users. While i l'

l 10 CFR 32.52 requires that specific licensee distributors report to the NRC or the Agreement 1 8 L

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State agency the name and/or title of the individual who constitutes the point of contact l

between the general licensee and the NRC, or the Agreement State agency, the General j License Study indicated that this individual, who is frequently in the purchasing department, I

often did not inform the individual who uses the device of the general license conditions.

Moreover, the study indicated that personnel turnover frequently eliminated the organization's knowledge of the license conditions. For similar reasons, information notices may also not reach the appropriate person within the organization of a general licensee since the contacts provided in the specific licensees' quarterly reports are frequently not the individuals l responsible for, or knowledgeable of, the devices after they have been received and are ceing used.

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

l example, the cost of disposal may cause some general licensees to dispose of devices  !

improperly. It is important that the generallicensees understand that the Commission will hold i

them responsible for these devices. Increased inspection of generallicensees and l enforcement of the requirements may improve compliance. However, without a registration system, increased inspection would be on a random basis and would not be very efficient.

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

I A registration system together with followup would be more effective in terms of accountability, and would provide a basis for more efficient use of inspection and enforcement efforts. j However, for those devices not subjected to a registration requirement, some increased contact such as an occasional information notice may be appropriate.

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3.3 Rulemaking to modify reporting requirements This alternative would amend 10 CFR 31.5 to help ensure that devices containing byproduct material are maintained and transferred properly and are not inadvertently discarded.

The general mechanism to be used is to require general licensees to verify compliance with certain conditions imposed by the general license.

The amendments, in a new suoparagraph (11) to 10 CFR 31.5(c), would require a general licensee to respond within 30 days (or as otherwise specified in the request) to requests from the NRC for verification of information relating to the general license and the generallicensee. The licensee can request an extension within the same allotted time if he is having difficulty in providing the information.

The NRC envisions that requests would be made for verification of the information currently on record concerning devices containing byproduct material which have been transferred to the general licensee. The general licensee would verify, correct, and add to the information, as necessary, and also report on the disposition of devices no longer in the i t

. organization's possession. This process would offer greater assurance that a general licensee j is informed of its regulatory responsibilities and will provide information from an independent I inventory as a mechanism to assist with verifying accountability of devices. The NRC would l make periodic (expected to be annual) requests for verification to remind general licensees of

! . their regulatory responsibilities and to reduce the likelihood that devices containing byproduct I material are illegally transferred or inadvertently discarded.

The registration conducted under this rulemaking will not completely address the factors discussed above concerning knowledge of the regulations reaching the appropriate persons;  ;

however, a subsequent rulemaking is planned which will consider changing the suppliers'  !

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. reporting requirements to provide information regarding a person with operational responsibility for the devices and a backup to this person, rather than simply a point of contact.

4 CONSEQUENCES

- 4.1 - Benefits of Proposed Alternative The revisions are intended to better ensure understanding of and compliance with the general license requirements, and thereby reduce the likelihood of incidents resulting in unnecessary exposures to the public, and contamination of property. Further, these revisions

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will better enable the NRC to verify the location, and disposition.of these devices,'and thereby confirm the efficacy of the generallicense regulatory program. The primary benel;ts of this proposed rule can be categorized into economic benefits and exposure aversion benefits. In this case, both of these aspects are very difficult to quantify. Although ranges of potential

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' exposures have been calculated and ranges of costs from individualincidents have been recorded, the working group concluded that none of the studies conducted are adequate to

. quantify an overall net cost of improperly disposed or lost devices. An admittedly uncertain etAimate was made of the current economic costs and exposures resulting from improper disposition of both specif~eally and generally licensed devices meeting the proposed criteria for increased oversight. The degree of effectiveness of a particular process is also uncertain and would depend on the level of effort used in enforcement of the provision.

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

Uncertainty in these estimates comes from a number of factors including:

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i The number of incidents of meltings reported is small overall; thus there is considerable statistical uncertainty in how representative the costs are of future costs averted.

The likelihood of loss may be different for specifically and generally licensed devices and for different categories oilevices. However, once a melting has occurred. it usually cannot be determined whether a generally or specifically licensed device was involved.

The cost of a cleanup depends on the type of steel mill; e.g., experience reported dKi not include incidents at large integrated steel mills and the resultant costs of such an {

incident are expected to be much greater than those experienced to date, as much as l

$100 million for a single incident.

The likelihood of meltings depends on the level of effort on the part of metal manufacturers and recyclers in monitoring for radioactive sources in scrap, which has generally increased over time, particularly at larger mills.  ;

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4.1.1 Radiation Exposure Averted Benefit '

This rule should avert radiation exposure to the public. Although it is reasonable to assume that a member of the public would not deliberately expose himself or herself or  !

I someone else to radiation, in some cases, these individuals might not understand that a l gamma gauge is a potential source of radiation. When a gamma gauge is distributed to a ,

l generallicensee, the gauge must bear durable, legible labels which include a caution that the l 1

gauge contains radioactive material. The generallicenst in 10 CFR 31.5 requires that the generallicensee maintain those labels. In the absence of such maintenance, however, the l

cautionary language can become corroded am unreadable or painted over. An individual who )

finds the gauge witnout this labeling ;c, &n uncontrolled situation would have no reason to suspect that the gauge conte. ins radioactive matenal.

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l if a generally licensed gauge were improperly transferred or disposed of such that it became available to a member of the general pubhe, no significant radiation exposure would result provided the radioactive material sealed source remained in the gauge and the shutter

. mechanism remained closed. In addition, temporary exposure to an intact gauge should not cause a significant radiation dose, and would normally include a warning label with a radiation symbol and ' cautionary words.

l However, if a gauge with a significant source of activity were to end up in the public 1 domain, the labeling were' to be destroyed, and a person somehow exposed the source, a significant exposure could result. Radiation exposure due to improper control could conceivably result in doses of a few rem to doses that are life threatening; however, the likelihood of situations which could result in the highest doses is extremely small. No incidents in the U.S. to date have resulted in doses in the upper range.

Based on a June 1994 PNL report, " Peer Review of Impropr Transfer / Disposal l l

I Scenarios for Generally Licensed Devices," the WG estimated the average dose received from  !

I incidents of lost devices involving cesium-137 (the most common nuclide involved in incidents  !

~ historically) could be 7 rem (70 mSv) and the maximum dose that might be received cculd be  ;

l somewhat over 1000 rem (10 Sv). The PNL study considered gamma gauges containing 20 mci or greater of cesium-137. The analysis was based on the average activity of cesium-137 within this category of 883 mci using data from the General License Data Base on i

devices registered in the Sealed Source Device Registry during the period 1987-1992. Gamma i

gauges were chosen for the example analysis as representative of relatively high risk sources  !

amongst generally licensed devices. These were very preliminary estimates. The data has known errors and the average activity per device being distributed has declined.

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Although the potential exists for individuals in the public to receive a very significant l l

exposure, the probability is very low. This rule would further reduce the probability of inadvertent exposures.

I 4.1.2 Economic Benefits There is a cost savings to industrie. which might inadvertently come into possession of an improperly disposed device. The most significant of these would be the avoidance of a melting of a source and resulting contamination of a steel mill and its products and wastes.

Based on the known incidents in the period 1983-1995 involving the nuclides for which registration would be required, the cost of decontamination and cleanup of these incidents (using the average cleanup costs) is about $12 million per year. This cost can be considered as a societal cost which may be mitigated or possibly averted in the future if the rule is implemented. If this rule covers 20% of the devices contributing to the melting experience to date (since this rule addresses only devices in NRC-regulated States and some of the melted devices may have been specifically licensed) and reduces the rate of incidents involving those devices by half, the average annual cleanup costs of $12 M would be reduced by about $1.2 M per year.

There are other costs, though less significant, associated with lost sources which could be reduced by this rulemaking.

The rulemaking should also reduce the number of orphaned sources. The cost of

.i disposalin the case of orphaned sources falls on parties other than the user of the device, such as government agencies, e. g., EPA or DOE, or individuals or organizations who inadvertently i

! come into possession of a device. 1 l

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

4.2 ' Costs of Proposed Alternative The revisions to 10 CFR 31.5 result in costs to general licensees and to the Commission. Thre also are costs to the Commission associated with the rulemaking process.

4.2.1 Costs of Revisions to 10 CFR 31.5 to General Licensees Registration process:

The revision requires general licensees to respond to requests from the NRC to verify

'information related to their generallicenses. Thisinformation can help the NRC confirm that the generallicensees still possess and are in control of their generally licensed devices containing byproduct materials and are meeting the general license conditions imposed by the Commission's regulations. The NRC plans to send a request for verification to each general licensee who has received a generally licensed device < meeting the criteria developed by the' l working group and should still be in possession of it according to the Commission's records.

The cost to industry would entail a small annual administrative cost to each of approximately 6000 general licensees. The General License Study found that the average time  ;

required to locate and verify license conditions for all devices in the possession of a general licensee was approximately 30 minutes. The general licensees included in the registration requirement as proposed in this rule have fewer devices per licensee on average, so we estimate an average time of 20 minutes per response. Assuming that the cost to industry for L staff time is $50/hr, the annual cost of this' step is estimated as:

4 Cost = 1/3 hour / licensee x $50/ hour x 6000 licensees = $100,000 15 r

This estimate assumes that the general licensees are in compliance with the existing requirements in 10 CFR 31.5. For some general licensees, particularly in the first year of l

. responding to the registration request, more effort would be involved because of their lack of awareness of existing requirements and noncompliance with some of them. The cost of this additional effort is not a direct cost of this rule.

Miscellaneous one time requests:

In addition to the registration program, there may be an occasional need to request other information from generallicensees under this provision. This might involve, for example,

' investigating the extent that other users have experienced a problem that has been identified with the desir;n of a particular device model. However, if significant modifications to the registration program such as, inclusion of a larger class of licensees were envisioned, the ,

Commission would not do so using this provision but would do so through rulemaking. It is estimated that no more than 100 such requests per year on average would be made. This could include any of the general licensees under 10 CFR 31.5. As the type of information requested would vary and would not be a routine request as in the registration process, the time to respond would vary and may be longer on average than the routine requests. In the unusual circumstance of a significant safety concern, the Comrnission could demand information in a a shorter time if appropriate.

l If the average time for responding is assumed to be 30 minutes:

l, Cost = 100 licensees x 0.5 hour5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> / licensee x $50/ hour = $2500.

l Extension requests: l The proposed rule would provide that if a general licensee cannot respond to the NRC's request within the allowed time limit, general licensees may request an extension of time to respond. For the mast part, generallicensees using devices for which registration will be 16

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requested have a limited number of such devices. Thirty days would usually be provided for l routine registration requests. It should be quite rare that an extension beyond the time allowed l

l would be needed. ' Also, few incidents are expected where information might be requested from other licensees.. Thus, it is estimated that only about 25 licensees would request an extension i

each year. _The NRC estimates that the extension process would average about 30 minutes.

This includes the time to research the subject, draft the correspondence, if the request is to be

' made in writing, and any subsequent communications with the NRC. In some cases, a fairly simple phone call may suffice. The cost of this effort would be:

Cost = 25 licensees x 0.5 hour5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> / licensee x $50/ hour = $625

!4.2.2 Operational Costs of Revisions to 10 CFR 31.5 to NRC Registration process:

The NRC will mail periodic (approximately annual) requests to general licensees to verify compliance with certain general license requirements for all devices meeting certain criteria in the possession of the generallicensees, it is assumed that the NRC uses the

, information provided by the specific licensees that is stored in the directory and that each j l

request is computer-generated. When the NRC rece~ives a response from a general licensee, it will log in the response into the computerized directory or record that verification has been received. It is assuTied that the staff effort associated with both of these steps costs approxirilate!y $3.00 per general licensee (averaging roughly 3 minutes per request, $56/ hour).

Cost = 6000 x $3.00 = $18A00

($56/ houris assumed because of the administrative / clerical nature of the work.)

This estimate assumes that all general licensees comply with the requirement. The l 1

number of general licensees not responding or responding inadequately is expected to be 17 I

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greatest in the first year (about 5%) and decline in subsequent years. The cost of followup for noncompliance is discussed further below. In addition, a number of general licensees may I

have difficulty accounting for devices which they have received; the number would also be greatest in the first year (adding an estimated 10% to ihose requiring followup), and fewer in subsequent years. A total of 15% of these general licensees needing followup is based in part l on the General License Study, as well as subsequent experience of some Agreement States which have :nitiated enhanced oversight programs. j l

i in addition, particularly in the first year or so, there may be calls from general licensees requesting clarifications regarding the registration process as well as other aspects of their responsibilities under 10 CFR 31.5. Assuming 30% of all generallicensees receiving a request for information call for technical assistance in the first year, and one-third of these require I

15 minutes to respond, and the remaining average 1/2 hour of staff time, about 750 hourd l

additi0nal staff time may result at a cost of approximately $42,000. After the initial implementation, this would be expected to be 150 hours0.00174 days <br />0.0417 hours <br />2.480159e-4 weeks <br />5.7075e-5 months <br /> (600 requests (10%) averaging 15 minutes) or roughly 58400.

Miscellaneous one time requests:

For the occasional requesis for information from general licensees made on a case-by-case basis under this provision, it is estimated that NRC will make no more than 100 such requests per year on average. This is primarily expected to be requests sent to a group of licensees for a particular type of information likely relating to a particular device or device type, if this involves an average of 30 minutes per request for determining what information is needed, sending out the requests, and reviewing the responses, the cost would be:

Cost = 100 requests x 0.5 hour5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> / request x $70/ hour = $3500.

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$70/ hour is used as it involves primarily time on the part of a professional reviewer.

Extension requests:

The cost to the NRC of processing requests for extensions is estimated to average 30 minutes per request. This includes the time to evaluate the request, respond to the general

. lice'nsee, if necessary, and to log in the action. The cost to the NRC for processing the estimated 25 requests is:

l Cost = 25 requests x 0.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> / request x $56/hr. = $700.

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Followup Costs; i

it is expected that there will be a significant cost for followup after the registration I i

process is initiated. The cost to NRC will come primarily from follow up in cases where j i

licensees either do not respond or cannot account for devices they have received, and 1 reconciliations of discrepancies between current NRC records and the registration information submitted by generallicensees.~ Most of this is not a direct cost of this rule, but a means of enforcing existing requirements. In fact, the re'gistration process allows for inspection and i enforcement efforts reiated to the requirements in 10 CFR 31.5 to be applied more efficiently and effectively (versus inspecting these generallicensees randomly). Although the Commission plans to increase inspection and enforcement actions as part of an overall effort to improve oversight of these generallicensees, most of the costs of this increased effort are not a direct result of this rulemaking; most of the effort will be followup related to lost or improperly disposed sources. .

NRC would incur followup costs directly related to this rule when licensees do not respond to the request for information or report unaccounted for discrepancies from information in NRC records.

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First Year:

In the first year, it is estimated that 6000 general licensees will be contacted and that

. approximately 5% will require followup efforts because of either nonresponse or discrepancies between the'information in the NRC records and the reports of the generallicensees. j If the followup averages 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> effort at $56/ hour: ,

Cost = 6000 x 0.05 x 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> x $56/hr. = $33,600 Second Year:

In the second year, the NRC would request verification from the same 6000 general licensees notified the first year, as well as any new generallicensees added to the database meeting the criteria for inclusion, as a result of quarterly transfer reports from the suppliers.

In the second year, a followup rate of 2% is projected.

Cost = 6000 x 0.02 x 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> x $56/hr. = $13,440 Third and subsequent years:

The NRC would continue to request verification from the entire list of general licensees in the database. In the third and subsequent years, the need for followup is estimated at 1%.

Cost = 6000 x 0.01 x 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> x $56/hr, = $6,720/ year after the first two years.

4.2.3 NRC Development and impiementation Costs i

. NRC development costs are the costs of preparing a regulation prior to its promulgation l l

and implementation. Such costs may include expenditures for research in support of the l regulatory action, publishing notices of rulemaking, responding to public comments, and issuing I a final rule. The General License Study, the working group process, and the additional

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contractual work which have been used to support this rulemaking have already been i performed and dealt with a broader range of issues; the costs of these are considered outside 20

the scope of this analysis. Development costs within the scope of this analysis are the costs of proceeding w2h this specific action and consist mainly of the costs of the effort of NRC professional staff members expended in developing the rule.

NRC implementation costs are those " front-end" costs necessary to effectuate the proposed action; they may arise from the necessity of developing procedures and guidance to assist licensees in complying with the final action. These costs do not include the cost to the NRC of improving and maintaining a computerized directory of devices, which is considered as a sunk cost, Although the computer database must be updated in order to implement this rule, and this will be done in a way to particularly accommodate a registration process, the database is in need of updating in any case, if it is to provide a reasonable information base for inspection and enforcement and regulatory actions related to 10 CFR Part 31 general licensees.

Additional costs related to accommodating the registration process are expected to be a small fraction of the overall costs for the update and are not estimated here.

The total development and implementation costs for this rule and associated guidance preparation is estimated as: $189,000 (1 % professional staff year x $126,000).

5 DECISION RATIONALE lt is recommended that this action be adopted because it represents a reasonable means for the Commission to fulfil! its obligation to protect public health and safety, property, and the environment. It would be implemented to better ensure that certain generallicensees are aware of those requirements with which they must comply, as well as to provide the information on the location, use, and disposition of generally licensed devices needed to l

confirm' the efficacy of the general license regulatory program ano the estimates of low risk from these devices. The rationale for this recommendation follows. l 21 l

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The results of the General License Study conducted by the NRC indicated that there is ri.'nempliance with the generallicense requirements contained in 10 CFR 31.5(c). Such ner. compliance presents a risk oflow but avoidable exposure of the public to radiation plus a l

low probability of significant exposure as a consequence of improper handling or disposal of the devices generally licensed. The Study revealed that a major reason for noncompliance is that users of the generally licensed devices are unaware that there are regulatory requirements l

associated with the possession and use of these devices.

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This regulatory action will establish a reasonable procedure to ensure that general licensees are aware of the provisions associated with the generallicense and comply with the applicable regulatory requirements. It is believed that increased awareness and understanding of the NRC's requirements on the part of the general licensees willincrease the likelihood that general licensees will comply with those requirements and thereby reduce the potential for I unnecessary radiation exposure to the public and prevent costs to industry from improper handling or disposal of generally licensed devices. Promulgation of this rule should result in '

improvement in the accountability for devices and would provide confidence that the use of generally licensed devices is being regulated in an appropriate manner.

It is estimated that adoption of this regulatory action would result in up-front development and implementation costs to the Commission of $189,000 and annual costs to industry and the Commission of $103,125 and $37,320 respectively, with somewhat higher costs in the first two years of implementation (mostly resulting from lack of awareness and noncompliance with existing requirements). Although the NRC estimates that the overall risk associated with these devices is small and, therefore, any risk reduction realized through improved compliance with the Commission's regulations by general licensees will also be small, there is some probability of significant dose to the public from incidents resulting from loss of 22 f

I devices. The staff has concluded that the benefit of increased confidence in the efficacy of the l general license regulatory program outweighs the nominal cost per device. The benefit to be realized even further overshadows the nominal costs when considered in light of the contribution of this action to the possible avoidance of the substantial cleanup costs which have occurred because of past improper disposition of generally licensed devices. If this rule covers

20% of the devices contributing to the melting experience to date and reduces the rate of incidence involving those devices by half, the average annual cleanup costs of $12 M would be reduced by about $1.2 M per year from the implementation of this rule and the increased inspection and enforcement efforts that are also planned.

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6 IMPLEMENTATION l l

The regulatory action is not expected to present any significant implementation problems. The computerized directory that would be required has already been implemented 4

by the Commission. However, it is outdated and will require improvement or replacement; this would be the case if it is to be useful at all whether this rule is made effective or not. General licensees will be sent a copy of the final Federal Register notice.

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7 EFFECT ON SMALL ENTITIES As was discussed in Section 4.2.1 of this analysis, the action will have some economic l impact on generallicensees of devices containing byproduct material. There are up to 45,000 general licensees under 10 CFR 31.5 of which 6000 will be routinely requested to verify information, some of whom may be "small entities" within the meaning of the Regulatory Flexibility. Act (P.L.96-534). However, the economic impact on these entities would not be significant.

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In Section 4.2.1 of this analysis, it was estimated that the cost of responding to the Commission's verification requests to general licensees would total about $100,000/yr.

l It is estimated that there are approximately 9.4,000 devices in the possession of the Commission's generallicensees which will come under the registration requirement. The average cost to the generallicensees per device per year is about $4.00. Therefore, the action would not have a significant economic impact on small entities.

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l ATTACHMENT 4 CONGRESSIONAL LETTERS

p f*"hg p t UNITED STATES E

[o j NUCLEAR REGULATORY COMMISSION t- WASHINGTON, o.C. 205n4001

$?,g jf l

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

Dear Mr. Chairman:

Enclosed for the information of the Subcommittee is a copy of a Notice of Proposed Rulemaking to be published in the Federal Reaister in the near future. The Nuclear Regulatory Commission is proposing to amend 10 CFR Part 31 to explicitly require certain general licensees who possess devices containing byproduct material to provide the NRC with  !

information concerning devices that they have received for use under a general license as requested by the NRC. This provision would be used primarily to institute a registration system for devices using certain quantities of specific radionuclides.

This amendment would allow NRC to account for devices which have been distributed for use under the general license and reduce the potential for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property. This change will have no adverse impact on the health and safety of workers or the public and is not expected to impose a significant burden on licensees.

Sincere!y,.

l Dennis K. Rathbun, Direr. tor Office of Congressional Affairs

Enclosure:

Federal Reo_ ister Notice

- cc: Senator Bob Graham

The Honorable James M. Inhofe, Chairman Subcommittee on Clean Air, Wetlands, 3

Private Property and Nuclear Safety i Committee on Environment and Public Works United States Senate Washington, DC 20510

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Dear Mr. Chairman:

Enclosed for the information of the Subcommittee is a copy of a Notice of Proposed Rulemaking to be published in the Federal Reaister in the near future. The Nuclear Regulatory Commission is proposing to amend 10 CFR Part 31 to explicitly require certain general licensees who possess devices containing byproduct material to provide the NRC with information concerning devices that they have received for use under a general license as .I requested by the NRC. This provision would be used primarih to institute a registration system for devices using certain quantities of specific radionuclides.

This amendment would allow NRC to account for devices which have been distributed for use under the generallicense and reduce the potential for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property. This change will have no adverse impact on the health and safety of workers or the public and is not expected to impose a significant burden on licensees.

Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs Enc %sure: Original letter sent to: The Hon. Dan Schaeffer Federal ReaistaI Notice Chairman, Subcommittee on ,

Energy and Power l

cc: Senator Bob Graham '

DISTRIBUTION: [O:\MATTSEN\GL1P\ PROP _31. CON)

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g UNITED STATES g- S NUCLEAR RECULATORY COMMISSION o f WASHINGTON, D.C. 20555-0001

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The Honorable Dan Schaefer, Chairman Subcommittee c 1 Energy and Power Committee on Commerce United States House of Representatives

. Washington, DC 20515

Dear Mr. Chairman:

Enclosed for the information of the Subcommittee is a copy of a Notice of Proposed Rulemaking to be published in the Federal Reoister in the near future. The Nuclear Regulatory Commission is proposing to amend 10 CFR Part 31 to explicitly require certain general licensees who possess devices containing byproduct material to provide the NRC with information concerning products that they have received for use under a general license as requested by the NRC. This provision would be used primarily to institute a registration system br devices using certain quantities of specific radionuclides.

This amendment would allow NRC to account for devices which have been distributed for use under the general license and reduce the potential for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property. This change will have no adverse impact on the health and safety of workers or the public and is not expected to impose a significant burden on licensees.

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

Enclosure:

Federal Reoister Notice cc: Representative Ralph Hall l

l The Honorable Dan Schaefer, Chairman i Subcommittee on Energy and Power e Committee on Commerce United States House of Representatives Washington, DC 20515

Dear Mr. Chairman:

3 Enclosed for the information of the Subcommittee is a copy of a Notice of Proposed Rulemaking to be published in the Federal ReaisteIin the near future. The Nuclear Regulatory Commission is proposing to amend 10 CFR Part 31 to explicitly require certain general licensees who possess devices containing byproduct material to provide the NRC with information concerning products that they have received for use under a generallicense as requested by the NRC. This provision would be used primarily to institute a registration system for devices using certain quantities of specific radionuclides.

This amendment would allow NRC to account for devices which have been distributed for use

• under the general license and reduce the potential for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property. This change will have no adverse impact on the health and safaty of workers or the public and is not expected to impose a significeret burden on licensees.

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

Enclosure:

Federal Reaister Notice cc: Representative Ralph Hall DISTRIBUTION: [O:\MATTSEN\GL1P\ PROP _31. CON]

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1 ATTACHMENT 5 DRAFT PRESS RELEASE

f: , 1 Draft Press Release i  !

i NRC REVISIONS TO GENERAL LICENSE FOR BYPRODUCT MATERIAL IN CERTAIN DEVICES i

i The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations J

1 governing the use of byproduct material in certain measuring, gauging, or controlling devices to l explicitly require general licensees who possess these devices to provide the NRC with I

information concerning the devices. The NRC intends to use this provision primarily to institute a registration system for the devices containing certain quantities of specific radionuclides that present a higher risk compared to other generally licensed devices of exposure to the public or property damage if a device were lost._ The rule, as proposed, is intended to ensure that generallicensees are aware of and understand the requirements for the possession of devices containing byproduct material and can account for their devices. Better awareness on the part of these licensees of their responsibilities would help to ensure that they comply with the requirements for proper handling and disposal of generally licensed devices and should help reduce the potential for incidents that could result in unnecessary radiation exposure to the public as well as cc,ntamination of property.

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ATTACHMENT 6 APPROVED FOR PUBLICATION l 4

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E Anoroved for Publication The Commission delegated to the EDO (10 CFR 1.31(c)) the authority to develop and I promulgate rules as defined in the APA (5 U.S.C. 551 (4)) subject to the limitations in NRC Management Directive 9.17, Organization and Functions, Office of the Executive Director for Operations, paragraphs 0213,038,039, and 0310.

The enclosed proposed rule, " Requirements for the Possession of Industrial Devices Containing Byproduct Material" would amend 10 CFR 31.5 to explicitly require general licensees who  ;

possess devices conti o gn byproduct material to provide the NRC with information concerning 1 products that they he . ;ceived for use under a generallicense as requested by the NRC.

This provision would be used primarily to institute a registration system for devices using certain quantities of specific radionuclides.

l This proposed rule does not constitute a significant question of policy, nor does it amend regulations contained in 10 CFR Parts 7,8, or 9 Subpart C concerning matters of policy. I, therefore, find that this rule is within the scope of my rulemaking authority and am proceeding to issue it.

Date L. Joseph Callan, Executive Director for Operations.

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