ML20216H121
| ML20216H121 | |
| Person / Time | |
|---|---|
| Issue date: | 12/15/1998 |
| From: | Cool D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Bangart R, Funches J, Galante A NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM), NRC OFFICE OF STATE PROGRAMS (OSP), NRC OFFICE OF THE CONTROLLER |
| Shared Package | |
| ML20216H047 | List: |
| References | |
| FRN-64FR40295, RULE-PR-170, RULE-PR-171, RULE-PR-30, RULE-PR-31, RULE-PR-32 AG03-1-003, NUDOCS 9910010289 | |
| Download: ML20216H121 (164) | |
Text
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t UNITED STATES j
NUCLEAR REGULATORY COMMISSION 2
WASHINGTON, D.c. 2006H001 December 15, 1998 i
MEMORANDUM TO: Richard L. Bangart, Director, OSP Jesse L. Funches, CFO Anthony J. Galante, CIO Joseph R. Gray, Associate General Counsel for Licensing and Regulation, OGC James Lieberman, Director, OE 1
David L. Meyer, Chief, RDB, ADM Brenda Jo Shelton, Chief, IRMB, OClO
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FROM:
Donald A. Cool, Director f
Division of Industrial and Medical Nuclear Safety, NMSS
SUBJECT:
OFFICE REVIEW AND CONCURRENCE: PROPOSED RULE TO i
AMEND 10 CFR PARTS 30,31,32,170, and 171, REQUIREMENTS FOR CERTAIN GENERALLY LICENSED INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL" Your concurrence is requested on the attached Commission paper forwarding the Federal Register notice for the subject proposed rule, i
1.
Title:
Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct Material,10 CFR Parts 30,31,32,170, and 171 2.
Reauested Action: Office concurrence.
- 3.
NMSS Task Leader: Catherine R. Mattsen,415-6264 4.
Workino Group Members on vour staff:
Maria Schwartz, OGC 415-1888 Jim Myers, OSP 415-2328 J. DelMedico, OE 415-2739 Beverly Jones, OCFO 415-6994 CONTACT: Catherine R. Mattsen, NMSS/IMNS (301) 415-6264 3
9910010289 990928 PDR PR 30 64FR40295 PDR cg l00 hM
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i R. L. Bangart et al.
2 5.
Backaround: In an SRM 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 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 States Working Group in NUREG-1551, apply fees to these general licensees, and incorporate requirements for permanent labeling of sources / devices. Other items in the SRM included an analysis of fee structure options and the development of an enforcement policy with a short amnesty program fo!! owed by increased civil penalties for lost or improperly disposed sources. The analysis of fee structure options is included as an attachment to this Commission Paper. The Interim Enforcement Policy was published on (Insert date).
The first of these proposed rules was published on December 2,1998, and contained 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. That provision is planned to 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 identification of devices, accountability for the devices, the persons responsible for compliance with the regulations, and the disposition of the devices.
This is the second, more comprehensive rule included in the SRM of April 13,1998. It proposes explicit provisions to delineate the registration program envisioned in the first proposed rule with the addition of a fee, additional provisions to allow more complete tracking of devices by NRC, additional labeling requirements, provisions to improve licensees awareness of the regulations, and some miscellaneous provisions for general licensees. This rule was developed with the help of a working group which included representatives from New Jersey and Maryland. In developing the proposed rule, the group reviewed the recommendations of the NRC-Agreement State Working Group, the provisions contained in the proposed rule of December 27,1991, and the public comments on that rule, and identified additionalissues for consideration.
Both of these rulemakings together are intended to ensure that generallicensees are aware of and understand the requirements for the possession of devices 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.
Additionally, the registration fee is specifically being added in order to improve equitability under the requirements for full cost recovery.
6.
Reauested Comotetion Date: January 15,1999. A meeting will be scheduled during the week of March 8,1999, to discuss and resolve any remaining issues / concerns
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including those raised in Agreement State and public comments. Please plan on having an official who can concur for your office available for this meeting. If there are no outstanding issues and all concurrences received, this meeting will be canceled.
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R. L. Bangart et al.
3 7.
Note: Attachment 6, Draft NUREG-1556, Vol.16, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About General License Distribution Licenses, is being developed and concurreo in separately and will be added to this Commission Paper prior to submittal to the Cummission. Attachment 1 Analysis of Fee Structure Options, is being developed by OCFO and will be forwarded to you before the requested concurrence date.
8.
Steerina Grouo: None 9.
Enhanced Public Particioation: Yes, through posting on Technical Conference Forum,
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approximately concurrent with this memorandum.
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10.
Comoatibility for Aareement States: Yes l
11.
Resources and Coordination: A copy of this concurrence package has been forwarded to the IG for information. Time for review of this package should be charged to RITS No. 222GD, TAC No. L20327.
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Attachment:
Commission Paper w/ attachments cc w/att:
H. T. Bell, OlG H. Miller, Rl/ ORA L. Reyes, Ril/ ORA J. E. Dyer, Rlll/ ORA E. W. Merschoff, RIV/ ORA C. Paperiello, NMSS M. Virgilio, NMSS W. Beecher, OPA i
I l
December 15, 1998 R. L. Bangart et al.
3 7.
Note: Attachment 6, Draft NUREG-1556, Vol.16, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About General License Distribution Licenses, is being developed and concurred in separately and will be added to this Commission Paper prior to submittal to the Commission. Attachment 1, Analysis of Fee Structure Options, is being developed by OCFO and will be forwarded to you be';re the requested concurrence date.
8.
Steerino Group; None 9.
Enhanced Public Participation: Yes, through posting on Technical Conference Forum, approximately concurrent with this memorandum, 10.
Comoatibility for Aoreement States: Yes Resources and Coordinatignn A copy of this concurrence package has been forwarded 11.
r to the IG for information. Time for review of this package should be charged to RITS No. 222GD, TAC No. L20327.
Attachment:
Commission Paper w/ attachments cc w/att:
H. T. Bell, OlG H. Miller, Rl/ ORA L. Reyes, Ril/ ORA J. E. Dyer, Rill / ORA E. W. Merschoff, RIV/ ORA C. Paperiello, NMSS M. Virgilio, NMSS W. Beecher, OPA l
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FOR:
The Commissioners FROM:
William D. Travers, Executive Director for Operations
SUBJECT:
PROPOSED RULE: 10 CFR PARTS 30,31,32,170, and 171 -
" REQUIREMENTS FOR CERTAIN GENERALLY LICENSED INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL" PURPOSE:
To request Commission approval of a proposed rule that would make explicit a requirement for generallicensees who possess certain devices containing byproduct material to register their devices, and would add other provisions to improve accountability of generally licensed devices.
BACKGROUND:
Devices containing radioactive material generally licensed under 10 CFR 31.5 have not always been disposed of, or handled properly. This has, on a number of occasions, resulted in unnecessary radiation exposure to the public and contamination of property. The staff concluded that more frequent and timely contact between the general licensee and NRC could remedy these problems. On December 27,1991 (56 FR 67011), NRC published a proposed rule addressing this issue. The proposed rule would have required general licensees under 10 CFR 31.5 to provide information at NRC's request. This provision would have provided the regulatory basis for the registration of devicer. The proposed rule also included additional requirements in 10 CFR 32.51a and 32.52 for the specific licensees who manufacture or initially transfer these devices to the generallicensees. A final rule was not implemented because the resources needed to properly implement the proposed rule were lacking.
In July 1995, with assistance from the Organization of Agreement States, NRC formed a working group to evaluate the issues related to the loss of control of generally and specifically licensed sources of radioactivity. This NRC/ Agreement State Working Group submitted a final report to NRC concerning its evaivation. On October 18,1996, the staff provided its evaluation of the working group recommendations in SECY 96-221. This report was published as NUREG-1551 in October 1996. On November 13,1996, the staff briefed the Commission on 4
its preliminary views of the NRC/ Agreement State Working Group's recommendations.
CONTACT:
Catherine R. Mattsen, NMSS/IMNS l
(301) 415-6264
I The Commissioners 2
In an April 13,1998, Staff Requirements Memorandum (SRM), responding to SECY-97-273,
" Improving NRC's Control Over and Licensees' Accountability for Generally and Specifically Licensed Devices," the Commission directed the staff to terminate the 1991 rulemaking except for the provisions that would enable NRC to request information from certain generallicensees to provide the regulatory basis for a registration program and to renotice those portions of the l
1991 proposed rule for public comment. That proposed rule notice was provided to the Commission in SECY-98199, approved by an SRM of October 23,1998, and published on December 2,1998 (63 FR 66492). The SRM of April 13,1998, also directed the staff to develop, in a subsequent rulemaking, a registration and follow-up program for generally
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licensed sources / devices identified by the NRC/ Agreement State Working Group in NUREG-1551, to assess fees to these generallice isces, and to incorporate requirements for the permanent labeling of sources / devices. The staff was also directed to explore the possibilities, advantages, and disadvantages of various fee approaches such as pro-rating the fees, e.g., per device (fixed or sliding scale) or per license and provide recommendations to the Commission and to determine the extent to which application of the small business rule will affect the fees. The analysis of fee options (Attachment 1) and this proposed rule (Attachment 2) respond to those directives.
DISCUSSION:
The proposed provisions delineating a registration requirement are essentially consistent with the plans for the registration process discussed in the first of these proposed rules. The criteria for determining which devices would be included in the registration program are those
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recommended by the working group. As part of the registration program, the licensees will be asked to verify information concerning the identification of devices, accountability for the devices, the persons responsible for compliance with the regulations, and the disposition of the devices. The staff estimates that approximately 6000 generallicensees would be required to provide registration information. As directed by the Commission, this rule would also add a registration fee.
' The proposed rule would require that general licensees under 31.5 appoint an individual to be responsible for ensuring day-to-day compliance with the regulations. The distributor would have to obtain the name and phone number of this person from the general licensee customers, rather than simply a contact, and provide this information to the NRC or the Agreement State in quarterly transfer reports. For those registering devices,information on this responsible individual would be updated through the registration process. The serial number of devices will also be added to the information reported in quarterly transfer reports and to reports of transfers by generallicensees so that individual devices can be tracked. Additional labeling would be required to better ensure that devices can be identified as containing radioactivity and can also be traced back to the responsible party after loss of control. There are some additional provisions, not addressed in the NRC-Agreement State recommendations, also intended to improve the accountability of devices generally licensed under @ 31.5 and to clarify the regulations pertaining to all generally licensed devices containing byproduct material.
The proposed rule is intended to better ensure that certain generallicensees are aware of and i
understand the requirements for possession of devices containing byproduct material and can account for their devices. This communication, accomplished primarily through registration, would provide NRC assurance of licensee accountability. The staff believes that if general licensees were more aware of their responsibilities, they would be more likely to comply with the L
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7p The Commissioners 3
requirements for proper handling and disposal of generally licensed devices. This would reduce the potential for incidents that could result in unnecessary radiation exposure to the public and the contamination of property.
I The proposed rule is also intended to better allow the NRC and the Agreement States to keep
. track of generallicensees, including tracking of specific devices. Tracking the general licensees is important so that they can be contacted and inspected as appropriate. Tracking will also allow devices to be traced back to the owner in the event that they havo been found in inappropriate locations.-
RESOURCES:
The resources needed to complete this action are in the current budget.
COORDINATION:
The Office of the General Counsel has no legal objection to the proposed rulemaking. The Office of the Chief Financial Officer has reviewed this paper for resource implications and has no objections. The Office of the Chief information Officer has reviewed the proposed rule for information technology and information management implications and concurs in it. However, the rule _ amends information collection requirements that must be submitted to and received by the Office of Management and Budget no later than the date the rule is published in the Federal Reaister.
RECOMMENDATIONS:
. That the Commission:
1.
Acorove the notice of proposed rulemaking (Attachment 2).
2.
Certify that this rule, if adopted, will not have a significant impact on a substantial number of small entities, to satisfy the requirements of the Regulatory Flexibility Act, 5 U.S.C. 605(b).
3.
Note:
l a.
-The rulemaking will be published in the Federal Reoister for E 75-day public comment period.
l b.
This rule has been reviewed by the Agreement States.
c.
Neither an environmental impact statement nor an environmental assessment has been prepared because the provisions in this proposed rule are the type of actions described in the categorical exclusions 10 CFR 51.22(c)(1) through (3),
i d.
A draft regulatory analysis has been prepared and will be available in the Public l
Document Room (Attachment 3).
e.
The appropriate Congressional committees will be informed (Attachment 4).
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l The Commissioners 4
f.
The Chief Counsel for _ Advocacy of the Small Business Administration will be informed of the certification regarding economic impact on small entities and the reasons for it as required by the Regulatory Flexibility Act.
i g.
The proposed rule would amend information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These
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requirements will be forwarded to the Office of Management and Budget for approval.
h.
- A draft press release will be issued by the Office of Public Affairs when the proposed rulemaking is filed with the Office of the Federal Register (Attachment 5).
i.
An optional Form XXX will be made available for distributors' quarterly transfer reports. (Attachment 6)
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Draft guidance for licenses for distribution to generallicensees will be published for comment. A brief appendix for use in providing guidance to 10 CFR 31.5 general licensees is included. (Attachment 7)
William D. Travers Executive Director for Operations 1
Attachments; 1. Analysis of Fee Structure Options
- 2. Draft Federal Reaister Notice J
- 3. Draft Regulatory Analysis
- 4. Draf t Congressional Letters
- 5. Draft Press Release
- 6. Draft Form XXX - Transfers of Industrial Devices Report
- 7. D aft NUREG 1556, Vol.16, Consolidated Guidance About Materials j
r Licenses: Program-Specific Guidance About General License Distribution Licenses I
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1 The Commissioners 4
f.
The Chief Counsel for Advocacy of the Small Business Administration will be informed of the certification regarding economic impact on small entities and the reasons for it as required by the Regulatory Flexibility Act, g.
The proposed rule would amend information collection requirements that are i
subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These requirements will be forwarded to the Office of Management and Budget for approval.
h.
A draft press release will be issued by the Office of Public Affairs when the proposed rulemaking is filed with the Office of the Federal Register (Attachment 5).
i.
An optional Form XXX will be made available for distributors' quarterly transfer
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reports. (Attachment 6) l j.
Draft guidance for licenses for distribution to general licensees will be published for comment. A brief appendix for use in providirg guidance to 10 CFR 31.5 general licensees is included. (Attachment 7)
William D. Travers Executive Director for Operations Attachments: 1. Analysis of Fee Structure Options
- 2. Draft Federal Reaister Notice
- 3. Draft Regulatory Analysis
- 4. Draft Congressional Letters
- 5. Draft Press Release
- 6. Draft Form XXX - Transfers of Industrial Devices Report
- 7. Draf t NUREG-1556, Vol.16, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About General License Distribution Licenses DOCUMENT NAM,E. o mattseng2pW2pcp t.. rw ei.* a r ne, c tan enre w ir e, - +, rin.
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ATTACHMENT 1 Analysis of Fee Structure Options
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ATTACHMENT 2 Federal Register Notice s
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[7590-01]
NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30,31,32,170, and 171 RIN 3150 - AG03 Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct Material AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC)is proposing to amend its regulations governing the use of byproduct material in certain measuring, gauging, or controlling devices.
. The proposed revision includes the addition of explicit requirements for a registration process that the NRC plans to initiate through an earlier proposed rule. This action proposes to add to the regulations the specific criteria for inclusion in the registration program and details about the information required; it would also add a registration fee. The amendments would also modify the quarterly transfer reporting, recordkee@ g, and labeling requirements for specific licensees who distribute certain generally licensed devices and clarify which provisions of the regulations apply to all general licenses for byproduct material. The proposed rule is inter 4ed to allow the NRC to better track certain general licensees, so that they can be contacted or inspected; to track generally licensed devices so that the devices can be identified even if lost or damaged;
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and to further ensure that generallicensees are aware of and understand the requirements for the possession of devices containing byproduct material. Greater awareness helps to ensure that general licensees will properly handle and dispose of generally licensed devices and reduce the potential for incidents that could result in unnecessary radiation exposure to the public and contamination of property.
DATES: Submit comments by (Insert date 75 days ;fter publication date). Comments received after this date will be considered if it is practical to do so, but the Commission is *.ble to ensure consideration only for comments received en or before this date.
ADDRESSES: Send comments by mail to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Attention: Rulemakings and Adjudications Staff.
Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland, between 7:30 am and 4:15 pm on Federal workdays.
You may also provide comments via the NRC's interactive rulemaking web site through the NRC home page (http /www.nrc. gov). This site provides the availability to upload J
comments'as files (any format), if your web browser supports that function. For information a'oout the interactive rulemaking site, contact Ms. Carol Gallagher (301) 415-5905; e-mail CAG @ nrc. gov.'
Certain documents related to this rulemaking, including comments received and the regulatory analysis, may be examined at the NRC Public Occument Room,2120 L Street NW.
(Lower Level), Washington, DC. These same documents also may be viewed and downloaded electronically via the interactive rulemaking website established by NRC for this rulemaking.
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FOR FURTHER INFORMATION CONTACT: Catherine R. Mattsen, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear R' gulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6264, or e-mail at CRM@nrc. gov.
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 (10 CFR 30.21(c)) for the use of byproduct material contained in certain measuring, gauging, or contro! ling devices. Under current regulations in 10 CFR 31.5, certain persons may receive and use a device containing byproduct material under this generallicense if the device has been manufactured and distributed according to a specific license issued by the NRC or by an Agreement State. A specific license authorizing distribution of generally licensed devices is issued if a regulatory authority determines that the safety features of the device and the instructions for safe operation of that device are adequate and meet regulatory requirements. These generallicensees are subject to requirements for maintaining labels, following instructions for safe use, proper storage or disposition of the device, and reporting transfers and failure of or damage to the device. For some devices, the general licensee must also comply with testing requirements for leakage and for proper operation of on-off mechanisms. Generallicensees are also subject to the terms and conditions in 10 CFR 31.2 concerning general license requirements, transfer of byproduct material, reporting and recordkeeping, and inspection. General licensees must comply with the safety instructions contained in or referenced on the label of the device and must have the 3
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o-e testing or servicing of the device performed by an individual who is 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 housing. The device is designed with inherent radiation safety 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 10 CFR 31.5 who possess about 600,000 devices that contain byproduct material. The NRC has not contacted or inspected general licensees on a regular basis because of the relatively small radiation risk posed by these devices.
These licensees are not always aware of applicable requirements and thus are not necessarily complying with all of the applicable requirements. Of most concern, are occurrences where generally licensed devices have not been handled or disposed of properly.
In some cases, this has resulted in radiation exposure to the public and contamination of property. For example, sources have been accidentally melted in steel mills causing considerable contamination of the mill, the steel product, and the wastes from the process, the slag and the baghouse dust. Although known exposures have generally not exceeded the public dose limits, there is a potential for significant exposures.
Because of these incidents, the NRC conducted a 3-year sampling (1984 through 1986) of generallicensees to assess the effectiveness of the generallicense program to determine whether there was an accounting problem with generally licensed device users. The sampling revealed several areas of concern regarding the use of generallicensed devices. The NRC 4
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4-L concluded that -- (1) Many general licensees are unaware of the applicable regulations and; (2)
Many general licensees are unable to account for their devices.
j Approximately 15 percent of the general licensees sampled could not account for all of their generally licensed devices. The NRC concluded that these problems could be resolved by more frequent and timely contact between the general licensee and the NRC.
On December 27,1991 (56 FR 67011), the NRC published a notice of proposed ruiemaking concerning the accountability of generally licensed devices. The proposed rule contained a number of provisions, including a requirement under 10 CFR 31.5 for general licensees to provide information to the NRC upon request, through which a device registry could be developed. The proposed rule also included requirements in 10 CFR 32.51a and 32.52 for specific licensees who manufacture or initially transfer generally licensed devices.
Although the public comments received were reviewed and a final rule developed, a final rule was not issued because the resources to fully implement the proposed rule were not available.
The NRC has continued to consider the issues related to the loss of control of generally licensed, as well as specifically licensed, devices. In July 1995, the NRC, with assistar.ce from the Organization of Agreement States, formed a working group to evaluate these issues. The working group consisted of both NRC and Agreement State regulatory personnel and l
encouraged the involvement of all persons having a stake in the process and its final recommendations. All working group meetings were open to the public. A final report was published in October 1996 as NUREG-1551," Final Report of the NRC Agreement State 1
Working Group to Evaluate Control and Accountability of Licensed Devices.
In considering the recommendations of this working group, the NRC has decided,
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i among other things, to initiate an annual registration, similar to the program originally proposed q
in the 1991 proposed rule, of devices generally licensed under 10 CFR 31.5. However, the 5
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NRC has decided to do so only for those devices considered to present a higher risk of potential exposure of the public or property loss in the case of loss of control (compared to other generally licensed devices). Initially, the NRC will use the criteria developed by the working group for determining which sources should be subject to the registration program.
These were based on considerations of relative risk and were limited to radionuclides currently in use in these types of devices. If quantities of other radionuclides that would present a similar risk are used in such devices in the future, this would be a reason for revising the criteria to include additional radionuclides. The Commission may, in future rulemaking, also consider revising the criteria to include a larger number of devices in the registration requirement for other reasons.
The Atomic Energy Act of 1954 (AEA), as amended, provides the NRC with the authority to request information from its licensees concerning licensed activities. In the case of 10 CFR 31.5 generallicensees, however, the Commission had not included an explicit provision in this regard in its regulations. On December 2,1998 (63 FR 66492), the Commission published a proposed rule that would explicitly require generallicensees who possess certain measuring, gauging, or controlling devices to provide the NRC with information about the devices. The NRC intends to use that provision primarily to institute a registration and accounting system for the devices containing certain quantities of specific radionuclides that present a higher risk of exposure to the public or property damage if a device were lost. That i
l rulemaking was not proposed as a matter of compatibility for Agreement States.
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' This rule would add specific requirements concerning the registration of devices and additional provisions of an enhanced regulatory oversight program for all general licensees in this category. It would also establish levels of compatibility for Agreement State regulations so that an increased level of oversight for general licensees in Agreement States would also be 6
required. Some States have already instituted some form of enhanced oversight for these general licensees, in a few cases, a registration program. A few States have a higher level of control on these devices through requiring specific licenses. Under the proposed level of compatibility for 31.5, the essential objectives of the regulation should be adopted by the State to avoid conflicts, duplications or gaps; the manner in which the essential objectives are addressed need not be the same as NRC. Strict compatibility would only be required for revisions to distributors requirements because of interjurisdictional distribution.
Discussion
' The proposed rule published on December 2,1998, for public comment, would provide one of the key elements in improving the accountability and control over devices of particular concern through the institution of a registration process; however, there are inadequate provisions in the regulations to allow for the NRC to keep track of generally licensed devices.
NRC needs to do so in order that the generallicensees can be contacted when situations arise which warrant such contact and for inspection purposes. As noted, it would not require
' compatibility of Agreement State regulations.
In addition, there are other means for reducing the likelihood of incidents of lost sources.
' The Commission has reconsidered the provisions in its 1991 proposed rule, evaluated the recommendations of the NRC-Agreement State Working Group, and identified additional issues concerning these devices in developing this proposed rule.
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l Summary and Discussion of Proposed Requirements l
Revisions to the Requirements for General Licensees under 9 31.5 - The principal change to the general license that would be made under this proposed rule would be to add explicit provisions delineating an annual registration requirement. The registration process is expected to be initiated under @ 31.5(c)(11), proposed on December 2,1998, which would require licensees to respond to requests for information frco NRC within 30 days or as otherwise specified. The specific provisions proposed here in a new 31.5(c)(13) are essentially consistent with the Commission's plans for the registration process discussed in that earlier proposed rule. This proposed rule would specifically require that the information about devices be verified through a physical inventory and checking labelinformation. The advantage of including more explicit requirements in the regulation is that information about the registration process will be more clearly defined and more available. When the distributor of a device supplies copies of 31.5 to its customers (under 32.51a(a)), the potential general licensees will be made aware of the registration requirement, including the devices to which it applies, what information will be requested, and also the fact that there will be a registration fee. The proposed rule would add a fee of $370 to 9170.31 to be assessed in conjunction with the registration process; this would be for each generallicensee possessing devices required to be registered regardless of the number of devices. NRC is required by law to recover all costs from licensees' fees. Registration fees are proposed in order to recover the cost of the general license program associated with this group of general licensees in an equitable way; that is, from those who are allowed to use devices under the general license rather than from others who hold specific licenses.
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The first registration, carried out under 10 CFR 31.5(c)(11), would depend on the NRC's ability to contact general licensees as information is requested only at NRC request. This proposed rule, as drafted, also specifies that the general licensee will complete registration by verifying, correcting, and/or adding to the information in a request for registration received from the Commission. It is silent on when or how generallicensees should register if the Commission fails to contact the generallicensee. The Commission seeks comment on whether the registration requirement should include a provisien that the general licensee is required to complete registration in any case by a certain time such as 15 months after the date of the previous registration certificate, the receipt of a device subject to registration, or the effective date of this rule,in the case of an unregistered device possessed at the time of the effective date of the rule. This would put the burden of registering on generallicensees who have not been notified by NRC of tM requirement.
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The time of year of registration will vary for licensees; however, requests for renewal of registration will be made approximately one year after the previous registration request for that licensee. Although registration would not be required prior to receipt of devices, the Commission plans to send requests for registration to new general licensees identified in distributors' quarterly transfer reports submitted under 32.52 shortly after receipt and recording of this information. For generallicensees who have previously registered devices and receive additional devices requiring registration, the addition of new devices to the I
registration will be done at the tirne of the annual reregistration. The Commission requests i
comment on whether the NRC should contact previous registrants who rece!/e additional i
devices earlier than this, either by an acknowledgment by NRC to the user or by a required response accounting for the additional device (s) by the general licensee.
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Additional proposed requirements for all general licensees under 6 31.5 include: (1) an explicit requirement for the general licensee to appoint an individual to carry out the general licensee's responsibilities to comply with the applicable regulations (new S 31.5(c)(12)); (2) a provision that limits the amount of time a generallicensee can keep an unused device in storage and allows the deferment of testing during the period of storage (new 31.5(c)(15));
(3) a provision to allow transfers to specific licensees authorized under Part 30, or Agreement State regulations, as waste collectors, in addition to currently allowed transfers to Part 32 (and Agreement State) licensees, and to also allow transfers to other specific licensees but only with prior written NRC approval (revision to 31.5(c)(8)); (4) the addition of the recipient's license number, the serial number of the device, and the date of transfer to the inf armation required to be provided to NRC upon a transfer of a device (revision of 31.5(c)(8)); (6; a provision to notify NRC of address changes (new @ 31.5(c)(14)); (6) for device damage or failures that are likely to or are known to have resulted in contamination, the addition of a plan for ensuring that premises and environs are suitable for unrestricted access, to the information that must be sent to NRC in the case of a failure, and a change to the addressee for reporting information concerning a failure (revision to 9 31.5(c)(5)); and (7) the revision of the reporting requirement, in the case of a transfer to a generallicensee taking over possession of a device at the same location, to provide the name and phone number for the person designated to be responsible for ensuring compliance with the appropriate regutetions and requirements, rather than simply a contact name, and the serial number of the device (revision to @ 31.5(9)(i)).
The rationale for each of these proposed amendments is:
(1) The " person" who holds a general license is usually a corporation, or public cr private l
institution, rather than an individual. In practice, in order for the general licensee to comply with existing regulations, some individual must be aware of the requirements and take the required 10 1
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actions. Appointing a specific individual to be responsible for ensuring compliance with i
regulations is an appropriate operational practice, which is, unfortunately, not always followed.
For devices not subject to testing under 31.5(c)(2), there are no routine actions required to be taken, as the requirements are generally restrictions on actions, such as not abandoning the
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device, or actions to be taken only in the case of particular, non-routine events, such as notification of NRC of the transfer or failure of the device. In this situation, it is particularly likely for knowledge of the nature of the device, the general license, and the associated regulations to not be maintained and passed on to individuals using the device. Requiring the assignment of the responsibility for compliance with regulations to a specific individual would improve the probability that the general licensees will do what they are already required to do. The impact of this should be minimal, somewhat limiting operational flexibility with regard to the assignment of duties. This individual would not necessarily be someone who works on site at the place of use of the device and would not necessarily be conducting all required actions, but would be responsible to ensure that required actions are taken.
(2) When a device is not in use for a prolonged time, it is particularly susceptible to being forgotten and "Pimately disposed of or transferred inappropriately. Generallicensees are unlikely to keep a device unused for more than two years and subsequently reuse it. If a device is being held in storage indefinitely, it is likely that it is being stored to avoid the costs of proper disposal. If a generallicensee does want to reuse a device after a period of more than two years of disuse, the device could be sent back to the supplier to be held under the distributer's specific license until later use or the general licensee could request ar' exemption from Q 31.5(c)(15) indicating the reason (s) why the licensee intends to use the device after two years and prefers to keep it on site in the interim.
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i If a period of storage exceeds the interval for testing, testing need not be done until the i
~ device is to be put back into use again. This would relieve the burden of unnecessary testing 1
during the period of storage as weil as eliminating any exposure that may occur during testing for that period.
(3) The proposed revision to Q 31.5(c)(8) would provide some flexibility to the general licensee in transferring a device while assuring that it is transferred appropriately. It would allow a general licensee to transfer a device d rectly to a waste collector for disposal, rather than going through a distributor. It would also allow the transfer of a device to other specific licensees, but would require NRC approval in these cases so that NRC can ensure that the recipient is authorized to receive it.
(4) The inclusion of a recipient's license number in the report of transfer would better ensure that the general licensee has verified that the recipient is a Part 32 licensee or a specific
)
licensee under equivalent Agreement State regulations authorized to receive it. It would also supply an additional means for NRC to identify the recipient, as company names and addresses sometimes change. The addition of the date of transfer will make the transfer easier to track
{
and help to ensure that the generallicensee makes the report in a timely manner (required within 30 days of the transfer).
-(5) The quarterly reports required of distributors under 32.52(a) and (b) are intended to provide NRC and the Agreement State regulatory agencies with the identity of general
. licensees in their jurisdictions and addresses at which these general licensees can be contacted (which is usually the location of use of the generally licensed c'evices). These generallicensees can then be contacted or inspected. if generallicensees move their operations without notifying the NRC, or appropriate Agreement State agency, they may be difficult to locate. This proposed requirement to report address changes would only apply to mailing addresses and, 12 1
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for portable devices, the address of the primary place of storage ~ although they may be used at multiple field sites. For those registering devices, changes in the address of use, if different from the mailing address, will be provided at the time of the next registration.
This simple change of address notification is intended to cover moves into and within NRC jurisdiction. The generallicense in 10 CFR 31.5 only applies within NRC jurisdiction. If a general licensee intends to move from one jurisdiction to another, they should contact the applicable regulatory authority, NRC or the particular Agreement State, prior to doing so in j
order to determine the applicable, current regulations in that jurisdiction. All jurisdictions do not have a comparable general license and specific provisions of the generallicense may vary among jurisdictions. Also,if a generallicensee who has obtained a portable device in an Agreement State and wishes to use the device within NRC jurisdiction, they must do so under l
10 CFR 31.5, as there is no reciprocity provision applicable to generallicenses. In this case, they would be subject to the provisions of 10 CFR 31.5.
j (6) Generallicensees are not subject to decommissioning requirements as a general license is granted by regulation and, under normal circumstances, does not involve any termination of license process. If a generally licensed device fails or is seriously damaged so as to cause significant contamination of the premises or environs, the NRC may need to respond to the notification of an incident made under 31.5(c)(5) to ensure that a facility is properly decontaminated if necessary. Following such an incident, the NRC would determine what actions are necessary on a case-by-case basis and could apply the requirements set out j
in 6 20.1402, " Radiological criteria for unrestricted use." The general licensee is exempt from i
l this section of Part 20 when only in possession of an intact generally licensed device. However, when a device has been damaged, the material in the device may no longer be only in the device, i.e., it may also be unsealed radioactive material. Such an action can be taken under 13 l
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Q 30.61," Modification and revocation of licenses," which 'is applicable to general licensees. The provision proposed in this action wou!d require that the general licensee propose to the Commission how it will be shown that the premises are or will be adequately cleaned up.
Depending on the nature of the event, the remedial action taken (and reported under existing l
requirements) along with any confirmatory surveys may be sufficient to complete action on the l
I event.
The addressee for submitting information under 9 31.5(c)(5) would be changed from l
Regional Adtninistrator to Director of Nuclear Material Safety and Safeguards so that all NRC addressees specified in 9 31.5 for reports by 'hese licensees are the same and to eliminate the need for the general licensee to refer to 10 CFR Part 20 to determine the appropriate addressee. The addressee and address for registration will be specified in the registrat!on request.
(7) Consistent with the provision for appointing an individual to act for the general licensee to ensure t ampliance with the applicable regulations and requirements and other reporting tequirements being proposed, it is more effective for the general licensee to provide the name of the new responsible individual when another generallicensee takes over the facility and responsibility for the device.
One other revision to 31.5 is being proposed that would clarify the status of a person who receives a device through an unauthorized transfer. Paragraph (b) would be revised to limit the applicability of the generallicense to those who receive a device through an authorized transfer. NRC has generally, although not consistently, interpreted the generallicense to apply I
to a recipient meeting the criteria for general licensee, i.e., ".. commercial and industrial firms I
and research, educational and medical institutions, individuals in the conduct of their business, and Federal, State or local govemment agencies..", even if the device is received through an l
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unauthorized transfer, This revision would clearly provide that the general license only applies if the device is obtained through an authorized transfer.
In addition to the proposed revisions to 6 31.5, a number of revisions are being proposed to clarify which sections of the regulations in Part 30 apply to all of the general licensees under Part 31. Section 31.1, " Purpose and scope," would be amended to clarify that only those paragraphs in Part 30 specified in Q 31.2, or the particular general license, apply to Part 31 general licensees. Section 31.2, " Terms and conditions," would be amended to include reference to the sections of Part 30 that are applicable to all of the Part 31 generallicensees, including 9 30.7, " Employee protection," S 30.9, " Completeness and accuracy of information,"
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and 30.10, " Deliberate misconduct." Under the proposed clarification, it would be easier for generallicensees to be aware of applicable regulations. In addition, future revisions to Part 30 that would apply to Part 31 general licensees would include a conforming amendment to l
Part 31. Note, however, that while @ 31.2 would specify applicable sections of Part 30, it would not eliminate the applicability of other Parts of the Commission's regulations that may apply, for example, Part 2," Rules of Practice for Domestic Licensing Proceedings and Issuance of Orders."
The applicability of 30.34(h) on bankruptcy notification to general licensees also needs to be clarified. Under the existing regulations, this requirement applies to alllicensees; however, it's application to general licensees is not clear because it is not referenced in G 31.2,
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I nor in 9 31.5. This proposed rule would make the bankruptcy notification requirement j
i applicable only to those generallicensees subject to the registration requirement. These licensees possess devices for which the Commission believes a higher level of oversight is appropriate. Thus, notiUcation that a general licensee is filing for bankruptcy may be important 15
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to allow the Commission to intervene to ensure that the financial status of the licensee does not lead to the improper disposal or abandonment of a device.
Requirements for Manufacturers and initial Distributors of Devices - The proposed regulation would modify the quarterly transfer reporting, recordkeeping, and labeling requirements for specific licensees who distribute these generally licensed devices, as well as
.the requirem'ent for providing information to users. These requirements are a matter of strict compatibility of Agreement State regulations and are proposed to continue to be so making
^
- equivalent revisions to' Agreement State regulations necessary. The basis of this compatibility requirement is significant direct transboundary implications.
Reoortina - To the existing quarterly transfer reporting requirement, the following
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. information would be added: the serial number and model number of the device; the date of transfer; indication if device is a replacement, and if so, the type, model number, and serial number of the one returned; name and license number of reporting company; and the specific reporting period. The model number of the device is already required in reports to Agreement l States. The_name and phone number of the person ' designated by the generallicensee to be
- responsible for the device and for ensuring compliance with the appropriate regulations will
, replace the name and/or position of a simple contact between the Commission and the general licensee.'. Also, a form will be provid' d for use in making these reports; however, the use of the e
i form would not be required as long as the report is clear and legible and includes all of the
- required information. Revisions would be made to 6 32.52(a) and (b).
The existing reporting requirement is intended to provide NRC and the Agreement State
" regulatory agencies with the identity of general licensees in their jurisdictions, addresses at which the general licensees can be contacted (which are usually the location of use of the 16 i,
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devices), the particulars of the type of device possessed, and the name (or position) of an individual who constitutes a point of contact between the NRC and the generallicensee. These generallicensees can then be contacted or inspected. Including the serial number will allow the NRC and Agreement States to track individual devices. The existing reporting requirement in 31.5(c)(8) does not require the general licensee to report a transfer if it is for the purpose of
. obtaining a replacement. This is consistent with the originalintent of this regulation in that the status of the general licensee is unchanged, only the specific device is changed. In order for individual devices to be tracked, the NRC or Agreement State needs to be informed of such a transfer. The proposed rule would require this of the distributor. Under existing requirements, quarterly reports include specifics on any new device transferred but not on the devices returned. It would not be a significant burden on the distributor to include this additional information in the quarterly reports and the distributor is likely to be more reliable than the generallicensee in providing this information. The name and license number of the reporting
- company and the specific reporting period are typically included in the reports in order to show compliance with the reporting requirement but are not always readily identifiable.
In order for an individual to act as contact with the NRC concerning the generallicense, the individual should have knowledge of the device, the general license, and the regulations pertaining to the general license. This is the intent of the existing requirement; however, in practice, the name given to the distributor and reported to the NRC (and the Agreement State j
-i agencies) frequently is not an individual with such knowledge.' The proposed rule would specify I
that the contact designated be the person responsible for ensuring compliance with the regulations.
Recordkeepino - The rule would add to the recordkeeping requirements information on final disposition of devices. The recordkeeping requirements concerning transfers would have 1
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p7 the period of retention extended from 5 years from the date of the recorded event to 3 years l
after the expected usefullife of the device or the final disposition, if known. Revisions would be made to Q 32.52(c).
It is important that information about the general licensees and the specific devices in their possession be available until the device is disposed of permanently. Requiring the l
distributor to keep these records for an extended time provides a useful backup to the l
recordkeeping of NRC and State regulatory agencies and the records include information on final distribution that may not have been included in reports to NRC and the Agreement States.
It is NRC's understanding that it is a general practice of these distributors to keep these records indefinitely; thus, this regulatory requirement should have little, if any, impact.
i An additional requirement would be added for the distributors to make available to the various regulatory agencies, records of final disposition of devices in the case of bankruptcy or termination of license. A new paragraph 9 32.51a(d) would be added.
l When a distributor goes out of business and terminates his license, he can no longer be required to retain these records. This requirement would give NRC, as well as State regulatory agencies, the opportunity to obtain and retain records of this type previously kept by the distributor, if deemed important. These records could be helpfulin verifying information used to keep track of devices relative to the final disposition of devices. This provision would not require distributors to automatically provide these records unless the NRC or the Agreement State in which the device was distributed makes a request for these records. In the case of bankruptcy, NRC or the Agreement State may want to secure these records early in the l
l-process, in case financial difficulties interfere with the licensee fulfilling its responsibilities.
Labelina - To the existing labeling requirements, would be added: an additional label on any separable source housing, and a permanent label on devices meeting the criteria for 1
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registration. The NRC would consider a label" permanent,"if, for example, it were embossed, etched, stamped, or engraved in metal. New paragraphs 9 32.51(a)(4) and (5) and 9 32.51a(c) would be added. Under these requirements, new distributors would have labels approved as part of obtaining a license; distributors including existing licensees would have the new labeling requirements as conditions of license in 32.51(a)(4) and (5). Approval of the new labels by NRC for existing distributcrs would not be required; however, distributors may voluntarily submit information for NRC review on how they plan to comply with the new labeling requirements. In any case, labeling is subject to inspection. To the extent necessary, the new labeling requirements would supercede anything contradictory in individual license conditions. The i
individual license conditions would be updated to include specifics related to the new requirements during the first license renewal or amendment following the effective date of those paragraphs of the rule.
I The first of these changes is simply an extension of the existing requirement and carries j
out the initialintent in the case of devices where the source may be separable in a housing that does not include the label. It is important that this housing, if separated from the remainder of the device, can also be identified. The impact of this should be minimal. The permanent label for devices requiring registration would provide better assurance that even when a device has been exposed to other than normal use conditions, for example, when a building has been demolished with the device in place, the label will be intact and the device may be identified and proper actions can be taken. This may result in a more significant change to the production of devices. Distributors would have one year after the effective date of the rule to implement these changes, in order to minimize any impact to the manufacturing and distributing process.
Information to be orovided to aeneral licensees - Revisions would be made to the requirements pertaining to the information distributors would be required to provide to the l
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generallicensee. They are now required to provide generallicensees with a copy of Q 31.5 at the time of transfer of the device. The proposed rule would require that 31.5 be provided prior to transfer. The distributor would also be required to provide copies of additional applicable sections of the regulations, a listing of the services that can only be performed by a specific licensee, and information regarding disposal options for the devices being transferred. The disposal options would inc!ude the estimated cost for disposal of the device at the end of its useful life to the extent that the cost information is available to the distributor at the time of the sale of the device. In the case of transfers to generallicensees in Agreement States, the distributor may furnish either the applicable NRC regulations or the comparable ones of the Agreement State. In addition, the distributor would furnish the name, address, and phone number of the contact at the Agreement State regulatory agency from which additional information may be obtained. Revisions would be made to Q 32.51a(a) and (b).
The generallicensee should be aware of the specific requirements prior to purchasing a generally licensed device, rather than afterward. While Q 31.5 contains the primary requirements related to the general license, it does not include reference to applicable sections of Part 30. The generallicensee should have copies of at least those regulations that may require an action on his part. The sections of the regulation proposed to be included in this requirement are believed to be the most important for the general licensee to be aware of. The
' inclusion of a listing of services that can only be performed by a specific licensee would clarify for the general licensee which services can and cannot be performed by the general licensee; these vary depending on the nature and design of the particular device and so are not specified in the regulations. Information on the estimated cost for disposal of the device at the end of its useful life may be a significant factor in a decision to purchase a device, because of the high 20 p
e costs of disposing of radioactive materials. In some cases, the cost could be several times the l
purchase price of the device.
l Additional clarifying amendments would be made in @ 30.31, 30.34(h), and 31.5(c)(9)(ii). The revised wording of Q 30.31 provides a similar clarification as that in the Suggested State Regulations with respect to generallicenses. The revision to @ 30.34(h)is consistent with the revision discussed above concerning reporting bankruptcy.
The revision of 6.31.5(c)(9)(ii) to include the term, " intermediate person,"is intended to provide clarification about intermediate persons holding devices. Specifically, intermediate persons holding devices in their original shipping containers at their intended location of use are generalli;ensees. Distributors licensed under 32.51, or equivalent Agreement State regulations, must provide information about both intermediate persons and intended users in their quarterly reports submitted under 32.52(a). Transfers from intermediate persons to intended users under s 31.5(c)(9)(ii) do not need to be reported to NRC since information about the intended user must be reported by the distributor under S 32.52(a).
I Minor conforming amendments would also be made to S 170.2,170.3,171.5, and 171.16.
Public Comments on the Original Proposed Rule I
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The NRC reviewed the comments received on the December 27,1991, proposed rule in developing both the proposed rule published on December 2,1998 (63 FR 66492) and this 1
1 l
proposed rule. There were 26 comment letters received from a variety of sources including private and publicly held corporations, private citizens, citizens groups, the Armed Forces, and 1
State governments. These comments have been considered to the extent applicable to each i
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rule. A detailed analysis of the comments received on the December 27,1991, proposed rule, j
which was withdrawn by the notice of proposed rulemaking on December 2,1998, is not presented in either of the subsequent proposed rules because many of the specific comments pertain to specific provisions that have been withdrawn, a great deal of time has passed since these comments were made, and additional opportunity for comment is being provided.
Interim Enforcement Policy On (Insert publication date of interim enforcement policy)(63 FR ), the Commission established an interim enforcement policy for violations of 10 CFR 31.5 that licensees discover and report during the initial cycle of the registration program. This policy supplements the j
i normal NRC Enforcement Policy in NUREG-1600, Rev.1. It will remain in effect through one complete cycle of the registration program.
Under the normal NRC Enforcement Policy, significant violations, such as those involving lost sources, could have resulted in escalated enforcement action including civil penalties. The interim policy provides that enforcement action normally will not be taken for violations identified by a licensee and reported to the NRC if appropriate corrective action is taken. For the period that the interim policy is in effect, it also applies to general licensees not subject to the registration requirement if they identify and report violations and take appropriate corrective action. This change in the NRC Enforcement Policy was intended to remove any disincentive to identify deficiencies that might be caused by a concern over potential enforcement action. This action should encourage general licensees to search their facilities to ensure sources are located, to determine if applicable requirements have been met, and to develop appropriate corrective action when deficiencies are found. A Notice of Violation (NOV) 22
c-1 without a civil penalty still may be issued if the NRC 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 formal manner required in a response to an NOV.
In addition, escalated enforcement action still will be considered for violations involving fP,ilure to provide the information requested, failure t'o take appropriate corrective action, or for willful violations including the submittal of false information or refusing to pay required fees.
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.
As noted in the earlier proposed rule notice of December 2,1998, the Commission also plans to increase the civil penalty amounts specified in its Enforcement Policy in NUREG-1600, Rev.1, for violations involving lost or improperly disposed sources or devices. This would be to ensure that, after the amnesty period, 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), the proposed rule will be a matter of compatibility between the NRC and the Agreement States, thereby providing consistency among State and Federal safety requirements. The revisions to Part 32 would be classified as Category B; the entire section 31.5 (including existing regulations) would become Category C; and the revisions to Parts 30,170, and 171 and the additional revisions to Part 31 would be Category D, 23 l
Category B means the provisions affect a program element with significant direct transboundary implications that the State should adopt with essentially identical langrage.
Category C means the provisions affect a program element, the essential objectives of which should be adopted by the State to avoid conflicts, duplications or gaps. The manner in which the essential objectives are addressed need not be the same as NRC provided the essential objectives are met. Category D means the provisions are not required for purposes of compatibility; however, if adopted by the State, they :hould be compatible with NRC.
1 Environmental Impact: Categorical Exclusion The NRC has determined that the revisions proposed in this rule are the types of actions j
described in the categorical exclusions in Q 51.22(c)(1) through (3). Therefore, neither an environmentalimpact statement nor an environmental assessment has been prepared for this regulation.
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i Paperwork Reduction Act Statement This proposed rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq). This rule has been submitted to the Office of Management and Budget for review and approval of the information collection requirements.
Approval of the Office of Management and Budget for the public reporting burden from the registration process was requested in conjunction with the proposed rule of December 2, 1908.
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r; The public reporting burden for this information collection is estimated to average 4 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the information collection. The time involved is small because most of the proposals are minor revisions to existing information collection requirements. The U.S. Nuclear Regulatory Commission is seeking public comment on the potentialimpact of the information collections cc itained in the proposed rule and on the following issues:
1.
Is the proposed information collection necessary for the proper performance of the functions of the NRC, including whether the information will have practical utility?
' 2.
Is the estimate of burden accurate?
3.
Is there a way to enhance the quality, utility, and clarity of the information to be collected?
4.
How can the burden of the information collection be minimized, including the use of automated collection techniques?
Send comments on any aspect of this proposed information collection, including suggestions for reducing the burden, to the Records Management Branch (T 6F33), U.S.
Nuclear Regulatory Commission Washington, DC 20555-0001, or by Internet electronic mail at BJS1 @NRC. GOV; and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202 (3150-0016), Office of Management and Budget, Washington, DC 20503.
Comments to OMB on the information collections or on the above issues should be submitted by (insert date 30 days after publication in the Federal Register). Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given to comments received after this date.
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Public Protection Notification l
If an information collection does not display a currently valid OMB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.
Regulatory Analysis The NRC has prepared a draft regulatory analysis for this proposed regulation. The analysis examines the cost and benefits of the alternatives considered by the NRC. The comments received on the draft regulatory analysis associated with the proposed rule of December 27,1991 have been considered to the extent that they apply to this action. The regulatory analysis is available for inspection in the NRC Public Document Room,2120 L Street NW. (Lower Level), Washington, DC. Single copies of the analysis may be obtained by calling Catherine R. Mattsen, U.S. Nuclear Regulatory Commission, Office of Nuclear Material Safety and Safeguards, Washington, DC,20555-0001; telephone (301) 415-6264; or e-mail at CRM @ nrc. gov.
Regulatory Flexibility Analysis As required by the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commission has evaluated the impact of this rule on small entities. The Commission certifies that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The most significant cost of this proposed rule would be the registration fee of $370.
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The proposed rule would apply to the approximately 45,000 persons using products under an l
NRC generallicense, many of whom may be classified as small entities. However, the registration requirement and associated fee would apply to about 6000 of these general licensees. Th'e NRC believes that the fees will not present a significant economic impact on
.. these licensees and that the economic impact of the additional proposed requirements on any generallicensee would be a negligible increase in administrative burden. The proposed rule would also revise requirements for specifically licersed distributors of certain generally licensed devices. Most of these licensees are not small entities and the impact to any of these distributors would not be significant in any case.
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 30 - Byproduct material, Criminal penalties, Government contracts, Intergovernmental relations, isotopes, Nuclear materials, Radiation protection, Reporting and i
recordkeeping requirements.
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10 CFR Part 31 - Byproduct material, Criminal penalties, Labeling, Nuclear materials, Packaging and containers, Radiatiol protection, Reporting and recordkeeping requirements, Scientific equipinent.
10 CFR Part 32 - Byproduct material, Criminal penalties, Labeling, Nuclear materials, Radiation protection, Reporting and recordkeeping requirements.
10 CFR Part 170 - Byproduct material, import and export licenses, Intergovernmental relations, Non-payment penalties, Nuclear materials, Nuclear power plants and reactors, Source material, Special nuclear material.
10 CFR Part 171 - Annual charges, Byproduct material, Holders of certificates, registrations, approvals, Intergovernmental relations, Non-payment penalties, Nuclear materials, Nuclear power plants and reactors, Source material, Special nuclear material.
For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganizatier. Act of 1974, as amended; and 5 U.S.C.
552 and 553, the NRC is proposing to adopt the following amendments to 10 CFR Parts 30,31, 32,170, and 171, 28 A
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PART 30 - RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL
- 1. The authority citation for Part 30 continues to read as follows:
Authority: Secs. 81, 82,161,182,183,186, 68 Stat. 935, 948, 953, 954, 955, as amended, sec. 234,83, Stat. 444, as arnended, (42 U.S.C. 2111,2112,2201,2232,2233, 2236,2282); secs. 41,5842, 5846).
Sec. 30.7 also issued under Pub. L.95-601, sec.10,92 Stat. 2951 as amended by Pub.
L.102-486; sec. 2902,106 Stat. 3123, (42 U.S.C. 5851). Section 30.34(b) also issued under sec.184,68 Stat. 954, as amended (42 U.S.C. 2234). Section 30.61 also issued under sec. 187,68 Stat. 955 (42 U.S.C. 2237).
- 2. Section 30.31 is revised to read as follows:
f 9 30.31 Types of Licenses Licenses for byproduct material are of two types: Genera' and specific. Specific licenses are issued to named persons upon applications filed purst nt to the regulations in this part and Parts 32-36, and 39. Generallicenses are effective without the filing of applications with the Commission or the issuance of licensing documents to particular persons, although registration with the Commission may be required by the particular general license.
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- 3. Section 30.34 is amended by revising paragraph (h)(1) to read as follows:
$ 30.34 Terms and conditions of licenses (h)(1) Each general licensee subject to the registration requirement in @ 31.5(c)(13) and each specific licensee shall notify the appropriate NRC Regional Administrator, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy under any chapter of title 11 (Bankruptcy) of the United States Code by or against:
(i) The licensee; (ii) An entity (as that term is defined in 11 U.S.C.101(14)) controlling the licensee or listing the license or licensee as property of the estate; or (iii) An affiliate (as that term is defined in 11 U.S.C.101(2)) of the licensee.
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PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL l
- 4. The authority citation for Part 31 continues to read as follows:
Authority: Secs. 81,161,183,68 Stat. 935,948,954, as amended (42 U.S.C. 2111, 2201,2233); secs. 201, as amended,202,88 Stat.1242, as amended, 1244 (42 U.S.C. 5841, l
5842).
Section 31.6 also issued under sec. 274,73 Stat. 688 (42 U.S.C. 2021).
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.4 (d) If a notification of bankruptcy has been made under @ 30.34(h) or the license is to be terminated, provide, upon request, to the NRC and to any appropriate Agreement State, l-records of final disposition required under 6 32.52(c).
- 11. Section 32.52 is revised to read as follows:
$ 32.52 Same: material transfer reports and records.
Each person licensed under 9 32.51 to initially transfer devices to generally licensed persons shall:
(a) Report quarterly,o the Director of the Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, all transfers of devices to persons for use under the generallicense in 31.5 of this chapter. Submit the repob on Form XXX " Transfers of Industrial Devices Report," or on a clear and legible re; containing all of the data required by the form. The required information includes: the identity of each generallicensee by name and address; the name and phone number of the person designated by the general licensee to be responsible for ensuring compliance with the appropriate regulations and requirements; the date of transfer; the type, model number, and serial number of the device transferred; and the quantity and type of byproduct material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the uset, the report must include the same information f6r each intermediate person, and c!sarly designate that person as an intermediate person. If the rievice transferred replaced another returned by the general licensee, report also the type, model number, and serial number of the one returned. If no transfers have been made to persons generally licensec* under 6 31.5 of this chapter during the 38
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- 5. Section 31.1 is revised to read as follows:
$ 31.1 Purpose and scope This part establishes generallicenses for the possession and use of byproduct material contained in certain items and a general license for ownership of byproduct material. Part 30 of this chapter also contains provisions, as specified in 31.2 or the particular general license, applicable to the subject matter of this part.
- 6. Section 31.2 is revised to read as follows:
5 31.E Terms and conditions.
The general licenses provided in this part are subject to the general provisions of Part 30 of this chapter ( 6 30.1 through 30.10) and the provisions of 30.14(d), 30.34(a) to (e),30.41,30.50 to 30.53,30.61 to 30.63, and Parts 19,20, and 21, of this chapter' unless indicated otherwise in the language of the general license,
' Attention is directed particularly to the provisions of the regulations in Part 20 of this chapter that relate to the labeling of containers.
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- 7. Section 31.5 is amended by revising paragraphs (b) and (c)(5),(8), and (9) and adding
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paragraphs (c)(12), (13), (14), and (15) to read as follows:
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9 31.5 Certain measuring, gauging, or controlling devices.2 (b) The generallicense in paragraph (a) of this section applies only to byproduct material contained in devices which have been manufactured or initially transferred and labeled in accordance with the specifications contained in a specific license issued pursuant to 32.51 of this chapter or in accordance with the specifications contained in a specific license issued by an Agreement State which authorizes distribution of the devices to persons generally licensed i
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by the Agreement State and which have been received from one of these specific licensees or through a transfer pursuant to paragraph (c)(9) of this section.
(c) 1 (5) Upon the occurrence of a failure of, or damage to, or any indication of a possible l
failure of or damage to, the shielding of the radioactive material or the on-off mechanism or j
i indicator, or upon the detection of 0.005 microcurie or more removable radioactive material, shallimmediately suspend operation of the device until it has been repaired by the l
manufacturer or other person holding a specific license pursuant to parts 30 and 32 of this 1
chapter or from an Agreement State to repair such devices, or disposed of by transfer to a person authorized by a specific license to receive the byproduct material contained in the l
device and, within 30 days, fumish to the Director of Nuclear Material Safety and Safeguards, 8Persons possessing byproduct material in devices under a general license in 31.5 before January 15,1975, may continue to possess, use, or transfer that material in accordance with I
the labeling requirements of 31.5 in effect on January 14,1975.
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r U.S. Nuclear Regulatory Commission, Washington, DC 20555, a report containing a brief description of the event and the remedial action taken; and, in the case of detection of 0.005 microcurie or more removable radioactive material or failure of or damage to a source likely to I
result in contamination of the premises or the environs, a plan for ensuring that the premises j
and environs are acceptable for unrestricted use; (8) Except as provided in paragraph (c)(9) of this section, shall transfer or dispose of the device containing byproduct material only by transfer to persons authorized to receive the device by a specific license issued under parts 30 and 32 of this chapter, a specific license issued under part 30 of this chapter that authorizes waste collection, or a specific license issued under equivalent regulations of an Agreement State. Within 30 days after transfer of a device j
to a specific licensee shall furnish to the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatcry Commission, Washington, DC 20555 a report containing identification of the device by manufacturer's name, model number, and serial number and the name, I
address, license number of the person receiving the device, and the date of the transfer. No J
report is required if the device is transferred to the specific licensee in order to obtain a j
replacement device. Devices may be transferred to other specific licensees only with written NRC approval prior to transfer; (9) Shall transfer the device to another general licensee only:
(i) Where the device remains in use at a particular location. In such case, the transferor e
shall give the transferee a copy of this section and any safety documents identified in the label of the device and within 30 days of the transfer, report to the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, the 33 I'
i manufacturer's name and model number and serial number of the device transferred, the name 1
and address of the transferee, and the name ano phone number of the individual designated by the transferee in accordance with @ 31.5(c)(12) to be responsible for ensuring compliance with the appropriate regulations and requirements; or (ii) Where the device is held in storage by an intermediate person in the original shipping container at its intended location of use prior to initial use by a general licensee.
(12) Shall appoint an individual to act for the general licensee as responsible for ensuring the day-to-day compliance with the appropriate regulations and requirements. This appointment does not relieve the generallicensee of responsibility in this regard.
(13)(i) Shall register devices containing at least 370 MBq (10 mci) of cesium-137, 3.7 MBq (0.1 mci) of strontium-90,37 MBq (1 mci) of cobalt-60, or 37 MBq (1 mci) of americium-241 or any other transuranic in accordance with paragraphs (c)(13)(ii) and (iii) of this section.
(ii) If in possession of a device (s) meeting the criteria of paragraph (c)(13)(i) of this section, shall register these devices annually with the Commission and shall pay the fee required by 6170.31 of this chapter. This must be done by verifying, correcting, and/or adding to the information in a request for registration received from the Commission. The registration information must be submitted *o the NRC within 30 days of the date of the request for registration or as otherwise indicated in the request. In addition, general licensees holding devices meeting the criteria of paragraph (c)(13)(i) of this section are subject to the bankruptcy notification requirement in 30.34(h) of this chapter.
(iii) In registering devices, the general licensee shall furnish the following information and any other information as may be specifically requested by the Commission:
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(A) Name and mailing address of the generallicensee.
(B) Information about each device: the manufacturer, model number, serial number, the radioisotope and activity (as indicated on the label).
(C) Name and telephone number of the responsible person designated as a representative of the generallicensee under 31.5(c)(12).
(D) Address at which the device (s) are used and/or stored. For portable devices, the address of the primary place of storage, (E) Certification by the responsible representative of the general licensee that the information concerning the device (s) has been verified through a physical inventory and checking of labelinformation.
(F) Certification by the responsible representative of the generallicensee that they are aware of the requirements of the generallicense.
(14) Shall report changes of address, within 30 days after the moving of a device, to the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Cornmission, Washington, DC 20555. For portable devices, this only applies to the device's primary place of storage.
(15) Shall not hold devices that are not in use for longer that two years. If devices are f
not being used, the shutter must be locked in the closed position. The testing required by paragraph (c)(2) of this section need not be performed during the period of storage only.
l However, when devices are put back into service or transferred to ancther person, and h. ave
- not been tested within the required test interval, they must be tested for leakage before use or l
transfer and the shutter tested before use.
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o PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
- 8. The authority citation for Part 32 continues to read as follows:
Authority: Secs. 81,161.182,183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111,2201,2232,2233); sec. 201,88 Stat.1242, as amended (42 U.S.C. 5841).
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- 9. Section 32.51 is amended by adding paragraphs (a)(4) and (5) to read as follows:
9 32.51 Byproduct material contained in devices for use under 9 31.5; requirements for license to manufacture, or initially transfer.
(a)
(4) For devices in which there is a separable source housing that provides the primary l
shielding for the source, the source hcusing must also bear a durable label containing the I
device model number and serial number, the isotope anJ quantity, the words, " Caution-Radioactive Material," the radiation symbol described in @ 20.1901 of this chapter, and the i
name of the manufacturer or initial distributor.
(5) For devices that meet the criteria of G 31.5(c)(13)(i), a permanent (e.g., embossed, etched, stamped, or engraved) label rnust ce affixed to the source housing if separable, or the device if the source housiag is not separable, that. includes the words, " Caution-Radioactive i
Material," and, if practicable, the radiation symbol described in Q 20.19(c1 of this chapter.
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- 10. Section 32.51a is amended by revising paragraphs (a) and (b) and adding paragraphs (c) and (d) to read as follows:
$ 32.51a Same: conditions of licenses (a) Prior to transfer of a device to a generallicensee, furnish copies of the general license contained in G 31.5 of this chapter and of @Q 31.2,30.51,20.2201, and 20.2202 of this chapter, a list of the services that can only be performed by a specific licensee, and information on acceptable disposal options including estimated costs of disposal to each person to whom he directly or through an intermediate person transfers byproduct material in a device for use I
under the generallicense contained in s 31.5 of this chapter.
(b) Prior to transfer of a device to a generallicensee, furnish a copy of the Agreement State's regulations equivalent to 31.5,31.2,30.51,20.2201, and 20.2202 of this chapter, or alternatively, furnish a copy of G@ 31.5,31.2,30.51,20.2201, and 20.2202 of this chapter, to each person to whom he directly or through an intermediate person transfers byproduct materialin a device for use pursuant to the generallicense of an Agreement State. Also furnish the name, address, and phone number of the contact at the Agreernent State regulatory agency from which additionalinformation may be obtained. If a copy of the generallicense in G 31.5 of this chapter is furnished to such person, it shall be accompanied by a note explaining that use of the device is regulated by the Agreement State.
(c) Label each device transferred after (insert date one year after the effective date of this rule) in accordance with the labeling requirements in 32.51(a)(3) through (5).
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reporting period, the report must so indicate. The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report. The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.
(b) Report to the responsible Agreement State agency all transfers of devices to persons for use under a general license in an Agreement State's regulations that are equivalent to 31.5 of this chapter. Submit the report on Form XXX " Transfers of Industrial Devices Report," or on a clear and legible report containing all of the data required by the form. The required information includes: the identity of each generallicensee by name and address; the name and phone number of the person designated by the generallicensee to be responsible for ensuring compliance with the appropriate regulations and requirements; the date of transfer; the type, model number, and serial number of the device transferred;'and the quantity and type of byproduct material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report must include the same information for each intermediate person, and clearly designate that individual as an intermediate person. The report must be submitted within 30 days after the end of each calendar quarter in which such a device is transferred to the generally licensed person and clearly indicate the period covered by the report. If the device transferred replaced another returned by the general licensee, report also the type, model number, and serial number of the one returned. The report must clearly identify the specific licensee submitting the report and must include the license number of the specific licensee. If no transfers have been made to a particular Agu,ement State during the reporting period, this information shall be reported to the responsible Agreement State agency upon request of the
- agency, i
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(c) Keep records of all transfers of devices for each generallicensee including all the information in the reports required by this section and records of final disposition. Records required by this paragraph must be maintained for a period of three years following the estimated usefullife of the device or the date of final disposition,if known.
PART 170 - FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED
- 12. The authority citation for Part 170 continues to read as follows:
Authority: 31 U.S.C. 9'01; sec. 301, Pub. L. 92 - 314,86 Stat. 222 (42 U.S.C. 2201w);
sec. 201,88 Stat.1242, as amended (42 U.S.C. 5841); sec. 205, Pub. L.101 - 576,104 Stat.
2842, (31 U.S.C. 902).
- 13. Section 170.2 is amended by adding a paragraph (r) to read as follows:
$ 170.2 Scope.
(r) A holder of a generallicense granted by 10 CFR Part 31 who is required to register a device (s).
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C.
i (c) Keep records of all transfers of devices for each generallicensee including all the information in the reports required by this section and records of final disposition. Records required by this paragraph must be maintained for a period of three years following the estimated usefullife of the device or the date of final disposition,if known.
PART 170 - FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED 1
- 12. The authority citation for Part 170 continues to read as follows:
Authority: 31 U.S.C. 9701; sec. 301, Pub. L. 92 - 314,86 Stat. 222 (42 U.S.C. 2201w);
sec. 201,88 Stat.1242, as amended (42 U.S.C. 5841); sec. 205, Pub. L.101 - 576,104 Stat.
l 2842, (31 U.S.C. 902).
- 13. Section 170.2 is amended by adding a paragraph (r) to read as follows:
9170.2 Scope.
(r) A holder of a generallicense granted by 10 CFR Part 31 who is required to register a device (s).
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- 14. In Section 170.3, the definition of Materials License is revised to read as follows:
9170.3 Definitions.
Materials License means a license, certificate, approval, registration, or other form of permission issued or granted by the NRC pursuant to the regulations in 10 CFR parts 30,31 through 36,39,40,61,70,71 and 72.
- 15. Section 170.31 is amended by adding a fee category,3. O. to the schedule of materials fees and revising footnote 1 by adding a paragraph (f).
9 170.31 Schedule of fees for materials licenses and other regulatory services, including inspections, and import and export licenses.
Schedule of Materials Fees
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Category of materials licenses and types of fees Fee 22 4
3.
O. Registration of a device (s) generally licensed pursuant to Part 31.....................$370
' Types of fees (f) Generallylicensed device registrations under to CFR 31.5. Submittals of registration information must be accompanied by the prescribed fee.
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1 Part 171 - ANNUAL FEES FOR REACTOR OPERATING LICENSES, AND FUEL CYCLE LICENSES AND MATERIALS LICENSES, INCLUDING HOLDERS OF i
CERTIFICATES OF COMPLIANCE, REGISTRATIONS, AND QUALITY ASSURANCE PROGRAM APPROVALS AND GOVERNMENT AGENCIES LICENSED BY THE NRC l
- 16. The authority citation for Part 171 continues to read as follows:
Authority: Sec. 7601, Pub. L.99-272,100 Stat.146, as amended by sec. 5601, Pub. L.
100-203,101 Stat.1330, as amended by sec. 3201, Pub. L.101-239,103 Stat. 2106 as amended by sec. 6101, Pub. L.101-508,104 Stat.1388 (42 U.S.C. 2213); sec. 301, Pub. L.
i 92-314,86 Stat. 222 (42 U.S.C. 2201(w)); sec. 201,88 Stat.1242 as amended (42 U.S.C.
l 5841; sec. 2903, Pub. L.102-486,106 Stat. 3125 (42 U.S.C. 2214 note).
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- 17. In Section 171.5, the definition of Materials License is revised to read as follows:
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Materials License means a license, certificate, approval, registration, or other form of permission issued or granted by the NRC pursuant to the regulations in 10 CFR Parts 30,31 l
through 36, 39, 40, 61, 70, 71, and 72.
- 18. In Section 171.16, paragraph (d) is revised by adding a fee category,3. O. to the schedule of annual fees.
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l 171.16 Annual fees: Material Licensees, Holders of Certificates of Compliance, Holders of Sealed Source and Device Registrations, Holders of Quality Assurance Program Approvals and Government Agencies Licensed by the NRC Schedule of Materials Annual Fees and Fees for Government Agencies Licensed by NRC Category of materials licenses Annual fees'2-3.
O. Registration of devices generally licensed pursuant to Part 31.........................."N/A
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i "No annual fee is charged for this category since the cost of the generallicense registration program will be recovered through 10 CFR Part 170 fees.
Dated at Rockville, Maryland, this day of 1999.
For the Nuclear Regulatory Commission.
Annette Vietti-Cook, Secretary of the Commission.
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ATTACHMENT 3 Regulatory Analysis a
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REGULATORY ANALYSIS:
I REQUIREMENTS FOR THE POSSESSION OF INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL I'
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s 1 STATEMENT OF THE PROBLEM..
.. 1
1.1 BACKGROUND
.. 1 1.2 NRC Study of Conformity with General License Conditions..
1 1.2.1 Part l Results
.2 1.2.2 Part il Results.....
.2 1.3 Subsequent Actions....
.3 2 O BJ ECTIVE S...............................
.5 3 ALTERNATIVES..............
.5 3.1 No action..................
.5 3.2 Non-rulemaking alternatives......
.... 6 3.3 Rulemaking to rnodify distributors labeling, reporting, and record keeping requirements and add additional provisions to the 9 31.5 generallicense...
7 4 DESCRIPTION AND DISCUSSION OF PROVISIONS AND COST ESTIMATES....... 7 4.1 Revisions to the Requirements for General Licensees in G 31.5
... 7 A.
Registration: Certain measuring, gauging or controlling devices (Q 31.5(c)(13))....................................... 7 8.
Responsible Individuat Certain measuring, gauging or cor' trolling devices ( 31.5(c)(12))
.8 C.
Storage: Certain measuring, gauging or controlling devices (Q 31.5(c)(15))......
.9 D.
Transfers of Devices: Certain measuring, gauging or controlling devices (Revision to 31.5(c)(8))..
........ 9 E.
Notification Requirements: Certain measuring, gauging or controlling devices (Q 31.5(c)(14))
10 F.
Decommissioning Requirements: Certain measuring, gauging or controlling devices (Revision to 31.5(c)(5))..
11 G.
Reports of Transfer to another generallicensee at same premises (Revision to 31.5(c)(9)(i))......
. 12 H.
Limitation of Applicability of General License (Revision to 31.5(b)).12 1.
Bankruptcy: Terms and conditions of licenses (Revision to 9 30.34(h))
.12 J.
Schedule of fees for materials licenses and other regulatory services, including inspections, and import and export licenses (Revision to 6 170.31)........
... 12 K.
Impact to General Licensees in Agreement States due to Compatibility Requirements for @ 31.5.
. 13 4.2 Requirements for Manufacturers and initial Distributors of Devices 13 A.
Quarterly Reports: Material transfer reports and records (9 32.52(a) and (b)).........
14 B.
Retention: Material transfer reports and records ( 32.52(c)).
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C.
Records: Conditions of licenses (% 32.51a(d))............
.. 15 i
D.
Labeling: Byproduct material contained in devices for use under 31.5:
requirements for license to manufacture, or initially transfer (@ 32.51(a)(4) and (5) and % 32.51a(c))..................
..........,16 i
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E.
Information provided to general licensees: Conditions of licenses
( 32.51a(a) and (b))........
17 4.3 Clarifying and Conforming Amendments...
18 A.
Types of licenses ( 30.31)
...... 18 B.
Fees for facilities, materials, import and export licenses, and other regulatory services under the Atornic Energy Act of 1954, as amended
( Pa rt 170).....................
... 18 C.
Annual Fees for reactor operating licenses, and fuel cycle licenses and materials licenses, including holders of certificates of compliance, registrations, and quality assurance program approvals and government agencies licensed by NRC (Part 171)........................ 18
- 4.4 Summary of Estimated Annual Costs of Proposed Rule............... 18 4.5 Annual Costs to Agreement States of Compatible Regulations
.. 19 5 BENEFITS OF PROPOSED RULE.......................................... 21 5.1 Summary of Benefits of Proposed Alternative.................... 21 5.2 Summary of Radiation Exposure Averted Benefit..
......... 22 5.3 Summary of Economic Benefits......................
.23 6 DECISION RATION ALE.............................................
25 7 IMPLEMENTATION......................
.26 8 EFFECT ON SMALL ENTITIES 26 ii
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l 1 STATEMENT OF THE PROBLEM 1,1 BACKGROUND On February 12,1959 (24 FR 1089), the U.S. Atomic Energy Commission (AEC) amended its regulations to provide a general license to possess and use byproduct material in certain devices designed and manufactured for the purpose of detecting, measuring, gauging, or.
- controlling thickness, density, level, interface location, radiation, leakage, or qualitative or
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quantitative chemical composition or for producing light or an ionized atmosphere. The devices had to be manufactured in accordance with the specifications contained in a specific license issued either by the Commission under 10 CFR Parts 30 and 32, or by an Agreement State.
l Today, there are approximately 45,000 " general lic : :nees," i.e., persons possessing and using such devices under the generallicense (@ 31.5). These generallicensees possess an estimated 600,000 devices.
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' A general licensee under the jurisdiction of the Commission is required to follow safety instructions on device labels and to test or service a device (with some exceptions) or to have i
the testing or servicing performed by the supplier or other specific licensee authorized to manufacture, install, or service the devices. Additionally, general licensees may not abandon devices, and must maintain records concerning the testing and servicing of these devices.
l Further, 31.5(c)(8) requires generallicensees to transfer or dispose of the generally licensed devices only to the holder of a specific license under Parts 30 and 32 or to the holder of a specific license issued by an Agreement State, Section 31.5(c)(9) provides a limited exception c
l to this requirement that allows general licensees to transfer the devices to other general l
licensees, but only if the device remains in use at a particular location or the device is held in storage in the original shipping container before initial use, in either case, transfers of devices l
by generallicensees must be reported to the NRC within 30 days of the transfer. No report of a transfer is required if a generally licensed device is transferred to a specific licensee in order to l-obtain a replacement device. Generallicensees must also report damage to or loss of devices.
Specific licensees making the transfer of generally licensed devices are required as part of its specific license to maintain records of the transfer and to be accountable for all radioactive material in its possession. The NRC is notified by specific licensees when these licensees transfer devices containing byproduct material to general licensees through quarterly reports
- submitted under 9 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 generallicensee); the type of device transferred; and the quantity and type of byproduct material contained in the device. Under compatible Agreement l
State regulations, similar information is obtained from suppliers in Agreement States on l
transfers to NRC general licensees, t
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. 1.2 NRC Study of Conformity with General License Conditions The NRC traditionally has had little contact with generallicensees. The NRC staff believes that this may account for why many general licensees are not aware or their responsibilities under a general license and that this results in incidents of mishandling and improper disposition of generally licensed devices. Mishandling and improper disposition of generally licensed devices, I
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in turn, has resulted in radiation exposure to the public and, in some cases, has entailed expensive investigation, cleanup, and disposal activities. In most instances, exposures to the public have not been significant. However, these exposures would probably not have occurred if the devices had been properly handled and disposed of.
The Commission conducted a study from 1984 through 1986 (General License Study) to ascertain the extent of compliance with generallicense conditions after it became aware of a l
few incidents where control over generally licensed devices was lost. The results of the study I
were discussed in SECY-87-167, dated July 9,1987, and in SECY-89-289, dated l
September 14,1989. Although current regulations ( 30.52) allow for the inspection of licensees possessing byproduct material, the Commission does not inspect general licensees on a regular basis primarily because of the large number of these licensees and the low risk presented by most of these devices. The Comminion's knowledge of whether general licensees are complying with the regulations for the proper use and disposal of generally licensed devices is limited.
Because of the broad range of devices covered under. 31.5, the study was divided into two parts. The first part covered industrial gauging and measuring devices, such as large-scale level, density, and thickness monitors. There were then approximately 10,000 Commission licensed devices in this category containing sources with activities in the 0.5 to 1 curie range.
The second part of the study covered devices which greatly varied in design and use, such as
.self luminous signs, analytical instruments such as x-ray fluorescence spectrometers or liquid scintillation spectrometers, and smaller-scale thickness, density, and level gauges. A summary of the results of the study presented below is based on an unpublished NRC report entitled
" General License Study Report."
1.2,1 Part i Results The Part I study inn ded 228 site surveys of general licensees by the study task force and 132 inspections conducted by NRC regional offices. Some Agreement States also contributed data to the " General License Study." The information gathered by the study, although from a small sample of generallicensees possessing large-scale gauges, clearly established that there is a compliance problem. Among the findings of Part I were the following:
Approximately 16 percent of these generallicensees could not account for all of their gauges.
A majority of these generallicensees either did not notify the NRC of transfers of their gauges or improperly transferred their gauges.
At least 25 percent of these 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 in landfills and, in one case, even in an abandoned paper mill.
1.2.2 Part 11 Results Although Part 11 of the study covered devices that vary greatly in design and use, the range of problems encountered in Part il is exemplified by the problem relating to self-luminous exit signs and beta backscatter gauges. Exit signs, which are one of the most common devices 2
i 1
i ;,
4 t
l covered 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 1
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 concern about these devices is the accountability of the removable source which is about one inch in diameter. Ninety-eight interviews were conducted of persons who possess these types of devices. The findings of Part ll are summarized below:
Nonconformity with general license conditions was very widespread.
Only 16 percent of the generallicensees for exit signs were aware of the I
regulatory requirements.
Manufacturers and distributors frequently under reported the number of exit signs sold to generallicensees. Generallicensees (electrical distributors and contractors) reported having about L0 percent more signs than were listed in quarterly reports of the manufacturers.
Three cases involved missing sources from beta backscatter gauges.
Only 45 percent of those surveyed for backscatter cauges were aware of the general license conditions.
Vendor reports did not accurately reflect the number of radioactive sources in the possession of generallicensees. When sources were returned by general licensees to the manufacturer for disposal, the NRC was not always notified.
Hence, NRC records were not always accurate.
1.3 Subsequent Actions On December 27,1991 (56 FR 67011), the NRC published a notice of proposed rulemaking 3
regarding the accountability of generallicensees under 31.5. It proposed a number of provisions, including a requirement for these licensees to provide information at the request of the NRC in order to provide the regulatory basis for the registration of these devices. The proposed rule also would have added requirements in @ 32.51a and 32.52 for specific licensees who manufacture or initially transfer these devices to the general licensees. Although the public comments received were reviewed and a final rule developed, that rule was not issued because resources to implement the proposed rule properly were not available.
The NRC has continued to consider the issues related to the loss of control of generally licensed, as well as specifically licensed, sources of radioactivity. In July 1995, the NRC, with assistance from the Organization of Agreement States, formed a working group to evaluate these issues. The working group consisted of both NRC and Agreement State personnel and encouraged the involvement of all persons having a stake in the process and its final recommendations. All working group meetings were open to the public. A final report was completed in July of 1996 and published in October of 1996 as NUREG-1551," Final Report of the NRC-Agreement State Working Group to Evaluate Control and Accountability of Licensed Devices."
l 3
U.U_.
y+
a One of the conclusions of the working group is that generallicensees possessing certain identified devices should report annually to their regulatory authority 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. This was the basis for the recent rule proposed on (Insert date)( FR )(Rule 1) which would revise Part 31 to add an explicit requirement that generallicensees under Q 31.5 respond to requests from NRC for information.
The intent is to use that provision to institute a registration program for devices recommended by the Working Group for enhanced regulatory oversight.
The additional recommendations of the working group provide the major basis for this rulemaking, which, among other things, would provide more explicit provisions with regard to a registration program. For generallicensees us ng devices containing at least 10 mci of cesium-137,0.1 mci of strontium-90,1 mci of cobalt-60, or 1 mci of any transuranic, the working group recommended the following:
Licensees must assign a Responsible individual (RI) and a Backup Responsible Individual (BRl). The RI and BRI must each be an individual that has the authority and responsibility for compliance.
Licensees must perform, at intervals not to exceed six months and maintain records of; (1) physicalinventories of devices including reconciliation of any discrepancies with previous inventories, and (2) inspections of each device for proper labeling including correction of any deficiencies.
Licensees must keep current inventory records.
Licensees must report changes concerning the RI and BRI and transfers or disposal of devices.
Licensees must report immediately following the filing of a voluntary or involuntary petition for bankruptcy.
For vendors of the same devices, the working group recommended the following:
Vendors must report transfers quarterly and the report must include the name, telephone number, and mailing address of the recipient, the address of use of the device, the model number and serial number of the device, the isotope and activity, any intermediate holders of the device, including the function of the intermediate holders, the specific reporting period covered by the report, and the name and license number of the repoding company.
Vendors must maintain records of transfer for all devices they have distributed, including final disposition, if known. The records must be maintained for three years after final disposition of the device.
Vendors must provide recipients with disposal information prior to transfer of the device.
Vendors must ensure each device, or separable source housing, is labeled with the model number and serial number, the isotope and activity, the trefoil symbol, the words " Caution - Radioactive Material," and the name of the device vendor.
Vendors must ensure that source housings are permanently marked (e.g.,
engraved or embossed) with the trefoil symbol and the words " Caution -
Radioactive Material," as practicable.
For both NRC and Agreement States, the working group recommended the following:
4
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NRC and Agreement States must verify that all transfers by their users are in accordance with their regulations and license conditions.
NRC and Agreement States must compare the annualinventories reported by their users against previous inventories and against transfer reports from vendors and other users. This provides an independent verification that licensees have maintained accountability and control of the devices.
NRC and Agreement States must resolve any discrepancies in the information with the assistance of the licensees.
NRC and Agreement States must acknowledge to their licensees that the transfers and inventories have been reviewed.
2 OBJECTIVES The objectives of the amendments to Parts 31 and 32 of the Commission's regulations are to ensure that certain generallicensees are aware of and understand the requirements attendant to the possession of generally licensed devices containing byproduct material and to better j
enable the NRC to verify the location, use, and disposition of such devices. The intent is to i
reduce the possibility of the devices being improperly transferred or inadvertently discarded and, ultimately, to avoid unnecessary radiation exposure to the public and unnecessary expense involved in retrieving the items, particularly in the scrap metal stream, as well as to avoid the contamination of steel mills, metals, and waste products.
In addition, the objective of the revision of Part 170 to add a registration fee for certain generally licensed devices is equity of fee recovery for the costs of the generallicense program.
3 ALTERNATIVES 3.1 No action.
This alternative is to continue the status quo. As costs and benefits are evaluated in terms of changes from the status quo, there are no costs or benefits associated with this alternative. In this case, it is assumed for the purpose of analysis, that Rule 1 is made effective and costs and benefits are evaluated as changes from a base case of having that rule in place and implementing a registration program under that provision.
1 No action, of course, does not address identified concerns. In the past, the only communication between a generallicensee and the NRC was through the requirement that the NRC be r,otified when a device containing byproduct material was transferred. Information notices have been
' sent and inspections have been made but only rarely.
As discussed in Section 1.2 of this analysis, 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 public and,in some cases, entailed expensive investigation, cleanup, and disposal activities. Rule 1 would begin to address this problem, but in a limited way. It does not require compatibility of Agreement State regulations, so only approximately one third of generally licensed devices meeting the criteria for enhanced oversight will be covered. It was estimated in the regulatory 5-
[.
l analysis for that action that it would affect about 20% of the devices presenting a significant risk in the case of loss (the other 80% being generally licensed under Agreement State regulations or held by specific licensees). It was also assumed that it would conceivably cut the rate of loss within this population by roughly one half, thus reducing the impacts from lost sources by 10%
- Also, Rule 1 will not completely address the factors discussed in the next section concerning knowledge of the regulations reaching the appropriate persons.
No action would not be appropriate because the factors listed in the preceding paragraph should be addressed.
3.2 Non-rulemaking alternatives With respect to the problem of lack of awareness or regulatory requirements on the part of generallicensees, there are a number of approaches that could be considered. Guidance could be provided in a number of forms; however, periodic contact with the general licensees would be expected to have the most significant impact on the level of awareness of requirements. The most appropriate means to remind users of their responsibilities would be periodic issuance of information notices; however, these information notices may not reach all users. While 32.52 requires that specifb licensee distributors report to the NRC or the Agreement State agency the name and'or title of the individual who constitutes the point of contact between the generallicensee and the NRC, or the Agreement State agency, the General License Study indicated that this individual, who is frequently in the purchasing department, often did not inform the individual who uses the device of the general license conditions. Moreover, the study indicated that personnel turnover frequently destroyed 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 responsible tor, or knowledgeable of, the devices after they have been received and are being used. In this case, the initial contact name received from a distributor would continue to not be the person responsible for the compliance with regulations and would present problems with the implementation of a registration program in Rule 1. The process will be more efficient it more appropriate contact information is received initially from the distributor.
Even when generallicensees are aware of their basic responsibilities concerning the devices, there may be other factors contributing to noncompliance with requirements. For example, the cost of disposal may cause some generallicensees to dispose of devices improperly. It is important that the general licensees understand that the Commission will hold them responsible for these devices. Increased inspection of generallicensees and enforcement of the requirements may improve compliance. However, without a registration system to verify compliance as well as additional requirements for general licensees such as, appointing a responsible individual, performing inventories, reporting of bankruptcy, time limit on storage of devices, and without additional requirements for vendors such as reporting Ris and serial nsmbers of devices transferred, providing recipients of disposal costs and maintaining transfer records including final disposition of devices as well as additional labeling requirements, there would not be sufficient regulatory requirements for general licensees to be responsible and accountable for their devices. Also, there would not be a large enough number of inspections and these inspections would be on a random basis and would not be very efficient.
6
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None of these actions would result in a high degree of accountability for these devi_ces.
Additional regulatory requirements would be more effective in terms of accountability, and
. would provide a basis for more efficient use of inspection and enforcement efforts.
3.3. Rulemaking to modify distributors labeling, reporting, and record keeping requirements and add additional provisions to the 9 31.5 general license This alternative would amend 10 CFR Parts 31 and 32 to help ensure that devices containing byproduct material are maintained and transferred properly and are not inadvertently discarded.
. The general mechanism to be used would be to add explicit provisions delineating the registration requirement so that general licensees verify compliance with certain conditions imposed by the generallicense, in addition, the amendments to 10 CFR Parts 31 and 32 would require a generallicensee to appoint a responsible individual, perform inventories, report bankruptcy, limit the time on storage of devices, and would require vendors to report responsible individuals and serial numbers of devices transferred, provide recipients of disposal costs, and maintain transfer records including final disposition of devices as well as additionallabeling requirements.
,Th'e NRC envisions that these are elements of a well defined registration program. They offer greater assurance that a general licensee is informed of its regulatory responsibilities and will assign a knowledgeable individual who will provide information to assist with verifying accountability for devices. The NRC would make periodic requests for verification to remind generallicensees of their regulatory responsibilities and to reduce the likelihood that devices
.containing byproduct material are illegally transferred or inadvertently discarded. In addition, for specific licensees who distribute these generally licensed devices, there would be changes in the reporting, record keeping, and labeling requirements.
4 DESCRIPTION AND DISCUSSION OF PROVISIONS AND COST ESTIMATES 4.1 Revisions to the Requirements for General Licensees in 9 31.5 A.
Registration: Certain measuring, gauging or controlling devices (9 31.5(c)(13))
Section 31.5 currently grants a general license to certain individuals and contains the requirements under that license. The principal change to the general license in 6 31.5 that
' would be made under this proposed rule would be to add explicit provisions delineating a registration requirement. This addition would provide generallicensees with the details of the registration requirement including which devices are subject to registration and the kinds of information that will be required to be submitted by this process. Specific provisions proposed here are essentially consistent with the Commission's plans for the registration process discussed in Rule 1. Annual registration is required for devices containing at least 370 MBq (10 mci) of cesium-137,3.7 MBq (0.1 mci) of strontium-90,37 MBq (1 mci) of cobalt-60, or 37.MBq (1 mci) of any transuranic. This provision would specifically require that the information about devices be verified through a physical inventory. The registration information that would be required is as follows:
Name and mailing address of the generallicensee.
7
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i information about each device: the manufacturer, model number, serial number, a
radioisotope, and activity.
Name and telephone number of the responsible person designated as a representative of the generallicensee under 31.5(c)(12).
Address at which the device (s) are used and/or stored. For portable devices, the
=
address of the primary place of storage.
Certification by the responsible representative of the generallicensee that the information concerning the device (s) has been verified through a physical inventory and checking of label information.
Certification by the responsible representative of the generallicensee that they are aware of the requirements of the generallicense.
Cost fmoacts:
None anticipated.
The cost to industry and to the NRC of the registration process were addressed in Rule 1 and are not a result of this action. Rule 1 would require generallicensees to respond to requests from the NRC to verify information related to their generallicensed devices. Specifically, it accounted for the costs associated with locating and verifying license conditions for all devices in the possession of generallicensees. This rule describes the information that will be required by registrants and would not require more than verification of the current location of all devices and verification of the information as is planned to be requested under the Rule 1.
The advantage of including more explicit requirements in the regulation is that information about the registration process will be more clearly defined and more available. When the distributor of a device supplies copies of 31.5 to its customers (under @ 32.51a(a)), the potential generallicensees will be made aware of the registration requirement, including to which devices it applies, what information will be requested, and also the fact that there will be a fie.
Having more explicit requirements would, if anything, simplify inspection and enforcement.
B.
Responsible Individual: Certain measuring, gauging or controlling devices
($ 31.5(c)(12))
The proposed rule would add an explicit requirement, 31.5(c)(12), for the generallicensee to appoint an individual to carry out the general licensee's responsibilities to comply with the applicable regulations.
Cost Imoacts:
None anticipated.
While apponting a person to be responsible for performing required actions should already be occurring in practice, this action would make that responsibility explicit. In other words, there must already be a person who performs shutter tests, leak tests, and compliance with regulations. This proposed rule would require generallicensees to designate the person who 8
ensures the performance of shutter tests, leak tests, and compliance with regulations as the
" responsible individual" L
No significant effect on inspection and enforcement is anticipated.
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C, Storage: Certain measuring, gauging or controlling devices (9 31.5(c)(15))
.The proposed rule would add a provision that limits the amount of time a generallicensee can keep a device unused and would eliminate leak testing and shutter testing while a device is in storage.
Cost impacts:
There are potential cost impacts to generallicensees in limiting the length of time they can store devices, but these are highly uncertain and difficult to quantify. The vast majority of generallicensees have devices in storage because they are no longer in use due to replacement of such devices. Almost all devices that would be in storage for as long as two 4
years are destined for disposal, however many in storage less that two years are put back into service. Licensees are storing devices to avoid disposal costs, however, disposal costs are inevitable. The actual difference in cost for any particular generallicensee will depend on actual discount rates and the charge in disposal costs between the time this provision lead to disposal and when it might have been disposed of absent this provision, whether there is significant decay of the radioactivity in that time, what arrangement the general licensee has with the distributor for returning the device, and the annual costs of keeping the device. For registered devices, the annual costs of keeping the device could include the registration fees which are to be imposed by this rule.
.There would be a cost savings for general licensees with the provision of Q 31.5(c)(15) allowing testing to be deferred during storage. These cost savings would result from no longer requiring the performance of leak tests and shutter tests during storage and are estimated in section 5 on benefits.
No significant effect on inspection and enforcement is anticipated.
D.
Transfers of Devices: Certain measuring, gauging or controlling devices (Revision to $ 31.5(c)(8))
The proposed rule would add a provision to allow transfers to specific licensees other than Part 32 licensees. This would add waste collectors specifically licensed under Part 30. It would also allow transfers to other specific licensees but only with prior written NRC approval. Also, it
'would add the recipient's license number, the serial number of the device, and the date of transfer to the information required to be provided to NRC upon a transfer of a device.
This would provide some ' flexibility to licensees. The addition of the license number to the reporting requirement increases assurance that the generallicensee will transfer devices only to appropriate recipients. The addition of the serial number of the device will allow tracking of the individual device. The date of transfer will make the transfer easier to track and help to
. ensure that the general licensee makes the report in a timely way (required in 30 days).
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Cost Imoacts-1 No anticipated costs to licensees since this proposed rule provides for an alternative method of transfer which avoids licensees having to request exemptions to regulations. Currently licensees must transfer devices only to Part 32 licensees so they must verify that the recipient is a Part 32 licensee. The additionalinformation in the report will have no significant impact.
Assumptions:
Cost to NRC:
Number of requests for approval per year: 100 Staff hours per submittal:
0.5 hr Professional staff hourly rate:
S70/hr Total cost per year:
S3,500 No significant effect on inspection and enforcement is anticipated.
E.
Notification Requirements: Certain measuring, gauging or controlling dev.23s
($ 31.5(c)(14))
The proposed rule would contain a provision that generallicensees notify NRC in the event of a change of address. This requirement is a necessary element of the registration program.
Without a current mailing address, the NRC would not be able to mail out the registrations.
This applies to all 31.5 general licensees, because it is important for NRC to keep track of all generallicensees so that they can be contacted whenever the need arises and inspected.
Cost impacts:
Assumptions:
General Licensees:
Number changing address per year:
100 Time spent:
0.10 Technical staff hourly rate
$50/hr Total licensee cost per year:
S500 NRC (recordina information):
I Number changing address per year:
100 Staff hrs per subinittal:
0.10 hrs Staff hourly rate:
S70/hr i
Total NRC cost per year:
S700 l
Total cost per year:
$1,200 l
No significant effect on inspection and enforcement is anticipated.
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h l
F.
Decommissioning Requirements: Certain measuring, gauging or controlling l
devhes (Revision to 6 31,5(c)(5))
The proposed rule would add, to the information that must be sent to NRC in the case of
' detection of 0.005 microcurie or more removable radioactive material or failure of or damage to a source likely to result in contamination of the premises or the environs, a plan for ensuring that premises are suitable for unrestricted access. It would also change addressee / address from appropriate Regional Administrator to Director, NMSS.
If contamination occurs at a facility, unrestricted areas must be cleaned up to a point where public health and safety is ensured. Generallicensees may not have adequate knowledge to evaluate the extent of decontamination activities needed due to a leaking or damaged source.
The NRC needs to evaluate, on a case by case basis, a decontamination plan to ensure facilities are suitable for unrestricted use. General licensee's submittals of information pertaining to cleanup of facilities will allow the NRC to carry out its mission. The intent is to provide additional assurance of the adequacy of decontamination of facilities for general licenseec.
The change to addressee will make all reports required under 31.5 to be sent to the same address and eliminate the need to reference Part 20 in this regard.
Cost Imoacts:
Assumptions:
General Licensees:
Number reporting (one third of total number reporting under 31.5(c)(5) per year):
7 Time spent:
8 hrs Technical staff hourly rate
$50/hr Total licensee cost per year.
S2,800 NRC:
Number reporting:
7 Staff hrs per submittal:
2 hrs Staff hourly rate:
S70/hr
-Total NRC cost per year:
S980 Total cost per year:
S3,780 j
This is only the cost of reviewing this additional submittal of information from the general license; additional effort may be involved in resolving the contamination problem; however, this is not an impact of this revision. In fact, having the general licensee include this additional information may reduce the overall cost of intervention for incidents of this type. The change in addressee / address will simplify reporting requirements for the general licensees.
No significant effect on inspection and enforcement is anticipated.
Il j
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G.
Reports of Transfer to another general licensee at same premises (Revision to j
$ 31.5(c)(9)(i))
i This revision would replace the name or position of a contact with the name and phone number of the transferee's responsible person, in reports of transfer to another generallicensee at the same location; it would also add the serial number of the device.
This would provide a more appropriate contact to the NRC in this instance; the serial number would make tracking of individual devices easier.
Cost Imoacts:
No anticipated costs to generallicensees. This is a minor revision to a reporting requirement which is applicable under very limited circumstances.
No significant effect on inspection and enforcement is anticipated.
H.
Limitation of Applicability of General License (Revision to 9 31.5(b))
The applicability of the general license to those who come into possession by an unauthorized means would be clarified such that they would not be considered general licensees.
Cost Impacts:
)
This would have no impact on authorized users, but would clarify enforcement issues with respect to unauthorized users and those who inadvertently come into possession of a generally licensed device. This should somewhat simplify enforcement actions involving unauthorized recipients on the part of NRC.
~
1.
Bankruptcy: Terms and conditions of licenses (Revision to 9 30.34(h))
The applicability of 30.34(h) on bankruptcy notification to generallicensees needs to be clarified. This proposed rule would clarify that this requirement is applicable only to those general licensees subject to the registration requirement.
Cost Imoacts:
None anticipated. These generallicensees are currently subject to 30.34(h); however, this is not clear because of the lack of a reference in @ 31.2.
No significant effect on inspection and enforcement is anticipated.
J.
Schedule of fees for materials licenses and other regulatory services, including inspections, and import and export licenses (Revision to 9170.31)
The proposed rule would add a fee required in conjunction with the registration process. Fees are proposed to be required in order to recover the cost of the general license program associated with this category of general license in an equitable way; that is, from those who are l
12 1
allowed to use devices under the generallicense rat'her that from others who hold specific licenses. NRC is required by law to recover all costs from licensees' fees.
Cost imoacts:
Assumptions:
General Licensees:
Number,4 registrants:
6000 Annur' '
S370 Totallicensee cost per year:
S2,220,000 The cost being recovered from the general licensees is not limited to those for implementing these revisions to the general license program; instead, the cost to general licensees consists of the cost of that fraction of the overall generallicense program associated with the devices subject to the registration requirement. Since the requirement for full cost recovery was enacted, all costs of the general license program have been recovered from specific licensees.
These cost estimates include an estimate of increased inspection and follow up efforts expected to be made as a result of the registration proces<; identifying noncompliance with existing regulations. That cost will now be passed on to the general licensees associated with the registration requirement. It is also expected that this cost will decline after the initial implementation of the registration process, in which case this fee might be reduced in the future.
NRC (for collection of fees and associated followuo):
Total NRC cost per year:
S100,000 Total cost per year:
$2,320,000 K.
Impact to General Licensees in Agreement States due to Compatibility Requirements for 6 31.5 -
This rule would make all of 31.5 a Category C level of compatibility Many of the Agreement States already have similar or identical provisions in their regulations to the existing 31.5.
Regulations that differ are generally more stringent, e.g., a few jurisdictions require a specific license for these types of devices. The most significant impact to Agreement State general licensees would be the change of the registration requirement, proposed in. Rule 1, from
]
Caiogory D to Category C. The impact to Agreement State generallicensees will depend on l
the approach used to achieve a Category C compatibility. Some States have already instituted a registration requirement or some other type of enhanced oversight program. The largest cost j
to NRC generallicensees under this rule would be the payment of fees; this provision would be Category D, no compatibility required.
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4.2 Requirements for Manufacturers and initial Distributors of Devices The proposed regulation would modify the quarterly transfer reporting, recordkeeping, and labeling requirements for specific heensees who distribute these generally licensed devices.
These cost estimates include costs to distributors in Agreement States under compatible Agreement State regulations. These provisions would be a compaability Category B.
A.
Quarterly Reports: Material transfer reports and records (f 32.52(a) and (b))
1 The proposed rule would add the following information to the existing quarterly transfer reporting requirement: the serial number and model number of the device; the date of transfer; indication if device is a replacement, and if so, the type, model number (Agreement States already require the model number), and serial qumber of the one returned; name and license number of reporting company, and the specific reporting period; the name and phone number of the person designated by the generallicensee to be responsible for the device and for
)
ensuring compliance with the appropriate regulations (which will replace that of a simple contact between the Commission and the generallicensee). Also, a form will be provided for use in making these reports; however, the use of the form would not be required as long as the report is clear and legible and includes all of the required information. Revisions would be made to j
32.52(a) and (b).
l This provision would provide a mechanism for tracking of individual devices. It would also
- clarify that the contact name to be obtained from the general licensee (and reported to NRC and the Agreement State regulatory bodies)is that of the individual who will be responsible for compliance with the regulations regarding generally licensed devices. The provision should improve NRC's ability to contact the appropriate person and to provide information to those actually knowledgeable of the device and the requirements for possession, improving general licensees knowledge of the regulations and thus their compliance with the regulations.
Cost Imoacts:
Most of the additionalinformation that would be provided under this proposed rule is information that vendors currently track and maintain records on. However, additional tinae may need to be spent to ke sp track of replacement devices.
l Assumpt'ons:
Distributer (NRC and Aareement State) reports to NRC:
Number of submittals per year:
356
((28 NRC+61 AS) licensees x 4 reports /yr)
Additional time spent:
0.2 nr Technical staff hourly rate
$50/hr Total licensee cost per year:
$3,560
.NRC (recordina information):
Number of submittals per year:
356 Staff hrs per submittal:
0.1 hrs Staff hourly rate:
S70/hr Total NRC cost per year:
$2,492 14 j
j
r" l
Distributor (NRC and Aoreement State) reports to Aareement States:
Number of submittals:
1780 (assuming an average of 5 States per distributor)
Staff hrs per submittal:
0.1 hrs Staff hourly rate:
550/hr Total cost per year for reports to States:
S8.900 Total cost per year:
S14,952 No significant effect on inspection and enforcement is anticipated.
B.
Retention: Material transfer reports and records (9 32.52(c))
The proposed rule alters the records retention so that records of transfers would have the period of retention extended from 5 years after a recorded event to 3 years after the expected usefullife of the device or the final disposition,if known. The proposed rule also adds a requirement for records on final disposition of devices.
This improves the ability to track individual devices. Further, these revisions will better enable the NRC to verify the location, and disposition of these devices, and thereby confirm the efficacy of the generallicense regulatory program.
Cost imoacts:
l This section of the proposed rule would create small incremental costs (i.e. <S1.000) for licensees as a result of the increase in the length of the records retention period and recording of the final disposition of devices. Most manufacturers record this information on a database and currently retain this information indefinitely, in addition, the time spent for data entry into a database for recording final disposition of devices is small making the corresponding costs small.
i No significant effect on inspection and enforcement is anticipated.
C.
Records: Conditions of licenses ($ 32.51a(d))
The proposed rule would add a requirement for the distributors to provide upon request to the NRC and Agreement States, records of final disposition of devices in the case of bankruptcy or termination of license. This information must be available upon request.
This will assist the NRC and the Agreement State agencies in tracking individual devices.
Further, these revisions will better enable the NRC to verify the location, and disposition of these devices, and thereby confirm the efficacy of the general license regulatory program.
, Cost Imoacts:
This section of the proposed rule wou'd create small incremental costs (i.e. <S1,000) for l
licensees as a result of making available to various regulatory agencies records of final disposition of devices in the case of bankruptcy or termination of license. Most manufacturers 15 d
7, 1
i i
record this information on a database; therefore, the time spent to transfer this information to regulatory agencies is small. Also, the number of manufacturer.s going bankrupt or requesting license termination is small, making the corresponding costs small. In addition, this information only needs to be provided upon request making the number of times the information needs to be provided even smaller.
No significant effect on inspection and enforcement is anticipated.
D.
Labeling: Byproduct material contained in devices for use under 9 31.5; requirements for license to manufacture, or initially transfer (9 32.51(a)(4) and (5) and 9 32.51a(c))
The proposed rule would revise @ 32.51(a)(4) and (5) and 32.51a(c) to add requirements for a.
label on any separable source housing, and a permanent label on devices meeting the criteria for registration.
The first of these changes is simply an extension of the existing requirement and carries out the initialintent of the current regulations in the case of devices where the source may be separable in a housing that does not include the label, it is important that this housing, if separated from the remainder of the device, can also be identified. Labels are approved by the NRC as part of the licensing process. Labels are generally put on separable housings under present practice; however, this should be clearly required. Aiso, many existing labels would already meet the " permanent" requirement.
This part of the proposed rule would increase the likelihood that devices, including any separable source housings, include labels that stay intact even in non-routine circumstances (such as theft, loss, damage), and as a result, would increase the likelihood that the device could be identified as containing radioactive material, thereby reducirg the likelihood of incidents resulting in unnecessary exposures to the public and contamination of property.
Cost Imoacts:
Assumptions:
Distributors:
Total NRC licensee cost per year:
Number of devices with separable source housings manufactured per year (5% of 9351 devices):
468 Price of additionallabel:
S4 Number of devices requiring registration 305 manufactured per year:
Price of permanent label:
S13 Total NRC licensee cost per year:
$5,837 16
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i-Estimated Agreement State licensee cost per year:
Number of devices with separable source housings manufactured per year 1300 Price of additionallabel:
$4 Number of devic e. requiring registration l
manufactured..s year:
800 l
Price of permanert label:
$13 l
Estimated Agreement State licensee cost per year:
$15,600 Total cost per year:
$21.437 This provision would not be expected to result in a significant impact to the NRC licensing staff for additional reviews of labels.
No significant effect on inspection and enforcement is anticipated.
E.
Information provided to general licensees: Conditions of licenses (9 32.51a(a) and (b))
The proposed rule would revise 32.51a(a) and (b) requirements pertaining to information distributors would be required to provide to the generallicensee. They are now required to provide general licensees with a copy of 31.5 at the time of transfer of the device. The proposed rule would require that 31.5 be provided prior to transfer. The distributor would also be required to provide copies of additional applicable sections of the regulations, a listing of services that can only be performed by a specific licensee, and informetion regarding disposal options for the devices being transferred. The disposal options would include the cost of disposing of the device at the end of its usefullife to the extent that the cost information is l
available to the specific licensee distributor at the time of the sale of the device. This is to i
provide general licensees with information needed concerning the applicable requirements as well as some idea of the additional costs for disposal of the device before making a decision to buy a device.
t Cost imoacts:
l Assumptions:
l Distributers (NRC and Aareement State):
Number of NRC generallicensees who are shipped l
generally licensed devices per year:
4,277 l
Time spent to provide additional information:
0.03 hr l
Technical staff hourly rate
$50/hr Total licensee cost per year for distribution to NRC generallicensees:
S6,415 17 Ilu i
l Estimated number of Agreement State generallicensees shipped generally licensed devices per year:
12,000 Time spent to provide additional information:
0.03 hr Technical staff hourly rate S50/hr Total licensee cost per year for distribution to Agreement State geners' licensees:
S18,000 Totallicensee cost:
$24,415 No significant effect on inspedion and enforcement is anticipated.
4.3 Clarifying and Conforming Amendments A.
Types of licenses (@ 30.31)
The proposed rule would add a clarifying amendment in 30.31.
Cost imoacts:
None B.
Fees for facilities, materials, import and export licenses, and other regulatory services under the Atomic Energy Act of 1954, as amended (Part 170)
The proposed rule would make minor conforming amendments to @@ 170.2 and 170.3.
C.
Annual Fees for reector operating licenses, and fuel cycle licenses and materials licenses, including holders of certificates of compliance, registrations, and quality assurance program approvals and government agencies licensed by NRC (Part 171)
The proposed rule would also make minor conforming amendments to @ 171.5 and 171.16.
4.4 Summary of Estimated Annual Costs of Proposed Rule Table 4-1 presents a summary of the estimated costs of the revisions to Parts 30,31,32,170 and 171. For each regulatory change described above, Table 4-1 lists the total costs estimated for that section.
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5 Table 4-1 Summary of the Proposed Rule's Annual Cost Effects Subpart Section Licensee Costs NRC Costs Total Costs 4.1 A 31.5 (c)(13) 0 0
0 4.1 B 31.5 (c)(12) 0 0
0 4.1 C 31.5 (c)(15)
- variable, O
- variable, unquantified unquantified 4.1 D 31.5 (c)(8) 0 3,500 3,500 4.1 E 31.5 (c)(14) 500 700 1,200 4.1 F 31.5 (c)(5) 2,800 980 3,780 4.1 G 31.5(c)(9)(i) 0 0
0 4.1 H 31.5(b) 0 0
0 4.11 30.34(h) 0 0
0 4.1 J 170.31 2,220,000 100,000 2.320,000 4.2_A 31.5? (a) and (b) 12,460 2,492 14,952 4.2 B
_ 32.52 (c) 0 0
0 4.2 C 32.51a (d) 0 0
0 4.2 D 31.51 (a)(4) and (5) 21,437 0
21,437 and 32.51a (c) 4.2 E 32.51a (a) and (b) 24,415 0
24,415 4.3 A 30.31 0
0 0
4.3 B 170-0 0
0 4.3 C 171 0
0 0
4.5 Annual Costs to Agreement States of Compatible Regulations Assuming that the Agreement States have jurisdiction over roughly twice as many devices as the NRC in total, and assuming the same average cost / licensee, approximate costs to Agreement States for carrying out a comparable oversight program would be estimated as
$83,000/ year after the first year or two. The first year costs would be higher, roughly $190,000.
However, the smaller number of generallicensees and specifically licensed distributors in individual States relative to the total number of NRC licensees may result in higher average costs / licensee. This cost is the administrative cost of exercising a similar level of control as the registration requirement initiated in Rule 1, which would now be a Compatibility Category C and for the additional requirements that would be placed on distributors, which would be 19 o
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Compatibility Category B. This does not include the cost of collection of fees, as this is Compatibility Category D. Also, the registration process or other oversight program willlikely uncover noncompliance with existing rules leading to a significant cost of followup, especially in the early years of implementation; this is also not included in this estimate as it is not a direct cost of compatibility with this rule, rather an enforcement of existing rules. The actual cost of achieving Compatibility level C for general licensees will depend on the approach taken by the various States and how much change this requires from existing requirements. In some cases, Agreement States have already instituted a registration systern or other enhanced oversight l
program..!n these cases, little or no additional action may be needed.
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4.6 Development rand implementation Costs NRC development costs are the costs of preparation of a regulation prior to its promulgation and implementation. Such costs may include expenditures for research in support of this regulatory action, publishing notices of rulemaking, holding public meetings, responding to public comments, and issuing a final rule. NRC implementation cost are those " front-end" costs necessary to effectuate the action; they may arise from the necessity of developing procedures and guidance to assist licensees in complying with the final action. The Working Group's recommendations, published as NUREG 1551 in October of 1996, which is the research in support of this regulatory action, has already been performed and is therefore outside the scope of this analysis. Developmental costs and implementation costs within the scope of this analysis are the costs of proceeding with a rulemaking. These are mainly costs of the effort of NRC professional staff members in the Office of Nuclear Materials Safety and Safeguards expended in developing the rule.
The action's preparation cost to the NRC is estimated to require a total of 4 professional staff-year. The estimated cost of one NRC professional staff member is $126,000/ staff-yr. The component of NRC's development cost due to staff effort, then, would be S504,000.
Registration will require a more efficient computer data base. A computerized directory has been previously used by the Commission. However, it is outdated and will require improvement or replacement; this would be the case if it is to be adequate for carrying out the Commissbn's mission in the area of generallicenses. This computer system upgrade cost was addressed in the previous proposed rule, which is to be used as a basis for initiating a registration, and, therefore, no additional cost is provided in this analysis.
i Additional costs wil' be incurred by the Agreement States for development and implementation of compatible regulations, including the change to Compatibility Category C for all of 31.5.
The costs will vary significantly by State because of differences in internal procedures for developing regulations and in the state of existing regulations in each State, some States l
having already instituted an enhanced oversight program, in some cases, specifically a registration program. Even in these cases, some rule change will be required to meet compatibility Category B for requirements for distributors. As these need to be essentially word-for-wcud compatibility, the process should be relatively simple for this part. If we assume an average of 1 FTE at $105,000/FTE for 30 States, the cost would be S3,150,000. In addition, the NRC/ Agreement State Working Group estimated that the cost of each State setting up a database for use in implementing such a program would be $20,000. Although some progress 20 A
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has been made by some States, we assume the same amount for all 30 States for a total of
- $600,000. Thus total front end costs to Agreement States would be in the area of S3,750,000.
1 Revision of distributors' manufacturing process to include additional labels would result in small
' incremental costs (i.e. <$1,000).
5 BENEFITS OF PROPOSED RULE 5.1 Summary of Benefits of Proposed Alternative The revisions are intended to better ensure understanding of and compliance with the general license requirements, and thereby reduce the likelihood of incidents resulting in unnecessary exposures to the public and contamination of property. These revisions will better enable the NRC to track the location., and disposition of these devices, and thereby confirm the efficacy of the generallicense regulatory program. NRC needs to keep track of the generallicensees so that they can be contacted or inspected. Further, the revisions would improve the likelihood that labels on devices will be retained under most circumstances so that devices can be 3
identified and appropriate actions can be taken. A number of the proposed provisions work together to_ achieve these benefits. Thus, the benefits of these provisions cannot be accounted separately. The basic rationale for each provision is discussed in section 4; the overall benefits are discussed below.
The primary benefits of this proposed rule can be categorized into economic benefits and exposure aversion benefits, in addition, there are less tangible benefits to improving accountibility for generally licensed devices. Many incidents involving generally licensed devices occur in the public domain. As a result, incidents to be averted by this rule have a significant impact on the public's perception of risks associated with the use of radioactive material. This,in turn, can affect the credibility of NRC in other areas. Therefore, this rulemaking could contribute to the alleviation of inappropriate public fear and improvement of NRC credibility in the future.
. All of these benefits are very difficult to quantify. Although ranges of potential exposures have been calculated and ranges of costs from individual incidents have been recorded, the working -
group concluded that none of the studies conducted are adequate to quantify an overall net
. cost of improperly disposed or lost devices. An admittedly uncertain estimate was made of the current economic costs and exposures resulting from improper disposition of both specifically and generally licensed devices meeting the proposed criteria for increased oversight. 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 steel industry).
Uncertainty in these estimates comes from a number of factors including:
.The number of incidents of meltings reported is small overall; thus there is
' considerable statistical uncertainty in how representative the costs are of future l
costs averted.
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I The likelihood of loss may be different for specifically and generally licensed devices and for different categories of devices; the experience cannot be separated as 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 did not include incidents at large integrated steel mills and the resultant costs of such an incident are expected to be much greater than those experienced to date, as much as $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 l
has generally increased over time, particularly at larger mills.
5.2 Summary of Radiation Exposure Avertt J 6enefit This rule should avert radiation exposure to the public, e. g., although it is reasonable to assume that a member of the public would not deliberately expose himself or herself or someone else to radiation, in some cases, these individuals might not understand that a gamma gauge is a potential source of radiation. When a gamma gauge is distributed to a general licensee, the gauge must bear durable, legible labels which include a caution that the gauge contains radioactive material. The generallicense in 31.5 requires that the general licensee maintain those labels. In the absence of such. maintenance, however, the cautionary language can become corroded and unreadable or painted over. An individual who finds the gauge without this labeling in an uncontrolled situation would have no reason to suspect that the gauge contains radioactive material.
l If a generally licensed gauge were improperly transferred or disposed of such that it became 1
available to a member of the general public, provided the radioactive material sealed source remained in the gauge and the shutter mechanism remained closed, no significant radiation exposure harm could result. Moreover, the gauge may be too heavy for anyone to casually i
l relocate so as to cause long-term exposure. In addition, temporary exposure to an intact gauge should not cause a significant radiation dose. Also, the intact gauge would normally include a waming label with a radiation symbol and cautionary words.
l If a gauge with a significant source of activity were to end up in the public domain, the labeling were to be destroyed, and a person somehow exposed the source, a significant exposure could l
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 j
the highest doses is extremely small. No incidents to date in the U. S. have resulted in the upper range of these potential doses.
Based on a June 1994 PNL report, " Peer Review of Improper Transfer / Disposal Scenarios for i
Generally Licensed Devices," the working group (WG) estimated the average dose received l
from incidents of lost devices involving cesium 137 (the most common nuclide involved in l
incidents historically) could be 7 rem (70 mSv) and the maximum dose that might be received could be somewhat over 1000 rem (10 Sv). The PNL study considered gamma gauges containing 20 mci or greater of cesium-137. The analysis was based on the average activity of 883 mci of cesium-137 within this category using data trom the General License Data Base on devices registered in the Sealed Source Device Registry (SSDR) during the period 19871992.
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1 The activities listed in the SSDR are the maximum allowed in a model and thus overestimate the average for the devices actually distributed. Gamma gauges were chosen for the example j
l analysis as representative of relatively high risk sources amongst generally licensed devices.
These were very rough estimates. The data has known errors and the average activity per device being distributed has declined.
)
5.3 Summary of Economic Benefits There is a cost savings to industries which might inadvertently come into possession of an improperly disposed device. The most significant of these would be the avoidance of a melting of a source and resulting contamination of a steel mill and its products and wastes.
Based on the known incidents in the period 1983-1995 involving the nuclides for which registration would be required, the cost of decontamination and clean-up of these incidents (using the average clean-up 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. The regulatory analysis for the previous proposed rule (Rule 1) estimated that it would cover 20% of the devices contributing to the melting experience to date (since that rule addressed only devices in NRC-regulated States and some of the melted devices may have j
been specifically licensed) and might reduce the rate of incidence involving those devices by half, and estimated that the average annual cleanup cost of S12 M would be reduced by about S1.2 M per year.
This rule would require Agreement State Compatibility Category C for the regulations governing generallicensees, so that generally licensed devices in Agreement States would be similarly controlled. Based on the estimates of the WG, this would involve approximately half of the i
devices considered by the WG as likely contributors to smelting incidents and as presenting a risk of significant exposure to the public. If we again estimate that the increased oversight of these devices reduces smelting incidents by one half amongst this population of devices, a potential savings of S3 M per year could result. It is recognized, however, that some States have already implemented increased oversight programs for generally licensed devices.
Improved tracking for devices distributed in the future, as well as improved awareness by generallicensees of their responsibilities, expecteo M result from this rulemaking, will also help to reduce future smelting incidents.
There are other costs, though less significant, associated with lost sources which could be reduced by this rulemaking.
In addition to registration, or comparable controls implemented under Agreement State regulations for certain devices, there are additional provisions in this rule that are expected to improve accountability and compliance with existing regulations for all devices generally licensed under $ 31.5 and equivalent regulatlons of the Agreement States, particularly those distributed in the future. Although the criteria chosen for determining which devices should be subject to a registration requirement are intended to include those devices that present the most risk of significant costs or significant exposures to the public if lost or improperly disposed of, other generally licensed devices present similar though lesser risks.
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The proposed revisions that are intended to allow NRC, and the Agreement States, to better track the location of generally licensed devices would maintain the regulatory bodies' ability to l-contact and inspect the general licensees. The proposed provisions would also allow the l
tracking of individual devices; this will aid the enforcement of regulations and the identification of the persons responsible for devices that are found in inappropriate places.
The rulemaking should thus reduce the number of orphaned sources.. The cost of disposalin the case of orphaned sources falls on parties other than the user of the device, such as government agencies, e. g., EPA or DOE, or individuals or organizations who inadvertently come into possession of a device.
These projected savings would not be entirely attributable to implementation of the rule, but also to the planned increase in inspection and enforcement efforts.
Additional Bbnefits from 9 31.5(c)(15):
The ALARA principal is one basis for alleviating the need for leak testing and shutter testing while a device is in storage. Indeed, it is an unnecessary exposure to personnel who perform such tests since, prior to removing the device from storage, the device must be checked.
Reduced burden on general licensees to perform activities while a device is in storage, resulting in exposure benefit and cost savings. Also, decreases the likelihood of loss of control of a device due to a fixed time period of storage of such devices. Devices that are in storage for long periods of time (i.e. greater than two years) are more likely to be forgotten and end up being improperly transferred or inadvertently discarded.
l Assumptions.
General Licensees:
l Number of 9 31.5 GL devices:
600,000 Percentage of devices requiring leak tests and shutter tests every 6 months:
10%
Percentage of devices in long term storage:
3%
Time per year to perform leak test and shutter test per device (assuming 15 minutes every 6 months):
0.5 hrs l
Technical staff hourly rate:
$50/hr Total Cost Savings (per year):
$45,000 Note that there is not strict compatibility of this requirement for Agreement States, however if there are similar changes made to an Agreement State's regulations, similar savings would result, potentially for a larger number of devices.
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I l-i 6 DECISION RATIONALE l
l-l It is recommended that this action be adopted because it represents a reasonable means for L
the Commission to fulfillits obligation to protect public health and safety, property, and the l
environment. It would be implemented to better ensure that certain generallicensees are aware of those requirements with which they must comply, and to provide a more complete system for NRC and the Agreement States regulatory bodies to keep track of the location of l
their general licensees as well as track individual devices. The rationale for this recommendation follows.
It is estimated that adoption of this regulatory action would result in up-front development and implementation costs to the Commission and to Agreement States of $504,000 and $3,750,000 respectively. Also, estimated annual costs would De $2,282,000 to industry, S107,700 to the Commission and $83,000 to Agreement States. These costs are appropriate considering; 1) the nominal cost per device and full cost recovery requirement,2) the averted radiation exposure, 3) savings in cleanup costs, and 4) increased confidence in the efficacy of the generallicense program.
First, almost the entire cost to licensees is the imposition of fees. This is being done as a matter of equity and is shifting a portion of the overall costs of implementing and enforcing the generallicense requirements from specific licensees to some of the generallicensees who benefit from the general license program. The cost being recovered from the generallicensees is not limited to those for implementing these revisions to the general license program; instead,
~
the cost to generallicensees consists of the cost of that fraction of the overall generallicense program associated with the devices subject to the registration requirement. Since the requirement for full cost recovery was enacted, all costs of the generallicense program have been recovered from specific licensees. The cost estimate used to develop the amount of the fee includes an estimate of increased inspection and follow up efforts expected to be made as a result of the registration process identifying noncompliance with existing regulations. That cost will now be passed on to the generallicensees associated with the registration requirement. It is also expected that this cost will decline after the initialimplementation of the registration process, in which case, this fee might be reduced in the future.
Although the total cost to general licensees of S2,200,000 is significant, the fee per general licensee is $370, which amounts to an average of 592 per device. The economic impact of this fee is not believed to be significant, especially in comparison to the fees placed upon specific licensees.
Second, the results of the General License Study conducted by the NRC indicated that there is noncompliance with the generallicense requirements contained in @ 31.5(c). The Study revealed that a major reason for noncompliance is that users of the generally licensed devices are unaware that there are regulatory requirements associated with the possession and use of I'
'these devices that must be met. Such noncompliance presents a risk of low but avoidable exposure of the public to radiation plus a low probability of significant exposure as a consequence of improper handling or disposal of the devices generally licensed.
Third, this regulatory action will establish a reasonable procedure to ensure that general licensees are aware of the provisions associated with the generallicense and comply with the 25 o
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applicable regulatory requirements. It is believed that increased awareness and understanding of the NRC's requirements on the part of the generallicensees willincrease the likelihood that general licensees will comply with those requirements and thereby prevent costs to industry, and to State government agencies, from improper handling or disposal of generally licensed devices. The benefit to be realized even further overshadows the small costs when considered in light of the contribution of this action to the possible avoidance of the substantial cleanup costs which have occurred because of past improper disposition of generally licensed devices.
And finally, promulgation of this rule should result in improvement in the accountability for devices and would provide confidence that the use of generally licensed devices is being regulated in an appropriate manner.
7 IMPLEMENTATION I
The regulatory action is not expected to present any significant implementation problems. The
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revised computer database system which willinclude the capability of processing registrations is already being developed. Generallicensees will be sent a copy of the final Federal Reaister notice.
8 EFFECT ON SMALL ENTITIES The action would have an economic impact on generallicensees of devices containing byproduct material. There are up to 45,000 generallicensees under @ 31.5 of which 6000 would be required to register devices and pay a fee, some of whom may be "small entities" within the meaning of the Regulatory Flexibility Act (P.L.96-534). The specific provisions proposed here are essentially consistent with the Commission's plans for the registration process discussed in the earlier proposed rule. With the exception of the fee, the provisions would add no further, or minimalimpact than that already planned and accounted for under the previous proposed rule. Therefore the economic impact on small entities would be the incurrence of the fee, in the proposed amount of $370, about $92 per device on average. The economic impact on the small entities are not believed to be significant. Most of the distributors of generally licensed devices are not small entities and the impact to any of these distributors would not be significant in any case.
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ATTACHMENT 4 Congressional Letters i
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'+9 *...,d 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 i
Washington, DC 20510
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of a Notice of Proposed Rulemaking to be published in the Federal Reoister soon. The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend 10 CFR Parts 30,31,32,170, and 171 to explicitly require that certain 1
generallicensees register certain devices that they have received for use under a general license and add a registration fee. The NRC plans to institute this registration system for devices using certain quantities of specific radionuclides that are primarily used in commercial and industrial applications under an earlier proposed rule. The enclosed rule would also revise requirements for transfers, storage, reporting, recordkeeping. labeling pertaining to these generally licensed devices.
NRC has observed a number of instances in the past where generally licensed devices nave not been properly handled or disposed of. This amendment would allow NRC to better account for devices that have been distributed for use under the generallicense and thereby reduce the potential for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property. This change will have no adverse impact on the health and safety of workers or the public and is not expected to impode a significant burden on licensees.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Register Notice cc: Senator Bob Graham 4
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UNITED STATES s
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The Honorable Dan Schaefer, Chairman Subcommittee on Energy and Power Committee on Commerce United States House of Representatives Washington, DC 20515
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of a Notice of Proposed Rulemaking to be published in the Federal Recister soon. The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend 10 CFR Parts 30,31,32,170, and 171 to explicitly require that certain generallicensees register certain devices that they have received for use under a general license and add a registration fee. The NRC plans to institute this registration system for devices using certain quantities of specific radionuclides that are primarily used in commercial and industrial applications under an earlier proposed rule. The enclosed rule would also revise requirements for transfers, storage, reporting, recordkeeping, labeling pertaining to these generally licensed devices.
NRC has observed a number of instances in the past where generally licensed devices have not been properly handled or disposed of. This amendment would allow NRC to better account for devices that have been distributed for use under the general license and thereby reduce the potential for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property. This change will have no adverse impact on the health and safety of workers or the public and is not expected to impose a significant burden on licensees.
Sincerely, i
i Dennis K. Rathbun, Director Office of Congressional Affairs
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Enclosure:
Federal Register Notice cc: Representative Ralph Hall l
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The Honorable James M. Inhofe, Chairman Subcommittee on Clean Air, Wetlands,
' Private Property and Nuclear Safety Committee on Environment and Public Works l
United States Senate l
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 soon. The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend 10 CFR Parts 30,31,32,170, and 171 to explicitly require that certain general licensees register certain devices that they i de received for use under a general
. license and add a registration fee. The NRC plans to institute this registration system for devices using certain quantities of specific radionuclides that are primarily used in commercial and industria applications under an earlier proposed rule. The enclosed rule would also revise requirements for transfers, storage, reporting, recordkeeping, labeling pertaining to these generally licensed devices.
NRC has observed a number of instances in the past where generally licensed devices have not been properly handled or disposed of. This amendment would allow NRC to better account for devices that have been distributed for use under the general license and thereby reduce the potential for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property. This change will have no adverse impact on the health and safety of workers or the public and is not expected to impose a significant burden on licensees.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Identicalletter sent to: The Honorable Dan Schaeffer l
Federal Register Notice Chairman, Subcommittee on Energy and Power cc: Senator Bob Graham DISTRIBUTION:
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ATTACHMENT 5 Draft Press Release t
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NRC PROPOSES ADDITIONAL REQUIREMENTS FOR CERTAIN DEVICES CONTAINING RADIOACTIVE MATERIAL The Nuclear Regulatory Commission is proposing to amend its regulations to establish additional requirements for users and distributors of radioactive material in certain measuring, gauging and controlling devices.
The revisions are aimed at providing greater assurance that users of the devices will properly handle and dispose of them, thus reducing the potential for unnecessary radiation exposure to the public or contamination of property.
The proposed revisions would provide the details of an annual registration program that the NRC plans to initiate. The changes would also require that distributors provide additional information to users to provide further assurance that they understand the requirements for possession of the devices.
Companies and individuals are permitted to use the devices under an NRC
" general license," which means that they need not have a specific license issued to a named individual or organization with specific license conditions and requirements. A generally licensed device usually consists of radioactive material contained in a sealed source within a shielded container. A common example is a fixed gauge used in a factory to monitor a production process and ensure quality control.
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Such a device is designed with inherent radiation safety features so that it can be used by persons with no radiation training or experience. The general license is meant to simplify the licensing process so that a case-by-case determination of the adequacy 1
of radiation training or experience of each user is not necessary.
In the past, NRC has not regularly ccmtacted general licensees because of the j
relatively small radiation risk posed by the devices. However, there have been a number of instances in which generally licensed devices have not been properly handled or properly disposed of.
The proposed registration requirement would apply to generally licensed measuring, gauging and controlling devices with quantities of certain radioactive materials posing a higher risk to public safety or of property damage if the device were lost than would other genera!!y licensed devices.
The majority of the devices meeting these criteria are used in commercial and industrial applications measuring thickness, density or chemical composition in industries such as petrochemical and steel manufacturing. About 6,000 general licensees possessing about 24,000 devices would come under the registration requirement.
General licensees affected by the registration requirement would have to pay the NRC an annual registration fee of $370.
Specific licensees who distribute the measuring, gauging and controlling devices would be required to provide-before transferring a device to a general licensee-copies of additional applicable sections of the NRC regulations, a listing of the types of service to the device that can only be performed by a specific licensee, and information 2
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1 regarding disposal options, including the cost for disposal. The amendments would also modify the reporting, recordkeeping and labeling requirements for distributors.
The Commission has established an interim enforcement policy for violations of NRC regulations that general licensees discover and report during the initial cycle of the registration program. The interim policy provides that enforcement action normally will not be taken for violations so identified and reported, provided appropriate corrective action has been taken. This amnesty period, which will remain in effect through one complete cycle of the registration program, should encourage general licensees to search their facilities to ensure that sources are located, to determine if applicable requirements have been met, and to develop appropriate corrective actions when deficiencies are found.
The Commission also plans to increase the civil penalty amounts that would be imposed for violations involving lost or improperly disposed-of devices or radioactive material from them. This increase would be to ensure that, after the amnesty period ends, civil penalties for lost sources will be significantly higher than the disposal costs.
Additional details of the proposed revisions to the regulations are contained in a Federal Register notice to be published shortly. Interested persons are invited to submit written comments within 75 days of the Federal Register notice to the Secretary, U.S.
Nuclear Regulatory Commission, Washington, D.C. 20555-0001, Attention: Rulemakings and Adjudications Staff. Comments may also be submitted via the NRC's interactive rulemaking web site through the NRC home page at http://www.nrc.aov. Information on this site is available from Carol Gallagher,301/415-5905; e-mail CAG @nrc.oov.
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ATTACHMENT 6 I
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~ Form XXX - Transfers of Industrial Devices Report t '
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1 Form XXX - Transfors of Industrial Devices Report Page of _
N:tma of Vendor:
Reporting Period:
License Number:
From:
To:
For each
- person" to whom a device (s) has been transferred dunng the reporting period, supply the following:
Intermediate Person (if any)
Name:
- and Street:
City, State, and Zip Code:
Ntme of Responsible Individual:
Telephone number:
General Licensee User Information Nime:
D;part.. ent:
- and Street:
City, State, and Zip Code:
NIme of Responsible Individual:
Telephone number:
Information on Device (s) Transferred:
Date of Transfer:
- ' d Type of Device:
Model Number:
Senal number:
Isotope:
Activity and Units:
reptacement in the case of replacements.
,.%., ; t-provce following for oevice(s)
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$5 MNT!I L Intermediate Person (if any)
Nime:
- and Street:
City, State, and Zip Code:
Nime of Responsible Individual:
Telephone number:
General Licensee User Information Ntme:
Dipartment:
- and Street:
City, State, and Zip Cide:
N me of Responsible adividual:
Telephone number:
Information on Device (s) Transferred:
Dite of Transfer:
<d Type of Device:
Model Number:
Senal number; Isotope:
Activity and Units:
replacement r:
in the case of replacements.
provide following for device (s)
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y g-ATTACHMENT 7 Draft NUREG-1556, Vol.16, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About.
General License Distribution Licenses
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PDR Staff Draft Proposed Rule Requirements for Certain Generally Licensed Industrial l-Devices Containing Byproduct Material
SUMMARY
- The Nuclear Regulatory Commission (NRC) is considering amending its regulations governing the use of byproduct material in certain measuring, gauging, or controlling devices. The planned revision includes the addition of explicit requirements for a registration process that the NRC plans to initiate through an earlier proposed rule. This action
- would propose to add to the regulations the specific criteria for inclusion in the registration program and details about the information required; it would also add a registration fee. The amendments would also modify the quarterly transfer reporting, recordkeeping, and labeling requirements for specific licensees who distribute certain generally licensed devices and clarify which provisions of the regulations apply to all general licenses for byproduct material. The proposed rule is intended to allow the NRC to better track certain general licensees, so that they can be contacted or inspected; to track generally licensed devices so that the devices can be identified even if lost or damaged; and to further ensure that general licensees are aware of and understand the requirements for the possession of devices containing byproduct material.
Greater awareness helps to ensuro that general licensees will properly handle and dispose of generally licensed devices and reduce the potential for incidents that could result in unnecessary radiation exposure to the public and contamination of property.
SUPPLEMENTARY INFORMATION:
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1 Background
On February 12,1959 (24 FR 1089), the Atomic Energy Commission (AEC) amended i
its regulations to provide a general license (10 CFR 30.21(c)) for the use of byproduct material contained in certain measuring, gauging, or controlling devices. Under current regulations in 10 CFR 31.5, certain persons may receive and use a device containing byproduct material under this general license if the device has been manufactured and distributed according to a specific license issued by the NRC or by an Agreement State. A specific license authorizing distribution of generally licensed devices is issued if a regulatory authority determines that the safety features of the device and the instructions for safe operation of that device are adequate and meet regulatory requirements. These general licensees are subject to requirements for maintaining labels, following instructions for safe use, proper storage or disposition of the device, and reporting transfers and failure of or damage to the device. For some devices, the general licensee must also comply with testing requirements for leakage and for proper operation of on-off mechanisms. Generallicensees are also subject to the terms and conditions in 10 CFR 31.2 concerning general license requirements, transfer of byproduct material, reporting and recordkeeping, and inspection. General licensees must comply with the safety instructions contained in or referenced on the label of the device and must have the testing or servicing of the device performed by an individual who is authorized to manufacture, install, or service these devices.
' A generally licensed device usually consists of radioactive material, contained in a sealed source, within a shielded housing. The device is designed with inherent radiation safety features so that it can be used by persons with no radiation training or experience. 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.
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l There are about 45,000 general licensees under 10 CFR 31.5 who possess about 600,000 devices that contain byproduct material. The NRC has not contacted or inspected general licensees on a regular basis because of the relatively small radiation risk posed by these devices.
These licensees are not always aware of applicable requirements and thus are not necessarily complying with all of the applicable requirements. Of most concern, are occurrences where generally licensed devices have not been handled or disposed of properly.
In some cases, this has resulted in radiation exposure to the public and contamination of i
property. For example, sources have been accidentally melted in steel mills causing i
considerable contamination of the mill, the steel product, and the wastes from the process, the J
l slag and the baghouse dust. Although known exposures have generally not exceeded the l
public dose limits, there is a potential for significant exposures.
Because of these incidents, the NRC conducted a 3-year sampling (1984 through 1986) of generallicensees to assess the effectiveness of the generallicense program to determine l
whether there was an accounting problem with generally licensed device users. The sampling revealed several areas of concern regarding the use of generallicensed devices. The NRC concluded that -- (1) Many general licensees are unaware of the applicable regulations and; (2)
Many general licensees are unable to account for their devices.
Approximately 15 percent of the generallicensees sampled could not account for all of their generally licensed devices. The NRC concluded that these problems could be resolved by i
more frequent and timely contact between the general licensee and the NRC.
On December 27,1991 (56 FR 67011), the NRC published a notice of proposed rulemaking concerning the accountability of generally licensed devices. The proposed rule contained a number of provisions, including a requirement under 10 CFR 31.5 for general i
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licensees to provide information to the NRC upon request, through which a device registry could be developed. - The proposed rule also included requirements in 10 CFR 32.51a and 32.52 for specific licensees who manufacture or initially transfer generally licensed devices.
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Although the public comments received were reviewed and a final rule developed, a final rule was not issued because the resources to fully implement the proposed rule were not available.
The NRC has continued to consider the issues related to the loss of control of generally
. licensed, as well as specifically licensed, devices. In July 1995, the NRC, with assistance from the Organization of Agreement States, formed a working group to evaluate these issues. The working group consisted of both NRC and Agreement State regulatory personnel and encouraged the involvement of all persons having a stake in the process and its final recommendations.- All working group meetings were open to the public. A final report was
. published in October 1996 as NUREG-1551, " Final Report of the NRC-Agreement State Working Group to Evaluate Control and Accountability of Licensed Devices."
In considering the recommendations of this working group, the NRC has decided, among other things, to initiate an annual registration, similar to the program originally proposed i
' in the 1991 proposed rule, of devices generally licensed under 10 CFR 31.5. However, the
- NRC has decided to do so only for those devices considered to present a higher risk of potential exposure of the public or property loss in the case of loss of control (compared to other generally' licensed devices). Initially, the NRC will use the criteria developed by the working group for determining which sources should be subject to the registration program.
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-These were based on considerations of relative risk and were limited to radionuclides currently in use in these types of devices. If quantities of other radionuclides that would present a similar risk are used in such devices in the future,' this would be a reason for revising the criteria to
' include additional radionuclides. The Commission may, in future rulemaking, also consider 4
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.. revising the criteria to include a larger number of devices in the registration requirement for other reasons.
The Atomic Energy Act of 1954 (AEA), as amended, provides the NRC with the authority to request information from its licensees concerning licensed activities. In the case of 10 CFR 31.5 general licensees, however, the Commission had not included an explicit provision
- in this regard in its regulations. On December 2,1998 (63 FR 66492), the Commission
- published a proposed rule that would explicitly require general licensees who possess certain measuring, gauging, or controlling devices to provide the NRC with information about the devices.1The NRC intends to use that provision primarily to institute a registration and accounting system for the devices containing certain quantities of specific radionuclides that l
present a higher risk of exposure to the public or property damage if a device were lost. That rulemaking was not proposed as a matter of compatibility for Agreement States.
'.This rule would add specific requirements concerning the registration of devices and
- additional provisions of an enhanced regulatory oversight program for all general licensees in i
this category.. It would also establish levels of compatibility for Agreement State regulations so
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that an increased level of oversight for general licensees in Agreement States would also be required. Some States have already instituted some form of enhanced oversight for these j
general licensees, in a few cases, a registration program. A few States have a higher level of control on these devices through requiring specific licenses. Under the proposed level of compatibility'for 9 31.5, the essential objectives of the regulation should be adopted by the State to avoid conflicts, duplications or gaps; the manner in which the essential objectives are addressed need not be the same as NRC. Strict compatibility would only be required for revisions to distributors requirements because of interjurisdictional distribution, j
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Discussion The proposed rule published on December 2,1998, for public comment, would provide one of the key elements in improving the accountability and control over devices of particular concern through the institution of a registration process; however, there are inadequate provisions in the regulations to allow for the NRC to keep track of generally licensed devices.
NRC needs to do so in order that the general licensees can be contacted when situations arise which warrant such contact and for inspection purposes. As noted, it would not require compatibility of Agreement State regulations.
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In addition, there are other means for reducing the likelihood of incidents of lost sources.
The Commission has reconsidered the provisions in its 1991 proposed rule, evaluated the recommendations of the NRC-Agreement State Working Group, and identified additionalissues concerning these devices in developing this proposed rule.
Summary and Discussion of Proposed Requirements Revisions to the Requirements for General Licensees under 6 31.5 - The principal change to the general license that would be made under this proposed rule would be to add explicit provisions delineating an annual registration requirement. The registration process is expected
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to be initiated under @ 31.5(c)(",, proposed on December 2,1998. which would require licensees to respond to requests for information from NRC within 30 days or as otherwise specified. The specific provisions proposed here in a new f 31.5(c)(13) are essentially consistent with the Commission's plans for the registration process discussed in that earlier proposed rule. This proposed rule would specifically require that the information about devices 6
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I be verified through a physical inventory and checking label information. The advantage of including more explicit requirements in the regulation is that information about the registration process will be more clearly defined and more available. When the distributor of a device supplies copies of 6 31.5 to its customers (under 6 32.51a(a)), the potential general licensees will be made awcre of the registration requirement, including the devices to which it applies, what information will be requested, and also the fact that there will be a registration fee. The proposed rule would add a fee of $370 to 6170.31 to be assessed in conjunction with the registration process; this would be for each general licensee possessing devices required to be registered regardless of the number of devices. NRC is required by law to recover all costs from licensees' fees. Registration fees are proposed in order to recover the cost of the general l
license program associated with this group of generallicensees in an equitable way; that is, from those who are allowed to use devices under the general license rather than from others who hold specific licenses.
The first registration, carried out under 10 CFR 31.5(c)(11), would depend on the NRC's ability to contact general licensees as information is requested only at NRC request. This proposed rule, as drafted, also specifies that the general licensee will complete registration by verifying, correcting, and/or adding to the information in a request for registration received from the Commission. It is silent on when or how ger eral licensees should register if the Commission fails to contact the general licensee. The Commission seeks comment on whether the registration requirement should include a provision that the general licensee is required to complete registration in any case by a certain time, such as 15 months after the date of the previous registration certificate, the receipt of a device subject to registration, or the effective date of this rule, in the case of an unregistered device possessed at the time of the effective 7
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date of the rule. This would put the burden of registering on generallicensees who have not L
l been notified by NRC of the requirement.
- The time of year of registration will vary for licensees; however, requests for renewal of
. registration will be made approximately one year after the previous registration request for that licensee. Although registration would not be required prior to receipt of devices, the Commission plans to send requests'for registration to new general licensees identified in distributors' quarterly transfer reports submitted under $ 32.52 shortly after receipt and recording of this information. For general licensees who have previously registered devices i
and receive additional devices requiring registration. the addition of new devices to the registration will be done at the time of the annual reregistration. The Commission requests comment on whether the NRC should contact previous registrants who receive additional devices earlier than this, either by an acknowledgment by NRC to the user or by a required response accounting for the additional device (s) by the general licensee.
Additional proposed requirements for all general licensees under 9 31.5 include: (1) an i
explicit requirement for the general licensee to appoint an individual to carry out the general licensee's responsibilities to comply with the applicable regulations (new $ 31.5(c)(12)); (2) a t
. provision that limits the amount of time a general licensee can keep an unused device in storage and allows the deferrnent of testing during the period of storage (new 6 31.5(c)(15));
(3) a provision to allow transfers to specific licensees authorized under Part 30, or Agreement l-State regulations, as waste collectors, in addition to currently allowed transfers to Part 32 (and
' Agreement State) licensees, and to also allow transfers to other specific licensees but only with prior written NRC approval (revision to 6 31.5(c)(8)); (4) the addition of the recipient's license number, the serial number of the device, and the date of transfer to the information required to be provided to NRC upon a transfer of a device (revision of 9 31.5(c)(8)); (5) a provision to 8
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notify NRC of ' address changes (new 9 31.5(c)(14)); (6) for device damage or failures that are likely to or are known to have resulted in contamination, the addition of a plan for ensuring that
. premises and environs are suitable for unrestricted access, to the information that must be sent to NRC in the case of a failure, and a change to the addressee for reporting information i
coecerning a failure (revision to 9 31.5(c)(5)); and (?) the revision of the reporting requirement, in the case of a transfer to a general licensee taking over possession of a device at the same location, to provide the name and phone number for the persori designated to be responsible l
for ensuring compliance 'with the appropriate reguls.tions and requirements, rather than simply a contact name, and the serial number of.the device (revision to 9 31.5(9)(i)).
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~ The rationale for each of these proposed amendments is:
(1) The " person" who holds a general license is usually a corporation, or public or private
- institution, rather than an individual. In practice, in order for the general licensee to comply with i.
existing regulations, some individual must be aware of the requirements and take the required actions. Appointing a specific individual to be responsible for ensuring compliance with regulations is an appropriate operational practice, which is,'unfortunately, not always followed.
i For devices not subject to testing under 9 31.5(c)(2), there are no routine actions required to be taken, 'as the requirements are generally restrictions on actions, such as not abandoning the
- device,'or actions to be taken only in the case of particular, non-routine events, such as J
notification of NRC of the transfer or failure of the device. In this situation, it is particularly likely for knowledge of the nature of the device, the general license, and the associated regulations to not be maintained and passed on to individuals using the device. Requiring the assignment of j
the responsibility for compliance with regulations to a specific individual would improve the probability that the general licensees will do what they are already required to do. The impact I
of this should be minimal, somewhat limiting operational flexibility with regard to the assignment i
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or duties. This individual would not necessarily be someone who works on site at the place of use of the device and would not necessarily be conducting all required actions, but would be responsible to ensure that required actions are taken.
(2) When a device is not in use for a prolonged time, it is particularly susceptible to being forgotten and ultimately disposed of or transferred inappropriately. General licensees are
- unlikely to keep a device ~ unused for more than two years and subsequently reuse it. If a device
~ is being held in storage indefinitely, it is likely that it is being stored to avoid the costs of proper disposal. If a generallicensee does want to reuse a device after a period of more than two years of disuse, the device could be sent back to the supplier to be held under the distributor's specific license until later use or the general licensee could request an exemption from 9 31.5(c)(15) indicating the reason (s) why the licensee intends to use the device after two years and prefers to keep it on site in the interim.
If a period of storage exceeds the interval for testing, testing need not be done until the device is to be put back into use again. This would relieve the burden of unnecessary testing during the period of storage as well as eliminating any exposure that may occur during testing for that period.
(3) The proposed revision to 6 31.5(c)(8) would provide some flexibility to the general licensee in transferring a device while assuring that it is transferred appropriately. It would allow a general licensee to transfer a device directly to a waste collector for disposal, rather than going through a distributor. It would also allow the transfer of a device to other specific licensees, but would require NRC approval in these cases so that NRC can ensure that the j
- recipient is authcrized to receive it.'
(4) The inclusion of a recipient's license number in the report of transfer would better ensure that the general licensee has verified that the recipient is a Part 32 licensee or a specific p
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licensee under equivalent Agreement State regulations authorized to receive it. It would also supply an additional means for NRC to identify the recipient, as company names and addresses l>
sometimes change. The addition of the date of transfer will make the transfer easier to track and help to ensure that the general licensee makes the report in a timely manner (required
'within 30 days of the transfer).
- (5) The quarterly reports required of distributors under 9 32.52(a) and (b) are intended to provide NRC and the Agreement State regulatory agencies with the identity of general licensees in their jurisdictions and addresses at which these genertal licensees can be contacted (which is usually the location of use of the generally licensed devices). These generallicensees can then be contacted or inspected. If general licensees move their operations without notifying the NRC, or appropriate Agreement State agency, they may be difficult to locate. This proposed requirement to report address changes would only apply to mailing addresses and, for portable devices, the address of the primary place of storage, although they may be used at multiple field sites. For those registering devices, changes in the address of use, if different from the mailing address, will be provided at the time of the next registration.
This simple change of address notification is intended to cover moves into and within NRC jurisdiction. The generallicense in 10 CFR 31.5 only applies within NRC jurisdiction. If a general licensee intends to move from one jurisdiction to another, they should contact the applicable regulatory authority, NRC or the particular Agreement State, prior to doing so in order to determine the applicable, current regulations in that jurisdiction.,All jurisdictions do not have a comparable general license and specific provisions of the general license may vary among jurisdictions. Also, if a general licensee who has obtained a portable device in an Agreement State and wishes to use the device within NRC jurisdiction, they must do so under i
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E 10 CFR 31.5, as there is no reciprocity provision applicable to general licenses. In this case, they would be subject to the provisions of 10 CFR 31.5.
(6) Generallicensees'are not subject to decommissioning requirements as a general license is granted by regulation and, under normal circumstances, does not involve any termination of license process. If a generally licensed device fails or is seriously damaged so as to cause significant contamination of the premises or environs, the NRC may need to respond to the notification of an incident made under 31.5(c)(5) to ensure that a facility is properly decontaminated if necessary. Following such an incident, the NRC would determine what actions are necessary on a case-by-case basis and could apply the requirements set out in 9 20.1402, " Radiological criteria for unrestricted use." The general licensee is exempt from this section of Part 20 when only in possession of an intact generally licensed device. However, when a device has been damaged, the material in the device may no longer be only in the device, i.e.,it may also be unsealed radioactive material. Such an action can be taken under 6 30.61, " Modification and revocation of licenses," which is applicable to general licensees. The provision proposed in this action would require that the general licensee propose to the l
Commission how it will be shown that the premises are or will be adequately cleaned up.
Depending on the nature of the event, the remedial action taken (and reported under exMing requirements) along with any confirmatory sure/s may be sufficient to complete action on the event.
The addressee for submitting information under % 31.5(c)(5) would be changed from Regional Administrator to Director of Nuclear Material Safety and Safeguards so that all NRC addressees specified in 6 31.5 for reports by these licensees are the same and to eliminate the i
need for the general licensee to refer to 10 CFR Part 20 to determine the appropriate 12 l
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j addressee. The addressee and address for registration will be specified in the registration request.
(7) Consistent with the provision for appointing an individual to act for the general licensee to ensure compliance with the applicable regulations and requirements and other reporting requirements being proposed, it is more effective for the general licensee to provide
' the name of the new responsible individual when another general licensee takes over the facility and responsibility for the device.
One other revision to 9 31.5 is being proposed that would clarify the status of a person who receives a device through an unauthorized transfer. Paragraph (b) would be revised to
.. limit the applicability of the general license to those who receive a device through an authorized transfer. NRC has generally, although not consistently, interpreted the general license to apply to a recipient meeting the criteria for general licensee, i.e., ".. commercial and industrial firms
'and research, educational and medical institutions, individuals in the conduct of their business, i
and Federal, State or local government agencies..", even if the device is received through an unauthorized transfer. This revision would clearly provide that the general license only applies if the device is obtained through an authorized transfer.
In addition to the proposed revisions to 9 31.5, a number of revisions are being proposed to clarify which sections of the regulations in Part 30 apply to all of the general licensees under Part 31. Section 31.1, " Purpose and scope," would be amended to clarify that only those paragraphs in Part 30 specified in 6 31.2, or the particular general license, apply to Part 31 general licensees. Section 31.2, " Terms and conditions," would be amended to inclu' e d
reference to the sections of Part 30 that are applicable to all of the Part 31 generallicensees, including 9 30.7, " Employee protection," $ 30.9, " Completeness and accuracy of information,"
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and 30.10," Deliberate misconduct." Under the proposed clarification, it would be easier for, j
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general licensees to be aware of applicable regulations. In addition, future revisions to Part 30 1
that would apply to Part 31 general licensees would include a conforming amendment to i
Part 31. Note, however, that while 6 31.2 would specify applicable sections of Part 30, it would
' not eliminate the' applicability of other Parts of the Coc mission's regulations that may apply, for example, Part 2, " Rules of Practice for Domestic Licensing Proceedings and issuance of
- Orders."
i The applicability of 30.34(h) on bankruptcy notification to general licensees also needs to be clarified. Under the existing regulations, this requirement applies to alllicensees; however, it's application to general licensees is not clear because it is not referenced in 9 31.2, nor in 31.5. This proposed rule would make the bankruptcy notification requirement applicable only to those general licensees subject to the registration requirement. These licensees possess devices for which the Commission believes a higher level of oversight is appropriate. Thus, notification that a general licensee is filing for bankruptcy may be important to allow the Commission to intervene to ensure that the financial status of the licensee does not lead to the improper disposal or abandonment of a device.
Requirements for Manufacturers and initial Distributors of Devices - The proposed regulation would modify the quarterly transfer reporting, recordkeeping, and labeling requirements for specific licensees who distribute these generally licensed devices, as well as s
the requirement for providing information to users. These requirements are a matter of strict compatibility of Agreement State regulations and are proposed to continue to be so making equivalent revisions to Agreement State regulations necessary. The basis of this compatibility requirement is significant direct transboundary implications.
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. Reoortina - To the existing quarterly transfer reporting requirement, the following information would be added: the serial number and model number of the device; the date of
. transfer; indication if device is a replacement,' and if so, the type, model number, and serial number of the ona returned; name and license number of reporting company; and the specific (reporting period.' The model' number of the device is already required in reports to Agreement States. The name and phone number of the person designated by the general licensee to be l'
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. responsible for the device and for ensuring compliance with the appropriate regulations will L
, replace the name and/or position of a simple contact between the Commission and the general licensee. - Also, a form will be provided for use in making these reports; however, the use of the form would not be required as long as the report is clear and legible and includes all of the required information. Revisions would be made to 9 32.52(a) and (b).
5 The existing reporting requirement is intended to provide NRC and the Agreement State
- regulatory agencies with the identity of general licensees in their jurisdictions, addresses at j
which the general licensees can be contacted (which are usually the location of use of the devices), the particulars of the type of device possessed, and the name (or position) of an individual who constitutes a point of contact between the NRC and the general licensee. These
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- general licensees can then be contacted or inspected.-- Including the serial number will allow the NRC 'and Agreement States to track individual devices. The existing reporting requirement in
- 9.31.5(6)(8) does not require the' general licensee to report a transfer if it is for the purpose of
' obtaining a replacement. This is consistent with the original intent of this regulation in that the status of the general licensee is unchanged, only the specific device is changed. in order for
. individual devices to be tracked, tho NRC or Agreement State needs to be informed of such a
< transfer. The, proposed rule would require this of the distributor. Under existing requirements,
. quarterly reports include specifics on any new device transferred but not on the devices i
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retumed. it would not be a significant burden on the distributor to include this additional information in the quarterly reports and the distributor is likely to be more reliable than the general licensee in providing this information. ' The name and license number of the reporting company and the specific reporting period are typically included in the reports in order to show compliance with the reporting requirement but are not always readily identifiable.
In order for an individual to act as contact with the NRC concerning the general license,
' the individual should have knowledge of the device, the general license, and the regulations
-pertaining to the general license. This is the intent of the existing requirement; however, in
. practice, the name given to the distributor and reported to the NRC (and the Agreement State agencies) frequently is not an individual with such knowledge. The proposed rule would specify that the contact designated be the person responsible for ensuring compliance with the regulations.~
Recordkeeping - The rule would add to the recordkeeping requirements information on final disposition of devices. The recordkeeping requirements concerning transfers would have the period of retention extended from 5 years from the date of the recorded event to 3 years after the expected useful life of the device or the final disposition, if known Revisions would be
. made to $ 32.52(c).
It is important that information about the general licensees and the specific devices in
- their possession be available until the device is disposed of permanently. Requiring the distributor to keep these records for an extended time provides a useful backup to the recordkeeping of NRC and State regulatory agencies and the records include information on final distribution that may not have been included in reports to NRC and the Agreement States.
It is NRC's understanding that it is a general practice of these distributors to keep these records 4
indefinitely; thus, this regulatory requirement should have little, if any, impact.
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An additional requirement would be added for the distributors to make available to the
' various regulatory agencies,' records of final disposition of devices in the case of bankruptcy or termination of license. A new paragraph 6 32.51a(d) would be added.
l When a distributor goes out of business and terminates his license, he can no longer be i
ll required to retain these records. This requirement would give NRC, as well as State regulatory.
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' agencies, the' opportunity to obtain and retain records of this type previously kept by the
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. distributor, if deemed important. These records could be helpful in verifying information used to keep track of devices relative to the final disposition of devices. This provision would not require distributors to automatically provide these records unless the NRC or the Agreement State in which the device was distributed makes a requect for these records. In the case of l
bankruptcy, NRC or the Agreement State may want to secure these records early in the process, in ~ case financial difficulties interfere with the licensee fulfilling its responsibilities.
Labeling - To the existing labeling requirements, would be added: an additional label on any separable source housing, and a permanent label on devices meeting the criteria for j
j registration. The NRC would consider a label " permanent," if, for example, it were embossed, i
3 etched, stamped, or engraved in' metal. New paragraphs 6 32.51(a)(4) and (5) and 6 32.51a(c) l
.would be' added. Under these requirements, new distributors would have labels approved as part of obtaining a license; distributors including existing licensees would have the new labeling l
+
(
' requirements as conditions of license in 6 32.51(a)(4) and (5). _ Approval of the new labels by NRC for existing distributors would not be required; however, distributors may voluntarily submit i
L information for NRC review on how they plan to comply with the new labeling requirements. In
)
i any case, labeling is subject to inspection. To the extent necessary, the new labeling i
requirements would supercede anything contradictory in individual license conditions. The individual license conditions would be updated to include specifics related to the new 1
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requirements during the first license renewal or amendment following the effective date of those I
i paragraphs of the rule.
{
The first of these changes is simply an extension of the existing requirement and carries out the initial intent in the case of devices where the source may be separable in a housing that does not include the label. It is important that this housing, if separated from the remainder of the device, can also be identified. The impact of this should be minimal. The permanent label for devices requiring registration would provide better assurance that even when a device has been exp; sed to other than normal use conditions, for example, when a building has been demolished with the device in place, the label will be intact and the device may be identified and proper actions can be taken. This may result in a more significant change to the production of devices. Distributors would have one year after the effective date of the rule to implement these changes, in order to minimize any impact to the manufacturing and distributing process.
Information to be provided to aeneral licensees - Revisions would be made to the requirements pertaining to the information distributors would be required to provide to the general licensee. They are now required to provide general licensees with a copy of 6 31.5 at the time of transfer of the device. The proposed rule would require that @ 31.5 be provided prior to transfer. The distributor would also be required to provide copies of additional applicable sections of the regulations, a listing of the services that can only be performed by a specific licensee, and information regarding disposal options for the devices being transferred. The disposal options would include the estimated cost for disposal of the device at the end of its useful life to the extent that the cost information is available to the distributor at the time of the sale'of the device. In the case of transfers to generallicensees in Agreement States, the distributor may furnish either the applicable NRC regulations or the comparable ones of the Agreement State. In addition, the distributor would furnish the name, address, and phone 18 J
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- 1
. number of the contact at the Agreement State regulatory agency from which additional information may be obtained. Revisions would be made to 6 32.51a(a) and w).
The generallicensee should be aware of the specific requirements prior to purchasing a generally licensed device,' rather than afterward. While 6 31.5 contains the primary
. requirements related to the general license, it does not include reference to applicable sections of Part 30. The generallicensee should have copies of at least those regulations that may require an action on his part. The section of the regulation proposed to be included in this requirement are believed to be the most important for the general licensee to be aware of. The inclusion of a listing of services that can only be performed by a specific licensee would clarify for the general licensee which services can and cannot be performed by the general licensee; these vary depending on the nature and design of the particular device and so are not specified in the regulations. Information on the estimated cost for disposal of the device at the end of its i
useful life.may be a significant factor in a decision to purchase a device, because of the high
)
I costs of disposing of radioactive materials. In some cases, the cost could be several times the purchase price of the device.
i Additional clarifying amendments would be made in 99 30.31,30.34(h), and 31.5(c)(9)(ii). The revised wording of 6 30.31 provides a similar clarification as that in the Suggested State Regulations with respect to general licenses.' The revision to 9 30.34(h) is consistent with the revision discussed above concerning reporting bankruptcy.
o The revision of f 31.5(c)(9)(ii) to include the term," intermediate person,"is intended to -
provide clarification about intermediate persons holding devices. Specifically, intermediate persons holding devices in their original shipping containers at their intended location of use are
~ generallicensees. Distributors licensed under 6 32.51, or equivalent Agretment State regulations, must provide information about both intermediate persons and intended users in i
19 i
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m, L
, their quarterly reports submitted under 32.52(a). Transfers from intermediate persons to intended users under f 31.5(c)(9)(ii) do not need to be reported to NRC since information about the intended user must be reported by the distributor under G 32.52(a).
Minor conforming amendments would also be made to @ 170.2,170.3,171.5, and 171.16.
Public Comments on the Original Proposed Rule The NRC reviewed the comments received on the December 27,1991, proposed rule in developing both the proposed rule published on December 2,1998 (63 FR 66492) and this proposed rule. There were 26 comment letters received from a variety of sources including private and publicly held corporations, private citizens, citizens groups, the Armed Forces, and State governments. These comments have been considered to the extent applicable to each rule. A detailed analysis of the comments received on the December 27,1991, proposed rule, which was withdrawn by the notice of proposed rulemaking on December 2,1998, is not presented in either of the subsequent proposed rules because many of the specific comments pertain to specific provisions that have been withdrawn, a great deal of time has passed since these comments were made, and additional opportunity for comment is being provided.
Interim Enforcement Policy
?
On (Insert publication date of interim enforcement policy)(63 FR ), the Commission established an interim enforcement policy for violations of 10 CFR 31.5 that licensees discover and report during the initial cycle of the registration program. This policy supplements the 20
a
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L normal NRC Enforcement Policy in NUREG-1600, Rev.1. It will remain in effect through one complete cycle of the registration program.
Under the normal NRC Enforcement Policy, significant violations, such as those involving lost sources, could have resulted in escalated enforcement action including civil penalties. The interim policy provides that enforcement action normally will not be taken for i
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\\
violations identified by a licensee and reported to the NRC if appropriate corrective action is j
taken. For the period that the interim policy is in effect, it also applies to general licensees not subject to the registration requirement if they identify and report violations and take appropriate corrective action. This change in the NRC Enforcement Policy was intended to remove any
' disincentive to identify deficiencies that might be caused by a concern over potential enforcement action.:This action should encourage general licensees to search their facilities to i
ensure sources are located, to determine if applicable requirements have been met, and to develop appropriate corrective action when deficiencies are found.' A Notice of Violation (NOV) without a civil penalty still may be issued if the NRC staff believes that taking this action is justified by the safety significance of the violation or the need to record and document the general licensee's corrective action in the formal manner required in a response to an NOV.
In addition, escalated enforcement action still will be considered for violations involving i
failure to provide the information requested, failure to take appropriate corrective action, or for wil%4 violations including the submittal of false information or refusing to pay required fees.
Sanction's in those situations may include significant civil penalties as well as orders to limit or revoke the authority to possess radioactive sources under a general license.
- i As noted in the earlier proposed rule notice of December 2,1998, the Commission also j
L'
. plans to increase the civil penalty amounts specified in its Enforcement Policy in NUREG 1600, Rev.1, for violations involving lost or improperly disposed sources or devices. This would be to i
21 l
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c ensure that,'atter the mnesty period, 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), the proposed rule will be a matter of compatibility between the NRC and the Agreement States, thereby providing
^
Lconsistency among State and Federal safety requirements. The revisions to Part 32 would be classified as Category B; the entire section 31.5 (including existing regulations) would become
~ Category C; and the revisions to Parts 30,170, and 171 and the additional revisions to Part 31 would be Category D.
, Category B means the provisions affect a program element with significant direct transboundary implications that the State should adopt with ' essentially identical language.
- Category C means the provisions affect a program element, the essential objectives of which should be adopted by the State to avoid conflicts, duplications or gaps. The manner in which the essential objectives are addressed need not be the same as NRC provided the essential objectives are met.1 Category D means the provisions are not required for purposes of i:
compatibility; however, if adopted by the State, they should be compatible with NRC.
Environmentalimpact: Categorical Exclusion 4
The NRC has determined that the revisions proposed in this rule are the types of actions 2 described in the categorical exclusions in 5 51.22(c)(1) through (3). Therefore, neither an i
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. environmental impact statement nor an environmental assessment has been prepared for this regulation.
Paperwork Reduction Act Statement This proposed rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq). This rule has been submitted to the
' Office of Management and Budget for review and approval of the information collection requirements.
Approval of the Office of Management and Budget for the public reporting burden from the registration process was requested in conjunction with the proposed rule of December 2, 1998.
The pLblic reporting burden for this information collection is estimated to average
' 4 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the information collection. The time involved is small because most of the proposals are minor revisions to existing information collection requirements.
Regulatory Flexibility Analysis As required by the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commission has evaluated the impact of this rule on small entities. The Commission certifies that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The most significant cost of this proposed rule would be the registration fee of $370.
23 5'-_
1 The proposed rule would apply to the approximately 45,000 persons using products under an NRC general license, many of whom may be classified as small entities. However, the j
registration requirement and associated fee would apply to about 6000 of these general licensees. The NRC believes that the fees will not present a significant economic impact on these licensees and that the economic impact of the additional proposed requirements on any general licensee would be a negligible increase in administrative burden. The proposed rule' would also revise requirements for specifically licensed distributors of certain generally licensed devices. Most of these licensees are not small entities and the impact to any of these d5tributors would not be significant in any case.
l Backfit Analysis i
I i
The NRC has determined that the backfit rule,10 CFR 50.109, does not apply to this j
' proposed rule and, therefore, a backfit analysis is not required because these amendments i
would not involve any provisions that would impose backfits as defined in 10 CFR 50.109(a)(1).
i List of Subjects l-I l'
i 10 CFR Part 30 - Byproduct material, Criminal penalties, Government contracts, intergovernmental relations, Isotopes, Nuclear materials, Radiation protection, Reporting and recordkeeping requirements.
24 J
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10 CFR Part 31 - Byproduct material, Criminal penalties, Labeling, Nuclear materials, Packaging and containers, Radiation protection, Reporting and recordkeeping requirements, Scientific equipment.
10 CFR Part 32 - Byproduct material, Criminal penalties, Labeling, Nuclear materials, Radiation protection, Reporting and recordkeeping requirements.
10 CFR Part 170 - Byproduct material, import and export licenses, Intergovernmental relations, Non-payment penalties, Nuclear materials, Nuclear power plants and reactors, Source material, Special nuciear material.
- 10 CFR Part 171 - Annual charges, Byproduct material, Holders of certificates, registrations, approvals, Intergovernmental relations, Non-pay ant penalties, Nuclear materials, Nuclear power plants and reactors, Source material, Special nuclear material.
For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C.
552 and 553, the NRC is proposing to adopt the following amendments to 10 CFR Parts 30,31, 32,170, and 171.
25
PART 30 - RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL
- 1. The authority citation for Part 30 continues to read as follows:
Authority: Secs. 81, 82,161,182,183,186, 68 Stat. 935, 948, 953, 954, 955, as amended, sec. 234,83, Stat. 444, as amended, (42 U.S.C. 2111,2112,2201,2232, 2233, 2236, 2282); secs. 41, 5842, 5846).
Sec. 30.7 also issued under Pub. L.95-601, sec.10,92 Stat. 2951 as amended by Pub.
L.102-486; sec. 2902,106 Stat. 3123, (42 U.S.C. 5851). Section 30.34(b) also issued under sec.184,68 Stat. 954, as amended (42 U.S.C. 2234). Section 30.61 also issued under sec. 187,68 Stat. 955 (42 U.S.C. 2237).
- 2. Section 30.31 is revised to read as follows:
9 30.31 Types of Licenses l
Licenses for byproduct material are of two types: General and specific. Specific licenses are issued to named persons upon applications filed pursuant to the regulations in this part and Parts 32-36, and 39. Generallicenses are effective without the filing of applications with the Commission or the issuance of licensing documents to particular persons, although registration with the Commission may be required by the particular general license.
26
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- 3. Section 30.34 is amended by revising paragraph (h)(1) to read as follows-l
' 6 30.34 Terms and conditions of licenses (h)(1) Each general licensee subject to the registration requirement in 6 31.5(c)(13) and each specific licensee shall notify the appropriate NRC Regional Administrator, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy under any
)
chapter of title 11 (Bankruptcy) of the United States Code by or against:
- (i).The licensee; j
(ii) An entity (as that term is defined in 11 U.S.C.101(14)) controlling the licensee or listing the license or licensee as property of the estate; or (iii) An affiliate (as that term is defined in 11 U.S.C.101(2)) of the licensee.
PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL l
- 4. The authority citation for Part 31 continues to read as follows:
i Authority: Secs. 81,161,183,68 Stat. 935,948,954, as amended (42 U.S.C. 2111,
- 2201, 2233); secs. 201, as amended, 202, 88 Stat.1242, as amended, 1244 (42 U.S.C. 5841, 5842).
Section 31.6 also issued under sec. 274,73 Stat. 688 (42 U.S.C. 2021).
27 a
5.- Section 31.1 is revised to read as follows:
. $ 31.1 Purpose and scope This part establishes general licenses for the possession and use of byproduct material contained in certain items and a general license for ownership of byproduct material. Part 30 of this chapter also contains provisions, as specified in 31.2 or the particular general license, applicable to the subject matter of this part.,
- 6. Section 31.2 is revised to read as follows:
$ 31.2 Terms and conditions.
The general licenses provided in this part are subject to the general provisions of.
Part 30 of this chapter ($$ 30.1 through 30.10) and the provisions of ff 30.14(d),30.34(a) to
- (e),30.41,30.50 to 30.53,30.61 to 30.63, and Parts'19,20, and 21, of this chapter' unless
. indicated otherwise in the language of the general license.
- Attention is directed particularly to the provisions of the regulations in Part 20 of this chapter that relate to the labeling of containers.
28
F.
- 7. Section 31.5 is amended by revising paragraphs (b) and (c)(5),(8), and (9) and adding paragraphs (c)(12), (13), (14), and (15) to read as follows:
$ 31.5 Certain measuring, gauging, or controlling devices.:
(b) The general license in paragraph (a) of this section applies only to byproduct material contained in devices which have been manufactured or initially transferred and labeled 1
in accordance with the specifications contained in a specific license issued pursuant to 32.51 of this chapter or in accordance with the specifications contained in a specific license issued by an Agreement State which authorizes distribution of the devices to persons generally licensed by the Agreement State and which have been received from one of these specific licensees or through a transfer pursuant to paragraph (c)(9) of this section.
(c)
(5) Upon the occurrence of a fai!ure of, or damage to, or any indication of a possible
)
failure of or damage to, the shielding of the radioactive material or the on-off mechanism or indicator, or upon the detection of 0.005 microcurie or more removable radioactive material, shallimmediately suspend operation of the device until it has been repaired by the manufacturer or other person holding a specific license pursuant to parts 30 and 32 of this chapter or from an Agreement State to repair such devices, or disposed of by transfer to a person authorized by a specific license to receive the byproduct material contained in the device and, within 30 days, furnish to the Director of Nuclear Material Safety and Safeguards, 2 Persons possessing byproduct meterial in devices under a generallicense in 6 31.5 before
- January 15,1975, may continue to possess, use, or transfer that material in accordance with the labeling requirements of 9 31.5 in effect on January 14,1975.
(
29 r
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. U.S. Nuclear Regulatory Commission, Washington, DC 20555, a report containing a brief description of the event and the remedial action taken; and, in the case of detection of 0.005 microcurie or more removable radioactive material or failure of or damage to a source likely to l
' result in contamination of the premises or the environs, a plan for ensuring that the premises
. and environs are acceptable for unrestricted use; (8) Except as provided in paragraph (c)(9) of this section, shall transfer or dispose of the device containing byproduct material only by transfer to persons authorized to receive the device by a specific license issued under parts 30 and 32 of this chapter, a specific license issued under part 30 of this chapter that authorizes waste collection, or a specific license issued under equivelent regulations of an Agreement State. Within 30 days after transfer of a device to a specific licensee shall furnish to the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555 a report containing identification of the device by manufacturer's name, model number, and serial number and the name, address, license number of the person receiving the device, and the date of the transfer. No report is required if the device is transferred to the specific licensee in order to obtain a
~
replacement device. Devices may be transferred to other specific licensees only with written NRC approval prior to transfer; (g) Shall transfer the device to another general licensee only:
i I-(i) Where the device remains in use at a particular location. In such case, the transferor shall give the transferee a copy of this section and any safety documents identified in the label of the device and within 30 days of the transfer, report to the Director of Nuclear Material Safety
- and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, the 1
30
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manufacturer's name and model number and serial number of the device transferred, the name and address of the transferee, and the name and phone number of the individual designated by the transferee in accordance with 9 31.5(c)(12) to be responsible for ensuring compliance with the appropriate regulations and requirements; or (ii) Where the device is held in storage by an intermediate person in the original shipping container at its intended location of use prior to initial use by a general licensee.
(12) Shall appoint an individual to act for the general licensee as responsible for ensuring the day-to-dav compliance with the appropriate regulations and requirements. This i
appointment does not relieve the generallicensee of responsibility in this regard.
(13)(i) Shall register devices containing at least 370 MBq (10 mci) of cesium-137, j
i 3.7 MBq (0.1 mci) of strontium-90,37 MBq (1 mci) of cobalt-60, or 37 MBq (1 mci) of americium-241 or any other transuranic in accordance with paragraphs (c)(13)(ii) and (iii) of this section.
(ii) If in possession of a device (s) meeting the criteria of paragraph (c)(13)(i) of this section, shall register these devices annually with the Commission and shall pay the fee required by 6170.31 of this chapter.' This must be done by verifying, correcting, and/or adding to the information in a request for registration received from the Commission. _ The registration information must be submitted to the NRC within 30 days of the date of the request for registration or as otherwise indicated in the request. In addition, general licensees holding devices meeting the criteria of paragraph (c)(13)(i) of this section are subject to the bankruptcy notification requirement in 6 30.34(h) of this chapter.
(iii) In registering devices, the general licensee shall furnish the following information and any other information as may be specifically requested by the Commission:
31
s (A) Name and mailing address of the generallicensee.
(B) Information about each device: the manufacturer, model number, serial number, the radioisotope and activity (as indicated on the label).
(C) Name and telephone number of the responsible person designated as a
. representative of the general licensee under $ 31.5(c)(12).
'(D) Address at which the device (s) are used and/or stored. For portable devices, the address of the primary place of storage.
(E) Certification by the responsible representative of the generallicensee that the information concerning the device (s) has been verified through a physical inventory and checking of labelinformation.
(F) Certification by the responsible representative of the generallicensee that they are aware of the requirements of the generallicense.
(14) Shall report changes of address, within 30 days after the moving of a du.., to the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555. For portable devices, this only applies to the device's primary place of storage.
(15) Shall not hold devices that are not in use for longer that two years. If devices are not being used, the shutter must be locked in the closed position. The testing required by paragraph (c)(2) of this section need not be performed during the period of storage only.
However, when devices are put back into service or transferred to another person, and have not been tested within the required test interval, they must be tested for leakage before use or transfer and the shutter tested before use.
I 32 i
p.
PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL l
- 8. The authority citation for Part 32 continues to read as follows:
Authority: Secs. 81,161,182,183,68 Stat. 935,948,953,954, as amended (42 U.S.C. 2111,2201,2232,2233); sec. 201,88 Stat.1242, as amended (42 U.S.C. 5841).
l
- 9. Section 32.51 is amended by adding paragraphs (a)(4) and (5) to read as follows:
6 32.51 Byproduct material contained in devices for use under 9 31.5; requirements far license to manufacture, or initially transfer.
(a)
(4) For devices in which there is a separable source housing that provides the primary shielding for the source, the source housing must also bear a durable label containing the device model number and serial number, the isotope and quantity, the words, " Caution-Radioactive Material," the radiation symbol described in 20.1901 of this chapter, and the name of the manufacturer or initial distributor.
(5) For devices that meet the criteria of 6 31.5(c)(13)(i), a permanent (e.g., embossed, etched, stamped, or engraved) label must be affixed to the source housing if separable, or the device if the source housing is not separable, that includes the words," Caution-Radioactive Material," and, if practicable, the radiation symbol described in 20.1901 of this chapter.
33
E. -
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f
- 10. Section 32.51a is amended by revising paragraphs (a) and (b) and adding paragraphs (c) and (d) to read as follows:
$ 32.51a Same: conditions of licenses (a) Prior to transfer of a device to a general licensee, furnish copies of the general
'j license contained in 9 31.5 of this chapter and of 6 31.2,30.51,20.2201, and 20.2202 of this chapter, a list of the services that can only be performed by a specific licensee, and information i
on acceptable disposal options including estimated costs of disposal to each person to whom i
he directly or through an intermediate person transfers byproduct material in a device for use under the general license contained in 6 31.5 of this chapter.
(b) Prior to trancier of a device to a generallicensee, furnish a copy of the Agreement State's regulations equivalent to @ 31.5,31.2,30.51,20.2201, and 20.2202 of this chapter, or alternatively, furnish a copy of 6Q 31.5,31.2,30.51,20.2201, and 20.2202 of this chapter, to each person to whom he directly or through an intermediate person transfers byproduct
.1 rn'aterialin a device for use pursuant to the generallicense of an Agreement State. Also furnich I
the name, address, and phone number of the contact at the Agreement State regulatory agency from which additionalinformation may be obtained. If a copy of the generallicense in 31.5 of this chapter is furnished to such person, it shall be accompanied by a note explaining that use of the device is regulated by the Agreement State.
(c) Label each device transferred after (insert date one year after the effective date of this rule) in accordance with the labeling requirements in 32.51(a)(3) through (5).
34
(d) If a notification of bankruptcy has been made under 30.34(h) or the license is to be
)
terminated, provide, upon request, to the NRC and to any appropriate Agreement State, records of final disposition required under 9 32.52(c).
i
- 11. Section 32.52 is revised to read as follows:
j
' $ 32.52 Same: material transfer reports and records.
Each person licensed under 32.51 to initially transfer devices to generally licensed persons shall:
(a) Report quarterly to the Director of the Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, all transfers of devices to persons for use under the general license in 6 31.5 of this chapter. Submit the report on Form XXX " Transfers of Industrial Devices Report," or on a clear and legible report j
containing all of the data required by the form. The required infom:ation includes: the identity of each generallicensee by name and address; the name and phone number of the person designated by the generallicensee to be responsible for ensuring compliance with the appropriate regulations and requirements; the date of transfer; the type, model number, and serial number of the device transferred; and the quantity and type of byproduct material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report must include the same information for each intermediate person, and clearly designate that person as an intermediate person. If the device transferred replaced another returned by the general licensee, report also the type, model number, and serial number of the one returned. if no transfers have been made to persons generally licensed under 31.5 of this chapter during the 35
T 9
reporting period, ' he report must so indicate. The ;eport must cover each calendar quarter, t
' must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report. The report must clearly identify the specific licensee submitting
~
i
~ the report and include the license number of the specific licensee.
. (b) Report to the responsible Agreement State agency all transfers of devices to
- persons for use under a general license in an Agreement State's regulations that are equivalent to 6 31.5 of this chapter. Submit the report on Form XXX " Transfers of Industrial Devices Report," or on a clear and legible report containing all of the data required by the form. The required information includes: the identity of each general licensee by name and address; the name and phone number of the person designated by the general licensee to be responsible l for ensuring compliance with the appropriate regulations and requirements; the date of transfer; the type, model number, and serial number of the device transferred; and the quantity and type of byproduct material contained in the device. If one or more intermediate persons will
. temporarily posse'ss the device at the intended place of use prior to its possession by the user, the report must include the same information for each intermediate person, and clearly designate that individual as an intermediate person. The report must be submitted within 30 days after the end of each calendar quarter in which such a device is transferred to the '
L generally licensed person and clearly indicate the period covered by the report. If the device transferred replaced another returned by the general licensee, report also the type, model number, and serial number of the one returned. The report must clearly identify the specific
- .: ; licensee submitting the report and must includ'e the license number of the specific licensee. If
- no transfers have been made to a particular Agreement State during the reporting period, this
' nformation shall be reported to the responsible Agreement State agency upon request of the i
- agency.
36 "c
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(c) Keep records of all transfers of devices for each general licensee including all the information in the reports required by this section and records of final disposition. Records required by this paragraph must be maintained for a period of three years following the estimated usefullife of the device or the date of final disposition,if known.
PART 170 - FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED
- 12. The authority citation for Part 170 continues to read as follows:
Authority: 31 U.S.C. 9701; sec. 301, Pub. L. 92 - 314,86 Stat. 222 (42 U.S.C. 2201w);
sec. 201,88 Stat.1242, as amended (42 U.S.C. 5841); sec. 205, Pub. L.101 - 576,104 Stat.
2842, (31 U.S.C. 902).
- 13. Section 170.2 is amended by adding a paragraph (r) to read as follows:
9170.2 Scope.
(r) A holder of a general license granted by 10 CFR Part 31 who is required to register a device (s).
l 37
- 14. In Section 170.3, the definition of Materials License is revised to read as follows:
$ 170.3 Definitions.
Materials License means a license, certificate, approval, registration, or other form of permission issued or granted by the NRC pursuant to the regulations in 10 CFR parts 30,31 through 36,39,40,61,70,71 and 72.
- 15. Section 170.31 is amended by adding a fee category,3. Q. to the schedule of materials fees and revising footnote 1 by adding a paragraph (f).
9 170.31 Schedule of fees for materials licenses and other regulatory services, including inspections, and import and export licenses.
Schedule of Materials Fees Category of materials licenses and types of fees Fee *#
3.
O. Registration of a device (s) generally licensed pursuant to Part 31.............................S370
' Types of fees J
(f) Generallylicensed device registrations under 10 CFR 31.5. Submittals of registration information must be accompanied by the prescribed fee.
i 38 j
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Part 171 - ANNUAL FEES FOR REACTOR OPERATING LICENSES, AND FUEL CYCLE LICENSES AND MATERIALS LICENSES, INCLUDING HOLDERS OF CERTIFICATES OF COMPLIANCE, REGISTRATIONS, AND QUALITY ASSURANCE PROGRAM APPROVALS AND GOVERNMENT AGENCIES LICENSED BY THE NRC
- 16. The authority citation for Part 171 continues to read as follows:
Authority: Sec. 7601, Pub. L.99-272,100 Stat.146, as amended by sec. 5601, Pub. L.
100-203,101 Stat.1330, as amended by sec. 3201, Pub. L.101-239,103 Stat. 2106 as i
amended by sec. 6101, Pub. L.101-508,104 Stat.1388 (42 U.S.C. 2213); sec. 301, Pub. L.92-314,86 Stat. 222 (42 U.S.C. 2201(w)); sec. 201,88 Stat.1242 as amended (42 U.S.C.
5841; sec. 2903, Pub. L.102-486,106 Stat. 3125 (42 U.S.C. 2214 note).
- 17. In Section 171.5, the definition of Materials License is revised to read as follows:
9171.5 Definitions.
Materials License means a license, certificate, approval, registration, or other form of permission issued or granted by the NRC pursuant to the regulations in 10 CFR Parts 30,31 through 36, 39, 40, 61, 70, 71, and 72.
I
- 18. In Section 171.16, paragraph (d) is revised by adding a fee category,3. O. to the schedule of annual fees.
39
g 171.16 Annual fees: Material Licensees, Holders of Certificates of Compliance, Holders of Sealed Source and Device Registrations, Holders of Quality Assurance Program Approvals and Government Agencies Licensed by the NRC Schedule of Materials Annual Fees and Fees for Government Agencies Licensed uy NRC Category of materials licenses Annual fees'#3 3.
O. Registration of devices generally licensed pursuant to Part 31............................"N/A "No annual fee is charged for this category since the cost of the general license registration program will be recovered through 10 CFR Part 170 fees.
40
p.,.
AGD3-\\
FBR
(
Summary of Proposed Requirements Revisions to the Reauirements for General Licensees 6 31.5(c)(11)
Proposed in first rule - requires information be provided upon request Would be used as a basis for first round of registration.
Used only for miscellaneous requests after second rule in place Also basis for requesting information on devices no longer in possession of the general licensee (thus not subject to registration).
$ 31.5(c)(12)
Add an explicit requirement for the general licensee to appoint an individual to carry out the general licensee's responsibilities to comply with the applicable regulations 6 31.5(c)(13)
Add explicit provisions delineating a registration requirement.
Specific provisions proposed here are essentially consistent with the Commission's plans for the registration process discussed in the earlier proposed rule.
Annual registration is required for devices containing at least 370 MBq (10 mci) of cesium-137,3.7 MBq (0.1 mci) of strontium-90,37 MBq (1 mci) of cobalt 60, or 37 MBq (1 mci) of any transuranic.
Registration information:
Name and mailing address of the generallicensee.
Information about each device: the manufacturer, model number, serial number, the radioisotope and activity.
Name and telephone number of the responsible person designated as a representative of the generallicensee under @ 31.5(c)(12).
Address at which the device (s) are used and/or stored. For portable i
devices, the address of the primary place of storage.
Certification that the information concerning the device (s) has been verified through a physical ir.ventory and checking of label information.
Certification by the respenf ible representative of the general licensee that they are aware of the requirements.
$ 31.5(c)(14)
Add provision to notify NRC in the event of change of address.
$ 31.5(c)(15)
Add a provision that limits the amount of time a generallicensee can keep a device in storage unused and that also allows the deferment of testing during the period of storage only revision to 6 31.5(c)(8)
Provision to allow transfers to specific licensees other than Part 32 licensees, but only with specific NRC approval
('
Add the recipient's license number and the date of transfer to the information required to i
be provided to NRC upon a transfer of a device L
revision to 6 31.5(c)(5) l'
i l
Add a plan for ensuring that premises are suitable for unrestricted access to the information that must be sent to NRC in the case of a failure, if the failure results in contamination of premises revision of f 31.1 Clarify that only those paragraphs of Part 30 specified in Q 31.2 apply to Part 31 general licensees.
revision of f 31.2 Clarify which regulations apply to all of the generallicensees under Part 31.
Include reference to the requirements of:
$ 30.7," Employee protection,"
9 30.9, " Completeness and accuracy of information," and
@ 30.10, " Deliberate misconduct."
revision of $ 30.34(h)
Applicability of bankruptcy notification to general licensees is also in need of clarification; this proposed rule would make it applicable only to those general licensees subject to the registration requirement.
revision of f 170.31 Add a fee assessed in conjunction with the registration process, $370 (one fee per generallicensee regardless of number of devices isgistered).
Reauirements for Manufacturers and initial Distributors of Devices Reportina reauirements revisions of 5 32.52(a) and (b)
Would modify the quarterly transfer reporting to add:
t'le serial number and model number of the device (The model number of the device is already required in reports to Agreement States.);
the date of transfer; Indication if device is a replacement, and if so, the type, model number, and serial number of the one returned; name and license number of reporting company; and the specific reporting period.
The name and phone number of the person designated by the generallicensee to be responsible for ensuring compliance with the appropriate regulations will replace that of a simple contact between the Commission and the general licensee.
A form will be provided for use in making these reports; however, the use of the form would not be required as long as the report is clear and legible and includes all of the required information.
Recordkeepina reauirements revision of f 32.52(c).
Records of transfers would have the period of retention extended to 3 years after the l
expected usefullife of the device or the final disposition,if known.
Add requirement for records on final disposition of devices
3 5 32.51a(d)
Add requirement to provide upon request to the NRC and appropriate Agreement States, records of final disposition of devices in the case of bankruptcy or termination of license.
Labelina reauirements
% 32.51(a)(4) and (5) and 9 32.51a(c)
Add requirement for:
A label on any separable source housing, and A permanent label on devices meeting the criteria for registration information distributors reauired to orovide to the ceneral licensees revisions to 9 32.51a(a) and (b)
Would require that & 31.5 be provided prior to transfer (rather than at transfer)
Add requirement for:
Copies of additional applicable sections of the regulations A listing of services that can only be performed by a specific licensee, and Information regarding disposal options for the devices being transferred. The disposal options would include the cost of disposing of the device at the end of its useful life to the extent that the cost information is available to the specific licensee at the time of the sale of the device.
In the case of generallicensees in Agreement States, the name, address, and phone number of the contact at the Agreement State regulatory agency from which additional information may be obtained.
Miscellaneous Additional clarifying amendment would be made in Q 30.31 and 31.5(c)(9)(ii).
Minor conforming amendments would also be made to 170.2,170.3,171.5, and 171.16.
7 AGo3-I PDR REGULATORY ANALYSIS:
. REQUIREMENTS FOR THE POSSESSION OF INDUSTRIAL 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 general license to possess and use byproduct material in certain devices designed and manufactured for the purpose of detecting, measuring, gauging, or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition or for producing light or an ionized atmosphere. The devices had to be manufactured in accordance with the specifications contained in a specific license issued either by the Commission under 10 CFR Parts 30 and 32, or by an Agreement State.
Today, there are approximately 45,000 " general licensees," i.e., persons possessing and using such devices under the general license ($ 31.5). These general licensees possess an estimated 600,000 devices.
A general licensee under the jurisdiction of the Commission is required to follow safety instructions on device labels and to test or service a device (with some exceptions) or to have the testing or servicing performed by the supplier or other specific licensee authorized to manufacture, install, or service the devices. Additionally, generallicensees may not abandon devices, and must maintain records concerning the testing and servicing of these devices.
Further, 6 31.5(c)(8) requires general licensees to transfer or dispose of the generally licensed devices only to the holder of a specific license under Parts 30 and 32 or to the holder of a specific license issued by an Agreement State. Section 31.5(c)(9) provides a limited exception to this requirement that allows general licensees to transfer the devices to other general licensees, but only if the device remains in use at a particular location or the device is held in storage in the original shipping container before initial use. In either case, transfers of devices by general licensees must be reported to the NRC within 30 days of the transfer. No report of a transfer is required if a generally licensed device is transferred to a specific licensee in order to obtain a replacement device. ' General licensees must also report damage to or loss of devices.
Specific licensees making the transfer of generally licensed devices are required as part of its specific license to maintain records of the transfer and to be accountable for all radioactive materialin its possession. The NRC is notified by specific licensees when these licensees transfer devices containing byproduct material to general licensees through quarterly reports submitted under 6 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 byproduct material contained in the device. Under compatible Agreement
. State regulations, similar information is obtained from suppliers in Agreement States on transfers to NRC generallicensees.
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7 L1.2 NRC Study of Conformity with General License Conditions
- The NRC traditionally has had little contact with'generallicensees. The NRC staff believes that
! this may account for why many general licensees are not aware of their responsibilities under a
- general license and that this results in incidents of mishandling and improper disposition of generally licensed devices. Mishandling and improper disposition of generally licensed devices, in turn, has resulted in radiation exposure to the public and, in some cases, has entailed expensive investigation, cleanup, and disposal activities. In most instances, exposures to the public have not been significant. However, these exposures would probably not have occurred
- lf the devices had been properly handied and disposed of.
The Commission conducted a study from 1984 through 1986 (General License Study) to ascertain the extent of compliance with general license conditions after it became aware of a
. few incidents where control over generally licensed devices was lost. The results of the study were discussed in SECY-87-167, dated July 9,1987, and in SECY-89 289, dated September 14,1989. Although current regulations ($ 30.52). allow for the inspection of licensees possessing byproduct material, the Commission does not inspect general licensees on a regular basis primarily because of the large number of these licensees and the low risk presented by most of these devices. The Commission's knowledge of whether general licensees are complying with the regulations for the proper use and disposal of generally licensed devices is limited.
Because of the broad range of devices covered under 9 31.5, the study was divided into two
- parts. The first part covered industrial gauging and measuring devices, such as large-scale level, density, and thickness monitors..There were then approximately 10,000 Commission licensed devices in this category containing sources with activities in the 0.5 to 1 curie range.
' The second part of the study covered devices which greatly varied in design and use, such as self-luminous signs, analytical instruments such as x-ray fluorescence spectrometers or liquid scintillation spectrometers, and smaller scale thickness, density, and level gauges. A summary of the results of the study presented below is based on an unpublished NRC report entitled.
" General License Study Report."
1.2.1 Part i Results The Part I study included 228 site surveys of general licensees by the study task force and 132 inspections conducted by NRC regional offices. Some Agreement States also contributed data
' to the " General License Study." The information gathered by the study, although from a small sample of general licensees possessing large-scale gauges, clearly established that there is a Loompliance problem, Among the findings of Part I were the following:
Approximately is percent of these general licensees could not account for all of
- their gauges.
A majority of these general licensees either did not notify the NRC of transfers of their gauges or improperly transferred their gauges.
At least 25 percent of these general licensees were not performing required leak tests or maintaining leak test records, or they were not inspecting a gauge's on/off shielding mechanisms or not inspecting them as required.
2
r Agreement States reported incidents of thickness gauges being found in landfills and, in one case, even in an abandoned paper mill.
1.2.2 Part il Results Although Part 11 of the study covered devices that vary greatly in design and use, the range of problems encountered in Part ll is exemplified by the problem relating to self-luminous exit signs and beta backscatter gauges. Exit signs, which sre one of the most common devices covered 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 1
concern about these' devices is the accountability of the removable source which is about one inch in diameter. Ninety-eight interviews were conducted of persons who possess these types of devices. The findings of Part ll are summarized below:
)
Nonconformity with general license conditions was very widespread.
Only 16 percent of the general licensees for exit signs were aware of the regulatory requirements.
Manufacturers and distributors frequently under reported the number of exit signs sold to general licensees. General licensees (electrical distributors and contractors) reported having about 30 percent more signs than were listed in quarterly reports of the manufacturers.
Three cases involved missing sources from beta backscatter gauges.
Only 45 percent of those surveyed for backscatter gauges were aware of the generallicense conditions.
Vendor reports did not accurately reflect the number of radioactive sources in the possession of generallicensees. When sources were returned by general
. licensees to the manufacturer for disposal, the NRC was not always notified.
Hence, NRC records were not always accurate.
1.3 Subsequent Actions
. On December 27,1991 (56 FR 67011), the NRC published a notice of proposed rulemaking regarding the accountability of generallicensees under 6 31.5. It proposed a number of provisions, including a requirement for these licensees to provide information at the request of the NRC in order to provide the regulatory basis for the registration of these devices. The
. proposed rule also would have added requirements in $$ 32.51a and 32.52 for specific licensees who manufacture or initially transfer these devices to the general licensees. Although the public comments received were reviewed and a final rule developed, that rule was not issued because resources to implement the proposed rule properly were not available.
The NRC has continued to consider the issues related to the loss of control of generally licensed, as well as specifically licensed, sources of radioactivity. In July 1995, the NRC, with assistance from the Organization of Agreement States, formed a working group to evaluate these issues. The working group consisted of both NRC and Agreement State personnel and encouraged the involvement of all persons having a stake in the process and its final i recommendations. All working group meetings were open to the public. A final report was
- completed in July of 1996 and published in October of 1996 as NUREG-1551, " Final Report of 3
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the NRC-Agreement State Workir$g Group to Evaluate Control and Accountability of Licensed L
Devices."
One of the conclusions of the working groep is that general licensees possessing certain identified devices should report annually to their regulatory authority 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. This was the basis for the recent rule proposed on (In sert date)( FR )(Rule 1) which would revise Part 31 to add an explicit requirement that general licensees under 6 31.5 respond to requests from NRC for information.
' The intent is to use that provision to institute a registration program for devices recommended by the Working Group for enhanced regulatory oversight.
. The additional recommendations of the working group provide the major basis for this 1-rulemaking, which, among other things, would provide more e::plicit provisions with regard to a registration program. For general licensees using devices containing at least 10 mci of i
cesium-137,0.1 mci of strontium-90,1 mci of cobalt-60, or 1 mci of any transuranic, the i
working group recommended the following:
Licensees must assign a Responsible Individual (RI) and a Backup Responsible Individual (BRI). The RI and BRI must each be an individual that has the authority and responsibility for compliance.
Licensees must perform, at intervals not to exceed six months and maintain records of; (1) physical inventories of devices including reconciliation of any discrepancies with previous inventories, and (2) inspections of each device for proper labeling including correction of any deficiencies.
Licensees must keep current inventory records.
Licensees must report changes concerning the RI and BRI and transfers or i
o disposalof devices.
Licensees must report immediately following the filing of a voluntary or involuntary petition for bankruptcy.
For vendors of the same devices, the working group recommended the following:
Vendors must report transfers quarterly and the report must include the name, telephone number, and mailing address of the recipient, the address of use of
' the device, the model number and serial number of the device, the isotope and activity, any intermediate holders of the device, including the function of the intermediate holders, the specific reporting period covered by the report, and the
- name and license number of the reporting company.
' Vendors must maintain records of transfer for all devices they have distributed,
' including final disposition, if known. The records must be maintained for three years after final disposition of the device.
Vendors must provide recipients with disposal information prior to transfer of the device.
Vendors must ensure each device, or separable source housing, is labeled with
' the model number and serial number, the isotope and activity, the trefoil symbol, the words " Caution - Radioactive Material," and the name of the device vendor.
Vendors must ensure that source housings are permanently marked (e.g.,
engraved or embossed) with the trefoil symbol and the words " Caution -
Radioactive Material," as practicable.
4 a
For both NRC and Agreement States, the. working group recommended the following:
i NRC and Agreement States must verify that all transfers by their users are in accordance with their regulations and license conditions.
NRC and Agreement States must compare the annual inventories reported by their users against previous inventories and against transfer reports from vendors and other users. This provides an independent verification that licensees have maintained accountability and control of the devices.
NRC and Agreement States must resolve any discrepancies in the information l
I-with the assistance of the licensees.
NRC and Agreement States must acknowledge to their licensees that the l
transfers and inventories have been reviewed.
2 OBJECTIVES l
The objectives of the amendments to Parts 31 and 32 of the Commission's regulations are to ensure that certain general licensees are aware of and understand the requirements attendant to the possession of generally. licensed devices containing byproduct material and to better enable the NRC to verify the location, use, and disposition of such devices. The intent is to reduce the possibility of the devices being improperly transferred or inadvertently discarded
^
and, ultimately, to avoid unnecessary radiation exposure to the public and unnecessary expense involved in retrieving the items, particularly in the scrap metal stream, as well as to avoid the contamination of steel mills, metals, and waste products.
3 ALTERNATIVES
~3.1 No action.
This attemative is to continue the status quo. As costs and benefits are evaluated in terms of changes from the status quo, there are no costs or benefits associated with this alternative. In this case, it is assumed for the purpose of analysis, that Rule 1 is made effective and costs and benefits are evaluated as changes from a base case of having that rule in place and l
-implementing a registration program under that provision.
No action, of course, does not address identified concerns. In the past, the only communication between a general licensee and the NRC was through the requirement that the NRC be notified
~ hen a device containing byproduct material was transferred. Information notices have been w
sent and inspections have been made but only rarely.
As discussed in Section 1.2 of this analysis, generallicensees have a lack of awareness of their y
responsibilities under a general license. 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 public and, in some cases, entailed expensive investigation, cleanup, and disposal activities. Rule 1 would
- begin to address this problem, but in a limited way. It does not require compatibility of l
Agreement State regulations, so only approximately one third of genera ~lly licensed devices
. meeting the criteria for enhanced oversight will be covered. It was estimated in the regulatory analysis for that action that it would affect about 20% of the devices presenting a significant risk in the case of loss (the other 80% being generally licensed under Agreement State regulations i
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or held by spelfic licensees).: it was also assumed that it would conceivably cut the rate of loss within this population by roughly one half, thus reducing the impacts from lost sources by 10%
Also, Rule 1 will not completely address the factors discussed in the next section concerning knowledge of the regulations reaching the appropriate persons.
No action would not be appropriate because the factors listed in the preceding paragraph
- should be addressed.
3.2 Non-rulemaking alternatives -
With respect to the problem of lack of awareness of regulatory requirements on the part of general licensees, there are a number of approaches that could be considered. Guidance could be provided in a number of forms; however, periodic contact with the general licensees would be expected to have the most significant impact on the level of awareness of requirements. ; The most appropriate means to remind users of their responsibilities would be periodic issuance of information notices; however, these information notices may not reach all users. While 6 32.52 requires that specific licensee distributors report to the NRC or the Agreement State agency the name and/or. title of the individual who constitutes the point of
- contact between the general licensee and the NRC, or the Agreement State agency, the L General License Study indicated that this individual, who is frequently in the purchasing department, often did not inform the individual who uses the device of the general license conditions. Moreover, the study indicated that personnel turnover frequently destroyed 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 responsible for, or knowledgeable of, the devices after they have been received and are being used. In this case, the initial contact name received from a distributor would continue
' to not be the person responsible for the compliance with regulatioris and would present problems with the implementation of a registration program in Rule 1. The process will be more efficient if more appropriate contact information is received initially from the distributor.
Even when general licensees are aware of their basic responsibilities conceming the devices, there may be other factors contributing to noncompliance with requirements. For example, the cost of disposal may cause some general licensees to dispose of devices improperly. It is
' important that the general licensees understand that the Commission will hold them responsible for these devices.' increased inspection of generallicensees and enforcement of the requirements may improve compliance. However, without a registration system to verify compliance as well as additional requirements for general licensees such as, assigning a responsible individual, performing inventories, reporting of bankruptcy, time limit on storage of devices, and without additional requirements for vendors such as reporting Ris and serial numbers of devices transferred, providing recipients of disposal costs and maintaining transfer records including final disposition of devices as well as additional labeling requirements, their would not be sufficient regulatory requirements for general licensees to be responsible and accountable for their devices. ' Also, there would not be a large enough number of inspections and these inspections would be on a random basis and would not be very efficient.
6 t
.h--
m None of these actions would result in a high degree of accountability for these devices.
Additional requirements would be more effective in terms of accountability, and would provide a l
basis for more efficient use of inspection and enforcement efforts.
1
-3.3 Rulemaking to modify distributors labeling, reporting, and record keeping requirements and add additional provisions to the 6 31.5 general license This alternative would amend 10 CFR Parts 31 and 32 to help ensure that devices containing i
l byproduct material are maintained and transferred properly and are not inadvertently discarded.
The general mechanism would be used to make explicit provisions delineating the registration requirement so that general licensees verify compliance with certain conditions imposed by the generallicense.
In addition, the amendments to 10 CFR Parts 31 and 32 would require a general licensee to assign a responsible individual, perform inventories, report bankruptcy, limit the time on storage of devices, and would require vendors to report responsible individuals and serial numbers of devices transferred, provide recipients of disposal costs, and maintain transfer records including final disposition of devices a.s well as additional labeling requirements.
I The NRC envisions that these are elements of a well defined registration program. They offer greater assurance that a general licensee is informed of its regulatory responsibilities and will assign a knowledgeabic individual who will provide information to assist with verifying i
accountability for devices. The NRC would make periodic requests for verification to remind general licensees of their regulatory responsibilities and to reduce the likelihood that devices containing byproduct material are illegally transferred or inadvertently discarded. In addition, for specific licensees who distribute these generally licensed devices, there would be changes in the reporting, record keeping, and labeling requirements.
4 DESCRIPTION AND DISCUSSION OF PROVISIONS AND COST ESTIMATES 4.1 Rev!sions to the Requirements for General Licensees in 6 31.5 A.
Registration. Certain measuring, gauging or controlling devices ($ 31.5 (c)(13))
Section 31.5 currently grants a general license to certain individuals and contains the requirements under that license. The principal change to the general license in G 31.5 that j
would be made under this proposed rule would be to add explicit provisions delineating a registration requirement. This addition would provide general licensees with the details of the registration requirement including which devices are subject to registration and the kinds of information that will be required to be submitted by this process. Specific provisions proposed here are essentially consistent with the Commission's plans for the registration process discussed in Rule 1. Annual registration is required for devices containing at least 370 MBq (10 mci) of ceslum-137,3.7 MBq (0.1 mci) of strontium-90,37 MBq (1 mci) of cobalt-60, or 37 MBq (1 mci) of any transuranic. This provision would specifically require that the
. Information about devices be verified through a physical inventory. The registration information that would be required is as follows:
Name and mailing address of the generallicensee.
)
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information about each device: the manufacturer, model number, serial number, the radioisotope and activity.
q Name and telephone number of the responsible person designated as a j
representative of the generallicensee under @ 31.5(c)(12).
I Address at which the device (s) are used and/or stored. For portable devices, the address of the primary place of storage, i
Certification that the information concerning the device (s) has been verified a
through a physical inventory and checking of label information.
Certification by the responsible representative of the general licensee that they are aware of the requirements of the generallicense.
Cost Imoacts:
None anticipated.
The cost to industry and to the NRC of the registration process were addressed in Rule 1 and are not a result of this action. Rule 1 would require generallicensees to respond to requests from the NRC to verify information related to their general licensed devices. Specifically, it accounted for the costs associated with locating and verifying license conditions for all devices in the possession of general licensees. This rule describes the information that will be required by registrants and would not require more than verification of the current location of all devices and verification of the information as is planned to be requested under the Rule 1.
The advantage of including more explicit requirements in the regulation is that information about the registration process will be more clearly defined and more available. When the distributor of a device supplies copies of 6 31.5 to its customers (under @ 32.51a(a)), the potential general licensees will be made aware of the registration requirement, including to which devices it applies, what information will be requested, and also the fact that there will be a fee.
B.
Responsible Individual: Certain measuring, gauging or controlling devices (6 31.5(c)(12))
The proposed rule would add an explicit requirement, S 31.5(c)(12), for the general licensee to assign an individual to carry out the general licensee's responsibilities to comply with the applicable regulations.
Cost imoacts:
None anticipated.
While assignment of a person responsible to perform compliance responsibilities should already be occurring in practice, this action would make that responsibility explicit. In other words, there must already be a person who performs shutter tests, leak tests, and compliance with regulations. This proposed rule would require general licensees to designate the person who ensures the performance of shutter tests, leak tests, and compliance with regulations as the
" responsible individual."
8
T-4 C.
Storage: Certain measuring, gauging or controlling devices ($ 31.5(c)(15))
- The proposed rule would add a provision that limits the amount of time a general licensee can I
? keep a device in storage unused and would eliminate leak testing and shutter testing while a -
device is in storage.
Cost Impacts-a No anticipated cost' impact to general licensees in limiting the length of time they can store devices. The vast majority of general licensees have devices in storage because they are no -
._ longer in use due to replacement of such devices. Almost all devices that would be in storage
- for as long as two years are destined for disposal, however many in storage less that two years are put back into service. Licensees are storing devices to avoid disposal costs, however, disposal costs are inevitable.
There would be a cost savings for general licensees with the addition of j 31.5(c)(15) in the
. proposed rule. These cost savings would result from no longer requiring the performance of
" leak tests and shutter tests during storage and are estimated in section 5 on benefits.
D. ~
Transfers o' f Devices: Certain measuring, gauging or controlling devices
($ 31.5(c)(8))
- The proposed rule would add a provision to allow transfers to specific licensees other than -
Part 32 licensees, but only with written NRC approval. Also, it would add the recipient's license number and the date of transfer to the information required to be provided to NRC upon a transfer of a device. The addition of the date of transfer will make the transfer easier to track 1
and help to ensure that the general licensee makes the report in a timely way (required in i
30 days).
i This would provide some flexibility to licensees.' The addition of the license number to the
. reporting requirement increases assurance that the general licensee will transfer devices only to appropriate recipients.
Cost Imoacts:
' No anticipated costs to licensees since this proposed rijle provides for an alternative method of
- transfer which avoids licensees having to request exemptions to regulations; Currently
- licensees must transfer devices only to Part 32 licensees so they must verify that the recipient is a Part 32 licensee.-
? Assumptions:
Cost to NRC:
o Number of requests for approval per year: 100 Staff hours per submittal:
0.5 hr.
9 L_
t Professional staff hourly rate:
$70/hr Total cost per year:
.$3,500 E.
Notification Requirements: Certain measuring, gauging or controlling devices
($ 31.5(c)(14))
)
. The proposed rule would contain a provision that generallicensees notify NRC in the event of a change of address. This requirement is a necessary element of the registration program.
Without a current mailing address, the NRC would not be able to mail out the registrations.
This applies to all 6 31.5 general licensees, because it is important for NRC to keep track of all general licensees so that they can be contacted whenever the need arises and inspected.
Cost Imcacts:
Assumptions:
General Licensees:
Number changing address per year:
100 Time spent:
0.10 i
l Technical staff hourly rate
$50/hr Totallicensce cost per year:
$500 NflQ:
Number changing address per year:
100 Staff hrs per submittal:
0.10 hrs Staff hourly rate:
$70/hr Total NRC cost per year:
$700 Total cost per year:
$1,200 F.
Decommissioning Requirements: Certain measuring, gauging or controllirig devices ($ 31.5(c)(5))
The proposed rule would add, to the information that must be sent to NRC in the case of detection of 0.005 microcurie or more removable radioactive material or failure of or damage to a source likely to result in contamination of the premises or the environs, a plan for ensuring that premises are suitable for unrestricted access.
If contamination occurs at a facility, unrestricted areas must be cleaned up to a point where public health and safety is ensured. General licensees may not have adequate knowledge to evaluate the extent of decontamination activities needed due to a leaking or damaged source.
The NRC needs to evaluate, on a case by case basis, a decontamination plan to ensure t
facilities are suitable for unrestricted use. General licensee's submittals of information i
pertaining to cleanup of facilities will allow the NRC to carry out its mission. The intent is to l
provide additional assurance of the adequacy of decontamination of facilities for general l
licensees.
10
i 1
Cost imoacts:
Assumptions:
General Lic9nsees:
Number reporting (one third of total number reporting under 31.5(c)(5) per year):
7 Time spent:
8 hrs Technical staff hourly rate
$50/hr Totallicereee cost per year:
$2,800 NRC:
1 Number reporting:
7
)
Staff hrs per submittal:
2 hrs Staff hourly rate:
$70/hr Total NRC cost per year:
$980 Total cost per year:
$3,780 This is only the cost of reviewing this additional submittal of information from the general license; additional effort may be involved in resolving the contamination problem; however, this is not an impact of this revision. In fact, having the generallicensee include this additional information may reduce the overall cost of intervention for incidents of this type.
G.
Bankruptcy: Terms and canditions of licenses ($ 30.34(h))
The applicability of 30.34(h) on bankruptcy notification to general licensees needs to be clarified. This proposed rule would clarify that this requirement is applicable only to those general licensees subject to the registration requirement.
i Cost Imoacts:
None anticipated. These general licensees are currently subject to Q 30.34(h); however, this is not clear because of the lack of a reference in 6 31.2.
H.
Schedule of fees for materials licenses and other regulatory services, including inspections, and import and export licenses ( $ 170.31)
The proposed rule would add a fee required in conjunction w4h the registration process. Fees are proposed to be required in order to recover the cost of the general license program associated with this category of general license in an equitable way; that is, from those who are allowed to use devices under the general license rather that from others who hold specific licenses. NRC is required by law to recover all costs from licensees' fees.
j Cost imoacts:
Assumptions:
General Licensees:
11 L
1 Number of registrants:
6000 Annual fee:
$370
)
Totallicenseo cost per year:
$2,220,000 The cost being recovered from the general licensees is not limited to those for implementing these revisions to the general license program; instead, the cost to general licensees consists of the cost of that fraction of the overall generallicense program associated with the registration
]
requirement. Since the requirement for full cost recovery was enacted, all costs of the general license program have been recovered from specific licensees. These cost estimates include an estimate of increased inspection and follow up efforts expected to be made as a result of the registration process identifying noncompliance with existing regulations. That cost will now be passed on to the generallicensees associated with the registration requirement, it is also expected that this cost will decline after the initial implementation of the registration process.
NRC:
Total NRC cost per year:
[ Awaiting input from fees department.]
Total cost per year:
4.2 Requirements for Manufacturers and initial Distributors of Devices l
The proposed regulation would modify the quarterly transfer reporting, recordkeeping, and j
labeling requirements for specific licensees who distribute these generally licensed devices.
A.
Quarterly Reports: Material transfer reports and records ($ 32.52(a) and (b))
The proposed rule would add the following information to the existing quarterly transfer reporting requirement: the serial number and model number of the device, the date of transfer; indication if device is a replacement, and if so, the type, model number (Agreement States already require the model number), and serial number of the one returned; name and license num%r of reporting company, and the specific reporting period; the name and phone number of "m arson designated by the general licensee to be responsible for the device and for eri, < ; compliance with the appropriate regulations (which will replace that of a simple contact betww the Commission and the general licensee). Also, a form will be provided for use in making these reports; however, the use of the form would not be required as long as the report is clear and legible and includes all of the required information. Revisions would be made to 6 32.52(a) and (b).
This provision would provide a mechanism for tracking of individual devices. It would also clarify that the contact name to be obtained from the general licensee (and reported to NRC and the Agreement State regulatory bodies) is that of the individual who will be responsible for compliance with the regulations regarding generally licensed devices. The provision should improve NRC's ability to contact the appropriate person and to provide information to those actually knowledgeable of the device and the requirements for possession, improving general licensees knowledge of the regulations and thus their compliance with the regulations.
12
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1 Cost Imoacts:
Most of the additional information that would be provided under this proposed rule is information that vendors currently track and maintain records on. However, additional time may need to be spent to keep track of replacement devices.
Assumptions:
L Distributer reoorts to NRC:
Number of submittals per year:
340
((28 NRC+S7 AS) licensees x 4 reports /yr)
Additional time spent:
0.2 hr Technical staff hourly rate
$50/hr Totallicent,ee cost per year:
$3,400 NRQ:
Number of submittals per year:
340 Staff hrs per submittal:
0.1 hrs l-Staff hourly rate:
$70/hr Total NRC cost per year:
$2,380 1
Distributor reports to Aareement States:
Number of submittals:
1700 (assuming an average of 5 States per distributor)
Staff hrs'per submittal:
0.1 hrs Staff hourly rate:
$50/hr Total Agreement State cost per year for reports to States: $8,500 Total cost per year:
$14,280 B.
Retention: Material transfer reports and records ($ 32.52(c))
l The proposed rule alters the records retention so that records of transfers would have the i
period of retention extended to 3 years after the expected useful life of the device or the final D
- disposition, if known. The proposed rule also adds a requirement for records on final disposition of devices.
This improves the ability to track individual devices. Further, these revisions will better enable the NRC to verify the location, and disposition of these devices, and thereby confirm the efficacy of the generallicense regulatory program.
Cost impacts:
l This section of the proposed rule would create small incremental costs (i.e. <$1,000) for i
licensees as a result of the increase in the length of the records retention period and recording i
of the final disposition of devices. Most manufacturers record this information on a database and currently retain this information indefinitely. In addition, the time spent for data entry into a database for recording final disposition of devices is small making the corresponding costs small.
l l
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is C.
Records: Conditions of licenses ($ 32.51a(d))1 The proposed rule would add a requirement for the distributors to provide upon request to the L
NRC and Agreement States, records of final disposition of devices in the case of bankruptcy or termination of license. This information must be available upon request.'
. This will assist the NRC and the Agreement State agencies in tracking individual devices.
Further, these revisions will better enable the NRC to verify the location, and disposition of these devices, and thereby confirm the efficacy of the general license regulatory program.
Cost impacts:
This section of the proposed rule would create small incremental costs (i.e. <$1,000) for licensees as a result of making available to various regulatory agencies records of final -
- disposition of devices in the case of bankruptcy or termination of license.- Most manufacturers
- record this information on a database; therefore, the time spent to transfer this information to regulatory agencies is small. Also, the number of manufacturers going bankrupt or requesting license termination is small, making the corresponding costs small. in addition, this information only needs to be provided upon request making the number of times the information needs to be provided even smaller.
D.
Labeling: Byproduct material contained in devices for use under 6 31.5; requirements for license to manufacture, or initially transfer ($ 32.51(a)(4) and (5)
- and 5 32.51a(c))
- The proposed rule would revise $ 32.51(a)(4) and (5) and 9 32.51a(c) to add requirements for a label on any separable source housing, and a permanent label on devices meeting the criteria for registration.
The first of these changes is simply an extension of the existing requirement and carries out the initial intent of the' current regulations in the case of devices where the source may be separable in a housing that does not include the label. It is important that this housing, if separated from the remainder of the device, can also be identified.
This part of the proposed rule would increase the likelihood that source housings contain labels that stay intact even in non-routine circumstances (such as theft, loss, damage), and as a
- result, would increase the likelihood that the device could be identified as containing radioactive material, thereby reducing the likelihood of incidents resulting in unnecessary exposures to the
- public and contamination of property.
Cost Imoacts:
Assumptions:
Distnbutors:
Totallicensee cost per year:
Number of devices with separable source housings 14' f
1
manufactured per year (5% of 9351 devices):
468 Price of additionallabel:
$3 Number of devices requiring registration 305 manufactured per year:
Price of permanent label:
$12 Total cost per year:
$5,064 1
E.
Information provided to general licensees: Conditions of licenses ($ 32.51a(a) and (b))
The proposed rule would revise 9 32.51a(a) and (b) requirements pertaining to information distributors would be required to provide to the general licensee. They are now required to provide generallicensees with a copy of 9 31.5 at the time of transfer of the device. The proposed rule would require that 6 31.5 be provided prior to transfer. The distributor would also be required to provide copies of additional applicable sections of the regulations, a listing of i
services tnat can only be performed by a specific lic 7nsee, and information regarding disposal options for the devices being transferred. The disposal options would include the cost of disposing of the device at the end of its usefullife to the extent that the cost information is available to the specific licensee at the time of the sale of the device. This is to provide general licensees with information needed concerning the applicable requirements as well as some idea i
of the additional costs for disposal of the device before making a decision to buy a device.
Cost imoacts:
Assumptions:
Distributer:
i Number of generallicensees who are shipped generally licensed devices per year:
4277 Time spent to provide additional information:
0.03 hr Technical staff hourly rate
$50/hr Totallicensee ::ost per year:
$6,415 4.3 Clarifying and Conforming Amendments A.
Types of licenses ($ 30.31)
The proposed rule adds a clarifying amendment would be made in Q 30.31.
Cost Imoacts:
None B.
Fees for facilities, materials, import and export licenses, and other regulatory services under the Atomic Energy Act of 1954, as amended (Part 170)
The proposed rule adds minor conforming amendments would also be made to 6Q 170.2 and 170.3.
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C.
Annual Fees for reactor operating licenses, and fuel cycle licenses and materials licenses, including holders of certificates of compliance, registrations, and quality assurance program approvals and government agencies licensed by NRC (Part 171) j The proposed rule would also make minor conforming amendments to %Q 171.5 and 171.16.
)
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4.4 -
Summary of Estimated Annual Costs of Proposed Rule Table 4-1 presents a summary of the estimated costs of the revisions to Parts 30,31,32,170
. and 171. For each regulatory change described above, Table 4-1 lists the total costs estimated for that section.
Table 4-1 Summary of the Proposed Rule's Cost Effects Subpart Section Licens'ee Costs NRC Costs Total Costs 4.1 A 31.5 (c)(13) 0-0 0
4.1 B 31.5 (c)(12).
0 0
0 4.1 C 31.5 (c)(15) 0 0
0 4.1 D 31.5 (c)(8) 0 3,500 3,500 4.1 E 31.5 (c)(14) 500 700 1,200
- 4.1 F 31.5 (c)(5) 2,800 980 3,780 4.1 G 30.34(h) 0 0
0 41H 170.31 2,220,000 awaiting info awaiting info 4.2 A 31.52 (a) and (b) 11,900 2,380 14,280 4.2 B 32.52 (c) 0 0
0 4.2 C 32.51a (d) -
0 0
0 4.2 D_
31.51 (a)(4) and (5) 5,064 0
0' and 32.51a (c) -
4.2 E 32.51a (a) and (b) 6,415 0
0 4.3 A.
30.31 0
0 0
4.3 B 170 0
0 0
4.3 C 171 0
0 0
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W 4.5 Implementation and Development Costs
' NRC development costs are the costs of preparation of a regulation prior to its promulgation and implementation. Such costs may include expenditures for research in support of this regulatory action, publishing notices of rulemaking, holding public meetings, responding to public comments, and issuing a final rule. NRC implementation cost are those " front-end" costs necessary to effectuate the action; they may arise from the necessity of developing procedures and guidance to assist licensees in complying with the final action. The Working Group's recommendations, published as NUREG-1551 in October of 1996, which is the research in support of this regulatory action, has already been performed and is therefore outside the scope of this analysis. Developmental costs and implementation costs within the scope of this analysis are the costs of proceeding with a rulemaking. These are mainly costs of the effort of NRC professional staff members in the Office of Nuclear Materials Safety and Safeguards expended in developing the rule.
1 The action's preparation cost to the NRC is estimated to require a total of 4 professional staff-year. The estimated cost of one NRC professional staff member is $126,000/ staff-yr. The component of NRC's development cost due to staff effort, then, would be $504,000.
Registration will require a more efficient computer data base. A computerized directory has been previously used by the Commission. However, it is outdated and will require improvement or replacement; this would be the case if it is to be adequate for carrying out the Commission's.
mission in the area of generallicenses. This computer system upgrade cost was addressed in the previous proposed rule which is to be used as a basis for initiating a registration and therefore no additional cost is provided in this analysis.
The estimated cost to vendors to revise their manufacturing process to include additional labels would create small incremental costs (i.e. <$1,000).
5 BENEFITS OF PROPOSED RULE 5.1 Summary of Benefits of Proposed Alternative The revisions are intended to better ensure understanding of and compliance with the general license requirements, and thereby reduce the likelihood of incidents resulting in unnecessary
- exposures to the public and contamination of property. These revisions will better enable the NRC to track the location, and disposition of these devices, and thereby confirm the efficacy of the generallicense regulatory program. NRC needs to keep track of the generallicensees so that they can be contacted or inspected. Further, the revisions would improve the likelihood that labels on devices will be retained under most circumstances so that devices can be identified and appropriate actions can be taken. A number of the proposed provisions work together to achieve these benefits. Thus, the benefits of these provisions cannot be accounted
~
separately. The basic rationale for each provision is discussed in section 4; the overall benefits are discussed below.
The primary benefits of this proposed rule can be categorized into economic benefits and L
exposure aversion benefits. In this case, both of these aspects are very difficult to quantify.
l Although ranges of potential exposures have been calculated and ranges of costs from L
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I ndividual incidents have been recorded, the working group concluded that none of the studies i
< conducted are adequate to quantify an overall net cost of improperly disposed or lost devices.
An admittedly uncertain estimate was made of the current economic costs and exposures resulting from improper disposition of both specifically and generally licensed devices meeting
]
- the proposed criteria for increased oversight. The degree of effectiveness of a particular process is alt.o uncertain and would depend on the level of effort used in enforcement of the provision.
i-
.The estimate of economic costs made by the working group and adjusted here for the number of devices covered by this proposed action is based on experience (as reported by the steel industry).
+
Uncertainty in these estimates comes from a number of factorr; including:
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 of devices; the experience cannot be separated as 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 did not include incidents at large integrated steel mills and the resultant costs of such an incident are expected to be much greater than those experienced to date, as much as.$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.
5.2 Summary of Radiation Exposure Averted Benefit This rule should avert radiation exposure to the public, e g., although it is reasonable to assume that a member of the public would not deliberately expose himself or herself or q
someone else to radiation, in some cases, these individuals might not understand that a t
gamma gauge is a potential source of radiation.' When a gamma gauge is d'stributed to a
- general licensee, the gauge must bear durable, legible labels which include a caution that the gauge contains radioactive material. The general license in 9 31.5 requires that the general licensee maintain those labels, in the absence of such maintenance, however, the cautionary language can become corroded and unreadable or painted over. An individual who finds the gauge without this labeling in an uncontrolled situation would have no reason to suspect that the gauge contains radioactive' material.
)
If a generally licensed gauge were improperly transferred or disposed of such that it became
. available to a member of the general public, provided the radioactive material sealed source remained iri the gauge and the shutter mechanism remained closed, no significant radiation
. exposure harm could result.' Moreover, the gauge may be too heavy for anyone to casually relocate so as to'cause long-term exposure, in addition, temporary exposure to an intact gauge should not cause a significant radiation dose. Also, the intact gauge would normally include a waming label with a radiation symbol and cautionary words.
y q
h
_ If a gauge with a significant' source of activity were to end up in the public domain, the labeling were to be destroyed, and a person somehow exposed the source, a significant exposure could 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 L
the highest doses is extremely small. No incidents to date in the U. S. have resulted in the upper range of these potential doses.
Based on a June 1994 PNL report, " Peer Review of Improper Transfer / Disposal Scenarios for Generally Licensed Devices," the working group (WG) estimated the average dose received from incidents of lost devices involving cesium 137 (the most common nuclide involved in incidents historically) could be 7 rem (70 mSv) and the maximum dose that might be received could be somewhat over 1000 rem (10 Sv). The PNL study considered gamma gauges
- containing 20 mci or greater of cesium-137. The analysis was based on the average activity of u
l.
_883 mCl of cesium-137 within this category using data froin the General License Data Base on devices registered in the Sealed Source Device Registry (SSDR) during the period 1987-1992.
The activities listed in the SSDR are the maximum allowed in a model and thus overestimate the average for the devices actually distributed. Gamma gauges were chosen for the example analysis as representative of relatively high risk sources amongst generally licensed devices.
These were very rough estimates. The data has known errors and the average activity per device being distributed has declined.
5.3 Summary of Economic Benefits There is a cost savings to industries which might inadvertently come into possession of an i
- improperly disposed device. The most significant of these would be the avoidance of a melting i
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 clean-up of these incidents (using the average clean-up 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.' The regulatory analysis for the previous proposed rule estimated that it would cover 20% of the devices contributing to the melting experience to date (since that rule addressed only devices in NRC-regulated States and some of the melted devices may have been specifically licensed) and might reduce the rate of incidence involving those devices by
. half, and estimated that the average annual cleanup cost of $12 M would be reduced by about
- $1.2 M per year.
This rule would require Agreement State Compatibility Category C for the regulations governing
- general licensees, so that generally licensed devices in Agreement States would be similarly controlled.~ Based on the estimates of the WG, this would involve approximately half of the devices considered by the WG as likely contributors to smelting incidents and as presenting a risk of significant exposure to the public. If we again estimate that the increased oversight of these devices reduces smelting incidents by one half amongst this population of devices, a L
' potential savings of $3 M per year could result. It is recognized, however, that some States y
have already implemented increased oversight programs for generally licensed devices.
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- There are other costs, though less significant, associated with lost sources which could be reduced by this rulemaking.
'In addition to registration, or comparable controls implemented under Agreement State regulations for certain devices, there are additional provisions in this rule that are expected to
' improve accountability and compliance with existing regulations for all devices generally licensed under 6 31.5 and equivalent regulations of the Agreement States, particularly those distributed in the future. Although the criteria chosen for determining which devices should be subject to a registration requirement are intended to include those devices that present the most risk of significant costs or significant exposures to the public if lost or improperly disposed of, other generally licensed devices present similar though lesser risks.'
The propose'd revisions that are intended to allow NRC, and the Agreement States, to better e
track the location of generally licensed devices would maintain the regulatory bodies' ability to contact and inspect the general licensees. The proposed provisions would also allow the tracking of individual devices; this will aid the enforcement of regulations and the identification of the persons responsible for devices that are found in inappropriate places.
-The rulemaking should thus reduce the number of orphaned sources. The cost of disposalin the case of orphaned sources falls on parties other than the user of the device, such as govemment agencies, e. g., EPA or DOE, or individuals or organizations who inadvertently
. come into possession of a device.
These projected savings would not be entirely attributable to implementation of the rule, but also to the planned increase in inspection and enforcement efforts.
Additional Benefits from 5 31.5(c)(15):
The ALARA principal is one basis for alleviating the need for leak testing and shutter testing while a device is in storage.- Indeed, it is an unnecessary exposure to personnel who perform such tests since, prior to removing the device from storage, the device must be checked.
Reduced burden on general licensees to perform activities while a device is in storage, resulting in exposure benefit and cost savings. Also, decreases the likelihood of loss of control of a device due to a fixed time period of storage of such devices. Devices that are in storage for long periods of time (i.e. greater than two years) are more likely to be forgotten and end up
/
being improperly trueerred or inadvertently discarded.
~ Assumptions:
General Licensees:
Number of f 31.5 GL devices:
600,000 Percentage of devices requiring leak tests and shutter tests every 6 months:
10%
Percentage of devices in long term. storage: _
3%
~ Time per year to perform leak test and shutter test per device (assuming 15' minutes every 6 months):
0.5brs-Technical staff hourly rate:
$50/hr 21
r;;
t l
l l
L Total Cost Savings (per year):
$45,000 J
Note that there is not strict compatibility of this requirement for Agreement States, however if there are similar changes made to an Agreement State's regulations, similar savings would result, potentially for a larger number of devices.
6 DECISION RATIONALE
. It is recommended that this action be adopted because it represents a reasonable means for -
l the Commission to fulfill 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, and to provide a more complete system for NRC and the Agreement States regulatory bodies to keep track of the location of l
their general licensees as well as track individual devices. The rationale for this recommendation follows.
The results of the General License Study conducted by the NRC indicated that there is
- noncompliance with the general license requirements contained in 9 31.5(c). Such noncompliance presents a risk of low but avoidable exposure of the public to radiation plus a low probability of significant exposure as a consequence of improper handling or disposal of the devices generally licensed. The Study revealed that a major reason for noncompliance is that users of the generally licensed devices are unaware that there are regulatory requirements associated with the possession and use of these devices that must be met.
This regulatory action will establish a reasonable procedure to ensure that general licensees are aware of the provisions associated with the general license and comply with the applicable regulatory requirements. It is believed that increased awareness and understanding of the NRC's requirements on the part of the general licensees will increase tne likelihood that general licensees will comply with those requirements and thereby reduce the potential for unnecessary l
radiation exposure to the public and prevent costs to industry, and to State government agencies, 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 $ 504,000 and annual costs to industry and the Commission of $2,246,000 and $ respectively. A large part of the cost to licensees is the imposition of fees. This is being done as a matter of equity and is shifting a portion of the l
overall costs of implementing and enforcing the general license requirements from specific i=
- licensees to the some of the general licensees who benefit from the general license program.
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 of loss of devices. The staff has concluded that the benefit of 22 l
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increased confidence in the efficacy of the generallicense regulatory program outweighs the nominal cost per device. The benefit to be realized even further overshadows the small costs when considered in light of the contribution of this action to the possible avoidance of the substantial cleanup costs which have occurred because of past improper disposition of generally licensed devices.
7 IMPLEMENTATION The regulatory action is not expected to present any significant implementation problems. The revised computer database system which will include the capability of processing registrations is already being developed. General licensees will be sent a copy of the final Federal Reaister notice.
8 EFFECT ON SMALL ENTITIES The action would have an economic impact on general licensees of devices containing byproduct material. There are up to 45,000 generallicensees under 31.5 of which 6000 would be required to register devices and pay a fee, some of whom may be "small entities" within the meaning of the Regulatory Flexibility Act (P.L.96-534). The specific provisions proposed here are essentially consistent with the Commission's plans for the registration process discussed in the earlier proposed rule. With the exception of the fee, the provisions
. would add no further, or minimal impact than that already planned and accounted for under the previous proposed rule. Therefore the economic impact on small entities would be the incurrence of the fee, in the proposed amount of $370, about $92 per device on average. The economic impact on the small entitles are not believed to be significant.
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