ML20217N016
| ML20217N016 | |
| Person / Time | |
|---|---|
| Issue date: | 07/29/1998 |
| From: | Combs F 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 | |
| ML20217M898 | List: |
| References | |
| FRN-63FR66492, FRN-63FR66942, RULE-PR-31 AG06-1-011, NUDOCS 9910280105 | |
| Download: ML20217N016 (10) | |
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UNITED STATES 4
y NUCLEAR REGULATORY COMMISSION t
WASHINGTON, D.C. 20555 0001
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i FROM:
Frederick C. Comts Act' g ir%ctor Division ofinpustrfil arid a
Medical Nublear hfetykNMSE[
SUBJECT:
OFFICE REVIEWSND CONCURRENCE: PROPOSED RULE TO AMEND 10 CFR 31.5, " REQUIREMENTS FOR THE POSSESSION OF INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL" By memorandum dated July 14,1998, the Commission paper and rulemaking package for the subject proposed rule was fonuarded for your review and concurrence.
Since that time, we have modified the Commission paper to include an outline of the procedures for the development of the automated registration program in a new attachment 2.
The Commission Paper and attachment 1 have been revised; these changes are shown in comparative text. No changes were made to the Regulatory Analysis or the Federal Register Notice. We would appreciate your quick review of the revised Commission Paper and first two attachments. Please provide us with comments and/or concurrence by August 4,1998. We have scheduled room T8F1 at 10:00 a.m. on Wednesday, August 5,1998, for representatives from the offices to meet to resolve any outstanding issues related to the 10 CFR 31.5 rulemaking package. If all concurrences are received by that date, the meeting will be cancelled.
CONTACT: Catherine R. Mattsen, NMSS/IMNS (301) 415-6264 9910280105 991022 PDR PR 31 63FR66492 PDR
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..R. L. Bangart et al.
2 Please note that, in a memorandum dated July 2,1998, the staff made a request to the Commission to extend the schedule on the comprehensive ru!e. If the extension request is approved, the milestones in Attachment 1 will be adjusted accordingly.
Attachment:
Commission Paper w/ attachments cc w/ctt:
H. T. Bell, OlG
_ H. Miller..Rl/ ORA <
' L. Reyes, Ril/Of% '
- C. Paperiello, kill / ORA
- E. W. Merschoff, RIV/ ORA.
M. Knapp,' NMSS
' W. Kane; NMSS -
W. Beecher, OPA -
L M. Schwartz, OGC-L' Rakovan, OSP, l
M. Lesar, ADM J.- DelMedico, OE
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RGordon/RF LRiani (WITS No. 9800070)
IMNS/ Central File Dh'endiola -
CPoland NMSS Ticket No. 963202 NMSS R/F -
CGallagher NRC Central File AWocausland LCamper Liubinski'
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NMSS FILE CODE NO.
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EQB-The Commissioners.
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FROM: ^
L. Joseph Callan, Executive Director for Operations l-I
SUBJECT:
PROPOSED RULE: 10 CFR PART 31 " REQUIREMENTS FOR THE I.
POSSESSION OF INDUSTRIAL DEVICES CONTAINING BYPRODUCT n
MATERIAL" F
PURPOSE:
To inform the Commission that the' EDO intends'to publish, as directed by the Commission, a
' proposed rule that would explicitly require general licensees, who possess certain devices -
- containing byproduct material, to provide the Nuclear Regulatory Commission (NRC) with <
information concerning devices that they have received for use under a general license. This
_' provision would be 'used primarily to institute a registration and accounting system for devices using certain quantities of specific radionuclides, BACKGROUND There have' been a number of occurrences where generally licensed devices containing
. radioactive material issued under 10 CFR 31.5 have not been properly disposed of, or properly
. he N, resulting in radiation exposure to the public and ccntamination of property. The staff Aed that more frequent and timely. contact between the general licensee and the NRC 4
so, remedy these problems.' 0:e December 27,1991 (56 FR 67011), the NRC published a c
proposed rule concerning this issue. The proposed rule included a requirement for general licensees under 10 CFR 31.5 to provide information at the request of the NRC that would form the regulatory basis for the registration of devices as well as additionci requirements in
,10 CFR 32.51a and 32.52 for the specific licensees who manufacture or initially transfer these devices to the general licensees._ A final rule was not implemented because of lack of resources to properly implement the provisions of the rule as proposed.
7 CONTACT:
~ Cathenne R. Mattsen, NMSS/IMNS (301) 415-6264
.-Jayne M.. McCausland, NMSS/lMNS
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- (301) 415-6219 s
The Commissioners.
2 In July 1995, with assistance from the Organization of Agreement States, NRC formed a working group to evaluate the issues related to the loss of control of generally licensed as well as specifically licensed sources of radioactivity. The working group submitted a final report to NRC concerning its evaluation, and 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 of 1996. On November 13,1996, the staff briefed the Commission on its preliminary
-views of the working group's recommendations.
On November 26,1997, SECY-97-273 requested Commission approval of the staff's recommendation te develop and implement a registration program for certain 10 CFR 31.5 generallicenseeF,. The staffs recommendation was based, in part, on its evaluation of the recommendations of the NRC/ Agreement State Working Group. In an SRM dated April 13, 1998, the Commission disapproved the staffs recommendation in SECY-97-273 and directed the staff to terminate the rulemaking on 10 CFR 31.5 that was initiated 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. The subject proposed rule responds to that directive. Also, in that SRM, the Commission directed the staff to develop, in a subsequent rulemaking, a registration and followup program for generally licensed sources / devices identified by the NRC/ Agreement State Working Group in NUREG-1551, apply fees to these general licensees, and incorporate equirements for permanent labeling of sources / devices. In addition, the Commission directed the staff to provide a set of milestones for implementing the second rulemaking described above. These mMilestones for development of the second rulemaking are included in Attachment 1.
The staff plans to initiate registration based on the first rulemaking. However, registration cannot be initiated until an automated registration system is developed. The automated registration system will facilitate the mailing of requests for registration, evaluating responses, comparing licensees' inventories against the information included in the automated system, and performing follow-up activities. Once the business case for the system has been developed and the project approved via the Capital Planning and investment Control process (CPIC),
development of the automated registration system will be performed in accordance with the System Development Life Cycle Methodology described by the Office of the Chief Information Officer, and the CPIC process described in SECY-98-032. The steps being followed in the development are included in Attachment 2.
Another item in the SRM was the development of an enforcement policy with a short amnosty program followed by increased civil penalties for lost or improperly disposed sources. The Federal Register notice for the proposed rule includes notification of the Commission's intent to make these changes to the enforcement policy. The interim policy will be provided to the Commission with the final rule and would be issued concurrently with the final rule.
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o The Commissioners 3
DISCUSSION:
The NRC has authority under the Atomic Energy Act of 1954 to request appropriate information from its licensees concerning licensed activities. However, in the case of 10 CFR 31.5 licensees, no explicit provision to this effect has been included in Part 31. This proposed rule would add an explicit requirement to 10 CFR 31.5 that general licensees respond in a timely way to written requests from the NRC for information concerning devices that they have received for use under the general license. This provision will be primarily used to institute a registration and accounting system for devices using certain quantities of specific radionuclides.
The criteria for determining which devices would be included in the registration program are j
those recommended by the working group. The licensees will be asked to verify information concerning the identification of devices, accountability for the devices, the persons acting as contact with the NRC, and the disposition of the devices, it is estimated that approximately 6000 generallicensees would be required to provide registration information to the NRC.
The proposed rule is intended to ensure that certain general licensees are aware of and understand the requirements for the possession of devices containing byproduct material and can account for their devices. This communication would provide NRC assurance of accountability on the part of these licensees. Better awareness on the part of generallicensees of their responsibilities would help to ensure that the generallicensees comply with the requirements for proper handling and disposal of generally licensed devices and should help reduce the potential for incidents that could result in unnecessary radiation exposure to the public, as well as contamination of property.
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 managerront 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 a notice of proposed rulemaking (Attachment 3) that would explicitly require general licensees who possess devices containing byproduct material to provide the NRC with information concerning devices that they have received for use under the generallicense as requested by the NRC.
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. The Commissioners -
4 2.
Certify that this' rule, if adopted, will not have a significant impact on a substantial number
. of small entities, in order to satisfy the requirements of the Regulatory Flexibility Act, 5 U.S.C. 605(b).
'3.
Holg:
a.
Staff requests action in 10 days. Action will not be taken until the SRM is received.
We consider this action within the delegated authority of the EDO; b.
- The rulemaking will be published in the Federal Reaister for a 75-day public comment period; c.
There has been no coordination of this rulemaking with the Agreement States; as directed by the SRM of April 13,1998, no compatibility of Agreement State regulations is required; the Agreement State compatibility issue will be addressed in the second, more comprehensive rule also dealing with this issue.
d.
Neither an environmental impact statement nor an environmental assessment has been prepared for this regulation because it does not have a significant effect on the environment; e.
A draft regulatory analysis has been prepared and will be available in the Public Document Room (Attachment 4);
f.
The appropriate Congressional committees will be informed (Attachment 5);
q g.
The Chief Counsel for Advocacy of the Small Business Administration will be
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informed of the certification regarding economic impact on small entities and the reasons for it as required by the Regulatory Flexibility Act;.
h.
The proposed rule would amend information collection requirements that are
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subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq). These i
requirements have been forwarded to the Office of Management and Budget for approval; l
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The Commissioners 5
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A draft press release will be issued by the Office of Public Affairs when the l
proposed rulemaking is filed with the Office of the Federal Register (Attachment 6).
I i
L. Joseph Callan Executive Director I
for Operations
. Attachments: 1. Milestones for comprehensive rule on generally licensed devices
- 2. Automated Registration System Development.
- 3. Draft Federal Register Notice
- 4. Draft Regulatory Analysis
- 5. Congressional Letters
- 6. Draft Press Release 7 ' Approval for Publication l
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F l-The Commissioners 5
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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 6).
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l L. Joseph Callan
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Executive Director for Operations Attachments: 1. Milestones for comprehensive rule on generally licensed devices
- 2. Automated Registration System Development
- 3. Draft Federal Register Notice 1
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- 4. Draft Regulatory Analysis
- 5. Congressional Letters
- 6. Draft Press Release
- 7. Approval for Publication 1
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DATE:
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AJGalante JGray JLieberman JFunches DATE:
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D/OSP Tech Ed D/NMSS DEDR EDO NAME:
RBangart EKraus CPaperiello HThompson LJCallan DATE:
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/ /98 OFFICIAL RECORD COPY NMSS FILE CODE NO.:-
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. Milestones for registratica progrera forcomprehensive rule on certain generally licensed devices Final rule package for this rule To EDO four months after the end of public comment period Effective Approximately 7/99 The second comprehensive rule Develop initial draft package 9/8/98 OMB package to IRM for review 10/6/98 Issued for Office concurrence and to Agreement States 10/27/98 Discut,s at OAS meeting 10/98 To EDO 12/24/98 To Commission 12/31/98 Publish in Federal Register and
- transmit OMB package to OMB (3/9/99)
End of public comment period 75 days after publication Develop draft final rule package 13 weeks after end of comment period.
To Agreement States for review 18 weeks after end of comment period To Office review 20 weeks after end of comment period To EDO '
25 weeks after end of comment period To Commission 28 weeks after end of comment period Aete.T.eted Reg letratien Syste.T.
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Automated Registration System Development i
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The staff will adhere to the following schedule in developing the automated registration system:
1.
An information technology proposal screening form has been submitted to the OClO for review and approval. NMSS is currently awaiting approval of the screening form by the Information Technology Business Council (ITBC).
2.
NMSS and OClO staff are currently working or) defining the requirements for the I
automated registration system.
3.
Once the requirements are defined (Step 2), the staff will negotiate a statement of work with the contractor (i.e., CSC), if necessary, to engineer and deploy the system and to agree upon a Project Management Plan (PMP). The PMP will be used as input for the Capital Planning and Investment Control (CPIC) process.
4.
The staff will work with the CPIC contractor to develop a business case for the project.
The business case willinclude: 1. the requirements (from Step 2),2. the definition and cost for the solution (finalized in Step 3 - PMP), 3. defined alternatives (from Step 2),
- 4. comparison of the benefits, costs, and risks of the alternatives (including status quo)
(input from Step 2 and finalized in this step), and 5. a detailed Project Management Plan (from Step 3).
5.
After the entire CPIC process is complete, the staff will submit the CPIC analysis and Project Management Plan to the ClO and ITBC for review. If the ITBC supports the CPIC analysis and alternative recommended, and the CIO agrees that the alternative is consistent with data and systems architectures, standards, etc., the project (via the CPIC analysis) is presented by the business sponsor to the Executive Council (EC) to request the authorization to "begin" the project phase.
6.
Once the budget has been approved by the EC, the staff will direct the contractor (CSC) to engineer and deploy the proposed solution.
Rased on information exchanges between NMSS and OClO staff, it is estimated that automated registration system will be ready for use starting in mia to late FY 2000. Therefore, registration will be initiated in mid to late FY 2000. This implementation schedule is an estimate at this point in time, and more refined dates will be established once the PMP is completed.
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