UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIALS SAFETY AND SAFEGUARDS
WASHINGTON, DC 20555 September 14, 2006 NRC REGULATORY ISSUE SUMMARY 2006-19 AVAILABILITY OF GUIDANCE ON
RADIOACTIVE SEED LOCALIZATION
ADDRESSEES
All medical licensees.
INTENT
The U.S. Nuclear Regulatory Commission (NRC) is issuing this Regulatory Issue Summary (RIS) to inform addressees of the availability of guidance on radioactive seed localization. No specific action or written response is required.
BACKGROUND
The National Materials Program (NMP) is a term that was developed in late 1990 to define the collective framework within which both NRC and the Agreement States function in carrying out their respective radiation safety regulatory programs. NRC and the Agreement States recognize that, as regulators, consistent approaches in addressing and resolving radiation protection issues are important. The NMP is a vehicle to help accomplish this objective.
In 2002, NRC initiated five pilot projects under the NMP to address various regulatory issues.
One of the projects was Pilot Project 4 - State Guidance Development. The goal of this project was to demonstrate that Agreement States can assume the responsibility for development of guidance for use by both NRC and Agreement States. The guidance was developed by the NMP Pilot Project 4 working group, which was led by the Organization of Agreement States, Inc.
Membership on the working group included four Agreement States members and one NRC
member.
The purpose of guidance developed under Pilot Project 4 was to create consistent approaches to the licensing and inspection of radioactive material used in emerging technologies.
SUMMARY OF ISSUE
Recently, guidance was developed for a 10 CFR 35.1000 medical-use procedure called radioactive seed localization. The purpose of radioactive seed localization of non-palpable
ML060810023
1 An area of suspicious tissue detected by mammography that needs further evaluation. lesions1 is to localize suspicious tissues for excision with the use of radioactive seeds.
Radioactive seed localization differs from current localization procedures, whereby a non- radioactive wire is implanted into the lesion site and excised along with affected tissue. The radioactive seed localization technique offers advantages, over the wire implantation technique for localizing lesions. For example, with the use of radioactive seed localization, the bracketing of lesions and the post-localization of mammograms is not impeded by wires, and radioactive seed localization can be performed up to 5 days before surgery, minimizing schedule conflicts.
Recipients of this RIS that intend to use this 10 CFR 35.1000 medical use are encouraged to review the radioactive seed localization guidance located at any one of the following websites:
NRCs medical users Licensee Toolkit at http://www.nrc.gov/materials/miau/med-use- toolkit.html;
NRCs Office of State and Tribal Programs website at http://nrc-stp.ornl.gov/materials.
html; and
The Organization of Agreement States website at http://www.agreementstates.org/
whatsnew.html.
NRC licensees desiring to use radioactive seed localization must submit an amendment request for the 10 CFR 35.1000 medical use to the appropriate NRC regional office.
BACKFIT DISCUSSION
This RIS requires no action nor written response and is, therefore, not a backfit under
10 CFR Part 72. Consequently, the staff did not perform a backfit analysis.
FEDERAL REGISTER NOTIFICATION
A notice of opportunity for public comment on this RIS was not published in the Federal Register because this RIS is informational, and does not represent a departure from current regulatory requirements.
CONGRESSIONAL REVIEW ACT
This RIS is not a rule as designated by the Congressional Review Act (5 U.S.C. §§ 801-886)
and, therefore, is not subject to the Act.
PAPERWORK REDUCTION ACT STATEMENT
This RIS does not contain information collections and therefore is not subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq.).
CONTACT
This RIS requires no specific action or written response. If you have any questions about this summary, please contact the individual listed below or the appropriate regional office.
/RA/
Charles L. Miller, Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Technical contact: Donna-Beth Howe
(301) 415-7848 e-mail: dbh@nrc.gov Enclosure: List of Recently Issued NMSS
Generic Communications
CONTACT
This RIS requires no specific action or written response. If you have any questions about this summary, please contact the individual listed below or the appropriate regional office.
/RA/
Charles L. Miller, Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Technical contact: Donna-Beth Howe
(301) 415-7848 e-mail: dbh@nrc.gov Enclosure: List of Recently Issued NMSS
Generic Communications DISTRIBUTION:
IMNS r/f AMcIntosh CHawes ML060810023 OFC
MSIB
MSIB
MSIB
Tech Editor NAME
AMcIntosh CFlannery SWastler Ekraus (via fax)
DATE
8/18/06
8/21 /06
8/21/06
8/18/06 OFC
MSIB
STP
OIS
OGC/CRA
NAME
TEssig JSchleuter BSt.Mary TRothschild DATE
08 / 24 /06
8/22/06
8/21/06
8/24/06 OFC
OGC
IMNS
NAME
S. Treby CMiller DATE
8/29/06
9 / 08 /06 OFFICIAL RECORD COPY
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| RIS 2006-02, Good Practices for Licensee Performance During the Emergency Preparedness Component of Force-On-Force Exercises | 23 February 2006 | Backfit | | RIS 2006-02, Good Practices For Licensee Performance During The Emergency Preparedness Component of Force-On-Force Exercises | 23 February 2006 | Backfit | | RIS 2006-03, Guidance on Requesting an Exemption from Biennial Emergency Preparedness Exercise Requirements | 24 February 2006 | Exemption Request
Backfit | | RIS 2006-04, Draft RAI on Meteorology for Full-Scope AST Application | 11 July 2006 | Loss of Offsite Power | | RIS 2006-05, Withdrawal of Transportation Safeguards Advisories SA-01-01 Rev 1 and SA-03-02 | 20 April 2006 | Enforcement Discretion
RAMQC
Fire Protection Program
Backfit | | RIS 2006-06, New Reactor Standardization Expectations Needed to Support the Design-Centered Licensing Review Approach | 31 May 2006 | Backfit
Pre-application | | RIS 2006-07, Proposed Changes to the Safety System Unavailability Performance Indicators | 12 June 2006 | Enforcement Discretion
Significance Determination Process
Backfit | | RIS 2006-08, Publicly Available Cover Letters for Security-Related Inspection Reports | 12 June 2006 | Significance Determination Process
Backfit | | RIS 2006-08, Publicly Available Cover Letters For Security-Related Inspection Reports | 12 June 2006 | | | RIS 2006-09, NRCs Procedures for Review of Decommissioning Funding Assurance Reports | 21 June 2006 | Backfit | | RIS 2006-09, Nrc'S Procedures For Review of Decommissioning Funding Assurance Reports | 21 June 2006 | | | RIS 2006-10, NRC Regulatory Issue Summary NRC Regulatory Issue Summary 2006-010 - Regulatory Expectations with Appendix R Paragraph Iii.G.2 Operator Manual Actions | 30 June 2006 | Hot Short
Safe Shutdown
Fire Barrier
Enforcement Discretion
Operator Manual Action
Exemption Request
Fire Protection Program
Manual Operator Action | | RIS 2006-10, NRC Regulatory Issue Summary NRC Regulatory Issue Summary 2006-010 - Regulatory Expectations with Appendix R Paragraph III.G.2 Operator Manual Actions | 30 June 2006 | Hot Short
Safe Shutdown
Fire Barrier
Enforcement Discretion
Operator Manual Action
Exemption Request
Fire Protection Program
Backfit
Manual Operator Action | | RIS 2006-11, Requesting Quality Assurance Program Approval Renewals Online by Electronic Information Exchange | 20 July 2006 | | | RIS 2006-12, Endorsing NEI White Paper, Enhancements to Emergency Preparedness Programs for Hostile Action | 19 July 2006 | Safeguards Contingency Plan
Backfit | | RIS 2006-12, Us Nuclear Regulatory Commission. NRC Regulatory Issue Summary 2006-12; Endorsement of Nuclear Energy Institute Guidance Enhancements to Emergency Preparedness Programs for Hostile Action | 19 July 2006 | Safe Shutdown
Safeguards Contingency Plan
Backfit | | RIS 2006-13, Information on the Changes Made to the Reactor Oversight Process to More Fully Address Safety Culture | 31 July 2006 | Fitness for Duty
Backfit | | RIS 2006-13, NRC000046-NRC Regulatory Issue Summary 2006-13, Information on the Changes Made to the Reactor Oversight Process to More Fully Address Safety Culture | 31 July 2006 | Fitness for Duty
Temporary Modification
Backfit | | RIS 2006-13, 2006/07/31-Intervenor-Exhibit 10-Information On The Changes Made To The Reactor Oversight Process To More Fully Address Safety Culture, Regulatory Issue Summary 2006-13, U.S. NRC | 31 July 2006 | Fitness for Duty
Backfit | | RIS 2006-14, NRC Regulatory Issue Summary - Enforcement Requirements for Facility Changes Under 10 CFR 70.72 (c) (2) | 22 September 2006 | Enforcement Discretion
Backfit | | RIS 2006-14, NRC Regulatory Issue Summary - Enforcement Requirements for Facility Changes Under 10 CFR 70.72 (C) (2) | 22 September 2006 | Enforcement Discretion
Backfit | | RIS 2006-15, Withdrawn NRC Regulatory Issue Summary 2006-15 Preparation and Scheduling of Operator Licensing Examinations | 14 August 2006 | Generic Fundamentals Examination
Backfit | | RIS 2006-16, Transfer of Management Oversight of Region I Licensees to Region IV | 15 August 2006 | Backfit | | RIS 2006-17, NRC Staff Position on the Requirements of 10 CFR 50.36, Technical Specification, with Respect to Limiting Safety System Settings (LSSS) During Periodic Testing and Calibration of Instrument Channels | 24 August 2006 | Functionality Assessment
Operability Determination
Backfit | | RIS 2006-18, WITS200500191/WITS200500192/WITS2005193 - NRC Regulatory Issue Summary 2006-18 Requesting Exemption from the Public Dose Limits for Certain Caregivers of Hospital Patients | 31 August 2006 | Enforcement Discretion
Exemption Request | | RIS 2006-18, Wits200500191/Wits200500192/Wits2005193 - NRC Regulatory Issue Summary 2006-18 Requesting Exemption From the Public Dose Limits for Certain Caregivers of Hospital Patients | 31 August 2006 | Exemption Request | | RIS 2006-19, Availability of Guidance on Radioactive Seed Localization | 14 September 2006 | Backfit | | RIS 2006-20, Enclosure 2 - List of Recently Issued Generic Communication | 14 September 2006 | | | RIS 2006-21, Improving Response Capabilities Through the Use of an Incident Response Electronic Library | 28 September 2006 | Reactor Vessel Water Level
Severe Accident Management Guideline
Backfit
Siren | | RIS 2006-22, Lessons Learned from Recent 10 CFR Part 72 Dry Cask Storage Campaign | 15 November 2006 | Safe Shutdown
Enforcement Discretion
Exemption Request
Control of Heavy Loads
Fuel cladding
Backfit | | RIS 2006-23, Post-Tornado Operability of Ventilating and Air-Conditioning (Vac) Systems Housed in Emergency Diesel Generator (EDG) Rooms | 6 December 2006 | Earthquake
Backfit | | RIS 2006-23, Post-Tornado Operability of Ventilating and Air-Conditioning (VAC) Systems Housed in Emergency Diesel Generator (EDG) Rooms | 6 December 2006 | | | RIS 2006-24, Revised Review and Transmittal Process for Accident Sequence Precursor Analyses | 6 December 2006 | Significance Determination Process
Loss of Offsite Power
Backfit | | RIS 2006-25, Requirements for the Distribution and Possession of Tritium Exit Signs and the Requirements in 10 CFR 31.5 Ad 32.51a | 7 December 2006 | Tritium Exit Sign | | RIS 2006-25, Requirements For the Distribution and Possession of Tritium Exit Signs and the Requirements in 10 CFR 31.5 Ad 32.51A | 7 December 2006 | Tritium Exit Sign
Exit Sign | | RIS 2006-26, Training and Experience and Grandfather Provisions for Authorized Medical Physicists Under 10 CFR 35 | 7 December 2006 | Enforcement Discretion | | RIS 2006-26, SECY-06-0248 Enclosure 2 - Regulatory Issue Summary 2006-26, Training and Experience and Grandfather Provisions for Authorized Medical Physicists Under 10 CFR Part 35 | 7 December 2006 | | | RIS 2006-27, Availability of NRC 313A Series of Forms and Guidance for Their Completion | 27 June 2007 | Brachytherapy
TheraSphere |
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