RIS 2009-07, Status Update for Implementation of NRC Regulatory Authority for Certain Naturally Occurring and Accelerator-Produced Radioactive Material: Difference between revisions

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{{#Wiki_filter:UNITED STATES NUCLEAR REGULATORY COMMISSION OFFICE OF FEDERAL AND STATE MATERIALS AND ENVIRONMENTAL MANAGEMENT PROGRAMS WASHINGTON, DC 20555-0001 May 07, 2009 NRC REGULATORY ISSUE SUMMARY 2009-07 STATUS UPDATE FOR THE IMPLEMENTATION OF NRC REGULATORY AUTHORITY FOR CERTAIN NATURALLY OCCURRING AND ACCELERATOR-PRODUCED RADIOACTIVE MATERIAL  
{{#Wiki_filter:UNITED STATES
                            NUCLEAR REGULATORY COMMISSION
                        OFFICE OF FEDERAL AND STATE MATERIALS
                      AND ENVIRONMENTAL MANAGEMENT PROGRAMS
                                  WASHINGTON, DC 20555-0001 May 07, 2009 NRC REGULATORY ISSUE SUMMARY 2009-07 STATUS UPDATE FOR THE IMPLEMENTATION OF NRC
REGULATORY AUTHORITY FOR CERTAIN NATURALLY OCCURRING
        AND ACCELERATOR-PRODUCED RADIOACTIVE MATERIAL


==ADDRESSEES==
==ADDRESSEES==
All U.S. Nuclear Regulatory Commission (NRC) material and fuel cycle licensees. All Radiation Control Program Directors and State Liaison Officers.
All U.S. Nuclear Regulatory Commission (NRC) material and fuel cycle licensees. All Radiation Control Program Directors and State Liaison Officers.


==INTENT==
==INTENT==
The NRC is issuing this regulatory issue summary (RIS) to inform recipients of the status of the agency's efforts to implement the requirements of section 651(e) of the Energy Policy Act of 2005 (EPAct) on "Treatment of Accelerator-Produced and Other Radioactive Material as Byproduct Material."  No specific action or written response is required. The NRC encourages recipients of this RIS to share this information with known users of the newly defined byproduct materials resulting from the EPAct, who may not currently possess an NRC byproduct materials license. The NRC is providing this Regulatory Issue Summary (RIS) to Agreement States for their information and distribution to their licensees as appropriate.
The NRC is issuing this regulatory issue summary (RIS) to inform recipients of the status of the agencys efforts to implement the requirements of section 651(e) of the Energy Policy Act of
2005 (EPAct) on Treatment of Accelerator-Produced and Other Radioactive Material as Byproduct Material. No specific action or written response is required. The NRC encourages recipients of this RIS to share this information with known users of the newly defined byproduct materials resulting from the EPAct, who may not currently possess an NRC byproduct materials license. The NRC is providing this Regulatory Issue Summary (RIS) to Agreement States for their information and distribution to their licensees as appropriate.


==BACKGROUND==
==BACKGROUND==
On August 8, 2005, the President signed the EPAct into law. Section 651(e) of the EPAct expands the definition of byproduct material as given in section 11e of the Atomic Energy Act of 1954 (AEA), as amended. This change places additional byproduct material under the NRC's jurisdiction, as defined in paragraphs 11e.(3) and 11e.(4) of the AEA. Thirty-Six States have previously certified that they have programs in place to properly regulate the newly defined byproduct materials.
On August 8, 2005, the President signed the EPAct into law. Section 651(e) of the EPAct expands the definition of byproduct material as given in section 11e of the Atomic Energy Act of 1954 (AEA), as amended. This change places additional byproduct material under the NRCs jurisdiction, as defined in paragraphs 11e.(3) and 11e.(4) of the AEA. Thirty-Six States have previously certified that they have programs in place to properly regulate the newly defined byproduct materials.


ML091030497 RIS-2009-07  
ML091030497
 
RIS-2009-07  


==SUMMARY OF ISSUE==
==SUMMARY OF ISSUE==
Final Regulations Section 651(e) of the EPAct requires that the NRC issue final regulations that establish requirements for licensing and regulating AEA Sections 11e.(3) and 11e.(4) byproduct material, while cooperating with the States and using model State standards to the maximum extent practicable. The NRC published its final regulations on October 1, 2007 (Volume 72, page 55864, of the Federal Register (72 FR 55864)). These final regulations became effective on November 30, 2007, and can be accessed on the NRC's Public Involvement Rulemaking Web site at http://www.nrc.gov/about-nrc/regulatory/rulemaking/public-involvement.html. Waiver Issued on August 31, 2005 (70 FR 51581)
Final Regulations Section 651(e) of the EPAct requires that the NRC issue final regulations that establish requirements for licensing and regulating AEA Sections 11e.(3) and 11e.(4) byproduct material, while cooperating with the States and using model State standards to the maximum extent practicable. The NRC published its final regulations on October 1, 2007 (Volume 72, page
  As authorized by section 651(e) of the EPAct, the NRC issued a waiver on August 31, 2005, to allow the continued use and possession of naturally occurring and accelerator-produced radioactive materials (NARM) while it developed a regulatory framework for regulation of NARM as a new type of byproduct material. The waiver was issued for a period of four years from the date of EPAct and will terminate on August 7, 2009. The NRC has begun terminating the waiver in phases. The first phase of waiver terminations occurred on November 30, 2007 (the effective date of the final rule). On this date, the NRC  
55864, of the Federal Register (72 FR 55864)). These final regulations became effective on November 30, 2007, and can be accessed on the NRCs Public Involvement Rulemaking Web site at http://www.nrc.gov/about-nrc/regulatory/rulemaking/public-involvement.html.
terminated the waiver for Federal Government agencies, Federally Recognized Indian Tribes, Delaware, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Indiana, Wyoming, and Montana. The second phase of waiver terminations occurred on September 30, 2008. On this date, the NRC terminated the waiver for Idaho, Missouri, South Dakota, Vermont, West Virginia, Guam and all other territories and possessions of the United States that were not part of Phase 1. Upon waiver termination, all persons who possessed the new byproduct materials in these States, U.S. Territories, or areas of exclusive Federal jurisdiction were to be in compliance with NRC regulations. Being in compliance means that such persons are responsible for the proper handling, transfer, and disposal of these new byproduct materials as specified in NRC regulations. The third and last phase of waiver terminations will occur on August 7, 2009, (74 FR 5797). This final phase will include Alaska, Connecticut, Hawaii, Michigan, New Jersey, and NRC licensees with headquarters in Canada. Additionally, the Commission terminated the waiver for non-Agreement States that entered into an Agreement with the NRC under Section 274b of the Atomic Energy Act of 1954, as amended, coincident with the effective date of such an agreement. The State of New Jersey has submitted an Agreement State application to the NRC. The New Jersey agreement may be completed prior to the waiver termination date at August 7, 2009. If their agreement goes into effect prior to the waiver termination date, then the waiver for New Jersey licenses will terminate to coincide the effective date of the agreement.
 
Waiver Issued on August 31, 2005 (70 FR 51581)
As authorized by section 651(e) of the EPAct, the NRC issued a waiver on August 31, 2005, to allow the continued use and possession of naturally occurring and accelerator-produced radioactive materials (NARM) while it developed a regulatory framework for regulation of NARM
as a new type of byproduct material. The waiver was issued for a period of four years from the date of EPAct and will terminate on August 7, 2009.
 
The NRC has begun terminating the waiver in phases. The first phase of waiver terminations occurred on November 30, 2007 (the effective date of the final rule). On this date, the NRC
terminated the waiver for Federal Government agencies, Federally Recognized Indian Tribes, Delaware, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Indiana, Wyoming, and Montana. The second phase of waiver terminations occurred on September 30, 2008. On this date, the NRC terminated the waiver for Idaho, Missouri, South Dakota, Vermont, West Virginia, Guam and all other territories and possessions of the United States that were not part of Phase 1. Upon waiver termination, all persons who possessed the new byproduct materials in these States, U.S. Territories, or areas of exclusive Federal jurisdiction were to be in compliance with NRC regulations. Being in compliance means that such persons are responsible for the proper handling, transfer, and disposal of these new byproduct materials as specified in NRC regulations.
 
The third and last phase of waiver terminations will occur on August 7, 2009, (74 FR 5797).
This final phase will include Alaska, Connecticut, Hawaii, Michigan, New Jersey, and NRC
licensees with headquarters in Canada. Additionally, the Commission terminated the waiver for non-Agreement States that entered into an Agreement with the NRC under Section 274b of the Atomic Energy Act of 1954, as amended, coincident with the effective date of such an agreement. The State of New Jersey has submitted an Agreement State application to the NRC. The New Jersey agreement may be completed prior to the waiver termination date at August 7, 2009. If their agreement goes into effect prior to the waiver termination date, then the waiver for New Jersey licenses will terminate to coincide the effective date of the agreement.
 
The NRC prepared and promulgated a transition plan (72 FR 59157), which was published in the Federal Register on October 19, 2007 to facilitate an orderly transition of regulatory authority with respect to the newly added byproduct material. As explained in the transition plan, under the final regulations, users of NARM in non-Agreement States and U.S. Territories are required to: (1) apply for license amendments for the new byproduct material within 6 months from the date the waiver is terminated, if they hold an NRC specific byproduct materials license, or (2)
submit a license application for the new byproduct material within 12 months from the date the
 
RIS-2009-07 waiver is terminated. Upon receipt of either a license amendment or a new license application, the respective NRC regional office will notify the applicant of its receipt of the request. The notification will document that the applicant complied with this aspect of the regulations.


The NRC prepared and promulgated a transition plan (72 FR 59157), which was published in the Federal Register on October 19, 2007 to facilitate an orderly transition of regulatory authority with respect to the newly added byproduct material.  As explained in the transition plan, under the final regulations, users of NARM in non-Agreement States and U.S. Territories are required to: (1) apply for license amendments for the new byproduct material within 6 months from the date the waiver is terminated, if they hold an NRC specific byproduct materials license, or (2) submit a license application for the new byproduct material within 12 months from the date the RIS-2009-07 waiver is terminated.  Upon receipt of either a license amendment or a new license application, the respective NRC regional office will notify the applicant of its receipt of the request.  The notification will document that the applicant complied with this aspect of the regulations.  Existing NRC licensees should note that the NRC will not amend licenses to include authorization to produce radioactive material using an accelerator; the agency will require a separate license for these activities. Therefore, existing licensees should contact their NRC Regional Office and prepare to submit a new license application to obtain authorization for the production of radioactive materials using an accelerator.
Existing NRC licensees should note that the NRC will not amend licenses to include authorization to produce radioactive material using an accelerator; the agency will require a separate license for these activities. Therefore, existing licensees should contact their NRC
Regional Office and prepare to submit a new license application to obtain authorization for the production of radioactive materials using an accelerator.


In addition, new NRC license applicants that are seeking authorization to produce radioactive materials using an accelerator should submit a license application for that authorization and should submit a separate license application for any other radioactive material authorizations they may seek (e.g., manufacturing of radiopharmaceuticals and medical use of byproduct material). Associated Supportive Activities The NRC staff has finalized the guidance in NUREG-1556, "Consolidated Guidance about Materials Licenses," Volume 9, Revision 2, "Program-Specific Guidance About Medical Use Licenses," issued January 2008; Volume 13, Revision 1, "Program-Specific Guidance About Commercial Radiopharmacy Licenses," issued November 2007; and the new Volume 21, "Program-Specific Guidance About Possession Licenses for Production of Radioactive Materials Using an Accelerator," issued October 2007. The NRC staff is also planning to make minor revisions, which reflect the regulation of the new byproduct material, to other NUREG-1556 licensing guidance and related inspection procedures (IPs) (e.g., IP 87125, "Materials Processor/Manufacturer Programs," and IP 87127, "Radiopharmacy Programs"). Information on NARM-related activities and recently issued Office of Federal and State Materials and Environmental Management Programs (FSME) generic communications are also available in the "NARM Toolbox" at the NRC's FSME Web site at http://nrc-stp.ornl.gov/narmtoolbox.html.
In addition, new NRC license applicants that are seeking authorization to produce radioactive materials using an accelerator should submit a license application for that authorization and should submit a separate license application for any other radioactive material authorizations they may seek (e.g., manufacturing of radiopharmaceuticals and medical use of byproduct material).
Associated Supportive Activities The NRC staff has finalized the guidance in NUREG-1556, Consolidated Guidance about Materials Licenses, Volume 9, Revision 2, Program-Specific Guidance About Medical Use Licenses, issued January 2008; Volume 13, Revision 1, Program-Specific Guidance About Commercial Radiopharmacy Licenses, issued November 2007; and the new Volume 21, Program-Specific Guidance About Possession Licenses for Production of Radioactive Materials Using an Accelerator, issued October 2007. The NRC staff is also planning to make minor revisions, which reflect the regulation of the new byproduct material, to other NUREG-1556 licensing guidance and related inspection procedures (IPs) (e.g., IP 87125, Materials Processor/Manufacturer Programs, and IP 87127, Radiopharmacy Programs). Information on NARM-related activities and recently issued Office of Federal and State Materials and Environmental Management Programs (FSME) generic communications are also available in the NARM Toolbox at the NRCs FSME Web site at http://nrc-stp.ornl.gov/narmtoolbox.html.


==BACKFIT DISCUSSION==
==BACKFIT DISCUSSION==
This RIS requires no action or written response. Any action on the part of addressees in accordance with the guidance contained in this RIS is strictly voluntary and, therefore, is not a backfit under any regulation in Title 10 of the Code of Federal Regulations (10 CFR).
This RIS requires no action or written response. Any action on the part of addressees in accordance with the guidance contained in this RIS is strictly voluntary and, therefore, is not a backfit under any regulation in Title 10 of the Code of Federal Regulations (10 CFR).


===FEDERAL REGISTER NOTIFICATION===
===FEDERAL REGISTER NOTIFICATION===
Line 43: Line 69:


==RELATED GENERIC COMMUNICATIONS==
==RELATED GENERIC COMMUNICATIONS==
RIS 2008-13, "Status And Plans For Implementation of NRC Regulatory Authority for Certain Naturally-Occurring and Accelerator-Produced Radioactive Material." 
RIS 2008-13, Status And Plans For Implementation of NRC Regulatory Authority for Certain Naturally-Occurring and Accelerator-Produced Radioactive Material.
 
RIS-2009-07  
RIS-2009-07  


===PAPERWORK REDUCTION ACT STATEMENT===
===PAPERWORK REDUCTION ACT STATEMENT===
This regulatory issue summary requires no specific action nor written response. If you have any questions about this summary, please contact the contact listed below or the appropriate regional office.
This regulatory issue summary requires no specific action nor written response. If you have any questions about this summary, please contact the contact listed below or the appropriate regional office.


===PUBLIC PROTECTION NOTIFICATION===
===PUBLIC PROTECTION NOTIFICATION===
Line 53: Line 80:


===CONGRESSIONAL REVIEW ACT===
===CONGRESSIONAL REVIEW ACT===
This RIS is not a rule as designated by the Congressional Review Act (5 U.S.C. §§ 801-808) and, therefore, is not subject to this Act.
This RIS is not a rule as designated by the Congressional Review Act (5 U.S.C. §§ 801-808)
and, therefore, is not subject to this Act.


/RA/
/RA/
Robert J. Lewis, Director Division of Materials Safety and State Agreements Office of Federal and State Materials and           Environmental Management Programs
                                              Robert J. Lewis, Director Division of Materials Safety and State Agreements Office of Federal and State Materials and Environmental Management Programs  


===Technical Contact:===
===Technical Contact:===
Shirley Xu, FSME   (301) 415-7640   E-mail: shirley.xu@nrc.gov
Shirley Xu, FSME
 
                        (301) 415-7640
Enclosure: Recently Issued FSME Generic Communications  
                        E-mail: shirley.xu@nrc.gov Enclosure: Recently Issued FSME Generic Communications


RIS-2009-07  
RIS-2009-07  


===PAPERWORK REDUCTION ACT STATEMENT===
===PAPERWORK REDUCTION ACT STATEMENT===
This regulatory issue summary requires no specific action nor written response. If you have any questions about this summary, please contact the contact listed below or the appropriate regional office.
This regulatory issue summary requires no specific action nor written response. If you have any questions about this summary, please contact the contact listed below or the appropriate regional office.


===PUBLIC PROTECTION NOTIFICATION===
===PUBLIC PROTECTION NOTIFICATION===
Line 72: Line 100:


===CONGRESSIONAL REVIEW ACT===
===CONGRESSIONAL REVIEW ACT===
This RIS is not a rule as designated by the Congressional Review Act (5 U.S.C. §§ 801-808) and, therefore, is not subject to this Act.
This RIS is not a rule as designated by the Congressional Review Act (5 U.S.C. §§ 801-808)
      and, therefore, is not subject to this Act.


Robert J. Lewis, Director Division of Materials Safety and State Agreements Office of Federal and State Materials and           Environmental Management Programs
Robert J. Lewis, Director Division of Materials Safety and State Agreements Office of Federal and State Materials and Environmental Management Programs  


===Technical Contact:===
===Technical Contact:===
Shirley Xu, FSME   (301) 415-7640   E-mail: shirley.xu@nrc.gov
Shirley Xu, FSME
                              (301) 415-7640
                              E-mail: shirley.xu@nrc.gov Enclosure: Recently Issued FSME Generic Communications ML091030497 OFFICE    FSME/MSSA              FSME/MSSA              ADM/TechEd            OGC-NLO            OGC-
                                                                                                  CRA
NAME    SXu                  ADWhite                K Azariah-Kribbs      BJones              TRothschild DATE          4/13/09                4/15 /09              4/27 /09              4/ 23 /09        4/20/09 OFFICE    FSME/MSSA                  OIS              FSME/MSSA          FSME/MSSA
NAME    AMcIntosh            TDonnell                R Reis                RJLewis DATE          4/30/09                4/ 17/09              4/ 30/09              5/6 /09 OFFICIAL RECORD COPY
 
RIS-2009-07 List of Recently Issued Office of Federal and State Material and Environmental Management Programs Generic Communications Date              GC No.                        Subject                                     


Enclosure: Recently Issued FSME Generic Communications ML091030497 OFFICE  FSME/MSSA
==Addressees==
  FSME/MSSA  ADM/TechEd  OGC-NLO
12/01/08        RIS-2008-31      Licensing Requirements for              All U.S. Nuclear Regulatory Commission Sentinel Lymph Node Biopsy              medical use licensees and NRC master material licensees. All Agreement State Radiation Control Program Directors and State Liaison Officers
  OGC-CRA  NAME SXu  ADWhite  K Azariah-Kribbs BJones TRothschild
    12/22/08        RIS-2008-10,    Notice Regarding Forthcoming            All U.S. Nuclear Regulatory Commission Suppl. 1      Federal Firearms Background Checks      licensees, certificate holders, and applicants for a license or certificate of compliance who use armed security personnel as part of their physical protection system and security organization. All Radiation Control Program Directors and State Liaison Officers
    01/12/09          IN-2008-22      Molybdenum-99    Breakthrough in      All U.S. Nuclear Regulatory Commission Molybdenum-99/Technetium-99m            medical, radiopharmacy, molybdenum-99/
                                      Generators                              technetium-99m generator manufacturers, and master material icensees authorized to manufacture or use generators. All Agreement State radiation control program directors and State liaison officers.


DATE  4/13/09  4/15 /09  4/27 /09  4/ 23 /09 4/20/09 OFFICE  FSME/MSSA
01/22/09         IN-2009-01     National Response Framework            All holders of operating licenses or certificates for nuclear power plants, research and test reactors, independent spent fuel storage installations, fuel cycle facilities, and radioactive materials. All holders of operating licenses for uranium recovery facilities and all holders of licenses or certificates for the following types of facilities undergoing decommissioning: nuclear power plants, research and test reactors, fuel cycle facilities, and uranium recovery facilities.
  OIS  FSME/MSSA  FSME/MSSA
     NAME  AMcIntosh TDonnell R Reis RJLewis  


DATE  4/30/09   4/ 17/09  4/ 30/09 5/6 /09  OFFICIAL RECORD COPY
02/03/09         IN-2009-05      Contamination  Events Resulting from    All U.S. Nuclear Regulatory Commission Damage to Sealed Radioactive Sources materials licensees; all Agreement State During Gauge DismantlementaAnd          Radiation Control Program Directors and State Nonroutine Maintenance Operations        Liaison Officers.
RIS-2009-07 List of Recently Issued Office of Federal and State Material  and Environmental Management Programs Generic Communications Date GC No. Subject


==Addressees==
03/30/09         IN-2009-07     Withholding of Proprietary             All current holders of and potential applicants Information from Public Disclosure      for licenses, certificates of compliance, permits, or standard design certifications, as well as any other persons submitting a request that information be withheld from public disclosure under the provisions of Title 10 of the Code of ederal Regulations (10 CFR) Section
12/01/08 RIS-2008-31 Licensing Requirements for Sentinel Lymph Node Biopsy All U.S. Nuclear Regulatory Commission medical use licensees and NRC master material licensees. All Agreement State Radiation Control Program Directors and State Liaison Officers 12/22/08 RIS-2008-10, Suppl. 1 Notice Regarding Forthcoming Federal Firearms Background Checks All U.S. Nuclear Regulatory Commission licensees, certificate holders, and applicants for a license or certificate of compliance who use armed security personnel as part of their physical protection system and security organization.  All Radiation Control Program Directors and State Liaison Officers 01/12/09 IN-2008-22 Molybdenum-99 Breakthrough in Molybdenum-99/Technetium-99m Generators All U.S. Nuclear Regulatory Commission  medical, radiopharmacy, molybdenum-99/  technetium-99m generator manufacturers, and master material icensees authorized to manufacture or use generators. All Agreement State radiation control program directors and State liaison officers. 01/22/09 IN-2009-01 National Response Framework All holders of operating licenses or certificates for nuclear power plants, research and test reactors, independent spent fuel storage installations, fuel cycle facilities, and radioactive materials. All holders of operating licenses for uranium recovery facilities and all holders of licenses or certificates for the following types of facilities undergoing decommissioning: nuclear power plants, research and test reactors, fuel cycle facilities, and uranium recovery facilities. 02/03/09 IN-2009-05 Contamination Events Resulting from Damage to Sealed Radioactive Sources During Gauge DismantlementaAnd Nonroutine Maintenance Operations All U.S. Nuclear Regulatory Commission materials licensees; all Agreement State Radiation Control Program Directors and State Liaison Officers. 03/30/09 IN-2009-07 Withholding of Proprietary Information from Public Disclosure All current holders of and potential applicants for licenses, certificates of compliance, permits, or standard design certifications, as well as any other persons submitting a request that information be withheld from public disclosure under the provisions of Title 10 of  
                                                                              2.390, Public inspections, exemptions, requests for withholding.


the Code of ederal Regulations (10 CFR) Section 2.390, "Public inspections, exemptions, requests for withholding. Note:   This list contains the six most recently issued generic communications, issued by the Office of Federal and State Materials and Environmental Management Programs (FSME). A full listing of all generic communications may be viewed at the NRC public website at the following address: http://www.nrc.gov/reading-rm/doc-collections/gen-comm/index.html
Note: This list contains the six most recently issued generic communications, issued by the Office of Federal and State Materials and Environmental Management Programs (FSME). A full listing of all generic communications may be viewed at the NRC public website at the following address: http://www.nrc.gov/reading-rm/doc-collections/gen-comm/index.html
}}
}}


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Revision as of 07:10, 14 November 2019

Status Update for Implementation of NRC Regulatory Authority for Certain Naturally Occurring and Accelerator-Produced Radioactive Material
ML091030497
Person / Time
Issue date: 05/07/2009
From: Robert Lewis
NRC/FSME/DMSSA
To:
Xu, Shirley
References
RIS-09-007
Download: ML091030497 (6)
v • d • e


UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF FEDERAL AND STATE MATERIALS

AND ENVIRONMENTAL MANAGEMENT PROGRAMS

WASHINGTON, DC 20555-0001 May 07, 2009 NRC REGULATORY ISSUE SUMMARY 2009-07 STATUS UPDATE FOR THE IMPLEMENTATION OF NRC

REGULATORY AUTHORITY FOR CERTAIN NATURALLY OCCURRING

AND ACCELERATOR-PRODUCED RADIOACTIVE MATERIAL

ADDRESSEES

All U.S. Nuclear Regulatory Commission (NRC) material and fuel cycle licensees. All Radiation Control Program Directors and State Liaison Officers.

INTENT

The NRC is issuing this regulatory issue summary (RIS) to inform recipients of the status of the agencys efforts to implement the requirements of section 651(e) of the Energy Policy Act of

2005 (EPAct) on Treatment of Accelerator-Produced and Other Radioactive Material as Byproduct Material. No specific action or written response is required. The NRC encourages recipients of this RIS to share this information with known users of the newly defined byproduct materials resulting from the EPAct, who may not currently possess an NRC byproduct materials license. The NRC is providing this Regulatory Issue Summary (RIS) to Agreement States for their information and distribution to their licensees as appropriate.

BACKGROUND

On August 8, 2005, the President signed the EPAct into law. Section 651(e) of the EPAct expands the definition of byproduct material as given in section 11e of the Atomic Energy Act of 1954 (AEA), as amended. This change places additional byproduct material under the NRCs jurisdiction, as defined in paragraphs 11e.(3) and 11e.(4) of the AEA. Thirty-Six States have previously certified that they have programs in place to properly regulate the newly defined byproduct materials.

ML091030497

RIS-2009-07

SUMMARY OF ISSUE

Final Regulations Section 651(e) of the EPAct requires that the NRC issue final regulations that establish requirements for licensing and regulating AEA Sections 11e.(3) and 11e.(4) byproduct material, while cooperating with the States and using model State standards to the maximum extent practicable. The NRC published its final regulations on October 1, 2007 (Volume 72, page

55864, of the Federal Register (72 FR 55864)). These final regulations became effective on November 30, 2007, and can be accessed on the NRCs Public Involvement Rulemaking Web site at http://www.nrc.gov/about-nrc/regulatory/rulemaking/public-involvement.html.

Waiver Issued on August 31, 2005 (70 FR 51581)

As authorized by section 651(e) of the EPAct, the NRC issued a waiver on August 31, 2005, to allow the continued use and possession of naturally occurring and accelerator-produced radioactive materials (NARM) while it developed a regulatory framework for regulation of NARM

as a new type of byproduct material. The waiver was issued for a period of four years from the date of EPAct and will terminate on August 7, 2009.

The NRC has begun terminating the waiver in phases. The first phase of waiver terminations occurred on November 30, 2007 (the effective date of the final rule). On this date, the NRC

terminated the waiver for Federal Government agencies, Federally Recognized Indian Tribes, Delaware, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Indiana, Wyoming, and Montana. The second phase of waiver terminations occurred on September 30, 2008. On this date, the NRC terminated the waiver for Idaho, Missouri, South Dakota, Vermont, West Virginia, Guam and all other territories and possessions of the United States that were not part of Phase 1. Upon waiver termination, all persons who possessed the new byproduct materials in these States, U.S. Territories, or areas of exclusive Federal jurisdiction were to be in compliance with NRC regulations. Being in compliance means that such persons are responsible for the proper handling, transfer, and disposal of these new byproduct materials as specified in NRC regulations.

The third and last phase of waiver terminations will occur on August 7, 2009, (74 FR 5797).

This final phase will include Alaska, Connecticut, Hawaii, Michigan, New Jersey, and NRC

licensees with headquarters in Canada. Additionally, the Commission terminated the waiver for non-Agreement States that entered into an Agreement with the NRC under Section 274b of the Atomic Energy Act of 1954, as amended, coincident with the effective date of such an agreement. The State of New Jersey has submitted an Agreement State application to the NRC. The New Jersey agreement may be completed prior to the waiver termination date at August 7, 2009. If their agreement goes into effect prior to the waiver termination date, then the waiver for New Jersey licenses will terminate to coincide the effective date of the agreement.

The NRC prepared and promulgated a transition plan (72 FR 59157), which was published in the Federal Register on October 19, 2007 to facilitate an orderly transition of regulatory authority with respect to the newly added byproduct material. As explained in the transition plan, under the final regulations, users of NARM in non-Agreement States and U.S. Territories are required to: (1) apply for license amendments for the new byproduct material within 6 months from the date the waiver is terminated, if they hold an NRC specific byproduct materials license, or (2)

submit a license application for the new byproduct material within 12 months from the date the

RIS-2009-07 waiver is terminated. Upon receipt of either a license amendment or a new license application, the respective NRC regional office will notify the applicant of its receipt of the request. The notification will document that the applicant complied with this aspect of the regulations.

Existing NRC licensees should note that the NRC will not amend licenses to include authorization to produce radioactive material using an accelerator; the agency will require a separate license for these activities. Therefore, existing licensees should contact their NRC

Regional Office and prepare to submit a new license application to obtain authorization for the production of radioactive materials using an accelerator.

In addition, new NRC license applicants that are seeking authorization to produce radioactive materials using an accelerator should submit a license application for that authorization and should submit a separate license application for any other radioactive material authorizations they may seek (e.g., manufacturing of radiopharmaceuticals and medical use of byproduct material).

Associated Supportive Activities The NRC staff has finalized the guidance in NUREG-1556, Consolidated Guidance about Materials Licenses, Volume 9, Revision 2, Program-Specific Guidance About Medical Use Licenses, issued January 2008; Volume 13, Revision 1, Program-Specific Guidance About Commercial Radiopharmacy Licenses, issued November 2007; and the new Volume 21, Program-Specific Guidance About Possession Licenses for Production of Radioactive Materials Using an Accelerator, issued October 2007. The NRC staff is also planning to make minor revisions, which reflect the regulation of the new byproduct material, to other NUREG-1556 licensing guidance and related inspection procedures (IPs) (e.g., IP 87125, Materials Processor/Manufacturer Programs, and IP 87127, Radiopharmacy Programs). Information on NARM-related activities and recently issued Office of Federal and State Materials and Environmental Management Programs (FSME) generic communications are also available in the NARM Toolbox at the NRCs FSME Web site at http://nrc-stp.ornl.gov/narmtoolbox.html.

BACKFIT DISCUSSION

This RIS requires no action or written response. Any action on the part of addressees in accordance with the guidance contained in this RIS is strictly voluntary and, therefore, is not a backfit under any regulation in Title 10 of the Code of Federal Regulations (10 CFR).

FEDERAL REGISTER NOTIFICATION

The NRC did not publish a notice of opportunity for public comment on this RIS in the Federal Register because this RIS is informational and does not represent a departure from current regulatory requirements.

RELATED GENERIC COMMUNICATIONS

RIS 2008-13, Status And Plans For Implementation of NRC Regulatory Authority for Certain Naturally-Occurring and Accelerator-Produced Radioactive Material.

RIS-2009-07

PAPERWORK REDUCTION ACT STATEMENT

This regulatory issue summary requires no specific action nor written response. If you have any questions about this summary, please contact the contact listed below or the appropriate regional office.

PUBLIC PROTECTION NOTIFICATION

The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting documents displays a currently valid OMB control number.

CONGRESSIONAL REVIEW ACT

This RIS is not a rule as designated by the Congressional Review Act (5 U.S.C. §§ 801-808)

and, therefore, is not subject to this Act.

/RA/

Robert J. Lewis, Director Division of Materials Safety and State Agreements Office of Federal and State Materials and Environmental Management Programs

Technical Contact:

Shirley Xu, FSME

(301) 415-7640

E-mail: shirley.xu@nrc.gov Enclosure: Recently Issued FSME Generic Communications

RIS-2009-07

PAPERWORK REDUCTION ACT STATEMENT

This regulatory issue summary requires no specific action nor written response. If you have any questions about this summary, please contact the contact listed below or the appropriate regional office.

PUBLIC PROTECTION NOTIFICATION

The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting documents displays a currently valid OMB control number.

CONGRESSIONAL REVIEW ACT

This RIS is not a rule as designated by the Congressional Review Act (5 U.S.C. §§ 801-808)

and, therefore, is not subject to this Act.

Robert J. Lewis, Director Division of Materials Safety and State Agreements Office of Federal and State Materials and Environmental Management Programs

Technical Contact:

Shirley Xu, FSME

(301) 415-7640

E-mail: shirley.xu@nrc.gov Enclosure: Recently Issued FSME Generic Communications ML091030497 OFFICE FSME/MSSA FSME/MSSA ADM/TechEd OGC-NLO OGC-

CRA

NAME SXu ADWhite K Azariah-Kribbs BJones TRothschild DATE 4/13/09 4/15 /09 4/27 /09 4/ 23 /09 4/20/09 OFFICE FSME/MSSA OIS FSME/MSSA FSME/MSSA

NAME AMcIntosh TDonnell R Reis RJLewis DATE 4/30/09 4/ 17/09 4/ 30/09 5/6 /09 OFFICIAL RECORD COPY

RIS-2009-07 List of Recently Issued Office of Federal and State Material and Environmental Management Programs Generic Communications Date GC No. Subject

Addressees

12/01/08 RIS-2008-31 Licensing Requirements for All U.S. Nuclear Regulatory Commission Sentinel Lymph Node Biopsy medical use licensees and NRC master material licensees. All Agreement State Radiation Control Program Directors and State Liaison Officers

12/22/08 RIS-2008-10, Notice Regarding Forthcoming All U.S. Nuclear Regulatory Commission Suppl. 1 Federal Firearms Background Checks licensees, certificate holders, and applicants for a license or certificate of compliance who use armed security personnel as part of their physical protection system and security organization. All Radiation Control Program Directors and State Liaison Officers

01/12/09 IN-2008-22 Molybdenum-99 Breakthrough in All U.S. Nuclear Regulatory Commission Molybdenum-99/Technetium-99m medical, radiopharmacy, molybdenum-99/

Generators technetium-99m generator manufacturers, and master material icensees authorized to manufacture or use generators. All Agreement State radiation control program directors and State liaison officers.

01/22/09 IN-2009-01 National Response Framework All holders of operating licenses or certificates for nuclear power plants, research and test reactors, independent spent fuel storage installations, fuel cycle facilities, and radioactive materials. All holders of operating licenses for uranium recovery facilities and all holders of licenses or certificates for the following types of facilities undergoing decommissioning: nuclear power plants, research and test reactors, fuel cycle facilities, and uranium recovery facilities.

02/03/09 IN-2009-05 Contamination Events Resulting from All U.S. Nuclear Regulatory Commission Damage to Sealed Radioactive Sources materials licensees; all Agreement State During Gauge DismantlementaAnd Radiation Control Program Directors and State Nonroutine Maintenance Operations Liaison Officers.

03/30/09 IN-2009-07 Withholding of Proprietary All current holders of and potential applicants Information from Public Disclosure for licenses, certificates of compliance, permits, or standard design certifications, as well as any other persons submitting a request that information be withheld from public disclosure under the provisions of Title 10 of the Code of ederal Regulations (10 CFR) Section

2.390, Public inspections, exemptions, requests for withholding.

Note: This list contains the six most recently issued generic communications, issued by the Office of Federal and State Materials and Environmental Management Programs (FSME). A full listing of all generic communications may be viewed at the NRC public website at the following address: http://www.nrc.gov/reading-rm/doc-collections/gen-comm/index.html


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