E7-10261. NUREG-1556, Volume 21, “Consolidated Guidance About Materials Licenses Program-Specific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator”; Draft Guidance Document for Comment

AGENCY:

Nuclear Regulatory Commission.

ACTION:

Notice of availability for public comment.

SUMMARY:

The Nuclear Regulatory Commission (NRC) has amended its regulations to include jurisdiction over certain radium sources, accelerator-produced radioactive materials, and certain naturally occurring radioactive material, as required by the Energy Policy Act of 2005 (EPAct), which was signed into law on August 8, 2005. The EPAct expanded the Atomic Energy Act of 1954 definition of byproduct material to include these radioactive materials. Subsequently, these radioactive materials were placed under NRC's regulatory authority. NRC is revising its regulations to provide a regulatory framework that includes these newly added radioactive materials. See SECY-07-0062, “Final Rule: Requirements for Expanded Definition of Byproduct Material,” dated April 3, 2007, for information on that rulemaking.

Two licensing guidance documents in the NUREG-1556 series are being revised along with these new regulations to provide guidance related to the new requirements: (1) NUREG-1556, Volume 13, Revision 1, “Consolidated Guidance About Materials Licenses—Program-Specific Guidance About Commercial Radiopharmacy Licenses,” and (2) NUREG-1556, Volume 9, Revision 2, “Consolidated Guidance About Materials Licenses—Program Specific Guidance About Medical Use Licenses.” A new volume in the NUREG-1556 series is also being developed to address the production of radioactive material using an accelerator. This NUREG is entitled, “NUREG-1556, Volume 21, “Consolidated Guidance About Materials Licenses—Program-Specific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator.”

This notice is announcing the availability of one of these three licensing guidance documents for public comment: NUREG-1556, Volume 21. NUREG-1556, Volume 13, Revision 1, and NUREG-1556, Volume 9, Revision 2, will be available for public comment in the near future by separate notices in the Federal Register.

DATES:

Please submit comments by June 28, 2007. Comments received after this date will be considered if practical to do so, but the NRC staff is able to ensure consideration only for those comments received on or before this date.

ADDRESSES:

Volume 21, “Consolidated Guidance About Materials Licenses—Program-Specific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator” is available for inspection and copying for a fee at the NRC's Public Document Room (PDR), Public File Area O-1F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland. Publicly available documents created or received at the NRC after November 1, 1999, are available electronically at the NRC's Electronic Reading Room at http://www.nrc.gov/​NRC/​ADAMS/​index.html. From this site, the public can gain entry into the NRC's Agencywide Document Access and Management System (ADAMS), which provides text and image files of the NRC's public documents. The ADAMS Accession Number for NUREG-1556, Volume 21 is ML071410035. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC PDR Reference staff at 1-800-397-4209, 301-415-4737, or by e-mail to [e-mail]. The document will also be posted on NRC's public Web site at: http://www.nrc.gov/​reading-rm/​doc-collections/​nuregs/​staff/​sr1556/​ on the “Consolidated Guidance About Materials Licenses (NUREG-1556)” Web site page.

A free single copy, to the extent of supply, may be requested by writing to Office of the Chief Information Officer, Reproduction and Distribution Services, U.S. Nuclear Regulatory Commission, Printing and Graphics Branch, Washington, DC 20555-0001; facsimile: 301-415-2289; e-mail: [e-mail].

Please submit comments to Chief, Rulemakings, Directives, and Editing Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC, 20555-0001. You may also deliver comments to 11545 Rockville Pike, Rockville, MD, between 7:30 a.m. and 4:30 p.m. Federal workdays, or by e-mail to: [e-mail].

FOR FURTHER INFORMATION CONTACT:

Torre Taylor, Division of Intergovernmental Liaison and Rulemaking, Office of Federal and State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone [phone], e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Background

On August 8, 2005, the President signed into law the EPAct. Among other provisions, Section 651(e) of the EPAct expanded the definition of byproduct material as defined in Section 11e. of the Atomic Energy Act of 1954 (AEA), placing additional byproduct material under the NRC's jurisdiction, and required the Commission to provide a regulatory framework for licensing and regulating these additional byproduct materials.

Specifically, Section 651(e) of the EPAct expanded the definition of byproduct material by: (1) adding any discrete source of radium-226 that is produced, extracted, or converted after extraction, before, on, or after the date of enactment of the EPAct for use for a commercial, medical, or research activity; or any material that has been made radioactive by use of a particle accelerator and is produced, extracted, or converted after extraction, before, on, or after the date of enactment of the EPAct for use for a commercial, medical, or research activity (Section 11e.(3) of the AEA); and (2) adding any discrete source of naturally occurring radioactive material, other than source material, that the Commission, in consultation with the Administrator of the Environmental Protection Agency (EPA), the Secretary of the Department of Energy (DOE), the Secretary of the Department of Homeland Security (DHS), and the head of any other appropriate Federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security; and is extracted or converted after extraction before, on, or after the date of enactment of the EPAct for use in a commercial, medical, or research activity (Section 11e.(4) of the AEA).

NRC is revising its regulations to provide a regulatory framework that includes these newly added radioactive materials. See SECY-07-0062, “Final Rule: Requirements for Expanded Definition of Byproduct Material,” dated April 3, 2007, for information on that rulemaking.

Discussion

As part of the rulemaking effort to address the mandate of the EPAct, the NRC also evaluated the need to revise certain licensing guidance to provide necessary guidance to applicants in preparing license applications to include the use of the newly added radioactive materials as byproduct material. Two NUREG-1556 documents are being revised to provide additional guidance to licensees: (1) NUREG-1556, Volume 13, Revision 1, “Consolidated Guidance About Materials Licenses—Program-Specific Guidance About Commercial Radiopharmacy Licenses,” and (2) NUREG-1556, Volume 9, Revision 2, “Consolidated Guidance About Materials Licenses—Program-Specific Guidance About Medical Use Licenses.” Additionally, a new NUREG-1556 volume is also being developed to address production of radioactive material using an accelerator. This NUREG-1556 volume is entitled: Volume 21, “Consolidated Guidance About Materials Licenses—Program-Specific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator.”

At this time, NRC is announcing the availability for public comment NUREG-1556, Volume 21, “Consolidated Guidance About Materials Licenses—Program-Specific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator.” The remaining two NUREG-1556 volumes, (1) NUREG-1556, Volume 13, Revision 1, “Consolidated Guidance About Materials Licenses—Program-Specific Guidance About Commercial Radiopharmacy Licenses,” Draft Report for Comment, and (2) NUREG-1556, Volume 9, Revision 2, “Consolidated Guidance About Materials Licenses—Program-Specific Guidance About Medical Use Licenses,” will be available for public comment in the near future.

NUREG-1556, Volume 21, provides guidance on preparing a license application for the production of radioactive material using an accelerator(s). It also includes the criteria that NRC staff will use in evaluating license applications for this use. This document includes guidance that is specific to the activities that take place once radioactive materials are produced by the accelerator, which include material in the target and associated activation products. This document does not include information for the operation of the accelerator as NRC does not regulate the accelerator or its operation.

Volume 21 provides guidance related to each of the items that applicants should address in their materials license application, which includes items such as radioactive material that will be produced and its purpose; information on individuals responsible for the radiation safety program; training for individuals that will handle radioactive material; description of the facilities and equipment used; and the radiation safety program. There are some aspects of producing radioactive materials using an accelerator that are unique to this type of use and are discussed in the document. Some examples include training and experience for individuals who will handle radioactive material during the maintenance and repair of the accelerator and other associated equipment, and guidance on the facility design and type of equipment needed to transfer and handle large radioactive materials with high activities. This document will also include guidance on the production and noncommercial distribution of positron emission tomography radioactive drugs to consortium members.

Dated at Rockville, Maryland, this 22nd day of May 2007.

For the Nuclear Regulatory Commission.

Dennis K. Rathbun,

Division Director, Division of Intergovernmental Liaison and Rulemaking, Office of Federal and State Materials and Environmental Management Programs.