E7-12856. NUREG-1556, Volume 13, Revision 1, “Consolidated Guidance About Materials Licenses Program-Specific Guidance About Commercial Radiopharmacy Licenses”; Draft Guidance Document for Comment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 has also been 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 13, Revision 1. NUREG-1556, Volume 9, Revision 2, will be available for public comment in the near future. NUREG-1556, Volume 21, was previously noticed for public comment in the Federal Register, on May 29, 2007 (72 FR 29555).

DATES:

Please submit comments on NUREG-1556, Volume 13, Revision 1, by August 2, 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:

NUREG-1556, Volume 13, Revision 1, “Consolidated Guidance About Materials Licenses—Program-Specific Guidance About Commercial Radiopharmacy Licenses,” Draft Report for Comment, 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 13, Revision 1, is ML071581047. 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, and on the Office of Federal and State Materials and Environmental Management Programs' NARM (Naturally-Occurring and Accelerator-Produced Radioactive Material) Toolbox Web site page at: http://nrc-stp.ornl.gov/​narmtoolbox.html under the heading of “Licensing Guidance.”

A free single copy, to the extent of supply, may be requested by writing to the 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, Rulemaking, 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 this additional byproduct material.

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, the Secretary of the Department of Energy, the Secretary of the Department of Homeland Security, 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 documents to provide necessary guidance to applicants in preparing license applications to include the use of the newly added radioactive material 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 has been developed as Volume 21 to address production of radioactive material using an accelerator. This NUREG-1556, Volume 21, is entitled: “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 13, Revision 1, “Consolidated Guidance About Materials Licenses—Program-Specific Guidance About Commercial Radiopharmacy Licenses,” Draft Report for Comment. 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, “Consolidated Guidance About Materials Licenses—Program-Specific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator,” was previously noticed for public comment in the Federal Register on May 29, 2007 (72 FR 29555), for a 30-day comment period.

NUREG-1556, Volume 13, Revision 1, “Consolidated Guidance About Materials Licenses—Program-Specific Guidance About Commercial Radiopharmacy Licenses,” provides guidance for applicants for commercial radiopharmacy licenses in preparing their license applications. Volume 13 is being revised primarily to provide additional guidance related to positron emission tomography (PET) radiopharmaceuticals for medical use. The guidance in Section 8.7.2, “Authorized Nuclear Pharmacist,” has been updated to reflect current 10 CFR Part 35 requirements. Additionally, other minor changes are being made that are administrative in nature, such as updating the Agreement State section and updating references. Also, information related to identifying and protecting sensitive information is being updated.

NRC is only requesting comments on the specific changes in this document related to the expanded definition of byproduct material and the NARM rule. The Abstract contains a brief summary of the nature of the changes that were made as well as a list of Sections in which substantial revisions were made or new guidance was provided. NRC will make corrections if any errors or editorial corrections are noted; however, any comments not related to these specific changes will be evaluated during the next routine review of the NUREG.

Dated at Rockville, Maryland, this 21st day of June, 2007.

For the Nuclear Regulatory Commission.

Dennis K. Rathbun,

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