The U.S. Nuclear Regulatory Commission (NRC) recently published two draft guidance documents for public comment that impact users of radioactive materials for medical use. With respect to the one of the two guidance documents (the Medical Use Guidance) the NRC staff has informed us that it will accept comments on all areas of the document.
On December 6, 2016, the NRC published a notice in the Federal Register requesting public comments on revisions to a key guidance document on the medical use of radioactive materials. The draft guidance, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses," NUREG-1556, Volume 9, Revision 3 (Medical Use Guidance) can be found here. Comments should be submitted by February 6, 2017.
On December 16, 2016, the NRC also published a notice in the Federal Register requesting public comments on revisions to another guidance document that could also impact medical use licensees. The draft guidance, “Consolidated Guidance About Materials Licenses - Program-Specific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator,” NUREG-1556, Volume 21, Revision 1 (Accelerator Guidance) can be found here. Although comments are currently due by January 20, 2017, the NRC staff has indicated to us that the comment period for the Accelerator Guidance will be extended to February 24, 2017.
Medical use guidance
Medical use guidance The Medical Use Guidance is intended to assist medical use licensees and applicants, as well as the NRC staff, on the applicable regulatory requirements associated with the medical use of radioactive materials. While the revision is not associated with any rulemaking, it nonetheless includes new information and concepts, particularly in the following areas:
— Safety Culture (e.g., Section 3.2);
— Security of Radioactive Materials (e.g., Section 8.10);
— Protection of Sensitive Information (e.g., Chapter 6); and
— General changes in regulatory policies and practices.
The update also revises and reorganizes the Medical Use Guidance to conform more closely and more accurately to the information specifically requested by the NRC in its license application form. Some of this revision appears in line with general updates ongoing with the NRC’s radioactive materials licensing guidance (i.e., the NUREG-1556 series), such as standardizing language, updating security requirements to align with regulatory changes, and adding safety culture information.
Nonetheless, there has been some back and forth on this revision between the NRC staff and the NRC Advisory Committee on the Medical Uses of Isotopes (ACMUI), an independent body within the NRC comprised of medical experts who advise on pertinent NRC activities. In 2015, a subcommittee of the ACMUI suggested a number of changes to the draft guidance seeking to clarify terms and requirements and remove duplication. It also noted that the NRC staff should not apply safety culture frameworks applicable to nuclear reactors to the medical device community without recognizing the unique features of the community first. It appears some, but not all, of the ACMUI subcommittee’s recommendations were adopted.
Given the extent of the revisions, the regulated community may want to take a closer look at the draft Medical Use Guidance and provide comments to the NRC staff as appropriate. The NRC staff has informed us that it is accepting comments at this time on all of the Medical Use Guidance, not just on the changed areas.
To note, this draft of the Medical Use Guidance does not include any revisions associated with the NRC’s ongoing rulemaking "Medical Use of Byproduct Material-Medical Event Definitions, Training and Experience, and Clarifying Amendments." The NRC published the proposed rule and corresponding changes to the Medical Use Guidance on July 14, 2014 in the Federal Register. This separate rulemaking would amend the Medical Use Guidance in regards to:
— Reporting and notification of medical event for permanent implant brachytherapy; training and experience for authorized users, medical physicists, Radiation Safety Officers, and nuclear pharmacists;
— Measuring molybdenum contamination and reporting of failed technetium and rubidium generators;
— Allowing Associate Radiation Safety Officers to be named on a medical use license; and
— Clarifying other revisions to the regulations.
This separate rulemaking appears to be nearing completion. The NRC staff sent a final draft rule to the Commission for approval in June 2016, and it is presently awaiting Commission action. If this final draft rule is approved, all the proposed revisions to the Medical Use Guidance will be consolidated before final publication.
The Accelerator Guidance is intended to assist NRC licensees and applicants, as well as the NRC staff, on the applicable regulatory requirements associated with the production of radioactive material using an accelerator. Such material is often used in medicine and research.
The guidance 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. The NRC does not regulate accelerators themselves. The draft reflects the first revision to the Accelerator Guidance since it was initially issued in 2007, in response to legislation and an accompanying rulemaking giving the NRC regulatory authority over this type of material. Like the Medical Use Guidance revision, the Accelerator Guidance revision is not associated with any rulemaking.
The new revision includes information on safety culture, clarifies what constitutes security-related information, and makes other edits due to changes in regulatory policies and practices, some of which are common among other revisions to the NRC’s radioactive materials licensing guidance. There are two changes to the guidance worth specifically noting, however. First, the appendices to the Accelerator Guidance have been significantly revised and expanded, in particular Appendix E, regarding the Audit Program. Second, security-related recommendations that stem from 10 C.F.R. Part 37 (physical protection of Category 1 and 2 radioactive sources) have been removed. This latter change appears to stem from recognition that nuclides produced from accelerators are generally not considered Category 1 or 2 sources.
The NRC and Agreement States regulate thousands of materials licenses in the United States, including those governing medical uses of radioactive materials. The NRC’s efforts to update, clarify, and standardize its NUREG-1556 guidance can prove quite helpful to both industry and the public. At the same time, it is important for the regulated community to be aware of the changes presented in each revision, and to pay close attention to safety culture and security programs that may be affected.
If you have questions or wish to learn more about these revisions, or the NRC’s regulation of radioactive materials in general, please contact the lawyers listed in this alert.