U.S. Nuclear Regulatory Commission

The U.S. Nuclear Regulatory Commission (NRC) periodically posts documents on their website that are important or of interest to Florida radioactive material licensees or the public. The NRC also occasionally asks the Bureau of Radiation Control to share information to our stakeholders. This is not intended to be all inclusive, so if you need more details about a particular topic visit U.S. Nuclear Regulatory Commission for more information.

• View NRC's Office of Federal and State Materials, and Environmental Management (FSME) Program Letters

Items of Interest

NRC Information Notice 2024-04
Recent Medical Events Involving Administration of Therapeutic Radiopharmaceuticals

Licensing for Technegas Aerosol and Plus System: (NRC ML23325A190 1-24-2024)
In September 2023, the U.S. Food and Drug Administration                (FDA) approved Technegas® aerosol for oral inhalation use. Technegas aerosol is a technetium-99m (Tc-99m) labeled carbon inhalation aerosol used as a diagnostic agent for ventilation studies. The aerosol is prepared in the Technegas Plus System by heating up a Technegas crucible loaded with Tc99m sodium pertechnetate

64E-5.627(4), Florida Administrative Code, requires a license amendment to use radioactive gases or aerosols and additional requirements are listed in 64E-5.629, F.A.C. The amendment request must also include a commitment to following the preparation and use procedures listed in:

• Preparation and use details: FDA’s 2023 Prescribing/Preparation Information to use TECHNEGAS®

NRC Information Notice 2023-05
Discontinuation of the U.S. Nuclear Regulatory Commissions  Recognition of the American Board of Radiology's Certification Processes

(STC-23-033) Notification of Issuance - Federal Register Notice Requesting Information Regarding Rulemaking on the Reporting of Nuclear Medicine Injection Extravasations as Medical Events

• Public meeting about this rulemaking was held on May 24, 2023.

Radioactive Material Licensees (additional protocol forms)to assist in meeting International Atomic Energy Agency (IAEA) treaty obligations - In accordance with 10 CFR 110.54(a)(1), reports of exports of nuclear facilities, equipment, and certain non-nuclear materials shipped by licensees under general license or specific license during the previous quarter.

Must be submitted by January 31, 2024, to BIS on DOC/NRC Forms AP-M or AP-13, and associated forms. The reports must contain information on all nuclear facilities, equipment, and nonnuclear materials listed in Annex II of the AP.

NRC Order Suspending General License Authority To Export Radioactive Material and Deuterium to the Russian Federation
The U.S. Nuclear Regulatory Commission issued an order suspending the general license authority under NRC regulations to export radioactive material, and deuterium for nuclear end use, to the Russian Federation.

Product Medical Advisory - Action Required TheraSphereTM Administration Sets
NRC has identified numerous medical events due to leakage with sets that contained a lubricant in the outlet luer. The lubricant could cause an unsecure connection to the patient catheter which would lead to leakage of the Y-90 from this connection.

NRC Information Notice 2021-02
Recent Issues associated with monitoring occupational exposure to radiation from licensed and unlicensed radiation sources.

NRC Information Notice 2019-11
Strontium-82/Rubidium-82 generator elution events and issues.

NRC Medical-Related Communications
Patients recently received Sr-82 and Sr-85 levels well in excess of the breakthrough limits for Sr-82/Rb-82 generators because of elution with Ringer’s lactate solution.

• Reminder to Florida licensees that they are required to follow manufacturer instructions, 2019 FDA DARRTS Reference ID  4425113 or 2019 FDA DARRTS Reference ID 4425127 and other requirements regarding the use of these generators. Please review your radioactive materials license for details.

NRC Information Notice 2019-07
Methods to prevent medical events.

NRC Information Notice 2019-06
Patient skin contamination events associated with I-131 Metaiodobenzylguanidine during neuroblastoma treatments.

NRC Information Notice 2019-05
Potential over-pressurization of high specific-activity alpha-emitting radioactivity sources.

Safety Culture
NRC's safety culture policy and website.

FSME 10-029
Development of joint NRC-NNSA key message document "Partnership For Securing Nuclear And Radioactive Materials."

FSME 10-027
Revised International Nuclear and Radiological Event Scale (INES) user manual.

FSME 10-019
Reporting requirements for industrial radiography, also Florida Information Notice 2010-03.

FSME 10-018
Notice of FSME on low level radioactive waste and source disposal.

SECY 09-0181
ProposedNRC’s Increased Controls Proposed Rule - (10 CFR Part 37): Physical Protection of Byproduct Material.

FSME 09-100
Notice of public comment on proposed regulatory issue summary 2009-XX, regarding monitoring the status of regulated activities.

FSME 09-095
Draft safety culture policy statement and notice of NRC workshops.