Radioactive Materials Program

 

Program Overview

The Radioactive Materials Program is responsible for the licensing and inspections of persons using radioactive materials in such areas as industrial, medical, educational and research applications.  Virginia became the 36th Agreement State on March 31, 2009.

This web site provides information on submitting an application for a radioactive materials license, guidance for a radiation protection program, licensing fees, general licensed devices, radiation protection regulations, and filing for reciprocity licenses.  If you have any questions regarding this information, please contact the Radioactive Materials Program at 804-864-8150.


Recent News, Information and Regulatory Actions

September 6, 2019:  The position of Radioactive Material Program Supervisor is vacant and under recruitment.  If you are interested in applying for this position, please use this link to the job posting and follow the instructions.

January 15, 2019:  Please note that there has been a change to the requirements for the licensing of X-Ray Fluorescence Analyzer Devices.  Effective January 2, 2019 the Virginia Department of Health (VDH) Radioactive Materials Program (RMP) no longer requires a Specific License (SL) for the possession and use of certain X-ray Fluorescence Analyzer (XRF) devices containing radioactive materials.  Some XRFs (depending on the manufacturer and model number) may now be possessed under a General License (GL).  VDH does not issue any licensing documents for GLs because all of the regulatory requirements are contained in the regulations.  Those regulations are contained in 12VAC5-481-430, “General Licenses – radioactive material other than source material.”

The VDH RMP believes that this change will be welcome news to most XRF licensees because VDH will not assess annual licensing fees for XRFs that are possessed under a GL.  In addition, the VDH RMP does not perform on-site inspections of GL XRF programs.

Licensees that would like to terminate their VDH RMP specific radioactive materials license, and “convert” their program to a GL program, will need to do the following:

  1. Determine if the XRF device has been evaluated and approved for a GL.  If it is approved, it will be labeled (with a “sticker”) that will state such.  In some cases, the only difference between the specifically licensed model and the generally licensed model is the label itself.  In that case, the manufacturer may be willing to send out a “replacement” GL label that can be simply placed over the SL label.
  2. Send the VDH RMP a request to terminate the SL.  Licensees will need to submit the request in writing, and supply evidence that the XRF device(s) are authorized for a GL.  One way to do this would be to submit a photo or image of the GL label.

GL XRFs must be possessed and used in accordance with the requirements in 12VAC5-481-430(b)(4), but as stated above, the VDH RMP does not issue any licensing documents and does not inspect these programs.

July 6, 2018:  A recent revision has been implemented on the majority of the applications and these updated applications have been uploaded to this website on the Forms page.  The most notable change for this revision is in the RSO section, requiring the duties and responsibilities and on-site evaluations to be addressed during the licensing process, either initial or renewal.  The physical inventory record information has also been added to the appropriate section.

May 5, 2018: Licensing guidance has been issued for the RadioGenix Molybdenum-99/Technetium-99m Generator System developed by Northstar Medical Radioisotopes.  Any licensee interested in adding this to their authorizations is encouraged to review this material (licensing guidance and enclosure 2 addressing questions). 

April 4, 2018: Please note that there has been a change in address for 12VAC5-481-451 fingerprinting request.  This address is now:  U. S. Nuclear Regulatory Commission, Criminal History Program, Division of Facilities and Security, 11545 Rockville Pike, Mail Stop T-7D04M, Rockville, MD  20852.  A letter will be sent shortly to affected licensees.

March 8, 2018:  As stated in the first January 18, 2018 update, 12VAC5-490, regarding the fees associated with registration and licenses, has been amended.  The overview of this regulation can be found here.  The proposed changes can be found here and here is where you would add your comment.  The comment period started last month on February 5, 2018 and ends April 8, 2018.

January 18, 2018: A proposal to update the X-ray and Radioactive Materials Program fees will be published on 02/05/2018 on the Regulatory Town Hall website (Volume: 34 Issue: 12).  A public comment forum will open on 2/5/2018 and remain open through 4/8/2018. To review and/or comment on the proposal during that time, please visit http://townhall.virginia.gov, locate the State Board of Health section and find  12VAC 5-490.

September 5, 2017: 12VAC5-481 has been updated to incorporate changes in various regulations. A copy of a presentation reviewing these changes is here and a copy of the proposed regulation change action summation can be found in Town Hall This regulatory action will be completed on September 19, 2017 and become effective at that time. No comment period will be available as these changes are required to maintain compliance with the NRC.

February 24, 2017:  12VAC5-481 has been updated for minor corrections.  These changes were implemented as a result of technical findings upon NRC review and are not alterations of any regulatory requirement.  Please use this link to for a current copy of the regulations: 12VAC5-481.

January 25, 2017:  The NRC is seeking input from licensees and members of the public regarding potential revisions to the regulations or processes requiring Category 3 source protection and accountability.  There will be a total of three public meetings and two webinars during the public comment period for this action.  The first webinar will be held on January 31, 2017 from 1:00 pm to 4:00 pm.  We highly encourage participation by all stakeholders who may be impacted by these changes.  This link will provide information about the initiative in general as well as the details regarding all the meetings and webinars.

December 1, 2016:  A Table of Contents for 12VAC5-481 with links to each section is available on the regulations page and here for your convenience.

September 29, 2016: Following the June 20th announcement, the RMP has created the following guidance for licensees desiring to amend their license and allow possession of the Ge-68 generator for the purpose of manufacturing the Ga-68 dose to be used for imaging.  Please use this document when creating your amendment request.  If you have any questions regarding this process, please contact us at 804-864-8150.  Ge-68-generator-amendment-requirements

September 23, 2016: On September 13th, we received the following letter from the Kentucky Energy and Environment Cabinet: 2016-9-6- Kentucky Letter.  The letter states that exporting NORM/TENORM in concentrations higher than 5 pCi/g is prohibited.  If you have any questions regarding sending waste in Kentucky, please contact us.

September 12, 2016:  Recently notification was sent to appropriate licensees regarding the authorization to utilize Instadose dosimeters and use of an electronic device that functions as both alarming ratemeter and electronic dosimeter.  A copy of these notifications is included here (Instadose Exemption and Electronic device exemption ) for your convenience.

September 6, 2016: On September 1st, the NRC updated the list of High Dose-Rate Remote Afterloaders (HDR) devices approved for patient treatment using sources exceeding 10 curies (Ci).  This list includes three HDR units that approved for source activities up to 11 Ci and five HDR units approved for activities up to 12 Ci.  This list can be found here: HDR Units Greater than 10Ci

August 31, 2016: On August 25th, a revision to the Virginia Radiation Protection Regulations (12VAC5-481) became effective.  This revision removed all references to 10 CFR and replaced them with verbiage; and updated the regulations to be compatible with 10 CFR.  Please visit our regulations page (left) to obtain pdf copies of the applicable parts relative to your licensed program.  If you have any questions please contact us.

July 25, 2016: Volume 32, Issue 24 (Virginia Register-32, 24) of the Virginia Register is published today with the revision to 12VAC5-481 “Virginia Radiation Protection Regulations”.  This revision removes all the references to 10 CFR and updates the regulations to be compatible with 10 CFR.  The revision will become effective on August 25th.  The new regulations will be published in a pdf format on our regulations webpage for you to download on August 25th.  For a copy of the revised regulations, click here: 2016-7-25 12VAC5-481 publication.

June 20, 2016:  Recently, the Food and Drug Administration (FDA) approved the use of a new diagnostic imaging agent to detect rare neuroendocrine tumors.  The FDA’s approval may be viewed at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm504524.htm.  This approval is specifically for the use of Netspot, a kit in the preparation of Ga-68 dotatate.  In order to produce this agent, a Ge-68 generator must be possessed and used.  The RMP is issuing the following exemption letter to medical licensees regarding the use of Ge-68 generators: 2016-6-20 Ge-68 exemption letter

May 25, 2016: Today the NRC released the revised gamma knife guidance to include the Icon.  The guidance is available by clicking: Icon Guidance 2016-5-25.

March 16, 2016: On March 8th, the NRC published Revision 9 to the “Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere® and SIR-Spheres® Licensing Guidance”.  This current licensing guidance revision has three major changes based on ACMUI recommendations. These changes (1) remove specifications for gastrointestinal tract and lung dose/activity in the written directive and exclude reporting dose/activity to an organ or tissue other than the treatment site as a medical event when the dose/activity is caused by shunting when the shunting was evaluated prior to treatment in accordance with manufacturer’s procedures, (2) specifically exclude reporting of events due to stasis or emergent patient conditions, and (3) allow for interventional radiologists certified by the American Osteopathic Board of Radiology to become Authorized Users.

The VRMP considers current licensees using older revisions to be grandfathered to this current revision.  For a copy of Revision 9, please click on the following: Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere® and SIR-Spheres® Licensing Guidance.

January 5, 2016: On December 14, 2015 the NRC issues Regulatory Issue Summary (RIS) 2015-18 titled “Sodium Iodide (I-131) Patient Release Information Collection.” To view the RIS and the Federal Register Notice listed in the RIS please click on the following:

RIS 2015-18 Sodium Iodide-131 (I-131) Patient Release Information Collection

80 FR 70843-70846

 

Looking for older posts?

On March 6, 2019, we archived everything from older than 2015, but don’t worry.  They are still available, just click on the year and you will find everything posted from that time:

2009        2010       2011       2012      2013        2014

 

 

 


Office of Radiological Health | 109 Governor Street,  7th Floor | Richmond, VA  23219

Telephone (804) 864-8150 | Fax: (804) 864-8155