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
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:
- 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.
- 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:
September 9, 2014: In June of 2011 the NRC issued its Safety Culture Policy Statement. The RMP sent out notices prior to this regarding the Safety Culture Policy. The NRC is now conducting a survey regarding the Safety Culture policy.
The survey consists of 20 questions and takes approximately 20 minutes to complete. It asks licensees for feedback regarding:
1. Awareness of the Safety Culture Policy Statement
2. Whether they have received safety culture materials from the NRC or Agreement States
3. Satisfaction with the outreach and education products they have received
4. Overall satisfaction with the level and quality of communications from the NRC or Agreement States about safety culture
Today we have sent out a letter to all licensees infomrming them of this survey and providing the following link if they wish to participate. If you wish to learn more about Safety Culture, please visit NRC’s site.
November 13, 2013: The CRCPD is extending the period for registering unwanted sources into the SCATR program for a roundup occuring in 2014. The following letter is being mailed to each licensee: CRCPD SCATR Letter
October 30, 2013: The FDA has approved Vizamyl (flutemetamol F 18 injection), a radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer’s disease (AD) and dementia. Here is to the FDA approval package: FDA’s Vizamyl Approval
June 17, 2013: The Source Collection and Threat Reduction Program (SCATR) administered by the Conference of Radiation Control Program Directors (CRCPD) is providing sealed source licensees in states which do not have access to an in-Compact low-level radioactive waste disposal facility an opportunity to dispose of certain unwanted radioactive sealed sources. CRCPD is offering generators who participate in this limited-time opportunity financial assistance equal to 50% of the cost of collection, processing, and disposal. Generators must register their sources with the Offsite Source Recovery Project (OSRP) OSRP by June 30, 2013 to qualify for participation in this cost-shared disposal effort.
May 16, 2013: On May 15th the FDA approved the use of Xofigo (Ra-223 dichloride) for the treatment of men with symptomatic late-stage (metastic) castration-resistant prostate cancer that has spread to the bones but not other organs. Bayer has the marketing rights to Xofigo. The use of Xofigo will be under 12VAC5-481-1950 and the Authorized Users must be approved for this use. The FDA approval information can be found here: FDA Ra-223/Xofigo Information. If you have any other questions regarding the use of Xofigo, please contact us.
May 9, 2013: On May 7, 2013 the NRC issued FSME-13-041 titled “Notice of an upcoming webinar and request for comments on consideration of rulemaking to address prompt remediation of residual radioactivity during operations.” This document states the webinar will be held on June 4th from 12 pm until 3 pm. For more information, the document can be found here: FSME-13-041
June 7, 2012: SCATR Program to Begin Collection of Class A Sources for Disposal at Clive. Click on the following link for a word document containing all the information regarding this issue: Clive Disposal
July 29, 2011: On Wednesday July 27th the Food and Drug Administation (FDA) released a safety communication to stop using CardioGen-82 for PET scans. Bracco Diagnostics, Inc. has issued a voluntary recall of CardioGen-82. For more information please read the communication: CardioGen-82 Recall.
July 17, 2011: On Friday July 15th the Food and Drug Administation (FDA) released a safety announcement regarding CardioGen-82 used for positron tomography (PET) scans. For more information please visit the FDA website at: FDA CardioGen-82 Announcement
September 8, 2010: Gulf Nuclear Model 71-2A Source: Model 71-2A Neutron Well Logging sources will be losing its special form certificate in the near future. For those licensee possessing these sources there are a few options for disposition of these sources. Gulf Nuclear has issued the following notice: Gulf Nuclear Notice and The Department of Energy’s Off-Site Source Recovery Project (OSRP) has issued the following notice: OSRP Notice.
January 7, 2010: On December 18, 2009 the NRC issued a press release (NRC Safety Culture Notice) relating to a draft policy on “safety culture”. The Federal Register, Vol. 74, No. 214 dated November 6, 2009 (found at: NRC-2009-0482) included the NRC draft policy statement. This federal register notice began a 90 day public comment period. The NRC will also be hosting public workshops in February, April and October. The information was published in the Federal Register, Vol. 74, No. 239 dated December 15, 2009 (found at: NRC-2009-0485). If you are interested in participating, contact the NRC. More information can be found at the NRC’s safety culture webpage (NRC Safety Culture Page).
March 27, 2009 Update: On March 23, 2009 the signed agreements were delivered to the NRC. On March 24, 2009 the NRC issued a press release stating: “NRC COMPLETES VIRGINIA AGREEMENT TO REGULATE CERTAIN RADIOACTIVE MATERIALS”. So beginning 12:00 a.m. on March 31st the Radioactive Materials Program will have authority over the licensing of radioactive materials in the Commonwealth of Virginia. If you have an amendment request you may either mail them or fax them to us, but please bear with us for the first couple of weeks as we must accept the NRC licensing files and place them in our filing system.
Office of Radiological Health | 109 Governor Street, 7th Floor | Richmond, VA 23219
Telephone (804) 864-8150 | Fax: (804) 864-8155