Changes to unsealed therapy radionuclide license listing

The department currently lists unsealed radioisotopes under the generic “Any radioactive material permitted by 25 TAC §289.256(kk)”. The medical field continues to evolve and develop new treatment modalities for unsealed radioactive materials requiring a written directive. During the next routine license amendment, we will be converting the generic listing of unsealed therapy radionuclides to identifying the specific radionuclide.

For the various radionuclides used, we will be reviewing the health physics and safe handling procedures and conducting a closer review of the procedures specific to the radionuclide.

Considerations for the different radionuclide uses include:

• Are there extra package receipt precautions?  [e.g. Alpha dart Ra-224]
• How are the doses determined? What dose calibrator standards are used to determine activity, especially the beta and alpha emitters.
• What survey instruments and detector types are used to measure the contamination? Are they appropriate for the gamma, beta, or alpha emitters?
• Contamination surveys are required for dose preparation and administration areas for unsealed therapy. What are the contamination action levels, and do they meet the requirements in §289.202(ggg)(6)? Can the survey meter and wipe counting equipment detect those radiation levels?
• Has the licensee addressed the limits for patient release criteria for that specific radionuclide and patient release instructions?  For example, the radionuclides NaI I-131, Sn-117m, and Ra-223 have different characteristics.
• How do licensees monitor for medical events? 

Are there any special waste considerations that need to be addressed?

Out-of-State Telemedicine Licenses for Authorized Users

The Department has received applications for physicians who carry a Texas Medical Board Telemedicine license to be an Authorized Users on radioactive materials licenses. The Department policy regarding the acceptance of an Out-of-State Texas Medical Board license is the following.

• The definition of an “Authorized User” in 25 TAC §289.256(c)(6) requires that a physician be licensed by the Texas Medical Board.
• According to the Texas Medical Board (TMB), based on a change in the law in 2017, a full medical license is required to practice telemedicine in Texas. Therefore, the issuance of telemedicine licenses has been suspended. The TMB is in the process of converting out-of-state telemedicine licenses to full Texas licenses.
• The Department will require that the physician have a full medical license through the Texas Medical Board. A physician who currently has an out-of-state telemedicine license will need to contact the TMB to convert their existing out-of-state telemedicine license to a full medical license. 

The Texas Medical Board information regarding the out-of-state telemedicine license is at https://www.tmb.state.tx.us/page/telemedicine-license.

EFFECTIVE IMMEDIATELY

The NRC has issued an Order that immediately suspends the general license authority to export special nuclear material, source material, or deuterium for nuclear end use to the People’s Republic of China. Exporters must now apply for a specific license in accordance with NRC regulation.  The provided link to the Federal Register details this effective order.

2023-17394.pdf (govinfo.gov)

Important Notice for Licensees Subject to Category 1 and Category 2 Quantities of Radioactive Material (formerly Increased Controls)

License Category

NRC NUREG 1556 series

The following NRC NUREG 1556 volume series are available at https://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/index.html

The Radioactive Materials Licensing Unit issues licenses that authorize the following uses of radioactive material:

How to Apply for a Radioactive Material License

To apply for a radioactive material license, you will need:

• The applicable NRC NUREG (see above) to help you prepare the application.
• RC Form 252-2 “Application for Radioactive Material License.” Complete Items 1 - 4 and 12 on the form. Submit separate attachments for Items 5 – 10.
• RC Form 252-1 “Business Information Form”.
• The required fee. For the fee amount contact (512) 231-5623 or RadiationFeesandRecords@dshs.texas.gov

Send all applications with fees to:

Department of State Health Services
Cash Receipts Branch – MC 2003
PO Box 149347
Austin, TX 78714-9347

Tips for completing and submitting an application:

• Provide enough detail to demonstrate that your equipment, facilities, training, experience, and radiation protection program are adequate to protect health and safety and minimize danger to life and property.
• Email a copy of the completed application to RAMLicensing@dshs.texas.gov
• Mail the check or money order with the required fee and a copy of RC Form 252-2 “Application for Radioactive Material License” to the address on the form.
• Contact us with questions RAMLicensing@dshs.texas.gov or 512-834-6661.

How to Renew your Radioactive Material License

You must submit a complete application for license renewal at least 30 days before the expiration date in condition 4 of your license. PAYMENT OF YOUR BIENNIAL FEE DOES NOT RENEW YOUR LICENSE.

A complete license renewal application includes:

• RC Form 252-2 “Application for Radioactive Material License”
• RC Form 252-1 “Business Information Form”
• Operating, Safety, and Emergency Procedures/Radiation Protection Program
• Diagram and description of RAM use and storage areas.

You do not need to submit qualifications for individuals already listed on the license.

NRC NUREG 1556 volume series provide more information on how to prepare the application. They can be located here. 

To minimize delays in processing radioactive material renewal and amendment applications, submit documents to RAMLicensing@dshs.texas.gov.

How to Request an Amendment to a Radioactive Material License

You must apply for and receive a license amendment before making changes to your radiation protection program such as:

• Changing the RSO.
• Receiving or using radioactive material not authorized on your current license.
• Adding or changing the areas in which you use or store radioactive material.
• Changing the address(es) of where you use or store radioactive material.
• Changing authorized users named on your license.
• Changing operating, safety, and emergency procedures.

Tips for Amendment Requests

• Include your license number on the request.
• Date your request.
• Clearly describe what changes you need and why you need them.
• Include supporting documentation such as facility diagrams, training documents, or revisions to your operating, safety, and emergency procedures.
• The request must be signed by either the radiation safety officer or a member of management.
• There is no fee required to amend a license.

Send the request to RAMLicensing@dshs.texas.gov

Common Amendment Requests

Below are guidelines for submitting common amendment requests. If you need to make a change to your license that is not described below, refer to the Application or NRC NUREG for your license type.

Change the Radiation Safety Officer (RSO)

To request an RSO change for your license you must submit:

• A letter signed by either the current radiation safety officer identified on the license or a member of management.
• A delegation of authority confirming the RSO’s responsibilities. You can use a Delegation of Authority Model Form or an equivalent document.
  • Medical
  • Fixed Gauge, Portable Gauge, Research & Development, Decontamination Services, NORM – Commercial Processing, Mobile Scanning Device, Manufacturer & Distribution
  • Industrial Radiography
  • Well Logging
• The proposed RSO’s telephone number and email address.
• Documents demonstrating the proposed RSO meets the minimum qualifications in rule for your license type, which may be located in the corresponding NRC NUREG for your license category.

Change the Associate Radiation Safety Officer (ARSO) and Site Radiation Safety Officer (SRSO)

To request a change or add an ARSO or SRSO to your license, submit ONE of the model forms or provide your own equivalent:

For Medical Use:

• Memorandum ARSO Designation

For Non-Medical Use:

• Memorandum SRSO Designation

Add an Authorized User (AU)

To add an authorized user to the license, submit ONE of the following:

• The number of a Department RAM license on which the physician was listed as an AU within the past 7 years for the same uses you are; or
• A copy of an Agreement State or Nuclear Regulatory Commission RAM license on which the physician was listed as an AU within the past 7 years for the same uses you are requesting; or
• A copy of an accepted board certification issued within the last 7 years. You can review accepted board certifications by visiting the Nuclear Regulatory Commission’s Medical Uses Licensee Toolkit; or
• The applicable form(s) for the types of use(s):
  • NRC Form 313A (AUD) – AU for Uptake, Dilution, and Excretion Studies; Imaging and Localization Studies, Sealed Sources for Diagnosis
  • NRC Form 313A (AUT) – Use of Unsealed RAM for which a Written Directive is Required (Including I-131)
  • NRC Form 313A(AMP) – Authorized Medical Physicist or Ophthalmic Physicist
  • NRC Form 313A(ANP) – Authorized Nuclear Pharmacist
  • NRC Form 313A (AUS) – Manual Brachytherapy, Ophthalmic Use of Sr-90, Remote Afterloaders, Teletherapy Units, or Gamma Stereotactic Radiosurgery Units

Add an additional use or storage location

Condition 9 of your license limits you to certain storage or use locations. To add a new location, submit:

• The complete address of the proposed site including street address, city, including zip code and suite number, if applicable.
• Identify the owner of the property.
• If you lease or rent, provide a letter from the property owner or owner’s agent acknowledging radioactive material will be used or stored on the premises.
• Submit drawings of the facility with sufficient detail to evaluate traffic flow, engineered controls, equipment and surroundings. A minimum of two drawings is typical, one floor plan and one enlarged drawing of the proposed use/storage areas.
  • The floor plan should outline the path of radioactive material transport to a temporary stress lab or permanent storage area. No drawing is needed when requesting temporary injection sites as various patient treatment areas.
  • Identify within the enlarged drawing all fixed radiation detection equipment, work counters, fixed safety equipment, shielding, decontamination sinks, areas of use or storage and adjacent areas.
  • Provide information that floors and counters are of a material design appropriate for non-contained radioactive material.
• Describe how restricted rooms are secured and how access is limited. Explain if restricted areas are dedicated to cyclotron material use.
• Describe the traffic flow and how the layout will minimize traffic into or through restricted areas.
• Describe the space and shielding used to deal with typical waste needs and/or higher energy radionuclides.
• Shielding. Typically, sufficient labeling on the drawing is adequate for most diagnostic areas. Additional discussion and evaluations must be submitted to warrant sealed source therapy storage and or use.
• Detailed location information for your license type, which may be found in the corresponding NRC NUREG for your license category.

Remove a use or storage location

To remove a location, submit:

• RC Form 252-4 “Certificate of Disposition of Materials”.
• All required attachments such as transfer records, the results of area and contamination surveys or leak test results.

How to Terminate a Radioactive Material License

Before you can terminate your license, ensure any compliance issues, or open enforcement cases are resolved. To terminate a license, submit:

• RC Form 252-4 “Certificate of Disposition of Materials”.
• All required attachments such as transfer records, the results of area and contamination surveys or leak test results.

Email the completed form and supporting documentation to RAMLicensing@dshs.texas.gov.

Change in Control and Bankruptcy

You are required to notify the Department in writing in advance of a change in control. 

You are required to notify the Department, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy by the licensee or its parent company, if the parent company is involved in the bankruptcy.

Rule Guide 8.1, “Guidance about Changes of Control and about Bankruptcy” provides detailed information on the licensing and notification process and how to complete the Transfer of Control Application Questionnaire.

To assist the department in determining whether a change of control has taken place answer the following:

Has there been a change to the Texas Secretary of State filing number?

• If NO, submit a request to amend the business name, if applicable. Include RC Form 252-1 "Business Information Form" with the applicable box checked under “Certification of Financial Qualification” and “Authorization to Conduct Business in Texas.”
• If YES, complete and submit the following:
• A signed letter by a member of management or the radiation safety officer describing the transaction.
• Appendix B: Transfer of Control Application Questionnaire [only for a Change in Control]
• RC Form 252-1 "Business Information Form" 
• Transferee’s Commitment to Abide by the Transferor’s Commitments.  You can use the example or an equivalent document. Example
• Only for Bankruptcy: Appendix C: Suggested Format for Requests for Additional Information Regarding Bankruptcy or an equivalent document

Email the completed form and supporting documentation to RAMLicensing@dshs.texas.gov.