Radiation proposed rulemakings and stakeholder processes

 
 
Active rulemakings
Part 20 TENORM (Technologically Enhanced Naturally Occurring Radioactive Material) and Part 12 Rulemaking
The Radiation Program is proposing a new regulation, known as Part 20, for regulation of TENORM (Technologically Enhanced Naturally Occurring Radioactive Material). TENORM materials are produced when activities such as uranium mining or sewage sludge treatment processes concentrate radioactive materials that occur naturally in ores, soils, water or other natural materials. The proposed rule may impact facilities producing these materials. Additionally, there are proposed changes to Part 12 of the regulations to accommodate the registration and specific licensing fees that may be required for some TENORM facilities.
 
 
Written comments
Stakeholders are encouraged to provide written comments on the proposed regulations to cdphe_coradregs@state.co.us on or before June 15, 2020. Consideration or incorporation of comments, on this first draft, received after June 15, 2020 will only be considered if practical to do so, but may be included for consideration when revisions on the second draft are being prepared. Stakeholders should avoid including confidential information in any submissions to the department. 
 
Next steps and information on additional stakeholder meetings, and the rulemaking schedule before the Board of Health.
 
Stakeholder meetings
On May 26, 2020, a virtual stakeholder meeting to review and discuss the proposed new rule/rule changes was held. The presentation from that meeting can be accessed here: 
May 26, 2020 PowerPoint presentation
 
During the July-August Comment period, an additional virtual stakeholder meeting to review and discuss the proposed changes will be held on July 27, 2020.
 
Details regarding the meeting times and platforms will be will be posted here when confirmed.

Additional information and resources
More information on TENORM and the development of this regulation.
 
Updates
Please continue to check this web page for periodic updates during the stakeholder process.
 

 
 
Part 2 and Part 6 Rulemaking
Following issuance of the revised Part 2 and Part 6 rules in January 2020, it was determined that technical changes to the standardized language regarding documents incorporated by reference (in 2.1.5 and 6.1.5) needed further revision to make them fully compliant with the Colorado Administrative Procedure Act. 
 
The rule is scheduled for a request for rulemaking on June 17, 2020, followed by a rulemaking hearing tentatively scheduled for August 19, 2020. 
 
Due to the minor nature of the proposed changes, no stakeholder process was conducted. This and other non-substantive changes to these rules can be found in the Board of Health request for rulemaking package for Part 2 and 6.
 
 

 

Part 17 and Part 22 Rulemaking
The Radiation Program is proposing revisions to Radiation Control Regulations Part 17 (Transportation) and Part 22 (Physical Security) that may impact radioactive material licensees who transport radioactive materials or certain licensees who may be required to implement enhanced security measures. The proposed changes also include additional technical and formatting changes and corrections.
 
 
 
 
Written comments and schedule
Stakeholders may provide written comments on the proposed regulations to cdphe_coradregs@state.co.us on or before May 7, 2020. Consideration or incorporation of comments received after this date will only be considered if practical to do so. Avoid including confidential information in any submissions to the department.
 
Next steps and additional information on the rulemaking schedule can be found in the rulemaking timeline.
Stakeholder meetings
  • Due to the minor nature of the proposed changes, a stakeholder meeting will not be held. Stakeholders and affected licensees may contact the division with any questions or comments.
 
Updates
Please continue to check this web page for periodic updates during the stakeholder process.
 

 

Part 3 and Part 7 rulemaking
 
 
Note - this meeting will be held virtually via zoom. Additional information will be posted prior to the June hearing on the Board of Health website

Rulemaking hearing scheduled

Following a stakeholder process in early 2020 and with consideration of comments received, a request for rulemaking before the Colorado Board of Health was conducted on March 18, 2020 for the proposed changes to the Part 7 and Part 3 regulations. An updated version of the draft rule that was presented to the Board can be found under the “Additional Information and Resources” header at the bottom of this page. As requested by the Division, during the March Board meeting, the Board set a rulemaking hearing date of June 17, 2020. A notice of rulemaking hearing will be sent to stakeholders at least 30 days prior to the hearing date and will be posted on this page as well. For further details, refer to the Board of Health website.
 
Background information and purpose
In January-February 2020, the Radiation Program conducted a stakeholder process to seek comments on proposed revisions to the Colorado Rules and Regulations Pertaining to Radiation Control, 6 CCR 1007-1, Part 3 (Licensing of radioactive material) and Part 7 (Use of radionuclides in the healing arts). The proposed rules impact radioactive material licensees who prepare or use radioactive materials for medical purposes (healing arts). The proposed rule changes are not applicable to x-ray machines.
 
These regulations are being revised to conform to federal rule changes of the U.S. Nuclear Regulatory Commission (NRC) in 10 CFR Part 35, which were amended July 16, 2018 (83 FR 33046). As an Agreement State program, Colorado is required to adopt rules which are compatible with these federal regulations. 
 
The more significant proposed changes to Colorado rule include:
  • Removing the requirement to obtain a written attestation for an individual who is certified by an accepted specialty board. 
  • Allowing grandfathering provisions for training and experience requirements for certain board-certified individuals. 
  • Amending the reporting and notification requirements for a medical event (termed a misadministration in current rule) for permanent implant brachytherapy. 
  • Clarifying the requirements for measuring molybdenum contamination in radionuclide generators and adding requirements for reporting of failed technetium and rubidium generators. 
  • Adding requirements for naming associate radiation safety officer(s) and ophthalmic physicists on a medical license. 
  • The addition of requirements related to written directives for permanent implant brachytherapy. 
  • Added requirements pertaining to completion of operational and safety training for certain therapy devices. 
  • Strengthening and adding flexibility to the requirements for individuals working as nuclear medicine technologists, physicists, students and others working under the supervision of an authorized user physician.  
  • Miscellaneous technical and formatting corrections to better align with the format, flow, and structure of the parallel federal rules. 
 
Additional information and resources
 
Updates
Please continue to check this web page for periodic updates during the stakeholder process.
 

Contact