STATEMENT OF BASIS AND PURPOSE
AND SPECIFIC STATUTORY AUTHORITY
for Amendments to
6 CCR 1007-1, Part 3, Licensing of Radioactive Material
Adopted by the Board of Health on April 16, 2014
Basis and Purpose.
The Colorado Radiation Control Act, Title 25, Article 11, Colorado Revised Statutes (the Act), Section 25-11-104, requires the State Board of Health (Board) to formulate, adopt and promulgate rules and regulations pertaining to radiation control.
Section 2511103 of the Act requires the Colorado Department of Public Health and Environment (Department) to develop and conduct programs for evaluation and control of hazards associated with the use of sources of ionizing radiation, including hazards from radioactive materials and to issue licenses pertaining to use of such radioactive materials.
Section 2511104 of the Act requires Colorado’s radiation regulations to be compatible with the Suggested State Regulations for Control of Radiation (SSRCR) of the Conference of Radiation Control Program Directors, Inc., except when the Board concludes, on the basis of detailed findings, that a substantial deviation from the SSRCR is warranted.
This amendment makes multiple changes to Part 3, Licensing of Radioactive Materials, previously adopted March 16, 2011, which became effective April 30, 2011. The proposed changes to Part 3 are being initiated to maintain compatibility with the national framework for regulation of radioactive materials licensing as contained in the federal regulations of 10 CFR Parts 20, 30, 31, 32, and 40; to maintain compatibility with the SSRCR Part C (2010); and to make minor corrections, improvements, and clarifications in the regulatory part based upon program needs.
The editorial comments, notes, and information that may be shown in the right side margin of draft proposed regulations are for information only, are intended to aid the reader, and are not considered part of the regulation. These will be removed from the final regulation prior to submission to the Colorado Secretary of State’s office for publishing in the Colorado register.
The following outlines the proposed changes to Part 3:
1. Throughout Part 3, typographical errors and cross-references are corrected, and where applicable, numbering is deleted, added or modified for consistency between and within the regulatory part. For brevity of this document, all items, and in particular those which are simplistic or redundant may not be specifically identified in the numbered items within this document (below) or in the side margin comments. Refer to the proposed draft rule language for further details.
2. In 3.1.5, a definition for “consortium” is added. The added definition is based on a request by NRC to add such a definition consistent with the language of 10 CFR 30.4. The term is used in later sections of Part 3, but is not used in other regulatory parts. A consortium is used to describe a non-commercial operating arrangement between a cyclotron PET radionuclide production facility and its end users. Colorado licensees do not currently have any such consortium or “co-op” type arrangements. The addition of the term is necessary for compatibility with NRC requirements.
3. In 3.3.2.4, and throughout Part 3, the date related to references to 10 CFRs is changed to 2013.
4. In 3.6.4.3(13), the isotope radium-226 (and quantities) are added, consistent with 10 CFR 31.5(c)(13). Radium was added to the list of devices requiring registration as “generally licensed devices” and is due to the expanded definition of byproduct material (which now includes discrete radium sources) as promulgated by NRC through the Environmental Policy Act of 2005. The addition of the term was requested by NRC and is necessary for compatibility with NRC requirements.
5. In 3.6.4.3(13), language is added, consistent with 31.5(c)(13) to clarify that each location where a generally licensed device is used requires a separate registration and fee. This approach is consistent with current radiation program practice and is not a new requirement in practice. The additional language was requested by NRC and is necessary for compatibility with NRC requirements.
6. In 3.8.9, a new section is added consistent with 10 CFR 30.32(g) which requires additional documentation when applying for a specific license to use a source or device containing radioactive material. The purpose of the addition is to ensure that proper safety aspects of the device have been evaluated and documented in the national registry or that equivalent information and evaluations are available or provided during the license application or amendment process. Prior to 2007, NRC did not regulate certain radioactive materials, including accelerator produced materials and discrete sources of radium-226, and therefore some devices containing these materials may have been distributed without being registered or fully evaluated by NRC. With NRC’s expanded definition of byproduct material, devices containing radioactive materials not previously registered are now registered and regulated as byproduct material. The added language provides a safety net mechanism to allow use of devices not previously regulated or regulated in the same manner. The additional language was requested by NRC and is necessary for compatibility with NRC requirements.
7. In 3.8.10, a new section is added consistent with 10 CFR 30.32(j), and SSRCR, Part C (C.24.h) which requires additional information when distributing Positron Emission Tomography (PET) materials (non-commercially) within a consortium. PET materials were previously not regulated under NRC regulation, but were included when NRC revised and expanded their definition for byproduct material. Colorado however, has always regulated PET and other accelerator produced materials. (Colorado does not currently have any licensees who are part of a consortium as defined earlier in this Part).
8. In 3.9.2.1, language is added to require that applicants for a specific license in Colorado must have facilities permanently located in Colorado. Colorado has issued specific licenses to entities who have facilities just outside Colorado’s border in the states of Utah, New Mexico, and Wyoming, but who desired to perform operations using radioactive materials within Colorado’s borders more than 180 days per year (the limit for reciprocal license recognition). The inspection of licensed activities and facilities outside of Colorado borders can be difficult for a variety of reasons, including issues regarding state inspection personnel using state vehicles outside of Colorado borders, evaluating for facility violations at a location not physically located in Colorado, etc. The radiation program has changed its policy regarding issuance of such licenses to entities outside Colorado borders and the proposed change is being made consistent with that policy. Through Part 1, Section 1.5.1, the radiation program would continue to have the ability to allow exceptions to the requirements under special circumstances.
9. In 3.9.5.10, references to the department are deleted at the request of NRC. Long term surveillance of certain facilities is handled by the federal government (U.S. Department of Energy) and not specifically the department. The current language presented potential jurisdictional issues and is therefore modified to be more general and not specify an agency for such surveillance activities.
10. In 3.9.6.4, requirements are added at the request of NRC consistent with federal regulations in 10 CFR 30.35(e), and 40.36(d). The proposed language requires that decommissioning funding plans must contain additional, specified information and that such plans must be reviewed and adjusted at least every three years.
11. In 3.10.2, a broad requirement is added consistent with federal rules in 10 CFR 20.1406(c). The proposed language requires that licensees of all types put forth efforts to minimize residual radioactive contamination that may impact future decommissioning efforts.
12. In 3.12.10.1, a reference to Part 7 is added for clarity and consistency with 10 CFR Part 32.72(a).
13. In 3.12.10.1(2), requirements are added at the request of NRC consistent with federal regulations in 10 CFR 32.72(a)(2)(i), and 32.72(iv). The added language clarifies that facilities performing certain activities related to drug manufacturing must be registered or licensed with the U.S. Food and Drug Administration or registered with the state Board of Pharmacy as a drug manufacturer; or are operating as a nuclear pharmacy within a federal medical institution.
14. In 3.12.10.2, language is added at the request of NRC consistent with 10 CFR Part 32. The added language clarifies and accepts a wider variety of training requirements for Nuclear Pharmacists, consistent with the requirements in Part 7. Additionally, due to NRC’s expansion of their definition of byproduct material, the revised language makes it clearer that nuclear pharmacists who were authorized to work at cyclotron facilities are also considered qualified to work at nuclear pharmacies that handled only byproduct material, or that worked at a federal (nuclear pharmacy) facility. (Also see prior comments relating to expanded definition of byproduct material).
15. In 3.12.12.1, the word “transmission” is added to the list of source types that an applicant may apply for, consistent with 10 CFR 32.74(a). Transmission sources are often used within PET imaging systems to provide patient specific quality control information prior to or during imaging.
16. In 3.15.2, language is added at the request of NRC consistent with 10 CFR Part 30.34(b) and other CFR sections. In addition to the language required by NRC, further detail is added to this section at the request of the radiation program. Colorado requires more information than that required by NRC when such transfers are requested. The added language clarifies that certain additional documentation must be provided when an entity wishes to transfer a license to another entity (transferee). Transfers may occur when one licensed company is bought by another company.
17. In 3.15.6, language is added which requires and clarifies the quality control tests needed when eluting a radiopharmaceutical generator. The requirements parallel those in Part 7 of the regulations and are consistent with what generator manufacturers require for the end users. The language added is at the request of NRC, consistent with the requirements of 10 CFR Part 30.34(g).
18. In 3.15.7, a new section is added at the request of NRC consistent with 10 CFR Part 30.34. The addition of new section 3.15.7 is based upon NRC’s expanded definition of byproduct material to include accelerator produced materials such as PET isotopes, and to address the unique requirements associated with non-commercial distribution within a consortium. Colorado does not currently have any licensees who are part of a consortium.
19. In 3.16.2.6, language is modified at the request of NRC. The term “residual radioactive material” is modified to read “residual radioactive contamination”. This change was requested by NRC so as not to create a conflict. According to NRC, the term “residual radioactive material” is reserved for and specific to, materials at sites subject to remediation under title I of the Uranium Mill Tailings Radiation Control Act of 1978, for which NRC maintains sole jurisdiction. Therefore, as Part 3 is a broad regulatory part applying to all types of licensed facilities, retaining the original language in Part 3 may result in a conflict with federal rule.
20. In 3.22.2.5, language is added at the request of radiation program staff. The added language references federal regulations of 10 CFR Part 110 which contain requirements for export of radioactive materials. NRC has sole jurisdiction for export licenses. The added language is intended to help both staff and the regulated community know where to look for export requirements. The language is similar to that found in 10 CFR 30.41(b)(6).
21. In 3.24.1.1, a change to a reference to federal statute is made, consistent with the language found in federal rule.
22. In Part 3, Schedule 3C (exempt items), the activity units for two numerical values are corrected (due to prior error) to the proper values consistent with federal rule.
23. In Part 3, Schedule 3E (quantities requiring consideration for an emergency plan), values for radium-226 are added to the table, consistent with Schedule C of 10 CFR Part 30.72 and as requested by NRC. The isotope radium-226 is added consistent with NRC’s re-definition of byproduct material, which now includes radium-226.
Specific Statutory Authority.
These rules are promulgated pursuant to the following statutes: 251.5101(1)(k), 25-1.5(1)(l), 25-11-104, and 25-1-108, C.R.S.
SUPPLEMENTAL QUESTIONS
Is this rulemaking due to a change in state statute?
______Yes, the bill number is ______; rules are ___ authorized ___ required.
___X__ No
Is this rulemaking due to a federal statutory or regulatory change?
___X__ Yes
______No
Does this rule incorporate materials by reference?
___X__ Yes
______No
Does this rule create or modify fines or fees?
______Yes
__X___ No