RQ
STATEMENT OF BASIS AND PURPOSE
AND SPECIFIC STATUTORY AUTHORITY
FOR
AMENDMENTS TO THE COLORADO STATE BOARD OF HEALTH
RULES AND REGULATIONS PERTAINING TO RADIATION CONTROL
6 CCR 1007-1
Part 7, Use of Radionuclides in the Healing Arts
November 30, 2011
Basis and Purpose.
The Colorado Radiation Control Act, Title 25, Article 11, Colorado Revised Statutes (the Act), requires the State Board of Health to formulate, adopt and promulgate rules and regulations pertaining to radiation control. Section 25-11-104 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 of Health concludes, on the basis of detailed findings, that a substantial deviation from the SSRCR is warranted. The Department’s regulations, in certain parts, must also be compatible with the regulations adopted by the U.S. Nuclear Regulatory Commission (NRC). The Act establishes the SSRCR as the model for Colorado to use in adopting NRC regulatory provisions. Part 7, Use of Radionuclides in the Healing Arts, is based upon Part G of the SSRCR. Part 7 was last revised September 20, 2006, with an effective date of November 30, 2006.
This amendment revises Part 7 to make several changes due to changes in 10 CFR Part 35 that have occurred since 2006. Themost significant changes involve revisions of the Part 7 sections pertaining to Radiation Safety Committee requirements, elimination of interpretation of scan requirements for authorized users (physicians), clarification of routine radiological survey requirements, easing of requirements pertaining to patient release, and streamlining of radiation safety officer, authorized user and other training requirements to better follow the flow and content of 10 CFR Part 35. Other minor changes and correction of typographical errors are also being made in the revision. A detailed description of the changes is as follows:
1. In 7.2, the definition for “Accredited Institution” is deleted as it is no longer used anywhere in Part 7. In the 2005 revision of Part 7, this definition was used in Appendix N. However, with the 2006 revision of Part 7, the term was deleted from Appendix N. Deleting the definition is expected to have no impact on licensees.
2. In 7.2, the definitions for “Authorized Medical Physicist”, “Authorized Nuclear Pharmacist”, “Authorized User”, and “Radiation Safety Officer” are modified and/or language has been added for consistency with 10 CFR Part 35.2. Language is added to these definitions, primarily to clarify that individuals named on existing licenses qualify as these authorized persons.
3. In 7.2, minor typographical errors are corrected.
4. In 7.3.1, references to subsequent sections are corrected.
5. In 7.3.2, additional language is added to be consistent with 10 CFR Part 35.6 with respect to requirements pertaining to human research subjects. In the current revision of Part 7 that became effective in 2006, the regulations do not clearly address requirements for human research that is not funded or controlled by a federal agency. The additional language addresses the missing requirements and parallels the requirements for federally based research. The language is consistent with SSRCR Part G (2010 Draft) and 10 CFR Part 35.
6. In 7.3.2.3, additional clarifying language added, since prior sections of 7.3.2 were modified.
7. In 7.3.4, the words “new or renewal” are added in this section for clarity and based upon stakeholder comments. The requirement for an applicant to submit a second copy of the application form is deleted, as the Department has determined over time that a second copy is typically not needed in the review process. The language “…and other procedures as requested by the Department” is added as a reminder, as licensees do not always provide complete documentation when requesting a new, renewal, or amendment to a license. Should all needed documentation not be provided to the Department, a request for information will be sent to the licensee.
8. The language of 7.3.4.2(1), and (2), and 7.3.4.3(1) and (2) is reworded for clarity based upon stakeholder comments.
9. In 7.4.2.1, language is modified for clarity.
10. In 7.8, the change would require a licensee who performs only one type of therapy with radioactive materials to hold (twice annually) a Radiation Safety Committee (RSC) meeting. The current regulatory provision requires facilities that use two types of therapy materials to have a RSC. The change will not impact facilities who perform only diagnostic procedures. The Department believes that the RSC provides a valuable mechanism for oversight of a licensees’ Radiation Safety Program. The change is expected to impact only a limited number of facilities who are not now required to hold RSC meetings.
11. In 7.10.2, language is added to reference Part 10, which contains general training requirements that are not medical specific. Although stated broadly in 7.1.3, the language reiterates that Part 7 requirements are required in addition to other portions of the regulations. This additional language is consistent with the language of 10 CFR Part 35.27 and is not expected to have an impact on licensees.
12. In 7.10.3, the language deletes the requirement for an authorized user (physician) to be physically present within one hour when summoned to the licensee facility. The change reduces the regulatory burden on licensees. Since this requirement was initially implemented in 2005, the Department has determined that the one hour requirement has not been particularly beneficial nor has it achieved its goal of improving radiation safety significantly. The language retains the requirement for an authorized user physician to be available by phone within 10 minutes however.
13. In 7.11.2.2, the language is modified to refer to (the more meaningful) values of target coordinate settings, rather than the number of target settings for gamma stereotactic radiosurgery licensees. This change is consistent with 10 CFR Part 35.40(b)(3) and SSRCR Part G (2010 Draft).
14. The requirement of 7.13.1.4 is deleted. The language eliminates the requirement that a physician be named as an Authorized User (AU) as a requirement for performing the final interpretation of tests, studies, or treatments. This requirement was initially implemented during the last major revision of Part 7 in 2005. Deleting this requirement is consistent with the requirements of most other Agreement States and the Nuclear Regulatory Commission. The training requirements for AUs in the Appendices of Part 7 do not explicitly prescribe requirements relating to interpretation of tests.
15. In 7.13.2.1, the language adds a reference to the requirements of 7.41. This does not add a new requirement, but rather restates (repeats) a provision that is already required (in 7.41). Section 7.13.2.1 is a summary section that summarizes the requirements from other sections. The change was suggested by the regulated community. The Department agrees that this added provision may be helpful to some licensees.
16. In 7.14, an error is corrected. Additionally, the language of this section is modified to be consistent with 10 CFR Part 35.49.
17. In 7.15, for clarity, the language adds subsections rather than have requirements stated in a single paragraph.
18. In 7.15.4, the section numbering is changed for ease of use. Additionally, a new recordkeeping requirement is added. Current regulations require a licensee is to perform quality control activities on equipment used for diagnostic imaging. With many years of inspecting diagnostic medical facilities, and seeing variation among them, the Department believes that the lack of a recordkeeping requirement makes the existing regulatory provision less effective. Therefore, the Department is proposing language that requires a licensee to retain the quality control records generated for a period of 3 years. The 3 year requirement is consistent with other recordkeeping provisions of the regulations, and inspection frequency.
19. In 7.16, language is added/revised to maintain consistency with 10 CFR Part 35.60(b) with respect to use of the term “calibration”. No regulatory requirements are being added.
20. In 7.18.2, formatting is changed slightly, and language is added for clarity. Language pertaining to investigational new drugs is added for consistency with 10 CFR Part 35.63.
21. In 7.19.3.2, a reference is changed, using the nomenclature found in other regulatory sections.
22. In 7.20, additional language is added, consistent with the language of 10 CFR Part 35.67(c). This is not a new regulatory requirement, rather it reiterates what is already effectively required by other more general regulatory parts (i.e., Part 4). The section is also renumbered as a result of the additional line. A typographical error is also corrected in this section.
23. In 7.25, the section is reformatted, renumbered and language clarified to aid the regulated community. No new requirements are being added. Through revision, the Department believes that the specific survey requirement language contained in this section clarifies the type and frequency of the required routine surveys. The reference to specific instrumentation requirements is deleted to allow the licensee flexibility in using different instrumentation.
24. In 7.26, the language is modified to eliminate certain requirements pertaining to release of patients who have been administered radioactive materials. Under the current regulatory requirements, a licensee must provide the released individual (the patient), with instructions on reducing the dose to other individuals they may encounter following their release. With this revision, there would be a threshold, below which these instructions would not be required. This threshold is not typically exceeded for the most common diagnostic procedures. With time, the Department has found that the instructions provided to patients vary greatly and do not provide significantly useful information or consistent instructions. Additionally, for the majority of diagnostic tests administered to patients, the dose to another person is well below the limits for dose to members of the public (set at 100 mrem/year per Part 4). For higher risk materials (i.e., therapeutic radioactive materials) the release of a patient would require additional evaluation and instructions (to the patient) as these types of procedures and materials will most often exceed the criteria of 7.26.2 or 7.26.4.
In addition to the above changes, the language of 7.26.4 is added consistent with 10 CFR Part 35.2075. Overall, the changes in this section are intended to be consistent with 10 CFR Part 35.75, SSRCR Part G (2010 Draft), and the approach used by the majority of other Agreement States.
A footnote referencing the NRC NUREG relating to medical use and patient release is added to this section, consistent with 10 CFR 35.75. This footnote reference is intended to be used as guidance information that licensees may choose to use to develop a patient release process. In the Departments’ experience, most licensee facilities already use and/or reference this NUREG in their patient release process.
25. In 7.27.7, the provision is deleted, as the Department believes it is adequately addressed in other parts of the regulations (e.g., 7.34).
26. In 7.29.1, language that was inadvertently omitted in prior revisions is inserted, consistent with 10 CFR Part 35.92.
27. In 7.30, 7.32, and 7.36, the sections are slightly renumbered as a result of the addition of language that states that PET (Positron Emission Tomography) may not be prepared by a facility not licensed as a PET production facility or pharmacy. PET production facilities/pharmacies are licensed under the provisions of Part 3 and not Part 7. The change is not expected to have any impact on licensees since a facility licensed as a medical facility (under Part 7) but desiring to produce PET radionuclides as well would also have to be licensed as a PET production/pharmacy facility (under Part 3). The change is made consistent with 10 CFR Part 35.100(b), 35.200(b).
28. In 7.30.1.2, the reference to training requirements has changed, consistent with 10 CFR 35.190. The 2007, and 2009 revisions to Part 35 clarify that there are additional requirements for authorized users preparing (or supervising those who prepare) radioactive drugs.
29. In 7.32.1.2, the reference to 7.32.2 is deleted and replaced with specific references to Appendix 7E, or Appendix 7F and Appendix 7E3.1(2)(g). This change is consistent with the language/format of 10 CFR 35.200(b)(2) which is Colorado’s equivalent section.
30. In 7.33.2., a provision is added to require each eluate from a radionuclide generator to be tested for radionuclide (cross) contamination. This change is consistent with what generator manufacturers have specified in their instructions to end-user facilities (medical licensees) and what many medical use facilities already do. Additionally, recent generator contamination problems identified by the U.S. Nuclear Regulatory Commission (NRC) have identified concerns and problems when only the first eluate is tested. The NRC is considering modification of Part 35 as a result of these issues. Section 7.33.2.2 is also modified to be consistent with current 10 CFR 35.204(c).
31. In 7.36.1, references to training requirements were modified to be consistent with equivalent references found in 10 CFR Part 35.300. The prior revision of regulations referenced interim sections (7.36.2, and 7.36.4) which did not reference the applicable Appendices of Part 7. Rather than reference an interim section of Part 7, the reader is directed to the applicable Appendix directly.
32. In 7.48.1.2, the provision is modified to be consistent with 10 CFR Part 35.600.
33. In 7.50, a typographical error in numbering is corrected.
34. In 7.59.4, the sequence of spot check requirements for afterloader devices is modified to provide a greater level of safety. Although not a regulatory requirement, licensees may perform the tests required by this section in the order they are stated in the regulations. The reordering of the requirements – when performed in order - is believed to provide an additional level of safety, should a licensee choose to perform them in the order given. No new requirements have been added to this section, only the order in which they are stated has changed.
35. Appendices A through M which contain the training requirements for Radiation Safety Officers, Authorized Medical Physicists, Authorized Nuclear Pharmacists, and Authorized Users (physicians) are being modified. The revision is intended to better follow the order and requirements contained in 10 CFR Part 35. Since the 2005 revision of Part 7, the NRC has made changes to regulatory requirements pertaining to training for physician authorized users and other authorized “persons”. The intent of the modifications to Part 7 is to capture these recent changes in the federal regulations. Also, by better matching the sequence of requirements between Colorado’s Part 7 and 10 CFR Part 35, the revised language should aid the regulated community when training documentation is submitted for review by the Department for those individuals coming from outside of Colorado.