Part 20 Statement of Basis and Purpose

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 20, Particle Accelerators and Therapeutic Radiation Machines in the Healing Arts

State Board of Health

November 28, 2007

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 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 to require registration of sources of ionizing radiation such as radiation machines and to issue licenses governing the use of radioactive materials.

Section 2511104 of the Act requires Colorado’s radiation regulations to be modeled after 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.

This amendment revises Part 20, Particle Accelerators and Therapeutic Radiation Machines in the Healing Arts. Part 20 is based upon Part X of the SSRCR. These changes clarify the adequate radiation safety training and experience of Part 20:

For a Radiation Therapy Physicist, requirements formerly in Section 20.3.2 are moved to new Appendix20B and made more consistent with the requirements in Parts 2 and 7;

For an authorized user (radiation therapy physician), requirements formerly in Section20.3.1 are moved to new Appendix20C; and

For a therapeutic radiation machine operator, Section 20.3.3 requirements are moved to Appendix20D and made consistent with technologist requirements in Parts 2 and 7.

These changes to Part 20 include provisions for quality management and reportable medical events, based on the January 2007 proposed Part X of the Suggested State Regulations for the Control of Radiation. New provisions are added related to Intensity Modulated Radiation Therapy (IMRT), computed tomography simulators, and other new technologies.

The attached itemized list of changes to Part 20 notes any detailed findings that are the basis for the Colorado deviations from Part X of the Suggested State Regulations for the Control of Radiation. These amendments are improvements in meaning or wording and are not more restrictive or stringent than equivalent sections in Part X. These amendments were developed with concerted assistance from representatives of the Rocky Mountain Chapter of the American Association of Physicists in Medicine and were approved by the Colorado Radiation Advisory Committee on August 22, 2007. The attached itemized list notes the sections in which editorial and formatting changes are made and explicitly details any significant variations from PartX.

These changes to Part 20 also conform to the Colorado Secretary of State June 21, 2004 Code of Colorado Regulations Rules Styling Procedures Manual, version 2.

The most recent prior changes to Part 20 were adopted July21,1999, and became effective August30, 1999.

Specific Statutory Authority

These rules are promulgated pursuant to the provisions of CRS Sections 25-1-108 and 251.5101(1)(1)(l), and 25-11-104.

Major Factual and Policy Issues Encountered

As summarized above, these revisions do not involve major factual issues. These revisions to Part 20 serve to incorporate additions from SSRCR Part X, to align Part 20 with Parts2 and 7, and to edit and reformat Part 20.

Alternative Rules Considered and Why Rejected

Because a key purpose of this revision to Part 20 of Colorado’s radiation regulations is to conform to the Suggested State Regulations for the Control of Radiation and the Colorado Secretary of State style manual, wording improvements were considered across a narrow range.

Appendix to Statement Of Basis And Purpose,

Including Detailed Findings Related to Amendments to Part 20,

Particle Accelerators and Therapeutic Radiation Machines in the Healing Arts

The changes to Part 20, noting deviations from Part X of the Suggested State Regulations, are:

1. Section 20.1 corresponds to Section X.1 of Part X of the Suggested State Regulations for the Control of Radiation (SSRCR). Section X.1 did not change from Part X as it was approved in 1999 by the Conference of Radiation Control Program Directors, Inc. (CRCPD) and the January 2007 proposed revised SSRCR Part X.

Colorado Section 20.1, Purpose and Scope, differs from X.1a. Colorado’s purpose and scope are enhanced for clarity and consistency. Like the purpose and scope section of other recently revised parts of Colorado’s radiation regulations, Section 20.1 includes subsections designated Authority, Basis and Purpose, Scope, Applicability and Published Material Incorporated by Reference.

SSRCR SectionX1.b is moved in Part 20 to Section 20.3.2.

1. In Section 20.1.4, new Section 20.1.4.2 states that a requirement of Part 20 applies equally whether the use of ionizing radiation is by registration or license. This statement is helpful for facilities having both radiation machines and a radioactive materials license. Section20.1.4.3 now explicitly mentions Part 1, which contains definitions applicable throughout the radiation regulations, and Parts 2 and 10.

1. For consistency of numbering, the prefix “RH” is deleted from section numbers and replaced by the word “Section” where it appeared in paragraph text. Numbered paragraphs drill down four levels, e.g. 1.1.1.1, then for the next three levels use (1), then (a), then romanette (i). Using (1) and (a) makes Colorado’s rules more parallel to both the Code of Federal Regulations and SSRCR structure. The unnecessary phrase “of these Regulations” is removed throughout Part 20. Existing subsections are renumbered throughout Part 20. Generally, unnumbered sentences are now designated by number.

1. Section 20.2 corresponds to X.2, Definitions. If appropriate, the reason for the change is given in brackets, [ ].

Many of the editorial improvements to Colorado’s Section 20.2 definitions were at the suggestion of representatives of the Rocky Mountain Chapter of the American Association of Physicists in Medicine (AAPM).

4.1.Part 1 definitions used throughout the regulations, thus omitted from Part20, are:

4.1.1.“absorbed dose”

4.1.2.“absorbed dose rate”

4.1.3.“air kerma”

4.1.4.“Gray”

4.1.5.“irradiation”

4.1.6.“kilo electron volt”

4.1.7.“kilovolt”

4.1.8.“mega electron volt”

4.1.9.“megavolt”

4.1.10.“Sievert”

4.1.11.“source” of radiation

4.2.Definitions in Part 20 and Part X since 1999 that have been modified based upon Department staff and Colorado stakeholder suggestions are:

4.2.1.“authorized user” [the definition in Section 20.2 points to the applicable training criteria, from X.3c and former Section 20.3.1, for an authorized user physician, now placed in Appendix 20C]

4.2.2.“beam scattering foil” [improved wording]

4.2.3.“changeable filter” [made singular]

4.2.4.“contacttherapy system” [slightly improved wording]

4.2.5.“external beam radiation therapy” [AAPM advisors suggested that this match the distance in centimeters used in the definition of contact therapy system]

4.2.6.“interlock” [significantly improved wording based on AAPM suggestions]

4.2.7.“isocenter” [improved wording]

4.2.8.“leakage radiation” [improved wording based on AAPM suggestions]

4.2.9.“moving beam radiation therapy” [improved based on AAPM suggestions]

4.2.10.“nominal treatment distance” [improved based on AAPM suggestions]

4.2.11.“periodic quality assurance check” [slight editorial improvement]

4.2.12.“Radiation Therapy Physicist” [This term for an individual who meets the requirements of Appendix 20B is used in 1999 Part X. A cross-reference is provided in Section 20.2 for “qualified medical physicist”, the equivalent term used in 2007 proposed Part X.]

4.3.Definitions now added to Colorado Part 20 unchanged from Part X are:

4.3.1.“barrier”

4.3.2.“bentbeam linear accelerator”

4.3.3.“detector”

4.3.4.“lead equivalent”

4.3.5.“monitor unit”

4.3.6.“peak tube potential”

4.3.7.“scattered primary radiation”

4.3.8.“scattered radiation”

4.3.9.“secondary dose monitoring system”

4.3.10.“secondary protective barrier”

4.3.11.“shutter”

4.3.12.“source-skin distance”

4.3.13.“stray radiation”

4.3.14.“tube”

4.3.15.“tube housing assembly”

4.3.16.“wedge filter”

4.3.17.“x-ray tube”

4.4.Definitions now added to Colorado Part 20 modified from Part X are:

4.4.1.“accessible surface” [improved wording]

4.4.2.“added filtration” [improved wording]

4.4.3.“beam axis” [qualified by the statement “for purposes of Part 20” to be sure that the term does not contradict its meaning in Part 6]

4.4.4.“conventional simulator” [more properly described by machine type, which is a “radiographic/fluoroscopic simulator”]

4.4.5.“electronic brachytherapy system” [clarified based on AAPM suggestions]

4.4.6.“half-value layer” [simplified based on a standard usage]

4.4.7.“intensity modulated radiation therapy” [improved based on AAPM suggestions]

4.4.8.“misadministration” [Stakeholders in Colorado prefer the term “reportable medical event”, since this comports with how hospitals and clinics handle sentinel events within the system of accountability to The Joint Commission on accreditation of hospital facilities.]

4.4.9.“patient” [improved from Part X based on AAPM suggestions], “phantom” [improved based on AAPM suggestions]

4.4.10.“prescribed dose” [made more concise and correct in relation to actual radiation therapy practice]

4.4.11.“qualified medical physicist” [a cross-reference and equivalent term to a radiation therapy physicist meeting the requirements of Appendix 20B]

4.4.12.“simulator” [clarified from Part X on advice Colorado AAPM members]

4.4.13.“tenthvalue layer” [simplified based on a standard usage]

4.4.14.“termination of irradiation” [slight word replacement]

4.4.15.“therapeutic radiation machine” [clarified to include the new technology called electronic brachytherapy]

4.4.16.“useful beam” [the wording is simplified and clarified]

4.4.17.“virtual simulator” [a cross-reference to simulator, the definition of which is clarified from Part X on advice Colorado AAPM members]

4.4.18.“written directive” [from Part X with only a minor editorial change]

4.5.Definitions added based upon Department staff and Colorado stakeholder suggestions, although not in Part X, are:

4.5.1.“AAPM Report 46” [short citation for a report used in several sections]

4.5.2.“AAPM Report 47” [short citation for a report used in several sections]

4.5.3.“AAPM Report 82” [short citation for a report used in several sections]

4.5.4.“AAPM Report 83” [short citation for a report used in several sections]

4.5.5.“ADCL” [the Accredited Dosimetry Calibration Laboratory of the American Association of Physicists in Medicine]

4.5.6.“central axis” [adds a cross-reference to “beam axis”]

4.5.7.“collimator” [for clarity, since the term is used in the rule]

4.5.8.“conventional simulator” [provides a cross-reference to “simulator”]

4.5.9.“fluoroscopic simulator” [provides a cross-reference to “simulator”]

4.5.10.“inherent filtration” [for clarity, since the term is used in the rule]

4.5.11.“operator” [provides a cross-reference to “therapeutic radiation machine operator”, an individual who meets the requirements of Appendix 20D]

4.5.12.“practitioner of the healing arts” [Added for clarity, this term used in X.1b means any person upon whom U.S. Food and Drug Administration has conferred the authority to administer prescription drugs; instead Colorado uses in Section 20.3.2 the more precise and pertinent terms “radiation therapy physician” and “radiation therapy veterinarian”.]

4.5.13.“radiation therapist” [provides a cross-reference for a synonym used for the “therapeutic radiation machine operator” or “operator” who meets the requirements of Appendix 20D]

4.5.14.“radiation therapy” [provides a reasonably succinct overall definition of radiation therapy--the therapeutic application of ionizing radiation to humans or animals for medical, research, or veterinary purposes]

4.5.15.“radiation therapy physician” [a physician trained to use therapeutic radiation machines on humans]

4.5.16.“radiation therapy veterinarian” [a veterinarian trained to use therapeutic radiation machines on animals]

4.5.17.“radiographic simulator” [provides a cross-reference to “simulator”]

4.5.18.“radiotherapy” [a cross-reference to the definition under “radiation therapy”

4.6.Definitions in Part X but not found to be used or useful in Part 20 are:

4.6.1.“planned displacement” [unneeded]

4.6.2.“practical range of electrons” [unneeded]

1. Section 20.3.1, Administrative Controls, is modified to better distinguish between the overall responsibility of the facility and the particular responsibility of the registrant. Section20.3.1 is equivalent to SSRCR X.3. Subsections 20.3.1.1 through 20.3.1.3 mirror X.3a. New Subsection 20.3.1.4 is equivalent to X.3b, and reinforces that a radiation machine not in compliance with Part 20 shall not be used in the healing arts.

Section20.3.1.5, previously adopted in Colorado and carried forward from Part 20 currently in effect, explicitly iterates that any requirement of Part 20 which is not applicable to veterinary practice may be waived upon request.

1. New Section 20.3.2, Supervision of Use, contains former Sections 20.1.2 and 20.1.3. Note that Part 1 already defines and distinguishes “general”, “direct” and “personal” supervision. General supervision is authorized in Section20.3.2.

1. Renumbered Sections 20.3.3, 20.3.4 and 20.3.5 now refer to Appendices 20C, 20B and 20D, respectively. These appendices now contain the adequate radiation safety training and experience requirements moved from former Sections2.3.1, 2.3.2 and 2.3.3. Corresponding training requirements for an authorized user, qualified medical physicist and operator are found, respectively, in X.3c, X.3d, and X.3e of SSRCR Part X. In Part X these are “bracketed”, which means that discretion is afforded in accord with State law and/or deliberation. As noted above, Colorado delineates a “therapeutic radiation machine operator”, also called a “radiation therapist” or “operator”, as well as “radiation therapy physician”, “radiation therapy physicist”, and “radiation therapy veterinarian”. Appendices20C, 20B and 20D closely parallel the analogous Part X model radiation safety training and experience qualification criteria.

1. Also in Section 20.3, Sections 20.3.5, 20.3.6 and 20.3.7 are renumbered and edited slightly.

1. Section 20.3.8 is revised to incorporate the concept of a written directive from the 2007 proposed Part X. Implementing a written directive is fundamental to Part 7 of the radiation regulations regarding use of radioactive materials in the healing arts. The medical physicists who reviewed Part X and this Part 20 agreed that having a written directive for use of therapeutic radiation machines is consistent and desirable for radiation protection. Similarly, Section20.3.9 is added, based on Section X.3i of Part X.

1. Revised Section 20.3.10 consolidates record maintenance and retention requirements. This section mirrors X.3k of SSRCR Part X. Editorial improvements are made for conciseness and consistency. In new 20.3.10.1(4), the Radiation Therapy Physicist determines particulars of the procedure for the return to use of a therapeutic radiation machine after service, repair, or upgrade.

1. Section 20.4 is analogous to SSRCR X.4, General Technical Requirements for Facilities Using Therapeutic Radiation Machines.

Section 20.4.1, Protection Surveys, is modified slightly based on suggestions from Departmental staff and AAPM advisors.

Section20.4.2 is only reformatted.

Section 20.4.3, Dosimetry Equipment, is reformatted and clarified based on extensive discussion with AAPM advisors and members of Colorado’s Radiation Advisory Committee.

Section 20.4.4 is improved by a cross-reference to Section 2.6.3 in Part 2.

New Section 20.4.5, Shielding and Safety Design Requirements, is former Section 20.10, logically moved earlier in Part 20 and slightly edited for clarity.

1. Section 20.5, formerly Section 20.6, consolidates the duties that are required to be performed by a Radiation Therapy Physicist. Minor editorial improvements are at the suggestion of AAPM advisors and Colorado’s Radiation Advisory Committee members.

1. New Section 20.6, Quality Management Program, incorporates from the January 2007 SSRCR X.5 a set of requirements intended to ensure that radiation will be administered as directed by the authorized user. Section 20.6.2 provides for written directives and procedures for administration of radiation. Section 20.6.3 delineates how a reportable medical event is to be handled. The provisions parallel the approach for radioactive materials in Part 7, Use of Radionuclides in the Healing Arts, which is in turn based on SSRCR Part G. Section 20.6 was closely scrutinized by medical physics stakeholders and by the Colorado Radiation Advisory Committee. Several editorial improvements from the wording in X.5 were made for clarity and conciseness.

1. Section 20.7, pertaining to Therapeutic Radiation Machines of Less Than 500 kV, is reformatted with minor revisions. Section 20.7 closely parallels X.6, subsection topic by subsection topic.

Section 20.7.1 is extensively edited for precision in the requirements, based on Colorado AAPM suggestions. The substantive requirements are unchanged from the previous X.6a and 20.7.1.

Sections 20.7.2 through 20.7.6 are reformatted only.

Sections 20.7.7, Beam Block, and 20.7.8, Timer, are edited for clarity.

Sections 20.7.9 through 20.7.13 are slightly edited and reformatted.

In Section 20.7.14, subsection 20.7.14.1 regarding two-way communication is modified to remove the word “aural” and incorporate the same provisions as 20.8.1.4.

Sections 20.7.15 through 20.7.18 are slightly edited and reformatted. The referenced report in 20.7.16.2 is updated.

Former Section 20.7.19, Possession of Survey Instrument(s), is moved to Section 20.10.

1. Section 20.8, pertaining to Therapeutic Radiation Machines - Photon Therapy Systems (500kV and Above) and Electron Therapy Systems (500 keV and Above), is also reformatted throughout. Section 20.8 closely parallels X.7, subsection topic by subsection topic.

Former Section 20.8.1, Possession of Survey Instrument(s), is moved to Section 20.10.

New Section 20.8.1 now contains the facility design requirements formerly in 20.8.17. Thesedesign requirements, from X.7q, are more logical to begin Section 20.8.

Sections20.8.2 through 20.8.16 and 20.8.18 are reformatted with minor editing. At the request of medical physics stakeholders, the phrase “or obtain equivalent measured and published leakage radiation data from the manufacturer or by other means acceptable to the Department” is added in 20.8.2.4 to provide additional flexibility. Similar flexibility is added in 20.8.5.1, which also now refers to “compliance with International Electrotechnical Commission, Document 601-2-1, June 1998, or equivalent criteria”, and similar flexibility is also added in 20.8.9.2(4). Former 20.8.4.1.1, regarding removal by tools of internal foils or filters, is renumbered to 20.8.4.5 and edited.

Section 20.8.17, Surveys for Residual Radiation, is modified to allow the Radiation Therapy Physicist to determine whether a survey is required consistent with the occupational dose limits in 4.6 and 4.18.1.1.

Section 20.8.19, Acceptance Testing, Commission and Full Calibration Measurements, is clarified, at the suggestion of AAPM reviewers, by using a short citation to each referenced guidance report and also by changing “direct supervision” to the defined term “personal supervision” in several subsections.

Section 20.8.20, Periodic Quality Assurance Checks, is clarified, at the suggestion of AAPM reviewers, by using a short citation to each referenced guidance report and also by selectively changing from the phrase “quality assurance” to the more precise phrase “radiation output” as appropriate in several subsections.