6 Colo. Code Regs. § 1007-1-8.1

Current through Register Vol. 47, No. 11, June 10, 2024
Section 6 CCR 1007-1-8.1 - Purpose and Scope
8.1.1 Authority.
A. Rules and regulations set forth herein are adopted pursuant to the provisions of sections 25-1-108, 25-1.5-101(1)(l), and 25-11-104, CRS.
8.1.2 Basis and Purpose.
B. A statement of basis and purpose accompanies this part and changes to this part. A copy may be obtained from the Department.
8.1.3 Scope.
A. This part provides special requirements for non-healing-arts radiation generating devices (RGDs) operating between 5 kiloelectron volts (keV) and 1 million electron volts (MeV). For machines operating at energies greater than 1 MeV, see Part 9.
B. The following machines and equipment are exempt from these regulations:
1. Domestic television receivers.
2. Cold-cathode gas discharge tubes, providing the exposure rates shall not exceed 10 mrem (0.1 mSv) per hour at a distance of thirty (30) centimeters from any point on the external surface of the tube.
3. Other electrical equipment that produces radiation incidental to its operation for other purposes, providing the dose rate to the whole body at the point of nearest approach to such equipment when any external shielding not integral to the equipment is removed, does not exceed 25 mrem (0.25 mSv) per year. The production testing or factory servicing for such equipment shall not be exempt.
4. Equipment described in 8.1.3.B shall not be exempt if it is used or handled in such a manner that any individual might receive a dose of radiation in excess of the limits specified in Part 4 of these regulations.
C. In addition to the requirements of this Part, all registrants are subject to the requirements of Parts 1, 2, 4, 10 and 13 of these regulations. This Part does not pertain to radiation safety requirements for x-ray equipment that is explicitly covered in other sections of these regulations, such as Part 5 (Radiation safety requirements for industrial radiographic operations), Part 6 (X-ray imaging in the healing arts), and Part 9 (Radiation safety requirements for particle accelerators not used in the healing arts).
D. Radiography that meets the definition of "cabinet radiography" as defined in 8.2 shall be regulated under this Part. This includes certified x-ray systems.
E. Radiography (excluding industrial radiography) that occurs in a shielded room as defined in 8.2 shall be regulated under this Part.
F. Industrial radiography that is open-beam, and not in a shielded room and not otherwise listed in this section, shall be regulated under Part 5 of these regulations.
8.1.4 Applicability.
A. The requirements and provisions of these regulations apply to applicants, and registrants within the scope of by Part 8 unless specifically exempted by Part 8.
B. The applicable special requirements of Part 5 also apply if an image receptor is used to transform incident x-ray photons either into a visible image or into another form that can be made into a visible image by further transformation.
C. The requirements of Part 8 are in addition to, and not in substitution for, applicable requirements in other parts of these regulations.
8.1.5 Intent.

RGDs are a broad class of equipment that generate x-rays or particle radiation having energies between 5 keV and 1 MeV, and not intended for medical use on humans. If applicable, all RGDs shall comply with FDA performance standards as defined in Title 21 Code of Federal Regulations, parts 1010 thru 1050.

Examples of RGDs include, but are not limited to:

A. Open and closed analytical x-ray equipment (table top and hand-held);
B. X-ray gauges;
C. Cabinet x-ray radiography;
D. Security screening units;
E. Quality or process control devices;
F. Ion implantation devices;
G. Electron beam welders; and
H. Non-human use x-ray fluoroscopy.
8.1.6 Published Material Incorporated by Reference.
A. Throughout this Part 8, federal regulations, state regulations, and standards or guidelines of outside organizations have been adopted and incorporated by reference. Unless a prior version of the incorporated material is otherwise specifically indicated, the materials incorporated by reference cited herein include only those versions that were in effect as of the most recent effective date of this Part 8 (August 2021), and not later amendments or editions of the incorporated material.
B. Materials incorporated by reference are available for public inspection, and copies (including certified copies) can be obtained at reasonable cost, during normal business hours from the Colorado Department of Public Health and Environment, Hazardous Materials and Waste Management Division, 4300 Cherry Creek Drive South, Denver, Colorado 80246. Additionally, https://www.colorado.gov/cdphe/radregs identifies where the incorporated materials are available to the public on the internet at no cost. Due to copyright restrictions certain materials incorporated in this Part are available for public inspection at the state publications depository and distribution center.
C. Availability from Source Agencies or Organizations.
1. All federal agency regulations incorporated by reference herein are available at no cost in the online edition of the Code of Federal Regulations (CFR) hosted by the U.S. Government Printing Office, online at www.govinfo.gov.
2. All state regulations incorporated by reference herein are available at no cost in the online edition of the Code of Colorado Regulations (CCR) hosted by the Colorado Secretary of State's Office, online at https://www.sos.state.co.us/CCR/RegisterHome.do.

6 CCR 1007-1-8.1

Colorado Register, Vol 37, No. 14. July 25, 2014, effective 8/14/2014
38 CR 02, January 25, 2015, effective 2/14/2015
38 CR 05, March 10, 2015, effective 3/30/2015
38 CR 12, June 25, 2015, effective 7/15/2015
38 CR 14, July 25, 2015, effective 8/14/2015
39 CR 02, January 25, 2016, effective 2/14/2016
39 CR 16, August 25, 2016, effective 9/14/2016
39 CR 22, November 25, 2016, effective 12/15/2016
40 CR 11, June 10, 2017, effective 6/30/2017
40 CR 20, October 25, 2017, effective 11/14/2017
42 CR 24, December 25, 2019, effective 1/14/2020
43 CR 14, July 25, 2020, effective 8/14/2020
43 CR 18, September 25, 2020, effective 10/15/2020
44 CR 11, June 10, 2021, effective 7/15/2021
44 CR 14, July 25, 2021, effective 8/14/2021
45 CR 22, November 25, 2022, effective 12/15/2022