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[Publication Instructions: STRIKE the current rule from the beginning through/up to 19.1 (inclusive) and INSERT the following amended/revised text.]
DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT
Hazardous Materials and Waste Management Division
RADIATION CONTROL - LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS
6 CCR 1007-1 Part 19
[Editor’s Notes follow the text of the rules at the end of this CCR Document.]
Adopted by the Board of Health on July 20, 2016
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PART 19: LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS
19.1 Purpose and scope.
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[Publication Instructions: STRIKE 19.1.4.3 and INSERT the following amended/revised text.]
19.1.4.3 The requirements of this part are in addition to the requirements of Parts 1, 3, 4, 10, 12, 13, 17 and 22.
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[Publication Instructions: STRIKE 19.3 through 19.4.3 (inclusive) and INSERT the following amended/revised text. Ensure that header “SPECIFIC LICENSING REQUIREMENTS” is retained as is with no changes before 19.3.]
19.3 Application for a specific license.
19.3.1 A person shall file an application for a specific license authorizing the use of sealed sources in an irradiator pursuant to Part 3, Section 3.8.
19.4 Specific licenses for irradiators.
19.4.1 The Department will approve an application for a specific license for the use of licensed material in an irradiator if the applicant meets the requirements contained in this section.
19.4.2 The applicant shall satisfy the general requirements specified in Part 3, Sections 3.9, 3.9.1, 3.9.2, 3.9.4, and 3.14.1 of the regulations and the requirements contained in this part.
19.4.3 The applicant must describe the training provided to irradiator operators including:
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[Publication Instructions: STRIKE 19.4.8 through 19.7.1 (inclusive) and INSERT the following amended/revised text.]
19.4.8 If licensee personnel are to load or unload sources, the applicant shall describe the qualifications and training of the personnel and the procedures to be used. If the applicant intends to contract for source loading or unloading at its facility, the loading or unloading must be done by an organization specifically authorized by the NRC or an Agreement State to load or unload irradiator sources.
19.4.9 The applicant shall describe the inspection and maintenance checks, including the frequency of the checks required by 19.23.
19.5 Commencement of construction.
19.5.1 Commencement of construction of a new irradiator may not occur prior to the submission to the Department of both the application for a license for the irradiator and the fee required by Part 12 of these regulations.
19.5.1.1 Any activities undertaken prior to the issuance of a license are entirely at the risk of the applicant and have no bearing on the issuance of a license with respect to the requirements of the Act, and rules, regulations, and orders issued under the Act.
19.5.1.2 Commencement of construction as defined in Part 1 may include non-construction activities if the activity has a reasonable nexus to radiological safety.
19.6 Applications for exemptions.
19.6.1 Any application for a license or for amendment of a license authorizing use of a teletherapy-type unit for irradiation of materials or objects may include proposed alternatives for the requirements of this part. The Department will approve the proposed alternatives if the applicant provides adequate rationale for the proposed alternatives and demonstrates that they are likely to provide an adequate level of safety for workers and the public.
DESIGN AND PERFORMANCE REQUIREMENTS FOR IRRADIATORS
19.7 Requirements and performance criteria for sealed sources.
Sealed sources shall:
19.7.1 Have a certificate of registration issued by the NRC or an Agreement State, or shall have been evaluated in accordance with 10 CFR 32.210 or the equivalent state regulation;
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[Publication Instructions: STRIKE 19.8 (section title only) and INSERT the following amended/revised text.]
19.8 Access control.
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[Publication Instructions: STRIKE 19.9 through the 19.10 section header (inclusive) and INSERT the following amended/revised text.]
19.9 Shielding.
19.9.1 The radiation dose rate in areas that are normally occupied during operation of a panoramic irradiator may not exceed 0.02 millisievert (2 millirem) per hour at any location 30 centimeters or more from the wall of the room when the sources are exposed.
19.9.1.1 The dose rate must be averaged over an area not to exceed 100 square centimeters having no linear dimension greater than 20 centimeters.
19.9.1.2 Areas where the radiation dose rate exceeds 0.02 millisievert (2 millirem) per hour must be locked, roped off, or posted.
19.9.2 The radiation dose at 30 centimeters over the edge of the pool of a pool irradiator may not exceed 0.02 millisievert (2 millirem) per hour when the sources are in the fully shielded position.
19.9.3 The radiation dose rate at 1 meter from the shield of a dry-source-storage panoramic irradiator when the source is shielded may not exceed 0.02 millisievert (2 millirem) per hour and at 5 centimeters from the shield may not exceed 0.2 millisievert (20 millirem) per hour.
19.10 Fire protection.
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[Publication Instructions: STRIKE 19.11 (section title only) and INSERT the following amended/revised text.]
19.11 Radiation monitors.
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[Publication Instructions: STRIKE 19.12 through 19.12.1.2 (inclusive) and INSERT the following amended/revised text.]
19.12 Control of source movement.
19.12.1 The mechanism that moves the sources of a panoramic irradiator must require a key to actuate.
19.12.1.1 Actuation of the mechanism must cause an audible signal to indicate that the sources are leaving the shielded position.
19.12.1.2 Only one key may be in use at any time, and only operators or facility management may possess it.
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[Publication Instructions: STRIKE 19.13 (section title only) and INSERT the following amended/revised text.]
19.13 Irradiator pools.
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[Publication Instructions: STRIKE 19.14 (section title only) and INSERT the following amended/revised text.]
19.14 Source rack protection.
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[Publication Instructions: STRIKE 19.15 (section title only) and INSERT the following amended/revised text.]
19.15 Power failures.
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[Publication Instructions: STRIKE 19.16 (section title only) and INSERT the following amended/revised text.]
19.16 Design requirements.
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[Publication Instructions: STRIKE 19.17 (section title only) and INSERT the following amended/revised text.]
19.17 Construction monitoring and acceptance testing.
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[Publication Instructions: STRIKE 19.18.3.1 and INSERT the following amended/revised text.]
19.18.3.1 The individual shall also demonstrate the ability to perform those portions of the operating and emergency procedures that he or she is to perform.
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[Publication Instructions: STRIKE 19.19 (section title only) and INSERT the following amended/revised text.]
19.19 Operating and emergency procedures.
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[Publication Instructions: STRIKE 19.20 (section title only) and INSERT the following amended/revised text.]
19.20 Personnel monitoring.
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[Publication Instructions: STRIKE 19.20. through 19.21 section header (inclusive) and INSERT the following amended/revised text.]
19.20 Personnel monitoring.
19.20.1 Irradiator operators shall wear a personnel dosimeter that is processed and evaluated by an accredited National Voluntary Laboratory Accreditation Program (NVLAP) processor while operating a panoramic irradiator or while in the area around the pool of an underwater irradiator.
19.20.1.1 The personnel dosimeter processor must be accredited for high-energy photons in the normal and accident dose ranges (see Part 4, Section 4.17.3).
19.20.1.2 Each personnel dosimeter must be assigned to and worn by only one individual.
19.20.1.3 Film badges must be processed at least monthly and other personnel dosimeters must be processed at least quarterly.
19.20.1.4 After replacement, each personnel dosimeter must be promptly processed.
19.20.2 Other individuals who enter the radiation room of a panoramic irradiator shall wear a dosimeter, which may be a pocket dosimeter.
19.20.2.1 For groups of visitors, only two people who enter the radiation room are required to wear dosimeters.
19.20.2.2 If pocket dosimeters are used to meet the requirements of this paragraph, a check of their response to radiation must be done at least annually.
19.20.2.3 Acceptable dosimeters must read within ±20 percent of the true radiation dose.
19.21 Radiation surveys.
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[Publication Instructions: STRIKE 19.21.5.1 and INSERT the following amended/revised text.]
19.21.5.1 The resins may be released only if the survey does not detect radiation levels above background radiation levels.
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[Publication Instructions: STRIKE 19.22 through 19.22.1.2 (inclusive) and INSERT the following amended/revised text.]
19.22 Detection of leaking sources.
19.22.1 Each dry-source-storage sealed source must be tested for leakage at intervals not to exceed 6 months using a leak test kit or method approved by the NRC or an Agreement State.
19.22.1.1 In the absence of a certificate from a transferor that a test has been made within the 6 months before the transfer, the sealed source may not be used until tested.
19.22.1.2 The test must be capable of detecting the presence of 200 becquerel (0.005 microcurie) of radioactive material and must be performed by a person approved by the NRC or an Agreement State to perform the test.
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[Publication Instructions: STRIKE 19.22.3 and INSERT the following amended/revised text.]
19.22.3 If a leaking source is detected, the licensee shall arrange to remove the leaking source from service and have it decontaminated, repaired, or disposed of by an NRC or Agreement State licensee that is authorized to perform these functions.
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[Publication Instructions: STRIKE 19.22.3.5 through 19.23 section header (inclusive) and INSERT the following amended/revised text.]
19.22.3.5 If contaminated equipment, facilities, or products are found, the licensee shall arrange to have them decontaminated or disposed of by a NRC or Agreement State licensee that is authorized to perform these functions.
19.22.3.6 If a pool is contaminated, the licensee shall arrange to clean the pool until the water contamination levels do not exceed the appropriate concentration in Part 4, Appendix 4B, Table 4B2, Column 2 (See Part 4, Sections 4.52 and 4.53 for notification and reporting requirements).
19.23 Inspection and maintenance.
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[Publication Instructions: STRIKE 19.24 through 19.24.1 (inclusive) and INSERT the following amended/revised text.]
19.24 Pool water purity.
19.24.1 Pool water purification systems must be run sufficiently to maintain the conductivity of the pool water below 20 microsiemens per centimeter under normal circumstances.
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[Publication Instructions: STRIKE 19.25. through 19.25.1 (inclusive) and INSERT the following amended/revised text.]
19.25 Attendance during operations.
19.25.1 Both an irradiator operator and at least one other individual, who is trained on how to respond and prepared to promptly render or summon assistance if the access control alarm sounds, shall be present onsite:
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[Publication Instructions: STRIKE 19.25.3.1 through 19.26 section header (inclusive) and INSERT the following amended/revised text.]
19.25.3.1 An individual who moves the product into or out of the pool of an underwater irradiator need not be qualified as an irradiator operator; however, each such individual shall have received the training required in 19.18.6 and 19.18.7. Static irradiations may be performed without a person present at the facility.
19.26 Entering and leaving the irradiation room.
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[Publication Instructions: STRIKE 19.27 through 19.27.2 (inclusive) and INSERT the following amended/revised text.]
19.27 Irradiation of explosive or flammable materials.
19.27.1 Irradiation of explosive material is prohibited unless the licensee has received prior written authorization from the Department.
19.27.1.1 Authorization will not be granted unless the licensee can demonstrate that detonation of the explosive would not rupture the sealed sources, injure personnel, damage safety systems, or cause radiation overexposures of personnel.
19.27.2 Irradiation of more than small quantities of flammable material (flash point below 140°F) is prohibited in panoramic irradiators unless the licensee has received prior written authorization from the Department.
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[Publication Instructions: STRIKE 19.28 section header and INSERT the following amended/revised text.]
19.28 Records and retention periods.
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[Publication Instructions: STRIKE 19.28.1.5 INSERT the following amended/revised text.]
19.28.1.5 Evaluations of personnel dosimeters (film badge, optically stimulated luminescence and thermoluminescence dosimeter) required by 19.20 in accordance with Part 4, Section 4.46 until the Department terminates the license;
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[Publication Instructions: STRIKE 19.28.1.13 and INSERT the following amended/revised text.]
19.28.1.13 Records related to decommissioning of the irradiator as required by Part 3, Section 3.16.5.
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[Publication Instructions: STRIKE 19.29.1 and INSERT the following amended/revised text.]
19.29.1 In addition to the reporting requirements in other parts of the regulations, the licensee shall report the following events if not reported under other parts of Department regulations:
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[Publication Instructions: STRIKE 19.29.2 and INSERT the following amended/revised text.]
19.29.2 The report must include a telephone report within 24 hours as described in Part 4, Section 4.53.1.1, and a written report within 30 days as described in Part 4, Section 4.53.1.2.
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