ML20352A357
| ML20352A357 | |
| Person / Time | |
|---|---|
| Issue date: | 12/09/2020 |
| From: | Michelle Beardsley NRC/NMSS/DMSST |
| To: | |
| Beardsley M | |
| Shared Package | |
| ML20352A309 | List: |
| References | |
| Download: ML20352A357 (5) | |
Text
1 DRAFT B 12/09/2020 Commented [JSJ1]:
Editorial note 1: All comments (such as this one) shown in 2 DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT the right side margin of this draft document are for information purposes only to assist the reader in understanding the proposed rule change during the review and comment 3 Hazardous Materials and Waste Management Division process.
These side margin notes are not part of the rule and all comments will be deleted prior to publication of the final rule 4 RADIATION CONTROL - LICENSES AND RADIATION SAFETY REQUIREMENTS FOR by the Colorado Secretary of State.
5 IRRADIATORS Editorial note 2: Alignment and formatting corrections and 6 6 CCR 1007-1 Part 19 minor typographical adjustments may be made in the rule and may not be specifically identified with a side margin comment.
7 [Editors Notes follow the text of the rules at the end of this CCR Document.]
Editorial note 3: Note that this is only a partial rule and only those sections impacted by the proposed changes are 8 _________________________________________________________________________ included.
9 Adopted by the Board of Health on July 20, 2016May 19, 2021, effective date July 15, 2021 Commented [JSJ2]:
Adoption and effective dates are tentative and subject to 10 PART 19: LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS change, pending Board of Health meeting schedule, final adoption of the rule, and the Colorado Register publication dates.
11 [
The annual rulemaking schedule (regulatory agenda) for the 12 * *
- DENOTES UNAFFECTED SECTIONS/PROVISIONS IN THE DRAFT RULE ] Department may be found online.
13 * *
- 14 19.1.5 Published Material Incorporated by Reference. Commented [JSJ3]:
Language in section 19.1.5, is revised and amended for 15 Published material incorporated in Part 19 by reference is available in accord with Part 1, Section consistency with the Colorado Administrative Procedure Act (24-4-103(12.5)(a)(2), CRS) regarding documents 16 1.4. incorporated by reference, and consistent with other recently amended rules.
17 19.1.5.1. Throughout this Part 19, federal regulations, state regulations, and 18 standards or guidelines of outside organizations have been adopted and 19 incorporated by reference. Unless a prior version of the incorporated 20 material is otherwise specifically indicated, the materials incorporated by 21 reference cited herein include only those versions that were in effect as of 22 the most recent effective date of this Part 19 (July 2021), and not later 23 amendments or editions of the incorporated material.
24 19.1.5.2. Materials incorporated by reference are available for public inspection, and 25 copies (including certified copies) can be obtained at reasonable cost, 26 during normal business hours from the Colorado Department of Public 27 Health and Environment, Hazardous Materials and Waste Management 28 Division, 4300 Cherry Creek Drive South, Denver, Colorado 80246.
29 Additionally, https://www.colorado.gov/cdphe/radregs identifies where the 30 incorporated materials are available to the public on the internet at no cost.
31 Due to copyright restrictions certain materials incorporated in this Part are 32 available for public inspection at the state publications depository and 33 distribution center.
34 19.1.5.3. Availability from Source Agencies or Organizations.
35 (1) All federal agency regulations incorporated by reference herein are 36 available at no cost in the online edition of the Code of Federal Regulations 37 (CFR) hosted by the U.S. Government Printing Office, online at 38 www.govinfo.gov.
1
CODE OF COLORADO REGULATIONS 6 CCR 1007-1 Part 19 Hazardous Materials and Waste Management Division 39 (2) All state regulations incorporated by reference herein are available at no 40 cost in the online edition of the Code of Colorado Regulations (CCR) 41 hosted by the Colorado Secretary of States Office, online at 42 https://www.sos.state.co.us/CCR/RegisterHome.do.
43 44 * *
- 45 Underwater irradiator means an irradiator in which the sources always remain shielded under 46 water and humans do not have access to the sealed sources or the space subject to irradiation 47 without entering the pool.
48 Commented [JSJ4]: Formatted to remove unneeded spaces/gaps in the current rule between the definition 49 underwater irradiator and section 19.3.
50 SPECIFIC LICENSING REQUIREMENTS 51 19.3 Application for a specific license.
52 * *
- 53 DESIGN AND PERFORMANCE REQUIREMENTS FOR IRRADIATORS 54 19.7 Requirements and performance criteria for sealed sources.
55 Sealed sources shall:
56 19.7.1 Have a certificate of registration issued by the NRC or an Agreement State, or shall have been 57 evaluated in accordance with 10 CFR Part 32.210 or the equivalent state regulation; 58 59 * *
- 60 61 19.8.7 Each entrance to the radiation room of a panoramic irradiator and each entrance to the area 62 within the personnel access barrier of an underwater irradiator must be posted as required by 63 Part 4, Section 4.28.
64 19.8.7.1 Radiation postings for panoramic irradiators must comply with the posting 65 requirements of Part 4, Section 4.28, except that signs may be removed, covered, or 66 otherwise made inoperative when the sources are fully shielded.
67 Commented [JSJ5]: Formatted to delete unneeded spaces/gaps in the current rule between 19.8.7.1 and 19.8.8.
68 19.8.8 If the radiation room of a panoramic irradiator has roof plugs or other movable shielding, it must 69 not be possible to operate the irradiator unless the shielding is in its proper location.
70 71 * *
- 2
CODE OF COLORADO REGULATIONS 6 CCR 1007-1 Part 19 Hazardous Materials and Waste Management Division 72 19.12.4 Each control for a panoramic irradiator must be clearly marked as to its function.
73 Commented [JSJ6]:
Formatted to delete unneeded spaces/gaps in the current rule between 19.12.4 and 19.13.
74 75 76 19.13 Irradiator pools.
77 * *
- 78 19.17.1.6 Source Rack.
79 (1) For panoramic irradiators, the licensee shall test the movement of the source 80 racks for proper operation prior to source loading, and testing must include 81 source rack lowering due to simulated loss of power.
82 (2) For all irradiators with product conveyor systems, the licensee shall observe and 83 test the operation of the conveyor system to assure that the requirements in 84 19.14 are met for protection of the source rack and the mechanism that moves 85 the rack.
86 (3) Testing must include tests of any limit switches and interlocks used to protect the 87 source rack and mechanism that moves the rack from moving product carriers.
88 Commented [JSJ7]:
Formatted to delete unneeded spaces/gaps in the current rule between 19.17.1.6(3) and 19.17.1.7.
89 19.17.1.7 Access Control.
90 (1) For panoramic irradiators, the licensee shall test the completed access control 91 system to assure that it functions as designed and that all alarms, controls, and 92 interlocks work properly.
93 94 * *
- 95 19.18.7 Individuals who must be prepared to respond to alarms required by 19.8.2, 19.8.9, 19.10.1, 96 19.11.1, 19.11.2, and 19.22.2 shall be trained and tested on how to respond.
97 19.18.7.1 Each individual shall be retested at least once a year.
98 19.18.7.2 Tests may be oral.
99 Commented [JSJ8]:
Formatted to delete unneeded spaces/gaps between 100 19.19 Operating and emergency procedures. 19.18.7.2 and 19.19 in the current rule.
101 102 * *
- 103 3
CODE OF COLORADO REGULATIONS 6 CCR 1007-1 Part 19 Hazardous Materials and Waste Management Division 104 19.20 Personnel monitoring.
105 19.20.1 Irradiator operators shall wear a personnel dosimeter that is processed and evaluated by an Commented [JSJ9]:
106 accredited National Voluntary Laboratory Accreditation Program (NVLAP) processor while The provisions of 19.20 are revised for consistency with 2020 107 operating a panoramic irradiator or while in the area around the pool of an underwater amendments to U.S. Nuclear Regulatory Commission (NRC) regulations in 10 CFR Part 36.55.
108 irradiator.Irradiator operators shall wear a personnel dosimeter while operating a 109 panoramic irradiator or while in the area around the pool of an underwater irradiator. The NRC amended this federal rule to authorize/allow the use of modern individual monitoring devices at panoramic irradiator facilities. In the past, NRC has required the use of 110 19.20.1.1 The personnel dosimeter processor must be accredited for high-energy photons personnel dosimetry that is processed and evaluated by an 111 in the normal and accident dose ranges (see Part 4, Section 4.17.3).The personnel accredited National Voluntary Laboratory Accreditation 112 dosimeter must be capable of detecting high energy photons in the normal and Program (NVLAP) processor. Some new dosimetry devices 113 accident dose ranges. do not require the type of processing envisioned in the text of the prior rule and may instead be read directly by internet-enabled computers, smartphones, and tablets by the licensee.
114 19.20.1.2 Each personnel dosimeter must be assigned to and worn by only one individual. The design of these newer devices (rather than the qualifications of the processor) allow for collection of accurate 115 19.20.1.3 Film badges must be processedreplaced at least monthly and all other dose information. The proposed rule is rephrased to allow the use of individual monitoring devices that do not require 116 personnel dosimeters that require replacement must be processedreplaced at NVLAP processing.
117 least quarterly.
NRC RATS 2020-1 118 19.20.1.4 After replacement, each personnel dosimeter must be promptly processed.All NRC Compatibility H&S 119 personnel dosimeters must be evaluated at least quarterly or promptly after 120 replacement, whichever is more frequent.
121 * *
- 122 19.21.2 If the radiation levels specified in 19.9 are exceeded, the facility must be modified to comply with 123 the requirements in 19.9.
124 Commented [JSJ10]:
Formatted to delete unneeded spaces/gaps in the current rule 125 between 19.21.2 and 19.21.3.
126 19.21.3 Portable radiation survey meters must be calibrated at least annually to an accuracy of 20 127 percent for the gamma energy of the sources in use.
128 * *
- 129 19.25.2 At a panoramic irradiator at which static irradiations (no movement of the product) are occurring, 130 an individual who has received the training required in 19.18.7 on how to respond to alarms must 131 be onsite.
132 Commented [JSJ11]:
Formatted to delete unneeded spaces/gaps in the current rule between 19.25.2 and 19.25.3.
133 134 135 19.25.3 At an underwater irradiator, an irradiator operator must be present at the facility whenever the 136 product is moved into or out of the pool.
137 * *
- 138 19.27.2.1 Authorization will not be granted unless the licensee can demonstrate that a fire 139 in the radiation room could be controlled without damage to the sealed sources or safety 140 systems and without radiation overexposures of personnel.
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CODE OF COLORADO REGULATIONS 6 CCR 1007-1 Part 19 Hazardous Materials and Waste Management Division 141 Commented [JSJ12]:
Formatted to delete unneeded spaces/gaps in the current rule 142 between 19.27.2.1 and 19.28.
143 144 145 RECORDS AND REPORTS 146 19.28 Records and retention periods.
147 19.28.1 The licensee shall maintain the following records at the irradiator for the periods specified:
148 19.28.1.1 A copy of the license, license conditions, documents incorporated into a license 149 by reference, and amendments thereto until superseded by new documents or until the 150 Department terminates the license for documents not superseded; 151 19.28.1.2 Records of each individuals training, tests, and safety reviews provided to meet 152 the requirements of 19.18.1, 19.18.2, 19.18.3, 19.18.4, 19.18.6, and 19.18.7 until 3 years 153 after the individual terminates work; 154 19.28.1.3 Records of the annual evaluations of the safety performance of irradiator 155 operators required by 19.18.5 for 3 years after the evaluation; 156 19.28.1.4 A copy of the current operating and emergency procedures required by 19.19 157 until superseded or the Department terminates the license. Records of the radiation 158 safety officers review and approval of changes in procedures as required by 19.19.3.3 159 retained for 3 years from the date of the change; 160 19.28.1.5 Evaluations of personnel dosimeters (film badge, optically stimulated Commented [JSJ13]:
161 luminescence and thermoluminescence dosimeter) required by 19.20 in accordance with Reference to specific types of dosimeters is removed for 162 Part 4, Section 4.46 until the Department terminates the license; consistency with the proposed change in Section 19.20. The proposed change will also make the language consistent with 10 CFR Part 36.81(e).
163 * *
- 164 19.28.1.13 Records related to decommissioning of the irradiator as required by Part 3, 165 Section 3.16.5.
166 Commented [JSJ14]:
Formatted to delete unneeded spaces/gaps in the current rule 167 between 19.28.1.13 and 19.29.
168 19.29 Reports.
169 * *
- 170 [NO FURTHER CHANGES TO THE RULE AFTER THIS POINT]
171 5