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