ML20281A519
| ML20281A519 | |
| Person / Time | |
|---|---|
| Issue date: | 10/01/2020 |
| From: | Michelle Beardsley NRC/NMSS/DMSST |
| To: | |
| Beardsley M | |
| Shared Package | |
| ML20281A277 | List: |
| References | |
| Download: ML20281A519 (109) | |
Text
Document 1 HRG Page 30 of 138 1 DRAFT 2 - 06/04/2020 2 DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT Commented [JJ28]:
EDITORIAL NOTE 1:
3 Hazardous Materials and Waste Management Division These side margin comments as shown here are not part of the rule and are for information only, with the intent to aid the reader in understanding the proposed changes in the draft 4 RADIATION CONTROL - USE OF RADIONUCLIDES IN THE HEALING ARTS regulations. All side margin comments will be removed prior to publication as a final rule and are not part of the rule.
5 6 CCR 1007-1 Part 07 EDITORIAL NOTE 2:
6 [Editors Notes follow the text of the rules at the end of this CCR Document.] Most of the proposed changes in this draft rule are based on the 2018 changes to U.S. Nuclear Regulatory Commission 7 _________________________________________________________________________ (NRC) federal rules in 10 CFR Part 30, 32 and 35. Final NRC regulations may be found at: https://www.nrc.gov/reading-rm/doc-collections/cfr/. Links to specific CFR sections are also 8 Adopted by the Board of Health June 17, 2020, effective date August 14, 2020 provided in the side margin comments for the draft rule.
Additionally, the changes to federal rule are summarized/consolidated in NRC Regulatory Action Tracking 9 PART 7: USE OF RADIONUCLIDES IN THE HEALING ARTS System (RATS) 2018-1 which is referenced in the side margin comments when applicable.
10 USE OF RADIONUCLIDES IN THE HEALING ARTS EDITORIAL NOTE 3:
Throughout the side margin comments for select provisions, 11 Section A - General Information the NRC compatibility category may be listed. Information on NRC compatibility may be found on page 6 of NRC procedure 12
7.1 Purpose and Scope
.Purpose and scope. SA-200 at:
https://scp.nrc.gov/impeptoolbox/impepcompatibility.html.
13 7.1.1 Authority EDITORIAL NOTE 4:
The NRC has issued implementation guidance on the federal 14 Rules and regulations set forth herein are adopted pursuant to the provisions of sections 25 regulations. These may be found at:
https://www.nrc.gov/docs/ML1817/ML18176A377.pdf 15 108, 25-1.5-101(1)(l), and 25-11-104, CRS.
Commented [JSJ29]: Note that adoption and effective dates 16 7.1.2 Basis and Purpose. are tentative and subject to change, pending Board of Health meeting schedule, final adoption of the rule, and the Colorado Register publication dates.
17 A statement of basis and purpose accompanies this part and changes to this part. A copy may be Commented [JSJ30]: Here and throughout the rule, a new 18 obtained from the Department. section headers are added for consistency with the format of 10 CFR 35. For example, 10 CFR 35 has Subpart A. In Part 19 7.1.3 Scope. 7, this is referred to as Section A.
20 This part establishes requirements and provisions for the production, preparation, compounding 21 and use of radionuclides in the healing arts and for issuance of licenses authorizing the medical 22 use of this material. These requirements and provisions provide for the protection of the public 23 health and radiation safety of workers, the general public, patients, and human research subjects.
24 The requirements and provisions of this part are in addition to, and not in substitution for, others 25 in these regulations.
26 7.1.4 Applicability.
27 The requirements and provisions of these regulations apply to applicants and licensees subject to 28 this part unless specifically exempted.
29 7.1.5 Published Mmaterial Iincorporated by Rreference. Commented [JJ31]:
Provisions in section 7.1.5, are revised and amended for consistency with the Colorado Administrative Procedure Act 30 Published material incorporated in Part 7 by reference is available in accord with 1.4.
(24-4-103(12.5)(a)(2), CRS) regarding documents incorporated by reference.
31 7.1.5.1 Throughout this Part 7, federal regulations, state regulations, and standards or 32 guidelines of outside organizations have been adopted and incorporated by reference.
33 Unless a prior version of the incorporated material is otherwise specifically indicated, the 34 materials incorporated by reference cited herein include only those versions that were in
Document 1 HRG Page 31 of 138 35 effect as of the most recent effective date of this Part 7 (August 2020), and not later 36 amendments or editions of the incorporated material.
37 7.1.5.2 Materials incorporated by reference are available for public inspection, and copies 38 (including certified copies) can be obtained at reasonable cost, during normal 39 business hours from the Colorado Department of Public Health and Environment, 40 Hazardous Materials and Waste Management Division, 4300 Cherry Creek Drive 41 South, Denver, Colorado 80246. Additionally, 42 https://www.colorado.gove/cdphe/radregs identifies where the incorporated federal 43 and state regulations are available to the public on the internet at no cost. A copy 44 of the materials incorporated in this Part is available for public inspection at the 45 state publications depository and distribution center.
46 7.1.5.3 Availability from Source Agencies or Organizations.
47 (1) All federal agency regulations incorporated by reference herein are 48 available at no cost in the online edition of the Code of Federal Regulations 49 (CFR) hosted by the U.S. Government Printing Office, online at 50 www.govinfo.gov.
51 (2) All state regulations incorporated by reference herein are available at no 52 cost in the online edition of the Code of Colorado Regulations (CCR) 53 hosted by the Colorado Secretary of States Office, online at 54 https://www.sos.state.co.us/CCR/RegisterHome.do.
55 56 (3) Copies of the standards or guidelines of outside organizations are 57 available either at no cost or for purchase from the source organizations 58 listed below.
59 60 a. The Federal Policy for the Protection of Human 61 Subjects: hhs.gov or https://www.hhs.gov/ohrp/regulations-and-62 policy/regulations/common-rule/index.html or 63 U.S. Department of Health & Human Services 64 200 Independence Avenue, S.W.
65 Washington, D.C.20201 66 Phone: 1-877-696-6775.
67 68 b. NUREG-1556, Vol. 9: nrc.gov or https://www.nrc.gov/reading-rm/doc-69 collections/nuregs/staff/sr1556/ or 70 U.S. Nuclear Regulatory Commission 71 Washington, DC 20555-0001 72 Phone: 1-800-368-5642.
73 7.2 Definitions.
74 As used in this part, these terms have the definitions set forth as follows:
75 Address of use means the building(s) identified on the license where radioactive material may Commented [JJ32]: Definition added, consistent with 2018 76 be produced, prepared, received, used or stored. amendments to 10 CFR Part 35.2 77 Area of use means a portion of an address of use that has been set aside for the purpose of The addition of this definition will specifically permit the 78 producing, preparing, receiving, using, or storing radioactive material. addition of one or more person(s) to serve as an associate to the primary radiation safety officer identified on a specific radioactive material license for medical use, provided they 79 Associate Radiation Safety Officer means, for the purposes of Part 7, an individual who: meet the applicable requirements of Part 7 or are already designated on another Department, NRC or agreement state 80 (1) Meets the requirements in Appendix 7A and 7.65; and license as such.
NRC Compatibility B NRC RATS 2018-1
Document 1 HRG Page 32 of 138 81 (2) Is currently identified as an Associate Radiation Safety Officer for the types 82 of use of radioactive material for which the individual has been assigned 83 duties and tasks by the Radiation Safety Officer on:
84 a. A specific medical use license issued by the Department, NRC or an 85 Agreement State; 86 b. A medical use permit issued by an NRC master material licensee.
87 Authorized medical physicist (AMP) means an individual who meets the requirements of 88 Appendix 7B; or 89 (1) Is identified as an authorized medical physicist or teletherapy physicist on:
90 a. A specific medical license issued by the Department, NRC, or 91 Agreement State; 92 b. A medical use permit issued by an NRC master material license; 93 c. A permit issued by an NRC or Agreement State broad scope medical 94 use licensee; or 95 d. A permit issued by an NRC master material license broad scope medical 96 use license 97 Authorized nuclear pharmacist (ANP) means a pharmacist who meets the requirements of 98 Appendix 7C; or 99 (1) Is identified as an authorized nuclear pharmacist on:
100 a. A specific license issued by the Department, NRC, or Agreement State 101 that authorizes medical use or the practice of nuclear pharmacy; 102 b. A permit issued by an NRC master material license that authorizes 103 medical use or the practice of nuclear pharmacy; 104 c. A permit issued by an NRC or Agreement State broad scope medical 105 use licensee that authorizes medical use or the practice of nuclear 106 pharmacy; or 107 d. A permit issued by an NRC master material license broad scope medical 108 use permitee that authorizes medical use or the practice of nuclear 109 pharmacy; or 110 (2) Is identified as an authorized nuclear pharmacist by a commercial nuclear 111 pharmacy that has been authorized to identify authorized nuclear pharmacists; or 112 (3) Is designated as an authorized nuclear pharmacist in accordance with Part 3.
113 Authorized user (AU) means a physician, dentist, or podiatrist who meets the applicable 114 requirements of Appendix 7D through Appendix 7M; or 115 (1) Is identified as an authorized user on:
116 a. A Department, NRC, or Agreement State license that authorizes the 117 medical use of radioactive material;
Document 1 HRG Page 33 of 138 118 b. A permit issued by an NRC master material license that is authorized to 119 permit the medical use of radioactive material; 120 c. A permit issued by an NRC or Agreement State specific licensee of 121 broad scope that is authorized to permit the medical use of radioactive 122 material; or 123 d. A permit issued by an NRC master material license broad scope 124 permitee that is authorized to permit the medical use of radioactive 125 material.
126 Brachytherapy means a method of radiation therapy in which plated, embedded, activated, or 127 sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by 128 surface, intracavitary, intraluminal or interstitial application.
129 Brachytherapy source means a radioactive source or a manufacturer-assembled source train or 130 a combination of these sources that is designed to deliver a therapeutic dose within a distance of 131 a few centimeters.
132 Client means, for mobile medical service, the person for whom, or in conjunction with whom, 133 medical service is provided.
134 Client's address means the address of use for the purpose of providing mobile medical service 135 in accordance with 7.27.
136 Dedicated check source means a radioactive source that is used to assure the consistent 137 response of a radiation detection or measurement device over several months or years.
138 Dentist means an individual licensed by a State or Territory of the United States, the District of 139 Columbia or the Commonwealth of Puerto Rico to practice dentistry.
140 Diagnostic clinical procedures manual means a collection of written procedures that describes 141 each method (and other instructions and precautions) by which the licensee performs diagnostic 142 clinical procedures; where each diagnostic clinical procedure has been approved by the 143 authorized user and includes the radiopharmaceutical, dosage, and route of administration, or in 144 the case of sealed sources for diagnosis, the procedure.
145 HDR, see high dose-rate remote afterloader.
146 High dose-rate remote afterloader (HDR) means a device that remotely delivers a dose rate in 147 excess of 12 gray (1200 rad) per hour at the treatment site.
148 LDR, see low dose-rate remote afterloader.
149 Low dose-rate remote afterloader (LDR) means a device that remotely delivers a dose rate of 150 less than or equal to 2 gray (200 rad) per hour at the treatment site (at the specified distance).
151 Management means the chief executive officer, or other individual having the authority to 152 manage, direct, or administer the licensee's activities, or such person's' delegate(s).
153 Manual brachytherapy means a type of therapy in which brachytherapy sources are manually 154 applied or inserted.
155 MDR, see medium dose-rate remote afterloader.
156 Medical institution means an organization in which two or more medical disciplines are 157 practiced.
Document 1 HRG Page 34 of 138 158 Medical event means an event that meets the criteria in 7.21.1 or 7.21.2. Commented [JSJ33]: For consistency with NRC language in 10 CFR Part 35, medical event replaces the current misadministration term here and throughout the rule.
159 Medical use means, for the purposes of Part 7, the intentional internal or external administration 160 of radioactive material or the radiation from radioactive material to patients or human research 161 subjects under the supervision of an authorized user.
162 Medium dose-rate remote afterloader (MDR) means a brachytherapy device that remotely Commented [JJ34]: Updated for consistency with same 163 delivers a dose rate of greater than 2 gray (200 rads) per hour, but less than, or equal to, 12 gray definition in 10 CFR 35.2.
164 (1200 rads) per hour at the treatment site (at the specified distance)point or surface where the Compatibility D.
165 dose is prescribed.
166 Misadministration means an event that meets the criteria in 7.21. Commented [JSJ35]: This term is deleted here and is replaced by medical event, consistent with the terminology of 167 Mobile medical service means the transportation of radioactive material to, or its medical use at, 10 CFR 35.
168 the clients address and/or a temporary job site.
169 Nuclear medicine technologist (NMT) means an individual who meets the requirements of 170 Appendix 7N and who under the supervision of an authorized user prepares or administers 171 radioactive drugs to patients or human research subjects, or performs in vivo or in vitro 172 measurements for medical purposes.
173 Nuclear medicine technology means the science and art of in vivo and in vitro detection and 174 measurement of radioactivity and the administration of radioactive drugs to patients or human 175 research subjects for diagnostic and therapeutic purposes.
176 Ophthalmic physicist means an individual who: Commented [JJ36]: Definition for Ophthalmic physicist added, consistent with 2018 amendments to 10 CFR Part 177 (1) Meets the requirements in 7.41.6.1(2) and 7.65; and 35.2.
The addition of this definition will specifically permit the 178 (2) Is identified as an ophthalmic physicist on a: addition of person(s) to serve as an ophthalmic physicist provided they meet the applicable requirements of Part 7 or are already designated on another Department, NRC or 179 a. Specific medical use license issued by the Department, NRC or an agreement state license for such use.
180 Agreement State; NRC Compatibility B 181 b. Permit issued by the Department, NRC or Agreement State broad NRC RATS 2018-1 182 scope medical use licensee; 183 c. Medical use permit issued by a NRC master material licensee; or 184 d. Permit issued by a NRC master material licensee broad scope 185 medical use permittee.
186 Output means the exposure rate, dose rate, or a quantity related in a known manner to these 187 rates, from a brachytherapy source, or a teletherapy, remote afterloader, or gamma stereotactic 188 radiosurgery unit, for a specified set of exposure conditions.
189 Patient intervention means actions by the patient or human research subject, whether 190 intentional or unintentional, such as dislodging or removing treatment devices or prematurely 191 terminating the administration.
192 PDR, see pulsed dose-rate remote afterloader.
193 Pharmacist means an individual licensed by a State or Territory of the United States, the District 194 of Columbia or the Commonwealth of Puerto Rico to practice pharmacy. (See also Authorized 195 nuclear pharmacist)
Document 1 HRG Page 35 of 138 196 Physician means an individual licensed by a State or Territory of the United States, the District 197 of Columbia or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine.
198 Podiatrist means an individual licensed by a State or Territory of the United States, the District 199 of Columbia or the Commonwealth of Puerto Rico to practice podiatry.
200 Preceptor means an individual who provides, directs or verifies training and experience required Commented [JJ37]: Definition updated, consistent with 201 for an individual to become an authorized user, an authorized medical physicist, an 2018 amendments to 10 CFR Part 35.2.
202 authorized nuclear pharmacist, a Radiation Safety Officer, an Associate Radiation Safety The changes to this definition incorporate the Associate 203 Officera radiation safety officer, an authorized user, an authorized medical physicist, an Radiation Safety Officer term as defined earlier in this section.
204 authorized nuclear pharmacist, a nuclear medicine technologist, or a radiation therapy 205 technologist (see appendices 7A through 7O7M, and 7P). The reference to preceptors for nuclear medicine technologists is removed as this term is proposed for removal from Appendix 7N. The reference to preceptors for radiation 206 Prescribed dosage means the specified activity or range of activity of a radioactive drug as therapy technologists is excluded since that term is only used 207 documented in: in Appendix 7O which is proposed for deletion (in its entirety).
NRC Compatibility D 208 (1) A written directive as specified in 7.11; or NRC RATS 2018-1 209 (2) Accordance with the directions of the authorized user for procedures performed 210 pursuant to 7.30, 7.32, or 7.36.
211 Prescribed dose means:
212 (1) For gamma stereotactic radiosurgery, the total dose as documented in the written 213 directive; 214 (2) For teletherapy, the total dose and dose per fraction as documented in the 215 written directive; 216 (3) For manual brachytherapy, either the total source strength and exposure time or 217 the total dose, as documented in the written directive; or 218 (4) For remote brachytherapy afterloaders, the total dose and dose per fraction as 219 documented in the written directive.
220 Pulsed dose-rate remote afterloader (PDR) means a special type of remote afterloading device 221 that uses a single source capable of delivering dose rates (at the specified distance) in the high 222 dose-rate range, but:
223 (1) Is approximately one-tenth of the activity of typical high dose-rate remote 224 afterloader sources; and 225 (2) Is used to simulate the radiobiology of a low dose rate treatment by inserting the 226 source for a given fraction of each hour.
227 Radiation safety officer (RSO) means, for the purposes of Part 7, an individual who has 228 demonstrated sufficient knowledge to apply radiation protection regulations appropriately, who in 229 accord with 7.7 has been assigned such responsibility by the licensee, and who meets the 230 requirements in Appendix 7A; or 231 (1) Is identified as a Radiation Safety Officer on:
232 a. A specific medical use license issued by the Department, NRC, or 233 Agreement State; or 234 b. A medical use permit issued by an NRC master material licensee.
Document 1 HRG Page 36 of 138 235 Radiation therapy technologist (RTT) means an individual who meets the requirements of Commented [JSJ38]:
236 Appendix 7O and is under the supervision of an authorized user to perform procedures and apply This definition is proposed for deletion as it is not used in the 237 radiation emitted from sealed radioactive sources to human beings for therapeutic purposes. body of the rule, nor is it being used during licensing and compliance activities by the radiation program. The term is used in Appendix 7O, which is also proposed for deletion.
238 Radiation therapy technology means the science and art of applying radiation emitted from 239 sealed radioactive sources to patients or human research subjects for therapeutic purposes. The term does not appear in 10 CFR 35.
(The term originated from SSRCR Part Z (2012).
240 Radioactive drug means any chemical compound containing radioactive material that may be 241 used on or administered to patients or human research subjects as an aid in the diagnosis, Commented [JSJ39]:
This definition is not used in the body of the rule nor is it used 242 treatment, or prevention of disease or other abnormal condition. in 10 CFR 35.
243 Sealed source means radioactive material that is permanently bonded or fixed in a capsule or 244 matrix designed to prevent release and dispersal of the radioactive material under the most 245 severe conditions which are likely to be encountered in normal use and handling.
246 Sealed Source and Device Registry means the national registry that contains the registration 247 certificates maintained by the Nuclear Regulatory Commission, that summarize the radiation 248 safety information for the sealed sources and devices and describe the licensing and use 249 conditions approved for the product.
250 Stereotactic radiosurgery means the use of external radiation in conjunction with a stereotactic 251 guidance device to precisely deliver a dose to a treatment site.
252 Structured educational program means an accredited educational program designed to impart 253 particular knowledge and practical education through interrelated studies and supervised training.
254 Teletherapy, as used in this part, means a method of radiation therapy in which collimated 255 gamma rays are delivered at a distance from the patient or human research subject.
256 Temporary job site, as used in Part 7, means a location where mobile medical services are 257 confined to the mobile unit not at a licensed address of use.
258 Therapeutic dosage means a dosage of unsealed radioactive material that is intended to deliver 259 a radiation dose to a patient or human research subject for palliative or curative treatment.
260 Therapeutic dose means a radiation dose delivered from a sealed source containing radioactive 261 material to a patient or human research subject for palliative or curative treatment.
262 Treatment site means the anatomical description of the tissue intended to receive a radiation 263 dose, as described in a written directive.
264 Trunnion means a support bar sometimes used as a bearing instead of a socket.
265 Type of use means use of radioactive material as specified under 7.30, 7.32, 7.36, 7.40, 7.42, 266 7.48 or 7.62.
267 Unit dosage means a dosage that:
268 (1) Is obtained or prepared in accordance with the regulations for uses described in 269 7.30, 7.32, or 7.36; and 270 (2) Is to be administered as a single dosage to a patient or human research subject 271 without any further manipulation of the dosage after it is initially prepared.
272 Written directive means an authorized user's written order for the administration of radioactive 273 material or radiation from radioactive material to a specific patient or human research subject, as 274 specified in 7.11.
Document 1 HRG Page 37 of 138 275 GENERAL REGULATORY REQUIREMENTS 276 7.3 License Required.License required.
277 7.3.1 Commented [JSJ40]: 7.3.1 is updated/realigned for consistency with the format and content of 10 CFR 35.11.
278 7.3.1.1 A person shallmay manufacture, produce, prepare, acquire, receive, possess, prepare,
[NON-RATS ITEM]
279 use, or transfer radioactive material for medical use only in accordance with a specific 280 license issued by the Department, an Agreement State or NRC, or as allowed in 7.3.1.1 281 or 7.3.1.2.
282 7.3.1.2 A specific license is not needed for an individual who:
283 7.3.1.(1) Unless prohibited by license condition, an individual may rReceives, 284 possess, uses, or transfers radioactive material in accordance with the 285 regulations in this part under the supervision of an authorized user as provided in 286 7.10, unless prohibited by license condition.; or 287 7.3.1.(2) Unless prohibited by license condition, an individual may pPrepares 288 unsealed radioactive material for medical use in accordance with the regulations 289 in this part under the supervision of an authorized nuclear pharmacist or 290 authorized user as provided in 7.10, unless prohibited by license condition.
291 7.3.2 Provisions for the protection of Human Research Subjects.
292 A licensee may conduct research involving human subjects using radioactive material under the 293 following conditions:
294 7.3.2.1 For research conducted, funded, supported, or regulated by a federal agency which has 295 implemented The Federal Policy for the Protection of Human Subjects (Federal Policy),
296 the licensee shall:
297 (1) Obtain prior informed consent from the human research subjects; and 298 (2) Obtain prior review and approval of the research activities by an Institutional 299 Review Board in accordance with the meaning of these terms as defined and 300 described in the Federal Policy; or 301 7.3.2.2 For research not conducted, funded, supported, or regulated by a federal agency which 302 has implemented the Federal Policy, then:
303 (1) The licensee shall apply for and receive a specific amendment to its Department 304 license before conducting such research. The amendment request shall include a 305 written commitment that the licensee will, before conducting research:
306 (a). Obtain prior informed consent from the human research subjects; and 307 (b). Obtain prior review and approval of the research activities by an 308 Institutional Review Board in accordance with the meaning of these 309 terms as defined and described in the Federal Policy; 310 7.3.2.3 A licensee not authorized pursuant to 3.11 shall apply for and receive approval of a 311 specific amendment to its Department license before conducting research involving 312 human subjects; 313 7.3.2.4 The research involving human subjects authorized in 7.3.2 shall be conducted using 314 radioactive material authorized for medical use in the license; and
Document 1 HRG Page 38 of 138 315 7.3.2.5 Nothing in 7.3.2 relieves licensees from complying with the other requirements in Part 7.
316 7.3.3 Nothing in this part relieves the licensee from complying with applicable FDA, other federal, and 317 state requirements governing radioactive drugs or devices.
318 7.3.4 Application for Llicense, Aamendment, or Rrenewal. Commented [JSJ41]: 7.3.4 is updated for consistency with the wording of 10 CFR 35.12.
319 7.3.4.1 An application shallmust be signed by the applicant's or licensee's management.
The revised language clarifies what information must be included in the application process, including the newly added 320 7.3.4.2 An application for a new or renewal license for medical use of radioactive material as Associate RSO and Ophthalmic physicist definitions.
321 described in 7.30, 7.32, 7.36, 7.40, 7.42, 7.48 or 7.62 must be made by:
NRC Compatibility D (all provisions within 7.3.4)
NRC RATS 2018-1 322 (1) Filing an original a completed Department Form R-12 (7C) that includes the 323 facility diagram, equipment, and training and experience qualifications of 324 the Radiation Safety Officer, Associate Radiation Safety Officer(s),
325 authorized user(s), authorized medical physicist(s), ophthalmic 326 physicist(s), and authorized nuclear pharmacist(s); and 327 (2) Submitting procedures required by Form R-12 (7C), and 7.12, 7.15, 7.51, 7.58, 328 7.59, and 7.61, as applicable, and other procedures as requested by the 329 Department.
330 7.3.4.3 A request for a license amendment must be made by:
331 (1) Submitting an original amendment request in letter format.
332 (2) Submitting procedures required by 7.12, 7.15, 7.51, 7.58, 7.59, and 7.61, as 333 applicable, and other procedures as requested by the Department.
334 7.3.4.4 In addition to the requirements in 7.3.4.2 and 7.3.4.3, an application for a new license, 335 renewal license, or amendment for medical use of radioactive material as described in 336 7.62 must also include: information regarding any radiation safety aspects of the medical 337 use of the material that is not addressed in 7.1 through 7.29, as well as any specific 338 information on:
Commented [JSJ42]: Note: due to structural differences, 339 (1) Radiation safety precautions and instructions;Any additional aspects of the the Subparts of 10 CFR Part 35 do not exactly parallel the 340 medical use of the material that are applicable to radiation safety that are Sections of Part 7.
341 not addressed in, or differ from: 10 CFR 35.12(d)(1) specifies that the license or amendment application include additional aspects applicable to radiation 342 (a) Section A through C (7.1 through 7.29); safety that are not addressed in subpart A through C, L, and M.
343 (b) Sections D through H (recordkeeping requirements); For reference:
- Subparts A through C of the CFR parallel Part 7 Sections A 344 (c) Section I (7.65); through C.
- Subpart B of the CFR also includes the training requirements of 35.50, 35.51, 35.55, and 35.57. For Part 7, these training 345 (d) Appendix 7A, 7B, 7C and 7P; requirements are found in Appendices 7A, 7B, 7C, and 7P, and are called out separately.
346 (2) Training and experience of proposed users; - Subpart B of the CFR also includes the recentness of training requirements of 35.59 which is found in Section 7I (provision 7.65).
347 (2) Identification of and commitment to follow the applicable radiation safety - Subpart L of the CFR contains the recordkeeping 348 program requirements in Sections D through H that are appropriate for the requirements which are found in Sections D through H of Part 349 specific 7.62 medical use; 7.
-Subpart M of the CFR contains the reporting requirements which are contained within Sections C through D of Part 7.
350 (3) Any additional specific information on:
NRC Compatibility D 351 (a) Radiation safety precautions and instructions; Commented [JSJ43]: Subparts D through H as referenced in the equivalent requirement of 10 CFR 35.12(d)(2) parallel the requirements of Section D through H of Part 7.
Document 1 HRG Page 39 of 138 352 (3) (b) Methodology for measurement of dosages or doses to be 353 administered to patients or human research subjects; and 354 (4) (c) Calibration, maintenance, and repair of instruments and 355 equipment necessary for radiation safety.; and 356 (4) Any other information requested by the Department in its review of 357 the application.
358 7.3.4.5 The applicant or licensee shall also provide any other information requested by the Commented [JSJ44]: Provision replaced by revised 359 Department in its review of the application. 7.3.4.4(4).
360 7.3.4.65 An applicant that satisfies the requirements specified in 3.11 may apply for a 361 Type A specific license of broad scope.
362 7.3.5 Mobile Medical Service Administrative Requirements.
363 7.3.5.1 The Department shall license mobile medical services or clients of such services. The 364 mobile medical service shall be licensed if the service receives, uses or possesses 365 radioactive material. The client of the mobile medical service shall be licensed if the client 366 receives or possesses radioactive material to be used by a mobile medical service.
367 7.3.5.2 Mobile medical service licensees shall obtain a letter signed by the management of each 368 location where services are rendered that authorizes use of radioactive material at the 369 client's address of use. This letter shall clearly delineate the authority and responsibility of 370 both the client and the mobile medical service. If the client is licensed, the letter shall 371 document procedures for notification, receipt, storage and documentation of transfer of 372 radioactive material delivered to the client's address for use by the mobile medical 373 service.
374 7.3.5.3 A mobile medical service shall not have radioactive material delivered directly from the 375 manufacturer or the distributor to the client, unless the client has a license allowing 376 possession of the radioactive material. Radioactive material delivered to the client shall 377 be received and handled in conformance with the client's license.
378 7.3.5.4 A mobile medical service shall inform the client's management who is on site at each 379 client's address of use at the time that radioactive material is being administered.
380 7.3.5.5 A licensee providing mobile medical services shall retain the letter required in 7.3.5.2 for 381 3 years after the last provision of service.
382 7.3.5.6 A mobile medical service licensee shall, at a minimum, maintain the following documents 383 on each mobile unit:
384 (1) The current operating and emergency procedures; 385 (2) A copy of the license; 386 (3) Copies of the letter required by 7.3.5.2; 387 (4) Current calibration records for each survey instrument and diagnostic equipment 388 or dose delivery device in use; and 389 (5) Survey records covering uses associated with the mobile unit during, at a 390 minimum, the preceding 30 calendar days.
Document 1 HRG Page 40 of 138 391 7.3.5.7 The mobile medical service shall designate and manage each area of use in the clients 392 facility as a restricted area while radioactive material is present. For each location where 393 radioactive materials will be routinely used, the licensee shall provide to the Department:
394 (1) A diagram of the location of use, including information about the placement of 395 required postings; and 396 (2) Calculation(s) or survey(s) results that demonstrate compliance with applicable 397 dose limits in 4.14 and 4.15 at the location of use.
398 7.3.5.8 The mobile medical service shall ensure that:
399 (1) Supervision by an authorized user is in accordance with 7.10.1; 400 (2) Radiation exposures to the clients personnel working in the client facility are:
401 (a) Below the dose limits to members of the public listed in 4.14; or 402 (b) The client's personnel are instructed as described in 10.3 and monitored 403 for exposure in accordance with 4.18 unless the licensee can 404 demonstrate that 4.18 does not apply.
405 7.3.5.9 A mobile medical service licensee shall maintain all records required by Parts 4 and 7 of 406 these regulations at a location within the Department's jurisdiction that is:
407 (1) A single address of use:
408 (a) Identified as the records retention location; and 409 (b) Staffed at all reasonable hours by individual(s) authorized to provide the 410 Department with access for purposes of inspection; or 411 (2) When no address of use is identified on the license for records retention, the 412 mobile unit:
413 (a) Identified in the license; and 414 (b) Whose current client's address of use and area of use schedule is 415 reported to the Department.
416 7.3.6 A licensee possessing a Type A specific license of broad scope for medical use, issued under Commented [JJ45]: Section updated for consistency with 417 Part 3 of these regulations is exempt from: 2018 amendments to 10 CFR 35.15.
NRC Compatibility D (all of 10 CFR 35.15) 418 7.3.6.1 The provisions of 7.3.4.4 regarding the need to file an amendment to the license for 419 medical uses of radioactive material as described in 7.62; 420 7.3.6.2 The provisions of 7.4.2 regarding the need to file an amendment before permitting 421 anyone to work as an authorized user, an authorized nuclear pharmacist or an authorized 422 medical physicist under the license; 423 7.3.6.3 The provisions of 7.4.5 regarding additions to or changes in the areas of use at the Commented [JJ46]: Updated for consistency with 10 CFR 424 addresses specifiedidentified in the application or onin the license; 35.15(c).
425 7.3.6.4 The provisions of 7.5.1 regarding notification to the Department for new authorized users, 426 new authorized nuclear pharmacists and new authorized medical physicists;
Document 1 HRG Page 41 of 138 427 7.3.6.5 The provisions of 7.5.2.1 for an authorized user, an authorized nuclear pharmacist, Commented [JJ47]: Added for consistency with 10 CFR 428 an authorized medical physicist or an ophthalmic physicist; 35.15(e).
429 7.3.6.6 The provisions of 7.5.2.5; and Commented [JJ48]: Added for consistency with 10 CFR 35.15(f).
430 7.3.6.57 The provisions of 7.14 regarding suppliers for sealed sources.
431 7.3.7 The Department may, upon application of any interested person or upon its own initiative, grant 432 such exemptions from the regulations in Part 7 as it determines are authorized by law and will not 433 endanger life or property or the common defense and security and are otherwise in the public 434 interest.
435 7.4 License Aamendments. Commented [JSJ49]: Language updates in section 7.4 are made consistent with 2018 changes to 10 CFR Part 35.13.
436 A licensee shall apply for and shall have received must receive a license amendment before the The recent revisions to 10 CFR Part 35 and this section apply 437 licensee: the ophthalmic physicist designation.
438 7.4.1 Before it receivesReceives, prepares, or uses radioactive material for a type of use that is NRC Compatibility D NCR RATS 2018-1 439 permitted under this part but that is not authorized on the licensees current license issued 440 pursuant tounder this part; 441 7.4.2 Before it permitsPermits anyone to work as an authorized user, authorized medical physicist, 442 ophthalmic physicist, or an authorized nuclear pharmacist under the license, except: in 443 accordance with the training and experience requirements specified in:
444 7.4.2.1 Appendix 7D through Appendix 7M for an authorized user for a specific type of use of Commented [JSJ50]: For cross reference to 10 CFR 35:
445 radioactive material;For an authorized user, an individual who meets the 446 requirements in Appendix 7P and one or more of the following: Section 7D1 of - 7.65 = 10 CFR 35.59 (recentness of training)
- App 7D = 10 CFR 35.190 (uptake, dilution, excretion) 447 Appendix D, Section 7E1 of Appendix E, Section 7F1 of Appendix F, Section 7G1 of - App 7E = 10 CFR 35.290 (imaging and localization) 448 Appendix 7G, Section 7H1 of Appendix 7H, Section 7K1 of Appendix K, Section 7J1 - App 7F = 10 CFR 35.390 (unsealed - written dir. req) 449 of Appendix J, or Section 7M1 of Appendix M; - App 7G = 10 CFR 35.392 (I-131 < 33 mCi)
- App 7H= 10 CFR 35.394 (I-131 > 33 mCi)
- App 7K = 10 CFR 35.490 (manual brachytherapy) 450 7.4.2.2 Appendix 7B for an authorized medical physicist;For an authorized nuclear - App 7J = 10 CFR 35.590 (sources for diagnosis) 451 pharmacist, an individual who meets the requirements in Section 7C1 of Appendix - App 7M = 10 CFR 35.690 (afterloaders, GSR) 452 7C and 7.65; Commented [JSJ51]:
453 7.4.2.3 Appendix 7C for an authorized nuclear pharmacist; andFor an authorized medical App 7C = 10 CFR 35.55 (auth nuclear pharmacist) 454 physicist, an individual who meets the requirements in Section 7B1 of Appendix 455 7B and 7.65; Commented [JSJ52]:
App 7B = 10 CFR 35.51 (authorized medical phys) 456 7.4.2.4 An individual who is identified as an authorized user, an authorized nuclear 457 pharmacist, authorized medical physicist, or an ophthalmic physicist on:
458 (1) A NRC or Agreement State license or other equivalent permit or license 459 recognized by the Department that authorizes the use of radioactive 460 material in medical use or in the practice of nuclear pharmacy; 461 (2) A permit issued by a NRC or Agreement State specific license of broad 462 scope that is authorized to permit the use of radioactive material in medical 463 use or in the practice of nuclear pharmacy; 464 (3) On a permit issued by a NRC master material licensee that is authorized to 465 permit the use of radioactive material in medical use or in the practice of 466 nuclear pharmacy; or 467 (4) By a commercial nuclear pharmacy that has been authorized to identify 468 authorized nuclear pharmacists.
Document 1 HRG Page 42 of 138 469 7.4.2.5 A physician, podiatrist, or dentist who used only accelerator-produced radioactive 470 materials, discrete sources of radium-226, or both, for medical uses or a nuclear 471 pharmacist who used only accelerator-produced radioactive materials in the 472 practice of nuclear pharmacy at a Government agency or Federally recognized 473 Indian Tribe before November 30, 2007 or at all other locations of use before 474 August 8, 2009, or an earlier date as noticed by the NRC, and for only those 475 materials and uses performed before these dates.
476 7.4.3 Before it Cchanges a Radiation Safety Officer, except as provided in 7.7.67.7.3; 477 7.4.4 Before it permits anyone to work as an Associate Radiation Safety Officer, or before the Commented [JSJ53]: Added for consistency with 10 CFR 478 Radiation Safety Officer assigns duties to an Associate Radiation Safety Officer that differ 35.13(d).
479 from those for which this individual is authorized on the license; 480 7.4.45 Before it Rreceives radioactive material in excess of the amount or in a different physical or 481 chemical form, or receives a different radionuclide than is authorized on the license; 482 7.4.56 Adds to or changes the area(s) of use or address(es) of use identified in the application or on the 483 license, except as specified in 7.5.2.4; andBefore it adds to or changes the areas of use 484 identified in the application or on the license, including areas used in accordance with 485 either 7.30 or 7.32 if the change includes addition or relocation of either an area where PET 486 radionuclides are produced or a PET radioactive drug delivery line from the PET 487 radionuclide/PET radioactive drug production area. Other areas of use where radioactive 488 material is used only in accordance with either 7.30 or 7.32 are exempt; 489 7.4.7 Before it changes the address(es) of use identified in the application or on the license; 490 7.4.68 Before it Cchanges statements, representations, and procedures which are incorporated into the 491 license; or 492 7.4.79 Before it Rreleases licensed facilities for unrestricted use.
Commented [JSJ54]:
493 7.4.10 Before it revises procedures required by 7.51, 7.58, 7.59, and 7.61, as applicable, where 7.51 = 10 CFR 35.610 494 such revision reduces radiation safety; and 7.58 = 10 CFR 35.642 7.59 = 10 CFR 35.643 495 7.4.11 Before it receives a sealed source from a different manufacturer or of a different model 7.61 = 10 CFR 35.645 496 number than authorized by its license unless the sealed source is used for manual Commented [JJ55]: Updated for consistency with 2018 497 brachytherapy, is listed in the Sealed Source and Device Registry, and is in a quantity and amendments to 10 CFR 35.14(a).
498 for an isotope authorized by the license.
The proposed language allows for a 30 day window in which documentation must be provided to the Department.
499 7.5 Notifications and maintenance of records. Consistent with 7.4.2, certain individuals may work under the license prior to the licensee providing the necessary documentation.
500 7.5.1 A licensee shall provide to the Department required documentation of adequate radiation safety 501 training and experience under Appendix 7B for each authorized medical physicist pursuant to NRC Compatibility D 502 7.4.2, under Appendix 7C for each authorized nuclear pharmacist, and under the applicable Commented [JSJ56]: 7.4.2 = 10 CFR 35.13(b) 503 appendix of Appendix 7D through Appendix 7M for each individual authorized user.A licensee 504 shall provide the Department, no later than 30 days after the date that the licensee permits Commented [JJ57]: Added for consistency with 10 CFR 505 an individual to work under the provisions of 7.4.2 as an authorized user, authorized 35.14(a)(1).
506 medical physicist, ophthalmic physicist, or authorized nuclear pharmacist: 7.5.1.1(1) = 35.14(a)(1)(i) 7.5.1.1(2) = 35.14(a)(1)(ii) 507 7.5.1.1 A copy of the board certification and, as appropriate, verification of completion of: 7.5.1.1(3) = 35.14(a)(1)(iii)
NRC Compatibility D 508 (1) Training for the authorized medical physicist under 7B3 of Appendix 7B; CROSS
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509 (2) Any additional case experience required in 7F2.1(2)(f) of Appendix 7F for an 7B3 = 10 CFR 35.51(c) 7F2.1(2)(f) = 10 CFR 35.390(b)(1)(ii)(G) 510 authorized user under 7.36; or 7.36 = 10 CFR 35.300 7M3 = 10 CFR 35.690(c) 7.48 = 10 CFR 35.600
Document 1 HRG Page 43 of 138 511 (3) Device specific training in 7M3 of Appendix 7M for the authorized user 512 under 7.48; or 513 7.5.1.2 A copy of the Department, NRC or Agreement State license, the permit issued by a Commented [JJ58]: Added for consistency with 10 CFR 514 NRC master material licensee, the permit issued by a NRC or Agreement State 35.14(a)(2) 515 licensee of broad scope, the permit issued by a NRC master material license broad NRC Compatibility D 516 scope permittee, or documentation that only accelerator-produced radioactive 517 materials, discrete sources of radium-226, or both, were used for medical use or in 518 the practice of nuclear pharmacy at a Government agency or Federally recognized 519 Indian Tribe before November 30, 2007, or at all other locations of use before 520 August 8, 2009, or an earlier date as noticed by the NRC for each individual whom 521 the licensee permits to work under the provisions of this section.
522 7.5.2 A licensee shall notify the Department in writing withinno later than 30 days after: Commented [JJ59]: Updated for consistency with 10 CFR 35.14(b).
523 7.5.2.1 An authorized user, anauthorized medical physicist authorized nuclear pharmacist, a 524 Radiation Safety Officer, an Associate Radiation Safety Officer, an authorized NRC Compatibility D 525 nuclear pharmacistmedical physicist, or Radiation Safety Officerophthalmic physicist 526 permanently discontinues performance of duties under the license or has a name 527 change; 528 7.5.2.2 The licensee permits an individual qualified to be a Radiation Safety Officer under Commented [JSJ60]:
529 Appendix 7A and 7.65 to function as a temporary Radiation Safety Officer and to CROSS
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530 perform the functions of a Radiation Safety Officer in accordance with 7.7.6. 7A = 35.50 7.65 = 35.59 7.7.6 = 35.24(c) 531 7.5.2.23 The licensee's mailing address changes; 532 7.5.2.34 The licensee's name changes, but the name change does not constitute a 533 transfer of control of the license as described in 3.15.2 of these regulations; or 534 7.5.2.45 The licensee has added to or changed the areas of use identified in the 535 application or on the license where radioactive material is used in accordance 536 with either 7.30 andor 7.32 if the change does not include addition or 537 relocation of either an area where PET radionuclides are produced or a PET 538 radioactive drug delivery line from the PET radionuclide/PET radioactive 539 drug production area.; or 540 7.5.2.6 The licensee obtains a sealed source for use in manual brachytherapy from a Commented [JSJ61]: CROSS
REFERENCE:
541 different manufacturer or with a different model number than authorized by its 7.4.11 = 10 CFR 35.13(i) 542 license for which it did not require a license amendment as provided in 7.4.11. The 543 notification must include the manufacturer and model number of the sealed 544 source, the isotope, and the quantity per sealed source.
545 7.5.3 The licensee shall submit the documents required in 7.5.1 and 7.5.2 to the Department.
546 7.5.34 Maintenance of Records.
547 Each record required by this part must be legible throughout the retention period specified by 548 each Department regulation. The record may be the original, a reproduced copy, or a microform 549 provided that the copy or microform is authenticated by authorized personnel and the microform 550 is capable of producing a clear copy throughout the required retention period. The record may 551 also be stored in electronic media with the capability for producing legible, accurate, and 552 complete records during the required retention period. Records such as letters, drawings, and 553 specifications must include all pertinent information such as stamps, initials, and signatures. The 554 licensee shall maintain adequate safeguards against tampering with and loss of records.
555 7.6 License Iissuance.
Document 1 HRG Page 44 of 138 556 7.6.1 The Department shall issue a license for the medical use of radioactive material if:
557 7.6.1.1 The applicant has filed Department Form R-12 in accordance with the instructions in 558 7.3.4; 559 7.6.1.2 The applicant has paid any applicable fee; 560 7.6.1.3 The applicant meets the requirements of Part 3 of these regulations; and 561 7.6.1.4 The Department finds the applicant equipped and committed to observe the safety 562 standards established by the Department in these regulations for the protection of the 563 public health and safety.
564 7.6.2 The Department shall issue a license for mobile services if the applicant:
565 7.6.2.1 Meets the requirements in 7.6.1, and in particular 7.3.5; and 566 7.6.2.2 Assures that individuals to whom radioactive drugs or radiation from implants containing 567 radioactive material will be administered may be released following treatment in 568 accordance with 7.26.
569 ADDITIONAL OVERALL REQUIREMENTS 570 Section B - General Administrative Requirements 571 7.7 Authority and Rresponsibilities for the Rradiation Pprotection Pprogram Commented [JSJ62]: Section 7.7 is updated, consistent with 2018 updates to 10 CFR 35.24 572 7.7.1 In addition to the radiation protection program requirements of 4.5 of these regulations, a NRC RATS 2018-1 573 licensee's management mustshall approve in writing:
574 7.7.1.1 Requests for license application, renewal, or amendments before submittal to the 575 Department; 576 7.7.1.2 Any individual before allowing that individual to work as an authorized user, authorized 577 nuclear pharmacist or authorized medical physicist; and 578 7.7.1.3 Radiation protection program changes that do not require a license amendment and are 579 permitted under 7.7. Commented [JJ63]: Provision updated, consistent with 2018 updates to 10 CFR 35.24(b) 580 7.7.2 A licensees management shall appoint a Radiation Safety Officer (RSO), who agrees in writing to The amended language introduces the new Associate 581 be responsible for implementing the radiation safety program. The licensee, through the RSO, Radiation Safety Officer terminology and associated 582 shall ensure that radiation safety activities are being performed in accordance with licensee- requirements.
583 approved procedures and regulatory requirements. A licensees management may appoint, in 584 writing, one or more Associate Radiation Safety Officers (ARSO) to support the RSO. The NRC RATS 2018-1 NRC Compatibility: H&S (7.7.2 / 35.24(b))
585 RSO, with written agreement of the licensees management, must assign the specific 586 duties and tasks to each ARSO. These duties and tasks are restricted to the types of use Commented [JSJ64]: Provision 7.7.3 revised, consistent 587 for which the ARSO is listed on a license. The RSO may delegate duties and tasks to the with 10 CFR 35.24(c). This provision replaces current 7.7.6.
588 ARSO but shall not delegate the authority or responsibilities for implementing the CROSS
REFERENCES:
589 radiation protection program. Appendix 7A = 10 CFR 35.50 7.65 = 10 CFR 35.59 590 7.7.3 For up to 60 days each year, a licensee may permit an individual qualified to be a 7.7.2 = 10 CFR 35.24(b) 591 Radiation Safety Officer, under Appendix 7A and 7.65, to function as a temporary 7.7.5 = 10 CFR 35.24(e) 592 Radiation Safety Officer and to perform the functions of a Radiation Safety Officer, as 7.7.6 = 10 CFR 35.24(g) 593 provided in 7.7.6, if the licensee takes the actions required in 7.7.2, 7.7.5, 7.7.6, and 7.7.7 7.7.7 = 10 CFR 35.24(h) 594 and notifies the Department in accordance with 7.5.2. 7.5.2 = 10 CFR 35.35.14(b)
NRC RATS 2018-1 NRC Compatibility: D (7.7.3 / 35.24(c))
Document 1 HRG Page 45 of 138 595 7.7.4 A licensee may simultaneously appoint more than one temporary Radiation Safety Officer Commented [JSJ65]: Provision 7.7.4 added, consistent with 596 in accordance with 7.7.3, if needed to ensure that the licensee has a temporary Radiation 10 CFR 35.24(d). This provision was previously omitted from 597 Safety Officer that satisfies the requirements to be a Radiation Safety Officer for each of Colorado rule.
598 the different types of uses of byproduct material permitted by the license. CROSS
REFERENCE:
7.7.3 = 10 CFR 35.24(c) 599 7.7.35 A licensee shall establish in writing the authority, duties, and responsibilities of the Radiation Commented [JSJ66]: Language revised for consistency 600 Safety Officer, and of the Alternate RSO, if required.A licensee shall establish the authority, with the phrasing of 10 CFR 35.24(e). No change in 601 duties, and responsibilities of the Radiation Safety Officer in writing. requirements.
NRC Compatibility D 602 7.7.46 A licensee shall provide the Radiation Safety Officer sufficient authority, organizational freedom, 603 time, resources, and management prerogative, to:
604 7.7.46.1 Identify radiation safety problems; 605 7.7.46.2 Initiate, recommend, or provide corrective actions; 606 7.7.46.3 Stop unsafe operations; and 607 7.7.46.4 Verify implementation of corrective actions.
608 7.7.5 A license shall retain a record of actions taken pursuant to 7.7.1, 7.7.2 and 7.7.3 for 5 years, Commented [JSJ67]: This provision has been replaced by 609 including: new 7.7.7.
NRC Compatibility D 610 7.7.5.1 A summary of the actions taken (and a signature of licensee management) in accordance 611 with 7.7.1; 612 7.7.5.2 A signed copy of the RSOs agreement (including the signature of the RSO and licensee 613 management) to be responsible for implementing the radiation safety program, as 614 required by 7.7.2; and 615 7.7.5.3 A current copy of the authorities, duties and responsibilities of the RSO as required by 616 7.7.3.
617 7.7.7 A licensee shall retain a record of actions taken under 7.7.1, 7.7.2, and 7.7.5 as follows: Commented [JSJ68]: This provision combines the 618 Records of authority and responsibilities for radiation protection programs. requirements found in 10 CFR 35.24(h) and 10 CFR 35.2024.
Provision 7.7.7.3 is new to 10 CFR 35 as a result of the 2018 619 7.7.7.1 A licensee shall retain a record of actions taken by the licensee's management in CFR changes, and addresses the recordkeeping requirements 620 accordance with 7.7.1 for 5 years. The record must include a summary of the pertaining to the (new) Associate Radiation Safety Officer 621 actions taken and a signature of licensee management. position.
622 7.7.7.2 The licensee shall retain a copy of both authority, duties, and responsibilities of NRC RATS 2018-1 623 the Radiation Safety Officer as required by 7.7.5, and a signed copy of each NRC Compatibility D 624 Radiation Safety Officer's agreement to be responsible for implementing the CROSS
REFERENCES:
625 radiation safety program, as required by 7.7.2, for the duration of the license. The 7.7.1 = 10 CFR 35.24(a) 626 records must include the signature of the Radiation Safety Officer and licensee 7.7.2 = 10 CFR 35.24(b) 627 management. 7.7.5 = 10 CFR 35.24(e) 628 629 7.7.7.3 For each Associate Radiation Safety Officer appointed under 7.7.2, the licensee 630 shall retain, for 5 years after the Associate Radiation Safety Officer is removed 631 from the license, a copy of the written document appointing the Associate 632 Radiation Safety Officer signed by the licensee's management.
633 7.7.6 For up to sixty days each year, a licensee may permit an authorized user or an individual qualified Commented [JJ69]: This provision is replaced by NEW 634 to be a radiation safety officer to function as a temporary Radiation Safety Officer and to perform 7.7.3 (above).
635 the functions of a Radiation Safety Officer, as provided in 7.7.4, provided the licensee takes the 636 actions required in 7.7.2, 7.7.3, 7.7.4 and 7.7.5.
Document 1 HRG Page 46 of 138 637 A licensee may simultaneously appoint more than one temporary RSO, if needed, to ensure that Commented [JSJ70]: This provision is replaced by NEW 638 the licensee has a temporary RSO that satisfies the requirements to be an RSO for each of the 7.7.4 (above).
639 different uses of radioactive material permitted by the license.
640 7.8 Radiation Ssafety Ccommittee.
641 7.8.1 Licensees that are authorized for one or more different types of radioactive material use under 642 7.36, 7.42, 7.48, or 7.62 shall establish a Radiation Safety Committee to oversee all uses of 643 radioactive material permitted by the license.
644 7.8.2 The Committee shall:
645 7.8.2.1 Include:
646 (1) An authorized user of each type of use permitted by the license; 647 (2) The Radiation Safety Officer 648 (3) A representative of the nursing service 649 (4) A representative of management who is neither an authorized user nor a 650 Radiation Safety Officer; and 651 (5) Other members as the licensee deems appropriate.
652 7.8.2.2 Meet as necessary, but at a minimum shall meet at intervals not to exceed 6 months.
653 7.8.2.3 Maintain minutes of each meeting, including:
654 (1) The date of the meeting; 655 (2) Members present; 656 (3) Members absent; and 657 (4) Summary of deliberations and discussions.
658 7.9 Radiation Pprotection Pprogram Cchanges.
659 7.9.1 A licensee may revise its radiation protection program without Department approval if:
660 7.9.1.1 The revision does not require an amendment under 7.4; 661 7.9.1.2 The revision is in compliance with the regulations and the license; 662 7.9.1.3 The revision has been reviewed and approved by the Radiation Safety Officer, licensee 663 management and licensee's Radiation Safety Committee (if applicable); and 664 7.9.1.4 The affected individuals are instructed on the revised program before the changes are 665 implemented.
666 7.9.2 A licensee shall retain a record of each change for 5 years, including 667 7.9.2.1 A copy of the old and new procedures; 668 7.9.2.2 The effective date of the change; and
Document 1 HRG Page 47 of 138 669 7.9.2.2 The signature of the licensee management that reviewed and approved the change.
670 7.10 Supervision.
671 7.10.1 A licensee that permits the receipt, possession, use, or transfer of radioactive material by an Commented [JJ71]: Updated to correct prior cross-672 individual under the supervision of an authorized user as allowed by 7.3.27.3.1.2(1) shall: reference and typographical errors and align with the renumbering of section 7.3.1. Formatting and alignment corrections are also made to this section.
673 7.10.1.1 In addition to the requirements of 10.3 of these regulations, instruct the 674 supervised individual in the licensee's written radiation protection procedures, 675 written directive procedures, regulations of Part 7, and license conditions with 676 respect to the use of radioactive material; and; 677 7.10.1.2 Require the supervised individual to follow the instructions of the supervising 678 authorized user for medical uses of radioactive material, written radiation 679 protection procedures, written directive procedures, regulations of Part 7, and 680 license conditions with respect to the medical use of radioactive material.
681 7.10.2 A licensee that permits the preparation of radioactive material for medical use by an individual Commented [JJ72]: Updated to correct a prior cross-682 under the supervision of an authorized nuclear pharmacist or physician who is an authorized reference error and align with the renumbering of section 683 user, as allowed by 7.3.37.3.1.2(2), shall: 7.3.1.
684 7.10.2.1 In addition to the requirements of 10.3, instruct the supervised individual in the 685 preparation of radioactive material for medical use, as appropriate to that 686 individual's use of radioactive material; and 687 7.10.2.2 Require the supervised individual to follow the instructions of the supervising 688 authorized user or authorized nuclear pharmacist regarding the preparation of 689 radioactive material for medical use, the written radiation protection procedures, 690 the regulations of Part 7, and license conditions.
691 7.10.3 Unless physical presence as described in other sections of Part 7 is required, a licensee who Commented [JSJ73]:
692 permits supervised activities under 7.10.1 and 7.10.2 shall require an authorized user to be This is a new proposed requirement intended to strengthen the requirements for persons who most often administer 693 immediately available by telephone within ten minutes to communicate with the supervised radioactive materials or radiation to patients while under the 694 individual, unless otherwise authorized by the Department with prior written approval. supervision of an authorized user physician named on the license. Such individuals may include physicians who may be 695 7.10.4 A licensee who permits supervised activities under 7.10.1 and 7.10.2 is responsible for the acts training on a particular type of use and are not yet named as authorized users on a license for that material; authorized 696 and omissions of the supervising authorized user and supervised individual(s). medical physicists; and nuclear medicine technologists.
697 7.10.5 A licensee who permits supervised activities under 7.10.1 and 7.10.2 shall require that the As a result of stakeholder feedback, the originally proposed 698 administration of radioactive material or radiation from radioactive material under the language is modified and expanded to include individuals in training for medical physics and nuclear medicine and to 699 supervision of an authorized user be performed only by: permit case-by-case authorizations for certain allied health and medical professionals who may be involved with 700 7.10.5.1 A physician; administration of radioactive materials. The Department recognizes that certain medical procedures may involve administration of radioactive materials under the supervision 701 7.10.5.2 An individual who meets the requirements of Appendix 7B or 7N; of an AU by persons other than a physician in training, authorized medical physicist, or nuclear medicine 702 7.10.5.3 An individual in training in medical physics while under personal technologist. These other individuals may include neurodiagnostic technicians trained to perform injections 703 supervision of an individual meeting the requirements of Appendix 7B; during seizures, or other individuals who may be involved in sentinel node procedures. The proposed provision provides a 704 7.10.5.4 An individual in training in nuclear medicine technology while under mechanism for licensees to request and be granted 705 personal supervision of an individual meeting the requirements of authorization for individuals who do not meet the requirements of 7.10.5.1 through 7.10.5.4.
706 Appendix 7N; or In all instances, the administration of radioactive materials is 707 7.10.5.5 An individual otherwise authorized in writing by the Department, or through performed under the supervision of an authorized user named 708 license condition(s). on the license in accordance with the requirements of 7.10.
This requirement is Colorado specific and is not found in 10 709 7.11 Written Ddirectives. CFR 35.
Document 1 HRG Page 48 of 138 710 7.11.1 A written directive must be dated and signed by an authorized user, including the signatory's Commented [JJ74]: Updated for consistency with the 2018 711 printed or typed name, prior tobefore the administration of: amendments to 10 CFR 35.40(a).
NRC Compatibility H&S 712 7.11.1.1 I-131 sodium iodide greater than 1.11 MBq (30 µCi), or NRC RATS 2018-1 713 7.11.1.2 Any therapeutic dosage of radioactive material, or 714 7.11.1.3 Any therapeutic dose of radiation from radioactive material.
715 If, because of the emergent nature of the patients condition, a delay in order to provide a Commented [JJ75]: This is not a new requirement but is 716 written directive would jeopardize the patients health, an oral directive is acceptable. The relocated from prior Section 7.11.3 for consistency with the 717 information contained in the oral directive must be documented as soon as possible in flow/format of 10 CFR 35.40.
718 writing in the patients record. A written directive must be prepared within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the 719 oral directive.
720 7.11.2 The written directive must contain the patient or human research subject's name and the 721 following:
722 7.11.2.1 For an administration of a dosage of radioactive drug containing radioactive 723 material, the name of the radioactive drug containing radioactive material, 724 dosage, and route of administration; 725 7.11.2.2 For gamma stereotactic radiosurgery, the total dose, treatment site, and values 726 for the target coordinate settings per treatment for each anatomically distinct 727 treatment site; 728 7.11.2.3 For teletherapy, the total dose, dose per fraction, number of fractions, and 729 treatment site; 730 7.11.2.4 For high dose rate remote afterloading brachytherapy:, the radionuclide, 731 treatment site, dose per fraction, number of fractions, and total dose; or 732 7.11.2.5 For permanent implant brachytherapy: Commented [JJ76]: Added for consistency with the 2018 amendments to 35.40(b)(6).
733 (1) Before implantation: the treatment site, the radionuclide, and the total The proposed language provides specific written directive 734 source strength: and requirements applicable to permanent implant brachytherapy consistent with federal rule. The proposed language primarily 735 (2) After implantation but before the patient leaves the post treatment recovery shifts the requirements from dose based criteria to activity (source strength/radioactivity) based criteria.
736 area: the treatment site, the number of sources implanted, the total source 737 strength implanted, and the date; or NRC RATS 2018-1 NRC Compatibility H&S 738 7.11.2.56 For all other brachytherapy, including LDR, MDR, and PDR:
739 (1) Prior to Before implantation: the treatment site, the radionuclide, and dose; and 740 (2) After implantation but prior tobefore completion of the procedure: the 741 radioisotoperadionuclide,; treatment site,; number of sources,; and total source 742 strength and exposure time (or the total dose); and date.
743 7.11.3 If, because of the emergent nature of the patient's condition, a delay in order to provide a written Commented [JJ77]: This provision is relocated to 7.11.1 for 744 directive would jeopardize the patient's health, an oral directive will be acceptable, provided that consistency with the flow/format of 10 CFR 35.40.
745 the information contained in the oral directive is documented as soon as possible in writing in the 746 patient's record and a written directive is prepared within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral directive.
747 7.11.43 A written revision to an existing written directive may be made provided thatif the revision is dated Commented [JJ78]: Updated for consistency with language 748 and signed by an authorized user prior tobefore the administration of the dosage of radioactive of 10 CFR 35.40(c)(1).
NRC Compatibility H&S
Document 1 HRG Page 49 of 138 749 drug containing unsealed radioactive material, the brachytherapy dose, the gamma stereotactic 750 radiosurgery dose, the teletherapy dose, or the next fractional dose.
751 7.11.57.11.3.1 If, because of the patient's condition, a delay in order to provide a written revision Commented [JJ79]: Updated for consistency with 10 CFR 752 to an existing written directive would jeopardize the patient's health, an oral 35.40(c)(2).
753 revision to an existing written directive will beis acceptable., provided that the NRC Compatibility H&S 754 The oral revision ismust be documented as soon as possible in the patient's 755 record. and aA revised written directive ismust be signed by the authorized user 756 within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral revision.
757 7.11.64 The licensee shall retain a copy of each written directive and/or written revision to an existing 758 written directive for 3 years.
759 7.12 Procedures for Aadministrations Rrequiring a Wwritten Ddirective.
760 7.12.1 For any administration requiring a written directive, the licensee shall develop, implement, and 761 maintain written procedures to provide high confidence that:
762 7.12.1.1 The patient's or human research subject's identity is verified before each 763 administration; and 764 7.12.1.2 Each administration is in accordance with the written directive.
Commented [JJ80]: Updated for consistency with wording 765 7.12.2 The procedures required by 7.12.1 must, at At a minimum, the procedures required by 7.12.1 of 10 CFR 35.41(b).
766 must address the following items that are applicable for the licensee's use of radioactive material:
Commented [JJ81]: Updated for consistency with wording of to 10 CFR 35.41(b)(5).
767 7.12.2.1 Verifying the identity of the patient or human research subject; 10 CFR 35.41(b)(2).
768 7.12.2.2 Verifying that the specific details of the administration areis in accordance with Commented [JSJ82]: Consistent with the reformatting of 769 the treatment plan, if applicable, and the written directive; 7.62, a reference to 7.62 is added.
770 7.12.2.3 Checking both manual and computer-generated dose calculations; and Ref: NRC Letter 02/20/2020 Commented [JJ83]: Added for consistency with 2018 771 7.12.2.4 Verifying that any computer-generated dose calculations are correctly transferred changes to 10 CFR 35.41(b)(5). This is a new provision in the CFR.
772 into the consoles of therapeutic medical units authorized by 7.48 or 7.62.
Requiring licensees to establish procedures to help evaluate 773 7.12.2.5 Determining if a medical event, as defined in 7.21, has occurred; and for and report medical events allows the Department (and nationally, the NRC) to identify if similar issues/errors are occurring across facilities.
774 7.12.2.6 Determining, for a permanent implant brachytherapy, within 60 calendar 775 days from the date the implant was performed, the total source strength NRC RATS 2018-1 776 administered outside of the treatment site compared to the total source NRC Compatibility H&S 777 strength documented in the post-implantation portion of the written CROSS
REFERENCE:
7.21 = 10 CFR 35.3045 778 directive, unless a written justification of patient unavailability is 779 documented. Commented [JJ84]: Added for consistency with 2018 changes to 10 CFR 35.41(b)(6). This is a new provision in the CFR.
780 7.12.3 A licensee shall retain a copy of the procedures required under 7.12.1 for the duration of 781 the license. This requires licensees to include in their procedures, an evaluation of whether the placement of implanted sources is consistent with the post-implantation portion of the written 782 7.13 Duties of Aauthorized Uuser and Aauthorized Mmedical Pphysicist. directive.
783 7.13.1 A licensee shall assure that only authorized users for the type of radioactive material used: NRC RATS 2018-1 NRC Compatibility H&S 784 7.13.1.1 Prescribe the radiopharmaceutical dosage and/or dose to be administered Commented [JSJ85]: 35.41 785 through the issuance of a written directive or reference to the diagnostic clinical Added for consistency with 10 CFR 35.41(c) and the recordkeeping requirements of 10 CFR 35.2041. This 786 procedures manual; and provision was previously omitted from the rule.
NRC Compatibility D
[Non-RATS item]
Document 1 HRG Page 50 of 138 787 7.13.1.2 Direct, as specified in 7.10 and 7.12, or in license conditions, the administration 788 of radioactive material for medical use to patients or human research subjects; 789 7.13.1.3 Prepare and administer, or supervise the preparation and administration of Commented [JJ86]: Updated to correct prior cross-790 radioactive material for medical use, in accordance with 7.3.27.3.1.2(1), 7.3.37.3.1.2(2) reference errors and align with the renumbering of section 791 and 7.10; 7.3.1.
792 7.13.2 A licensee shall assure that only authorized medical physicists perform, as applicable:
793 7.13.2.1 Measurements and calculations as described in 7.41; 794 7.13.2.2 Full calibration measurements as described in 7.54, 7.55, and 7.56; 795 7.13.2.3 Periodic spot checks as described in 7.58, 7.59 and 7.61; and 796 7.13.2.4 Radiation surveys as described in 7.57.
797 7.14 Suppliers for Sealed Sources or Devices for Medical Use.Suppliers for sealed sources or Commented [JSJ87]: Minor changes to this provision, 798 devices for medical use. consistent with 10 CFR 35.49.
NRC Compatibility C 799 For medical use, a licensee may only use: [NON-RATS ITEM]
800 7.14.1 Sealed sources or devices manufactured, labeled, packaged, and distributed in accordance with 801 a license issued pursuant to Part 3 of these regulations or the equivalent regulations of another 802 Agreement State, a Licensing State or the NRC; 803 7.14.2 Sealed source or devices non-commercially transferred from a Part 7 licensee or an Agreement 804 State or NRC medical use licensee; or 805 7.14.3 Teletherapy sources manufactured and distributed in accordance with a license issued pursuant 806 to Part 3 of these regulations, or the equivalent regulations of another Agreement State, a 807 Licensing State, or the NRC.
808 SPECIFIC REQUIREMENTSSection C - General Technical Requirements 809 7.15 Quality Control of Diagnostic Equipment.
810 7.15.1 Each licensee shall establish written quality control procedures for all diagnostic equipment used 811 for radionuclide studies.
812 7.15.2 As a minimum, quality control procedures and frequencies shall be:
813 7.15.2.1 Those recommended by equipment manufacturers; or 814 7.15.2.2 Procedures which have been approved by the Department.
815 7.15.3 The licensee shall conduct quality control of diagnostic equipment in accordance with written 816 procedures.
817 7.15.4 A licensee shall retain a record of each quality control test required by the written quality control 818 procedures for 3 years.
819 7.16 Possession, Use, and Testing of Instruments to Measure the Activity of Unsealed Radioactive 820 Materials.Possession, use, and calibration of instruments used to measure the activity of 821 unsealed radioactive material.
Document 1 HRG Page 51 of 138 822 7.16.1 For direct measurements performed in accordance with 7.18, a licensee shall possess and use 823 instrumentation to measure the activity of unsealed radioactive materials prior to administration to 824 each patient or human research subject.
825 7.16.2 A licensee shall calibrate the instrumentation required in 7.16.1 in accordance with nationally 826 recognized standards or the manufacturer's instructions.
827 7.16.3 In addition to the calibration required in 7.16.2, the licensee shall at a minimum also perform tests 828 for constancy, linearity, and geometry dependence, as appropriate to demonstrate proper 829 operation of the instrument.
830 7.16.4 A licensee shall retain a record of each instrument calibration and test required by 7.16 for 3 831 years. The record shall include the:
832 7.16.4.1 Model and serial number of the instrument; 833 7.16.4.2 Date of the calibration and other tests; 834 7.16.4.3 Results of the calibration and other tests; and 835 7.16.4.4 Name of the individual who performed the calibration and other tests.
836 7.17 Calibration of Survey Instruments.Calibration of survey instruments. Commented [JSJ88]: Language and format/flow is updated for consistency with 10 CFR 35.61 except as indicted below.
837 7.17.1 A licensee shall ensure thatcalibrate the survey instruments used to show compliance with Part 4 Proposed 7.17.1.1 parallels the existing requirement in 838 and Part 7 have been calibrated before first use, annually at intervals not to exceed 12 months, 7.17.2.1 (below).
839 and following any repair that will affects the calibration. A licensee shall:
Proposed 7.17.1.3 parallels the existing requirement in 7.17.2.3 840 7.17.1.1 Calibrate all scales with readings up to 10 mSv (1000 mrem) per hour with a 841 radiation source; Although not found in 10 CFR 35, the phrase at intervals not to exceed 12 months is retained from the current rule as the 842 7.17.1.2 Calibrate two separate readings on each scale or decade that will be used radiation program believes it adds clarity to the requirement.
843 to show compliance; and NRC Compatibility H&S: 7.17.1.1, 7.17.1.2, 7.17.2 NRC Compatibility D: 7.17.1.3, 7.17.3 844 7.17.1.3 Conspicuously note on the instrument the date of calibration.
845 7.17.2 To satisfy the requirements of 7.17.1 the licensee shall:
846 7.17.2.1 Calibrate all required scale readings up to 10 mSv (1 rem) per hour with a Commented [JSJ89]: The requirement in 7.17.2.1 is 847 radiation source; replaced by 7.17.1.1 (above).
848 7.17.2.2 Have each radiation survey instrument calibrated as follows, or by acceptable Commented [JSJ90]:
849 equivalent methods: The requirements of 7.17.2.2 are not found in Part 35 and are deleted. Due to the various makes, models and design configurations of modern survey instruments, calibration 850 (1) At energies appropriate for use and at intervals not to exceed 12 months or after requirements are generally best determined by the facility 851 instrument servicing, except for battery changes; performing the calibration. Licensed facilities typically perform calibrations in accordance with standard practices and nationally accepted standards appropriate for the specific 852 (2) For linear scale instruments, at 2 points located approximately one-third and two- instrument.
853 thirds of full-scale on each scale; 854 (3) For logarithmic scale instruments, at mid-range of each decade and at 2 points of 855 at least one decade; 856 (4) For digital instruments, at 3 points between 0.02 and 10 mSv (2 and 1000 mrem) 857 per hour; and
Document 1 HRG Page 52 of 138 858 (5) For dose rate instruments, so that an accuracy within plus or minus 20 percent of 859 the true radiation dose rate can be demonstrated at each point checked.
860 7.17.2.3 Conspicuously note on the instrument the date of calibration. Commented [JSJ91]: The requirement in 7.17.2.3 is replaced by 7.17.1.3 (above).
861 7.17.32 TheA licensee shallmay not use survey instruments if the difference between the indicated 862 exposure rate and the calculated exposure rate is greatermore than 20 percent.
863 7.17.43 TheA licensee shall retain a record of each survey instrument calibration required by 7.17 for 3 864 years. The record shall include the:
865 7.17.43.1 Model and serial number of the instrument; 866 7.17.43.2 Date of the calibration; 867 7.17.43.3 Results of the calibration; and 868 7.17.43.4 Name of the individual who performed the calibration.
869 7.18 Determination of Dosages of Radioactive Material for Medical Use.Determination of dosages of 870 unsealed radioactive material for medical use.
871 7.18.1 A licensee shall determine and record the activity of each dosage prior tobefore medical use.
872 7.18.1.1 For photon-emitting radioactive material, this determination shall be within 30 873 minutes prior to medical use.
874 7.18.1.2 For all other radioactive material, this determination shall be within the period 875 before medical use that is no greater than 10 percent of the physical half-life of 876 the radioactive material.
877 7.18.2 For a unit dosage, the determination required by 7.18.1 shall be made by:
878 7.18.2.1 dDirect measurement of radioactivity; or 879 7.18.2.2 aA decay correction, based on the measurement made by:
880 (1) aA manufacturer or preparer licensed pursuant to Part 3 of these regulations or 881 equivalent provisions of another Agreement State, or NRC; or 882 (2) anAn NRC or Agreement State licensee for use in research in accordance with a 883 Radioactive Drug Research Committee-approved protocol or an Investigational 884 New Drug (IND) protocol accepted by FDA.
885 (3) A PET radioactive drug producer licensed under Part 3, Section 3.8.10 or Commented [JSJ92]: Added, consistent with the 886 equivalent NRC or Agreement State requirements. requirements of 10 CFR 35.63(b)(2)(iii). This provision has been in federal rule for a number of years, but was omitted during prior rule amendments.
887 7.18.3 For other than a unit dosages, the determination by 7.18.1 shall be made by:
NRC Compatibility H&S 888 7.18.3.1 dDirect measurement of radioactivity; or 889 7.18.3.2 by a cCombination of measurements of radioactivity and mathematical 890 calculations; or 891 7.18.3.3 by a cCombination of volumetric measurements and mathematical calculations, 892 based on the measurement made by:
Document 1 HRG Page 53 of 138 893 (1) aA manufacturer or preparer licensed pursuant to Part 3 of these regulations or 894 equivalent provisions of another Agreement State, or NRC.
895 (2) A PET radioactive drug producer licensed under Part 3, Section 3.8.10 or Commented [JSJ93]: Added, consistent with the 896 equivalent NRC or Agreement State requirements. requirements of 10 CFR 35.63(c)(3)(ii). This provision has been in federal rule for a number of years, but was omitted during prior rule amendments.
897 7.18.4 Unless otherwise directed by the authorized user, a licensee shall not use a dosage if the dosage 898 differs from the prescribed dosage by more than 20 percent. NRC Compatibility H&S 899 7.18.5 A license shall retain a record of the each dosage determination required by 7.18.1 for 3 years. Commented [JJ94]:
900 The record shall contain the: Correction of numbering errors made in this section.
901 7.18.5.1 Name of the radioactive drug; 902 7.18.5.2 Patient's or human research subjects name, and identification number if one has 903 been assigned; 904 7.18.3.35.3 Prescribed dosage; 905 7.18.3.45.4 Determined dosage; or a notation that the total activity is less than 1.1 MBq (30 906 µCi);
907 7.18.3.55.5 Date and time of the dosage determination; and 908 7.18.3.65.6 Name of the individual who determined the dosage.
909 7.19 Authorization for Calibration, Transmission and Reference Sources.Authorization for Commented [JSJ95]: Section 7.19 is revised for 910 calibration, transmission and reference sources. consistency with the 2018 amendments to 10 CFR 35.65.
NRC Compatibility D 911 7.19.1 Any person authorized by 7.3 for medical use of radioactive material may receive, possess, and NRC RATS 2018-1 912 use any of the following radioactive material for check, calibration, transmission and reference 913 use:
914 7.19.17.19.1.1 Sealed sources manufactured and distributed by persons specifically licensed 915 pursuant to Part 3 of these regulations or equivalent provisions of the another 916 Agreement State, a Licensing State, or NRC, and that do not exceed 1.1 GBq 917 (30 mCi) each;Sealed sources, not exceeding 1.11 GBq (30 mCi) each, 918 manufactured and distributed by a person licensed under Part 3, by NRC 919 under 10 CFR 32.74 or equivalent Agreement State regulations; 920 7.19.1.2 Sealed sources, not exceeding 1.11 GBq (30 mCi) each, redistributed by a Commented [JSJ96]: This provision is not new to federal 921 licensee authorized to redistribute the sealed sources manufactured and rule, but was previously omitted from Colorado rule.
922 distributed by a person licensed under Part 3, by NRC under 10 CFR 32.74 NRC Compatibility D 923 or equivalent Agreement State regulations, providing the redistributed 924 sealed sources are in the original packaging and shielding and are 925 accompanied by the manufacturers approved instructions; 926 7.19.27.19.1.3 Any radioactive material with a half-life not longer than 120 days or less in 927 individual amounts not to exceed 0.550.56 GBq (15 mCi);
928 7.19.37.19.1.4 Any radioactive material with a half life greaterlonger than 120 days in individual 929 amounts not to exceed the smaller of 7.4 MBq (200 uCi) or 1000 times the 930 quantities in Part 3 Schedule 3B:; or 931 7.19.3.1 7.4 MBq (200 µCi);
932 7.19.3.2 1000 times the quantities in Part 3 Schedule 3B; and
Document 1 HRG Page 54 of 138 933 7.19.47.19.1.5 Technetium-99m in amounts as needed.
934 7.19.2 Radioactive material in sealed sources authorized by this provision shall not be: Commented [JSJ97]: This is a new provision/requirement in federal rule, added for consistency with the 2018 amendments 935 7.19.2.1 Used for medical use as defined in 7.2 except in accordance with the to 10 CFR Part 35.65(b).
936 requirements in 7.40; or The added language clarifies that while sources may be authorized under 7.19 (35.50) they may only be used for 937 7.19.2.1 Combined (i.e., bundled or aggregated) to create an activity greater than medical purposes under the requirements of 7.40 (35.500).
The NRC considers the exposure of humans/patients to a 938 the maximum activity of any single sealed source authorized under 7.19. radioactive source to be medical use.
939 7.19.3 A licensee using calibration, transmission, and reference sources in accordance with the Compatibility D 940 requirements in 7.19.1 or 7.19.2 need not list these sources on a specific medical use NRC RATS 2018-1 941 license. CROSS
REFERENCES:
7.2 = 10 CFR 35.2 942 7.20 Requirements for Possession of Sealed Sources and Brachytherapy Sources.Requirements for 7.40 = 10 CFR 35.500 943 possession of sealed sources and brachytherapy sources. Commented [JSJ98]: This is a new provision/requirement, added for consistency with the 2018 amendments to 10 CFR 944 7.20.1 A licensee in possession of any sealed source or brachytherapy source shall follow the radiation Part 35.65(c).
945 safety and handling instructions supplied by the manufacturer or equivalent instructions approved Compatibility D 946 by the Department and shall maintain the instructions for the duration of source use in a legible NRC RATS 2018-1 947 form convenient to users.
CROSS
REFERENCES:
7.19.1 = 10 CFR 35.65(a) 948 7.20.2 A licensee in possession of a sealed source shall test the source for leakage: 7.19.2 = 10 CFR 35.65(b) 949 7.20.2.1 In accordance with Part 4 of these regulations; andTest the source for leakage Commented [JSJ99]: Rather than defer to Part 4, the 950 before its first use unless the licensee has a certificate from the supplier requirements are incorporated into Part 7, consistent with the 951 indicating that the sources was tested within 6 months before transfer to format of 10 CFR 35.67. These requirements are the same as 952 the licensee; and those currently found in Part 4.
[Non-RATS item]
953 7.20.2.2 Test the source for leakage Atat intervals not to exceed 6 months or at 954 intervals approved by the Department, another Agreement State, a Licensing 955 State or the NRC in the Sealed Source and Device Registry.
956 7.20.2.3 A licensee shall retain records of leak tests required by 7.20.2 for 3 years. Commented [JSJ100]: This provision is added for clarity 957 The records must include the model number, and serial number if one has consistent with 10 CFR 35.67(d).
958 been assigned, of each source tested; the identity of each source by The provision in Part 4 pertaining to recordkeeping for leak 959 radionuclide and its estimated activity; the results of the test; the date of test is not specific with regard to the leak testing record. The 960 the test; and the name of the individual who performed the test. proposed language adds clarity to the recordkeepoing (and similar to the existing requirement for source inventory in 961 7.20.3 To satisfy the leak test requirements of 7.20, the licensee shall measure the sample so that the 7.20.5).
962 leak test can detect the presence of 185 Bq (0.005 uCi) of radioactive material in the sample. The proposed change also provides some regulatory relief by reducing the duration that leak test records must be 963 7.20.4 If the leak test reveals the presence of 0.005 microcurie (185 Bq) or more of removable maintained - from 5 years to 3 years.
964 contamination, the licensee shall: [Non-RATS item]
965 7.20.4.1 Immediately withdraw the sealed source from use and store, dispose or cause it 966 to be repaired in accordance with the requirements of these regulations; and 967 7.20.4.2 File a written report with the Department within 5 days of receiving the leak test 968 result, including the model number and serial number, if assigned, of the leaking source, 969 the radionuclide and its estimated activity, the date and results of the test, and the action 970 taken.
971 7.20.5 A licensee in possession of a sealed source or brachytherapy source, except for a gamma 972 stereotactic radiosurgery source, shall conduct a semi-annual physical inventory of all such 973 sources. The licensee shall retain each inventory record for 3 years. The inventory records 974 shallmust contain the model number of each source, and serial number if one has been
Document 1 HRG Page 55 of 138 975 assigned, the identity of each source by radionuclide and its estimated activity, the location of 976 each source, and the name of the individual who performed the inventory.
977 7.21 Reports and Notifications of Misadministrations.Report and notification of a medical event. Commented [JJ101]: Consistent with current NRC language in 10 CFR 35, Part 7 is being modified to change the 978 7.21.1 Other than events that result from intervention by a patient or human research subject, a licensee term misadministration to medical event.
979 shall report any event in which the administration of radioactive material or radiation from 980 radioactive material results in:A licensee shall report any event as a medical event, except Commented [JJ102]: Reworded for consistency with 10 CFR 35.3045.
981 for an event that results from patient or human research subject intervention, in which:
Due to the change in certain requirements related to 982 7.21.1.1 The administration of radioactive material or radiation from radioactive permanent implant brachytherapy, the requirements pertaining 983 material, except permanent implant brachytherapy, results in: to medical events for these materials are modified in 7.21.
NRC Compatibility C 984 7.21.1.1 (1) A dose that differs from the prescribed dose or dose that would have NRC RATS 2018-1 985 resulted from the prescribed dosage by more than 0.05 Sv (5 rem) effective Commented [JSJ103]: Language pertaining to human 986 dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) research subject intervention is retained from the current rule 987 shallow dose equivalent to the skin; and either although it is not found in 10 CFR 35.
988 (1) (a) The total dose delivered differs from the prescribed dose by 20 percent 989 or more; 990 (2) (b) The total dosage delivered differs from the prescribed dosage by 20 991 percent or more or falls outside the prescribed dosage range; or 992 (3) (c) The fractionated dose delivered differs from the prescribed dose, for a 993 single fraction, by 50 percent or more.
994 7.21.1.2 (2) A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv 995 (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the 996 skin from any of the following:
997 (1) (a) An administration of a wrong radioactive drug containing Commented [JSJ104]: 35.3045(a)(1)(ii)(A) 998 radioactive material or the wrong radionuclide for a brachytherapy 999 procedure; NRC Compatibility C 1000 (2) (b) An administration of a radioactive drug containing radioactive 1001 material by the wrong route of administration; 1002 (3) (c) An administration of a dose or dosage to the wrong individual or 1003 human research subject; 1004 (4) (d) An administration of a dose or dosage delivered by the wrong 1005 mode of treatment; or 1006 (5) (e) A leaking sealed source.
1007 7.21.1.3 (3) A dose to the skin or an organ or tissue other than the treatment site that 1008 exceeds by:
1009 (a) 0.5 Sievert (50 rem) to an organ or tissue and0.5 Sievert (50 1010 rem) or more the expected dose to that site from the procedure if 1011 the administration had been given in accordance with the written 1012 directive prepared or revised before administration; and 1013 (b) 50 percent of the dose expected from the administration defined 1014 in the written directive (excluding, for permanent implants, seeds that 1015 were implanted in the correct site but migrated outside the treatment
Document 1 HRG Page 56 of 138 1016 site).50 percent or more the expected dose to that site from the 1017 procedure if the administration had been given in accordance with 1018 the written directive prepared or revised before administration.
1019 7.21.1.2 For permanent implant brachytherapy, the administration of radioactive Commented [JSJ105]: This is a new requirement added 1020 material or radiation from radioactive material (excluding sources that were consistent with the 2018 amendments to 10 CFR 1021 implanted in the correct site but migrated outside the treatment site) that 35.3045(a)(2) pertaining to permanent implant brachytherapy.
1022 results in: NRC RATS 2018-1 NRC Compatibility C 1023 (1) The total source strength administered differing by 20 % or more 1024 from the total source strength documented in the post-implantation 1025 portion of the written directive; 1026 (2) The total source strength administered outside of the treatment site 1027 exceeding 20 % of the total source strength documented in the 1028 post-implantation portion of the written directive; or 1029 (3) An administration that includes any of the following:
1030 1031 (a) The wrong radionuclide; 1032 1033 (b) The wrong individual or human research subject; 1034 1035 (c) Sealed source(s) implanted directly into a location 1036 discontiguous from the treatment site, as documented in the 1037 post-implantation portion of the written directive; or 1038 1039 (d) A leaking sealed source resulting in a dose that exceeds 0.5 1040 Sv (50 rem) to an organ or tissue.
1041 7.21.2 A licensee shall report any event resulting from intervention of a patient or human research 1042 subject in which the administration of radioactive material or radiation from radioactive material 1043 results, or will result in, unintended permanent functional damage to an organ or a physiological 1044 system, as determined by a physician.
1045 7.21.3 The licensee shall notify the Agency by telephone the Department no later than the next 1046 calendar day after discovery of the misadministrationmedical event.
1047 7.21.4 The licensee shall submit a written report to the AgencyDepartment within 15 days after 1048 discovery of the misadministrationmedical event.
1049 7.21.4.1 The written report must include:
1050 (1) The licensee's name; 1051 (2) The name of the prescribing physician; 1052 (3) A brief description of the event; 1053 (4) Why the event occurred; 1054 (5) The effect, if any, on the individual(s) who received the administration; 1055 (6) What actionsActions, if any, that have been taken, or are planned, to prevent 1056 recurrence; and
Document 1 HRG Page 57 of 138 1057 (7) Certification that the licensee notified the individual (or the individual's 1058 responsible relative or guardian), and if not, why not.
1059 7.21.4.2 The report may not contain the individual's name or any other information that 1060 could lead to identification of the individual.
1061 7.21.5 The licensee shall provide notification of the misadministrationmedical event to the referring 1062 physician and also notify the individual who is the subject of the misadministrationmedical event 1063 no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after its discovery, unless the referring physician personally informs the 1064 licensee either that he or she will inform the individual or that, based on medical judgment, telling 1065 the individual would be harmful. The licensee is not required to notify the individual without first 1066 consulting the referring physician. If the referring physician or the affected individual cannot be 1067 reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall notify the individual as soon as possible thereafter.
1068 The licensee may not delay any appropriate medical care for the individual, including any 1069 necessary remedial care as a result of the misadministrationmedical event, because of any 1070 delay in notification. To meet the requirements of this paragraph7.21.5, the notification of the 1071 individual who is the subject of the misadministrationmedical event may be made instead to that 1072 individual's responsible relative or guardian. If a verbal notification is made, the licensee shall 1073 inform the individual, or appropriate responsible relative or guardian, that a written description of 1074 the event can be obtained from the licensee upon request. The licensee shall provide such a 1075 written description if requested.
1076 7.21.6 Aside from the notification requirement, nothing in this section affects any rights or duties of 1077 licensees and physicians in relation to each other, to individuals affected by the 1078 misadministrationmedical event, or to that individual's responsible relatives or guardians.
1079 7.21.7 A licensee shall retain a record of a misadministration for 3 years. The record must contain: Commented [JSJ106]: This provision is replaced by the revised requirements in new 7.21.7 (below).
1080 7.21.7.1 The licensee's name; 1081 7.21.7.1 Names of the individuals involved; 1082 7.21.7.1 The social security number or other identification number if one has been 1083 assigned, of the individual who is the subject of the misadministration; 1084 7.21.7.1 A brief description of the event and why it occurred; 1085 7.21.7.1 The effect, if any, on the individual; 1086 7.21.7.1 The actions, if any, taken, or planned, to prevent recurrence; and 1087 7.21.7.1 Whether the licensee notified the individual (or the individual's responsible 1088 relative or guardian) and, if not, whether such failure to notify was based on guidance 1089 from the referring physician.
1090 7.21.7 A licensee shall: Commented [JSJ107]: In part, this provision replaces some requirements of the prior 7.21.7, consistent with 10 CFR 1091 7.21.7.1 Annotate a copy of the report provided to the Department with the: 35.3045(g).
1092 (1) Name of the individual who is the subject of the event; and Commented [JSJ108]: This provision is rephrased to conform to an NRC (federal) rulemaking that is currently in 1093 (2) Identification number or if no other identification number is available, the process for 10 CFR 35.3045. The federal rulemaking is 1094 social security number of the individual who is the subject of the event; intended to provide protection of social security information by 1095 and limiting its use in regulatory documents where possible.
Proposing this change now is expected to help eliminate the 1096 7.21.7.2 Provide a copy of the annotated report to the referring physician, if other need for a future rulemaking.
1097 than the licensee, no later than 15 days after the discovery of the event.
Refer to FR 85 33527 for additional information.
Document 1 HRG Page 58 of 138 1098 7.21.8 A copy of the record required under 7.21.7 shall be provided to the referring physician if other Commented [JSJ109]: This provision is replaced by new 1099 than the licensee, within 15 days after discovery of the misadministration. 7.21.7.2.
1100 7.22 Notification to the Department of Deceased Patients or Human Research Subjects Containing 1101 Radioactive Material.Notification to the Department of deceased patients or human research 1102 subjects containing radioactive material.
1103 7.22.1 The licensee shall notify the Department by telephone immediately upon discovery that a patient 1104 or human research subject containing radioactive material has died, and it is possible that any 1105 individual could receive exposures in excess of Part 4, section 4.14 as a result of the deceased's 1106 body.
1107 7.22.2 The licensee shall submit a written report to the Department within 30 days after discovery that 1108 the patient or human research subject referenced in 7.22.1 has died. The written report must 1109 include the:
1110 7.22.2.1 Licensee's name; 1111 7.22.2.2 Date of death; 1112 7.22.2.3 Radionuclide, chemical and physical form and calculated activity at time of death; 1113 and 1114 7.22.2.4 Names (or titles) and address(es) of known individuals who might have received 1115 exposures exceeding 5 mSv (500 mrem).
1116 7.22.3 The licensee shall retain a record of each written report required by 7.22 for 3 years.
1117 7.23 Report and Notification of a Dose to an Embryo/Fetus or a Nursing Child.Report and 1118 notification of a dose to an embryo/fetus or a nursing child 1119 7.23.1 A licensee shall report any dose to an embryo/fetus that is greater than 5 mSv (500 mrem) dose 1120 equivalent that is a result of an administration of radioactive material or radiation from radioactive 1121 material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, 1122 in advance, by the authorized user.
1123 7.23.2 A licensee shall report any dose to a nursing child, that was not specifically approved, in advance, 1124 by the authorized user, that is a result of an administration of radioactive material to a breast 1125 feeding individual that:
1126 7.23.2.1 Is greater than 5 millisievert (500 mrem) total effective dose equivalent; or 1127 7.23.2.2 Has resulted in unintended permanent functional damage to an organ or a 1128 physiological system of the child, as determined by a physician.
1129 7.23.3 The licensee shall notify by telephone the AgencyDepartment no later than the next calendar day 1130 after discovery of a dose to the embryo/fetus or nursing child that requires a report in 7.23.1 or 1131 7.23.2.
1132 7.23.4 The licensee shall submit a written report to the AgencyDepartment within 15 days after 1133 discovery of a dose to the embryo/fetus or nursing child that requires a report in 7.23.1 or 7.23.2.
1134 7.23.4.1 The written report must include:
1135 (1) The licensee's name; 1136 (2) The name of the prescribing physician;
Document 1 HRG Page 59 of 138 1137 (3) A brief description of the event; 1138 (4) Why the event occurred; 1139 (5) The effect on the embryo/fetus or the nursing child; 1140 (6) What actions, if any, have been taken, or are planned, to prevent recurrence; and 1141 (7) Certification that the licensee notified the pregnant individual or mother (or the 1142 mother's or child's responsible relative or guardian), and if not, why not.
1143 7.23.4.2 The report must not contain the individual's or child's name or any other 1144 information that could lead to identification of the individual or child.
1145 7.23.5 The licensee shall notifyprovide notification of the event to the referring physician and also 1146 notify the pregnant individual or mother, both hereafter referred to as the mother, no later than 24 1147 hours after discovery of an event that would require reporting under 7.23.1 or 7.23.2, unless the 1148 referring physician personally informs the licensee either that he or she will inform the mother or 1149 that, based on medical judgment, telling the mother would be harmful. The licensee is not 1150 required to notify the mother without first consulting with the referring physician. If the referring 1151 physician or mother cannot be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall make the appropriate 1152 notifications as soon as possible thereafter. The licensee may not delay any appropriate medical 1153 care for the embryo/fetus or for the nursing child, including any necessary remedial care as a 1154 result of the event, because of any delay in notification. To meet the requirements of this 1155 paragraph7.23.5, the notification may be made to the mother's or child's responsible relative or 1156 guardian instead of the mother, when appropriate. If a verbal notification is made, the licensee 1157 shall inform the mother, or the mother's or child's responsible relative or guardian, that a written 1158 description of the event can be obtained from the licensee upon request. The licensee shall 1159 provide such a written description if requested.
1160 7.23.6 A licensee shall: retain a record of a dose to an embryo/fetus or a nursing child for 3 years. The 1161 record must contain:
1162 7.23.6.1 The licensee's name; 1163 7.23.6.2 Names of all the individuals involved; 1164 7.23.6.3 Social security number or other identification number if one has been assigned to 1165 the pregnant individual or nursing child who is the subject of the event; 1166 7.23.6.4 A brief description of the event and why it occurred; 1167 7.23.6.5 The effect, if any, on the embryo/fetus or nursing child; 1168 7.23.6.6 The actions, if any, taken, or planned, to prevent recurrence; and 1169 7.23.6.7 Whether the licensee notified the pregnant individual or mother (or the mother's Commented [JSJ110]: This provision replaces 7.23.6.1 1170 or child's responsible relative or guardian) and, if not, whether such failure to through 7.23.6.7, consistent with the approach and format 1171 notify was based on guidance from the referring physician. used in 10 CFR Part 35.3047, and to parallel the changes to 7.21.7.
1172 7.23.6.1 Annotate a copy of the report provided to the Department with the:
Current provision 7.23.4 provides requirements for the contents of the specified report, which is largely repeated in 1173 (1) Name of the pregnant individual or the nursing child who is the the prior language of 7.23.6 that is proposed for deletion. The 1174 subject of the event; and proposed change to 7.23.6 streamlines the process by requiring the licensee to annotate the existing required report with the specified information.
Proposing this change now is expected to help eliminate the need for a future rulemaking.
Document 1 HRG Page 60 of 138 1175 (2) Identification number or if no other identification number is Commented [JSJ111]: This provision is rephrased to 1176 available, the social security number of the individual who is the conform to an NRC (federal) rulemaking that is currently in 1177 subject of the event. process for 10 CFR Part 35.3047. The federal rulemaking is intended to provide protection of social security information by limiting its use in regulatory documents where possible.
1178 7.23.7 A copy of the record required under 7.23.6 shall be provided to the referring physician, if other 1179 than the licensee, within 15 days after discovery of the event. Refer to FR 85 33527 for additional information.
1180 7.24 Vial Shields and Labels.Labeling of vials and syringes.
1181 7.24.1 A licensee shall require each individual preparing or handling a vial that contains a 1182 radiopharmaceutical to keep the vial in a vial radiation shield.
1183 7.24.2 Each syringe and vial that contains a radioactive drug shall be labeled to identify the radioactive 1184 drug, to include the isotope and amount of radioactivity. Each syringe shield and vial shield shall 1185 also be labeled unless the label on the syringe or vial is visible when shielded.
1186 7.25 Surveys for Contamination and Ambient Exposure Rate.Surveys for contamination and 1187 ambient exposure rate.
1188 7.25.1 Surveys required by 7.25.2 and 7.25.3 are in addition to surveys required by Part 4.
1189 7.25.2 Daily Survey Requirements 1190 7.25.2.1 At the end of each day of use, a licensee shall survey with an exposure rate 1191 instrument, all areas where radioactive drugs containing radioactive material 1192 requiring a written directive were prepared for use or administered.
1193 (1) A licensee does not need to perform the surveys required by 7.25.2.1 in an area 1194 where patients or human research subjects are confined when they cannot be 1195 released pursuant to 7.26.
1196 7.25.2.2 At the end of each day of use, a licensee shall survey for removable 1197 contamination all areas where generators and bulk radioactive drugs are 1198 prepared for use. An instrument capable of detecting 33.3 becquerels (2000 1199 dpm) of contamination on each wipe sample shall be used.
1200 7.25.3 Weekly Survey Requirements 1201 7.25.3.1 At least once each week, a licensee shall survey, with an exposure rate 1202 instrument, all areas where radioactive drugs or radioactive wastes are stored.
1203 7.25.3.2 At least once each week, a licensee shall survey for removable contamination in 1204 all areas where radioactive materials other than sealed sources as defined in 1205 Part 7 are stored. An instrument capable of detecting 33.3 becquerels (2000 1206 dpm) of contamination on each wipe sample shall be used.
1207 7.25.4 A licensee shall establish action levels for the surveys required by 7.25.2 and 7.25.3 and shall 1208 require that the individual performing the survey immediately notify the Radiation Safety Officer if 1209 action levels are exceeded.
1210 7.25.5 A licensee shall retain a record of each survey required by 7.25.1, 7.25.2 and 7.25.3 for 3 years.
1211 The record must include:
1212 7.25.5.1 The date of the survey; 1213 7.25.5.2 The results of the survey;
Document 1 HRG Page 61 of 138 1214 7.25.5.3 The instrument used to make the survey (including, if applicable, that the 1215 instrument was checked for consistent response with a dedicated check source 1216 prior to each daily use); and 1217 7.25.5.4 The name of the individual who performed the survey.
1218 7.26 Release of Individuals Containing Radioactive Drugs or Implants.Release of individuals 1219 containing unsealed radioactive material or implants containing radioactive material.
1220 7.26.1 A licensee may authorize the release from the licensees control of any individual who has been 1221 administered radioactive drugs or permanent implants containing radioactive material if the total 1222 effective dose equivalent to any other individual from exposure to the released individual is not 1223 likely to exceed 5 mSv (0.5 rem).1 1224 1 Appendix U of U.S. Nuclear Regulatory Commission NUREG-1556, Vol. 9, Consolidated Guidance 1225 About Materials Licenses: Program Specific Guidance About Medical Licenses describes methods for 1226 calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 1227 5 mSv (0.5 rem).
1228 7.26.2 A licensee shall provide the released individual or the individuals parent or guardian with 1229 instructions, including written instructions on the actions recommended to maintain doses to other 1230 individuals as low as is reasonably achievable if the total effective dose equivalent to any other 1231 individual is likely to exceed 1 mSv (0.1 rem).
1232 7.26.2.1 If the total effective dose equivalent to a nursing infant or child could exceed 1 1233 mSv (0.1 rem) assuming there were no interruption in breast-feeding, the 1234 instructions shall also include:
1235 (1) Guidance on the interruption or discontinuation of breast-feeding; and 1236 (2) Information on the potential consequences, if any, of failure to follow the 1237 guidance.
1238 7.26.3 If the total effective dose equivalent to a nursing infant or child could exceed 5 mSv (0.5 rem) 1239 from continued breast-feeding, the licensee shall maintain a record that the instructions required 1240 by 7.26.2 were provided to a breast-feeding woman.
1241 7.26.4 The licensee shall maintain a record of the basis for authorizing the release of an individual in 1242 accordance with 7.26, if the total effective dose equivalent is calculated by:
1243 7.26.4.1 Using the retained activity rather than the administered activity; 1244 7.26.4.2 Using an occupancy factor less than 0.25 at 1 meter; 1245 7.26.4.3 Using the biological or effective half-live; and 1246 7.26.4.4 Considering the shielding by tissue.
1247 7.26.5 The records required by 7.26.3 and 7.26.4 must be retained for 3 years after the date of release 1248 of the individual.
1249 7.26.6 Reports of Patient Departure Prior to Authorized Release.
1250 7.26.6.1 The licensee shall notify the Department by telephone immediately upon 1251 discovery that a patient or human research subject has departed from the 1252 licensee's facility without authorization under 7.26.
Document 1 HRG Page 62 of 138 1253 7.26.6.2 The licensee shall submit a written report to the Department within 30 days after 1254 discovery of the unauthorized departure. The written report must include:
1255 (1) The licensee's name; 1256 (2) The date and time of the unauthorized departure; 1257 (3) The projected date and time when release would have occurred; 1258 (4) The address of the patient's or human research subject's home or anticipated 1259 destination following departure; 1260 (5) The radionuclide, chemical and physical form and calculated activity at time of 1261 release; 1262 (6) The apparent reason(s) for the departure prior to authorized release; and 1263 (7) A description of any changes in the licensee's patient release criteria or patient 1264 instructions that are designed to avoid a recurrence of such an event.
1265 7.27 Mobile Nuclear Medicine Service Technical Requirements.Mobile nuclear medicine service 1266 technical requirements.
1267 A licensee providing mobile nuclear medicine service shall:
1268 7.27.1 Transport to each clients address of use only syringes or vials containing prepared drugs or 1269 radioactive materials that are intended for reconstitution of radioactive drug kits; 1270 7.27.2 Bring into each clients address of use all radioactive material to be used and, before leaving, 1271 remove all unused radioactive material and associated radioactive waste; 1272 7.27.3 Secure or keep under constant surveillance and immediate control all radioactive material when 1273 in transit or at a clients address of use; 1274 7.27.4 Check instruments used to measure the activity of unsealed radioactive material for proper 1275 function before medical use at each client's address or on each day of use, whichever is more 1276 frequent. At a minimum, the check for proper function shall include a constancy check; 1277 7.27.5 Check survey instruments for consistent response with a dedicated check source before use at 1278 each client's address; 1279 7.27.6 Prior to leaving a clients address of use, perform area surveys and survey for removable 1280 contamination in all areas of use, to ensure compliance with Part 4 of these regulations; and 1281 7.27.7 Retain a record of each survey required by 7.27.6 for 3 years. The record must include the date 1282 of the survey, the results of the survey, the instrument used to make the survey, and the name of 1283 the individual who performed the survey.
1284 7.28 Storage of Volatiles and Gases.
1285 7.28.1 A licensee shall store volatile radioactive materials and radioactive gases in a radiation shield and 1286 container.
1287 7.28.2 A licensee shall store and use a multi-dose container in a properly functioning fume hood.
1288 7.28.3 A licensee who administers radioactive aerosols or gases shall do so with a system that will keep 1289 airborne concentrations within the limits prescribed in Part 4 of these regulations.
Document 1 HRG Page 63 of 138 1290 7.28.3.1 The system shall either be directly vented to the atmosphere through an air 1291 exhaust or provide for collection and decay or disposal of the aerosol or gas in a 1292 shielded container.
1293 7.28.3.2 A licensee shall check the operation of collection systems monthly. Records of 1294 these checks shall be maintained for 3 years.
1295 7.29 Decay-In-Storage.Decay-in-storage. Commented [JSJ112]: Wording and formatting/alignment modifications were made for consistency with 10 CFR 35.92.
1296 7.29.1 A licensee may hold radioactive material with a physical half-life of less than or equal to 120 days 1297 for decay-in-storage before disposal without regard forto its radioactivity if the licenseeit:
1298 7.29.1.1 Monitors radioactive material at the container surface before disposal and 1299 determines that its radioactivity cannot be distinguished from the background 1300 radiation level with aan appropriate radiation detection survey instrumentmeter 1301 set on its most sensitive scale and with no interposed shielding; and 1302 7.29.1.32 Removes or obliterates all radiation labels, except for radiation labels on 1303 materials that are within containers and that will be handledmanaged as 1304 biomedical waste after they have been released from the licensee; and 1305 7.29.1.4 Separates and monitors each generator column individually with all radiation 1306 shielding removed to ensure that its contents have decayed to background 1307 radiation level before disposal.
1308 7.29.2 Records of Decay-in-Storage. Commented [JSJ113]:
This provision combines the requirements found in 10 CFR 35.92(b) and 10 CFR 35.2092.
1309 For radioactive material disposed in accordance with 7.29.1, the licensee shall retain a record of 1310 each disposal for 3 years.A licensee shall retain a record of each disposal permitted under The CFR (Part 35) structure retains recordkeeping 1311 7.29.1 as follows: requirements in one area of the rule, while in Part 7, the recordkeeping requirements are generally retained with the requirement that drives the record.
1312 7.29.2.1 A licensee shall maintain records of the disposal of licensed materials, as 1313 required by 7.29, for 3 years. The record must include the date of the disposal, The proposed language does not change the requirement 1314 the survey instrument used, the background radiation level, the radiation level found in current rule.
1315 measured at the surface of each waste container, and the name of the individual 1316 who performed the survey.
1317 SPECIFIC REQUIREMENTS FOR THE USE OF RADIOACTIVE MATERIAL FOR UPTAKE, DILUTION, 1318 AND EXCRETION STUDIES 1319 Section D - Unsealed Radioactive Material - Written Directive Not Required 1320 7.30 Use of Unsealed Radioactive Material for Uptake, Dilution, and Excretion Studies for which a Commented [JSJ114]: Modified format to sentence case 1321 Written Directive is Not Required.Use of unsealed radioactive material for uptake, dilution, for consistency with 10 CFR Part 35.
1322 and excretion studies for which a written directive is not required.
1323 7.30.1 A licensee may use any unsealed radioactive material, in quantities that do not require a written Commented [JSJ115]: Language updated for consistency 1324 directive, as described in 7.11, for a diagnostic use involving measurements of uptake, dilution, or with the flow and format of 10 CFR 35.100.
1325 excretion that:Except for quantities that require a written directive under 7.11.2, a licensee
[Non-NRC RATS 2018-1 items]
1326 may use any unsealed radioactive material prepared for medical use for uptake, dilution, 1327 or excretion studies that is: CROSS REFERENCES USED IN THIS SECTION:
7.11.2 = 10 CFR 35.40(b) 1328 7.30.1.1 Is obtained fromObtained from: 3.8.10 = 10 CFR 30.32(j) 1329 (1) aA manufacturer or preparer licensed pursuant tounder Part 3, Section 1330 3.12.10 or equivalent regulations of another Agreement State, a 1331 Licensing State, or NRC; or;
Document 1 HRG Page 64 of 138 1332 (2) A PET radioactive drug producer licensed under Part 3, Section 1333 3.8.10 or equivalent regulations of an Agreement State or NRC; or 1334 7.30.1.2 Excluding production of PET radioactive material, is prepared by an authorized 1335 nuclear pharmacist, a physician who is an authorized user and who meets the 1336 requirements specified in Appendix 7E, Appendix 7F, or Appendix 7E3.1(2)(g), or 1337 an individual under the supervision of either as specified in 7.10; 1338 7.30.1.2 Excluding production of PET radionuclides, prepared by: Commented [JSJ116]:
CROSS
REFERENCES:
1339 (1) An authorized nuclear pharmacist; Appendix 7E = 10 CFR 35.290 Appendix 7F = 10 CFR 35.390 Section 7E3.1(2)(g) of App 7E = 35.290(c)(1)(ii)(G) 1340 (2) A physician who is an authorized user and who meets the 7.10 = 10 CFR 35.27 1341 requirements specified in Appendix 7E, or Appendix 7F and Section 1342 7E3.1(2)(g) of Appendix 7E; or 1343 (3) An individual under the supervision, as specified in 7.10, of the 1344 authorized nuclear pharmacist in 7.30.1.2(1) or the physician who is 1345 an authorized user in 7.30.1.2(2); or 1346 1347 7.30.1.3 Is oObtained from and prepared by a Department, Agreement State, Licensing 1348 State or NRC licensee for use in research in accordance with a Radioactive Drug 1349 Research Committee-approved protocol or an Investigational New Drug (IND) 1350 protocol accepted by FDA; or 1351 7.30.1.4 Is pPrepared by the licensee for use in research in accordance with a 1352 Radioactive Drug Research Committee-approved application or an 1353 Investigational New Drug (IND) protocol accepted by FDA for use in research.
1354 7.30.2 Authorized User Training For Uptake, Dilution, And Excretion Studies.
1355 The licensee shall require an authorized user of an unsealed radioactive material for the uses 1356 authorized under 7.30 to meet the requirements of Appendix 7D.
1357 7.31 Possession of Survey Instrument.Reserved Commented [JSJ117]: This requirement does not appear in 10 CFR Part 35. The requirement originated from G.45 in SSR 1358 A licensee authorized to use radioactive material for uptake, dilution, and excretion studies shall Part G (2003) and is believed to be unnecessary.
1359 possess a portable radiation detection survey instrument capable of detecting dose rates over the 1360 range 1.0 µSv (0.1 mrem) per hour to 500 µSv (50 mrem) per hour. The instrument shall be 1361 operable and calibrated in accordance with 7.17.
1362 SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED RADIOACTIVE MATERIAL - WRITTEN 1363 DIRECTIVE NOT REQUIRED 1364 7.32 Use of Unsealed Radioactive Material for Imaging and Localization Studies for which a Written Commented [JSJ118]:
1365 Directive is Not Required.Use of unsealed radioactive material for imaging and localizations Section 7.32 is modified for consistency with the format and 1366 studies for which a written directive is not required. content of 10 CFR 35.200.
CROSS REFERENCES IN THIS SECTION:
1367 Except for quantities that require a written directive under 7.11, a licensee may use any unsealed 7.11 = 10 CFR 35.40(b) 1368 radioactive material prepared for medical use for imaging and localization studies that is: 3.8.10 = 10 CFR 30.32(j) 1369 7.32.1 A licensee may use, for imaging and localization studies, any radioactive material prepared for 1370 medical use, in quantities that do not require a written directive, as described in 7.11, that:
1371 7.32.1 Obtained from:
Document 1 HRG Page 65 of 138 1372 7.32.1.1 Is obtained from a A manufacturer or preparer licensed pursuant to Part 3, 1373 Section 3.12.10 or equivalent regulations of another Agreement State, a 1374 Licensing State, or NRC; or; 1375 7.32.1.2 A PET radioactive drug producer licensed under Part 3, Section 3.8.10; or 1376 7.32.1.2 Excluding production of PET radioactive material, is prepared by an authorized Commented [JSJ119]: This provision is replaced with the 1377 nuclear pharmacist, a physician who is an authorized user and who meets the reformatted requirements of 7.32.2 below.
1378 requirements specified in Appendix 7E, or Appendix 7F and Appendix 7E3.1(2)(g), or an 1379 individual under the supervision of either as specified in 7.10.
1380 7.32.2 Excluding production of PET radionuclides, prepared by: Commented [JSJ120]:
CROSS REFERENCES IN THIS SECTION:
1381 7.32.2.1 An authorized nuclear pharmacist; Appendix 7E = 10 CFR 35.290 Appendix 7F = 10 CFR 35.390 7E3.1(2)(g) = 10 CFR 35.290(c)(1)(ii)(G) 1382 7.32.2.2 A physician who is an authorized user and who meets the requirements 7.10 = 10 CFR 35.27 1383 specified in Appendix 7E, or Appendix 7F and 7E3.1(2)(g); or 7.32.2.1 = paragraph (b)(1) of 10 CFR 35.200 7.32.2.2 = paragraph (b)(2) of 10 CFR 35.200 1384 7.32.2.3 An individual under the supervision, as specified in 7.10, of the authorized 1385 nuclear pharmacist in 7.32.2.1 or the physician who is an authorized user in 1386 7.32.2.2; 1387 7.32.1.37.32.3 Is oObtained from and prepared by a Department, Agreement State, Licensing State or 1388 NRC licensee for use in research in accordance with a Radioactive Drug Research 1389 Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by 1390 FDA; or 1391 7.32.1.47.32.4 Is pPrepared by the licensee in accordance with a Radioactive Drug Research 1392 Committee-approved application or an Investigational New Drug (IND) protocol accepted 1393 by FDA for use in research.
1394 7.32.25 Authorized User Training for Imaging and Localization Studies for which a Written Directive is Not 1395 Required.
1396 The licensee shall require an authorized user of an unsealed radioactive material for the uses 1397 authorized under 7.32 to meet the requirements of Appendix 7E.
1398 7.33 Radionuclide Contaminants.Permissible molybdenum-99, strontium-82, and strontium-85 1399 concentrations.
1400 7.33.1 A licensee shallmay not administer to humans a radioactive drug containingthat contains: Commented [JSJ121]:
This provision is revised to follow the format of 10 CFR 35.204(a). This is a change in formatting only and does not 1401 7.33.1.1 More than 0.15 kBq of molybdenum-99 per MBq of technetium-99m (0.15 µCi of change the current requirement.
1402 99 Mo per mCi of 99mTc).; or 1403 7.33.1.2 More than 0.02 kBq of strontium-82 per MBq of rubidium-82 chloride injection 1404 (0.02 µCi of 82Sr per mCi of 82Rb chloride); or more than 0.2 kBq of strontium-1405 85 per MBq of rubidium-82 chloride injection (0.2 µCi of 85Sr per mCi of 1406 82Rb).
1407 7.33.1.3 More than 0.2 kBq of strontium-85 per MBq of rubidium-82 chloride injection (0.2 Commented [JSJ122]: This provision is combined with 1408 µCi of 85Sr per mCi of 82Rb). 7.33.1.2 (above) consistent with the formatting of 10 CFR 35.204(a)(2).
1409 7.33.2 To demonstrate compliance with 7.33.1, the licensee preparing radioactive drugs from 1410 radionuclide generators shall measure the concentration of radionuclide contaminant in:
1411 7.33.2.1 Each eluate after receipt of a molybdenum-99/technetium-99m generator;
Document 1 HRG Page 66 of 138 1412 7.33.2.2 Each eluate or extract, before the first patient use of the day, as appropriate for 1413 other than molybdenum-99/technetium-99m generator systems.
1414 7.33.2 A licensee that uses molybdenum-99/technetium-99m generators for preparing a Commented [JSJ123]: Language is revised for consistency 1415 technetium-99m radioactive drug shall measure the molybdenum-99 concentration in each with 10 CFR 35.204(b).
1416 eluate from a generator to demonstrate compliance with 7.33.1.
The revised language does not effectively change the requirement from the current Part 7 requirement - only the 1417 7.33.3 A licensee that uses a strontium-82/rubidium-82 generator for preparing a rubidium-82 wording is changed.
1418 radioactive drug shall, before the first patient use of the day, measure the concentration of 1419 radionuclides strontium-82 and strontium-85 to demonstrate compliance with 7.33.1. NRC Compatibility H&S NRC RATS 2018-1 1420 7.33.3 Records of Radionuclide Purity. Commented [JSJ124]: Revised language for consistency with 10 CFR 35.204(c).
1421 A licensee who must measure radionuclide contaminant concentration shall retain a record of 1422 each radionuclide contaminant test for 3 years. The record shall include, for each measured 1423 elution of radionuclide used to prepare a radioactive drug, the ratio of the measures expressed as NRC Compatibility H&S 1424 kBq of contaminant per MBq of desired radionuclide (µCi/ mCi), the time and date of the test, and NRC RATS 2018-1 1425 the name of the individual who made the measurement. Commented [JSJ125]: This provision is replaced by 7.33.4.
1426 1427 7.33.4 If a licensee is required to measure the molybdenum-99 concentration or strontium-82 and Commented [JSJ126]: Recordkeeping requirement 1428 strontium-85 concentrations, the licensee shall retain a record of each measurement as language is updated for consistency with the 2018 changes to 1429 follows: 10 CFR 35.204(d) and 10 CFR 35.2204.
1430 This provision replaces (prior) 7.33.3. The proposed 1431 7.33.4.1 A licensee shall maintain a record of the molybdenum-99 concentration or requirements are similar to those found in 7.33.3 with slight 1432 strontium-82 and strontium-85 concentration tests required by 7.33.2 and variation in wording. The proposed wording is specific to the 1433 7.33.3 for 3 years. The record must include: type of generator rather than the more generic language of the current provision.
1434 1435 (1) For each measured elution of technetium-99m, the ratio of the measures NRC Compatibility H&S 1436 expressed as kilobecquerel of molybdenum-99 per megabecquerel of NRC RATS 2018-1 1437 technetium-99m (or microcuries of molybdenum per millicurie of CROSS REFERENCES IN THIS SECTION:
1438 technetium), the time and date of the measurement, and the name of the 7.33.2 = 10 CFR 35.204(b) 1439 individual who made the measurement; or 7.33.3 = 10 CFR 35.204(c) 1440 1441 (2) For each measured elution of rubidium-82, the ratio of the measures 1442 expressed as kilobecquerel of strontium-82 per megabecquerel of 1443 rubidium-82 (or microcuries of strontium-82 per millicurie of rubidium),
1444 kilobecquerel of strontium-85 per megabecquerel of rubidium-82 (or 1445 microcuries of strontium-85 per millicurie of rubidium), the time and date of 1446 the measurement, and the name of the individual who made the 1447 measurement.
1448 7.33.5 The licensee shall report any measurement that exceeds the limits in 7.33.1 at the time of Commented [JSJ127]: Reporting language is updated for 1449 generator elution, as follows: consistency with the 2018 changes to 10 CFR 35.
This provision combines the requirements of 35.204(e) for 1450 Report and notification for an eluate exceeding permissible molybdenum-99, strontium-82, reporting/notification of an eluate that exceeds the specified 1451 and strontium-85 concentrations. limits, and the associated recordkeeping requirements of 10 CFR 35.3204.
1452 7.33.5.1 The licensee shall notify by telephone the Department and the distributor of The proposed language provides some regulatory relief by 1453 the generator within 7 calendar days after discovery that an eluate specifying that the Department and distributor be notified by 1454 exceeded the permissible concentration listed in 7.33.1 at the time of telephone within 7 days (rather than immediately) when a 1455 generator elution. The telephone report to the Department must include the generator elution exceeds the specific criteria. The licensee must follow up within 30 days with a written report.
1456 manufacturer, model number, and serial number (or lot number) of the 1457 generator; the results of the measurement; the date of the measurement; While Colorado rule has required notification to the 1458 whether dosages were administered to patients or human research Department (per prior 7.33.4) when generator contamination 1459 subjects, when the distributor was notified, and the action taken. exceeds specific limits, federal rule prior to the 2018 amendment did not have such notification requirement.
1460 7.33.5.2 The licensee shall submit a written report to the Department within 30 NRC Compatibility H&S 1461 calendar days after discovery of an eluate exceeding the permissible NRC RATS 2018-1 1462 concentration at the time of generator elution. The written report must
Document 1 HRG Page 67 of 138 1463 include the action taken by the licensee; the patient dose assessment; the 1464 methodology used to make this dose assessment if the eluate was 1465 administered to patients or human research subjects; and the probable 1466 cause and an assessment of failure in the licensees equipment, 1467 procedures or training that contributed to the excessive readings if an error 1468 occurred in the licensees breakthrough determination; and the information 1469 in the telephone report as required by 7.33.5.1.
1470 7.33.4 Immediate Report.
1471 A licensee shall report immediately to the Department each occurrence of radionuclide 1472 contaminant concentration exceeding a limit specified in 7.33.1.
1473 7.34 Aerosols and Ggases.
1474 Provided the conditions of 7.28 are met, a licensee shall use radioactive aerosols or gases only if 1475 specific application is made to and approved by the Department.
1476 7.35 Radiation Detection Capability.Reserved Commented [JSJ128]:
Provision is deleted as the general requirements of Part 4 apply. Licensees are required to possess instruments capable 1477 A licensee authorized to use radioactive material pursuant to 7.32, 7.36, or 7.42 shall possess of performing measurements needed to demonstrate 1478 portable radiation detection survey instrumentation capable of detecting dose rates over the compliance with the license and regulations.
1479 range 1.0 µSv (0.1 mrem) per hour to 500 µSv (50 mrem) per hour and over the range of 10 µSv 1480 (1 mrem) per hour to 10 mSv (1 rem) per hour. Each instrument shall be operable and calibrated 1481 in accordance with 7.17.
1482 SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED RADIOACTIVE MATERIAL - WRITTEN 1483 DIRECTIVE REQUIRED 1484 Section E - Unsealed Radioactive Material - Written Directive Required Commented [JSJ129]: Section header added for consistency with 10 CFR Part 35.
1485 7.36 Use of Unsealed Radioactive Material for Which A Written Directive Is Required.Use of unsealed 1486 radioactive material for which a written directive is required.
1487 7.36.1 A licensee may use any unsealed radioactive material identified in 7F2.1(2)(f) prepared for Commented [JSJ130]: Section has been reformatted for 1488 diagnostic or therapeutic medical use and for which a written directive is required that is: alignment and consistency with 10 CFR 35.300.
Introductory text in 7.36.1 revised for consistency with 2018 1489 7.36.1.1 Obtained from: changes to 35.300 per NRC RATS 2018-1 (Compatibility B).
1490 7.36.1.1 (1) Is obtained from a manufacturer or preparer licensed pursuant to 3.12.10 Other changes in 7.36.1 and 7.36.2 are not associated with NRC RATS 2018-1.
1491 or equivalent regulations of another Agreement State, a Licensing State, 1492 or NRC; orA manufacturer or preparer licensed under Part 3, Section CROSS
REFERENCES:
1493 3.12.10 or equivalent regulations of NRC or an Agreement State; or 7F2.1(2)(f) = 10 CFR 35.390(b)(1)(ii)(G) 3.8.10 = 10 CFR 35.32(j) 7.10 = 10 CFR 35.27 1494 (2) A PET radioactive drug producer licensed under Part 3, Section 7.36.1.2(1) = 10 CFR 35.300(b)(1) 1495 3.8.10 or equivalent Agreement State or NRC regulations; or 7.36.1.2(2) = 10 CFR 35.300(b)(2) 1496 7.36.1.2 Excluding production of PET radioactive material, is prepared by: an authorized Commented [JSJ131]:
1497 nuclear pharmacist, a physician who is an authorized user and who meets the This is a change in formatting only - no requirements are 1498 requirements specified in Appendix 7E, or Appendix 7F, or an individual under changing.
1499 the supervision of either as specified in 7.10; 1500 (1) An authorized nuclear pharmacist; 1501 (2) A physician who is an authorized user and who meets the 1502 requirements specified in Appendix 7E, or Appendix 7F; or
Document 1 HRG Page 68 of 138 1503 (3) An individual under the supervision, as specified in 7.10, of the 1504 authorized nuclear pharmacist in 7.36.1.2(1) or the physician who is 1505 authorized under 7.36.1.2(2); or 1506 7.36.1.3 Is obtainedObtained from and prepared by a Department, Agreement State, Commented [JSJ132]:
1507 Licensing State or NRC licensee for use in research in accordance witha Consistent with federal rule in 10 CFR Part 35.300(c), the 1508 Radioactive Drug Research Committee-approved protocol or an Investigational reference to the Radioactive Drug Research Committee is deleted.
1509 New Drug (IND) protocol accepted by FDA; or Ref: NRC Letter 02/20/2020 1510 7.36.1.4 Is prepared by the licensee in accordance with a Radioactive Drug Research 1511 Committee-approved application or an Investigational New Drug (IND) protocol 1512 accepted by FDA for use in research.Prepared by the licensee for use in 1513 research in accordance with an Investigational New Drug (IND) protocol 1514 accepted by FDA.
1515 7.36.2 Authorized User Training For Use Of Any Unsealed Radioactive Material For Diagnostic Or 1516 Therapeutic Medical Use For Which A Written Directive Is Required.
1517 The licensee shall require an authorized user of an unsealed radioactive material for diagnostic or 1518 therapeutic medical use for which a written directive is required under 7.36 to meet the 1519 requirements of Appendix 7F.
1520 7.36.3 Authorized User Training For Oral Administration of < / = 1.22 GBq 131 I (33 mCi) Sodium Iodide 1521 Requiring A Written Directive.
1522 The licensee shall require an authorized user of an unsealed radioactive material for oral 1523 administration of < / = 1.22 GBq 131 I (33 mCi) sodium iodide requiring a written directive under 1524 7.36 to meet the requirements of Appendix 7G.
1525 7.36.4 Authorized User Training For Oral Administration Of > 1.22 GBq 131 I (33 mCi) Sodium Iodide 1526 Requiring A Written Directive.
1527 The licensee shall require an authorized user of an unsealed radioactive material for oral 1528 administration of > 1.22 GBq 131 I (33 mCi) sodium iodide requiring a written directive under 7.36 1529 to meet the requirements of Appendix 7H.
1530 7.36.5 Authorized User Training For Parenteral Administration Requiring A Written Directive.
1531 The licensee shall require an authorized user of an unsealed radioactive material for parenteral 1532 administration requiring a written directive under 7.36 to meet the requirements of Appendix 7I.
1533 7.37 Safety Iinstruction. Commented [JSJ133]: Section 7.37 is revised for consistency with the wording and formatting of 10 CFR 35.310.
1534 In addition to the requirements of Part 10 of these regulations:
These changes are not associated with RATS 2018-1.
1535 7.37.1 TheA licensee shall provide radiation safety instruction, initially and at least annually, to 1536 personnel caring for patients or human research subjects that have received therapy with a NRC Compatibility H&S (7.37.1) 1537 radioactive drug, and who cannot be released in accordance with 7.26. To satisfy this 1538 requirement, the instruction must be commensurate with the duties of the personnel and 1539 include:
1540 7.37.2 The instruction required by 7.37.1 shall be appropriate for the duties of the personnel and include: Commented [JSJ134]: This requirement is incorporated into 7.37.1.
1541 7.37.21.1 Patient or human research subject control; Commented [JSJ135]:
1542 7.37.21.2 Visitor control, to include the following;including: Visitation requirements are clarified, consistent with 10 CFR Part 35.310.
Document 1 HRG Page 69 of 138 1543 (1) Routine visitation to hospitalized individuals in accordance with Part 4, Section 1544 4.14.1.1 of these regulations; and 1545 (2) Visitation authorized in accordance with Part 4, Section 4.14.2; 1546 7.37.1.3(2) Contamination control; 1547 7.37.1.4(3) Waste control; and 1548 7.37.1.5(4) Notification of the RSO, or his or her designee, and thean authorized user if the 1549 patient or the human research subject dies or has a medical emergency or dies.
1550 7.37.32 A licensee shall keepretain a record of individuals receiving safety instructions required by Commented [JSJ136]: 7.37.2 combines the requirements 1551 7.37.1 and maintain such records for 3 years. The record shallmust include a list of the topics of 10 CFR 35.310 and the recordkeeping requirements of 10 1552 covered, the date of the instruction, the name(s) of the attendee(s), and the name(s) of the CFR 35.2310.
1553 individual(s) who gaveprovided the instruction. NRC Compatibility D 1554 7.38 Safety Pprecautions. Commented [JSJ137]: 7.38 is revised for consistency with 10 CFR 35.315.
1555 7.38.1 For each patient or human research subject receiving radiopharmaceutical therapy and These changes are not associated with RATS 2018-1.
1556 hospitalized for compliance with 7.26 who cannot be released under 7.26, a licensee shall:
NRC Compatibility H&S (7.38) 1557 7.38.1.1 Quarter the patient or the human research subject either in:
CROSS
REFERENCES:
7.26 = 10 CFR 35.75 1558 (1) A private room with a private sanitary facility; or 1559 (2) A room, with a private sanitary facility, with another individual who also has 1560 received similar radiopharmaceutical therapy with unsealed radioactive 1561 material and who also cannot be released in accordance with 7.26; and 1562 7.38.1.2 Visibly post the patient's or the human research subjects doorroom with a 1563 Caution: Radioactive Materials sign. and 1564 7.38.1.3 Nnote on the door or onin the patient's or the human research subjects chart 1565 where and how long visitors may stay in the patient's or the human research 1566 subjects room; and 1567 7.38.1.34 Either monitor material and items removed from the patient's or the human 1568 research subjects room to determine that their radioactivity cannot be 1569 distinguished from the natural background radiation level with a radiation 1570 detection survey instrument set on its most sensitive scale and with no 1571 interposed shielding, or handle suchthe materials and items as radioactive 1572 waste.
1573 7.38.2 A licensee shall notify the RSO, or his or her designee, and thean authorized user immediately if 1574 the hospitalized patient dies or has a medical emergency and notify the Department as required 1575 by 7.39.as soon as possible if the patient or human research subject has a medical 1576 emergency or dies.
1577 7.39 Emergency Notification.Reserved. Commented [JSJ138]: This provision is redundant with the requirements of 7.22 and is therefore deleted here.
1578 The licensee shall notify the Department in accordance with 7.22 if it is possible that any 1579 individual could receive exposures in excess of 4.14 as a result of a deceased's body.
1580 SPECIFIC REQUIREMENTS FOR THE USE OF SEALED SOURCES FOR DIAGNOSIS 1581 Section F - Sealed Sources for Diagnosis
Document 1 HRG Page 70 of 138 1582 7.40 Use of Sealed Sources for Diagnosis.Use of sealed sources and medical devices for Commented [JSJ139]: 7.40 is revised for consistency with 1583 diagnosis. 10 CFR 35.500 as a result of 2018 changes to 10 CFR 35 (RATS 2018-1).
1584 7.40.1 A licensee shall use for diagnostic medical uses only sealed sources: NRC Compatibility C (7.40) 1585 7.40.1.1 Approved in the Sealed Source and Device Registry; and CROSS REFERENCES IN THIS SECTION:
7.14.1 = 10 CFR 35.49(a) 1586 7.40.1.2 Handled in accordance with the manufacturer's radiation safety and handling 1587 instructions:
1588 7.40.1 A licensee must use only sealed sources that are not in medical devices for diagnostic 1589 medical uses if the sealed sources are approved in the Sealed Source and Device Registry 1590 for diagnostic medicine. The sealed sources may be used for diagnostic medical uses that 1591 are not explicitly listed in the Sealed Source and Device Registry but must be used in 1592 accordance with the radiation safety conditions and limitations described in the Sealed 1593 Source and Device Registry.
1594 7.40.2 A licensee must only use medical devices containing sealed sources for diagnostic 1595 medical uses if both the sealed sources and medical devices are approved in the Sealed 1596 Source and Device Registry for diagnostic medical uses. The diagnostic medical devices 1597 may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source 1598 and Device Registry but must be used in accordance with the radiation safety conditions 1599 and limitations described in the Sealed Source and Device Registry.
1600 7.40.3 Sealed sources and devices for diagnostic medical uses may be used in research in 1601 accordance with and active Investigational Device Exemption (IDE) application accepted 1602 by the U.S. Food and Drug Administration provided the requirements of 7.14.1 are met.
1603 7.40.24 Authorized User Training For Use Of Sealed Sources For Diagnosis.Training for use of sealed 1604 sources and medical devices for diagnosis.
1605 The licensee shall require an authorized user under 7.40 to meet the requirements of Appendix 1606 7J.
1607 SPECIFIC REQUIREMENTS FOR THE USE OF SEALED SOURCES FOR MANUAL 1608 BRACHYTHERAPY 1609 Section G - Manual Brachytherapy 1610 7.41 Calibration Measurements of Brachytherapy Sealed Sources.Calibration measurements of Commented [JSJ140]: Section 7.41 is updated for 1611 brachytherapy sources. consistency with the wording of 10 CFR 35.432. These changes are not associated with NRC RATS 2018-1.
1612 7.41.1 Prior toBefore the first medical use of a brachytherapy sealed source on or after October 25, CROSS
REFERENCES:
1613 2005, a licensee shall perform the followinghave: 7.53 = 10 CFR 35.630(a) 1614 7.41.1.1 Determined the source output or activity using a dosimetry system that meets the 1615 requirements of 7.53; 1616 7.41.1.2 Determined source positioning accuracy within applicators; and 1617 7.41.1.3 Used published protocols currently accepted by nationally recognized bodies to 1618 meet the requirements of 7.41.1.1 and 7.41.1.2.
1619 7.41.2 A Instead of a licensee making its own measurements as required in 7.41.1, the licensee 1620 may use measurements provided by the source manufacturer or by a calibration laboratory 1621 accredited by the American Association of Physicists in Medicine that are made in accordance 1622 with 7.41.1.
Document 1 HRG Page 71 of 138 1623 7.41.3 A licensee shall mathematically correct the outputs or activities determined in 7.41.1 for physical 1624 decay at intervals consistent with 1.0 percent physical decay.
1625 7.41.4 An authorized medical physicist shall perform or review the measurements and calculations made 1626 pursuant to 7.41.1, 7.41.2, or 7.41.3.
1627 7.41.5 A licensee shall retain a record of each calibration as follows: Commented [JSJ141]: Provision revised for consistency 1628 with 10 CFR 35.432(d). This provision replaces (prior) 7.41.6.
1629 7.41.5.1 A licensee shall maintain a record of the calibrations of brachytherapy 10 CFR 35.432(d) references 10 CFR 35.2432 for the 1630 sources required by 7.41.1 for 3 years after the last use of the source. recordkeeping requirement. In Part 7, the recordkeeping 1631 requirement is incorporated into the section that mandates the 1632 7.41.5.2 The record must include: requirement in the body of the rule.
1633 NRC Compatibility D 1634 (1) The date of the calibration; 1635 CROSS
REFERENCES:
1636 (2) The manufacturer's name, model number, and serial number for the 7.41.1 = 10 CFR 35.432 1637 source and the instruments used to calibrate the source; 1638 1639 (3) The source output or activity; 1640 1641 (4) The source positioning accuracy within the applicators; and 1642 1643 (5) The name of the individual, the source manufacturer, or the 1644 calibration laboratory that performed the calibration.
1645 7.41.6 Strontium-90 sources for ophthalmic treatments. Commented [JSJ142]: Language in this section is amended and expanded for consistency with the 2018 amendments to 10 CFR 35.433 as related to the new term 1646 7.41.5 Only an authorized medical physicist shall calculate the activity of each strontium-90 source that and requirements associated with an ophthalmic physicist.
1647 is used to determine the treatment times for ophthalmic treatments. The actual source output 1648 shall consider decay based on the activity determined in accordance with paragraphs 7.41.1, 7.41.6.1 (~10 CFR 35.433(a)) = NRC B Compatibility 1649 7.41.2, or 7.41.3. [Previously, this provision was a compatibility H&S]
7.41.6.3 (~10 CFR 35.433(c)) = NRC D Compatibility 1650 7.41.6.1 Licensees who use strontium-90 for ophthalmic treatments must ensure All remaining 10 CFR 35.433 provisions paralleled in 7.41.6 1651 that certain activities as specified in 7.41.6.2 are performed by either: are NRC H&S Compatibility NRC RATS 2018-1 1652 (1) An authorized medical physicist; or CROSS
REFERENCES:
1653 (2) An individual who: 7.41.6.2 = 10 CFR 35.433(b) 1654 (a) Is identified as an ophthalmic physicist on a specific medical use Commented [JSJ143]: This provision is revised and 1655 license issued by NRC or an Agreement State; permit issued by a replaced by the added language in 7.41.6.2.
1656 NRC or Agreement State broad scope medical use licensee; 1657 medical use permit issued by a NRC master material licensee; or 1658 permit issued by a NRC master material licensee broad scope 1659 medical use permittee; and 1660 (b) Holds a masters or doctors degree in physics, medical physics, 1661 other physical sciences, engineering, or applied mathematics from 1662 an accredited college or university; and 1663 (c) Has successfully completed 1 year full-time training in medical 1664 physics and an additional year of full-time work experience under 1665 the supervision of a medical physicist; and 1666 (d) Has documented training in:
Document 1 HRG Page 72 of 138 1667 (i) The creation, modification, and completion of written 1668 directives; 1669 (ii) Procedures for administrations requiring a written directive; 1670 and 1671 (iii) Performing the calibration measurements of brachytherapy 1672 sources as detailed in 7.41.1 through 7.41.5.
1673 7.41.6.2 The individuals who are identified in 7.41.6.1 must:
1674 (1) Calculate the activity of each strontium-90 source that is used to determine 1675 the treatment times for ophthalmic treatments. The decay must be based 1676 on the activity determined under 7.41.1 through 7.41.5; and 1677 (2) Assist the licensee in developing, implementing, and maintaining written 1678 procedures to provide high confidence that the administration is in 1679 accordance with the written directive. These procedures must include the 1680 frequencies that the individual meeting the requirements in 7.41.6.1 will 1681 observe treatments, review the treatment methodology, calculate treatment 1682 time for the prescribed dose, and review records to verify that the 1683 administrations were in accordance with the written directives.
1684 7.41.6.3 Licensees must retain a record of the activity of each strontium-90 source Commented [JSJ144]: This provision is incorporated for 1685 as follows: consistency with 10 CFR 35.2433.
This provision replaces the current requirement found in 1686 (1) A licensee shall maintain a record of the activity of a strontium-90 source (prior) 7.41.7 (below), although the Part 35 requirement does 1687 required by 7.41.6 for the life of the source. not explicitly require the medical physicist signature. It is 1688 implied however since a medical physicist is required to 1689 (2) The record must include: perform activity calculations.
1690 NRC Compatibility D (35.2433).
1691 (a) The date and initial activity of the source as determined under 1692 7.41.1 through 7.41.5; and 1693 1694 (b) For each decay calculation, the date and the source activity as 1695 determined under 7.41.6.
1696 7.41.6 A licensee shall retain a record of each calibration on brachytherapy sources required by 7.41.1 Commented [JSJ145]: This provision is replaced by 7.41.5 1697 for 3 years after the last use of the source. The record must include the date of the calibration; the (above) to better align with the format and wording of 10 CFR 1698 manufacturer's name, model number, and serial number for the source and the instruments used 35.
1699 to calibrate the source; the source output or activity; source positioning accuracy within 1700 applicators; and the signature of the authorized medical physicist.
1701 7.41.7 A licensee shall retain a record of decay calculations required by 7.41.5 for the life of the source. Commented [JSJ146]: This provision is replaced by 1702 The record must include the date and initial activity of the source as determined under 7.41, and 7.41.6.3 (above).
1703 for each decay calculation, the date, the source activity and the signature of the authorized 1704 medical physicist.
1705 7.42 Use of Ssealed Ssources Ffor Mmanual Bbrachytherapy.
1706 7.42.1 A licensee shall use for manual brachytherapy only sealed sources:A licensee must use only Commented [JSJ147]: This provision is updated for 1707 brachytherapy sources: consistency with the 2018 amendments to 10 CFR 35.400.
Similar to the proposed requirements in 7.40, the language 1708 7.42.1.1 Approved in the Sealed Source and Device Registry; or for manual here is modified to clarify that sources may be used for 1709 brachytherapy use. The manual brachytherapy sources may be used for purposes not explicitly listed in the Sealed Source and Device Registry.
1710 manual brachytherapy uses that are not explicitly listed in the Sealed 1711 Source and Device Registry, but must be used in accordance with the NRC Compatibility C NRC RATS 2018-1
Document 1 HRG Page 73 of 138 1712 radiation safety conditions and limitations described in the Sealed Source 1713 and Device Registry; or 1714 7.42.1.2 In research to deliver therapeutic doses for medical use in accordance with 1715 an effectiveactive Investigational Device Exemption (IDE) application accepted 1716 by the FDA provided the requirements of 7.14.1 are met.
1717 7.42.2 Authorized User Training For Use Of Sealed Sources For Manual Brachytherapy.
1718 The licensee shall require an authorized user under 7.42 to meet the requirements of Appendix 1719 7K.
1720 7.42.3 Authorized User Training For Use Of Strontium-90 Sealed Sources For Ophthalmic Uses.
1721 The licensee shall require an authorized user of strontium-90 sealed sources for ophthalmic uses 1722 under 7.42 to meet the requirements of Appendix 7L.
1723 7.43 Safety Iinstruction.
1724 In addition to the requirements of Part 10 of these regulations:
1725 7.43.1 The licensee shall provide radiation safety instruction, initially and at least annually, to personnel 1726 caring for patients or human research subjects that are undergoing implant therapy and cannot 1727 be released in accordance with 7.26.
1728 7.43.2 The instruction required by 7.43.1 shall be commensurate with the duties of the personnel and 1729 include:
1730 7.43.2.1 Size and appearance of the brachytherapy sources; 1731 7.43.2.2 Safe handling and shielding instructions in case of a dislodged source; 1732 7.43.2.3 Patient or human research subject control; 1733 7.43.2.4 Visitor control, including both; 1734 (1) Routine visitation to hospitalized individuals in accordance with 4.14.1.1; and 1735 (2) Visitation authorized in accordance with 4.14.3; and 1736 7.43.2.5 Notification of the RSO, or his or her designee, and the authorized user if the 1737 patient or the human research subject dies or has a medical emergency.
1738 7.43.3 A licensee shall keepretain a record of individuals receiving safety instructions required by Commented [JSJ148]: 7.43.3 combines the requirements 1739 7.43.1 and maintain such records for 3 years. The record shallmust include a list of the topics of 10 CFR 35.410 and 10 CFR 35.2310.
1740 covered, the date of the instruction, the names(s) of the attendee(s), and the name(s) of the NRC Compatibility D 1741 individual(s) who gaveprovided the instruction.
1742 7.44 Safety Pprecautions.
1743 7.44.1 For each patient or the human research subject that is receiving brachytherapy and cannot be 1744 released in accordance with 7.26, a licensee shall:
1745 7.44.1.1 Not place the patient or the human research subject in the same room with a 1746 patient who is not receiving radiation therapy;
Document 1 HRG Page 74 of 138 1747 7.44.1.2 Visibly post the patient's or human research subjects door with a Caution:
1748 Radioactive Material sign and note on the door or on the patient's or human 1749 research subjects chart where and how long visitors may stay in the patient's or 1750 human research subjects room.
1751 7.44.2 A licensee shall have emergency response equipment available near each treatment room to 1752 respond to a source that inadvertently becomes:
1753 7.44.2.1 Dislodged from the patient; or 1754 7.44.2.2 Lodged within the patient following removal of the source applicators.
1755 7.44.3 A licensee shall notify the RSO , or his or her designee, and thean authorized user immediatelyas 1756 soon as possible if the hospitalized patient or human research subject dies or has a medical 1757 emergency or diesand notify the Department as required by 7.39. Commented [JSJ149]: 7.39 is proposed for deletion due to overlap/redundancy with 7.22, so the reference to that section 1758 7.45 Brachytherapy Ssources Iinventory. is deleted here.
1759 7.45.1 A licensee shall maintain accountability at all times for all brachytherapy sources in storage or 1760 use.
1761 7.45.2 PromptlyAs soon as possible after removing brachytherapy sources from a patient or a human Commented [JSJ150]: Some language updated for 1762 research subject, a licensee shall return brachytherapy sources to a secure storage area and consistency with 10 CFR 35.406(b).
1763 count or otherwise verify the number returned to ensure that all sources taken from the storage 1764 area have been returned.
1765 7.45.3 A licensee shall maintain a record of brachytherapy source accountability for 3 years. Commented [JSJ151]: Section 7.45.3 has been formatted for alignment.
1766 7.45.3.1 For temporary implants, the record must include: the number and activity of Provisions reworded for consistency with the format of 10 1767 sources: CFR 35.2406.
1768 (1) The number and activity of sources Rremoved from storage, the time and date 1769 they were removed from storage, the name of the individual who removed them 1770 from storage, and the location of use; and 1771 (2) The number and activity of sources returned to storageNot implanted, the 1772 time and date they were returned to storage, and the name of the individual who 1773 returned them to storage.
1774 7.45.3.2 For permanent implants, the record must include: the number and activity of 1775 sources:
1776 (1) The number and activity of sources Rremoved from storage, the date they 1777 were removed from storage, and the name of the individual who removed them 1778 from storage; 1779 (2) The number and activity of sources not implanted, the date they were 1780 Rreturned to storage, the date they were returned to storage, and the name of 1781 the individual who returned them to storage; and 1782 (3) The number and activity of sources Ppermanently implanted in the patient or 1783 human research subject.
1784 7.46 Surveys After Source Implant and Removal.Surveys after source implant and removal.
1785 7.46.1 Immediately after implanting sources in a patient or a human research subject, the licensee shall 1786 perform a survey to locate and account for all sources that have not been implanted.
Document 1 HRG Page 75 of 138 1787 7.46.2 Immediately after removing the last temporary implant source from a patient or a human research 1788 subject, the licensee shall perform a radiation survey of the patient with a radiation detection 1789 survey instrument to confirm that all sources have been removed. The licensee shall not release 1790 from confinement for medical care a patient treated by temporary implant until all sources have 1791 been removed.
1792 7.46.3 A licensee shall maintain a record of patient surveys which demonstrate compliance with 7.46.1 Commented [JJ152]: Correction of numbering error.
1793 and 7.6.27.46.2 for 3 years. Each record shallmust include the date and results of the survey, the 1794 survey instrument used, and the name of the individual who made the survey.
1795 7.47 Therapy-related Computer Systems.Therapy-related computer systems.
1796 7.47.1 The licensee shall perform acceptance testing on the treatment planning system in accordance 1797 with published protocols accepted by nationally recognized bodies.
1798 7.47.2 At a minimum, the acceptance testing required by 7.47.1 shall include, as applicable, verification 1799 of:
1800 7.47.2.1 The source-specific input parameters required by the dose calculation algorithm; 1801 7.47.2.12 The accuracy of dose, dwell time, and treatment time calculations at 1802 representative points; 1803 7.47.2.13 The accuracy of isodose plots and graphic displays; and 1804 1805 7.47.2.14 The accuracy of the software used to determine radioactive source positions 1806 from radiographic images.
1807 1808 Section H - Photon Emitting Remote Afterloader Units, Teletheraphy Units, and Gamma 1809 Stereotactic Radiosurgery Units 1810 SPECIFIC REQUIREMENTS FOR PHOTON-EMITTING REMOTE AFTERLOADER UNITS, 1811 TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS 1812 7.48 Use of a Sealed Source in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic 1813 Radiosurgery Unit.Use of a sealed source in a remote afterloader unit, teletherapy unit, or 1814 gamma stereotactic radiosurgery unit.
1815 7.48.1 A licensee shall use sealed sources in remote afterloader units, teletherapy units, or gamma Commented [JSJ153]: Due to changes in wording this 1816 stereotactic radiosurgery units for therapeutic medical uses: provision is replaced in its entirety by new provision 7.48.1.
1817 7.48.1.1 Approved in the Sealed Source and Device Registry; and 1818 7.48.1.2 In research in accordance with an active Investigational Device Exemption (IDE) Commented [JSJ154]: As a result of the 2018 amendments 1819 application accepted by the FDA provided the requirements of 7.14.1 are met. to 10 CFR 35.600, this provision is revised.
1820 7.48.1 A licensee must only use sealed sources: Consistent with federal rule, the revised provision makes a distinction between the devices (afterloader, teletherapy, gamma stereotactic radiosurgery units) and the radioactive 1821 7.48.1.1 Approved and as provided for in the Sealed Source and Device Registry in sources contained within these units as there is typically a 1822 photon emitting remote afterloader units, teletherapy units, or gamma separate sealed source and device registry (SSDR) for each.
1823 stereotactic radiosurgery units to deliver therapeutic doses for medical Additionally, the wording is revised to allow the units to be used for medical uses that are not explicitly listed in the 1824 uses; or SSDR.
1825 7.48.1.2 In research involving photon-emitting remote afterloader units, teletherapy NRC RATS 2018-1 1826 units, or gamma stereotactic radiosurgery units in accordance with an NRC Compatibility C 1827 active Investigational Device Exemption (IDE) application accepted by the CROSS
REFERENCES:
7.14.1 = 10 CFR 35.49(a)
Document 1 HRG Page 76 of 138 1828 U.S. Food and Drug Administration provided the requirements of 7.14.1 are 1829 met.
1830 1831 7.48.2 A licensee must use photon-emitting remote afterloader units, teletherapy units, or gamma 1832 stereotactic radiosurgery units:
1833 1834 7.48.2.1 Approved in the Sealed Source and Device Registry to deliver a therapeutic 1835 dose for medical use. These devices may be used for therapeutic medical 1836 treatments that are not explicitly provided for in the Sealed Source and 1837 Device Registry, but must be used in accordance with radiation safety 1838 conditions and limitations described in the Sealed Source and Device 1839 Registry; or 1840 1841 7.48.2.2 In research in accordance with an active Investigational Device Exemption 1842 (IDE) application accepted by the FDA provided the requirements of 7.14.1 1843 are met.
1844 7.48.27.48.3 Authorized User Training For Use of a Remote Afterloader Unit, Teletherapy Unit, or 1845 Gamma Stereotactic Radiosurgery Unit.
1846 The licensee shall require an authorized user under 7.48 to meet the requirements of Appendix 1847 7M.
1848 7.49 Installation, Mmaintenance, Aadjustment, and Rrepair.
1849 7.49.1 Only a person specifically licensed by the Department, another Agreement State, or the NRC 1850 shall install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma 1851 stereotactic radiosurgery unit that involves work on the source(s) shielding, the source(s) driving 1852 unit, or other electronic or mechanical component that could expose the source(s), reduce the 1853 shielding around the source(s), or compromise the radiation safety of the unit or the source(s).
1854 7.49.2 Except for low dose-rate remote afterloader units, only a person specifically licensed by the 1855 Department, another Agreement State, a Licensing State, or the NRC shall install, replace, 1856 relocate, or remove a sealed source or source contained in other remote afterloader units, 1857 teletherapy units, or gamma stereotactic radiosurgery units.
1858 7.49.3 For a low dose-rate remote afterloader unit, only a person specifically licensed by the 1859 Department, another Agreement State, a Licensing State, or the NRC, or an authorized medical 1860 physicist shall install, replace, relocate, or remove a sealed source(s) contained in the unit.
1861 7.49.4 A licensee shall retain a record of the installation, maintenance, adjustment and repair done onof Commented [JSJ155]: Language modified for consistency 1862 remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units for 3 years. with 10 CFR 35.2605.
1863 For each installation, maintenance, adjustment and repair, Tthe record shallmust include the 1864 date, description of the service, and name(s) of the individual(s) who performed the work.
1865 7.50 Surveys of Patients and Human Research Subjects Treated with a Remote Afterloader 1866 Unit.Surveys of patients and human research subjects treated with a remote afterloader.
1867 7.50.1 Before releasing a patient or a human research subject from licensee control, a licensee shall 1868 make a survey of the patient or the human research subject and the remote afterloader unit with a 1869 portable radiation detection survey instrument to confirm that the source(s) has been removed 1870 from the patient or human research subject and returned to the safe, shielded position.
1871 7.50.2 A licensee shall maintain a record of patient surveys which demonstrate compliance with 7.50.1 1872 for 3 years. Each record shall include the date and results of the survey, the survey instrument 1873 used, and the name of the individual who made the survey.
Document 1 HRG Page 77 of 138 1874 7.51 Safety Procedures and Instructions for a Remote Afterloader Unit, Teletherapy Unit, or Gamma Commented [JSJ156]: Reformatted to remove 1875 Stereotactic Radiosurgery Unit.Safety procedures and instructions for remote afterloader capitalization and for consistency with wording of 10 CFR 1876 units, teletherapy units, or gamma stereotactic radiosurgery units. 35.610. Section has been formatted for alignment.
1877 7.51.1 A licensee shall:
1878 7.51.1.1 Secure the unit, the console, the console keys, and the treatment room when not 1879 in use or unattended; 1880 7.51.1.2 Permit only individuals approved by the authorized user, RSO, or authorized 1881 medical physicist to be present in the treatment room during treatment with the 1882 source(s), if such presence is necessary and justified; 1883 7.51.1.3 Prevent dual operation of more than one radiation producing device in a 1884 treatment room, if applicable; and 1885 7.51.1.4 Develop, implement, and maintain written procedures for responding to an 1886 abnormal situation when the operator is unable to place the source(s) in the 1887 shielded position, or remove the patient or human research subject from the 1888 radiation field with controls from outside the treatment room. ThisThese 1889 procedures must include:
1890 (1) Instructions for responding to equipment failures and the names of the individuals 1891 responsible for implementing corrective actions; 1892 (2) The process for restricting access to and posting of the treatment area to 1893 minimize the risk of inadvertent exposure; and 1894 (3) The names and telephone numbers of the authorized users, the authorized 1895 medical physicist, and the RSO to be contacted if the unit or console operates 1896 abnormally.
1897 7.51.2 A copy of the procedures required by 7.51.1.4 shallmust be physically located at the unit console.
1898 7.51.3 A licensee shall conspicuously post instructions at the unit console to inform the operator of the Commented [JSJ157]: Provision revised to fit the format of 1899 names and telephone numbers of the authorized users, the authorized medical physicist, and the 10 CFR 35.610(c).
1900 RSO to be contacted if the unit or console operates abnormally.A licensee shall post 1901 instructions at the unit console to inform the operator of:
1902 7.51.3.1 The location of the procedures required by 7.51.1.4; and 1903 7.51.3.2 The names and telephone numbers of the authorized users, the authorized 1904 medical physicist, and the Radiation Safety Officer to be contacted if the 1905 unit or console operates abnormally.
Commented [JSJ158]: This sub-section heading is added 1906 7.51.4 Operational and safety training. for formatting and numbering purposes to parallel/maintain 1907 consistency with the flow and format of 10 CFR 35.610(d).
1908 7.51.4.1 Prior to the first use for patient treatment of a new unit or an existing unit Commented [JSJ159]: This is a new provision added for 1909 with a manufacturer upgrade that affects the operation and safety of the consistency with the 2018 amendments/additions to 10 CFR 1910 unit, a licensee shall ensure that vendor operational and safety training is 35. 610(d).
1911 provided to all individuals who will operate the unit. The vendor operational This requirement specifies that training must be provided by 1912 and safety training must be provided by the device manufacturer or by an the vendor or individual certified by the device manufacturer 1913 individual certified by the device manufacturer to provide the operational following an upgrade impacting the operation and safety of the 1914 and safety training. unit and prior to the first use on a patient. Also see NRC FAQ
- 51, #52 for further information.
1915 7.51.4.2 A licensee shall provide operational and safety instructions, initially and at least NRC RATS 2018-1 1916 annually, to all individuals who operate athe unit at the facility, as appropriate to NRC Compatibility H&S for all but 35.610(f) / 7.51.6, which is compatibility D
Document 1 HRG Page 78 of 138 1917 the individual's assigned duties., in: The instructions shall include instruction 1918 in:
1919 7.51.4.1(1) The procedures identified in 7.51.1.4; and 1920 7.51.4.2(2) The operating procedures for the unit.
1921 7.51.5 A licensee shall ensure that operators, authorized medical physicists, and authorized users 1922 participate in drills of the emergency procedures, initially and at least annually.
1923 7.51.6 A licensee shall keepretain a record of individuals receiving instruction required by 7.51.4 in Commented [JSJ160]: This provision has been reformatted 1924 accordance with the following:and maintain such records for 3 years. The record shall include to better align with language in 10 CFR 35.610(f) and 10 CFR 1925 a list of the topics covered, the date of instruction, the names(s) of the attendee(s), and the 35.2310.
1926 name(s) of the individual(s) who gave the instruction. The proposed language does not significantly change the current requirements.
1927 (1) A licensee shall maintain a record of the operational and safety instructions 1928 required by 7.51.4 for 3 years. The record must include a list of the topics covered, NRC RATS 2018-1 NRC Compatibility D (for 35.610(f) and 35.2310) 1929 the date of the instruction, the name(s) of the attendee(s), and the name(s) of the 1930 individual(s) who provided the instruction.
1931 7.51.7 A licensee shall retain a copy of the procedures required by 7.51.1.4 and 7.51.4.2(2) until Commented [JSJ161]: Added for consistency with 10 CFR 1932 the licensee no longer possesses the remote afterloader, teletherapy unit, or gamma 35.610(g) and 10 CFR 35.2610. The proposed provision 1933 stereotactic radiosurgery unit. combines the requirements of these two provisions.
Provision (g) of 10 CFR 35.610 was revised as a result of the 1934 7.52 Doors, Interlocks, and Warning Systems.Safety precautions for remote afterloader units, 2018 amendments.
1935 teletherapy units, and gamma stereotactic radiosurgery units.
NRC RATS 2018-1 NRC Compatibility H&S 1936 7.52.1 A licensee shall control access to the treatment room by a door at each entrance.
Commented [JSJ162]: Title of this section revised for consistency with 10 CFR 35.615.
1937 7.52.2 A licensee shall equip each entrance to the treatment room with an electrical interlock system that 1938 shallwill: Provisions in 7.52 have been formatted for alignment which is not indicated by strikeout/revised text.
1939 7.52.2.1 Prevent the operator from initiating the treatment cycle unless each treatment 1940 room entrance door is closed; 1941 7.52.2.2 Cause the source(s) to be shielded promptly when an entrance door is opened; 1942 and 1943 7.52.2.3 Prevent the source(s) from being exposed following an interlock interruption until 1944 all treatment room entrance doors are closed and the source(s) on/off control is 1945 reset at the console.
1946 7.52.3 A licensee shall require any individual entering the treatment room to assure, through the use of 1947 appropriate radiation monitors, that radiation levels have returned to ambient levels.
1948 7.52.4 Except for low-dose remote afterloader units, a licensee shall construct or equip each treatment 1949 room with viewing and intercom systems to permit continuous observation of the patient or the 1950 human research subject from the treatment console during irradiation.
1951 7.52.5 For licensed activities where sources are placed within the patient's or human research subject's 1952 body, a licensee shall only conduct treatments which allow for expeditious removal of a 1953 decoupled or jammed source.
1954 7.52.6 In addition to the requirements specified in 7.52.1 through 7.52.5, a licensee shall:
1955 7.52.6.1 For low dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader 1956 units, require:
Document 1 HRG Page 79 of 138 1957 (1) An authorized medical physicist and either an authorized user or a physician, 1958 under the supervision of an authorized user, who has been trained in the 1959 operation and emergency response for the unit, to be physically present during 1960 the initiation of all patient treatments involving the unit; and 1961 (2) An authorized medical physicist and either an authorized user or an individual, 1962 under the supervision of an authorized user, who has been trained to remove the 1963 source applicator(s) in the event of an emergency involving the unit, to be 1964 immediately available during continuation of all patient treatments involving the 1965 unit.
1966 7.52.6.2 For high dose-rate remote afterloader units, require:
1967 (1) An authorized user and an authorized medical physicist to be physically present 1968 during the initiation of all patient treatments involving the unit; and 1969 (2) An authorized medical physicist and either an authorized user or a physician, 1970 under the supervision of an authorized user, who has been trained in the 1971 operation and emergency response for the unit, to be physically present during 1972 continuation of all patient treatments involving the unit.
1973 7.52.6.3 For gamma stereotactic radiosurgery units, require an authorized user and an 1974 authorized medical physicist to be physically present throughout all patient 1975 treatments involving the unit.
1976 7.52.6.4 If a patient or research subject suffers a medical emergency during radiation 1977 therapy:
1978 (1) Cease the therapy immediately; 1979 (2) Remove the source(s); and 1980 (3) Provide appropriate care to the patient or research subject.
1981 7.52.6.5 If the patient expires during treatment, remove the source(s) before further 1982 actions are taken.
1983 7.52.6.6 Notify the RSO, or his or her designee, and an authorized user as soon as 1984 possible, if the patient or human research subject has a medical emergency and, 1985 immediately, if the patient dies.
1986 7.52.7 A licensee shall have applicable emergency response equipment available near each treatment 1987 room, to respond to a situation in which a source inadvertentlysource:
1988 7.52.7.1 RemainsRemaining in the unshielded position; or 1989 7.52.7.2 Lodgesd within the patient following completion of the treatment.
1990 7.53 Dosimetry Eequipment.
1991 7.53.1 Except for low dose-rate remote afterloader sources where the source output or activity is 1992 determined by the manufacturer, a licensee shall have a calibrated dosimetry system available for 1993 use. To satisfy this requirement, one of the following two conditions shallmust be met:
1994 7.53.1.1 The system shallmust have been calibrated using a system or source traceable 1995 to the National Institute of Standards and Technology and published protocols 1996 accepted by nationally recognized bodies, or by a calibration laboratory
Document 1 HRG Page 80 of 138 1997 accredited by the American Association of Physicists in Medicine. The calibration 1998 shall have been performed within the previous 2 years and after any servicing 1999 that may have affected system calibration; or 2000 7.53.1.2 The system shallmust have been calibrated within the previous 4 years; 18 to 30 2001 months after that calibration, the system shall have been intercompared with 2002 another dosimetry system that was calibrated within the past 24 months by the 2003 National Institute of Standards and Technology or by a calibration laboratory 2004 accredited by the American Association of Physicists in Medicine. The results of 2005 the intercomparison must have indicated that the calibration factor of the 2006 licensee's system had not changed by more than 2 percent. The licensee shall 2007 not use the intercomparison result to change the calibration factor. When 2008 intercomparing dosimetry systems to be used for calibrating sealed sources for 2009 therapeutic units, the licensee shall use a comparable unit with beam attenuators 2010 or collimators, as applicable, and sources of the same radionuclide as the source 2011 used at the licensee's facility.
2012 7.53.2 The licensee shall have available for use a dosimetry system for spot-check output 2013 measurements. To meet this requirement, the system may be compared with a system that has 2014 been calibrated in accordance with 7.53.1. This comparison shall have been performed within the 2015 previous year and after each servicing that may have affected system calibration. The spot-check 2016 system may be the same system used to meet the requirement in 7.53.1.
2017 7.53.3 The licensee shall maintainretain a record of each calibration, intercomparison, and comparison 2018 for the duration of the license. For each calibration, intercomparison, or comparison, the record 2019 shallmust include:
2020 7.53.3.1 The date; 2021 7.53.3.2 The manufacturers name, the model numbers and serial numbers of the 2022 instruments that were calibrated, intercompared, or compared as required by 2023 7.53.1 and 7.53.2; 2024 7.53.3.3 The correction factor that werewas determined from the calibration or 2025 comparison or the apparent correction factor that was determined from an 2026 intercomparison; 2027 7.53.3.4 The names of the individuals who performed the calibration, intercomparison, or 2028 comparison.
2029 7.54 Full Ccalibration Mmeasurements on Tteletherapy Uunits.
2030 7.54.1 A licensee authorized to use a teletherapy unit for medical use shall perform full calibration 2031 measurements on each teletherapy unit:
2032 7.54.1.1 Before the first medical use of the unit; 2033 7.54.1.2 Before medical use under the following conditions:
2034 (1) Whenever spot-check measurements indicate that the output differs by more 2035 than 5 percent from the output obtained at the last full calibration corrected 2036 mathematically for radioactive decay; 2037 (2) Following replacement of the source or following reinstallation of the teletherapy 2038 unit in a new location; and
Document 1 HRG Page 81 of 138 2039 (3) Following any repair of the teletherapy unit that includes removal of the source or 2040 major repair of the components associated with the source exposure assembly; 2041 and 2042 7.54.1.3 At intervals not exceeding 1 year.
2043 7.54.2 To satisfy the requirement of 7.54.1, full calibration measurements shall include determination of:
2044 7.54.2.1 The output within +/- 3 percent for the range of field sizes and for the distance or 2045 range of distances used for medical use; 2046 7.54.2.2 The coincidence of the radiation field and the field indicated by the light beam 2047 localizing device; 2048 7.54.2.3 The uniformity of the radiation field and its dependence on the orientation of the 2049 useful beam; 2050 7.54.2.4 Timer accuracy, constancy, and linearity; 2051 7.54.2.5 On off error; and 2052 7.54.2.6 The accuracy of all distance measuring and localization devices in medical use.
2053 7.54.3 A licensee shall use the dosimetry system described in 7.53 to measure the output for one set of 2054 exposure conditions. The remaining radiation measurements required in 7.54.2.1 may then be 2055 made using a dosimetry system that indicates relative dose rates.
2056 7.54.4 A licensee shall make full calibration measurements required by 7.54.1 in accordance with 2057 published protocols accepted by nationally recognized bodies.
2058 7.54.5 A licensee shall correct mathematically the outputs determined in 7.54.2.1 for physical decay for 2059 intervals not exceeding 1 month for cobalt 60, 6 months for cesium 137, or at intervals consistent 2060 with 1 percent decay for all other nuclides.
2061 7.54.6 Full calibration measurements required by 7.54.1 and physical decay corrections required by 2062 7.54.5 shall be performed by the authorized medical physicist.
2063 7.54.7 A licensee shall maintain a record of each calibration for the duration of the license. The record 2064 shall include:
2065 7.54.7.1 The date of the calibration; 2066 7.54.7.2 The manufacturer's name, model number, and serial number for the teletherapy 2067 unit, source(s), and instruments used to calibrate the teletherapy unit; 2068 7.54.7.3 The results and assessments of the full calibrations; and 2069 7.54.7.4 The signature of the authorized medical physicist who performed the full 2070 calibration.
2071 7.55 Full Ccalibration Mmeasurements on Rremote Aafterloader Uunits.
2072 7.55.1 A licensee authorized to use a remote afterloader unit for medical use shall perform full 2073 calibration measurements on each unit:
2074 7.55.1.1 Before the first medical use of the unit;
Document 1 HRG Page 82 of 138 2075 7.55.1.2 Before medical use under the following conditions:
2076 (1) Following replacement of the source or following reinstallation of the unit in a new 2077 location outside the facility; and 2078 (2) Following any repair of the unit that includes removal of the source or major 2079 repair of the components associated with the source exposure assembly; and 2080 7.55.1.3 At intervals not exceeding one (1) calendar quarter for high dose-rate, medium 2081 dose-rate, and pulsed dose-rate remote afterloader units with sources whose 2082 half-life exceeds 75 days; and 2083 7.55.1.4 At intervals not exceeding 1 year for low dose-rate remote afterloader units.
2084 7.55.2 To satisfy the requirement of 7.55.1, full calibration measurements must include, as applicable, 2085 determination of:
2086 7.55.2.1 The output within +/- 5 percent; 2087 7.55.2.2 Source positioning accuracy to within +/- 1 millimeter; 2088 7.55.2.3 Source retraction with backup battery upon power failure; 2089 7.55.2.4 Length of the source transfer tubes; 2090 7.55.2.5 Timer accuracy and linearity over the typical range of use; 2091 7.55.2.6 Length of the applicators; and 2092 7.55.2.7 Function of the source transfer tubes, applicators, and transfer tube-applicator 2093 interfaces.
2094 7.55.3 In addition to the requirements for full calibrations for low dose-rate remote afterloader units in 2095 7.55.2, a licensee shall perform an autoradiograph of the source(s) to verify inventory and 2096 source(s) arrangement at intervals not exceeding one quarter.
2097 7.55.4 A licensee shall use the dosimetry system described in 7.53 to measure the output.
2098 7.55.5 A licensee shall make full calibration measurements required by 7.55.1 of this section in 2099 accordance with published protocols accepted by nationally recognized bodies.
2100 7.55.6 For low dose-rate remote afterloader units, a licensee may use measurements provided by the 2101 source manufacturer that are made in accordance with 7.55.1 through 7.55.5.
2102 7.55.7 A licensee shall mathematically correct the outputs determined in 7.55.2.1 for physical decay at 2103 intervals consistent with 1 percent physical decay.
2104 7.55.8 Full calibration measurements required by 7.55.1 and physical decay corrections required by 2105 7.55.7 must be performed by the authorized medical physicist.
2106 7.55.9 A licensee shall retain a record of each calibration for the duration of the license. The record shall 2107 include:
2108 7.55.9.1 The date of the calibration;
Document 1 HRG Page 83 of 138 2109 7.55.9.2 The manufacturer's name, model number, and serial number for the remote 2110 afterloader unit, source(s), and instruments used to calibrate the remote 2111 afterloader unit; 2112 7.55.9.3 The results and assessments of the full calibrations; 2113 7. 55.9.4 The results of the autoradiograph required for low dose-rate remote afterloader 2114 units; and 2115 7. 55.9.5 The signature of the authorized medical physicist who performed the full 2116 calibration.
2117 7.56 Full Ccalibration Mmeasurements on Ggamma Sstereotactic Rradiosurgery Uunits.
2118 7.56.1 A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall 2119 perform full calibration measurements on each unit:
2120 7.56.1.1 Before the first medical use of the unit; 2121 7.56.1.2 Before medical use under the following conditions:
2122 (1) Whenever spot-check measurements indicate that the output differs by more 2123 than 5 percent from the output obtained at the last full calibration corrected 2124 mathematically for radioactive decay; 2125 (2) Following replacement of the sources or following reinstallation of the gamma 2126 stereotactic radiosurgery unit in a new location; and 2127 (3) Following any repair of the gamma stereotactic radiosurgery unit that includes 2128 removal of the sources or major repair of the components associated with the 2129 source assembly; and 2130 7.56.1.3 At intervals not exceeding 1 year, with the exception that relative helmet factors 2131 need only be determined before the first medical use of a helmet and following 2132 any damage to a helmet.
2133 7.56.2 To satisfy the requirement of 7.56.1, full calibration measurements must include determination of:
2134 7.56.2.1 The output within +/-3 percent; 2135 7.56.2.2 Relative helmet factors; 2136 7.56.2.3 Isocenter coincidence; 2137 7.56.2.4 Timer accuracy and linearity over the range of use; 2138 7.56.2.5 On-off error; 2139 7.56.2.6 Trunnion centricity; 2140 7.56.2.7 Treatment table retraction mechanism, using backup battery power or hydraulic 2141 backups with the unit off; 2142 7.56.2.8 Helmet microswitches; 2143 7.56.2.9 Emergency timing circuits; and
Document 1 HRG Page 84 of 138 2144 7.56.2.10 Stereotactic frames and localizing devices (trunnions).
2145 7.56.3 A licensee shall use the dosimetry system described in 7.53 to measure the output for one set of 2146 exposure conditions. The remaining radiation measurements required in 7.56.2.1 may be made 2147 using a dosimetry system that indicates relative dose rates.
2148 7.56.4 A licensee shall make full calibration measurements required by 7.56.1 in accordance with 2149 published protocols accepted by nationally recognized bodies.
2150 7.56.5 A licensee shall mathematically correct the outputs determined in 7.56.2.1 at intervals not 2151 exceeding 1 month for cobalt-60 and at intervals consistent with 1 percent physical decay for all 2152 other radionuclides.
2153 7.56.6 Full calibration measurements required by 7.56.1 and physical decay corrections required by 2154 7.56.5 must be performed by the authorized medical physicist.
2155 7.56.7 A licensee shall retain a record of each calibration for the duration of the license. The record shall 2156 include:
2157 7. 56.7.1 The date of the calibration; 2158 7. 56.7.2 The manufacturer's name, model number, and serial number for the gamma 2159 stereotactic radiosurgery unit, source(s), and instruments used to calibrate the 2160 gamma stereotactic radiosurgery unit; 2161 7. 56.7.3 The results and assessments of the full calibrations; 2162 7. 56.7.4 The signature of the authorized medical physicist who performed the full 2163 calibration.
2164 7.57 Radiation Ssurveys of Ttherapeutic Ttreatment Uunits.
2165 7.57.1 A licensee authorized to use radioactive material in remote afterloader units, teletherapy units, 2166 and gamma stereotactic radiosurgery units shall possess a portable radiation detection survey 2167 instrument capable of detecting dose rates over the range of 1 µSv (0.1 mrem) per hour to 500 2168 µSv (50 mrem) per hour, and a portable radiation measurement survey instrument capable of 2169 measuring dose rates over the range of 10 µSv (1 mrem) per hour to 10 mSv (1 rem) per hour.
2170 The instruments shall be operable and calibrated in accordance with 7.17.
2171 7.57.2 In addition to the survey requirements in Part 4 of these regulations, a person licensed pursuant 2172 to Part 7 shall make surveys to ensure that the maximum radiation levels and average radiation 2173 levels from the surface of the main source safe with the source(s) in the shielded position does 2174 not exceed the levels stated in the Sealed Source and Device Registry.
2175 7.57.3 The licensee shall make the survey required by 7.57.2 at installation of a new source and 2176 following repairs to the source(s) shielding, the source(s) driving unit, or other electronic or 2177 mechanical component that could expose the source, reduce the shielding around the source(s),
2178 or compromise the radiation safety of the unit or the source(s).
2179 Records of surveys of therapeutic treatment units 2180 7.57.4 A licensee shall retain a record of the radiation surveys required by 7.57.2 for the duration of use 2181 of the unit. The record must include:
2182 7.57.4.1 The date of the measurements;
Document 1 HRG Page 85 of 138 2183 7.57.4.2 The manufacturer's name, model number and serial number of the treatment 2184 unit, source, and instrument used to measure radiation levels; 2185 7.57.4.3 Each dose rate measured around the source while the unit is in the off position 2186 and the average of all measurements; and 2187 7.57.4.4 The signature of the authorized medical physicistindividual who performed the Commented [JSJ163]: 35.2652(b)(4) 2188 test.
2189 7.58 Periodic sSpot Cchecks for Tteletherapy Uunits.
2190 7.58.1 A licensee authorized to use teletherapy units for medical use shall perform output spot checks 2191 on each teletherapy unit once in each calendar month, includingthat include determination of:
2192 7.58.1.1 Timer accuracy, and timer linearity over the range of use; 2193 7.58.1.2 On off error; 2194 7.58.1.3 The coincidence of the radiation field and the field indicated by the light beam 2195 localizing device; 2196 7.58.1.4 The accuracy of all distance measuring and localization devices used for medical 2197 use; 2198 7.58.1.5 The output for one typical set of operating conditions measured with the 2199 dosimetry system described in 7.53; and 2200 7.58.1.6 The difference between the measurement made in 7.58.1.5 and the anticipated 2201 output, expressed as a percentage of the anticipated output (i.e., the value 2202 obtained at last full calibration corrected mathematically for physical decay).
2203 7.58.2 A licensee shall perform spot checks required by 7.58.1 in accordance with procedures 2204 established by the authorized medical physicist. That individual need not actually perform the 2205 output spot-check measurements.
2206 7.58.3 A licensee shall have the authorized medical physicist review the results of each spot check 2207 within 15 days. The authorized medical physicist shall promptly notify the licensee in writing of the 2208 results of each spot check.
2209 7.58.4 A licensee authorized to use a teletherapy unit for medical use shall perform safety spot checks 2210 of each teletherapy facility once in each calendar month and after each source installation to 2211 assure proper operation of:
2212 7.58.4.1 Electrical interlocks at each teletherapy room entrance; 2213 7.58.4.2 Electrical or mechanical stops installed for the purpose of limiting use of the 2214 primary beam of radiation restriction of source housing angulation or elevation, 2215 carriage or stand travel, and operation of the beam on off mechanism; 2216 7.58.4.3 Source exposure indicator lights on the teletherapy unit, on the control console, 2217 and in the facility; 2218 7.58.4.4 Viewing and intercom systems; 2219 7.58.4.5 Treatment room doors from inside and outside the treatment room; and
Document 1 HRG Page 86 of 138 2220 7.58.4.6 Electrically assisted treatment room doors with the teletherapy unit electrical 2221 power turned off.
2222 7.58.5 If the results of the checks required in 7.58.4 indicate the malfunction of any system, a licensee 2223 shall lock the control console in the off position and not use the unit except as may be 2224 necessary to repair, replace, or check the malfunctioning system.
2225 7.58.6 A licensee shall maintain a record of each spot check required by 7.58.1 and 7.58.54, and a Commented [JSJ164]: Correction of cross-reference error 2226 copy of the procedures required by 7.58.2 for 3 years. The record shall include: and additional language added for consistency with 10 CFR 35.642(f) to clarify that a copy of the procedures used for spot checks must also be maintained.
2227 7.58.6.1 The date of the spot check; 7.58.6 combines the provisions of 10 CFR 35.642 and 10 CFR 2228 7.58.6.2 The manufacturer's name, model number, and serial number for the teletherapy 35.2642.
2229 unit, source, and instrument used to measure the output of the teletherapy unit; 2230 7.58.6.3 An assessment of timer linearity and constancy; 2231 7.58.6.4 The calculated on off error; 2232 7.58.6.5 A determination of the coincidence of the radiation field and the field indicated by 2233 the light beam localizing device 2234 7.58.6.6 The determined accuracy of each distance measuring or localization device; 2235 7.58.6.7 The difference between the anticipated output and the measured output; 2236 7.58.6.8 Notations indicating the operability of each entrance door electrical interlock, 2237 each electrical or mechanical stop, each source exposure indicator light, and the 2238 viewing and intercom system and doors; and 2239 7.58.6.9 The name of the individual who performed the periodic spot check and the 2240 signature of the authorized medical physicist who reviewed the record of the spot 2241 check.
2242 7.59 Periodic Sspot Cchecks for Rremote Aafterloader Uunits.
2243 7.59.1 A licensee authorized to use remote afterloader units for medical use shall perform spot checks of 2244 each remote afterloader facility and on each unit:
2245 7.59.1.1 At the beginning of each day of use of a high dose-rate, medium dose-rate or 2246 pulsed dose-rate remote afterloader unit; 2247 7.59.1.2 Prior to each patient treatment with a low dose-rate remote afterloader unit; and 2248 7.59.1.3 After each source installation.
2249 7.59.2 The licensee shall have the authorized medical physicist establish written procedures for 2250 performing the spot checks required in 7.59.1 The authorized medical physicist need not actually 2251 perform the spot-check measurements.
2252 7.59.3 A licensee shall have the authorized medical physicist review the results of each spot check 2253 within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in 2254 writing of the results of each spot check.
2255 7.59.4 To satisfy the requirements of 7.59.1, spot checks must, at a minimum, assure proper operation 2256 of:
Document 1 HRG Page 87 of 138 2257 7.59.4.1 Emergency response equipment; 2258 7.59.4.2 Viewing and intercom systems in each high dose-rate, medium dose-rate and 2259 pulsed dose-rate remote afterloader facility; 2260 7.59.4.3 Radiation monitors used to indicate the source position; 2261 7.59.4.4 Electrical interlocks at each remote afterloader unit room entrance; 2262 7.59.4.5 Source exposure indicator lights on the remote afterloader unit, on the control 2263 console, and in the facility; 2264 7.59.4.6 Timer accuracy; 2265 7.59.4.7 Clock (date and time) in the unit's computer; and 2266 7.59.4.8 Decayed source(s) activity in the unit's computer.
2267 7.59.5 If the results of the checks required in 7.59.4 indicate the malfunction of any system, a licensee 2268 shall lock the control console in the off position and not use the unit except as may be necessary 2269 to repair, replace, or check the malfunctioning system.
2270 7.59.6 A licensee shall retain a record of each check required by 7.59.4, and a copy of the procedures Commented [JSJ165]: Additional language added for 2271 required by 7.59.2 for 3 years. The record must include, as applicable: consistency with 10 CFR 35.643 to clarify that a copy of the procedures used for spot checks must also be maintained.
2272 7.59.6.1 The date of the spot check; 7.59.6 combines the provisions of 10 CFR 35.643 and 10 CFR 35.2643.
2273 7.59.6.2 The manufacturer's name, model number, and serial number for the remote This provision has been formatted and aligned.
2274 afterloader unit and source; 2275 7.59.6.3 An assessment of timer accuracy; 2276 7.59.6.4 Notations indicating the operability of each entrance door electrical interlock, 2277 radiation monitors, source exposure indicator lights, viewing and intercom 2278 systems, and clock and decayed source activity in the unit's computer; and 2279 7.59.6.5 The name of the individual who performed the periodic spot check and the 2280 signature of the authorized medical physicist who reviewed the record of the spot 2281 check.
2282 7.60 Additional Ttechnical Rrequirements for Mmobile Rremote Aafterloader Uunits. Commented [JSJ166]: Select provisions in 7.60 have been formatted for alignment purposes which are not easily 2283 7.60.1 A licensee providing mobile remote afterloader service shall: reflected by text changes/redlines.
2284 7.60.1.1 Check survey instruments for consistent response before medical use at each 2285 address of use or on each day of use, whichever is more frequent; and 2286 7.60.1.2 Account for all sources before departure from a client's address of use.
2287 7.60.2 In addition to the periodic spot checks required by 7.59, a licensee authorized to use mobile 2288 afterloaders for medical use shall perform checks on each remote afterloader unit before use at 2289 each address of use. At a minimum, checks must be made to verify the operation of:
2290 7.60.2.1 Electrical interlocks on treatment area access points; 2291 7.60.2.2 Source exposure indicator lights on the remote afterloader unit, on the control 2292 console, and in the facility;
Document 1 HRG Page 88 of 138 2293 7.60.2.3 Viewing and intercom systems; 2294 7.60.2.4 Applicators, source transfer tubes, and transfer tube-applicator interfaces; 2295 7.60.2.5 Radiation monitors used to indicate room exposures; 2296 7.60.2.6 Source positioning (accuracy); and 2297 7.60.2.7 Radiation monitors used to indicate whether the source has returned to a safe 2298 shielded position.
2299 7.60.3 In addition to the requirements for checks in 7.60.2, a licensee shall ensure overall proper 2300 operation of the remote afterloader unit by conducting a simulated cycle of treatment before use 2301 at each address of use.
2302 7.60.4 If the results of the checks required in 7.60.2 indicate the malfunction of any system, a licensee 2303 shall lock the control console in the off position and not use the unit except as may be necessary 2304 to repair, replace, or check the malfunctioning system.
2305 7.60.5 A licensee shall retain a record of each check for mobile remote afterloader units required by 2306 7.60.2 for 3 years. The record must include:
2307 7.60.5.1 The date of the check; 2308 7.60.5.2 The manufacturer's name, model number, and serial number of the remote 2309 afterloader unit; 2310 7.60.5.3 Notations accounting for all sources before the licensee departs from a facility; 2311 7.60.5.4 Notations indicating the operability of each entrance door electrical interlock, 2312 radiation monitors, source exposure indicator lights, viewing and intercom 2313 system, applicators, and source transfer tubes, and source positioning accuracy; 2314 and 2315 7.60.5.5 The signature of the individual who performed the check.
2316 7.61 Periodic Sspot Cchecks for Ggamma Sstereotactic Rradiosurgery Uunits.
2317 7.61.1 A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall 2318 perform spot -checks of each gamma stereotactic radiosurgery facility and on each unit:
2319 7.61.1.1 Monthly; 2320 7.61.1.2 At the beginning of each day of useBefore the first use on a given day; and 2321 7.61.1.3 After each source installation.
2322 7.61.2 The licensee shall have the authorized medical physicist:A licensee shall: Commented [JSJ167]: Section 7.61.2 revised for consistency with 10 CFR 35.645. This change is not a RATS item.
2323 7.61.2.1 Establish written procedures for performing the spot checks required in 7.61.1; 2324 andPerform the measurements required by 7.61.1 in accordance with 2325 written procedures established by the authorized medical physicist. That 2326 individual need not actually perform the spot check measurements.
2327 7.61.2.2 Have the authorized medical physicist Rreview the results of each spot -check Commented [JSJ168]: The language regarding the AMP 2328 required by 7.61.1.1 within 15 days. of the check. The authorized medical not being required to perform the spot check is incorporated 2329 physicist need not actually perform the spot-check measurements. The into 7.61.2.1 (above).
Document 1 HRG Page 89 of 138 2330 authorized medical physicist shall notify the licensee as soon as possible, in 2331 writing, of the results of theeach spot -check.
2332 7.61.3 To satisfy the requirements of 7.61.1.1 spot checks must, at a minimum:
2333 7.61.3.1 Assure proper operation of:
2334 (1) Treatment table retraction mechanism, using backup battery power or hydraulic 2335 backups with the unit off; 2336 (2) Helmet microswitches; 2337 (3) Emergency timing circuits; and 2338 (4) Stereotactic frames and localizing devices (trunnions).
2339 7.61.3.2 Determine:
2340 (1) The output for one typical set of operating conditions measured with the 2341 dosimetry system described in 7.53.2; 2342 (2) The difference between the measurement made in 7.61.3.2(1) and the 2343 anticipated output, expressed as a percentage of the anticipated output (i.e., the 2344 value obtained at last full calibration corrected mathematically for physical 2345 decay);
2346 (3) Source output against computer calculation; 2347 (4) Timer accuracy and linearity over the range of use; 2348 (5) On-off error; and 2349 (6) Trunnion centricity.
2350 7.61.4 To satisfy the requirements of 7.61.1.2 and 7.61.1.3, spot -checks must assure proper operation 2351 of:
2352 7.61.4.1 Electrical interlocks at each gamma stereotactic radiosurgery room entrance; 2353 7.61.4.2 Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on 2354 the control console, and in the facility; 2355 7.61.4.3 Viewing and intercom systems; 2356 7.61.4.4 Timer termination; 2357 7.61.4.5 Radiation monitors used to indicate room exposures; and 2358 7.61.4.6 Emergency off buttons.
2359 7.61.5 A licensee shall arrange for prompt repair of any system identified in 7.61.3 that is not operating 2360 properly.
2361 7.61.6 If the results of the checks required in 7.61.4 indicate the malfunction of any system, a licensee 2362 shall lock the control console in the off position and not use the unit except as may be necessary 2363 to repair, replace, or check the malfunctioning system.
Document 1 HRG Page 90 of 138 2364 7.61.7 A licensee shall retain a record of each spot-check for gamma stereotactic radiosurgery units Commented [JSJ169]: This section has been 2365 required by 7.61.3 and 7.61.4 for 3 years. The record must include: formatted/aligned for appearance. Alignment corrections may not appear as strike out/changed text.
2366 7.61.7.1 The date of the spot check; Clarifying language added for consistency with 10 CFR 35.2645(a).
2367 7.61.7.2 The manufacturer's name, model number, and serial number for the gamma 2368 stereotactic radiosurgery unit and the instrument used to measure the output of 2369 the unit; 2370 7.61.7.3 An assessment of timer linearity and accuracy; 2371 7.61.7.4 The calculated on-off error; 2372 7.61.7.5 A determination of trunnion centricity; 2373 7.61.7.6 The difference between the anticipated output and the measured output; 2374 7.61.7.7 An assessment of source output against computer calculations; 2375 7.61.7.8 Notations indicating the operability of radiation monitors, helmet microswitches, 2376 emergency timing circuits, emergency off buttons, electrical interlocks, source 2377 exposure indicator lights, viewing and intercom systems, timer termination, 2378 treatment table retraction mechanism, and stereotactic frames and localizing 2379 devices (trunnions); and 2380 7.61.7.9 The name of the individual who performed the periodic spot check and the 2381 signature of the authorized medical physicist who reviewed the record of the spot 2382 check.
2383 7.61.8 A licensee shall retain a copy of the procedures required by 7.61.2 until the licensee no Commented [JSJ170]: This provision parallels the 2384 longer possesses the gamma stereotactic radiosurgery unit. requirement of 10 CFR 35.2645(c).
2385 7.62 Other Mmedical Uuses of Rradioactive Mmaterial or Rradiation Ffrom Rradioactive Mmaterial.
2386 7.62.1 A licensee may use radioactive material or a radiation source approved for medical use that is not 2387 specifically addressed in Part 7 if:
2388 7.62.1.1 The applicant or licensee has submitted the information required by 7.3.4.2, 2389 7.3.4.3, and 7.3.4.4; and 2390 7.62.1.2 The applicant or licensee has received written approval from the Department, an 2391 Agreement State, Licensing State, or NRC in a license and uses the material in 2392 accordance with the regulations and specific conditions that the Department, 2393 Agreement State, Licensing State, or NRC considers necessary for the medical 2394 use of the material.
2395 7.63 Five Year Inspection.Full-inspection servicing for teletherapy and gamma stereotactic Commented [JJ171]: Updated for consistency with 2396 radiosurgery units changes to 10 CFR 35.655(a).
The title was changed to reflect the revised/extended servicing 2397 7.63.1 A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully interval (from 5 years to 7 years) for gamma stereotactic 2398 inspected and serviced during source replacement or at intervals not to exceed 5 years, radiosurgery (GSR) units.
2399 whichever comes first, to assure proper functioning of the source exposure mechanism. A 2400 licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully In consideration of the 6 month periodic maintenance interval and due to the high cost of source replacement for GSR units, 2401 inspected and serviced during each source replacement to assure proper functioning of stakeholders (nationally) requested a change in this servicing 2402 the source exposure mechanism and other safety components. The interval between each interval.
2403 full inspection servicing shall not exceed 5 years for each teletherapy unit and shall not 2404 exceed 7 years for each gamma stereotactic radiosurgery unit. NRC Compatibility H&S RATS 2018-1
Document 1 HRG Page 91 of 138 2405 7.63.2 This inspection and servicing shall only be performed by persons specifically licensed to do so by 2406 the Department, another Agreement State, a Licensing State, or the NRC.
2407 Records of full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units.
2408 7.63.3 A licensee shall keepmaintain a record of the full-inspection and servicing for teletherapy and Commented [JSJ172]: Updated for consistency with 10 2409 gamma stereotactic radiosurgery units required by 7.63 for the duration of the licenseuse of CFR 35.2655.
2410 the unit. The record shall contain:
NRC Compatibility D 2411 7.63.4 The record required by 7.63.3 must contain: CROSS
REFERENCE:
7.63 = 10 CFR 35.655 2412 7.63.34.1 The inspector's radioactive materials license number; 2413 7.63.34.2 The date of inspection; 2414 7.63.34.3 The manufacturer's name and model number and serial number of both the 2415 treatment unit and source; 2416 7.63.3.4 A list of components inspected and serviced; Commented [JSJ173]: Prior provisions 7.63.3.4 and 7.63.3.5 are replaced by an equivalent requirement in 2417 7.63.3.54.4 A list of components inspected and serviced, and the type of service; and 7.63.4.4.
2418 7.63.3.6 A list of components replaced; and Commented [JSJ174]: There is no equivalent provision in 10 CFR 35.
2419 7.63.3.7 The signature of the inspector. Commented [JSJ175]: Prior provision 7.63.3.7 is replaced by an equivalent requirement in 7.63.4.5.
2420 7.63.4.5 The signature of the inspector.
2421 7.64 Therapy-related computer systems. Commented [JSJ176]: Provision added for consistency with 10 CFR 35.657.
2422 7.64.1 The licensee shall perform acceptance testing on the treatment planning system in With the exception of 7.64.2.5, these requirements are 2423 accordance with published protocols accepted by nationally recognized bodies. equivalent to those already found in the current 7.47 found in Section G for manual brachytherapy. They are added 2424 7.64.2 At a minimum, the acceptance testing required by 7.64.1 shall include, as applicable, (repeated) here for consistency with the format of the federal rule which is best suited to the computer based systems used 2425 verification of: with the afterloader, teletherapy, and GSR devices of Section H. The provision of 10 CFR 35.657(e) is incorporated in 2426 7.64.2.1 The source-specific input parameters required by the dose calculation 7.64.2.5 as it previously omitted.
2427 algorithm; This is not a RATS item.
2428 7.64.2.2 The accuracy of dose, dwell time, and treatment time calculations at 2429 representative points; 2430 7.64.2.3 The accuracy of isodose plots and graphic displays; and 2431 7.64.2.4 The accuracy of the software used to determine radioactive source 2432 positions from radiographic images.
2433 7.64.2.5 The accuracy of electronic transfer of the treatment delivery parameters to 2434 the treatment delivery unit from the treatment planning system.
2435 Section I - Recentness of training.
2436 7.65 The training and experience specified in 7.65.1 through 7.65.6 must have been obtained Commented [JSJ177]: This provision parallels 2437 within the 7 years preceding the date of application or the individual must have had related requirements in 10 CFR Part 35.59, and replaces and 2438 continuing education and experience since the required training and experience was consolidates similar existing requirements that are repeated in the appendices of the current (in effect) rule (now proposed 2439 completed. for deletion).
Document 1 HRG Page 92 of 138 2440 2441 7.65.1 Section B,Section I, Appendix 7A, 7B, 7C, and 7P. Commented [JSJ178]: Section B refers to provisions 7.7 through 7.14 (inclusive) pertaining to general administrative 2442 7.65.2 Section D, Appendix 7D, and 7E. requirements which parallels subpart B of 10 CFR 35, with the following exceptions: due to formatting differences and limitations, Section B of Part 7 does not directly include 7.65 2443 7.65.3 Section E, Appendix 7F, 7G, 7H and 7I. (Section I) or specific references to Appendix 7A, 7B, 7C, and 7P. Therefore, these provisions are explicitly listed.
2444 7.65.4 Section F, Appendix 7J.
Commented [JSJ179]: Section D refers to provisions 7.30 2445 7.65.5 Section G, Appendix 7K and Appendix 7L. through 7.34 (inclusive) pertaining to unsealed radioactive material NOT requiring a written directive which parallels subpart D of 10 CFR 35.
2446 7.65.6 Section H, and Appendix 7M.
2447 Commented [JSJ180]: Section E refers to provisions 7.36 through 7.38 (inclusive) pertaining to unsealed radioactive material requiring a written directive which parallels subpart E of 10 CFR 35.
Commented [JSJ181]: Section F refers to provision 7.40 for sealed sources for diagnosis which parallels subpart G of 10 CFR 35.
Commented [JSJ182]: Section G refers to provisions 7.41 through 7.47 (inclusive) pertaining to manual brachytherapy which parallels subpart F of 10 CFR 35.
Commented [JSJ183]: Section H refers to 7.48 through 7.63, and Appendix 7M which parallels subpart H of 10 CFR 35.
Document 1 HRG Page 93 of 138 2448 PART 7, APPENDIX 7A: TRAINING FOR RADIATION SAFETY OFFICER (RSO) AND ASSOCIATE Commented [JJ184]: For final publication, insert a page 2449 RADIATION SAFETY OFFICER (ARSO) break to ensure each new appendices begins at the top of the page.
2450 TheExcept as provided in Appendix 7P, the licensee shall require thean individual fulfilling the Commented [JJ185]: Introductory text modified, consistent 2451 responsibilities of the Radiation Safety Officer (RSO) or an individual assigned duties and tasks as an with 2018 amendments to 10 CFR 35.50.
2452 Associate Radiation Safety Officer (ARSO) as provided in 7.7 to be an individual who:
The changes incorporate the requirements associated with the new Associate Radiation Safety Officer terminology.
2453 7A1 Is certified by a specialty board whose certification process has been recognized by NRC or an 2454 Agreement State and who meets the requirements in paragraphs 7A4 and 7A5 of this Appendix. NRC Compatibility B NRC RATS 2018-1 2455 NRC recognized specialty boards are posted on the NRC website at 2456 http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html. Is certified by a 2457 specialty board whose certification process has been recognized by the NRC or an NOTE: The changes in this and in other subsequent 2458 Agreement State and who meets the requirements in 7A4 of this Appendix. The names of appendices are similar and include the following:
2459 board certifications that have been recognized by the NRC or an Agreement State are
- 1. Removal of the specific NRC web address (where the 2460 posted on the NRCs Medical Uses Licensee Toolkit Web page. To have its certification accepted board certifications are located) and use a more 2461 process recognized, a specialty board shall require all candidates for certification to: generic website reference.
- 2. Relocation of the recentness of training requirements to 2462 To have its certification process recognized, a specialty board shall require all candidates for certification Section 7.65.
2463 to:
- 3. Relocation (and revision of) the requirements for an 2464 7A1.1 experienced individual to the new (proposed) Appendix 7P.
2465 (1) Hold a bachelor's or graduate degree from an accredited college or university in 2466 physical science or engineering or biological science with a minimum of 20 2467 college credits in physical science; 2468 and 2469 (2) Have 5 or more years of professional experience in health physics (graduate Commented [JJ186]: Wording and format updated for 2470 training may be substituted for no more than 2 years of the required consistency and alignment of 10 CFR 35.50(a).
2471 experience) including at least 3 years in applied health physics;, provided:
There is no change to the requirement. Only the formatting is changed to better align with CFR.
2472 (a) At least 3 years are in applied health physics; 2473 and 2474 (b) Graduate training may substitute for no more than 2 years of the required 2475 5 years of experience; 2476 and 2477 (3) Pass an examination administered by diplomates of the specialty board, which 2478 evaluates knowledge and competence in radiation physics and instrumentation, 2479 radiation protection, mathematics pertaining to the use and measurement of 2480 radioactivity, radiation biology, and radiation dosimetry; 2481 or 2482 7A1.2 2483 (1) Hold a master's or doctor's degree in physics, medical physics, other physical 2484 science, engineering, or applied mathematics from an accredited college or 2485 university; 2486 and
Document 1 HRG Page 94 of 138 2487 (2) Have 2 years of full-time practical training and/or supervised experience in 2488 medical physics: that is:
2489 (a) Under the supervision of a medical physicist who is certified in medical 2490 physics by a specialty board recognized by an Agreement State or NRC; 2491 or 2492 (b) In clinical nuclear medicine facilities providing diagnostic and / or 2493 therapeutic services under the general supervision direction of 2494 physicians who meet the requirements for Authorized Users in 2495 7A7Appendix 7P, Appendix 7E or Appendix 7F; 2496 and 2497 (3) Pass an examination administered by diplomates of the specialty board, that 2498 assesses knowledge and competence in clinical diagnostic radiological or 2499 nuclear medicine physics and in radiation safety.
2500 or 2501 7A2 Has satisfied the following criteria:
2502 7A2.1 Has completed a structured educational program consisting of both:
2503 (1) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training in the following areas:
2504 (a) Radiation physics and instrumentation; 2505 (b) Radiation protection; 2506 (c) Mathematics pertaining to the use and measurement of radioactivity; 2507 (d) Radiation biology; and 2508 (e) Radiation dosimetry; 2509 and 2510 (2) 1One year of full-time radiation safety experience, under the supervision of the Commented [JSJ187]: This provision is revised for 2511 individual identified as anthe RSO or Alternate RSO, on an NRC or an consistency with the 2018 amendments to 10 CFR 2512 Agreement State license or NRC license or permit issued by a NRC master 35.50(b)(1)(ii).
2513 material licensee that authorizes similar type(s) of use(s) of radioactive material., With the introduction of the concept of an Associate RSO (as 2514 involving the following: An Associate Radiation Safety Officer may provide defined in Section 7.2) arising from the 2018 amendments to 2515 supervision for those areas for which the Associate Radiation Safety Part 35, the revised language in this requirement clarifies that 2516 Officer is authorized on a NRC or an Agreement State license or permit for an individual who is in the process of becoming a RSO for a medical licensee, the experience gained while under the 2517 issued by a NRC master material licensee. The full-time radiation safety supervision of an Associate RSO is acceptable for those 2518 experience must involve the following: areas for which the Associate RSO is authorized on the license.
2519 (a) Shipping, receiving, and performing related radiation surveys; 2520 (b) Using and performing checks for proper operation of dose 2521 calibratorsinstruments used to determine the activity of dosages, 2522 survey meters, and, if appropriate, instruments used to measure 2523 radionuclides; 2524 (c) Securing and controlling radioactive material;
Document 1 HRG Page 95 of 138 2525 (d) Using administrative controls to avoid mistakes in the administration of 2526 radioactive material; 2527 (e) Using procedures to prevent or minimize radioactive contamination and 2528 using proper decontamination procedures; 2529 (f) Using emergency procedures to control radioactive material; and 2530 (g) Disposing of radioactive material; 2531 and 2532 7A2.2 This individual must obtain a written attestation, signed by a preceptor RSO or 2533 ARSO who has experience with the radiation safety aspects of similar types of use 2534 of radioactive material for which the individual is seeking approval as a RSO or an 2535 ARSO. The written attestation must state that the individual has satisfactorily 2536 completed the requirements in 7A2.1 and 7A4 of Appendix 7A and is able to 2537 independently fulfill the radiation safety related duties as a RSO or as an ARSO for 2538 a medical use license; 2539 or 2540 7A3 Meets the following requirements: Commented [JJ188]: 35.50(c) 2541 7A3.1 Is a medical physicist who has been certified by a specialty board whose certification 2542 process has been recognized by the NRC or an Agreement State under Appendix 7B, 2543 Section 7B1, and has experience inwith the radiation safety aspects for of similar types 2544 of use of radioactive material for which the licensee is seekingseeks the approval of the 2545 individual as Radiation Safety OfficerRSO or an ARSO, and who meets the requirements 2546 in 7A4 and 7A5.
2547 or 2548 7A3.2 Is an authorized user, authorized medical physicist, or authorized nuclear pharmacist 2549 identified on the licensees license and has experience with the radiation safety aspects 2550 of similar types of use of radioactive materials for which the individual has RSO 2551 responsibilities;Is an authorized user, authorized medical physicist, or authorized 2552 nuclear pharmacist identified on a Department, NRC or an Agreement State 2553 license, a permit issued by a NRC master material license, a permit issued by a 2554 NRC or an Agreement State licensee of broad scope, or a permit issued by a NRC 2555 master material broad scope permitee, has experience with the radiation safety 2556 aspects of similar types of use of radioactive material for which the licensee seeks 2557 the approval of the individual as the RSO or ARSO, and meets the requirements in 2558 7A4; 2559 or 2560 7A3.3 Has experience with the radiation safety aspects of the types of use of radioactive Commented [JJ189]: 35.50(c)(3).
2561 material for which the individual is seeking simultaneous approval both as the 2562 Radiation Safety Officer and the authorized user on the same new medical use NRC Compatibility B RATS 2018-1 2563 permit issued by a NRC master material license. The individual must also meet the 2564 requirements in 7A4.
2565 and 2566 7A4 Has provided written attestation(s), signed by a preceptor RSO, that the individual has 2567 satisfactorily completed the requirements in 7A5 and in 7A1.1(1) and 7A1.1(2) or 7A1.2(1) and
Document 1 HRG Page 96 of 138 2568 7A1.2(2) or 7A2.1 or 7A3.1 or 7A3.2, and has achieved a level of radiation safety knowledge 2569 sufficient to function independently as an RSO for a medical use licensee; 2570 and 2571 7A57A4 Has training in the radiation safety, regulatory issues, and emergency procedures for the Commented [JJ190]: This provision is updated for 2572 types(s) of use for which a licensee seeks approval. This training requirement may be satisfied by consistency with the 2018 amendment to 10 CFR 35.50(d).
2573 completing training that is supervised by an RSO, Alternate RSO, an Associate RSO, authorized 2574 medical physicist, authorized nuclear pharmacist, or authorized user, as appropriate, who is 2575 authorized on an Agreement State or NRC license for the type(s) of use of radioactive material for 2576 which the licensee is seeking approval.
2577 and 2578 7A6 Meets the following recentness of training requirements: Commented [JJ191]:
Here and in multiple subsequent Appendices, the requirements for recentness of training have been relocated to 2579 7A6.1 The training and experience required by Appendix 7A shall have been obtained within the new provision 7.65 in order to consolidate the requirements in 2580 7 years preceding the date of license application or amendment request; one location in the rule. (The requirements of 7.65 parallel the requirements of 10 CFR 35.59.)
2581 or 2582 7A6.2 The individual must have had related, documented continuing education and experience 2583 since the required training and experience was obtained.
2584 or 2585 7A7 Meets the following requirements for an experienced Radiation Safety Officer: Commented [JJ192]:
Here and in multiple subsequent Appendices, the requirements for an experienced authorized individual is 2586 7A7.1 An individual identified as a Radiation Safety Officer on a license issued by the NRC or replaced with the requirements contained in (new) Appendix 2587 Agreement State, a permit issued under an NRC or Agreement State broad scope 7P in order to consolidate the requirements in one location.
2588 license before October 25, 2005, are not required to comply with the training 2589 requirements of 7A1 through 7A6.7A7.2 Individuals not required to comply with the The requirements of Appendix 7P parallel the requirements of 2590 training requirements of 7A1 through 7A6 may serve as preceptors for, and supervisors 10 CFR 35.57.
2591 of, applicants seeking authorization on licenses for the same uses for which these 2592 individuals are authorized.
2593 2594
Document 1 HRG Page 97 of 138 2595 PART 7, APPENDIX 7B: TRAINING FOR AN AUTHORIZED MEDICAL PHYSICIST (AMP) Commented [JJ193]: For final publication, insert a page break to ensure each new appendices begins at the top of the 2596 The licensee shall require each authorized medical physicist to be an individual who:Except as page.
2597 provided in Appendix 7P, the licensee shall require the authorized medical physicist to be an 2598 individual who:
2599 7B1 Is certified by a medical specialty board whose certification process has been recognized by the Commented [JJ194]: Appendix 7B is updated for 2600 NRC or an Agreement State and who meets the requirements in paragraph 7B2.3 and 7B3 of this consistency with the 2018 amendments to 10 CFR 35.51.
2601 Appendix. NRC recognized specialty boards are posted on the NRC website at NRC RATS 2018-1 2602 http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.Is certified by a NRC Compatibility B 2603 specialty board whose certification process has been recognized by the NRC or an 2604 Agreement State and who meets the requirements in 7B3 of this Appendix. The names of 2605 board certifications that have been recognized by the NRC or an Agreement State are 2606 posted on the NRCs Medical Uses Licensee Toolkit Web page. To have its certification 2607 process recognized, a specialty board shall require all candidates for certification to:
2608 7B1.1 To have its certification process recognized, a specialty board shall require all candidates 2609 for certification to:
2610 (1)7B1.1 Hold a master's or doctor's degree in physics, medical physics, other physical 2611 science, engineering, or applied mathematics from an accredited college or university; 2612 and 2613 (2)7B1.2 Have 2 years of full-time practical training and/or supervised experience in 2614 medical physics:
2615 (a1) Under the supervision of a medical physicist who is certified in medical physics 2616 by a specialty board whose certification process has been recognized under 2617 7B1 by the NRC or an Agreement State or NRC; 2618 or 2619 (b2) In clinical radiation facilities providing high energy, external beam therapy 2620 (photons and electrons with energies greater than or equal to 1 million electron 2621 volts) and brachytherapy services under the direction of physicians who meet the 2622 requirements for authorized users in 7B5Appendix 7P, Appendix 7K or Appendix 2623 7M; 2624 and 2625 (3)7B1.3 Pass an examination administered by diplomates of the specialty board, that 2626 assesses knowledge and competence in clinical radiation therapy, radiation safety, 2627 calibration, quality assurance, and treatment planning for external beam therapy, 2628 brachytherapy, and stereotactic radiosurgery; 2629 or 2630 7B2 Has satisfied the following criteria:
2631 7B2.1 Holds a master's or doctor's degree in physics, medical physics, other physical science, 2632 engineering, or applied mathematics from an accredited college or university; and has 2633 completed 1 year of full-time training in medical physics and an additional year of 2634 full-time work experience under the supervision of an individual who meets the 2635 requirements for an authorized medical physicist for the type(s) of use for which 2636 the individual is seeking authorization. This training and work experience must be
Document 1 HRG Page 98 of 138 2637 conducted in clinical radiation facilities that provide high-energy, external beam 2638 therapy (photons and electrons with energies greater than or equal to 1 million 2639 electron volts) and brachytherapy services and must include:
2640 and 2641 7B2.2 Has completed 1 year of full-time training in medical physics and an additional year of Commented [JSJ195]: This provision is replaced by the 2642 full-time work experience under the supervision of an individual who meets the prior updated provision in 7B2.1 in keeping with the format 2643 requirements for an authorized medical physicist for the type(s) of use for which the and flow of 10 CFR 35.51.
2644 individual is seeking authorization.
2645 (1) The training and work experience of 7B2.2 must be:
2646 Conducted in clinical radiation facilities that provide high-energy, external beam 2647 therapy (photons or electrons with energies greater than or equal to 1 MeV) and 2648 brachytherapy services and must include:
2649 (a1) Performing sealed source leak tests and inventories; 2650 (b2) Performing decay corrections; 2651 (c3) Performing full calibration and periodic spot checks of external beam treatment 2652 units, stereotactic radiosurgery units, and remote afterloading units as applicable; 2653 and 2654 (d4) Conducting radiation surveys around external beam treatment units, stereotactic 2655 radiosurgery units, and remote afterloading units as applicable; 2656 and 2657 7B2.32 Has obtained written attestation that the individual has satisfactorily completed the Commented [JJ196]: Updated for consistency with 10 CFR 2658 requirements in: 7B2.1 and 7B3, and is able to independently fulfill the radiation 35.51(b)(2).
2659 safety-related duties as an authorized medical physicist for each type of 2660 therapeutic medical unit for which the individual is requesting authorized medical 2661 physicist status. The written attestation must be signed by a preceptor authorized 2662 medical physicist who meets the requirements in Appendix 7B, Appendix 7P, or 2663 equivalent NRC or Agreement State requirements for an authorized medical 2664 physicist for each type of therapeutic medical unit for which the individual is 2665 requesting authorized medical physicist status.
2666 (1) 7B3 and 7B1.1(1) and 7B1.1(2);
2667 or 2668 (2) 7B2 and 7B3; 2669 and 2670 (3) Has achieved a level of competency sufficient to function independently as an 2671 authorized medical physicist for each type of therapeutic medical unit for which 2672 the individual is requesting authorized medical physicist status. The written 2673 attestation must be signed by a preceptor authorized medical physicist who 2674 meets the requirements in this Appendix (7B), 7B5, or equivalent NRC or 2675 Agreement State requirements for an authorized medical physicist for each type 2676 of therapeutic medical unit for which the individual is requesting authorized 2677 medical physicist status;
Document 1 HRG Page 99 of 138 2678 and 2679 7B3 Has met the following requirements: Commented [JSJ197]: This provision is replaced by revised 7B3 (below) to maintain the flow and format of 10 CFR 35.51(c).
2680 7B3.1 Has training for the type(s) of use for which authorization is sought that includes:
The requirements remain the same. Only the numbering and 2681 (1) Hands-on device operation, some phrasing has changed.
2682 (2) Safety procedures, 2683 (3) Clinical use, 2684 and 2685 (4) The operation of a treatment planning system.
2686 7B3.2 The training required by 7B3.1 may be satisfied by:
2687 (1) Satisfactorily completing a training program provided by the vendor; 2688 or 2689 Through training supervised by an authorized medical physicist authorized for the type(s) 2690 of use for which the individual is seeking authorization.
2691 7B3 Has training for the type(s) of use for which authorization is sought that includes hands-on 2692 device operation, safety procedures, clinical use, and the operation of a treatment 2693 planning system. This training requirement may be satisfied by satisfactorily completing 2694 either a training program provided by the vendor or by training supervised by an 2695 authorized medical physicist authorized for the type(s) of use for which the individual is 2696 seeking authorization.
2697 7B4 Meets the following recentness of training requirements:
2698 7B4.1 Training and experience required by Appendix 7B shall have been obtained within the 7 2699 years preceding the date of license application or amendment request; 2700 or 2701 7B4.2 The individual must have had related, documented, continuing education and experience 2702 since the required training and experience was obtained.
2703 or 2704 7B5 Meets the following requirements for an experienced authorized medical physicist:
2705 7B5.1 An individual identified as an authorized medical physicist on a license issued by the 2706 NRC or Agreement State, a permit issued under an NRC or Agreement State broad 2707 scope license before October 25, 2005, are not required to comply with the training 2708 requirements of 7B1 through 7B4.
2709 or 2710 2711 7B5.2 An experienced medical physicist who has demonstrated to the Department experience 2712 in the type(s) of use for which the individual is requesting authorized medical physicist
Document 1 HRG Page 100 of 138 2713 status (and thus need not comply with the specific training and experience requirements 2714 of 7B1 through 7B4):
2715 (1) Having been certified before October 25, 2005 by the American Board of 2716 Radiology in:
2717 (a) Therapeutic radiological physics; 2718 (b) Roentgen ray and gamma ray physics; 2719 (c) X-ray and radium physics; 2720 or 2721 (d) Radiological physics; 2722 or 2723 (2) Having been certified before October 25, 2005 by the American Board of Medical 2724 Physics in radiation oncology physics; 2725 and 2726 (3) Has sufficient work experience that includes the tasks listed in 7.13.2 and/or 2727 other sections of these regulations related to medical physics, as applicable 2728 (having also satisfied 7B2.1 and being trained in therapeutic radiological 2729 physics).
2730 7B5.3 Individuals not required to comply with the training requirements of 7B1 through 7B4 may 2731 serve as preceptors for, and supervisors of, applicants seeking authorization on licenses 2732 for the same uses for which these individuals are authorized.
2733
Document 1 HRG Page 101 of 138 2734 PART 7, APPENDIX 7C: TRAINING FOR AND AUTHORIZED NUCLEAR PHARMACIST (ANP) Commented [JJ198]: For final publication, insert a page break to ensure each new appendices begins at the top of the 2735 The licensee shall require each authorized nuclear pharmacist to be a pharmacist who has a page.
2736 current active Colorado State Board of Pharmacy license and who:Except as provided in Appendix 7C is amended, consistent with the 2018 revisions 2737 Appendix 7P, the licensee shall require the authorized nuclear pharmacist to be a pharmacist to 10 CFR 35.55.
2738 who:
NRC RATS 2018-1 NRC Compatibility B 2739 7C1 Is certified by a medical specialty board whose certification process has been recognized by the 2740 NRC or an Agreement State and who meets the requirements in paragraph 7C2.2 of this 2741 Appendix. NRC recognized specialty boards are posted on the NRC website at 2742 http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.Is certified by a 2743 specialty board whose certification process has been recognized by the NRC or an 2744 Agreement State. The names of board certifications that have been recognized by the NRC 2745 or an Agreement State are posted on the NRCs Medical Uses Licensee Toolkit Web page.
2746 To have its certification process recognized, a specialty board shall require all candidates 2747 for certification to:
2748 7C1.1 To have its certification process recognized, a specialty board shall require all candidates 2749 for certification to:
2750 (1)7C1.1 Have graduated from a pharmacy program accredited by the American Council 2751 on Pharmaceutical Education (ACPE) or have passed the Foreign Pharmacy 2752 Graduate Examination Committee (FPGEC) examination; 2753 (2)7C1.2 Hold a current, active license to practice pharmacy; 2754 (3)7C1.3 Provide evidence of having acquired at least 4000 hours0.0463 days <br />1.111 hours <br />0.00661 weeks <br />0.00152 months <br /> of training/experience in 2755 nuclear pharmacy practice. (aAcademic training may be substituted for no more 2756 than 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br /> of the required training and experience);
2757 and 2758 (4)7C1.3 Pass an examination, in nuclear pharmacy administered by diplomates of the 2759 specialty board, whichthat assesses knowledge and competency in 2760 procurement, compounding, quality assurance, dispensing, distribution, health 2761 and safety, radiation safety, provision of information and consultation, monitoring 2762 patient outcomes, and research and development.;
2763 or 2764 7C2 Has satisfied the following criteria:
2765 7C2.1 Has completed 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> in a structured educational program that includesconsisting of 2766 both:
2767 (1) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training in the following areas: Commented [JJ199]: 35.55(b)(1)(i)(A) - (E)
(a) = 35.55(b)(1)(i)(A) 2768 (a) Radiation physics and instrumentation; (b) = 35.55(b)(1)(i)(B)
(c) = 35.55(b)(1)(i)(C) 2769 (b) Radiation protection; (d) = 35.55(b)(1)(i)(D)
(e) = 35.55(b)(1)(i)(E) 2770 (c) Mathematics pertaining to the use and measurement of radioactivity; 2771 (d) Chemistry of radioactive material for medical use; and 2772 (e) Radiation biology;
Document 1 HRG Page 102 of 138 2773 and 2774 (2) Supervised practical experience in nuclear pharmacy involving: Commented [JJ200]: 35.55(b)(1)(ii)(A) - (E)
= (a) through (e) 2775 (a) Shipping, receiving, and performing related radiation surveys; 2776 (b) Using and performing checks for proper operation of instruments to 2777 determine the activity of dosages, survey meters, and, if appropriate, 2778 instruments used to measure alpha- or beta-emitting radionuclides; 2779 (c) Calculating, assaying, and safely preparing dosages for patients or 2780 human research subjects; 2781 (d) Using administrative controls to avoid misadministrationsmedical events 2782 in the administration of radioactive material; 2783 and 2784 (e) Using procedures to prevent or minimize radioactive contamination and 2785 using proper decontamination procedures; 2786 and 2787 7C2.2 Has provided obtained written attestation(s), signed by a preceptor authorized nuclear Commented [JJ201]: Updated for consistency with 2788 pharmacist, that the individual has satisfactorily completed the requirements in 7C1.1(1), 35.55(b)(2).
2789 7C1.1(2), and 7C1.1(3) or 7C27C2.1, and has achieved a level of competency sufficient NRC Compatibility B 2790 to function independently is able to independently fulfill the radiation safety related RATS 2018-1 2791 duties as an authorized nuclear pharmacist.
2792 and 2793 7C3 Meets the following recentness of training requirements:
2794 7C3.1 The training and experience required by Appendix 7C shall have been obtained within the 2795 7 years preceding the date of license application or amendment request; 2796 or 2797 7C3.2 The individual must have had related, documented, continuing education and experience 2798 since the required training and experience was obtained.
2799 or 2800 7C4 Meets the following requirements for an experienced authorized nuclear pharmacist.
2801 7C4.1 An individual identified as an authorized nuclear pharmacist on a license issued by the 2802 NRC or Agreement State, a permit issued under an NRC or Agreement State broad 2803 scope license before October 25, 2005, are not required to comply with the training 2804 requirements of 7C1 through 7C3.
2805 7C4.2 Individuals not required to comply with the training requirements of 7C1 through 7C3 may 2806 serve as preceptors for, and supervisors of, applicants seeking authorization on licenses 2807 for the same uses for which these individuals are authorized.
2808
Document 1 HRG Page 103 of 138 2809 PART 7, APPENDIX 7D: AUTHORIZED USER TRAINING FOR UPTAKE, DILUTION AND EXCRETION Commented [JJ202]:
2810 STUDIES (7.30 USES) For final publication, insert a page break to ensure each new 2811 The licensee shall require an authorized user of an unsealed radioactive material for the uses authorized appendices begins at the top of the page.
2812 under 7.30 to be a physician who has a current active State of Colorado license and:Except as provided Appendix 7D is updated for consistency with the 2018 2813 in Appendix 7P, the licensee shall require an authorized user of unsealed radioactive material for amendments to 10 CFR 35.190.
2814 the uses authorized under 7.30 to be a physician who:
2815 Appendix 7D has been realigned/formatted for consistency with the formatting of other sections of Part 7 and with the flow 2816 7D1 Is certified by a medical specialty board whose certification process has been recognized by the and format of 10 CFR 35.
2817 NRC or an Agreement State. and who meets the requirements in paragraph 7D3.2 of this 2818 Appendix. NRC recognized specialty boards are posted on the NRC website at Compatibility B 2819 http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html. The names of board NRC RATS 2018-1 2820 certifications that have been recognized by the NRC or an Agreement State are posted on 2821 the NRCs Medical Uses Licensee Toolkit web page. To have its certification process 2822 recognized, a specialty board shall require all candidates for certification to:
2823 7D1.1 To have its certification process recognized, a specialty board shall require that all 2824 candidates for certification to:(1)Complete 60 hours6.944444e-4 days <br />0.0167 hours <br />9.920635e-5 weeks <br />2.283e-5 months <br /> of training and experience in basic 2825 radionuclide handling techniques and radiation safety applicable to the medical use of unsealed 2826 radioactive materials for uptake, dilution, and excretion studies as described in 7D3.1(1) through 2827 7D3.1(2)(f);
2828 and 2829 (2)7D1.2 Pass an examination, administered by diplomates of the specialty board, that 2830 assesses knowledge and competence in radiation safety, radionuclide handling, and quality 2831 control.;
2832 or 2833 7D2 Is an authorized user under Appendix 7E, Appendix 7F, or equivalent Agreement State or NRC 2834 requirements; or 7D3 2835 or 2836 7D3 Has satisfied the following criteria: Commented [JSJ203]: Section 7D3 has been realigned/formatted for consistency with other sections of Part 2837 7D3.1 Has satisfactorily completed 60 hours6.944444e-4 days <br />0.0167 hours <br />9.920635e-5 weeks <br />2.283e-5 months <br /> of training and experience, including a minimum of 7 and the flow and format of 10 CFR 35.
2838 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> of classroom and laboratory training, in basic radionuclide handling techniques applicable 7D3 is an unnumbered header to align with 10 CFR Part 35 2839 to the medical use of unsealed radioactive materials for uptake, dilution, and excretion studies. structure.
2840 The training and experience must include:
2841 (1) Classroom and laboratory training in the following areas:
2842 (a) Radiation physics and instrumentation; 2843 (b) Radiation protection; 2844 (c) Mathematics pertaining to the use and measurement of radioactivity; 2845 (d) Chemistry of radioactive material for medical use; and 2846 (e) Radiation biology; 2847 and 2848 (2) Work experience under the supervision of an authorized user who meets the 2849 requirements of 7D5in Appendix 7P, 7D, 7E, 7F, or equivalent Agreement State 2850 or NRC requirements, involving:
2851 (a) Ordering, receiving, and unpacking radioactive materials safely and 2852 performing the related radiation surveys; 2853 (b) Performing quality control procedures on instruments used to determine 2854 the activity of dosages and performing checks for proper operation of 2855 survey meters; 2856 (c) Calculating, measuring, and safely preparing patient or human research 2857 subject dosages;
Document 1 HRG Page 104 of 138 2858 (d) Using administrative controls to prevent a misadministrationmedical 2859 event involving the use of unsealed radioactive material; 2860 (e) Using procedures to contain spilled radioactive material safely and using 2861 proper decontamination procedures; and 2862 (f) Administering dosages to patients or human research subjects; 2863 And 2864 7D3.2 Has provided written attestation(s), signed by a preceptor authorized user who meets the Commented [JSJ204]: Here, and in other appendices 2865 requirements of 7D5, Appendix 7D, Appendix 7E, or Appendix 7F, or equivalent governing training requirements for authorized users, the 2866 Agreement State or NRC requirements, that the individual has satisfactorily completed requirements for attestation statements are revised, consistent with the 2018 amendments to 10 CFR 35.
2867 the requirements in 7D1.1(1) or 7D3.1, and has achieved a level of competency sufficient 2868 to function independently as an authorized user for the medical uses authorized under In general, the requirements for a physician to become an 2869 7.30.Has obtained written attestation that the individual has satisfactorily authorized user to be named on a license for a specific type of 2870 completed the requirements in 7D3.1 and is able to independently fulfill the radioactive materials use are through one of three mechanisms:
2871 radiation safety-related duties as an authorized user for the medical uses (1) they are currently a named authorized user on an existing 2872 authorized under 7.30. The attestation must be obtained from either: Department, NRC or other agreement state license; OR 2873 (1) A preceptor authorized user who meets the requirements in Appendix 7P, (2) they are board certified by a board that has been 2874 Appendix 7D, Appendix 7E, or Appendix 7F, or equivalent NRC or recognized by the Department, NRC or an agreement state for the particular type of use; OR 2875 Agreement State requirements; or (3) they do not yet meet the requirements of (1) or (2) and 2876 (2) A residency program director who affirms in writing that the attestation therefore must demonstrate adequate training and experience 2877 represents the consensus of the residency program faculty where at least through the alternate pathway mechanism and provide a 2878 one faculty member is an authorized user who meets the requirements in signed preceptor statement.
2879 Appendix 7P, Appendix 7D, Appendix 7E, Appendix 7F, or equivalent NRC The proposed language provides some regulatory relief by no 2880 or Agreement State requirements, and concurs with the attestation longer requiring a preceptor statement for individuals who are 2881 provided by the residency program director. The residency training board certified by a recognized board.
2882 program must be approved by the Residency Review Committee of the The revised language of this appendices allows for residency 2883 Accreditation Council for Graduate Medical Education or the Royal College program directors to sign off/provide the attestations for 2884 of Physicians and Surgeons of Canada or the Council on Postdoctoral individuals who are demonstrating training through the 2885 Training of the American Osteopathic Association and must include alternate pathway.
2886 training and experience specified in 7D3.1.
2887 and 2888 7D4 Meets the following recentness of training requirements:
2889 7D4.1 The training and experience required by Appendix 7D shall have been obtained within the 2890 7 years preceding the date of license application or amendment request; or 2891 7D4.2 The individual must have had related, documented, continuing education and experience 2892 since the required training and experience was obtained.
2893 or 2894 7D5 Meets the following requirements for an experienced authorized user for 7.30 uses:
2895 7D5.1 An individual identified as an authorized user for the medical use of radioactive material 2896 on a license issued by the NRC or Agreement State, a permit issued under an NRC or 2897 Agreement State broad scope license that authorizes medical use before October 25, 2005, 2898 who perform only those medical uses for which they were authorized on that date are not 2899 required to comply with the training requirements of 7D1 through 7D4.
2900 7D5.2 Individuals not required to comply with the training requirements of 7D1 through 7D4 may 2901 serve as preceptors for, and supervisors of, applicants seeking authorization on licenses 2902 for the same uses for which these individuals are authorized.
2903
Document 1 HRG Page 105 of 138 2904 PART 7, APPENDIX 7E: AUTHORIZED USER TRAINING FOR IMAGING AND LOCALIZATION Commented [JJ205]: For final publication, insert a page 2905 STUDIES (7.32 USES) break such that each appendix begins on a new page.
This appendix is updated for format and content, consistent 2906 The licensee shall require an authorized user of an unsealed radioactive material for the uses with the 2018 amendments to 10 CFR 35.290.
2907 authorized under 7.32 to be a physician who has a current active State of Colorado license 2908 and:Except as provided in Appendix 7P, the licensee shall require an authorized user of unsealed 2909 radioactive material for the uses authorized under 7.32 to be a physician who:
2910 7E1 Is certified by a medical specialty board whose certification process has been recognized by the 2911 NRC or an Agreement State and who meets the requirements in paragraph 7E3.2 of this 2912 Appendix. NRC recognized specialty boards are posted on the NRC website at 2913 http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html. Is certified by a 2914 medical specialty board whose certification process has been recognized by the NRC or 2915 an Agreement State. The names of board certifications that have been recognized by the 2916 NRC or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit web 2917 page. To have its certification process recognized, a specialty board shall require all 2918 candidates for certification to:
2919 7E1.1 To have its certification process recognized, a specialty board shall require all candidates 2920 for certification to:
2921 (1) 2922 7E1.1 Complete 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and experience in basic radionuclide handling techniques 2923 and radiation safety applicable to the medical use of unsealed radioactive materials for 2924 imaging and localization studies as described in 7E3.1(1) through 7E3.1(2)(g);
2925 and 2926 (2) 2927 7E1.2 Pass an examination, administered by diplomates of the specialty board, which assesses 2928 knowledge and competence in radiation safety, radionuclide handling, and quality control; 2929 or 2930 7E2 Is an authorized user under Appendix 7F and meets the requirements in 7E3.1(2)(g), or 2931 equivalent Agreement State or NRC requirements; 2932 or 2933 7E3 Has satisfied the following criteria:
2934 7E3.1 Has satisfactorily completed 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />, including a minimum of 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom 2935 and laboratory training in basic radionuclide handling techniques applicable to the 2936 medical use of unsealed radioactive materials for imaging and localization studies. The 2937 training and experience must include at a minimum:
2938 (1) Classroom and laboratory training in the following areas:
2939 (a) Radiation physics and instrumentation; 2940 (b) Radiation protection; 2941 (c) Mathematics pertaining to the use and measurement of radioactivity;
Document 1 HRG Page 106 of 138 2942 (d) Chemistry of radioactive material for medical use; and 2943 (e) Radiation biology; 2944 and 2945 (2) Work experience under the supervision of an authorized user who meets the 2946 requirements of 7E5, 7E, or 7F and 7E3.1(2)(g), or equivalent Agreement State 2947 or NRC requirements, involving:
2948 2949 (2) Work experience, under the supervision of an authorized user who meets 2950 the requirements in Appendix 7P, 7E, or 7F and 7E3.1(2)(g), or equivalent 2951 NRC or Agreement State requirements. An authorized nuclear pharmacist 2952 who meets the requirements in Appendix 7C or Appendix 7P may provide 2953 the supervised work experience for 7E3.1(2)(g). Work experience must 2954 involve:
2955 (a) Ordering, receiving, and unpacking radioactive materials safely and 2956 performing the related radiation surveys; 2957 (b) Performing quality control procedures on instruments used to determine 2958 the activity of dosages and performing checks for proper operation of 2959 survey meters; 2960 (c) Calculating, measuring, and safely preparing patient or human research 2961 subject dosages; 2962 (d) Using administrative controls to prevent a misadministrationmedical 2963 event involving the use of unsealed radioactive material; 2964 (e) Using procedures to safely contain spilled radioactive material safely 2965 and using proper decontamination procedures; and 2966 (f) Administering dosages to patients or human research subjects; and 2967 (g) Eluting generator systems appropriate for preparation of radioactive 2968 drugs for imaging and localization studies, measuring and testing the 2969 eluate for radiochemical purity, and processing the eluate with reagent 2970 kits to prepare labeled radioactive drugs; 2971 and 2972 7E3.2 Has provided written attestation(s), signed by a preceptor authorized user who meets the 2973 requirements of 7E5, Appendix 7E, or Appendix 7F and 7E3.1(2)(g), or equivalent 2974 Agreement State or NRC requirements, that the individual has satisfactorily completed 2975 the requirements in 7E1.1(1) or 7E3, and has achieved a level of competency sufficient to 2976 function independently as an authorized user for the medical uses authorized under 7.30 2977 and 7.32. Has obtained written attestation that the individual has satisfactorily 2978 completed the requirements in 7E3.1 and is able to independently fulfill the 2979 radiation safety-related duties as an authorized user for the medical uses 2980 authorized under 7.30 and 7.32. The attestation must be obtained from either:
2981 2982 (1) A preceptor authorized user who meets the requirements in Appendix 7P, 2983 7E, or 7F and 7E3.1(2)(g), or equivalent NRC or Agreement State 2984 requirements; 2985 2986 or 2987
Document 1 HRG Page 107 of 138 2988 (2) A residency program director who affirms in writing that the attestation Commented [JSJ206]: The requirements for attestation 2989 represents the consensus of the residency program faculty where at least statements are revised, consistent with the 2018 amendments 2990 one faculty member is an authorized user who meets the requirements in to 10 CFR 35.
2991 Appendix 7P, 7E, or 7F and 7E3.1(2)(g), or equivalent NRC or Agreement The revised language of this provision allows for residency 2992 State requirements, and concurs with the attestation provided by the program directors to sign off/provide the attestations for 2993 residency program director. The residency training program must be individuals who are demonstrating training through the 2994 approved by the Residency Review Committee of the Accreditation Council alternate pathway.
2995 for Graduate Medical Education or the Royal College of Physicians and 2996 Surgeons of Canada or the Council on Postdoctoral Training of the 2997 American Osteopathic Association and must include training and 2998 experience specified in 7E3.1.
2999 and 3000 7E4 Meets the following recentness of training requirements: Commented [JSJ207]: Requirements for recentness of training is now addressed in 7.65 3001 7E4.1 The training and experience required by Appendix 7E shall have been obtained within the 3002 7 years preceding the date of license application or amendment request; 3003 or 3004 7E4.2 The individual must have had related, documented, continuing education and experience 3005 since the required training and experience was obtained.
3006 or 3007 7E5 Meets the following requirements for an experienced authorized user for 7.32 uses: Commented [JSJ208]: Training for experienced individuals is now addressed in Appendix 7P.
3008 7E5.1 An individual identified as an authorized user for the medical use of radioactive material 3009 on a license issued by the NRC or Agreement State, a permit issued under an NRC or 3010 Agreement State broad scope license that authorizes medical use before October 25, 3011 2005, who perform only those medical uses for which they were authorized on that date 3012 are not required to comply with the training requirements of 7E1 through 7E4.7E5.2 3013 Individuals not required to comply with the training requirements of 7E1 through 7E4 may 3014 serve as preceptors for, and supervisors of, applicants seeking authorization on licenses 3015 for the same uses for which these individuals are authorized.
3016 3017
Document 1 HRG Page 108 of 138 3018 PART 7, APPENDIX 7F: AUTHORIZED USER TRAINING FOR DIAGNOSTIC OR THERAPEUTIC USE Commented [JJ209]: For final publication, insert a page 3019 OF UNSEALED RADIOACTIVE MATERIAL REQUIRING FOR WHICH A WRITTEN DIRECTIVE IS break such that each appendix begins on a new page.
3020 REQUIRED (7.36.2 USES)
Changes to this appendix are based on the 2018 amendments 3021 to 10 CFR 35.390.
3022 The licensee shall require an authorized user of an unsealed radioactive material for the uses 3023 authorized under 7.36.2 to be a physician who has a current active State of Colorado license and: NRC RATS 2018-1 3024 Except as provided in Appendix 7P, the licensee shall require an authorized user of unsealed All of 10 CFR 35.390 is NRC compatibility B 3025 radioactive material for the uses authorized under 7.36 to be a physician who:
3026 7F1 Is certified by a medical specialty board whose certification process has been recognized by the 3027 NRC or an Agreement State and who meets the requirements in paragraph 7F2.1(2)(f) and 7F2.2 3028 of this Appendix. NRC recognized specialty boards are posted on the NRC website at 3029 http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.
3030 3031 7F1 Is certified by a medical specialty board whose certification process has been recognized Commented [JSJ210]:
3032 by the NRC or an Agreement State and who meets the requirements in 7F2.1(2)(f). The Consistent with federal rule, this provision is amended to 3033 names of board certifications that have been recognized by the NRC or an Agreement eliminate the requirement for a preceptor statement for individuals who have a board certification identified on NRCs 3034 State are posted on the NRC's Medical Uses Licensee Toolkit web page. To be recognized, medical toolkit web page for the applicable use. The board 3035 a specialty board shall require all candidates for certification to: certification combined with the recentness of training requirements (found in 7.65) are deemed acceptable to demonstrate adequate training and experience for regulatory 3036 7F1.1 To have its certification process recognized, a specialty board shall require all candidates purposes.
3037 for certification to:
3038 (1) Successfully complete residency training in a radiation therapy or nuclear medicine Commented [JSJ211]:
3039 training program or a program in a related medical specialty. These residency training Revised to use the correct terminology for the residency 3040 programs must include 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and experience as described in 7F2.1(1) approval organization of the American Osteopathic Association.
3041 through 7F2.1(2)(e). Eligible training programs must be approved by the Residency 3042 Review Committee of the Accreditation Council for Graduate Medical Education, the 3043 Royal College of Physicians and Surgeons of Canada, or the Committee on Post-3044 GraduateCouncil on Postdoctoral Training of the American Osteopathic Association; 3045 and 3046 (2)7F1.2 Pass an examination, administered by diplomates of the specialty board, which 3047 tests knowledge and competence in radiation safety, radionuclide handling, quality 3048 assurance, and clinical use of unsealed radioactive material for which a written directive 3049 is required; 3050 or 3051 7F2 Has satisfied the following criteria:
3052 7F2.1 Has satisfactorily completed 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and experience, including a minimum Commented [JSJ212]: Clarifying wording added for 3053 of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training, in basic radionuclide handling consistency with 10 CFR Part 35.390(b)(1).
3054 techniques applicable to the medical use of unsealed radioactive material requiring a Ref: NRC Letter 02/20/2020 3055 written directive. The training and experience must include:
3056 (1) Classroom and laboratory training in the following areas:
3057 (a) Radiation physics and instrumentation; 3058 (b) Radiation protection; 3059 (c) Mathematics pertaining to the use and measurement of radioactivity; 3060 (d) Chemistry of radioactive material for medical use; and
Document 1 HRG Page 109 of 138 3061 (e) Radiation biology; 3062 and 3063 (2) Work experience, under the supervision of an authorized user who meets the 3064 requirements of 7F4Appendix 7P, or 7F, or equivalent Agreement State or NRC 3065 requirements. A supervising authorized user, who meets the requirements in 3066 7F2.1, must also have experience in administering dosages in the same dosage 3067 category or categories (i.e., 7F2.1(2)(f)) as the individual requesting authorized 3068 user status. The work experience must involve:
3069 (a) Ordering, receiving, and unpacking radioactive materials safely and 3070 performing the related radiation surveys; 3071 (b) Performing quality control procedures on instruments used to determine 3072 the activity of dosages and performing checks for proper operation of 3073 survey meters; 3074 (c) Calculating, measuring, and safely preparing patient or human research 3075 subject dosages; 3076 (d) Using administrative controls to prevent a misadministrationmedical 3077 event involving the use of unsealed radioactive material; 3078 (e) Using procedures to contain spilled radioactive material safely and using 3079 proper decontamination procedures; 3080 and 3081 (f) Administering dosages of radioactive drugs to patients or human Commented [JJ213]: Updated for consistency with 10 CFR 3082 research subjects involving a minimum of 3 cases in each of the 35.390(b)(1)(ii)(G).
3083 following categories for which the individual is requesting authorized user NRC Compatibility B 3084 status:Administering dosages of radioactive drugs to patients or 3085 human research subjects from the three categories in 7F2.1(2)(f).
3086 Radioactive drugs containing radionuclides in categories not 3087 included in 7F2.1(2)(f) are regulated under 7.62. This work 3088 experience must involve a minimum of three cases in each of the 3089 following categories for which the individual is requesting 3090 authorized user status:
3091 (i) Oral administration of less than or equal to 1.22 3092 GBqgigabecquerels (33 mCimillicuries) of Nasodium iodide I-3093 131, for which a written directive is required; 3094 (ii) Oral administration of greater than 1.22 GBq (33 mCi) of Na I- Commented [JSJ214]: Note that footnote 2 is associated 3095 131 for which a written directive is required [experience with at with this provision.
3096 least 3 cases in 7F2.1(2)(f)(ii) also satisfies the requirement in 3097 category 7F2.1(2)(f)(i)];Oral administration of greater than 3098 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131;2 3099 (iii) Parenteral administration of any radioactive drug that contains 3100 a radionuclide that is primarily used for its electron 3101 emission, beta emitterradiation characteristics, alpha 3102 radiation characteristics, or a photon-emitting radionuclide with 3103 a photon energy less than 150 keV, for which a written directive 3104 is required;
Document 1 HRG Page 110 of 138 3105 and/or 3106 (iv) Parenteral administration of any other radionuclide for which a 3107 written directive is required; 3108 and 3109 7F2.2 Has provided written attestation(s), that the individual has satisfactorily completed the 3110 requirements in 7F1.1(1) and 7F2.1(2)(f) or 7F2.1, and has achieved a level of 3111 competency sufficient to function independently as an authorized user for the medical 3112 uses authorized under 7.36. The written attestation must be signed by a preceptor 3113 authorized user who:Has obtained written attestation that the individual has 3114 satisfactorily completed the requirements in 7F2.1 and is able to independently 3115 fulfill the radiation safety-related duties as an authorized user for the medical uses 3116 authorized under 7.36. The attestation must be obtained from either:
3117 (1) Meets the requirements in 7F4, Appendix 7F, or equivalent NRC or Agreement Commented [JSJ215]: This provision is revised, based on 3118 State requirements; andA preceptor authorized user who meets the the 2018 amendments to 10 CFR 35.390(b)(2)(i) and replaces 3119 requirements in 7P, 7F, or equivalent Agreement State requirements and the language in the current 7F2.2(2).
3120 has experience in administering dosages in the same dosage category or The previously referenced requirements of 7F4 are now 3121 categories as the individual requesting authorized user status; or addressed in Appendix 7P.
The revised provision clarifies that the preceptor must have 3122 (2) The preceptor authorized user, who meets the requirements in 7F2.1 must have experience administering materials in the same categories as 3123 experience in administering dosages in the same dosage category or categories the individual requesting authorization. This provision would 3124 (i.e., 7F2.1(2)(f)) as the individual requesting authorized user status.A residency apply to an individual who may be an authorized user named 3125 program director who affirms in writing that the attestation represents the on a license for other types of use, but would like obtain 3126 consensus of the residency program faculty where at least one faculty authorization in 7F.
3127 member is an authorized user who meets the requirements in 7P, 7F, or 3128 equivalent Agreement State or NRC requirements, has experience in Commented [JSJ216]: This is a new provision based on the 2018 amendments to 10 CFR 35.390(b)(2)(ii).
3129 administering dosages in the same dosage category or categories as the 3130 individual requesting authorized user status, and concurs with the For recent graduates of medical training programs, the revised 3131 attestation provided by the residency program director. The residency language of this provision allows for residency program 3132 training program must be approved by the Residency Review Committee of directors to sign off/provide the attestations for individuals who are demonstrating training through the alternate pathway.
3133 the Accreditation Council for Graduate Medical Education or the Royal 3134 College of Physicians and Surgeons of Canada or the Council on 3135 Postdoctoral Training of the American Osteopathic Association and must 3136 include training and experience specified in 7F2.1.
3137 2
3138 Experience with at least three cases in Category 7F2.1(2)(f)(ii) also satisfies the requirement in 3139 Category 7F2.1(2)(f)(i).
3140 and 3141 7F3 Meets the following recentness of training requirements: Commented [JSJ217]:
This provision has been replaced by 7.65, which parallels the requirements of 10 CFR 35.59.
3142 7F3.1 The training and experience required by Appendix 7F shall have been obtained: within 3143 the 7 years preceding the date of license application or amendment request; 3144 or 3145 7F3.2 The individual must have had related, documented, continuing education and experience 3146 since the required training and experience was obtained.
3147 or 3148 7F4 Meets the following requirements for an experienced authorized user for 7.36.2 uses: Commented [JSJ218]: This provision has been replaced by Appendix 7P, consistent with the format of 10 CFR 35.390.
Document 1 HRG Page 111 of 138 3149 7F4.1 An individual identified as an authorized user for the medical use of radioactive material 3150 on a license issued by the NRC or Agreement State, a permit issued under an NRC or 3151 Agreement State broad scope license that authorizes medical use before October 25, 3152 2005, who perform only those medical uses for which they were authorized on that date 3153 are not required to comply with the training requirements of 7F1 through 7F3.
3154 7F4.2 Individuals not required to comply with the training requirements of 7F1 through 7F3 may 3155 serve as preceptors for, and supervisors of, applicants seeking authorization on licenses 3156 for the same uses for which these individuals are authorized.
3157
Document 1 HRG Page 112 of 138 3158 PART 7, APPENDIX 7G: AUTHORIZED USER TRAINING FOR THE ORAL ADMINISTRATION OF Commented [JJ219]: For final publication, insert a page 3159 SODIUM IODIDE I-131 REQUIRING A WRITTEN DIRECTIVE IN QUANTITIES LESS THAN OR break such that each appendix begins on a new page.
3160 EQUAL TO 1.22 Gbqgigabeckquerels I (33 mCimillicuries) (7.36.3 USES)
Appendix 7G is updated for consistency with 10 CFR 35.392.
3161 The licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a 3162 written directive in quantities less than or equal to 1.22 GBq (33 mCi), to be a physician who has a current 3163 active State of Colorado license and:Except as provided in Appendix 7P, the licensee shall require 3164 an authorized user for the oral administration of sodium iodide requiring a written directive in 3165 quantities less than or equal to 1.22 Gigabecquerels (33 millicuries), to be a physician who:
3166 3167 7G1 Is certified by a medical specialty board whose certification process includes all of the Commented [JSJ220]:
3168 requirements in 7G3.1 and 7G3.1(2)7G3.2 of this Appendix and whose certification process has Consistent with federal rule, this provision is amended to 3169 been recognized by the NRC or an Agreement State. and who meets the requirements in eliminate the requirement for a preceptor statement for individuals who have a board certification identified on NRCs 3170 paragraph 7G3.1(3) of this Appendix. NRC recognized specialty boards are posted on the NRC medical toolkit web page for the applicable use. The board 3171 website at http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.The names of certification combined with the recentness of training 3172 board certifications that have been recognized by the NRC or an Agreement State are requirements (found in 7.65) are deemed acceptable to 3173 posted on the NRC's Medical Uses Licensee Toolkit web page; demonstrate adequate training and experience for regulatory purposes.
3174 or 3175 7G2 Is an authorized user under Appendix 7F for uses listed in 7F2.1(2)(f)(i) or 7F2.1(2)(f)(ii),
3176 Appendix 7H, or equivalent NRC or Agreement State requirements; 3177 or 3178 7G3 Has satisfied the following criteria:
3179 7G3.1 Has satisfactorilysuccessfully completed 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and laboratory training, 3180 applicable to the medical use of sodium iodide I-131 for procedures requiring a written 3181 directive.: The training must include:
3182 (1) The 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and laboratory training must include:
3183 (a1) Radiation physics and instrumentation; 3184 (b2) Radiation protection; 3185 (c3) Mathematics pertaining to the use and measurement of radioactivity; 3186 (d4) Chemistry of radioactive material for medical use; and 3187 (e5) Radiation biology; 3188 and 3189 7G3.2(2) Has work experience, under the supervision of an authorized user who meets the 3190 requirements of 7G5in Appendix 7P, or Appendix 7F, Appendix 7G, Appendix 7H or 3191 equivalent Agreement State or NRC requirements. A supervising authorized user, who 3192 meets the requirements in 7F2.1, must also have experience in administering dosages as 3193 specified in 7F2.1(2)(f)(i) or 7F2.1(2)(f)(ii). as the individual requesting authorized user 3194 status. The work experience must involve:
3195 (a1) Ordering, receiving, and unpacking radioactive materials safely and performing 3196 the related radiation surveys;
Document 1 HRG Page 113 of 138 3197 (b2) Performing quality control procedures on instruments used to determine the 3198 activity of dosages and performing checks for proper operation of survey meters; 3199 (c3) Calculating, measuring, and safely preparing patient or human research subject 3200 dosages; 3201 (d4) Using administrative controls to prevent a misadministrationmedical event 3202 involving the use of unsealed radioactive material; 3203 (e5) Using procedures to contain spilled radioactive material safely and using proper 3204 decontamination procedures; 3205 and 3206 (f6) Administering dosages to patients or human research subjects that includes at 3207 least 3 cases involving the oral administration of less than or equal to 1.22 3208 gigabecquerels (33 millicuries) of sodium iodide I-131; 3209 and 3210 7G3.3(3) Has provided written attestation(s), that the individual has completed the 3211 requirements of 7G3.1(1) and 7G3.1(2), and has achieved a level of competency 3212 sufficient to function independently as an authorized user for the medical uses of 3213 unsealed radioactive materials using Na I-131 authorized under 7.36. The written 3214 attestation must be signed by a preceptor authorized user who:Has obtained written 3215 attestation that the individual has satisfactorily completed the requirements in 3216 7G3.1 and 7G3.2, and is able to independently fulfill the radiation safety-related 3217 duties as an authorized user for oral administration of less than or equal to 1.22 3218 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized 3219 under 7.36. The attestation must be obtained from either:
3220 (a1) A preceptor authorized user who Mmeets the requirements in 7G5Appendix Commented [JSJ221]:
3221 7P, Appendix 7F, Appendix 7G, or Appendix 7H, or equivalent NRC or The revised provision clarifies that the preceptor must have 3222 Agreement State requirements and has experience administering dosages as experience administering materials in the same categories as the individual requesting authorization. This provision would 3223 specified in 7F2.1(2)(f)(i) or 7F2.1(2)(f)(ii); apply to an individual who may be an authorized user named on a license for other types of use, but would like obtain 3224 andor authorization for uses under 7G.
3225 (b) The preceptor authorized user, who meets the requirements in 7F2.1 must have 3226 experience in administering dosages as specified in 7F2.1(2)(f)(i) or 7F2.1(2)(f)(ii).
3227 (2) A residency program director who affirms in writing that the attestation Commented [JSJ222]: This provision is new, based on the 3228 represents the consensus of the residency program faculty where at least 2018 amendments to 10 CFR 35.392(c)(3)(ii).
3229 one faculty member is an authorized user who meets the requirements in For recent graduates, the revised language of this provision 3230 Appendix 7P, Appendix 7F, Appendix 7G, Appendix 7H, or equivalent NRC allows for residency program directors to sign off/provide the 3231 or Agreement State requirements, has experience in administering dosages attestations for individuals who are demonstrating training 3232 as specified in 7F2.1(2)(f)(i) or 7F2.1(2)(f)(ii), and concurs with the through the alternate pathway.
3233 attestation provided by the residency program director. The residency 3234 training program must be approved by the Residency Review Committee of 3235 the Accreditation Council for Graduate Medical Education or the Royal 3236 College of Physicians and Surgeons of Canada or the Council on 3237 Postdoctoral Training of the American Osteopathic Association and must 3238 include training and experience specified in 7G3.1 and 7G3.2.
3239 and 3240 7G4 Meets the following recentness of training requirements:
3241 7G4.1 The training and experience required by Appendix 7G shall have been obtained within 3242 the 7 years preceding the date of license application or amendment request;
Document 1 HRG Page 114 of 138 3243 or 3244 7G4.2 The individual must have had related, documented, continuing education and experience 3245 since the required training and experience was obtained.
3246 or 3247 7G5 Meets the following requirements for an experienced authorized user for 7.36.3 uses:
3248 7G5.1 An individual identified as an authorized user for the medical use of radioactive material 3249 on a license issued by the NRC or Agreement State, a permit issued under an NRC or 3250 Agreement State broad scope license that authorizes medical use before October 25, 3251 2005, who perform only those medical uses for which they were authorized on that date 3252 are not required to comply with the training requirements of 7G1 through 7G4.
3253 7G5.2 Individuals not required to comply with the training requirements of 7G1 through 7G4 may 3254 serve as preceptors for, and supervisors of, applicants seeking authorization on licenses 3255 for the same uses for which these individuals are authorized.
3256
Document 1 HRG Page 115 of 138 3257 PART 7, APPENDIX 7H: AUTHORIZED USER TRAINING FOR THE ORAL ADMINISTRATION OF Commented [JJ223]: For final publication, insert a page 3258 SODIUM IODIDE I-131 REQUIRING A WRITTEN DIRECTIVE IN QUANTITIES GREATER THAN 1.22 break such that each appendix begins on a new page.
3259 GBqGIGABECQUERELS (33 mCimillicuries) (7.36.4 USES)
Appendix 7H is updated for consistency with the format and 3260 The licensee shall require an authorized user for the oral administration of sodium iodide I-131 2018 updates to 10 CFR 35.394.
3261 requiring a written directive in quantities greater than 1.22 GBq (33 mCi), to be a physician who 3262 has a current active State of Colorado license and:Except as provided in Appendix 7P, the 3263 licensee shall require an authorized user for the oral administration of sodium iodide I-131 3264 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries), to be a 3265 physician who:
3266 3267 7H1 Is certified by a medical specialty board whose certification process includes all of the 3268 requirements in 7H3.1, and 7H3.1(2)7H3.2 and whose certification has been recognized by the 3269 NRC or an Agreement State., and who meets the requirements in paragraph 7H3.2 of this 3270 Appendix. NRC recognized specialty boards are posted on the NRC website at 3271 http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html. The names of board 3272 certifications that have been recognized by the NRC or an Agreement State are posted on 3273 the NRC's Medical Uses Licensee Toolkit web page; 3274 or 3275 7H2 Is an authorized user under Appendix 7F for uses listed in 7F2.1(2)(f)(ii), or equivalent NRC or 3276 Agreement State requirements; 3277 or 3278 7H3 Has satisfied the following criteria:
3279 7H3.1 Has satisfactorilysuccessfully completed 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and laboratory training, 3280 applicable to the medical use of sodium iodide I-131 for procedures requiring a written 3281 directive. The training must include:
3282 (1) The 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and laboratory training must include:
3283 (a1) Radiation physics and instrumentation; 3284 (b2) Radiation protection; 3285 (c3) Mathematics pertaining to the use and measurement of radioactivity; 3286 (d4) Chemistry of radioactive material for medical use; and 3287 (e5) Radiation biology; 3288 and 3289 7H3.2(2) Has work experience, under the supervision of an authorized user who meets the 3290 requirements ofin 7H5Appendix 7P, Appendix 7F, Appendix 7H or equivalent 3291 Agreement State or NRC requirements. A supervising authorized user, who meets the 3292 requirements in 7F2.17F2, must also have experience in administering dosages as 3293 specified in 7F2.1(2)(f)(ii). The work experience must involve:
3294 (a1) Ordering, receiving, and unpacking radioactive materials safely and performing 3295 the related radiation surveys; 3296 (b2) Performing quality control procedures on instruments used to determine the 3297 activity of dosages and performing checks for proper operation of survey meters;
Document 1 HRG Page 116 of 138 3298 (c3) Calculating, measuring, and safely preparing patient or human research subject 3299 dosages; 3300 (d4) Using administrative controls to prevent a misadministrationmedical event 3301 involving the use of unsealed radioactive material; 3302 (e5) Using procedures to contain spilled radioactive material safely and using proper 3303 decontamination procedures; 3304 and 3305 (f6) Administering dosages to patients or human research subjects, that includes at 3306 least 3 cases involving the oral administration of greater than 1.22 3307 gigabecquerels (33 millicuries) of sodium iodide I-131; 3308 andand 3309 7H3.3(3) Has provided written attestation(s), that the individual has completed the 3310 requirements of 7H3.1(1) and 7H3.1(2), and has achieved a level of competency 3311 sufficient to function independently as an authorized user for the medical uses of 3312 unsealed radioactive materials using Na I-131 in activities greater than 1.22 GBq (33 3313 mCi) authorized under 7.36. The written attestation must be signed by a preceptor 3314 authorized user who:Has obtained written attestation that the individual has 3315 satisfactorily completed the requirements in 7H3.1 and 7H3.2, and is able to 3316 independently fulfill the radiation safety-related duties as an authorized user for 3317 oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium 3318 iodide I-131 for medical uses authorized under 7.36. The attestation must be 3319 obtained from either:
3320 (1) A preceptor authorized user who Meetsmeets the requirements in 3321 7H5Appendix 7P, Appendix 7F, or Appendix 7H, or equivalent NRC or Agreement State 3322 requirements; and has experience in administering dosages as specified in 3323 7F2.1(2)(f)(ii); or 3324 andand 3325 (2) The preceptor authorized user, who meets the requirements in 7F2.1 must have 3326 experience in administering dosages as specified in 7F2.1(2)(f)(ii).
3327 (2) A residency program director who affirms in writing that the attestation Commented [JSJ224]: This provision is new, based on the 3328 represents the consensus of the residency program faculty where at least 2018 amendments to 10 CFR 35.392(c)(3)(ii).
3329 one faculty member is an authorized user who meets the requirements in For recent graduates, the revised language of this provision 3330 Appendix 7P, Appendix 7F, Appendix 7H, or equivalent NRC or Agreement allows for residency program directors to sign off/provide the 3331 State requirements, has experience in administering dosages as specified attestations for individuals who are demonstrating training 3332 in F2.1(2)(f)(ii), and concurs with the attestation provided by the residency through the alternate pathway.
3333 program director. The residency training program must be approved by the 3334 Residency Review Committee of the Accreditation Council for Graduate 3335 Medical Education or the Royal College of Physicians and Surgeons of 3336 Canada or the Council on Postdoctoral Training of the American 3337 Osteopathic Association and must include training and experience 3338 specified in 7H3.1 and 7H3.2.
3339 and 3340 7H4 Meets the following recentness of training requirements:
3341 7H4.1 The training and experience required by Appendix 7H shall have been obtained within the 3342 7 years preceding the date of license application or amendment request;
Document 1 HRG Page 117 of 138 3343 or 3344 7H4.2 The individual must have had related, documented, continuing education and experience 3345 since the required training and experience was obtained.
3346 or 3347 7H5 Meets the following requirements for an experienced authorized user for 7.36.4 uses:
3348 7H5.1 An individual identified as an authorized user for the medical use of radioactive material 3349 on a license issued by the NRC or Agreement State, a permit issued under an NRC or 3350 Agreement State broad scope license that authorizes medical use before October 25, 3351 2005, who perform only those medical uses for which they were authorized on that date 3352 are not required to comply with the training requirements of 7H1 through 7H4.
3353 7H5.2 Individuals not required to comply with the training requirements of 7H1 through 7H4 may 3354 serve as preceptors for, and supervisors of, applicants seeking authorization on licenses 3355 for the same uses for which these individuals are authorized.
3356
Document 1 HRG Page 118 of 138 3357 PART 7, APPENDIX 7I: AUTHORIZED USER TRAINING FOR THE PARENTERAL ADMINISTRATION Commented [JJ225]: For final publication, insert a page 3358 OF UNSEALED RADIOACTIVE MATERIAL REQUIRING A WRITTEN DIRECTIVE (7.36.5 USES) break such that each appendix begins on a new page.
3359 The licensee shall require an authorized user for parenteral administration of unsealed radioactive This appendix is updated for consistency with the 2018 3360 material for which a written directive is required to be a physician who has a current active State amendments to 10 CFR 35.396.
3361 of Colorado license and:
3362 7I1 Except as provided in Appendix 7P, the licensee shall require an authorized user for the NRC RATS 2018-1 3363 parenteral administration requiring a written directive to be a physician who: NRC Compatibility B 3364 7I1.1 Is an authorized user under Appendix 7F for uses listed in 7F2.1(2)(f)(iii) or 3365 7F2.1(2)(f)(iv), or equivalent NRC or Agreement State requirements; 3366 or 3367 7I1.2 Is an authorized user under Appendix 7K, Appendix 7M, or equivalent NRC or 3368 Agreement State requirements and who meets the requirements in 7I2; 3369 or 3370 7I1.3 Is certified by a medical specialty board whose certification process has been 3371 recognized by the NRC or an Agreement State under Appendix 7K or Appendix 7M, 3372 and who meets the requirements in paragraph 7I2 of this section.
3373 or 3374 7I2 Is an authorized user under Appendix 7K, Appendix 7M, or equivalent NRC or Agreement State Commented [JSJ226]: Provision replaced by 7I1.2 above.
3375 requirements and who meets the requirements in 7I4; 3376 or 3377 7I3 Is certified by a medical specialty board whose certification process has been recognized by the Commented [JSJ227]: Provision replaced by 7I1.3 above.
3378 NRC or an Agreement State under Appendix 7K or Appendix 7M, and who meets the 3379 requirements in paragraph 7I4 of this section.
3380 or 3381 7I4 Has satisfied the following criteria:
3382 7I2 The physician:
3383 7I4.12.1 Has satisfactorilysuccessfully completed 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and laboratory 3384 training, applicable to parenteral administrations listed in 7F2.1(2)(f)(iii)., for which a 3385 written directive is required, of any beta emitter, or any photon-emitting radionuclide with 3386 a photon energy less than 150 keV, and/or parenteral administration of any other 3387 radionuclide for which a written directive is required. The training must include:
3388 (1) The training must include:
3389 (a)(1) Radiation physics and instrumentation; 3390 (b)(2) Radiation protection; 3391 (c)(3) Mathematics pertaining to the use and measurement of radioactivity; 3392 (d)(4) Chemistry of radioactive material for medical use; 3393 and 3394 (e)(5) Radiation biology; 3395 andand
Document 1 HRG Page 119 of 138 3396 (2)7I2.2 Has work experience under the supervision of an authorized user who meets the 3397 requirements of Appendix 7P7I6, Appendix 7F, Appendix 7I, or equivalent Agreement 3398 State or NRC requirements, in the parenteral administrations listed in 7F2.1(2)(f)(iii)., for 3399 which a written directive is required, of any beta emitter, or any photon-emitting 3400 radionuclide with a photon energy less than 150 keV, and/or parenteral administration of 3401 any other radionuclide for which a written directive is required. A supervising authorized 3402 user, who meets the requirements in 7F, must have experience in administering dosages 3403 as specified in 7F2.1(2)(f)(iii) and/or 7F2.1(2)(f)(iv). A supervising authorized user, 3404 who meets the requirements in Appendix 7F, 7I, or equivalent Agreement State or 3405 NRC requirements, must have experience in administering dosages in the same 3406 category or categories as the individual requesting authorized user status. The 3407 work experience must involve:
3408 (a)(1) Ordering, receiving, and unpacking radioactive materials safely and performing 3409 the related radiation surveys; 3410 (b)(2) Performing quality control procedures on instruments used to determine the 3411 activity of dosages and performing checks for proper operation of survey meters; 3412 (c)(3) Calculating, measuring, and safely preparing patient or human research subject 3413 dosages; 3414 (d)(4) Using administrative controls to prevent a misadministrationmedical event 3415 involving the use of unsealed radioactive material; 3416 (e)(5) Using procedures to contain spilled radioactive material safely and using proper 3417 decontamination procedures; 3418 and 3419 (f)(6) Administering dosages to patients or human research subjects that include:
3420 (i) At at least 3 cases involving the parenteral administrations as specified in 3421 7F2.1(2)(f)(iii), for which a written directive is required, of any beta emitter, or 3422 any photon-emitting radionuclide with a photon energy less than 150 keV; 3423 and/or 3424 (ii) At least 3 cases involving the parenteral administration of any other radionuclide, 3425 for which a written directive is required; 3426 and 3427 (3)7I2.3 Has providedobtained written attestation(s) that the individual has satisfactorily 3428 completed the requirements in 7I2 or 7I37I2.1 or 7I2.2, and has achieved a level of 3429 competency sufficient to function is able to independently fulfill the radiation safety-3430 related duties as an authorized user for the parenteral administration of unsealed 3431 radioactive materials requiring a written directive. The written attestation must be signed 3432 by a preceptor authorized user who:The attestation must be obtained from either:
3433 (a) Meets the requirements in 7I6, Appendix F, or Appendix I, or equivalent 3434 NRC or Agreement State requirements; 3435 and
Document 1 HRG Page 120 of 138 3436 (b) Meets the requirements in Appendix 7F must have experience in 3437 administering dosages as specified in 7F2.1(2)(f)(iii) and/or 3438 7F2.1(2)(f)(iv).
3439 (1) A preceptor authorized user who meets the requirements in Appendix 7P, 3440 Appendix 7F, 7I, or equivalent Agreement State or NRC requirements. A 3441 preceptor authorized user who meets the requirements in Appendix 7F, 7I, 3442 or equivalent Agreement State or NRC requirements, must have experience 3443 in administering dosages in the same category or categories as the 3444 individuals requesting authorized user status; 3445 or 3446 (2) A residency program director who affirms in writing that the attestation Commented [JSJ228]:
3447 represents the consensus of the residency program faculty where at least For recent graduates, the revised language of this provision 3448 one faculty member is an authorized user who meets the requirements in allows for residency program directors to sign off/provide the attestations for individuals who are demonstrating training 3449 Appendix 7P, Appendix 7F, Appendix 7I, or equivalent Agreement State or through the alternate pathway.
3450 NRC requirements, has experience in administering dosages in the same 3451 dose category or categories as the individual requesting authorized user 3452 status, and concurs with the attestation provided by the residency program 3453 director. The residency training program must be approved by the 3454 Residency Review Committee of the Accreditation Council for Graduate 3455 Medical Education or the Royal College of Physicians and Surgeons of 3456 Canada or the Council on Postdoctoral Training of the American 3457 Osteopathic Association and must include training and experience 3458 specified in 7I2.1 and 7I2.2.
3459 and 3460 7I5 Meets the following recentness of training requirements: Commented [JSJ229]: The recentness of training requirements have been relocated to a single location in 7.65.
3461 7I5.1 The training and experience required by Appendix 7I shall have been obtained within the 3462 7 years preceding the date of license application or amendment request; 3463 or 3464 7I5.2 The individual must have had related, documented, continuing education and experience 3465 since the required training and experience was obtained.
3466 or 3467 7I6 Meets the following requirements for an experienced authorized user for 7.36.5 uses: Commented [JSJ230]: The requirements for an experienced authorized individual have been consolidated in 3468 7I6.1 An individual identified as an authorized user for the medical use of radioactive material Appendix 7P.
3469 on a license issued by the NRC or Agreement State, a permit issued under an NRC or 3470 Agreement State broad scope license that authorizes medical use before October 25, 3471 2005, who perform only those medical uses for which they were authorized on that date 3472 are not required to comply with the training requirements of 7I1 through 7I5.
3473 7I6.2 Individuals not required to comply with the training requirements of 7I1 through 7I5 may 3474 serve as preceptors for, and supervisors of, applicants seeking authorization on licenses 3475 for the same uses for which these individuals are authorized.
3476
Document 1 HRG Page 121 of 138 3477 PART 7, APPENDIX 7J: AUTHORIZED USER TRAINING FOR USE OF SEALED SOURCES AND Commented [JJ231]: For final publication, insert a page 3478 MEDICAL DEVICES FOR DIAGNOSIS (7.40 USES) break such that each appendix begins on a new page.
3479 The licensee shall require an authorized user of a diagnostic sealed source for use in a device This appendix is updated for consistency with the 2018 3480 authorized under 7.40 to be a physician, dentist or podiatrist who has a current active State of amendments to 10 CFR 35.590.
3481 Colorado license and:Except as provided in Appendix 7P, the licensee shall require the authorized 3482 user of a diagnostic sealed source or a device authorized under 7.40 to be a physician, dentist, or 3483 podiatrist who:
3484 7J1 Is certified by a specialty board whose certification process includes all of the requirements in 7J2 3485 and 7J3, and whose certification process has been recognized by the NRC or an Agreement 3486 State.; NRC recognized specialty boards are posted on the NRC website at 3487 http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.Is certified by a 3488 specialty board whose certification process includes all of the requirements in 7J3 and 3489 7J4 and whose certification process has been recognized by the NRC or an Agreement 3490 State. The names of board certifications that have been recognized by the NRC or an 3491 Agreement State are posted on the NRCs Medical Uses Licensee Toolkit web page; 3492 or 3493 7J2 Has satisfied the following criteria:Is an authorized user for uses listed in 7.32 or equivalent 3494 NRC or Agreement State requirements; 3495 or 3496 7J2.17J3 Has completed 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> of classroom and laboratory training in basic radionuclide 3497 handling techniques specifically applicable to the use of the device. The training must include 3498 (1) The training must include:
3499 (a1) Radiation physics and instrumentation; 3500 (b2) Radiation protection; 3501 (c3) Mathematics pertaining to the use and measurement of radioactivity; 3502 (d4) Radiation biology; 3503 and 3504 7J34 Has completed training in the use of the device for the uses requested.
3505 and 3506 7J4 Meets the following recentness of training requirements:
3507 7J4.1 The training and experience required by Appendix 7J shall have been obtained within the 3508 7 years preceding the date of license application or amendment request; 3509 or 3510 7J4.2 The individual must have had related, documented, continuing education and experience 3511 since the required training and experience was obtained.
3512 or 3513 7J5 Meets the following requirements for an experienced authorized user for 7.40 uses:
3514 7J5.1 An individual identified as an authorized user for the medical use of radioactive material 3515 on a license issued by the NRC or Agreement State, a permit issued under an NRC or
Document 1 HRG Page 122 of 138 3516 Agreement State broad scope license that authorizes medical use before October 25, 3517 2005, who perform only those medical uses for which they were authorized on that date 3518 are not required to comply with the training requirements of 7J1 through 7J4.;
3519 7J5.2 Individuals not required to comply with the training requirements of 7J1 through 7J4 may 3520 serve as preceptors for, and supervisors of, applicants seeking authorization on licenses 3521 for the same uses for which these individuals are authorized.
3522
Document 1 HRG Page 123 of 138 3523 PART 7, APPENDIX 7K: AUTHORIZED USER TRAINING FOR THE USE OF MANUAL Commented [JJ232]: For final publication, insert a page 3524 BRACHYTHERAPY SOURCES (7.42 USES) break such that each appendix begins on a new page.
3525 The licensee shall require an authorized user of a manual brachytherapy source for the uses This appendix is updated for consistency with the 2018 3526 authorized under 7.42 to be a physician who has a current active State of Colorado license amendments to 10 CFR 35.490.
3527 and:Except as provided in Appendix 7P, the licensee shall require an authorized of a manual 3528 brachytherapy source for the uses authorized under 7.42 to be a physician who: NRC RATS 2018-1 3529 NRC Compatibility B 3530 7K1 Is certified by a medical specialty board whose certification process has been recognized by the 3531 NRC or an Agreement State., and who meets the requirements in paragraph 7K2.3 of this 3532 Appendix. NRC recognized specialty boards are posted on the NRC website at 3533 http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.The names of board 3534 certifications that have been recognized by the NRC or an Agreement State are posted on 3535 the NRCs Medical Uses Licensee Toolkit web page. To have its certification process 3536 recognized, a specialty board shall require all candidates for certification to:
3537 7K1.1 To have its certification process recognized, a specialty board shall require all candidates for 3538 certification to:
3539 (1)7K1.1 Successfully complete a minimum of 3 years of residency training in a radiation 3540 oncology program approved by the Residency Review Committee of the 3541 Accreditation Council for Graduate Medical Education or the Royal College of 3542 Physicians and Surgeons of Canada or the Committee on Post-GraduateCouncil Commented [JSJ233]:
3543 on Postdoctoral Training of the American Osteopathic Association; and Revised to use the correct terminology for the residency 3544 and approval organization of the American Osteopathic Association.
3545 (2)7K1.2 Pass an examination, administered by diplomates of the specialty board, that 3546 tests knowledge and competence in radiation safety, radionuclide handling, 3547 treatment planning, quality assurance, and clinical use of manual brachytherapy; 3548 or 3549 7K2 Has satisfied the following criteria:
3550 7K2.1 Has satisfactorily completed a structured educational program in basic radionuclide 3551 handling techniques applicable to the medical use of manual brachytherapy sources, that 3552 includes:
3553 (1) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training in the following areas:
3554 (a) Radiation physics and instrumentation; 3555 (b) Radiation protection; 3556 (c) Mathematics pertaining to the use and measurement of radioactivity; 3557 (d) Radiation biology; 3558 and 3559 (2) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of work experience, under the supervision of an authorized user who Commented [JSJ234]: The change in this provision is 3560 meets the requirements in 7K4Appendix 7P, Appendix 7K, or equivalent NRC or updated for consistency with the 2018 amendments to 10 3561 Agreement State requirements at a medical institutionfacility authorized to use CFR 35.490(b)(1)(ii).
3562 radioactive materials under 7.42, involving: The current term medical institution (as specifically defined in 7.2) unnecessarily limits where the work experience for an 3563 (a) Ordering, receiving, and unpacking radioactive materials safely and authorized user can be obtained. The language is modified to medical facility which will allow physician authorized users 3564 performing the related radiation surveys; additional flexibility.
3565 (b) Checking survey meters for proper operation; 3566 (c) Preparing, implanting, and removing brachytherapy sources;
Document 1 HRG Page 124 of 138 3567 (d) Maintaining running inventories of material on hand; 3568 (e) Using administrative controls to prevent a misadministrationmedical 3569 event involving the use of radioactive material; 3570 (f) Using emergency procedures to control radioactive material; 3571 and 3572 7K2.2 Has completed 3 years of supervised clinical experience in radiation oncology, under an 3573 authorized user who meets the requirements in 7K4Appendix 7P, Appendix 7K, or 3574 equivalent Agreement State or NRC requirements, provided that the experience:
3575 (a) Isas part of a formal training program approved by the Residency Review Committee for 3576 Radiation Oncology of the Accreditation Council for Graduate Medical Education or the 3577 Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral 3578 Training of the American Osteopathic Association.; This experience may be obtained 3579 concurrently with the supervised work experience required by 7K2.1 3580 and 3581 (b) May be obtained concurrently with the supervised work experience required by 3582 7K2.1(2).
3583 and 3584 7K2.3 Has provided written attestation(s), signed by a preceptor authorized user who meets the 3585 requirements in 7K4, Appendix 7K, or equivalent Agreement State or NRC requirements, 3586 that the individual has satisfactorily completed the requirements in 7K1.1(1), or 3587 paragraphs 7K2.1 and 7K2.2, and has achieved a level of competency sufficient to 3588 function independently as an authorized user of manual brachytherapy sources for the 3589 medical uses authorized under 7.42.Has obtained written attestation that the 3590 individual has satisfactorily completed the requirements in 7K2.1 and 7K2.2 and is 3591 able to independently fulfill the radiation safety-related duties as an authorized 3592 user of manual brachytherapy sources for the medical uses authorized under 7.42.
3593 The attestation must be obtained from either:
3594 (1) A preceptor authorized user who meets the requirements in Appendix 7P, 3595 Appendix 7K, or equivalent Agreement State or NRC requirements.
3596 or 3597 (2) A residency program director who affirms in writing that the attestation Commented [JSJ235]:
3598 represents the consensus of the residency program faculty where at least For recent graduates, the revised language of this provision 3599 one faculty member is an authorized user who meets the requirements in allows for residency program directors to sign off/provide the attestations for individuals who are demonstrating training 3600 Appendix 7P, Appendix 7K, or equivalent Agreement State or NRC through the alternate pathway.
3601 requirements, and concurs with the attestation provided by the residency 3602 program director. The residency training program must be approved by the 3603 Residency Review Committee of the Accreditation Council for Graduate 3604 Medical Education or the Royal College of Physicians and Surgeons of 3605 Canada or the Council on Postdoctoral Training of the American 3606 Osteopathic Association and must include training and experience 3607 specified in 7K2.1 and 7K2.2.
3608 and 3609 7K3 Meets the following recentness of training requirements:
Document 1 HRG Page 125 of 138 3610 7K3.1 The training and experience required by Appendix 7K shall have been obtained: within 3611 the 7 years preceding the date of license application or amendment request; 3612 or 3613 7K3.2 The individual must have had related, documented, continuing education and experience 3614 since the required training and experience was obtained.
3615 or 3616 7K4 Meets the following requirements for an experienced authorized user for 7.42 uses:
3617 7K4.1 An individual identified as an authorized user for the medical use of radioactive material 3618 on a license issued by the NRC or Agreement State, a permit issued under an NRC or 3619 Agreement State broad scope license that authorizes medical use before October 25, 3620 2005, who perform only those medical uses for which they were authorized on that date 3621 are not required to comply with the training requirements of 7K1 through 7K3.
3622 7K4.2 Individuals not required to comply with the training requirements of 7K1 through 7K3 may 3623 serve as preceptors for, and supervisors of, applicants seeking authorization on licenses 3624 for the same uses for which these individuals are authorized.
3625
Document 1 HRG Page 126 of 138 3626 PART 7, APPENDIX 7L: AUTHORIZED USER TRAINING FOR OPHTHALMIC USE OF STRONTIUM- Commented [JJ236]: For final publication, insert a page 3627 90 (7.42 USES) break such that each appendix begins on a new page.
10 CFR 35.491 3628 The licensee shall require an authorized user of a Strontium-90 source for ophthalmic radiotherapy 3629 authorized under 7.42 to be a physician who has a current active State of Colorado license and:Except NRC RATS 2018-1 3630 as provided in Appendix 7P, the licensee shall require the authorized of strontium-90 for NRC Compatibility B 3631 ophthalmic radiotherapy to be a physician who:
3632 7L1 Is an authorized user under Appendix 7K or equivalent NRC or Agreement State requirements; 3633 or 3634 7L2 Has satisfied the following criteria:
3635 7L2.1 Has satisfactorily completed 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of classroom and laboratory training applicable to 3636 the medical use of strontium-90 for ophthalmic radiotherapy. The training must include:
3637 (1) The training must include:
3638 (a1) Radiation physics and instrumentation; 3639 (b2) Radiation protection; 3640 (c3) Mathematics pertaining to the use and measurement of radioactivity; and 3641 (d4) Radiation biology; 3642 and 3643 (2)7L2.2 Supervised clinical training in ophthalmic radiotherapy under the supervision of 3644 an authorized user at a medical institution, clinic, or private practice that includes the use 3645 of strontium-90 for the ophthalmic treatment of five individuals,. This supervised clinical 3646 training must involve:
3647 (a1) Examination of each individual to be treated; 3648 (b2) Calculation of the dose to be administered; 3649 (c3) Administration of the dose; and 3650 (d4) Follow-up and review of each individual's case history; 3651 and 3652 (3)7L3.3 Has providedobtained written attestation(s), signed by a preceptor authorized 3653 user who meets the requirements in 7L4Appendix 7P, Appendix 7K, Appendix 7L, or 3654 equivalent NRC or Agreement State requirements, that the individual has satisfactorily 3655 completed the requirements of 7L27L2.1 and 7L2.2 and has achieved a level of 3656 competency sufficient to function independently as an authorized user of strontium-90 for 3657 ophthalmic radiotherapy uses authorized under 7.42.is able to independently fulfill the 3658 radiation safety-related duties as an authorized user of strontium-90 for ophthalmic 3659 use.
3660 and 3661 7L3 Meets the following recentness of training requirements:
Document 1 HRG Page 127 of 138 3662 7L3.1 The training and experience required by Appendix 7L shall have been obtained within the 3663 7 years preceding the date of license application or amendment request; 3664 or 3665 7L3.2 The individual must have had related, documented, continuing education and experience 3666 since the required training and experience was obtained.
3667 or 3668 7L4 Meets the following requirements for an experienced authorized user for 7.42 opthalmic 3669 radiotherapy uses:
3670 7L4.1 An individual identified as an authorized user for the medical use of radioactive material 3671 on a license issued by the NRC or Agreement State, a permit issued under an NRC or 3672 Agreement State broad scope license that authorizes medical use before October 25, 3673 2005, who perform only those medical uses for which they were authorized on that date 3674 are not required to comply with the training requirements of 7L1 through 7L3.
3675 7L4.2 Individuals not required to comply with the training requirements of 7L1 through 7L3 may 3676 serve as preceptors for, and supervisors of, applicants seeking authorization on licenses 3677 for the same uses for which these individuals are authorized.
3678
Document 1 HRG Page 128 of 138 3679 PART 7, APPENDIX 7M: AUTHORIZED USER TRAINING FOR USE OF SEALED SOURCES IN Commented [JJ237]: For final publication, insert a page 3680 REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC break such that each appendix begins on a new page.
3681 RADIOSURGERY UNITS (7.48 USES)
This appendix is updated for consistency with the 2018 changes to 10 CFR 35.690.
3682 The licensee shall require an authorized user of a sealed source for use in a device authorized under 3683 7.48 to be a physician who has a current active State of Colorado license and:Except as provided in NRC RATS 2018-1 3684 Appendix 7P, the licensee shall require an authorized user of a sealed source for a use authorized NRC Compatibility B 3685 under 7.48 to be a physician who:
3686 3687 7M1 Is certified by a medical specialty board whose certification process has been recognized by the 3688 NRC or an Agreement State and who meets the requirements in paragraph 7M2.3 and 7M3. of 3689 this Appendix. NRC recognized specialty boards are posted on the NRC website at 3690 http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html. The names of board 3691 certifications that have been recognized by the NRC or an Agreement State are posted on 3692 the NRCs Medical Uses Licensee Toolkit web page. To have its certification process 3693 recognized, a specialty board shall require all candidates for certification to:
3694 7M1.1 To have its certification process recognized, a specialty board shall require all candidates 3695 for certification to:
3696 (1)7M1.1 Successfully complete a minimum of 3 years of residency training in a radiation 3697 therapy program approved by the Residency Review Committee of the Accreditation 3698 Council for Graduate Medical Education or the Royal College of Physicians and 3699 Surgeons of Canada or the Committee on Post-GraduateCouncil on Postdoctoral Commented [JSJ238]:
3700 Training of the American Osteopathic Association; Revised to use the correct terminology for the residency approval organization of the American Osteopathic Association.
3701 and 3702 (1)7M1.2 Pass an examination, administered by diplomates of the specialty board, which 3703 tests knowledge and competence in radiation safety, radionuclide handling, treatment 3704 planning, quality assurance, and clinical use of stereotactic radiosurgery, remote 3705 afterloaders and external beam therapy; 3706 or 3707 7M2 Has satisfied the following criteria:
3708 7M2.1 Has satisfactorily completed a structured educational program in basic radionuclide 3709 handling techniques applicable to the use of a sealed sources in a therapeutic medical 3710 unit that includes:
3711 (1) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training in the following areas:
3712 (a) Radiation physics and instrumentation; 3713 (b) Radiation protection; 3714 (c) Mathematics pertaining to the use and measurement of radioactivity; and 3715 (d) Radiation biology; 3716 and
Document 1 HRG Page 129 of 138 3717 (2) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience, under the supervision of an authorized 3718 user who meets the requirements in 7M5Appendix 7P, Appendix 7M, or 3719 equivalent Agreement State or NRC requirements at a medical institutionfacility 3720 that is authorized to use radioactive materials in 7.48, involving:
3721 (a) Reviewing full calibration measurements and periodic spot checks; 3722 (b) Preparing treatment plans and calculating treatment doses and times; 3723 (c) Using administrative controls to prevent a misadministrationmedical 3724 event involving the use of radioactive material; 3725 (d) Implementing emergency procedures to be followed in the event of the 3726 abnormal operation of the medical unit or console; 3727 (e) Checking and using survey meters; and 3728 (f) Selecting the proper dose and how it is to be administered; 3729 and 3730 7M2.2 Has completed 3 years of supervised clinical experience in radiation therapy, under an 3731 authorized user who meets the requirements in 7M5Appendix 7P, Appendix 7M, or 3732 equivalent Agreement State or NRC requirements, as part of a formal training program 3733 approved by the Residency Review Committee for Radiation Oncology of the 3734 Accreditation Council for Graduate Medical Education or the Royal College of Physicians 3735 and Surgeons of Canada or the CommitteeCouncil on Postdoctoral Training of the Commented [JSJ239]:
3736 American Osteopathic Association. This experience may be obtained concurrently with Committee appear to be incorrect here and in NRC rule.
3737 the supervised work experience required by paragraph 7M2.1(2) of this section; and; Council appears to be consistent with other uses in part 35.
Clarification from NRC is pending 3738 and 3739 7M2.3 Has provided written attestation(s) that the individual has satisfactorily completed the 3740 requirements of 7M1 or 7M2.1 and 7M2.2, and 7M3, and has achieved a level of 3741 competency sufficient to function independently as an authorized user of each type of 3742 therapeutic medical unit for which the individual is requesting authorized user status. The 3743 written attestation must be signed by a preceptor authorized user who meets the 3744 requirements in 7M5, Appendix 7M, or equivalent Agreement State or NRC requirements 3745 for an authorized user for each type of therapeutic medical unit for which the individual is 3746 requesting authorized user status; Has obtained written attestation that the individual 3747 has satisfactorily completed the requirements in 7M2.1 and 7M2.2 and 7M3; and is 3748 able to independently fulfill the radiation safety-related duties as an authorized 3749 user of each type of therapeutic medical unit for which the individual is requesting 3750 authorized user status. The attestation must be obtained from either:
3751 (1) A preceptor authorized user who meets the requirements in Appendix 7P, 3752 Appendix 7M, or equivalent Agreement State or NRC requirements for the 3753 type(s) of therapeutic medical unit for which the individual is requesting 3754 authorized user status; 3755 or 3756 (2) A residency program director who affirms in writing that the attestation Commented [JSJ240]:
3757 represents the consensus of the residency program faculty where at least For recent graduates, the revised language of this provision 3758 one faculty member is an authorized user who meets the requirements in allows for residency program directors to sign off/provide the attestations for individuals who are demonstrating training 3759 Appendix 7P, Appendix 7M, or equivalent Agreement State or NRC through the alternate pathway.
3760 requirements, for the type(s) of therapeutic medical unit for which the
Document 1 HRG Page 130 of 138 3761 individual is requesting authorized user status, and concurs with the 3762 attestation provided by the residency program director. The residency 3763 training program must be approved by the Residency Review Committee of 3764 the Accreditation Council for Graduate Medical Education or the Royal 3765 College of Physicians and Surgeons of Canada or the Council on 3766 Postdoctoral Training of the American Osteopathic Association and must 3767 include training and experience specified in 7M2.1 and 7M2.2.
3768 and 3769 7M3 Has received training in device operation, safety procedures, and clinical use for the type(s) of 3770 use for which authorization is sought. This training requirement may be satisfied by: satisfactory 3771 completion of a training program provided by the vendor for new users or by receiving 3772 training supervised by an authorized user or authorized medical physicist, as appropriate, 3773 who is authorized for the type(s) of use for which the individual is seeking authorization.
3774 7M3.1 Satisfactorily completing a vendor training program; 3775 or 3776 7M3.2 By receiving training supervised by an authorized user or authorized medical physicist, as 3777 appropriate, who is authorized for the type(s) of use for which the individual is seeking 3778 authorization; 3779 and 3780 7M4 Meets the following recentness of training requirements:
3781 7M4.1 The training and experience required by Appendix 7M shall have been obtained within 3782 the 7 years preceding the date of license application or amendment request; 3783 or 3784 7M4.2 The individual must have had related, documented, continuing education and experience 3785 since the required training and experience was obtained.
3786 or 3787 7M5 Meets the following requirements for an experienced authorized user for 7.48 uses.
3788 7M5.1 An individual identified as an authorized user for the medical use of radioactive material 3789 on a license issued by the NRC or Agreement State, a permit issued under an NRC or 3790 Agreement State broad scope license that authorizes medical use before October 25, 3791 2005, who perform only those medical uses for which they were authorized on that date 3792 are not required to comply with the training requirements of 7M1 through 7M4.
3793 7M5.2 Individuals not required to comply with the training requirements of 7M1 through 7M4 3794 may serve as preceptors for, and supervisors of, applicants seeking authorization on 3795 licenses for the same uses for which these individuals are authorized.
3796 3797
Document 1 HRG Page 131 of 138 3798 PART 7, APPENDIX 7N: NUCLEAR MEDICINE TECHNOLOGIST (NMT) ADEQUATE RADIATION Commented [JJ241]: There are no equivalent requirements 3799 SAFETY TRAINING AND EXPERIENCE in NRC regulations. NRC does not recognize nuclear medicine technologists.
3800 The licensee shall require the nuclear medicine technologist using radioactive materials under the Also see provision 7.10 of the proposed rule.
3801 supervision of an authorized user to be an individual who can, upon the request of the 3802 Department, demonstrate: Commented [JJ242]: For final publication, insert a page break such that each appendix begins on a new page.
3803 7N1 Has provided: Evidence of:
3804 7N1.1 Evidence of:(1) Current registration with The American Registry of Radiologic 3805 Technologists with competency in Nuclear Medicine (ARRT(N));
3806 or 3807 7N1.2(2) Current certification by The Nuclear Medicine Technology Certification Board in Nuclear 3808 Medicine (CNMT);
3809 or 3810 7N1.3(3) Being board-eligible to take the CNMT or ARRT(N) examination; 3811 or 3812 7N1.4(4) Current certification by a recognized specialty board recognized in writing by the 3813 Department(see 7N5);
3814 and 3815 7N1.2 Has provided written attestation(s), signed by a preceptor authorized user, that the 3816 individual has achieved a level of competency sufficient to function independently as a 3817 nuclear medicine technologist; 3818 (1) Each preceptor authorized user supervising the experiential training required by 3819 Appendix 7N shall meet the requirements of Appendix 7N, or equivalent 3820 Agreement State or NRC requirements.
3821 or 3822 7N2 Has satisfied the following criteria: Commented [JSJ243]:
This proposed change eliminates the option of an alternate pathway for Nuclear Medicine Technologists, effectively 3823 7N2.1 Has provided written attestation(s), signed by a preceptor authorized user, that the requiring certification.
3824 individual has satisfactorily completed 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> in a structured educational program in 3825 basic radionuclide handling techniques applicable to the medical use of unsealed 3826 radioactive materials, including:
3827 (1) Classroom and laboratory training in the following areas:
3828 (a) Radiation physics and instrumentation; 3829 (b) Radiation protection; 3830 (c) Mathematics pertaining to the use and measurement of radioactivity; 3831 (d) Chemistry of radioactive material for medical use; and 3832 (e) Radiation biology; and
Document 1 HRG Page 132 of 138 3833 (2) Work experience, involving:
3834 (a) Ordering, receiving, and unpacking radioactive materials safely and 3835 performing the related radiation surveys; 3836 (b) Quality Control checking of instruments used to determine the activity of 3837 dosages and performing checks for proper operation of survey meters; 3838 (c) Calculating, measuring, and safely preparing patient or human research 3839 subject dosages; 3840 (d) Using administrative controls to prevent a misadministration involving the 3841 use of unsealed radioactive material; 3842 (e) Using procedures to contain spilled radioactive material safely and using 3843 proper decontamination procedures; and 3844 (f) Administering dosages to patients or human research subjects; 3845 7N2.2 Has provided written attestation(s), signed by a preceptor authorized user, that the 3846 individual has achieved a level of competency sufficient to function independently as a 3847 nuclear medicine technologist; 3848 or 3849 7N32 Has demonstratedIs able to demonstrate adequate prior experience as:
3850 7N32.1 A full-time nuclear medicine technologist for a minimum of two years performing during 3851 the past five-year period prior to August 14, 2020 under the supervision of an 3852 authorized user and has provided written attestation(s), signed by a preceptor authorized 3853 user, that the individual has achieved a level of competency sufficient to function 3854 independently as a nuclear medicine technologist; 3855 or 3856 7N32.2 An experienced nuclear medicine technologist working at a facility holding a Department 3857 license before October 25, 2005. (and thus need not comply with the requirements of 3858 7N2);
3859 7N4 Meets the following recentness of training requirements:
3860 7N4.1 The training and experience required by Appendix 7N shall have been obtained within the 3861 7 years preceding the date of license application or amendment request; 3862 or 3863 7N4.2 The individual must have had related, documented, continuing education and experience 3864 since the required training and experience was obtained.
3865 7N5 To be recognized by the Department, a specialty board shall require that each candidate for 3866 certification as a nuclear medicine technologist satisfactorily complete a certification process that 3867 includes all of the training requirements in 7N2.1.
3868
Document 1 HRG Page 133 of 138 3869 PART 7, APPENDIX 7O: RADIATION THERAPY TECHNOLOGIST (RTT) ADEQUATE RADIATION Commented [JSJ244]:
3870 SAFETY TRAINING AND EXPERIENCERESERVED The requirements of this appendix is proposed for deletion as it is generally not used by the radiation program during licensing or compliance activities. The radiation program is 3871 The licensee shall require the radiation therapy technologist using radioactive materials under the generally unaware of radiation therapy technologists who are 3872 supervision of an authorized user to be an individual who: performing activities involving radioactive material.
Requirements for radiation therapy technologists are generally dictated by the specific facilities occupational and/or 3873 7O1 Has provided: accreditation requirements.
3874 7O1.1 Evidence of: There is no equivalent to these requirements in 10 CFR Part 35.
3875 (1) Current registration with The American Registry of Radiologic Technologists with 3876 competency in Radiation Therapy; 3877 or 3878 (2) Current certification by a recognized specialty board (see 7O5);
3879 or 3880 (3) Being board-eligible to take the ARRT(T) examination; 3881 or 3882 (4) Having successfully completed a training program in radiation therapy which has 3883 resulted in a certificate, associate degree, or baccalaureate degree in a 3884 radiologic technology program that complies with the requirements of the Joint 3885 Review Committee on Education in Radiologic Technology (consult the 3886 Essentials and Guidelines of an Accredited Educational Program for the 3887 Radiation Therapy Technologist, Joint Review Committee on Education in 3888 Radiologic Technology, 1988);
3889 and 3890 7O1.2 Written attestation(s), signed by a preceptor authorized user, that the individual has 3891 achieved a level of competency sufficient to function independently as a radiation therapy 3892 technologist; 3893 (1) Each preceptor authorized user supervising the experiential training required by 3894 Appendix 7O shall meet the requirements of Appendix 7O, or equivalent 3895 Agreement State or NRC requirements.
3896 or 3897 7O2 Has satisfied the following criteria:
3898 7O2.1 Has provided written attestation(s), signed by a preceptor authorized user, that the 3899 individual has satisfactorily completed 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> in a structured educational program in 3900 basic radionuclide handling techniques applicable to the medical use of unsealed 3901 radioactive materials, including:
3902 (1) Classroom and laboratory training in the following areas:
3903 (a) Radiation physics and instrumentation; 3904 (b) Radiation protection;
Document 1 HRG Page 134 of 138 3905 (c) Mathematics pertaining to the use and measurement of radioactivity; 3906 (d) Radiation biology; 3907 and 3908 (2) Work experience, involving:
3909 (a) Ordering, receiving, and unpacking radioactive materials safely and 3910 performing the related radiation surveys; 3911 (b) Assisting the authorized user in simulating the patient for treatment; 3912 (c) Preparing the patient for treatment; 3913 (d) Implementing treatment plans as prescribed by the authorized user; 3914 (e) Providing written documentation of treatment setup and patient 3915 treatments; 3916 (f) Quality control checks to determine that devices used to deliver the 3917 radiation doses are in compliance with institutional standards and 3918 performing checks for proper operation of survey meters; 3919 (g) Preparing or assisting in the preparation of sources, and implantation 3920 and removal of sealed sources; 3921 (h) Delivering doses to patients or human research subjects under the 3922 supervision of the authorized user; 3923 (i) Maintaining running inventories of radioactive material on hand; 3924 (j) Using administrative controls to prevent a misadministration involving the 3925 use of radioactive material; and, 3926 (k) Properly implementing emergency procedures; 3927 7O2.2 Has provided written attestation(s), signed by a preceptor authorized user, that the 3928 individual has achieved a level of competency sufficient to function independently as a 3929 radiation therapy technologist; 3930 or 3931 7O3 Has demonstrated adequate prior experience as:
3932 7O3.1 A full-time radiation therapy technologist for a minimum of two years performing during 3933 the past five-year period under the supervision of an authorized user and has provided 3934 written attestation(s), signed by a preceptor authorized user, that the individual has 3935 achieved a level of competency sufficient to function independently as a radiation therapy 3936 technologist; 3937 or 3938 7O3.2 An experienced radiation therapy technologist working at a facility holding a Department 3939 license before October 25, 2005 (and thus need not comply with the requirements of 3940 7O2);
Document 1 HRG Page 135 of 138 3941 7O4 Meets the following recentness of training requirements:
3942 7O4.1 The training and experience required by Appendix 7O shall have been obtained within 3943 the 7 years preceding the date of license application or amendment request; 3944 or 3945 7O4.2 The individual must have had related, documented, continuing education and experience 3946 since the required training and experience was obtained.
3947 7O5 To be recognized by the Department, a specialty board shall require that each candidate for 3948 certification as a radiation therapy technologist satisfactorily complete a certification process that 3949 includes all of the training requirements in 7O2.1.
3950
Document 1 HRG Page 136 of 138 3951 PART 7, APPENDIX 7P: TRAINING FOR EXPERIENCED RADIATION SAFETY OFFICER, Commented [JJ245]:
3952 TELETHERAPY OR MEDICAL PHYSICIST, AUTHORIZED MEDICAL PHYSICIST, AUTHORIZED This is a new appendix that parallels the requirements found 3953 USER, NUCLEAR PHARMACIST, AND AUTHORIZED NUCLEAR PHARMACIST. in 10 CFR 35.57, which was amended in 2018.
Some requirements of this appendix are already contained in 3954 7P1 and are repeated multiple times in the existing Appendices of Part 7. Within this proposed rule, the requirements for an experienced authorized individual (such as RSO, medical 3955 7P1.1 An individual identified on a Department, NRC or an Agreement State license or a physicist, authorized user, etc.) would be captured in one 3956 permit issued by a Department, NRC or an Agreement State broad scope licensee location rather than being repeated in multiple locations in the 3957 or master material license permit or by a master material license permittee of rule, parallel with the approach used in 10 CFR 35. This 3958 broad scope as a Radiation Safety Officer, a teletherapy or medical physicist, an appendix will consolidate the requirements in one location and replace multiple (repeated) provisions found in other 3959 authorized medical physicist, a nuclear pharmacist or an authorized nuclear appendices.
3960 pharmacist on or before August 14, 2020 need not comply with the training 3961 requirements of Appendix 7A, 7B, or 7C, respectively, except the Radiation Safety As a result of the 2018 changes to the CFR, the following 3962 Officers and authorized medical physicists identified in 7P1.1 must meet the provisions are new: 7P1.2, 7P1.3, and 7P2.2(1) through (4).
These provisions were added to federal rule in 2018 based on 3963 training requirements in 7A4 of Appendix 7A or 7B3 of Appendix 7B, as a stakeholder petition to NRC to address (correct) a 3964 appropriate, for any material or uses for which they were not authorized prior to grandfathering related issue that existed in the (federal) rule 3965 this date. prior to 2018.
August 14, 2020 is the anticipated effective date of the Part 7 3966 7P1.2 Any individual certified by the American Board of Health Physics in rule under the current rulemaking schedule.
3967 Comprehensive Health Physics; American Board of Radiology; American Board of 3968 Nuclear Medicine; American Board of Science in Nuclear Medicine; Board of NRC RATS 2018-1 3969 Pharmaceutical Specialties in Nuclear Pharmacy; American Board of Medical All provisions are NRC Compatibility B, with the exception of 7P1.4, which is compatibility D.
3970 Physics in radiation oncology physics; Royal College of Physicians and Surgeons 3971 of Canada in nuclear medicine; American Osteopathic Board of Radiology; or 3972 American Osteopathic Board of Nuclear Medicine on or before October 24, 2005, 3973 need not comply with the training requirements of Appendix 7A to be identified as 3974 a Radiation Safety Officer or as an Associate Radiation Safety Officer on an NRC or 3975 an Agreement State license or NRC master material license permit for those 3976 materials and uses that these individuals performed on or before October 24, 2005.
3977 7P1.3 Any individual certified by the American Board of Radiology in therapeutic 3978 radiological physics, Roentgen ray and gamma ray physics, xray and radium 3979 physics, or radiological physics, or certified by the American Board of Medical 3980 Physics in radiation oncology physics, on or before October 24, 2005, need not 3981 comply with the training requirements for an authorized medical physicist 3982 described in Appendix 7B, for those materials and uses that these individuals 3983 performed on or before October 24, 2005.
3984 7P1.4 A Radiation Safety Officer, a medical physicist, or a nuclear pharmacist, who used 3985 only accelerator-produced radioactive materials, discrete sources of radium-226, 3986 or both, for medical uses or in the practice of nuclear pharmacy at a Government 3987 agency or Federally recognized Indian Tribe before November 30, 2007, or at all 3988 other locations of use before August 8, 2009, or an earlier date as noticed by the 3989 NRC, need not comply with the training requirements of Appendix 7A, 7B, or 7C 3990 respectively, when performing the same uses. A nuclear pharmacist, who prepared 3991 only radioactive drugs containing accelerator-produced radioactive materials, or a 3992 medical physicist, who used only accelerator-produced radioactive materials, at 3993 the locations and during the time period identified in 7P1.4, qualifies as an 3994 authorized nuclear pharmacist or an authorized medical physicist, respectively, for 3995 those materials and uses performed before these dates, for the purposes of the 3996 regulations.
3997 7P2 3998 7P2.1 Physicians, dentists, or podiatrists identified as authorized users for the medical 3999 use of radioactive material on a license issued by the NRC or an Agreement State, 4000 a permit issued by a NRC master material licensee, a permit issued by a NRC or an
Document 1 HRG Page 137 of 138 4001 Agreement State broad scope licensee, or a permit issued by a NRC master 4002 material license broad scope permittee on or before August 14, 2020, who perform 4003 only those medical uses for which they were authorized on or before that date 4004 need not comply with the training requirements of Sections D through H.
4005 7P2.2 Physicians, dentists, or podiatrists not identified as authorized users for the 4006 medical use of radioactive material on a license issued by the NRC or an 4007 Agreement State, a permit issued by a NRC master material licensee, a permit 4008 issued by a NRC or an Agreement State broad scope licensee, or a permit issued 4009 by a NRC master material license of broad scope on or before October 24, 2005, 4010 need not comply with the training requirements of Sections D through H for those 4011 materials and uses that these individuals performed on or before October 24, 2005, 4012 as follows:
4013 (1) For uses authorized under 7.30 or 7.32, or oral administration of sodium 4014 iodide I-131 requiring a written directive for imaging and localization 4015 purposes, a physician who was certified on or before October 24, 2005, in 4016 nuclear medicine by the American Board of Nuclear Medicine; diagnostic 4017 radiology by the American Board of Radiology; diagnostic radiology or 4018 radiology by the American Osteopathic Board of Radiology; nuclear 4019 medicine by the Royal College of Physicians and Surgeons of Canada; or 4020 American Osteopathic Board of Nuclear Medicine in nuclear medicine; 4021 (2) For uses authorized under 7.36, a physician who was certified on or before 4022 October 24, 2005, by the American Board of Nuclear Medicine; the 4023 American Board of Radiology in radiology, therapeutic radiology, or 4024 radiation oncology; nuclear medicine by the Royal College of Physicians 4025 and Surgeons of Canada; or the American Osteopathic Board of Radiology 4026 after 1984; 4027 (3) For uses authorized under 7.42 or 7.48, a physician who was certified on or 4028 before October 24, 2005, in radiology, therapeutic radiology or radiation 4029 oncology by the American Board of Radiology; radiation oncology by the 4030 American Osteopathic Board of Radiology; radiology, with specialization in 4031 radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of 4032 the Royal College of Radiology"; or therapeutic radiology by the Canadian 4033 Royal College of Physicians and Surgeons; and 4034 (4) For uses authorized under 7.40, a physician who was certified on or before 4035 October 24, 2005, in radiology, diagnostic radiology, therapeutic radiology, 4036 or radiation oncology by the American Board of Radiology; nuclear 4037 medicine by the American Board of Nuclear Medicine; diagnostic radiology 4038 or radiology by the American Osteopathic Board of Radiology; or nuclear 4039 medicine by the Royal College of Physicians and Surgeons of Canada.
4040 7P2.3 Physicians, dentists, or podiatrists who used only accelerator-produced 4041 radioactive materials, discrete sources of radium-226, or both, for medical uses 4042 performed at a Government agency or Federally recognized Indian Tribe before 4043 November 30, 2007, or at all other locations of use before August 8, 2009, or an 4044 earlier date as noticed by the NRC, need not comply with the training requirements 4045 of Sections D through H when performing the same medical uses. A physician, 4046 dentist, or podiatrist, who used only accelerator-produced radioactive materials, 4047 discrete sources of radium-226, or both, for medical uses at the locations and time 4048 period identified in 7P2, qualifies as an authorized user for those materials and 4049 uses performed before these dates, for the purposes of the regulations.
Document 1 HRG Page 138 of 138 4050 7P3 Individuals who need not comply with training requirements as described in Appendix 7P 4051 may serve as preceptors for, and supervisors of, applicants seeking authorization on 4052 Department licenses for the same uses for which these individuals are authorized.
4053