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{{#Wiki_filter:Document 1                                                              HRG                                                Page 30 of 138 1 DRAFT 2 - 06/04/2020 2 DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT                                                                  Commented [JJ28]:
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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
 
==REFERENCES:==
 
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
 
==REFERENCES:==
 
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 &#xb5;Ci), 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 hours 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 hours 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 hours 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                        &#xb5;Ci);
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 &#xb5;Ci);
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 hours 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 hours, 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 hours, 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 &#xb5;Sv (0.1 mrem) per hour to 500 &#xb5;Sv (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 &#xb5;Ci 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 &#xb5;Ci 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 &#xb5;Ci 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                &#xb5;Ci 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 (&#xb5;Ci/ 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 &#xb5;Sv (0.1 mrem) per hour to 500 &#xb5;Sv (50 mrem) per hour and over the range of 10 &#xb5;Sv 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 &#xb5;Sv (0.1 mrem) per hour to 500 2168        &#xb5;Sv (50 mrem) per hour, and a portable radiation measurement survey instrument capable of 2169        measuring dose rates over the range of 10 &#xb5;Sv (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 hours 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 hours of training/experience in 2755                            nuclear pharmacy practice. (aAcademic training may be substituted for no more 2756                            than 2000 hours 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 hours in a structured educational program that includesconsisting of 2766                  both:
2767                  (1)      200 hours 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 hours 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 hours of training and experience, including a minimum of    7 and the flow and format of 10 CFR 35.
2838        8 hours 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 hours 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 hours, including a minimum of 80 hours 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 hours 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 hours of training and experience, including a minimum      Commented [JSJ212]: Clarifying wording added for 3053                  of 200 hours 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 hours 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 hours 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 hours 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 hours 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 hours 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 hours 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 hours 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 hours 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 hours 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 hours 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 hours 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 hours 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 hours 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.
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Revision as of 17:31, 29 November 2024

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v • d • e


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