ML22245A011
| ML22245A011 | |
| Person / Time | |
|---|---|
| Issue date: | 08/30/2022 |
| From: | Office of Nuclear Material Safety and Safeguards |
| To: | State of NM, Environment Dept |
| Poy S | |
| Shared Package | |
| ML22243A198 | List: |
| References | |
| Download: ML22245A011 (61) | |
Text
State Regulation, 20.3 NMAC Federal Regulation 10 CFR Comments 20.3.3.315 SPECIAL REQUIREMENTS FOR A SPECIFIC RATS 2018-1 category - B In § 32.72:
LICENSE TO MANUFACTURE, ASSEMBLE, REPAIR OR § 32.72 Manufacture, preparation, or transfer for (a)Revise the introductory text of DISTRIBUTE COMMODITIES, PRODUCTS OR DEVICES commercial distribution of radioactive drugs containing (a)(4); The applicant commits to the WHICH CONTAIN RADIOACTIVE MATERIAL: J.(1) byproduct material for medical use under part 35 following labeling requirements:
(d) The applicant commits to [satisfies] the following (a)(4) The applicant commits to the following labeling Based on RATS 2018-1 letter dated labeling requirements. requirements: July 16, 2018 20.3.3.315 SPECIAL REQUIREMENTS FOR A SPECIFIC RATS 2018-1 category - B § In § 32.72:
LICENSE TO MANUFACTURE, ASSEMBLE, REPAIR OR 32.72 Manufacture, preparation, or transfer for commercial (b)Revise (b)(5)(i);
DISTRIBUTE COMMODITIES, PRODUCTS OR DEVICES distribution of radioactive drugs containing byproduct A copy of each individuals WHICH CONTAIN RADIOACTIVE MATERIAL: (J)(2) material for medical use under part 35 certification by a specialty board (f)shall provide to the Commission [department] a copy of (5) Shall provide to the Commission: whose certification process has been (i)each individuals certification by a specialty board whose (i) A copy of each individual's certification by a specialty board recognized by the Commission or an certification process has been recognized by the whose certification process has been recognized by the Agreement State as specified in § Commission [department, NRC] or agreement state as Commission or an Agreement State as specified in § 35.55(a) 35.55(a) of this chapter; or specified in 10 CFR 35.55(a)[Subsection C of 20.3.7.714 of this chapter; or Based on RATS 2018-1 letter dated NMAC, incorporating 10 CFR 35.55(a), with the written July 16, 2018 attestation signed by a preceptor as required by Subsection C of 20.3.7.714 NMAC, incorporating 10 CFR 35.55(b)(2)]; or 20.3.3.315 SPECIAL REQUIREMENTS FOR A SPECIFIC none § 32.72 RCB Correction LICENSE TO MANUFACTURE, ASSEMBLE, REPAIR OR Manufacture, preparation, or transfer for commercial To align with current federal DISTRIBUTE COMMODITIES, PRODUCTS OR DEVICES distribution of radioactive drugs containing byproduct regulation WHICH CONTAIN RADIOACTIVE MATERIAL: material for medical use under part 35 (f) (5) (ii) The ii)the Commission [department, NRC] or agreement state Commission or Agreement State license, or license, or (iii) Commission [the permit issued by a NRC] master (iii) Commission master materials licensee permit, or material licensee permit, or (iv)the permit issued by a licensee or Commission (iv) The permit issued by a licensee or Commission master
[department, NRC or agreement state licensee, or NRC] materials permittee of broad scope or the authorization from master materials permittee of broad scope, or the a commercial nuclear pharmacy authorized to list its own authorization from a commercial nuclear pharmacy authorized nuclear pharmacist, or authorized to list its own authorized nuclear pharmacist, or
20.3.3.315 SPECIAL REQUIREMENTS FOR A SPECIFIC RATS 2018-1 category - B § (c)Redesignate paragraph (d) as LICENSE TO MANUFACTURE, ASSEMBLE, REPAIR OR 32.72 Manufacture, preparation, or transfer for commercial paragraph (e); and (d) Add new DISTRIBUTE COMMODITIES, PRODUCTS OR DEVICES distribution of radioactive drugs containing byproduct paragraph (d). to read as follows:
WHICH CONTAIN RADIOACTIVE MATERIAL: material for medical use under part 35 A licensee shall satisfy the labeling (f) (c)(2) requirements in paragraph (a)(4) of (4) A licensee shall satisfy the labeling requirements in (d) A licensee shall satisfy the labeling requirements in this section.
paragraph J(1)(d) of this section [Nothing in this section paragraph (a)(4) of this section. Based on RATS 2018-1 letter dated relieves the licensee from complying with applicable FDA, (e) Nothing in this section relieves the licensee from July 16, 2018 or other federal and state requirements governing complying with applicable FDA, other Federal, and State radioactive drugs]. requirements governing radioactive drugs.
(5)Nothing in this section relieves the licensee from complying with applicable FDA, or other federal and state requirements governing radioactive drugs.
20.3.3.317 TERMS AND CONDITIONS OF LICENSES: RATS 2018-2 category - C § C: 70.32(a)(2), (a)(3), & (a)(8).
A. Each license issued pursuant to the requirements in 70.32 Conditions of licenses. (a) (a) Each license shall contain and be this part shall be subject to all the provisions of the act, Each license shall contain and be subject to the following subject to the following conditions:
now or hereafter in effect, and to all rules, regulations and conditions: (2) No right to the special nuclear orders of the board or department. (2) No right to the special nuclear material shall be conferred material shall be conferred by the (1) No right to the special nuclear material shall be by the license except as defined by the license; license except as defined by the conferred by the license except as defined by the license; (3) Neither the license nor any right under the license shall be license; (2) Neither the license nor any right under the license assigned or otherwise transferred in violation of the (3) Neither the license nor any right shall be assigned or otherwise transferred in violation of provisions of the Act; under the license shall be assigned or the provisions of 20.3.3.317 NMAC; (8) The license shall be subject to and the licensee shall otherwise transferred in violation of (3) The license shall be subject to and the licensee shall observe, all applicable rules, regulations and orders of the the provisions of the Act; observe, all applicable rules, regulations and orders of the Commission. (8) The license shall be subject to and department. the licensee shall observe, all applicable rules, regulations and orders of the Commission.
Based on RATS 2018-2 letter dated November 21, 2018
20.3.3.317 TERMS AND CONDITIONS OF LICENSES: RATS 2018-2 category - H&S H&S: 70.32(a)(9)
E.Filing for bankruptcy. § 70.32 Conditions of licenses. § 70.32 Conditions of licenses.
(1)Each general licensee that is required to register by (a) Each license shall contain and be subject to the following (a) Each license shall contain and be Paragraph (m) of Subsection B of 20.3.3.305 NMAC and conditions: (9)(i) Each subject to the following conditions:
each specific licensee shall notify the department and licensee shall notify the appropriate NRC Regional (9)(i) Each licensee shall notify the appropriate NRC Regional Administrator in writing, Administrator, in writing, immediately following the filing of a appropriate NRC Regional immediately following the filing of a voluntary or voluntary or involuntary petition for bankruptcy under any Administrator, in writing, involuntary petition for bankruptcy under any chapter of Chapter of Title 11 (Bankruptcy) of the United States Code by immediately following the filing of a title 11 (bankruptcy) of the United States Code by or or against: voluntary or involuntary petition for against: bankruptcy under any Chapter of Title 11 (Bankruptcy) of the United States Code by or against: Based on RATS 2018-2 letter dated November 21, 2018 20.3.3.317 TERMS AND CONDITIONS OF LICENSES: I. RATS 2018-1 category - B § In § 30.34, add a third sentence to Generators. Each licensee preparing technetium-99m 30.34 Terms and conditions of licenses paragraph (g) to read as follows:
radiopharmaceuticals from molybdenum-99/technetium- (g) Each licensee preparing technetium-99m (g)The licensee shall report the 99m generators or rubidium-82 from strontium- radiopharmaceuticals from molybdenum-99/technetium-99m results of any test that exceeds the 82/rubidium-82 generators shall test the generator eluates generators or rubidium-82 from strontium-82/rubidium-82 permissible concentration listed in § for molybdenum-99 breakthrough or strontium-82 and generators shall test the generator eluates for molybdenum- 35.204(a) of this chapter at the time strontium-85 contamination, respectively, in accordance 99 breakthrough or strontium-82 and strontium-85 of generator elution, in accordance with 20.3.7.706 NMAC of this chapter. The licensee shall contamination, respectively, in accordance with § 35.204 of with § 35.3204 of this chapter.
record the results of each test and retain each record for 3 this chapter. The licensee shall record the results of each test Based on RATS 2018-1 letter dated years after the record is made. The licensee shall report and retain each record for 3 years after the record is made. July 16, 2018 the results of any test that exceeds the permissible The licensee shall report the results of any test that exceeds concentration listed in 10 CFR 35.204(a) at the time of the permissible concentration listed in § 35.204(a) of this generator elution, in accordance with 10 CFR 35.3204. chapter at the time of generator elution, in accordance with § 35.3204 of this chapter.
20.3.7.7 DEFINITIONS: RATS 2018-1 category - B § In § 35.2, add, in alphabetical order, C.Associate Radiation Safety Officer (ARSO) means an 35.2 Definitions. the definitions for Associate individual who Associate Radiation Safety Officer means an individual who Radiation Safety Officer...
(1) Meets the requirements in §§ 35.50 and 35.59; and (1) Meets the requirements in §§ 35.50 and 35.59; and Based on RATS 2018-1 letter dated (2) Is currently identified as an Associate Radiation Safety (2) Is currently identified as an Associate Radiation Safety July 16, 2018 Officer for the types of use of byproduct material for which Officer for the types of use of byproduct material for which the individual has been assigned duties and tasks by the the individual has been assigned duties and tasks by the Radiation Safety Officer on Radiation Safety Officer on (a) A specific medical use license issued by the Commission (i) A specific medical use license issued by the Commission or or an Agreement State; or an Agreement State; or (b) A medical use permit issued by a Commission master (ii) A medical use permit issued by a Commission master material licensee. material licensee.
20.3.7.7 DEFINITIONS: RATS 2018-1 category - B § In § 35.2, add, in alphabetical order, V. Ophthalmic physicist means an individual who 35.2 Definitions. Ophthalmic the definitions for.... Ophthalmic (1) Meets the requirements in § 35.433(a)(2) and § 35.59; physicist means an individual who physicist.
and (1) Meets the requirements in §§ 35.433(a)(2) and 35.59; and Based on RATS 2018-1 letter dated (2) Is identified as an ophthalmic physicist on a (2) Is identified as an ophthalmic physicist on a July 16, 2018 (a) Specific medical use license issued by the Commission (i) Specific medical use license issued by the Commission or an or an Agreement State; Agreement State; (b) Permit issued by a Commission or Agreement State (ii) Permit issued by a Commission or Agreement State broad broad scope medical use licensee; scope medical use licensee; (c) Medical use permit issued by a Commission master (iii) Medical use permit issued by a Commission master material licensee; or material licensee; or (d) Permit issued by a Commission master material (iv) Permit issued by a Commission master material licensee licensee broad scope medical use permittee. broad scope medical use permittee.
20.3.7.7 DEFINITIONS: RATS 2018-1 category - B § In § 35.2, ... and revise the definition
[AA]CC. Preceptor means an individual who provides, 35.2 Definitions. Preceptor for Preceptor Based on RATS directs or verifies training and experience required for an means an individual who provides, directs, or verifies training 2018-1 letter dated July 16, 2018 individual to become an authorized user, an authorized and experience required for an individual to become an medical physicist, an authorized nuclear pharmacist, [or a] authorized user, an authorized medical physicist, an R[r]adiation S[s]afety O[o]fficer, or a Associate Radiation authorized nuclear pharmacist, a Radiation Safety Officer, or Officer. an Associate Radiation Safety Officer.
20.3.7.702GENERAL ADMINISTRATIVE REQUIREMENTS: RATS 2018-1 category - H&S § In § 35.24, revise paragraphs (b) to A.Radiation safety officer. 35.24 Authority and responsibilities for the radiation read as follows: (b)
(1)A licensee or licensees management shall appoint a protection program. (b) A A licensee's management shall radiation safety officer, who agrees, in writing, to be licensee's management shall appoint a Radiation Safety appoint a Radiation Safety Officer responsible for implementing a radiation protection Officer who agrees, in writing, to be responsible for who agrees, in writing, to be program. The licensee, through the radiation safety officer, implementing the radiation protection program. The licensee, responsible for implementing the shall ensure that radiation safety activities are being through the Radiation Safety Officer, shall ensure that radiation protection program. The performed in accordance with licensee-approved radiation safety activities are being performed in accordance licensee, through the Radiation procedures and regulatory requirements. A licensee's with licensee-approved procedures and regulatory Safety Officer, shall ensure that management may appoint, in writing, one or more requirements. A licensee's management may appoint, in radiation safety activities are being writing, one or more...... performed in accordance with licensee-approved procedures and regulatory requirements.
A licensees management may appoint, in writing, one or more
Continued Continued Continued Associate Radiation Safety Officers to support the Associate Radiation Safety Officers to support the Radiation Associate Radiation Safety Officers to Radiation Safety Officer. The Radiation Safety Officer, with Safety Officer. The Radiation Safety Officer, with written support the Radiation Safety Officer.
written agreement of the licensee's management, must agreement of the licensee's management, must assign the The Radiation Safety Officer, with assign the specific duties and tasks to each Associate specific duties and tasks to each Associate Radiation Safety written agreement of the licensees Radiation Safety Officer. These duties and tasks are Officer. These duties and tasks are restricted to the types of management, must assign the restricted to the types of use for which the Associate use for which the Associate Radiation Safety Officer is listed specific duties and tasks to each Radiation Safety Officer is listed on a license. The Radiation on a license. The Radiation Safety Officer may delegate duties Associate Radiation SafetyOfficer.
Safety Officer may delegate duties and tasks to the and tasks to the Associate Radiation Safety Officer but shall These duties and tasks are restricted Associate Radiation Safety Officer but shall not delegate not delegate the authority or responsibilities for to the types of use for which the the authority or responsibilities for implementing the implementing the radiation protection program. Associate Radiation Safety Officer is radiation protection program. listed on a license. The Radiation Safety Officer may delegate duties and tasks to the Associate Radiation Safety Officer but shall not delegate the authority or responsibilities for implementing the radiation protection program. Based on RATS 2018-1 letter dated July 16, 2018
20.3.7.702GENERAL ADMINISTRATIVE REQUIREMENTS: RATS 2018-1 category - H & S (b) revise paragraph (b)(6) to read as G.Written directive. § 35.40 Written directives. follows (3)(f)For permanent implant brachytherapy: (6) For permanent implant brachytherapy: (6) For permanent implant (i) Before implantation: The treatment site, the (i) Before implantation: The treatment site, the radionuclide, brachytherapy:
radionuclide, and the total source strength; and and the total source strength; and (i) Before implantation: the (ii) After implantation but before the patient leaves the (ii) After implantation but before the patient leaves the post- treatment site, the radionuclide, and post-treatment recovery area: The treatment site, the treatment recovery area: The treatment site, the number of the total source strength; and number of sources implanted, the total source strength sources implanted, the total source strength implanted, and (ii) After implantation but before the implanted, and the date; or [for all other brachytherapy, the date; or patient leaves the post-treatment including low, medium and pulsed dose rate remote recovery area: the treatment site, afterloaders, before implantation: treatment site, the the number of sources implanted, radionuclide and dose; and after implantation but before the total source strength implanted, completion of the procedure: the radionuclide, treatment and the date; or site, number of sources, total source strength and Based on RATS 2018-1 letter dated exposure time (or the total dose).] July 16, 2018
20.3.7.702GENERAL ADMINISTRATIVE REQUIREMENTS: RATS 2018-1 category - H & S (b) revise paragraph (b)(6) to read as G.Written directive. § 35.40 Written directives. follows (7)
(3)(g) for all other brachytherapy, including low, medium (7) For all other brachytherapy, including low, medium, and For all other brachytherapy, including and pulsed dose rate remote afterloaders: before pulsed dose rate remote afterloaders: low, medium, and pulsed dose rate implantation: the treatment site, [the] radionuclide and (i) Before implantation: The treatment site, radionuclide, and remote afterloaders:
dose; and after implantation but before completion of the dose; and (i) Before implantation: the procedure: the radionuclide, treatment site, number of (ii) After implantation but before completion of the treatment site, radionuclide, and sources, total source strength and exposure time (or the procedure: The radionuclide; treatment site; number of dose; and total dose); and date. sources; total source strength and (ii) After implantation but before exposure time (or the total dose); and date. completion of the procedure: the radionuclide; treatment site; number of sources; total source strength and exposure time (or the total dose);
and date.
(c)(1) A written revision to an existing written directive may be made if the revision is dated and signed by an authorized user before the administration of the dosage of unsealed byproduct material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose. Based on RATS 2018-1 letter dated July 16, 2018
20.3.7.702 GENERAL ADMINISTRATIVE RATS 2018-1 category - H & S Redesignate paragraph (c)(1) as REQUIREMENTS: § 35.40 Written directives. (c)(1) paragraph (c)(2)
G.Written directive. (4) A written revision to an existing written directive may be to read as follows:
A written revision to an existing written directive may be made if the revision is dated and signed by an authorized user (c)(1) A written revision to an made if the revision is dated and signed by an authorized before the administration of the dosage of unsealed existing written directive may be user before the administration of the dosage of unsealed byproduct material, the brachytherapy dose, the gamma made if the revision is dated and byproduct material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the signed by an authorized user before stereotactic radiosurgery dose, the teletherapy dose, or next fractional dose. the administration of the dosage of the next fractional dose. unsealed byproduct material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose.
Continued If, Continued (2) If, Continued because of the patient's condition, a delay in order to because of the patient's condition, a delay in order to provide (2) If, because of the patient's provide a written revision to an existing written directive a written revision to an existing written directive would condition, a delay in order to provide would jeopardize the patient's health, an oral revision to jeopardize the patient's health, an oral revision to an existing a written revision to an existing an existing written directive is acceptable. The oral revision written directive is acceptable. The oral revision must be written directive would jeopardize must be documented as soon as possible in the patient's documented as soon as possible in the patient's record. A the patient's health, an oral revision record. A revised written directive must be signed by the revised written directive must be signed by the authorized to an existing written directive is authorized user within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral revision. user within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral revision. acceptable. The oral revision must be documented as soon as possible in the patient's record. A revised written directive must be signed by the authorized user within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral revision.
Based on RATS 2018-1 letter dated July 16, 2018
20.3.7.702 GENERAL ADMINISTRATIVE RATS 2018-1 category - H & S § add new paragraphs (b)(5) and (b)(6)
REQUIREMENTS: 35.41 Procedures for administrations requiring a written to read as follows:
H.Procedures for administrations requiring a written directive. (5) (5) Determining if a medical event, as directive. (2)(e) Determining if a medical event, as defined in § 35.3045, has defined in § 35.3045, has occurred; Determining if a medical event, as defined in 20.3.7.716 occurred; and and NMAC and 10 CFR 35.3045, has occurred; and (6) Determining, for permanent implant brachytherapy, (6) Determining, for permanent (f) Determining, for permanent implant brachytherapy, within 60 calendar days from the date the implant was implant brachytherapy, within 60 within 60 calendar days from the date the implant was performed, the total source strength administered outside of calendar days from the date the performed, the total source strength administered outside the treatment site compared to the total source strength implant was performed, the total of the treatment site compared to the total source documented in the post-implantation portion of the written source strength administered outside strength documented in the post-implantation portion of directive, unless a written justification of patient unavailability of the treatment site compared to the written directive, unless a written justification of is documented. the total source strength patient unavailability is documented. documented in the post-implantation portion of the written directive, unless a written justification of patient unavailability is documented.
Based on RATS 2018-1 letter dated July 16, 2018
20.3.7.706 PERMISSIBLE MOLYBDENUM-99, RATS 2018-1 category - H&S § In § 35.204, revise paragraph (b) and STRONTIUM-82 AND STRONTIUM-85 CONCENTRATIONS: 35.204 Permissible molybdenum-99, strontium-82, and add new paragraph (e) to read as B.Measurement. strontium-85 concentrations. follows:
(1) A licensee preparing technetium-99m (b) A licensee that uses molybdenum-99/technetium-99m (b) A licensee that uses molybdenum-radiopharmaceutical from molybdenum-99/technetium- generators for preparing a technetium-99m 99/technetium-99m generators for 99m generators shall measure the molybdenum-99 radiopharmaceutical shall measure the molybdenum-99 preparing a technetium-99m concentration [of the first eluate after the receipt of the concentration in each eluate from a generator to radiopharmaceutical shall measure generator to demonstrate compliance with Subsection A of demonstrate compliance with paragraph (a) of this section. the molybdenum-99 concentration in this section] in each eluate from a generator to (e) The licensee shall report any measurement that exceeds each eluate from a generator to demonstrate compliance with Subsection A of this section. the limits in paragraph (a) of this section at the time of demonstrate compliance with D. Reporting. The licensee shall report any generator elution, in accordance with § 35.3204. paragraph (a) of this section.
measurement that exceeds the limits in paragraph (a) of this section at the time of generator elution, in accordance (e) The licensee shall report any with subsection D of 20.3.7.716 measurement that exceeds the limits NMAC and 10 CFR 35.3204. in paragraph (a) of this section at the time of generator elution, in accordance with § 35.3204.
Based on RATS 2018-1 letter dated July 16, 2018
20.3.7.708USE OF UNSEALED RADIOACTIVE MATERIAL RATS 2018-1 category - B § revise the introductory text to read FOR WHICH A WRITTEN DIRECTIVE IS REQUIRED: 35.300 Use of unsealed byproduct material for which a as follows: A A licensee may use any unsealed byproduct [radioactive] written directive is required. licensee may use any unsealed material identified in 10 CFR 35.390(b)(1)(ii)(G) prepared A licensee may use any unsealed byproduct material byproduct material identified in for medical use and for which a written directive is identified in § 35.390(b)(1)(ii)(G) prepared for medical use §35.390(b)(1)(ii)(G) prepared for required that is [either]: and for which a written directive is required that is medical use and for which a written directive is required that is Based on RATS 2018-1 letter dated July 16, 2018
20.3.7.710MANUAL BRACHYTHERAPY: RATS 2018-1 category - B § In § 35.400 revise paragraphs (a) and A. Use of sources for manual brachytherapy. The 35.400 Use of sources for manual brachytherapy. (b) to read as follows:
regulations of the NRC set forth in 10 CFR 35.400 are A licensee must use only brachytherapy sources: A licensee must use only hereby incorporated by reference. [A licensee shall use (a) Approved in the Sealed Source and Device Registry for brachytherapy sources:
only brachytherapy sources for therapeutic medical uses: manual brachytherapy medical use. The manual (a) Approved in the Sealed Source (1)as approved in the sealed source and device brachytherapy sources may be used for manual and Device Registry............. are met.
registry; or brachytherapy uses that are not explicitly listed in the Sealed Based on RATS 2018-1 letter dated (2)in research in accordance with an active Source and Device Registry, but must be used in accordance July 16, 2018 investigational device exemption application accepted by with the radiation safety conditions and limitations described the FDA provided the requirements of Paragraph (1) of in the Sealed Source and Device Registry; or Section I of 20.3.7.702 NMAC are met.] (b) In research to deliver therapeutic doses for medical use in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of § 35.49(a) are met.
20.3.7.710MANUAL BRACHYTHERAPY: RATS 2018-1 category - B § In § 35.433, revise paragraph (a), add G.Decay of strontium-90 sources for ophthalmic 35.433 Strontium-90 sources for ophthalmic treatments. new paragraphs (b), (b)(1) and (2),
treatments. The regulations of the NRC set forth in 10 CFR (a) Licensees who use strontium-90 for ophthalmic and redesignate paragraph (c) to read 35.433 are hereby incorporated by reference. [(1)Only an treatments must ensure that certain activities as specified in as follows: (a) authorized medical physicist shall calculate the activity of paragraph (b) of this section are performed by either: Licensees who use strontium-90 for each strontium-90 source that is used to determine the (1) An authorized medical physicist; or ophthalmic treatments must ensure treatment times for ophthalmic treatments. The decay (2) An individual who: that ........ Based on must be based on the activity determined under (i) is identified as an ophthalmic physicist on a specific medical RATS 2018-1 letter dated July 16, Subsection F of 20.3.7.710 NMAC. use license issued by the Commission or an Agreement State; 2018 (2)A licensee shall retain a record of the activity of each permit issued by a Commission or Agreement State broad strontium-90 source in accordance with Subsection S of scope medical use licensee; medical use permit issued by a 20.3.7.715 NMAC.] Commission master material licensee; or permit issued by a Commission master material licensee broad scope medical use permittee; and (ii) holds a master's or doctor's degree in physics, medical physics, other physical sciences, engineering, or applied mathematics from an accredited college or university; and (iii) has successfully completed 1 year of full-time training in medical physics and an additional year of full-time work experience under the supervision of a medical physicist; and (iv) Has documented training in:
Continued Continued (A) Continued The creation, modification, and completion of written directives; (B) Procedures for administrations requiring a written directive; and (C) Performing the calibration measurements of brachytherapy sources as detailed in § 35.432.
(b) The individuals who are identified in paragraph (a) of this section must:
(1) Calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the activity determined under § 35.432; and (2) Assist the licensee in developing, implementing, and maintaining written procedures to provide high confidence that the administration is in accordance with the written directive. These procedures must include the frequencies that the individual meeting the requirements in paragraph (a) of this section will observe treatments, review the treatment methodology, calculate treatment time for the prescribed dose, and review records to verify that the administrations were in accordance with the written directives.
(c) Licensees must retain a record of the activity of each strontium-90 source in accordance with § 35.2433.
20.3.7.711PHOTON EMITTING REMOTE AFTERLOADER RATS 2018-1 category - H&S § In § 35.610, add new paragraph UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC 35.610 Safety procedures and instructions for remote (d)(1) and revise paragraphs (d) and RADIOSURGERY UNITS: D(4) Prior to the first use for afterloader units, teletherapy units, and gamma stereotactic (g) to read as follows:
patient treatment of a new unit or an existing unit with a radiosurgery units. (d)(1) Prior to manufacturer upgrade that affects the operation and the first use for patient treatment of a new unit or an existing *****
safety of the unit, a licensee shall ensure that vendor unit with a manufacturer upgrade that affects the operation (d)(1) Prior to the first use for patient operational and safety training is provided to all individuals and safety of the unit, a licensee shall ensure that vendor treatment of a new unit or an existing who will operate the unit. The vendor operational and operational and safety training is provided to all individuals unit with a manufacturer upgrade safety training must be provided by the device who will operate the unit. The vendor operational and safety that affects the operation and safety manufacturer or by an individual certified by the device training must be provided by the device manufacturer or by of the unit, a licensee shall ensure manufacturer to provide the operational and safety an individual certified by the device manufacturer to provide that vendor operational and safety training. the operational and safety training. training is provided to all individuals (5[4])A licensee shall provide operational and safety who will operate the unit. The instruction, initially and at least annually, to all individuals (2) A licensee shall provide operational and safety instructions vendor operational and safety who operate the unit at the facility, as appropriate to the initially and at least annually to all individuals who operate training must be provided by the individual's assigned duties, in: the unit at the facility, as appropriate to the individual's device manufacturer or by an (a)the procedures identified in Subparagraph (d) of assigned duties. The instructions shall include instruction in individual certified by the device Paragraph (1) of this subsection; and (i) The procedures identified in paragraph (a)(4) of this manufacturer to provide the (b)the operating procedures for the unit. section; and operational and safety training.
(ii) The operating procedures for the unit. (2) A licensee shall provide operational and safety instructions initially and at least annually to all individuals who operate the unit at the facility, as
Continued Continued Continued (8[7])A licensee shall retain a copy of the procedures appropriate to the individual's required by Subparagraph (d) of Paragraph (1) and assigned duties. The instructions Subparagraph (b) of Paragraph (5[4]) of this subsection in shall include instruction in (i) accordance with Subsection U of 20.3.7.715 NMAC. The procedures identified in paragraph (a)(4) of this section; and (ii) The operating procedures for the unit.
(g) A licensee shall retain a copy of the procedures required by paragraphs (a)(4) and (d)(2)(ii) of this section in accordance with § 35.2610.
Based on RATS 2018-1 letter dated July 16, 2018
20.3.7.711PHOTON EMITTING REMOTE AFTERLOADER RATS 2018-1 category - H&S § In § 35.655, revise the section UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC 35.655 Full-inspection servicing for teletherapy and gamma heading and paragraph (a) to read as RADIOSURGERY UNITS: O.Five-year inspection stereotactic radiosurgery units. follows:
for teletherapy and gamma stereotactic radiosurgery units. (a) A licensee shall have each teletherapy unit and gamma (a) A licensee shall have each (1)A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during each source replacement to assure proper functioning stereotactic radiosurgery unit fully during source replacement [or at intervals not to exceed 5 of the source exposure mechanism and other safety inspected and serviced during each years, whichever comes first,] to assure proper functioning components. The interval between each full-inspection source replacement to assure proper of the source exposure mechanism and other safety servicing shall not exceed 5 years for each teletherapy unit functioning of the source exposure components. The interval between each full inspection and shall not exceed 7 years for each gamma stereotactic mechanism and other safety servicing shall not exceed 5 years for each teletherapy unit radiosurgery unit. components. The interval between and shall not exceed 7 years for each gamma stereotactic each full inspection servicing shall not radiosurgery unit. exceed 5 years for each teletherapy unit and shall not exceed 7 years for each gamma stereotactic radiosurgery unit.
Based on RATS 2018-1 letter dated July 16, 2018
20.3.7.712 SEALED SOURCES FOR DIAGNOSIS: RATS 2018-1 category - C § In § 35.500 revise paragraph (a), and A.Use of sealed sources for diagnosis. A licensee shall use 35.500 Use of sealed sources and medical devices for add new paragraphs (b) and (c) to only sealed sources for diagnostic medical uses [as diagnosis. read as follows:
approved in the sealed source and device registry] if the (a) A licensee must use only sealed sources that are not in (a) A licensee must use only sealed sealed sources are approved in the Sealed Source and medical devices for diagnostic medical uses if the sealed sources that are not in medical Device Registry for diagnostic medicine. The sealed sources sources are approved in the Sealed Source and Device devices for diagnostic medical uses if may be used for diagnostic medical uses that are not Registry for diagnostic medicine. The sealed sources may be the sealed sources are approved in explicitly listed in the Sealed Source and Device Registry used for diagnostic medical uses that are not explicitly listed the Sealed Source and Device but must be used in accordance with the radiation safety in the Sealed Source and Device Registry but must be used in Registry for diagnostic medicine. The conditions and limitations described in the Sealed Source accordance with the radiation safety conditions and sealed sources may be used for and Device Registry. limitations described in the Sealed Source and Device diagnostic medical uses that are not B. A licensee must only use medical devices Registry. explicitly listed in the Sealed Source containing sealed sources for diagnostic medical uses if and Device Registry but must be used both the sealed sources and medical devices are approved (b) A licensee must only use medical devices containing in accordance with the radiation in the Sealed Source and Device Registry for diagnostic sealed sources for diagnostic medical uses if both the sealed safety conditions and limitations medical uses. The diagnostic medical devices may be used sources and medical devices are approved in the Sealed described in the Sealed Source and for diagnostic medical uses that are not explicitly listed in Source and Device Registry for diagnostic medical uses. The Device Registry.
the Sealed Source and Device Registry but must be used in diagnostic medical devices may be used for diagnostic (b) A licensee must only use medical accordance with the radiation safety conditions and medical uses that are not explicitly listed in the Sealed Source devices containing sealed sources for limitations described in the Sealed Source and Device and Device Registry but must be used in accordance with the diagnostic medical uses if both the Registry. radiation safety conditions and limitations described in the sealed sources and medical devices Sealed Source and Device Registry. are approved in the Sealed Source and Device Registry for diagnostic medical uses.
Continued C. Continued (c) Continued Sealed sources and devices for diagnostic medical uses Sealed sources and devices for diagnostic medical uses may The diagnostic medical devices may may be used in research in accordance with an active be used in research in accordance with an active be used for diagnostic medical uses Investigational Device Exemption (IDE) application Investigational Device Exemption (IDE) application accepted that are not explicitly listed in the accepted by the U.S. Food and Drug Administration by the U.S. Food and Drug Administration provided the Sealed Source and Device Registry provided the requirements of 10 CFR 35.49(a) are met. requirements of § 35.49(a) are met. but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry.
(c) Sealed sources and devices for diagnostic medical uses may be used in research in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of § 35.49(a) are met.
Based on RATS 2018-1 letter dated July 16, 2018 20.3.7.714 TRAINING REQUIREMENTS: RATS 2018-1 category - B § Revise § 35.50 to read as follows:
A.Radiation safety officer and Associate Radiation Safety 35.50 Training for Radiation Safety Officer and Associate incorporated by reference Officer. The regulations of the NRC set forth in 10 CFR Radiation Safety Officer. Based on RATS 2018-1 letter dated 35.50 are hereby incorporated by reference. July 16, 2018
20.3.7.716 REPORTS: RATS 2018-1 category - C In § 35.3045, revise paragraph (a) to A.Report and notification of a medical event. Subpart MReports read as follows:
(1) A licensee shall report any event, except for an § 35.3045 Report and notification of a medical event. (a) A licensee shall report any event event that results from patient intervention, in which the (a) A licensee shall report any event as a medical event, as a medical event, exceptfor an administration of byproduct [radioactive] material or except for an event that results from patient intervention, in event that results from patient radiation from byproduct [radioactive] material, except which intervention, in which permanent implant brachytherapy, results in: (1) The administration of byproduct material or radiation (1) The administration of byproduct (a) a dose that differs from the prescribed dose or dose from byproduct material, except permanent implant material or radiation from byproduct that would have resulted from the prescribed dosage by brachytherapy, results in material, except permanent implant more than 5 rems (50 millisieverts) effective dose (i) A dose that differs from the prescribed dose or dose that brachytherapy, results in equivalent, 50 rems (0.5 sievert) to an organ or tissue or 50 would have resulted from the prescribed dosage by more (i) A dose that differs from the rems (0.5 sievert) shallow dose equivalent to the skin; and: than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 prescribed dose or dose that would (i)the total dose delivered differs from the prescribed rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose have resulted from the prescribed dose by twenty percent or more; equivalent to the skin; and dosage by more than 0.05 Sv (5 rem)
(ii)the total dosage delivered differs from the prescribed (A) The total dose delivered differs from the prescribed dose effective dose equivalent, 0.5 Sv (50 dosage by twenty percent or more or falls outside the by 20 percent or more; rem) to an organ or tissue, or 0.5 Sv prescribed dosage range; or (B) The total dosage delivered differs from the prescribed (50 rem) shallow dose equivalent to (iii)the fractionated dose delivered differs from the dosage by 20 percent or more or falls outside the prescribed the skin; and prescribed dose, for a single fraction, by fifty percent or dosage range; or (A) The total dose delivered differs more; (C) The fractionated dose delivered differs from the from the prescribed dose by 20 (b)a dose that exceeds 5 rems (50 millisieverts) effective prescribed dose for a single fraction, by 50 percent or more. percent or more; dose equivalent, 50 rems (0.5 sievert) to an organ or (ii) A dose that exceeds 0.05 Sv (5 rem) effective dose tissue, or 50 rems (0.5 sievert) shallow dose equivalent to equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 the skin from any of the following: rem) shallow dose equivalent to the skin from any of the following
Continued Continued Continued (i)an administration of a wrong radioactive drug A) An administration of a wrong radioactive drug containing (B) The total dosage delivered differs containing byproduct[radioactive] material; byproduct material or the wrong radionuclide for a from the prescribed dosage by 20 (ii)an administration of a radioactive drug containing brachytherapy procedure; percent or more or falls outside the radioactive material by the wrong route of administration; (B) An administration of a radioactive drug containing prescribed dosage range; or (iii)an administration of a dose or dosage to the wrong byproduct material by the wrong route of administration; (C) The fractionated dose delivered individual or human research subject; (C) An administration of a dose or dosage to the wrong differs from the prescribed dose for a (iv)an administration of a dose or dosage delivered by the individual or human research subject; single fraction, by 50 percent or wrong mode of treatment; or (D) An administration of a dose or dosage delivered by the more20 percent of the total source (v)a leaking sealed source; and wrong mode of treatment; or strength documented in the post-(E) A leaking sealed source. implantation portion of the written directive; or (c)a dose to the skin or an organ or tissue other than the (iii) A dose to the skin or an organ or tissue other than the Continued (ii) treatment site that exceeds by 50 rems (0.5 sievert) to an treatment site that exceeds by: A dose that exceeds 0.05 Sv (5 rem) organ or tissue and fifty percent or more of the dose (A) 0.5 Sv (50 rem) or more the expected dose to that site effective dose equivalent, 0.5 Sv (50 expected from the administration defined in the written from the procedure if the administration had been given in rem) to an organ or tissue, or 0.5 Sv directive (excluding, for permanent implants, seeds that accordance with the written directive prepared or revised (50 rem) shallow dose equivalent to were implanted in the correct site but migrated outside before administration; and the skin from any of the following the treatment site). (B) 50 percent or more the expected dose to that site from (A) An administration of a wrong (d) For permanent implant brachytherapy, the the procedure if the administration had been given in radioactive drug containing administration of byproduct material or radiation from accordance with the written directive prepared or revised byproduct material or the wrong byproduct material (excluding sources that were implanted before administration. radionuclide for a brachytherapy in the correct site but migrated outside the treatment site) (2) For permanent implant brachytherapy, the administration procedure; that results in of byproduct material or radiation from byproduct material (B) An administration of a radioactive (excluding sources that were implanted in the correct site but drug containing byproduct material migrated outside the treatment site) that results in by the wrong route of administration;
Continued Continued (i) Continued (i) The total source strength administered differing by 20 The total source strength administered differing by 20 (C) An administration of a dose or percent or more from the total source strength percent or more from the total source strength documented dosage to the wrong individual or documented in the post-implantation portion of the in the post-implantation portion of the written directive; human research subject; written directive; (ii) The total source strength administered outside of (D) An administration of a dose or (ii) The total source strength administered outside of the thetreatment site exceeding 20 percent of the total source dosage delivered by the wrong mode treatment site exceeding 20 percent of the total source strength documented in the post-implantation portion of the of treatment; or strength documented in the post-implantation portion of written directive; or (E) A leaking sealed source.
the written directive; or (iii) An administration that includes any of the following: (iii) A dose to the skin or an organ or (iii) An administration that includes any of the following: (A) The wrong radionuclide; tissue other than the treatment site the wrong radionuclide; the wrong individual or human (B) The wrong individual or human research subject; that exceeds by:
research subject; sealed source(s) implanted directly into a (C) Sealed source(s) implanted directly into a location (A) 0.5 Sv (50 rem) or more the location discontiguous from the treatment site, as discontiguous from the treatment site, as documented in the expected dose to that site from the documented in the post-implantation portion of the post-implantation portion of the written directive; or procedure if the administration had written directive; or a leaking sealed source resulting in a (D) A leaking sealed source resulting in a dose that exceeds been given in accordance with the dose that exceeds 0.5 Sv (50 rem) to an organ or tissue. 0.5 Sv (50 rem) to an organ or tissue. written directive prepared or revised before administration; and
Continued Continued Continued (B) 50 percent or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration. (2) For permanent implant brachytherapy, the administration of byproduct material or radiation from byproduct material (excluding sources that were implanted in the correct site but migrated outside the treatment site) that results in (i) The total source strength administered differing by 20 percent or more from the total source strength documented in the post-implantation portion of the written directive; Continued Continued Continued (ii) The total source strength administered outside of the treatment site exceeding 20 percent of the total source strength documented in the post-implantation portion of the written directive; or (iii) An administration that includes any of the following:
(A) The wrong radionuclide; (B) The wrong individual or human research subject;
Continued Continued Continued (C) Sealed source(s) implanted directly into a location discontiguous from the treatment site, as documented in the post-implantation portion of the written directive; or (D) A leaking sealed source resulting in a dose that exceeds 0.5 Sv (50 rem) to an organ or tissue.
Based on RATS 2018-1 letter dated July 16, 2018
20.3.7.716REPORTS: D. RATS 2018-1 category - C § Add a new § 35.3204 to subpart M Report and notification for an eluate exceeding permissible 35.3204 Report and notification for an eluate exceeding to read as follows:
molybdenum-99, strontium-82, and strontium-85 permissible molybdenum-99, strontium-82, and strontium- (a) The licensee shall notify by concentrations: 85 concentrations. (a) The licensee telephone the NRC Operations (1) The licensee shall notify by telephone the department shall notify by telephone the NRC Operations Center and the Center and the distributor of the and NRC Operations Center and the distributor of the distributor of the generator within 7 calendar days after generator within 7 calendar days generator within 7 calendar days after discovery that an discovery that an eluate exceeded the permissible after discovery that an eluate eluate exceeded the permissible concentration listed in § concentration listed in § 35.204(a) at the time of generator exceeded the permissible 35.204(a) at the time of generator elution. The telephone elution. The telephone report to the NRC must include the concentration listed in § 35.204(a) at report to the department and NRC must include the manufacturer, model number, and serial number (or lot the time of generator elution. The manufacturer, model number, and serial number (or lot number) of the generator; the results of the measurement; telephone report to the NRC must number) of the generator; the results of the measurement; the date of the measurement; whether dosages were include the manufacturer, model the date of the measurement; whether dosages were administered to patients or human research subjects, when number, and serial number (or lot administered to patients or human research subjects, the distributor was notified, and the action taken. number) of the generator; the results when the distributor was notified, and the action taken. of the measurement; the date of the measurement; whether dosages were administered to patients or human research subjects, when the distributor was notified, and the action taken.
Continued (2) Continued (b) By Continued By an appropriate method listed in § 30.6(a) of this an appropriate method listed in § 30.6(a) of this chapter, the (b) By an appropriate method listed chapter, the licensee shall submit a written report to the licensee shall submit a written report to the appropriate NRC in § 30.6(a) of this chapter, the department and appropriate NRC Regional Office listed in Regional Office listed in § 30.6 of this chapter within 30 licensee shall submit a written report
§ 30.6 of this chapter within 30 calendar days after calendar days after discovery of an eluate exceeding the to the appropriate NRC Regional discovery of an eluate exceeding the permissible permissible concentration at the time of generator elution. Office listed in § 30.6 of this chapter concentration at the time of generator elution. The written The written report must include the action taken by the within 30 calendar days after report must include the action taken by the licensee; the licensee; the patient dose assessment; the methodology used discovery of an eluate exceeding the patient dose assessment; the methodology used to make to make this dose assessment if the eluate was administered permissible concentration at the time this dose assessment if the eluate was administered to to patients or human research subjects; and the probable of generator elution. The written patients or human research subjects; and the probable cause and an assessment of failure in the licensee's report must include the action taken cause and an assessment of failure in the licensees equipment, procedures or training that contributed to the by the licensee; the patient dose equipment, procedures or training that contributed to the excessive readings if an error occurred in the licensee's assessment; the methodology used excessive readings if an error occurred in the licensees breakthrough determination; and the information in the to make this dose assessment if the breakthrough determination; and the information in the telephone report as required by paragraph (a) of this section. eluate was administered to patients telephone report as required by paragraph (1) of this or human research subjects; section.
Continued Continued Continued and the probable cause and an assessment of failure in the licensee's equipment, procedures or training that contributed to the excessive readings if an error occurred in the licensee's breakthrough determination; and the information in the telephone report as required by paragraph (a) of this section.
Based on RATS 2018-1 letter dated July 16, 2018
RCB Corrections and Amendments 20.3.3.307 FILING APPLICATION FOR SPECIFIC none RCB Correction to allign with NRC LICENSES: regulations.
E.An application for a specific license of category 1 and category 2 quantities of radioactive material shall comply with 10 CFR 37. The licensee shall comply with 10 CFR 37 except as follows:
(4)the license required report of events or notification in 10 CFR 37.45, 10 CFR 37.57, 10 CFR 71, 10 CFR 37.77(a) through (d), and 10 CFR 37.81 shall use the following address when applicable: New Mexico Environment Department/RCB, P.O. Box 5469, Santa Fe, NM 87502-5469.
20.3.3.315 SPECIAL REQUIREMENTS FOR A SPECIFIC None PART RCB Correction to align with current LICENSE TO MANUFACTURE, ASSEMBLE, REPAIR OR 32SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR federal regulation DISTRIBUTE COMMODITIES, PRODUCTS OR DEVICES TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT WHICH CONTAIN RADIOACTIVE MATERIAL: MATERIAL § J.Manufacture, preparation or transfer for commercial 32.72 Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct distribution of radioactive drugs containing byproduct
[radioactive] material for medical use under 20.3.7 NMAC. material for medical use under part 35 20.3.5.10 SPECIFIC LICENSE FOR INDUSTRIAL none RCB Correction to allign with NRC RADIOGRAPHY: E. An regulations.
application for a specific license of category 1 and category 2 quantities of radioactive material shall comply with 10 CFR 37. The licensee shall comply with 10 CFR 37 except as follows: (4)for any reporting or notification requirements that the licensee must follow in 10 CFR 37.45, 10 CFR 37.57, 10 CFR 37.77(a) through (d), and 10 CFR 37.81 the licensee shall use the following address when applicable: New Mexico Environment Department/RCB, P.O. Box 5469, Santa Fe, NM 87502-5469 address information.
20.3.7.700GENERAL REGULATORY REQUIREMENTS: none RCB Correction to allign with NRC E. Application for license, amendment or renewal. regulations.
(3)An application for a specific license of category 1 and category 2 quantities of radioactive material shall comply with 10 CFR 37. The licensee shall comply with 10 CFR 37 except as follows: (d)for any reporting or notification requirements that the licensee must follow in 10 CFR 37.45, 10 CFR 37.57, 10 CFR 37.77(a) through (d), and 10 CFR 37.81, the licensee shall use the following address when applicable: New Mexico environment department/RCB, P.O. Box 5469, Santa Fe, NM 87502-5469 address information.
20.3.12.9 SPECIFIC LICENSES FOR WELL LOGGING: B. none RCB Correction to allign with NRC An application for a specific license of category 1 and regulations.
category 2 quantities of radioactive material shall comply with 10 CFR 37. The licensee shall comply with 10 CFR 37 except as follows: (4) for any reporting or notification requirements that the licensee must follow in 10 CFR 37.45, 10 CFR 37.57, 10 CFR 37.77(a) through (d), and 10 CFR 37.81, the licensee shall use the following address when applicable: New Mexico Environment Department/RCB, P.O. Box 5469, Santa Fe, NM 87502-5469 address information.
20.3.15.1502 SPECIFIC LICENSES FOR IRRADIATORS: none RCB Correction to allign with NRC B. An application for a specific license of category 1 and regulations.
category 2 quantities of radioactive material shall comply with 10 CFR 37. The licensee shall comply with 10 CFR 37 except as follows: (4) for any reporting or notification requirements that the licensee must follow in 10 CFR 37.45, 10 CFR 37.57, 10 CFR 37.77(a) through (d), 10 CFR 37.81, the licensee shall use, when applicable, New Mexico Environment Department/RCB, P.O. Box 5469, Santa Fe, NM 87502-5469 address information.