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Oklahoma Administrative Code (Last Updated: March 11, 2021) |
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TITLE 252. Department of Environmental Quality |
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Chapter 410. Radiation Management |
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Subchapter 10. Radioactive Materials Program |
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Part 35. MEDICAL USE OF BYPRODUCT MATERIAL |
SECTION 252:410-10-35. 10 CFR 35 incorporations by reference
Latest version.
- (a) Incorporations by reference. The following provisions are hereby incorporated by reference from 10 CFR 35, Medical Use of Byproduct Material:(1) Subpart A; General Information.(A) 35.1 - Purpose and scope(B) 35.2 - Definitions(C) 35.5 - Maintenance of records(D) 35.6 - Provisions for the protection of human research subjects(E) 35.7 - FDA, other Federal and State requirements(F) 35.10 - Implementation(G) 35.11(a), (b) and (c)(2) - License required(H) 35.12 - Application for license, amendment or renewal(I) 35.13(a)(2), and (b) through (g) - License amendments(J) 35.14 - Notifications(K) 35.15 - Exemptions regarding Type A specific licenses of broad scope(L) 35.18 - License issuance(M) 35.19 - Specific exemptions(2) Subpart B; General Administrative Requirements.(A) 35.24 - Authority and responsibilities for the radiation protection program(B) 35.26 - Radiation protection program changes(C) 35.27 - Supervision(D) 35.40 - Written directives(E) 35.41 - Procedures for administrations requiring a written directive(F) 35.49 - Suppliers for sealed sources or devices for medical use(G) 35.50 - Training for Radiation Safety Officer and Associate Radiation Safety Officer(H) 35.51 - Training for an authorized medical physicist(I) 35.55 - Training for an authorized nuclear pharmacist(J) 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist(K) 35.59 - Recentness of Training(3) Subpart C; General Technical Requirements.(A) 35.60 - Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material(B) 35.61 - Calibration of survey instruments(C) 35.63 - Determination of dosages of unsealed byproduct material for medical use(D) 35.65 - Authorization for calibration, transmission, and reference sources(E) 35.67 - Requirements for possession of sealed sources and brachytherapy sources(F) 35.69 - Labeling of vials and syringes(G) 35.70 - Surveys of ambient radiation exposure rate(H) 35.75 - Release of individuals containing unsealed byproduct material or implants containing byproduct material(I) 35.80 - Provision of mobile medical service(J) 35.92 - Decay-in-storage(4) Subpart D; Unsealed Byproduct Material-Written Directive Not Required.(A) 35.100 - Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required(B) 35.190 - Training for uptake, dilution, and excretion studies(C) 35.200 - Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required(D) 35.204 - Permissible molybdenum-99, strontium-82, and strontium-85 concentrations(E) 35.290 - Training for imaging and localization studies(5) Subpart E; Unsealed Byproduct Material - Written Directive Required.(A) 35.300 - Use of unsealed byproduct material for which a written directive is required(B) 35.310 - Safety instruction(C) 35.315 - Safety precautions(D) 35.390 - Training for use of unsealed byproduct material for which a written directive is required(E) 35.392 - Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)(F) 35.394 - Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries)(G) 35.396 - Training for the parenteral administration of unsealed byproduct material requiring a written directive(6) Subpart F; Manual Brachytherapy.(A) 35.400 - Use of sources for manual brachytherapy(B) 35.404 - Surveys after source implant and removal(C) 35.406 - Brachytherapy sources accountability(D) 35.410 - Safety instruction(E) 35.415 - Safety precautions(F) 35.432 - Calibration measurements of brachytherapy sources(G) 35.433 - Strontium-90 sources for ophthalmic treatments(H) 35.457 - Therapy related computer systems(I) 35.490 - Training for use of manual brachytherapy sources(J) 35.491 - Training for ophthalmic use of strontium-90(7) Subpart G; Sealed Sources for diagnosis.(A) 35.500 - Use of sealed sources and medical devices for diagnosis(B) 35.590 - Training for use of sealed sources and medical devices for diagnosis(8) Subpart H; Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units.(A) 35.600 - Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit(B) 35.604 - Surveys of patients and human research subjects treated with a remote afterloader unit(C) 35.605 - Installation, maintenance, adjustment, and repair(D) 35.610 - Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units(E) 35.615 - Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units(F) 35.630 - Dosimetry equipment(G) 35.632 - full calibration measurements on teletherapy units(H) 35.633 - Full calibration measurements on remote afterloader units(I) 35.635 - Full calibration measurements on gamma sterotactic radiosurgery units(J) 35.642 - Periodic spot-checks for teletherapy units(K) 35.643 - Periodic spot-checks for remote afterloader units(L) 35.645 - Periodic spot-checks for gamma stereotactic radiosurgery units(M) 35.647 - Additional technical requirements for mobile remote afterloader units(N) 35.652 - Radiation surveys(O) 35.655 - Full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units(P) 35.657 - Therapy-related computer systems(Q) 35.690 - Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units(9) Subpart I.(10) Subpart K; Other Medical Uses of Byproduct Material or Radiation From Byproduct Material. 35.1000 - Other medical uses of byproduct material or radiation from byproduct material(11) Subpart L; Records.(A) 35.2024 - Records of authority and responsibilities for radiation protection programs(B) 35.2026 - Records of radiation protection program changes(C) 35.2040 - Records of written directives(D) 35.2041 - Records for procedures for administration requiring a written directive(E) 35.2060 - Records of calibrations of instruments used to measure the activity of unsealed byproduct materials(F) 35.2061 - Records of radiation survey instrument calibrations(G) 35.2063 - Records of dosages of unsealed byproduct material for medical use(H) 35.2067 - Records of leaks tests and inventory of sealed sources and brachytherapy sources(I) 35.2070 - Records of survey for ambient radiation exposure rate(J) 35.2075 - Records of the release of individuals containing unsealed byproduct material or implants containing byproduct material(K) 35.2080 - Records of mobile medical services(L) 35.2092 - Records of decay-in-storage(M) 35.2204 - Records of molybdenum-99, strontium-82, and strontium 85 concentrations.(N) 35.2310 - Records of safety instruction(O) 35.2404 - Records of surveys after source implant and removal(P) 35.2406 - Records of brachytherapy source accountability(Q) 35.2432 - Records of calibration measurements of brachytherapy sources(R) 35.2433 - Records of decay of strontium-90 sources for ophthalmic treatments(S) 35.2605 - Records of installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units(T) 35.2610 - Records of safety procedures(U) 35.2630 - Records of dosimetry equipment used with remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units(V) 35.2632 - Records of teletherapy, remote afterloader, and gamma stereotactic radiosurgery full calibrations(W) 35.2642 - Records of periodic spot-checks for teletherapy units(X) 35.2643 - Records of periodic spot-checks for remote afterloader units(Y) 35.2645 - Records of periodic spot checks for gamma sterotactic radiosurgery units(Z) 35.2647 - Records of additional technical requirements for mobile remote afterloader units(AA) 35.2652 - Records of surveys of therapeutic treatment units(BB) 35.2655 - Records of full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units(12) Subpart M; Reports.(A) 35.3045 - Report and notification of a medical event(B) 35.3047 - Report and notification of a dose to an embryo/fetus or a nursing child(C) 35.3067 - Report of a leaking source(D) 35.3204 - Report and notification for an eluate exceeding permissible molybdenum-99, strontium-82 and strontium-85 concentrations(b) Exceptions. The provisions for communication with NRC of 10 CFR § 30.6 referenced in §§ 35.12 and 35.14 are not incorporated by reference. All correspondence regarding license requirements, and any notifications or reports required by this Part, shall be directed to DEQ.