10 C.F.R. Subpart B—General Administrative Requirements
Title 10 - Energy
(a) In addition to the radiation protection program requirements of §20.1101 of this chapter, a licensee's management shall approve in writing— (1) Requests for a license application, renewal, or amendment before submittal to the Commission; (2) Any individual before allowing that individual to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist; and (3) Radiation protection program changes that do not require a license amendment and are permitted under §35.26; (b) A licensee's management shall appoint a Radiation Safety Officer, who agrees, in writing, to be responsible for implementing the radiation protection program. The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements. (c) For up to 60 days each year, a licensee may permit an authorized user or an individual qualified to be a Radiation Safety Officer, under §§35.50 and 35.59, to function as a temporary Radiation Safety Officer and to perform the functions of a Radiation Safety Officer, as provided in paragraph (g) of this section, if the licensee takes the actions required in paragraphs (b), (e), (g), and (h) of this section and notifies the Commission in accordance with §35.14(b). (d) A licensee may simultaneously appoint more than one temporary Radiation Safety Officer in accordance with paragraph (c) of this section, if needed to ensure that the licensee has a temporary Radiation Safety Officer that satisfies the requirements to be a Radiation Safety Officer for each of the different types of uses of byproduct material permitted by the license. (e) A licensee shall establish the authority, duties, and responsibilities of the Radiation Safety Officer in writing. (f) Licensees that are authorized for two or more different types of uses of byproduct material under Subparts E, F, and H of this part, or two or more types of units under Subpart H of this part, shall establish a Radiation Safety Committee to oversee all uses of byproduct material permitted by the license. The Committee must include an authorized user of each type of use permitted by the license, the Radiation Safety Officer, a representative of the nursing service, and a representative of management who is neither an authorized user nor a Radiation Safety Officer. The Committee may include other members the licensee considers appropriate. (g) A licensee shall provide the Radiation Safety Officer sufficient authority, organizational freedom, time, resources, and management prerogative, to— (1) Identify radiation safety problems; (2) Initiate, recommend, or provide corrective actions; (3) Stop unsafe operations; and, (4) Verify implementation of corrective actions. (h) A licensee shall retain a record of actions taken under paragraphs (a), (b), and (e) of this section in accordance with §35.2024. (a) A licensee may revise its radiation protection program without Commission approval if— (1) The revision does not require a license amendment under §35.13; (2) The revision is in compliance with the regulations and the license ; (3) The revision has been reviewed and approved by the Radiation Safety Officer and licensee management; and (4) The affected individuals are instructed on the revised program before the changes are implemented. (b) A licensee shall retain a record of each change in accordance with §35.2026. (a) A licensee that permits the receipt, possession, use, or transfer of byproduct material by an individual under the supervision of an authorized user, as allowed by §35.11(b)(1), shall— (1) In addition to the requirements in §19.12 of this chapter, instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, regulations of this chapter, and license conditions with respect to the use of byproduct material; and (2) Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of byproduct material, written radiation protection procedures established by the licensee, written directive procedures, regulations of this chapter, and license conditions with respect to the medical use of byproduct material. (b) A licensee that permits the preparation of byproduct material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by §35.11(b)(2), shall— (1) In addition to the requirements in §19.12 of this chapter, instruct the supervised individual in the preparation of byproduct material for medical use, as appropriate to that individual's involvement with byproduct material; and (2) Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of byproduct material for medical use, written radiation protection procedures established by the licensee, the regulations of this chapter, and license conditions. (c) A licensee that permits supervised activities under paragraphs (a) and (b) of this section is responsible for the acts and omissions of the supervised individual. (a) A written directive must be dated and signed by an authorized user before the administration of I-131 sodium iodide greater than 1.11 megabecquerels (MBq) (30 microcuries (µCi)), any therapeutic dosage of unsealed byproduct material or any therapeutic dose of radiation from byproduct material. (1) If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive is acceptable. The information contained in the oral directive must be documented as soon as possible in writing in the patient's record. A written directive must be prepared within 48 hours of the oral directive. (b) The written directive must contain the patient or human research subject's name and the following information— (1) For any administration of quantities greater than 1.11 MBq (30 µCi) of sodium iodide I-131: the dosage; (2) For an administration of a therapeutic dosage of unsealed byproduct material other than sodium iodide I-131: the radioactive drug, dosage, and route of administration; (3) For gamma stereotactic radiosurgery: the total dose, treatment site, and values for the target coordinate settings per treatment for each anatomically distinct treatment site; (4) For teletherapy: the total dose, dose per fraction, number of fractions, and treatment site; (5) For high dose-rate remote afterloading brachytherapy: the radionuclide, treatment site, dose per fraction, number of fractions, and total dose; or (6) For all other brachytherapy, including low, medium, and pulsed dose rate remote afterloaders: (i) Before implantation: treatment site, the radionuclide, and dose; and (ii) After implantation but before completion of the procedure: the radionuclide, treatment site, number of sources, and total source strength and exposure time (or the total dose). (c) 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. (1) If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive is 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 hours of the oral revision. (d) The licensee shall retain a copy of the written directive in accordance with §35.2040. [67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002; 68 FR 75389, Dec. 31, 2003] (a) For any administration requiring a written directive, the licensee shall develop, implement, and maintain written procedures to provide high confidence that: (1) The patient's or human research subject's identity is verified before each administration; and (2) Each administration is in accordance with the written directive. (b) At a minimum, the procedures required by paragraph (a) of this section must address the following items that are applicable to the licensee's use of byproduct material— (1) Verifying the identity of the patient or human research subject; (2) Verifying that the administration is in accordance with the treatment plan, if applicable, and the written directive; (3) Checking both manual and computer-generated dose calculations; and (4) Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by §35.600. (c) A licensee shall retain a copy of the procedures required under paragraph (a) in accordance with §35.2041. For medical use, a licensee may only use— (a) Sealed sources or devices manufactured, labeled, packaged, and distributed in accordance with a license issued under 10 CFR Part 30 and 10 CFR 32.74 of this chapter or equivalent requirements of an Agreement State; (b) Sealed sources or devices non-commercially transferred from a Part 35 licensee or an Agreement State medical use licensee. (c) Teletherapy sources manufactured and distributed in accordance with a license issued under 10 CFR Part 30 or the equivalent requirements of an Agreement State. [67 FR 20370, Apr. 24, 2002, as amended at 71 FR 15008, Mar. 27, 2006] Except as provided in §35.57, the licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer as provided in §35.24 to be an individual who— (a) Is certified by a specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraphs (d) and (e) of this section. (The names of board certifications which have been recognized by the Commission or an Agreement State will be posted on the NRC's Web page.) To have its certification process recognized, a specialty board shall require all candidates for certification to: (1)(i) Hold a bachelor's or graduate degree from an accredited college or university in physical science or engineering or biological science with a minimum of 20 college credits in physical science; (ii) Have 5 or more years of professional experience in health physics (graduate training may be substituted for no more than 2 years of the required experience) including at least 3 years in applied health physics; and (iii) Pass an examination administered by diplomates of the specialty board, which evaluates knowledge and competence in radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, radiation biology, and radiation dosimetry; or (2)(i) Hold a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; (ii) Have 2 years of full-time practical training and/or supervised experience in medical physics— (A) Under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by the Commission or an Agreement State; or (B) In clinical nuclear medicine facilities providing diagnostic and/or therapeutic services under the direction of physicians who meet the requirements for authorized users in §§35.290 or 35.390; (iii) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in clinical diagnostic radiological or nuclear medicine physics and in radiation safety; or (b)(1) Has completed a structured educational program consisting of both: (i) 200 hours of classroom and laboratory training in the following areas-(ii) (A) Radiation physics and instrumentation; (B) Radiation protection; (C) Mathematics pertaining to the use and measurement of radioactivity; (D) Radiation biology; and (E) Radiation dosimetry; and (ii) One year of full-time radiation safety experience under the supervision of the individual identified as the Radiation Safety Officer on a Commission or Agreement State license or permit issued by a Commission master material licensee that authorizes similar type(s) of use(s) of byproduct material involving the following— (A) Shipping, receiving, and performing related radiation surveys; (B) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and instruments used to measure radionuclides; (C) Securing and controlling byproduct material; (D) Using administrative controls to avoid mistakes in the administration of byproduct material; (E) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; (F) Using emergency procedures to control byproduct material; and (G) Disposing of byproduct material; or (2) [Reserved] (c)(1) Is a medical physicist who has been certified by a specialty board whose certification process has been recognized by the Commission or an Agreement State under §35.51(a) and has experience in radiation safety for similar types of use of byproduct material for which the licensee is seeking the approval of the individual as Radiation Safety Officer and who meets the requirements in paragraphs (d) and (e) of this section; or (2) Is an authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation safety aspects of similar types of use of byproduct material for which the individual has Radiation Safety Officer responsibilities; and, (d) Has obtained written attestation, signed by a preceptor Radiation Safety Officer, that the individual has satisfactorily completed the requirements in paragraph (e) and in paragraphs (a)(1)(i) and (a)(1)(ii) or (a)(2)(i) and (a)(2)(ii) or (b)(1) or (c)(1) or (c)(2) of this section, and has achieved a level of radiation safety knowledge sufficient to function independently as a Radiation Safety Officer for a medical use licensee; and (e) Has training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval. This training requirement may be satisfied by completing training that is supervised by a Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user, as appropriate, who is authorized for the type(s) of use for which the licensee is seeking approval. [67 FR 20370, Apr. 24, 2002, as amended at 70 FR 16361, Mar. 30, 2005; 71 FR 1926, Jan. 12, 2006; 71 FR 15008, Mar. 27, 2006] Except as provided in §35.57, the licensee shall require the authorized medical physicist to be an individual who— (a) Is certified by a specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraphs (b)(2) and (c) of this section. (The names of board certifications which have been recognized by the Commission or an Agreement State will be posted on the NRC's Web page.) To have its certification process recognized, a specialty board shall require all candidates for certification to: (1) Hold a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; (2) Have 2 years of full-time practical training and/or supervised experience in medical physics— (i) Under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by the Commission or an Agreement State; or (ii) In clinical radiation facilities providing high-energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services under the direction of physicians who meet the requirements for authorized users in §§35.490 or 35.690; and (3) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in clinical radiation therapy, radiation safety, calibration, quality assurance, and treatment planning for external beam therapy, brachytherapy, and stereotactic radiosurgery; or (b)(1) Holds a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; and has completed 1 year of full-time training in medical physics and an additional year of full-time work experience under the supervision of an individual who meets the requirements for an authorized medical physicist for the type(s) of use for which the individual is seeking authorization. This training and work experience must be conducted in clinical radiation facilities that provide high-energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services and must include: (i) Performing sealed source leak tests and inventories; (ii) Performing decay corrections; (iii) Performing full calibration and periodic spot checks of external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and (iv) Conducting radiation surveys around external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and (2) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (c) and (a)(1) and (2), or (b)(1) and (c) of this section, and has achieved a level of competency sufficient to function independently as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written attestation must be signed by a preceptor authorized medical physicist who meets the requirements in §35.51, or equivalent Agreement State requirements for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status; and (c) Has training for the type(s) of use for which authorization is sought that includes hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system. This training requirement may be satisfied by satisfactorily completing either a training program provided by the vendor or by training supervised by an authorized medical physicist authorized for the type(s) of use for which the individual is seeking authorization. [67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 69 FR 55737, Sept. 16, 2004; 70 FR 16362, Mar. 30, 2005; 71 FR 15008, Mar. 27, 2006] Except as provided in §35.57, the licensee shall require the authorized nuclear pharmacist to be a pharmacist who— (a) Is certified by a specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraph (b)(2) of this section. (The names of board certifications which have been recognized by the Commission or an Agreement State will be posted on the NRC's Web page.) To have its certification process recognized, a specialty board shall require all candidates for certification to: (1) Have graduated from a pharmacy program accredited by the American Council on Pharmaceutical Education (ACPE) or have passed the Foreign Pharmacy Graduate Examination Committee (FPGEC) examination; (2) Hold a current, active license to practice pharmacy; (3) Provide evidence of having acquired at least 4000 hours of training/experience in nuclear pharmacy practice. Academic training may be substituted for no more than 2000 hours of the required training and experience; and (4) Pass an examination in nuclear pharmacy administered by diplomates of the specialty board, that assesses knowledge and competency in procurement, compounding, quality assurance, dispensing, distribution, health and safety, radiation safety, provision of information and consultation, monitoring patient outcomes, research and development; or (b)(1) Has completed 700 hours in a structured educational program consisting of both: (i) 200 hours of classroom and laboratory training in the following areas— (A) Radiation physics and instrumentation; (B) Radiation protection; (C) Mathematics pertaining to the use and measurement of radioactivity; (D) Chemistry of byproduct material for medical use; and (E) Radiation biology; and (ii) Supervised practical experience in a nuclear pharmacy involving— (A) Shipping, receiving, and performing related radiation surveys; (B) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides; (C) Calculating, assaying, and safely preparing dosages for patients or human research subjects; (D) Using administrative controls to avoid medical events in the administration of byproduct material; and (E) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; and (2) Has obtained written attestation, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements in paragraphs (a)(1), (a)(2), and (a)(3) or (b)(1) of this section and has achieved a level of competency sufficient to function independently as an authorized nuclear pharmacist. [67 FR 20370, Apr. 24, 2002, as amended at 70 FR 16362, Mar. 30, 2005] (a)(1) An individual identified as a Radiation Safety Officer, a teletherapy or medical physicist, or a nuclear pharmacist on a Commission or Agreement State license or a permit issued by a Commission or Agreement State broad scope licensee or master material license permit or by a master material license permittee of broad scope before October 24, 2002, need not comply with the training requirements of §§35.50, 35.51, or 35.55, respectively. (2) An individual identified as a Radiation Safety Officer, an authorized medical physicist, or an authorized nuclear pharmacist on a Commission or Agreement State license or a permit issued by a Commission or Agreement State broad scope licensee or master material license permit or by a master material license permittee of broad scope between October 24, 2002 and April 29, 2005 need not comply with the training requirements of §§35.50, 35.51, or 35.55, respectively. (b)(1) Physicians, dentists, or podiatrists identified as authorized users for the medical use of byproduct material on a license issued by the Commission or Agreement State, a permit issued by a Commission master material licensee, a permit issued by a Commission or Agreement State broad scope licensee, or a permit issued by a Commission master material license broad scope permittee before October 24, 2002, who perform only those medical uses for which they were authorized on that date need not comply with the training requirements of Subparts D through H of this part. (2) Physicians, dentists, or podiatrists identified as authorized users for the medical use of byproduct material on a license issued by the Commission or Agreement State, a permit issued by a Commission master material licensee, a permit issued by a Commission or Agreement State broad scope licensee, or a permit issued by a Commission master material license broad scope permittee who perform only those medical uses for which they were authorized between October 24, 2002 and April 29, 2005, need not comply with the training requirements of Subparts D through H of this part. [70 FR 16363, Mar. 30, 2005] The training and experience specified in Subparts B, D, E, F, G, and H of this part must have been obtained within the 7 years preceding the date of application or the individual must have had related continuing education and experience since the required training and experience was completed. [71 FR 15008, Mar. 27, 2006]
Title 10: Energy
PART 35—MEDICAL USE OF BYPRODUCT MATERIAL
Subpart B—General Administrative Requirements
§ 35.24 Authority and responsibilities for the radiation protection program.
§ 35.26 Radiation protection program changes.
§ 35.27 Supervision.
§ 35.40 Written directives.
§ 35.41 Procedures for administrations requiring a written directive.
§ 35.49 Suppliers for sealed sources or devices for medical use.
§ 35.50 Training for Radiation Safety Officer.
§ 35.51 Training for an authorized medical physicist.
§ 35.55 Training for an authorized nuclear pharmacist.
§ 35.57 Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.
§ 35.59 Recentness of training.
