§ 175.104 Specific Types of Radioactive Materials Licenses.
RCNY § 175.104
(a)Types of license. The requirements specified in this section are in addition to, and not in substitution for, others in this Article. In particular, the incorporated provisions of 10 C.F.R. Part 30 apply to all license applications and all specific radioactive materials licenses. For the purposes of this Article, the following specific license types of radioactive materials apply: (1) A specific license of limited scope for gamma stereotactic radiosurgery (GSR) or for teletherapy means a license that authorizes receipt, acquisition, ownership, possession, use and transfer of specified quantities and types of radioactive material for use in GSR or teletherapy programs.
(2)A specific license of limited scope for medical use means a license that authorizes receipt, acquisition, ownership, possession, use and transfer of specified quantities and types of radioactive material for use in or on humans in a medical program, but does not include GSR or teletherapy.
(3)A specific license of limited scope for other use means a license that authorizes receipt, production, acquisition, ownership, possession, use and transfer of specified quantities and types of radioactive material for uses other than in or on humans.
(4)A specific license of broad scope for medical use means a license that authorizes receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of the radioactive materials specified in the license, for use in or on humans in a medical program, but does not include GSR or teletherapy.
(5)A specific license of broad scope for research and development means a license that authorizes receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive materials specified in the license, in quantities not exceeding those specified in the license, for uses other than in or on humans.
(b)Specific licenses for human use of radioactive materials in institutions. An application by a medical institution for a specific license for medical use of radioactive material may be approved if: (1) pursuant to §§ 175.103 and 175.105, the applicant satisfies the requirements specified in the incorporated provisions of 10 C.F.R. Parts 30 and 35; and (2) the applicant possesses adequate facilities for the clinical care of patients; and (3) the physician designated on the application as the individual authorized user has training and experience as specified in 10 C.F.R. Part 35, in the proposed use, handling and administration of radionuclides and the clinical management of radioactive patients. The physician must furnish evidence of such experience with the application. A statement from the physician's preceptor at the medical institution where the physician acquired such training and experience, indicating their amount and nature, may be submitted as evidence of such experience.
(c)Specific licenses to individual physicians for human use of radioactive materials. An application by an individual physician for a specific license for human use of radioactive material may be approved if: (1) pursuant to §§ 175.103 and 175.105, the applicant satisfies the requirements specified in the incorporated provisions of 10 C.F.R. Parts 30 and 35; and (2) the applicant has training and experience as specified in 10 C.F.R. Part 35 in the proposed use, handling and administration of radionuclides, and the clinical management of radioactive patients. The physician must furnish evidence of such training and experience with the application. A statement from the physician's preceptor at the institution where the physician acquired such training and experience, indicating their amount and nature, may be submitted as evidence of such experience.
(d)Specific licenses of broad scope.
(1)A specific license of broad scope is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of the byproduct material specified in the license, but not exceeding quantities specified in the license. Approved authorized users do not need to be listed on the license. Specific licenses of broad scope for medical use are exempted from certain requirements as listed in 10 C.F.R. § 35.15.
(e)Specific licenses for non-human use. An application for a specific license authorizing non-human use of radioactive materials may be approved if: (1) the applicant satisfies the general requirements specified in 10 C.F.R. § 30.33; and (2) the applicant, or the applicant's personnel, has training and experience commensurate with the proposed amounts, types and uses of radioactive materials which must minimally include: (i) a college degree at the bachelor level in a physical, biological, environmental or engineering science; and (ii) at least 40 hours of training and experience in the safe handling of radioactive materials appropriate to the type and forms of such materials to be used, which must include: (A) characteristics of ionizing radiation; (B) units of radiation dose and quantities; (C) radiation detection instrumentation; and (D) biological hazards of exposure to radiation.
(f)General licenses.
