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§ 30194. Approval of Applications and Specific Terms and Conditions for Specific Licenses.

17 CA ADC § 30194Barclays Official California Code of RegulationsEffective: July 1, 2022

Barclays California Code of Regulations
Title 17. Public Health
Division 1. State Department of Health Services (Refs & Annos)
Chapter 5. Sanitation (Environmental) (Refs & Annos)
Subchapter 4. Radiation
Group 2. Licensing of Radioactive Materials
Article 4. Licenses
Effective: July 1, 2022
17 CCR § 30194
§ 30194. Approval of Applications and Specific Terms and Conditions for Specific Licenses.
(a) An application for a new specific license or for renewal or amendment of an existing license will be approved if the Department determines that:
(1) the applicant or his specified personnel are qualified by reason of training and experience to use radioactive material of the kinds and quantities and for the purposes requested, in such a manner as to provide reasonable and adequate assurance of protection to health, life, and property;
(2) the applicant's equipment, facilities, proposed uses and procedures are such as to provide reasonable and adequate assurance of protection to health, life, and property;
(3) the issuance of the license will not jeopardize the health and safety of the public;
(4) the applicant satisfies all applicable requirements of the Act and regulations thereunder.
(b) Prior to issuing, amending or renewing a license pursuant to the provisions of this subchapter, the Department may inspect at any reasonable time the place of business, or premises and facilities of any applicant in order to verify information contained in the application or to obtain additional information for the purpose of completing the application.
(c) No license or any right under a license shall be assigned or otherwise transferred unless approved in advance by the Department. The request for transfer of a license shall include the identity and technical and financial qualifications of the proposed transferee, and the financial assurance for decommissioning information required by section 30195.1.
(d) Each licensee shall restrict possession of licensed material to the locations and conditions of the use authorized in the license.
(e) Each specific license shall expire on the expiration date specified as a condition of the license. However, the license shall continue to be valid if a timely application for renewal is filed. An application for renewal shall be timely if filed at least 30 days prior to the expiration date. The existing license shall not expire until the department has taken final action on the timely filed application for renewal.
(f) Applications and documents submitted shall be made available for public inspection except where the applicant identifies portions of the application as “trade secret” and the Department finds that the information is “trade secret” pursuant to provisions of the Public Records Act and Evidence Code Section 1060.
(g) Each specific licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators shall test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, in accordance with Title 10, Code of Federal Regulations, Part 35 (10 CFR 35), section 35.204, incorporated by reference in section 30195(a). The licensee shall record the results of each test and retain each record for three years after the record is made. The licensee shall report the results of any test that exceeds the permissible concentration listed in 10 CFR 35, section 35.204(a) at the time of generator elution, in accordance with 10 CFR 35, section 35.3204, incorporated by reference in section 30195(a).
(h) Applications for specific licenses filed under Group 2 shall include information and material addressing, as applicable, the provisions of sections 30194.1, 30195, 30195.1, 30195.2, 30195.3, 30196 and 30220.

Credits

Note: Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115165, 115230, 115235, 131050, 131051 and 131052, Health and Safety Code.
History
1. Amendment filed 7-8-87; operative 8-7-87 (Register 87, No. 29).
2. New subsection (g) filed 10-16-95 as an emergency; operative 10-16-95 (Register 95, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-13-96 or emergency language will be repealed by operation of law on the following day.
3. Certificate of Compliance as to 10-16-95 order, including amendment of Note, transmitted to OAL 2-9-96 and filed 3-25-96 (Register 96, No. 13).
4. Amendment section heading, subsections (c) and (g) and Note filed 12-30-2014; operative 4-1-2015 (Register 2015, No. 1).
5. Amendment of subsection (g) filed 3-18-2019; operative 7-1-2019 (Register 2019, No. 12).
6. New subsection (g) and subsection relettering filed 3-30-2022; operative 7-1-2022 (Register 2022, No. 13).
This database is current through 4/26/24 Register 2024, No. 17.
Cal. Admin. Code tit. 17, § 30194, 17 CA ADC § 30194
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