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Part III: Radioactive Materials
(a) All persons subject to the requirements of this Part (24 RCNY Health Code §§ 175.100 through 175.108) are required to comply with the specific provisions of Title 10 of the Code of Federal Regulations ("C.F.R.") issued by the United States Nuclear Regulatory Commission ("NRC") as expressly indicated in this Part and which are hereby incorporated by reference herein to this Article with the same force and effect as if fully set forth herein in their entirety. For the purposes of this Part, such incorporation by reference shall mean the specific provisions of Title 10 of the C.F.R. in effect as of the effective date of this Part, and any successor regulations promulgated by the NRC in Title 10 of the C.F.R. expressly indicated in this Part. Any such successor regulation shall be considered adopted in this Part as of the effective date of the provision in the C.F.R.
(1) "10 C.F.R." or "C.F.R." means Title 10 of the Code of Federal Regulations, Chapter I (Nuclear Regulatory Commission).
(2) "City" means the 5 boroughs of New York City.
(3) Except as indicated in subdivision (c) of this section, references to "Department" means the New York City Department of Health and Mental Hygiene.
(4) "Radioactive material" means any solid, liquid, or gas which spontaneously emits alpha particles, beta particles, gamma rays, x rays, neutrons, high-speed electrons, high-speed protons, or other particles capable of producing ions. For the purposes of this Part, radioactive material does not include material that emits only non-ionizing radiation, such as radiowaves or microwaves, visible, infrared or ultraviolet light.
(c) To reconcile differences between this Article and the incorporated sections of the C.F.R., the following meanings are substituted for certain terms in the incorporated language of the C.F.R.:
(1) Except as indicated in paragraph (2) of this subdivision, any reference to ''NRC'' or ''Commission'' in the incorporated C.F.R. regulations means the Department. Any notifications and correspondence required to be sent to the NRC in the incorporated regulations of the C.F.R. should instead be sent to the Department at the address provided in 24 RCNY Health Code § 175.01(c).
(2) The following references to "NRC" or "Commission" in the incorporated C.F.R. regulations shall continue to refer to and mean the Nuclear Regulatory Commission:
(i) References in 10 C.F.R. § 30.12 to Commission contractors;
(ii) References in 10 C.F.R. Part 35 to Commission master material license or licensee;
(iii) References in 10 C.F.R. Part 35 to the "NRC's web page" for listing of acceptable board certifications;
(iv) References in 10 C.F.R. § 37.27 relating to criminal history record checks;
(v) Reference in 10 C.F.R. § 37.29(a)(1) to "an employee of the Commission";
(vi) References in 10 C.F.R. Part 71 to NRC-approved packaging.
(3) The references to "Department" in 10 C.F.R. §§ 30.12 and 30.14(b)(1) means the U.S. Department of Energy.
(4) Any reference to ''agreement state'' within the incorporated C.F.R. regulations means an external regulatory authority other than this Department.
(5) Any cross reference within the incorporated C.F.R. regulations means a cross reference to the C.F.R. unless otherwise specified;, for example, a reference to "§ 30.18 of this Chapter" means "10 C.F.R. § 30.18."
(6) References to forms in the incorporated C.F.R. regulations mean the appropriate forms prescribed by the Department.
(d) The C.F.R. provisions incorporated by reference herein may be obtained from:
(1) the Department at the address provided in 24 RCNY Health Code § 175.01(c), or
(2) the United States Government Publishing Office (GPO), 710 North Capitol Street, N.W., Washington, DC 20401 (866) 512-1800, or, online at (3) the U.S. Nuclear Regulatory Commission online at
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) Except as set forth in subdivision (b) of this section, 10 C.F.R. Part 19 is hereby incorporated by reference herein to this Article with the same force and effect as if fully set forth in its entirety.
(b) The following provisions from 10 C.F.R. Part 19 are not so incorporated: § 19.1, § 19.2, the definition of "regulated entities" in § 19.3, § 19.4, § 19.5, § 19.8, §§ 19.11(b)-(e), § 19.14(a), § 19.18, § 19.30, § 19.31, § 19.32 and§ 19.40.
(c) Additional requirements.
(1) Instructions to workers as required in 10 C.F.R. § 19.12 must be given to all individuals working in or frequenting any portion of a restricted area.
(2) In addition to the requirements of 10 C.F.R. § 19.12, individuals must be instructed in the operating procedures applicable to work under the license and must be required to demonstrate familiarity with precautions, procedures, and devices included in the instructions.
(3) Records documenting individual worker instruction shall be maintained for inspection by the Department for a period of 3 years.
(4) Each licensee must inform each worker annually of the worker's exposure to radiation or radioactive material as shown in the records maintained by the licensee pursuant to 10 C.F.R. § 20.2106.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) Except as set forth in subdivision (b) of this section, 10 C.F.R. Part 20 is hereby incorporated by reference herein to this Article with the same force and effect as if fully set forth in its entirety.
(b) The following provisions from 10 C.F.R. Part 20 are not so incorporated: § 20.1001, § 20.1002, §§ 20.1006 through 20.1009, § 20.1406(b), § 20.1905(g), § 20.2203(c), § 20.2206, § 20.2401, § 20.2402 and Part 20 Appendix D.
(c) Additional requirements.
(1) Radiation protection programs.
(i) Each licensee must:
(A) provide a radiation safety officer pursuant to 10 C.F.R. §§ 35.24 and 35.50 who shall be delegated authority to ensure the implementation of this radiation protection program and ensure radiation doses are As Low As Reasonably Achievable (ALARA) (as defined in 10 C.F.R. § 20.1003 and more fully described in 24 RCNY Health Code § 175.105(c)(1)). The radiation safety officer or associate radiation safety officer named on the license, or an authorized user designated to act as the radiation safety officer in the radiation safety officer's absence, must be present on the premises at least 50 percent of the time that radioactive material is being handled or equipment containing radioactive material is being operated;
(B) provide for a radiation safety committee to administer the radiation protection program in medical centers, hospitals and institutions of higher education. The committee must include the facility operator or a person with the authority to act on behalf of the facility operator, and representation from departments within the facility where radiation sources are used. The committee must meet at least quarterly and must oversee all uses of radioactive materials within the facility, must review the activities of the radiation safety officer, and must review the radiation safety program at least annually. The committee, or a subcommittee, must oversee the administration of a quality assurance program as required by 24 RCNY Health Code § 175.108;
(C) provide a quality assurance program for diagnostic and therapeutic uses of radioactive materials pursuant to 24 RCNY Health Code § 175.108 and other applicable provisions of this Article; and
(D) ensure that all personnel involved in planning for, or administering radiation doses to humans, or in the use of radioactive materials for other lawful purposes, are supervised, are instructed as described in 10 C.F.R. § 19.12 and are competent to safely use such radiation sources and services.
(ii) For non-human use radioactive materials installations, the radiation safety officer specified in 24 RCNY Health Code § 175.102(c)(1)(i)(A) must be:
(A) a physicist certified by the American Board of Health Physics, the American Board of Radiology or the American Board of Medical Physics in a branch of physics related to the type and use of radioactive material in the installation; or
(B) a person with equivalent training and experience as determined by the Department; or
(C) an authorized user named on the radioactive materials license issued by the Department.
(2) Individual monitoring.
(i) In addition to the criteria in 10 C.F.R. § 20.1502(a)(2),(3), each licensee must monitor occupational exposure for minors and declared pregnant women likely to receive, in 1 year from sources external to the body, a deep dose equivalent in excess of 10 percent of any of the applicable limits in 10 C.F.R. §§ 20.1201 or 20.1208.
(ii) A person supplying personnel monitoring devices to individuals pursuant to 10 C.F.R. § 20.1502 must ensure that the individuals wear such devices as follows:
(A) An individual monitoring device used for monitoring the dose to the whole body must be worn at the unshielded location of the whole body likely to receive the highest exposure, except when monitoring is performed in accordance with 24 RCNY Health Code § 175.17(b)(4).
(B) An individual monitoring device used for monitoring the dose to an embryo/fetus of a declared pregnant worker pursuant to 10 C.F.R. § 20.1208 must be located at the waist under any protective garment worn by the declared pregnant worker.
(C) An individual monitoring device used for monitoring the lens dose equivalent must be located at the neck outside any protective garment worn by the individual, or at an unshielded location closer to the eye.
(D) An individual monitoring device used for monitoring the dose to the extremities must be worn on the extremity likely to receive the highest exposure. The device must be oriented to measure the highest dose to the extremity being monitored.
(iii) The licensee must ensure that adequate precautions are taken to prevent a deceptive exposure of an individual monitoring device, and no licensee must remove an exposure from an individual's exposure record without prior authorization from the Department. The licensee must submit the dosimeter for processing with due diligence and in no event in excess of the time period specified by the manufacturer of the dosimeter.
(3) Respiratory protection.
(i) If the licensee uses respiratory protection equipment to limit intakes pursuant to 10 C.F.R. §§ 20.1701 through 20.1705, the licensee must issue a written policy statement on respirator usage covering:
(A) the routine, non-routine, and emergency use of respirators; and
(B) limitations on periods of respirator use and relief from respirator use; and
(C) the use of process or other engineering controls, instead of respirators.
(ii) For a licensee to make allowance for respiratory equipment when estimating the exposure of individuals to airborne radioactive material, the following additional condition applies: the licensee selects respiratory protection equipment that provides a protection factor, specified in 10 C.F.R. Part 20 Appendix A, greater than the multiple by which peak concentrations of airborne radioactive materials in the working area are expected to exceed the values specified in Table 1, Column 3 of 10 C.F.R. Part 20 Appendix A. However, if the selection of respiratory protection equipment with a protection factor greater than this multiple of peak concentration is inconsistent with the goal specified in 10 C.F.R. § 20.1702 of keeping the total effective dose equivalent ALARA, the licensee may select respiratory protection equipment with a lower protection factor provided that such a selection would result in a total effective dose equivalent that is ALARA. In estimating the dose to individuals from intake of airborne radioactive materials, the concentration of radioactive material in the air that is inhaled when respirators are worn is initially assumed to be the ambient concentration in air without respiratory protection, divided by the assigned protection factor. If the dose is later found to be greater than the initially estimated dose, the corrected value must be used. If the dose is later found to be less than the initially estimated dose, the corrected value may be used.
(4) Requirements for possession of sealed sources.
(i) The licensee in possession of any sealed source must follow the radiation safety and leak testing requirements specified in 10 C.F.R. § 35.67.
(ii) Reports of test results for leaking or contaminated sealed sources must be made pursuant to 10 C.F.R. § 35.3067.
(iii) A licensee authorized for medical use in possession of a licensed sealed source or brachytherapy source must survey with a radiation survey instrument at intervals not to exceed 3 months all areas where such sources are stored. This shall not apply to sources in teletherapy units or gamma stereotactic radiosurgery units or to sealed sources in diagnostic devices.
(5) Radioactive material must not be stored with either food or beverages.
(6) No person shall bury any licensed radioactive material within New York City.
(7) The provisions of 10 C.F.R. § 20.2005 do not authorize the licensed materials described to be disposed of inside the City as if they were not radioactive; however, these materials may be shipped for disposal outside of the City as if they were not radioactive provided that the receiving jurisdiction allows the disposal of such materials as if they were not radioactive.
(8) Vacating premises. Each specific licensee must notify the Department in writing of intent to vacate not less than 30 days before vacating or relinquishing possession or control of premises which may have been contaminated with radioactive material as a result of licensed activities. When deemed necessary by the Department, the licensee must decontaminate the premises to such levels as the Department may specify.
(9) Recordkeeping requirements for receipt, use, and disposition of radioactive material.
(i) Each licensee must maintain records of the receipt, use, and disposition of radioactive material in units of becquerels or microcuries and must include from whom such materials were received and the ultimate disposition.
(ii) The licensee must retain these records for 3 years after the record is made.
(10) The Department may order the removal, through an authorized person, or the surrender to the Department, of any radiation source by any person who:
(i) does not hold, or continue to hold, a valid license issued by the Department; or
(ii) is not able or equipped, or who fails to observe with regard to such radiation source, those radiation protection standards established or enforced by the Department or who uses such radiation source in violation of law, regulation, this Article, order or license issued by the Department. Such person must decontaminate any premises which may have been contaminated with radioactive material as a result of any such activities to such radiation levels as the Department may specify. The expenses incidental to such transfer, surrender, and decontamination must be borne by such person responsible for the source.
(11) In determining the extent of any individual's exposure to radiation subsequent to any radiation accident, contamination, theft or loss, the licensee must comply with all orders of the Department directing such licensee to make available to such individual appropriate medical evaluation services or appropriate tests and to furnish a copy of the reports of such evaluation or test to the Department.
(12) A licensee or applicant for a license must obtain any permits required by the New York State Department of Environmental Conservation pursuant to 6 NYCRR Part 380, or any successor law or regulation, and must develop, document, and implement a discharge minimization program required by the New York State Department of Environmental Conservation pursuant to 6 NYCRR § 380-7, or any successor law or regulation.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) Except for the removal of source material from its place of origin in nature, or as otherwise may be provided in this Article, no person subject to this Article shall transfer, receive, produce, possess or use in New York City any radioactive material except pursuant to a license issued by the Department.
(b) Except as set forth in subdivision (c) of this section, 10 C.F.R. Part 30 and the following provisions from 10 C.F.R. Part 40: § 40.3, the definition of "byproduct material and "depleted uranium" in § 40.4 § 40.11, § 40.12(a), § 40.13 (except § 40.13(c)(5)(iv)), § 40.21, § 40.22, § 40.41(a)-(c),(f), §§ 40.42 (c)-(k)(3),(l), § 40.46, § 40.51 (except 40.51(b)(6)), § 40.54, § 40.55, § 40.60 and § 40.61 are hereby incorporated by reference herein to this Article with the same force and effect as if fully set forth in their entirety.
(c) The following provisions from 10 C.F.R. Parts 30 are not so incorporated: § 30.1, § 30.2, the definitions of "commencement of construction" and "construction" in § 30.4, §§ 30.5 through 30.8, § 30.21(c), § 30.32(e), § 30.34(d), § 30.34(e)(1), § 30.34(e)(3), § 30.36 (d)-(k), §§ 30.37 through 30.39, § 30.41(b)(6), § 30.53, 30.55, § 30.62, § 30.63 and § 30.64 .
(d) References to "Department" in the incorporated regulations of 10 C.F.R. §§ 30.12 and 30.41(b)(1) means the U.S. Department of Energy.
(e) Any reference to "byproduct material" in the incorporated regulations of 10 C.F.R. §§ 30.31 through 30.62 means "radioactive material" as defined in this Article.
(f) Additional requirements.
(1) License termination requirements.
(i) If a licensee does not submit an application for renewal of a radioactive materials license pursuant to 10 C.F.R. § 30.32, then the licensee must, on or before the expiration date stated in the license,:
(A) Terminate use of radioactive material;
(B) Dispose of all radioactive material in accordance with all applicable regulations in effect at the time of disposal;
(C) Submit a written certification of the disposition of all radioactive materials authorized by the license on forms prescribed by the Department;
(D) Remove radioactive contamination to the extent practicable; and
(E) Conduct a radiation survey of the premises where the licensed activities were carried out and submit a copy of this survey to the Department. Such survey must be subject to approval by the Department and must include:
a. Levels of radiation in units (or multiples) of Gy-hr-1 (millirads-hr-1) at 1 cm for beta-gamma radiation or at 1 m for gamma radiation;
b. Levels of removable and fixed contamination, including alpha, in units of disintegrations (transformations) per min (becquerels) per 100 cm
2
for surfaces;
c. becquerels-ml-1 (mCi-ml-1) for water;
d. becquerels-kg-1 (pCi-g-1) for solids such as soil or concrete; and
e. a description of the survey or other measuring instruments used, including manufacturer and model numbers and date of most recent calibration.
(F) If the information submitted pursuant to clauses (A) through (E) of subparagraph (i) of paragraph (1) of subdivision (f) of this section does not adequately demonstrate that the premises are suitable for unrestricted use, the Department shall inform the licensee of the appropriate further actions required for the termination of the license, including, but not limited to, decontamination of the licensed premises to such levels and within such time frames as the Department may prescribe.
(ii) Each specific license shall continue in effect, beyond the expiration date if necessary, with respect to the presence of any residual radioactive materials that may be present as contamination until the Department terminates the license. During this time, the licensee must:
(A) Limit activities involving radioactive material to those related to decommissioning; and
(B) Continue to control entry to restricted areas until the Department determines they are suitable for release for unrestricted use and the Department terminates the license.
(iii) The Department can terminate a specific license when the Department determines that:
(A) All licensed radioactive material has been properly transferred or disposed; and
(B) premises have been decontaminated to such levels that the total effective dose equivalent (TEDE) from residual radioactivity distinguishable from background radiation, to an average member of the public will not exceed 25 mrem (0.25 mSv) per year;
(C) a radiation survey has been performed which describes all radiation levels and levels of fixed and removable contamination; and
(D) the licensee submits sufficient documentation to support a determination that the requirements of clauses (A) through (E) of subparagraph (i) of paragraph (1) of subdivision (f) of this section have been met.
(2) Amendment of licenses by the Department.
(i) A corrective amendment of any license may be issued by the Department at any time upon its initiative.
(ii) Any license may be amended or revoked by the Department by reason of the amendment of this Article, or any other applicable law.
(3) The licensee must notify the Department, in writing, within 30 days if an authorized user, radiation safety officer or radiation therapy physicist permanently discontinues performance of duties under the license.
(4) No person, in any advertisement or public posting, expressly or by implication, shall refer to the fact that a radiation installation is licensed by the Department, and no person shall state or imply that a radiation installation or its activities have been approved by the Department, the Board of Health or the Commissioner.
(5) Reciprocity. The holder of a license issued by the New York State Department of Environmental Conservation, the New York State Department of Health, the U.S. Nuclear Regulatory Commission or any Agreement State, may bring, possess or use radioactive material covered by such license within the Department's jurisdiction for a period not in excess of 30 days in any 12 consecutive months without obtaining a license from the Department, provided that:
(i) such license does not limit the holder's possession or use of such material to a specific installation or installations;
(ii) such holder, prior to bringing such material into the City, files with the Department a notice indicating the period, type and location of proposed possession and use within the Department's jurisdiction, and a copy of the license;
(iii) such holder supplies such additional information as the Department may reasonably request;
(iv) such holder, during the period of this possession and use of such material within the City, complies with all applicable sections of this Article except 24 RCNY Health Code § 175.103(a); and
(v) such holder, during such period, complies with all the terms and conditions of his license, except if any such license terms or conditions are determined by the Department to be inconsistent with the requirements of this Article.
(6) If the holder of a license issued by this Department, the New York State Department of Environmental Conservation, the New York State Department of Health, or an Agreement State intends to conduct any licensed activity in areas of exclusive federal jurisdiction within New York City, then before engaging in any such licensed activity for the first time in a calendar year, such licensee must provide the U.S. Nuclear Regulatory Commission with at least 3 days advanced notice of its proposed activity in such areas under exclusive federal jurisdiction within New York City.
(Added City Record 4/24/2019, eff. 5/24/2019)
(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:
(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.
(4) The license application is signed by the chairman of the radiation safety committee and an authorized representative of the medical institution.
(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:
(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.
(2) A specific license of broad scope shall be issued only to medical institutions, research laboratories, or institutions of higher education; such licenses shall not be issued to individuals.
(3) An application for a specific license of broad scope may be approved if:
(i) the applicant satisfies the general requirements specified in 10 C.F.R. § 30.33; and
(ii) the applicant has engaged in a reasonable number of activities involving the use of radioactive material as determined by the Department; and
(iii) the applicant has established administrative controls and provisions relating to organization and management, procedures, recordkeeping, material control, and accounting and management review that are necessary to assure safe operations, including:
(A) the establishment of a radiation safety committee pursuant to 24 RCNY Health Code § 175.102(c)(1)(i)(B); and
(B) the appointment of a full-time radiation safety officer pursuant to 10 C.F.R. Part 20; and
(C) the establishment of appropriate administrative procedures to assure:
a. control of procurement and use of radioactive material; and
b. completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and
c. review, approval, and recording by the radiation safety committee of safety evaluations of proposed uses prepared in accordance with 24 RCNY Health Code § 175.104(d)(3)(iii)(C)(b) prior to the use of radioactive materials.
(4) The following are conditions of all specific licenses of broad scope. Unless specifically authorized pursuant to other provisions of this Article, broad scope licensees must not:
(i) conduct tracer studies in the environment involving direct release of radioactive material;
(ii) receive, acquire, own, possess, use, transfer, or import devices containing 3.7 E6 GBq (100,000 Ci) or more of radioactive material in sealed sources used for irradiation of materials;
(iii) add, or cause the addition of, radioactive material to any food, beverage, cosmetic, drug or other product designed for ingestion by, or application to, a human being except as authorized in the license.
(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.
(1) Except as set forth in paragraph (2) of this subdivision, 10 C.F.R. Part 31 is hereby incorporated by reference herein to this Article with the same force and effect as if fully set forth in its entirety.
(2) The following provisions from 10 C.F.R. Part 31 are not incorporated: § 31.1, § 31.2, § 31.4, § 31.22 and § 31.23.
(3) Any reference to "byproduct material" in the incorporated 10 C.F.R. § 31.9 means "radioactive material" as defined in this Article.
(4) Reference to "non-Agreement State" in the incorporated 10 C.F.R. § 31.6 means this Department. (5) Licensees exempt pursuant to incorporated 10 C.F.R. § 31.12(b) are similarly exempt from the analogous license requirements of this Article.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) Except as set forth in subdivision (b) of this section, 10 C.F.R. Part 35 is hereby incorporated by reference herein to this Article with the same force and effect as if fully set forth in its entirety.
(b) The following provisions from 10 C.F.R. Part 35 are not so incorporated: § 35.1, § 35.8, § 35.11(c)(1), § 35.13(a)(1), § 35.4001 and § 35.4002.
(c) Additional requirements.
(1) ALARA program.
(i) Each licensee must develop and implement a written program to maintain radiation doses and releases of radioactive material in effluents to unrestricted areas to be As Low As Reasonably Achievable (ALARA) in accordance with this subdivision.
(ii) To satisfy the requirement of subparagraph (i) of this paragraph (1):
(A) for licensees that are medical institutions, the management, radiation safety officer and all authorized users must participate in the establishment, implementation, and operation of the program as required by this Article or required by the radiation safety committee; or
(B) for licensees that are not medical institutions, management and all authorized users must participate in the program as requested by the radiation safety officer.
(iii) The ALARA program must include notice to workers of the program's existence and workers' responsibility to help keep dose equivalents ALARA.
(iv) For licensees that are medical institutions, the ALARA program must include an annual review by the radiation safety committee as indicated in paragraph (1) of subdivision (c) of 24 RCNY Health Code § 175.102.
(v) For licensees that are not medical institutions, the ALARA program must include an annual management review of summaries of the types and amounts of radioactive material used, occupational dose reports, and continuing education and training for all personnel who work with or in the vicinity of radioactive material, prepared by all authorized users or the radiation safety officer.
(vi) The purpose of the review required by subparagraphs (iv) and (v) of this paragraph (1) is to ensure that every reasonable effort to maintain occupational doses, doses to the general public, and releases of radioactive material to unrestricted areas, are ALARA, taking into account the state of technology and the cost of improvements in relation to benefits.
(vii) The licensee must retain a current written description of their ALARA program for the duration of the license. The written description must include:
(A) a commitment by management to keep occupational doses as low as reasonably achievable;
(B) a requirement that the radiation safety officer brief management at least once each year on the radiation safety program; personnel exposure investigational levels that, when exceeded, will initiate an investigation by the radiation safety officer of the cause of the exposure (ALARA I); and personnel exposure investigational levels that, when exceeded, will initiate a prompt investigation by the radiation safety officer of the cause of the exposure and a consideration of actions that might to be taken to reduce the probability of recurrence (ALARA II).
(2) Qualified personnel. Personnel, duly licensed by the New York State Department of Health to practice nuclear medicine technology (other than physicians or registered professional nurses), at licensee locations involved in the performance of diagnostic procedures utilizing radioactive material, which includes parenteral administration of radioactive material by intravenous, intramuscular or subcutaneous methods, must:
(i) have satisfactorily completed an educational program in nuclear medicine technology accredited by the Committee on Allied Health Education and Accreditation, or the accrediting agency of the state in which the program was completed, provided such state accreditation requires education and training in the above methods of parenteral administration; or
(ii) possess certification as a nuclear medicine technologist by the American Registry of Radiologic Technologists or certification by the Nuclear Medicine Technology Board; and
(iii) prior to permitting parenteral administration by a nuclear medicine technologist, the medical board of a hospital, a physician, or the radiation safety committee of an institution who have no medical board, must adopt with governing authority approval:
(A) procedures to assure that the nuclear medicine technologist possesses the education and training or certification set forth in this subdivision and is proficient in the competent performance of parenteral administration; and
(B) requirements for authorized user physician, which at a minimum must require supervision by such physician when parenteral administration of radioactive material for diagnostic testing is performed by a qualified nuclear medicine technologist.
(iv) The requirements of this paragraph concerning qualified personnel are in addition to, and not in place of, any other requirements in this Article or in the incorporated 10 C.F.R. sections relating to supervision or the presence of an authorized user.
(3) Possession, use, calibration and check of dose calibrators.
(i) A medical use licensee authorized to administer radioactive materials must possess a dose calibrator and use it to measure the amount of activity administered to each patient.
(ii) A licensee must:
(A) check each dose calibrator for constancy with a dedicated check source at the beginning of each day of use. To satisfy this requirement, the check must be done on a frequently used setting with a sealed source of any photon-emitting radionuclide with a half-life greater than 90 days;
(B) test each dose calibrator for accuracy upon installation and at intervals not to exceed 12 months thereafter by assaying at least 2 sealed sources of appropriate source activity, containing different radionuclides, the activity of which the manufacturer has determined by traceability to a national standard to be within 5 percent of the stated activity;
(C) test each dose calibrator for linearity upon installation and at intervals not to exceed 3 months thereafter over the range of use between 1 MBq (27 µCi) and the highest dosage that will be administered; and
(D) test each dose calibrator for geometry dependence upon installation over the range of volumes and volume configurations for which it will be used. The licensee must keep a record of this test for the duration of the use of the dose calibrator.
(iii) Notwithstanding the provisions of subparagraph (ii) of paragraph (3) of this subdivision, a licensee that uses a dose calibrator to measure the activity of beta- emitting radioactive materials to be administered to a patient must perform additional checks specified in clauses (A) and (B) of subparagraph (ii) of paragraph (3) of this subdivision using the same radionuclide to be administered and having an activity of at least 50 percent, but not more than 200 percent, of the prescribed activity or by equivalent procedures approved by the Department. Records must be kept pursuant to 24 RCNY Health Code § 175.105(c)(3)(vi).
(iv) A licensee must mathematically correct dosage readings for any geometry or linearity error that exceeds ±10 percent if the dosage is greater than 370 kBq (10µCi) and must repair or replace the dose calibrator if the accuracy or constancy error exceeds ±10 percent.
(v) A licensee must also perform checks and tests required by 24 RCNY Health Code § 175.103(c)(3)(ii) following adjustment or repair of the dose calibrator.
(vi) A licensee must retain a record of each check and test required by subparagraphs (ii), (iii) and (v) of 24 RCNY Health Code § 175.105(c)(3) for 3 years. Such records must include:
(A) for clause (A) of 24 RCNY Health Code § 175.105(c)(3)(ii), the models and serial numbers of the dose calibrator and check source, the identity and calibrated activity of the radionuclide contained in the check source, the date of the check, the activity measured, the instrument settings, and the name of the individual who performed the check;
(B) for clause (B) of 24 RCNY Health Code § 175.105(c)(3)(ii), the model and serial number of the dose calibrator, the model and serial number of each source used and the identity of the radionuclide contained in the source and its activity, proof of traceability to a national standard, the date of the test, the results of the test, the instrument settings, and the signature of the radiation safety officer; (C) for clause (C) of 24 RCNY Health Code § 175.105(c)(3)(ii), the model and serial number of the dose calibrator, the calculated activities, the measured activities, the date of the test, and the signature of the radiation safety officer; and
(D) for clause (D) of 24 RCNY Health Code § 175.105(c)(3)(ii), the model and serial number of the dose calibrator, the configuration and calibrated activity of the source measured, the activity of the source, the activity measured and the instrument setting for each volume measured, the date of the test, and the signature of the radiation safety officer.
(4) Possession and calibration of portable survey instruments.
(i) A licensee authorized to use radioactive material for any medical use permitted in 10 C.F.R. §§ 35.100, 35.200, 35.300, 35.400, 35.500, or 35.600 must have in its possession a portable, radiation detection survey instrument capable of detecting dose rates over the range of 1.0 µSv (0.1 mrem) per hour to 1,000 µSv (100 mrem) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 µSv (1 mrem) per hour to 10 mSv (1,000 mrem) per hour. This requirement may be met by possession of two survey instruments or by possession of one survey instrument that meets both criteria. The instruments must be operable and calibrated in accordance with 10 C.F.R. § 35.61.
(ii) To meet the requirements of 24 RCNY Health Code § 175.105(c)(4)(i), the licensee must perform such calibrations as authorized by specific license condition, or must obtain the services of persons licensed by the U.S. Nuclear Regulatory Commission or an agreement state to perform calibrations of survey instruments.
(iii) A licensee must check each survey instrument for proper operation with the dedicated check source before each use. The licensee is not required to keep records of these checks.
(5) Surveys of exposure rate and contamination. In addition to the requirements of 10 C.F.R. § 35.70, a licensee must:
(i) survey with a radiation detection survey instrument at least once each week all areas where unsealed byproduct materials or radioactive wastes are stored;
(ii) conduct the surveys required by 10 C.F.R. § 35.70 and 24 RCNY Health Code § 175.105(c)(5)(i) so as to be able to detect and measure dose rates as low as 1 µSv (0.1 mrem) per hour.
(iii) establish dose rate action levels for the surveys required by 10 C.F.R. § 35.70 and 24 RCNY Health Code § 175.103(c)(5)(i) and must require that the individual performing the survey immediately notify the radiation safety officer if a dose rate exceeds an action level.
(iv) perform wipe tests for removable contamination once each week on all areas where radioactive materials are routinely prepared for use or administered and where unsealed sources of radioactive materials are stored, so as to be able to detect contamination on each wipe sample of 35 Bq (2100 disintegrations or transformations per minute).
(v) establish removable contamination action levels for the surveys required by 24 RCNY Health Code § 175.105(c)(5)(iv) and must require that the individual performing the survey immediately notify the radiation safety officer if contamination exceeds action levels.
(vi) retain a record of each survey or wipe test required by 10 C.F.R. § 35.70 and 24 RCNY Health Code § 175.105(c)(5) for 3 years. The record must include the date of the survey, a sketch of each area surveyed, action levels established for each area, the measured dose rate at several points in each area expressed in Sv (mrem) per hour or the removable contamination in each area expressed in becquerels (disintegrations or transformations per minute) per 100 square centimeters, the serial number and the model number of the instrument used to make the survey or analyze the samples, and the initials of the individual who performed the survey.
(6) Additional requirements for use of generators aerosols, gases, and volatile materials.
(i) A licensee approved to use unsealed byproduct material for medical use permitted in 10 C.F.R. § 35 Subpart D may use generators, radioactive aerosols, or radioactive gases only if specific application is made to and approved by the Department. (ii) Storage of volatiles and gases.
(A) A licensee must store volatile radiopharmaceuticals and radioactive gases in the shippers' radiation shield and container.
(B) After drawing the first dosage, a licensee must store and use a multidose container in a properly functioning fume hood.
(iii) Control of aerosols and gases.
(A) A licensee who administers radioactive aerosols or gases must do so with a system that will keep airborne concentrations within the limits prescribed by 10 C.F.R. Part 20.
(B) The system must provide for collection and decay or disposal of the unused aerosol or gas in a shielded container.
(C) Before receiving, producing, using, or storing a radioactive gas, the licensee must calculate the amount of time needed after a release to reduce the concentration in the area of use to the ALI listed in Table 1 of Appendix A of 10 C.F.R. Part 20. The calculation must be based on the highest activity of gas handled in a single container and the measured available air exhaust rate.
(D) A licensee must post the time calculated in 24 RCNY Health Code § 175.105(c)(6)(iii)(C) at the area of use, as well as safety measures to be instituted in case of a spill at the area of use.
(E) A licensee must check the operation of collection systems monthly and measure the ventilation rates in areas of use at intervals not to exceed 6 months. Records of these checks and measurements must be maintained for 3 years.
(F) A copy of the calculations, including assumptions, measurements and calculations made, required in 24 RCNY Health Code § 175.105(c)(6)(iii)(C) must be recorded and retained for the duration of the license.
(7) Radioactive cadavers.
(i) If any patient containing radioactive material administered/implanted for therapeutic purposes dies, the physician who pronounces such patient as dead must notify immediately the physician in charge of the case or such physician's designated representative.
(ii) No person shall commence any autopsy on any cadaver that contains more than 185 MBq (5 mCi) of radioactive material administered/implanted for therapeutic purposes without first having consulted with, and having been advised by, the radiation safety officer of the hospital or the physician responsible for the administration/implantation of the radioactive material. If neither is available, a designated representative may serve.
(iii) A radioactivity report on every cadaver containing more than 185 MBq (5 mCi) of radioactive material administered/implanted for therapeutic purposes must be completed by the radiation safety officer or the physician responsible for the administration of the radioactive material or their designated representative. The report must include the name, address and radioactive materials license number of the hospital; the name of the deceased; the name, address and telephone number of the next of kin; the name, address and telephone number of the funeral home to which the deceased will be sent; the radionuclide involved; the approximate activity on the date of the report and the physical form; the location of the radioactive materials within the body and the external dose rate at the body surface closest to the source; the precautions to be observed during autopsy or handling of the body by the funeral director; and the name of the person who prepared the form. This report must accompany the body, whether autopsied or not, when it is surrendered to the funeral director. The Department must be notified in person, by telephone, or by facsimile within 24 hours of the death and a copy of the radioactivity report must be sent to the Department within 15 days of the date of death.
(8) Safety requirements for uses authorized in 10 C.F.R. § 35 Subparts E and F. For each patient or research subject who cannot be released pursuant to 10 C.F.R. § 35.75, a licensee must:
(i) authorize visits by individuals under age 18 only on a patient-by- patient basis with the approval of the authorized user after consultation with the radiation safety officer.
(ii) promptly after implanting the dosage or sources, measure the dose rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with the requirements of 10 C.F.R. Part 20 and retain for 3 years a record of each survey that includes the time and date of the survey, a sketch of the area or list of points surveyed, the measured dose rate at several points expressed in mSv (mrem) per hour, the instrument used to make the survey, and the initials of the individual who made the survey.
(9) Additional requirements for uses authorized in 10 C.F.R. § 35 Subpart H.
(i) Amendment requests. In addition to the requirements specified in 10 C.F.R. § 35.13, a licensee must apply for and have received a license amendment prior to:
(A) making any change in the treatment room shielding;
(B) making any change in the location of a gamma stereotactic radiosurgery (GSR) unit or a teletherapy unit within the treatment room;
(C) using the GSR or teletherapy unit in a manner that could result in increased radiation levels in areas outside the treatment room;
(D) relocating the GSR or teletherapy unit; or
(E) allowing an individual not listed on the licensee's license to perform the duties of the authorized medical physicist.
(ii) A licensee must furnish a copy of the records required in 10 C.F.R. §§ 35.632 and 35.635 and the output from the teletherapy source expressed as Sv (rem) per hour at one meter from the source determined during the surveys required in 10 C.F.R. § 35.652 to the Department within 30 days following completion of the action that initiated the record requirement.
(iii) Modification of a GSR or teletherapy unit or room before beginning a treatment program. If the survey required by 10 C.F.R. § 35.652 or 24 RCNY Health Code § 175.105(c)(9)(iv) indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by 10 C.F.R. Part 20, before beginning the treatment program, the licensee must:
(A) either equip the unit with stops or add additional radiation shielding to ensure compliance with 10 C.F.R. Part 20;
(B) perform the survey required by 10 C.F.R. § 35.652 again; and
(C) include in the report required by 24 RCNY Health Code § 175.105(c)(9)(ii), the results of the initial survey, a description of the modification made to comply with 10 C.F.R. § 35.652(a) and the results of the second survey; or
(D) request and receive a license amendment that authorizes radiation levels in unrestricted areas greater than those permitted by 10 C.F.R. Part 20.
(10) Records.
(i) In lieu of the retention requirements of 10 C.F.R. § 35.2067, records of leak tests required by 10 C.F.R. § 35.67(b) and the semi-annual physical inventory of sealed sources and brachytherapy sources required by 10 C.F.R. § 35.67(g) shall be retained for 5 years.
(ii) In addition to the requirements of 10 C.F.R. § 35.2630, for each intercomparison, the record must include evidence that the intercomparison reading was sanctioned by a calibration laboratory or radiologic physics center accredited by the American Association of Physicists in Medicine.
(11) Visiting authorized user. Notwithstanding other provisions of this Article, a licensee may permit any physician to act as a visiting authorized user under the term of the license for up to 60 days per calendar year if:
(i) the visiting authorized user has the prior written permission of the licensee's management and, if the use occurs on behalf of an institution, the institution's Radiation Safety Committee (where applicable); and
(ii) the visiting authorized is specifically named as a user on a license issued by the Department, Nuclear Regulatory Commission, or an Agreement State, and only performs procedures for which they are specifically authorized on that license, and
(iii) the licensee maintains copies of the written permission required by subparagraph (i) of this paragraph and documentation that the visiting authorized user met the requirements of subparagraph (ii) of this paragraph for 5 years from the date of the last visit.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) Except as set forth in subdivision (b) of this section, 10 C.F.R. Part 71 is hereby incorporated by reference herein to this Article with the same force and effect as if fully set forth in its entirety.
(b) The following provisions from 10 C.F.R. Part 71 are not so incorporated: § 71.2, § 71.6, § 71.11, § 71.14(b), § 71.19, §§ 71.31 through 71.45, §§ 71.51 through 71.77, § 71.85(a)- (c), § 71.91(b), § 71.99, § 71.100, § 71.101(c)(2), § 71.101(d)-(f), § 71.107 through § 71.125.
(c) Licensees must ascertain that the certificate holder determinations in subsections (a) through (c) of 10 C.F.R. § 71.85 have been made.
(d) The requirements of the incorporated 10 C.F.R. §§ 71.106 and 71.135 apply to general licensees and do not apply to certificate of compliance holders or applicants for certificates of compliance as those terms are defined in 10 C.F.R. § 71.4.
(e) A licensee's quality assurance program referenced in the incorporated 10 C.F.R. Part 71 Subpart H regulations as to packaging must be submitted to the Department at the address provided in 24 RCNY Health Code § 175.01(c).
(f) Transport authorized by the incorporated 10 C.F.R. § 71.13 must not be by public modes of transportation including, but not limited to, buses, subways, trams, taxicabs, car services, trains, ferries, or other public conveyance, which would be returned immediately to public use after transporting licensed material.
(Added City Record 4/24/2019, eff. 5/24/2019)
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