§ 175.68 Therapeutic Radiation Machines – Quality Assurance for Simulation Systems.

Quality assurance for a conventional or virtual simulator must include acceptance testing and periodic verification of system performance. This testing and verification must:

   (a)   be performed in accordance with "Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy Committee Task Group No. 40: AAPM Report No. 46" (or the most current revision or successor national standard) for a conventional simulator; or

   (b)   be performed in accordance with "Quality assurance for computed tomography simulators and the computed tomography-simulation process: Report of the AAPM Radiation Therapy Committee Task Group No. 66: AAPM Report No. 83" (or the most current revision or successor national standard) for a virtual simulator.

(Added City Record 4/24/2019, eff. 5/24/2019)

§ 175.69 Therapeutic Radiation Machines – Electronic Brachytherapy.

   (a)   Applicability.

      (1)   An electronic brachytherapy device that does not meet the requirements of this section must not be used for irradiation of patients.

      (2)   An electronic brachytherapy device must only be utilized for human use applications that is specifically approved by the U.S. Food and Drug Administration, unless participating in a research study approved by the registrant's Institutional Review Board.

      (3)   Electronic brachytherapy devices are exempt from the requirements of 24 RCNY Health Code § 175.64.

   (b)   Possession of survey instruments. Each facility location authorized to use an electronic brachytherapy device in accordance with this section must possess appropriately calibrated portable monitoring equipment. At a minimum, such equipment must include 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. The survey instruments must be operable and calibrated in accordance with 24 RCNY Health Code § 175.66 for the applicable electronic brachytherapy source energy.

   (c)   Facility design requirements. In addition to shielding adequate to meet the requirements of 24 RCNY Health Code § 175.67, an electronic brachytherapy device treatment room must meet the following design requirements:

      (1)   If applicable, provision must be made to prevent simultaneous operation of more than one therapeutic radiation machine in a treatment room.

      (2)   Access to the treatment room must be controlled by a door at each entrance.

      (3)   Each treatment room must have provisions to permit continuous aural communication and visual observation of the patient from the treatment control panel during irradiation. The electronic brachytherapy device must not be used for patient irradiation unless the patient can be observed.

      (4)   For electronic brachytherapy devices capable of operating below 150 kV, radiation shielding for the staff in the treatment room must be available, either as a portable shield or as localized shielded material around the treatment site.

      (5)   For electronic brachytherapy devices capable of operating at greater than 150 kV:

         (i)   the control panel must be located outside the treatment room; and

         (ii)   electrical interlocks must be provided for all doors to the treatment room that will:

            (A)   prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;

            (B)   cause the source to be shielded when an entrance door is opened; and

            (C)   prevent the source from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source on-off control is reset at the console.

   (d)   Control panel. The control panel, in addition to the displays required by other provisions in this section, must:

      (1)   provide an indication of whether electrical power is available at the control panel and if activation of the electronic brachytherapy source is possible;

      (2)   provide an indication of whether x-rays are being produced;

      (3)   provide a means for indicating electronic brachytherapy source potential and current;

      (4)   provide the means for terminating an exposure at any time; and

      (5)   include an access control (locking) device that will prevent unauthorized use of the electronic brachytherapy device.

   (e)   Timer. A suitable irradiation control device (timer) must be provided to terminate the irradiation after a pre-set time interval or integrated charge on a dosimeter-based monitor.

      (1)   A timer must be provided at the treatment control panel. The timer must indicate planned setting and the time elapsed or remaining.

      (2)   The timer must not permit an exposure if set at zero.

      (3)   The timer must be a cumulative device that activates with an indication of "BEAM- ON" and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it must be necessary to reset the elapsed time indicator before irradiation can be resumed.

      (4)   The timer must terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system has not previously terminated irradiation.

      (5)   The timer must permit setting of exposure times as short as 0.1 second.

      (6)   The timer must be accurate to within 1 percent of the selected value or 0.1 second, whichever is greater.

   (f)   QMP support.

      (1)   The services of a QMP must be required in facilities having electronic brachytherapy devices. The QMP must be responsible for:

         (i)   evaluation of the output from the electronic brachytherapy source;

         (ii)   generation of the necessary dosimetric information;

         (iii)   supervision and review of treatment calculations prior to initial treatment of any treatment site;

         (iv)   establishing the periodic and day-of-use quality assurance checks and reviewing the data from those checks as required by subdivision (j) of this section;

         (v)   consultation with the authorized user in treatment planning, as needed; and

         (vi)   performing calculations/assessments regarding patient treatments that may constitute a medical event.

      (2)   If the QMP is not a full-time employee of the registrant, the operating procedures required by subdivision (g) of this section must also specifically address how the QMP is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the QMP can be contacted.

   (g)   Operating procedures.

      (1)   Electronic brachytherapy devices must not be made available for medical use, unless the requirements of 24 RCNY Health Code § 175.61(a) and subdivisions (i) and (j) of this section have been met.

      (2)   The electronic brachytherapy device must be inoperable, either by hardware or password, when unattended by qualified staff or service personnel.

      (3)   Only individuals approved by the authorized user, radiation safety officer, or QMP shall be present in the treatment room during treatment.

      (4)   During operation, the electronic brachytherapy device operator must monitor the position of all persons in the treatment room, and all persons entering the treatment room, to prevent entering persons from unshielded exposure from the treatment beam.

      (5)   If a patient must be held in position during treatment, mechanical supporting or restraining devices must be used.

      (6)   Written procedures must be developed, implemented, and maintained for responding to equipment malfunction and any deviation from expected clinical outcomes. These procedures must include:

         (i)   instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions; and

         (ii)   the names and telephone numbers of the authorized users, the QMP, and the radiation safety officer to be contacted if the device or console operates abnormally.

      (7)   A copy of the current operating and emergency procedures must be physically located at the electronic brachytherapy device control console. If the control console is integral to the electronic brachytherapy device, the required procedures must be kept where the operator is located during electronic brachytherapy device operation.

      (8)   Instructions must be posted at the electronic brachytherapy device control console to inform the operator of the names and telephone numbers of the authorized users, the QMP, and the radiation safety officer to be contacted if the device or console operates abnormally.

      (9)   The radiation safety officer or a designee, and an authorized user must be notified as soon as possible if a medical event occurs. The radiation safety officer or the QMP must inform the Department of the event.

   (h)   Safety precautions.

      (1)   A QMP must determine which persons in the treatment room require monitoring when the beam is energized.

      (2)   An authorized user and a QMP must be physically present during the initiation of all patient treatments involving the electronic brachytherapy device.

      (3)   A QMP and either an authorized user or a physician or electronic brachytherapy device operator, under the supervision of an authorized user, who has been trained in the operation and emergency response for the electronic brachytherapy device, must be physically present during continuation of all patient treatments involving the electronic brachytherapy device.

      (4)   When shielding is required by paragraph (4) of subdivision (c) of this section, the electronic brachytherapy device operator must use a survey meter to verify proper placement of the shielding immediately upon initiation of treatment. Alternatively, a QMP must designate shield locations sufficient to meet the requirements of this Article for any individual, other than the patient, in the treatment room.

      (5)   All personnel in the treatment room are required to remain behind shielding during treatment. A QMP must approve any deviation from this requirement and must designate alternative radiation safety protocols, compatible with patient safety, to provide an equivalent degree of protection.

   (i)   Source calibration measurements.

      (1)   Calibration of the electronic brachytherapy source output for an electronic brachytherapy device subject to this section must be performed by, or under the direct supervision of, a QMP.

      (2)   Calibration of the electronic brachytherapy source output must be made for each electronic brachytherapy source, or after any repair affecting the x-ray beam generation, or when indicated by the electronic brachytherapy source quality assurance checks.

      (3)   Calibration of the electronic brachytherapy source output must utilize a dosimetry system described in 24 RCNY Health Code § 175.61(c).

      (4)   Calibration of the electronic brachytherapy source output must include, as applicable, the determination of:

         (i)   the output within 2 percent of the expected value, if applicable, or determination of the output if there is no expected value;

         (ii)   timer accuracy and linearity over the typical range of use;

         (iii)   proper operation of back-up exposure control devices;

         (iv)   evaluation that the relative dose distribution about the source is within 5 percent of that expected; and

         (v)   source positioning accuracy to within 1 millimeter within the applicator;

      (5)   Calibration of the x-ray source output required by paragraphs (1) through (4) of this subdivision must be in accordance with current published recommendations from a recognized national professional association with expertise in electronic brachytherapy (when available). In the absence of a calibration protocol published by a national professional association, the manufacturer's calibration protocol must be followed.

      (6)   The registrant must maintain a record of each calibration in an auditable form for the duration of the registration. The record must include:

         (i)   the date of the calibration;

         (ii)   the manufacturer's name, model number and serial number for the electronic brachytherapy device and a unique identifier for its electronic brachytherapy source;

         (iii)   the model numbers and serial numbers of the instrument used to calibrate the electronic brachytherapy device; and

         (iv)   the name and signature of the QMP responsible for performing the calibration.

   (j)   Periodic and day-of-use quality assurance checks.

      (1)   Quality assurance checks must be performed on each electronic brachytherapy device subject to this section:

         (i)   at the beginning of each day of use;

         (ii)   each time the device is moved to a new room or site ("site" here is intended to include each day of use at each operating location for a self-contained electronic brachytherapy unit transported in a van or trailer); and

         (iii)   after each x-ray tube installation.

      (2)   The registrant must perform periodic quality assurance checks required by paragraph (1) of this subdivision in accordance with procedures established by the QMP.

      (3)   To satisfy the requirements of paragraph (1) of this subdivision, radiation output quality assurance checks must include as a minimum:

         (i)   verification that output of the electronic brachytherapy source falls within 3 percent of expected values, as appropriate for the device, as determined by:

            (A)   output as a function of time, or

            (B)   output as a function of setting on a monitor chamber.

         (ii)   verification of the consistency of the dose distribution to within 3 percent of that found during calibration required by subdivision (i) of this section.; and

         (iii)   validation of the operation of positioning methods to ensure that the treatment dose exposes the intended location within 1 mm; and

      (4)   The registrant must use a dosimetry system that has been intercompared within the previous 12 months with the dosimetry system described in 24 RCNY Health Code § 175.61(c)(1) to make the quality assurance checks required by paragraph (3) of this subdivision.

      (5)   The registrant must review the results of each radiation output quality assurance check according to the following procedures:

         (i)   an authorized user and QMP must be immediately notified if any parameter is not within its acceptable tolerance. The electronic brachytherapy device must not be made available for subsequent medical use until the QMP has determined that all parameters are within their acceptable tolerances

         (ii)   if all radiation output quality assurance check parameters appear to be within their acceptable range, the quality assurance check must be reviewed and signed by either the authorized user or QMP within 2 days; and

         (iii)   the QMP must review and sign the results of each radiation output quality assurance check at intervals not to exceed 30 days.

      (6)   To satisfy the requirements of paragraph (1) of this subdivision, safety device quality assurance checks must, at a minimum, assure:

         (i)   proper operation of radiation exposure indicator lights on the electronic brachytherapy device and on the control console;

         (ii)   proper operation of viewing and intercom systems in each electronic brachytherapy facility, if applicable;

         (iii)   proper operation of radiation monitors, if applicable;

         (iv)   the integrity of all cables, catheters or parts of the device that carry high voltages; and

         (v)   connecting guide tubes, transfer tubes, transfer-tube-applicator interfaces, and treatment spacers are free from any defects that interfere with proper operation.

      (7)   If the results of the safety device quality assurance checks required by paragraph (6) of this subdivision indicate the malfunction of any system, a registrant must secure the control console in the OFF position and not use the electronic brachytherapy device except as may be necessary to repair, replace, or check the malfunctioning system.

      (8)   The registrant must maintain a record of each quality assurance check required by paragraphs (3) through (7) of this subdivision in an auditable form for 3 years.

         (i)   The record must include the date of the quality assurance check; the manufacturer's name, model number and serial number for the electronic brachytherapy device; the name and signature of the individual who performed the periodic quality assurance check and the name and signature of the QMP who reviewed the quality assurance check;

         (ii)   For radiation output quality assurance checks required by paragraph (3) of this subdivision, the record must also include the unique identifier for the electronic brachytherapy source and the manufacturer's name; model number and serial number for the instruments used to measure the radiation output of the electronic brachytherapy device.

   (k)   Therapy-related computer systems. The registrant must perform acceptance testing on the treatment planning system of electronic brachytherapy-related computer systems in accordance with current published recommendations from a recognized national professional association with expertise in electronic brachytherapy (if available). In the absence of an acceptance testing protocol published by a national professional association, the manufacturer's acceptance testing protocol must be followed.

      (1)   Acceptance testing must be performed by, or under the direct supervision of, a QMP. At a minimum, the acceptance testing must include, as applicable, verification of:

         (i)   the source-specific input parameters required by the dose calculation algorithm;

         (ii)   the accuracy of dose, dwell time, and treatment time calculations at representative points;

         (iii)   the accuracy of isodose plots and graphic displays;

         (iv)   the accuracy of the software used to determine radiation source positions from radiographic images; and

         (v)   if the treatment-planning system is different from the treatment- delivery system, the accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.

      (2)   The position indicators in the applicator must be compared to the actual position of the source or planned dwell positions, as appropriate, at the time of commissioning.

      (3)   Prior to each patient treatment regimen, the parameters for the treatment must be evaluated and approved by the authorized user and the QMP for correctness through means independent of that used for the determination of the parameters.

   (l)   Training.

      (1)   A registrant must provide instruction, initially and at least annually, to all individuals who operate the electronic brachytherapy device, as appropriate to the individual's assigned duties, in the operating procedures identified in subdivision (g) of this section. If the interval between patients exceeds one year, retraining of the individuals shall be provided.

      (2)   In addition to the requirements of subdivisions (c) of 24 RCNY Health Code § 175.60 as to authorized users, these individuals must also receive device specific instruction initially from the manufacturer and annually from either the manufacturer or other qualified trainer. The training must be of a duration recommended by a recognized national professional association with expertise in electronic brachytherapy (if available). In the absence of any training protocol recommended by a national professional association, the manufacturer's training protocol must be followed. The training must include, but not be limited to:

         (i)   device-specific radiation safety requirements;

         (ii)   device operation;

         (iii)   clinical use for the types of use approved by the FDA;

         (iv)   emergency procedures, including an emergency drill; and

         (v)   the registrant's quality assurance program.

      (3)   A registrant must retain a record of individuals receiving instruction required by paragraphs (1) and (2) of this subdivision for 3 years. The record must include a list of the topics covered, the date of the instruction, the names of the attendees, and the names of the individuals who provided the instruction.

   (m)   Mobile electronic brachytherapy service. A registrant providing mobile electronic brachytherapy service must, at a minimum:

      (1)   check all survey instruments before medical use at each address of use or on each day of use, whichever is more restrictive;

      (2)   account for the electronic brachytherapy source in the electronic brachytherapy device before departure from the client's address;

      (3)   perform, at each location on each day of use, all of the required quality assurance checks specified in subdivision (j) of this section to assure proper operation of the device.

(Added City Record 4/24/2019, eff. 5/24/2019)

§ 175.70 Therapeutic Radiation Machines – Other Use of Electronically-Produced Radiation.

A person must not utilize any device which is designed to electrically generate a source of ionizing radiation to deliver therapeutic radiation dosage, or which is not appropriately regulated under any existing category of therapeutic radiation machine, until:

   (a)   the applicant or registrant has, at a minimum, provided the Department with:

      (1)   a detailed description of the device and its intended application;

      (2)   facility design requirements, including shielding and access control;

      (3)   documentation of appropriate training for authorized user physicians and QMPs;

      (4)   methodology for measurement of dosages to be administered to patients or human research subjects;

      (5)   documentation regarding calibration, maintenance, and repair of the device, as well as instruments and equipment necessary for radiation safety;

      (6)   radiation safety precautions and instructions; and

      (7)   other information requested by the Department in its review of the application; and

   (b)   the applicant or registrant has received written approval from the Department to utilize the device in accordance with the requirements and specific conditions the Department considers necessary for the medical use of the device.

(Added City Record 4/24/2019, eff. 5/24/2019)

Part III: Radioactive Materials

§ 175.100 Incorporation of Federal Regulations.

   (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.

   (b)   In this Part (24 RCNY Health Code §§ 175.100 through 175.108), the following definitions apply:

      (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 [phone], or, online at (3) the U.S. Nuclear Regulatory Commission online at

(Added City Record 4/24/2019, eff. 5/24/2019)

§ 175.101 Notices, Instructions and Reports to Workers.

   (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)

§ 175.102 Standards for Protection Against Radiation.

   (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)

§ 175.103 General Requirements for Radioactive Materials.

   (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)

§ 175.104 Specific Types of Radioactive Materials Licenses.

   (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.

      (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:

      (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.

      (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)