N.Y. Comp. Codes R. & Regs. tit. 10 § 16.10

Current through Register Vol. 46, No. 45, November 2, 2024

Section 16.10 - Inspections, surveys, checks and tests; vacating installations; securing radiation sources

(a) Each person who possesses any radiation source shall make, or cause to be made, the applicable surveys required under this section and such additional surveys as may be necessary for him/her to comply with other sections in this Part or as the department may direct in order to evaluate the extent of the radiation hazard that may be present.[FN4] Each person who possesses any radioactive material not in a sealed source for which surveys are required shall provide or have available appropriate calibrated and operable instruments capable of detecting and measuring radiation and radioactive contamination.

(1) Any radiation installation subject to the registration requirements of section 16.50(a) of this Part shall be inspected periodically to assure compliance with this Part and the maintenance of radiation exposures as far below the limits set forth in this Part as is reasonably achievable. Except as otherwise provided in subparagraph (ii) of this paragraph, inspections shall be made at a frequency as specified in subparagraph (i) of this paragraph, with the first inspection of an installation to be made at the time of the beginning of operation and subsequent inspections not to exceed the maximum interval specified for such installation in subparagraph (i) of this paragraph. The inspection shall be performed in a manner, and reported in writing on a form, prescribed by the department. The person who makes the inspection shall include in such report all recommendations necessary to accomplish compliance with this Part, and to reduce radiation exposure as far below the limits set forth in this Part as reasonably achievable. The inspection shall be made by the department, the New York City Department of Health or, as the department shall direct, by the appropriate county or part-county health officer having jurisdiction or by a certified radiation equipment safety officer. Such county or part-county health officer or the New York City health commissioner shall make the inspection only under an inspection program that is certified by the department in writing as approved and in effect. He/she may make the inspection or have it made by a duly authorized representative approved for such purpose by both such health officer and the department. The operator of an installation required to be inspected by a certified radiation equipment safety officer, shall be solely responsible for having all such required inspections made.

(i) Hospital, clinic, mammography and radiologist installations shall be inspected at least once every year; dental, podiatric and veterinary installations at least once every three years; and all other installations at least once every two years. Follow-up inspections shall be made at intervals of 60 days or less for the correction of any violation found during an inspection and remaining uncorrected at the conclusion thereof.

(ii) The department may establish a schedule of required inspections of any installation different from the schedule specified in this paragraph.

(iii) The certified radiation equipment safety officer or the health officer having jurisdiction, as the case may be, shall furnish the inspection report, signed by the person who made the inspection, to the operator of the installation and a copy thereof to the department in accordance with the instructions of the prescribed form.

(2) Radiation installations wherein radioactive materials are handled or installed which will have any readily accessible area in which there is reasonable expectation that a radiation level will exist in excess of two millirems per hour shall be surveyed during the initial operation and whenever any change is made in the installation or its use that might increase the radiation level to which a person could be exposed.

(3) Accessible areas and equipment within radiation installations wherein radioactive material not contained in a sealed source is handled or installed shall be surveyed at least once a month for radioactive contamination unless a shorter interval is specified in a license issued pursuant to this Part. Radioactive contamination of surfaces shall be kept ALARA and shall be brought to levels not to exceed the limits specified in Appendix 16-A, Table 7, infra.

(4) Each sealed source, containing radioactive material other than Hydrogen 3, with a half- life greater than 30 days and in any form other than gas shall be tested for leakage prior to initial use and at successive intervals thereafter not to exceed six months, except that each source designed for the purpose of emitting alpha particles shall be tested at intervals not to exceed three months. Notwithstanding the periodic leak test required by this paragraph, any licensed sealed source is exempt from such leak tests when the source contains 100 microcuries or less of beta and/or gamma emitting material or 10 microcuries or less of alpha emitting material. Except for alpha sources, the periodic leak test required by this paragraph shall not apply to sealed sources that are stored and not being used. The sources excepted from this test shall be tested for leakage prior to any use or transfer to another person unless they have been leak tested within six months prior to the date of use or transfer. In the absence of the delivery of a certificate by the transferor to the transferee indicating that a test pursuant to the applicable provisions of this Part was made within six months prior to the transfer, the source shall not be used until tested for leakage. If there is reason to suspect that a sealed source might have been damaged, or might be leaking, such source shall be tested for leakage before further use. The test sample shall be taken from selected accessible surfaces of the sealed source or from the surfaces of the device in which the sealed source is permanently mounted or stored. For teletherapy and/or irradiator sources, the selected accessible surfaces should be those surfaces on which one might expect contamination (if there were to be leakage) to accumulate and shall include the inner surface of the most frequently used treatment cone or beam collimating device. The test sample shall be taken with the source in the "off" position. The leak test technique shall be capable of detecting:

(i) the escape of radon at the rate of 0.001 microcurie or more per 24 hours for sealed radium sources; or

(ii) 0.005 microcurie or more of removable radioactivity from all other sealed sources.

Detection of a leak in any sealed source in excess of the sensitivity levels set forth in this paragraph shall result in immediate suspension in the use of such source until such source is decontaminated and repaired or disposed of in accordance with section 16.8 of this Part. Records of leak test results shall be kept in units of microcuries per test sample and maintained for inspection by the department. A leaking source report shall be submitted to the department for each source found to be leaking in excess of the above sensitivity levels within five days of detection of the leak and shall describe the equipment involved, the test results, and the corrective action taken.

(5) Protective devices such as interlocks, safety switches, fume hoods, filters and trapping devices for radioactive gases, shall be maintained in good repair and proper operating condition.

(b) Each person who possesses any radioactive material shall, no less than 30 days prior to decontrolling a controlled area or vacating, or relinquishing possession or control of premises wherein radioactive material is or has been stored or used shall have the premises surveyed and shall notify the department in writing of his intent to decontrol a controlled area or to vacate and the results of the survey. When deemed necessary by the department, such person shall decontaminate the premises to such radiation levels as the department may specify. Such person shall provide the health officer having jurisdiction, the operator of the installation housed on the premises and the landlord or subsequent tenant with a copy of a report of the results of the survey made pursuant to this subdivision.

(c) Each person who possesses any radiation source shall secure such source against its unauthorized removal from its place of storage or use. The following additional restrictions apply to noncontrolled areas:

(1) Radiation sources stored in a noncontrolled area shall be stored in a locked facility in the original shipping container, or a container providing equivalent radiation protection. Such a facility may be a cabinet, a safe or a room, providing the facility is locked at all times when no activities are in progress relating to the use of the radiation sources.

(2) Radiation sources in a noncontrolled area and not in storage shall be tended under the constant surveillance and immediate control of the licensee or registrant.

[FN4] The specific survey requirements set forth in this section shall not be construed as relieving any person from any survey requirements specified in any registration or license.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 16.10