TABLE OF CONTENTS - New York State Department of Health

TABLE OF CONTENTS PART 16 - IONIZING RADIATION

(Statutory authority: Public Health Law, Section 225)

16.0 Introductory note................................................................................................................... 1 GENERAL PROVISIONS ........................................................................................................................ 2

16.1 Applicability and inapplicability of this Part ........................................................................ 2 16.2 Definitions............................................................................................................................. 2 16.3 Granting exemptions or variations...................................................................................... 20 16.4 Exemption of certain radiation sources from the requirements of this Part ....................... 20 16.5 Responsibility for radiation safety ...................................................................................... 20 16.6 Occupational dose limits..................................................................................................... 21 16.7 Radiation dose limits for individual members of the public............................................... 27 16.8 Waste disposal .................................................................................................................... 28 16.9 Professional practitioners and related provisions ............................................................... 28 16.10 Inspections, surveys, checks and tests; vacating installations; securing sources.............. 29 16.11 Personnel monitoring ........................................................................................................ 31 16.12 Radiation symbol, signs, labels, and control devices........................................................ 33 16.13 Notices, instructions and reports to workers; inspections................................................. 39 16.14 Records ............................................................................................................................. 44 16.15 Reports .............................................................................................................................. 47 16.16 Procedures for picking up, receiving, and opening packages ........................................... 51 16.17 Transportation ................................................................................................................... 52 16.18 Additional requirements; surrender of radioactive material; sealing of equipment ......... 53 16.19 Limitations on application of radiation to humans ........................................................... 54 16.20 Hearings ............................................................................................................................ 55 16.21 Reserved............................................................................................................................ 55 16.22 X-ray screening; general requirements; mammography................................................... 55 16.23 Quality assurance programs for diagnostic facilities ........................................................ 57 16.24 Quality assurance programs for the use of radiation for therapy in humans .................... 59 16.25 Misadministrations............................................................................................................ 63 16.26 Respiratory protection and controls to restrict internal exposure ..................................... 65

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16.40 Fees ................................................................................................................................... 68 16.41 Fee schedule...................................................................................................................... 69 RADIATION EQUIPMENT ................................................................................................................... 72 16.50 Registration of installations with radiation equipment; notification of transfer ............... 72 16.51 General requirements for and prohibited uses of radiation equipment............................. 74 16.52 Electrical hazards .............................................................................................................. 74 16.53 Dental radiographic installations ...................................................................................... 74 16.54 Veterinary radiographic and fluoroscopic installations .................................................... 76 16.55 Podiatric radiographic installations................................................................................... 80 16.56 Radiographic installations excluding dental, veterinary and podiatric installations......... 80 16.57 Portable X-ray equipment excluding dental, veterinary and podiatric ............................. 82 16.58 Fluoroscopic installations excluding veterinary installations ........................................... 83 16.60 Therapy equipment operated at potentials up to 10 million volts..................................... 87 16.61 Therapy equipment operating at potentials of 60 kVp and below .................................... 89 16.62 Television receivers and other household appliances ....................................................... 89 16.63 Miscellaneous and special types of radiation producing equipment ................................ 89 LICENSING OF RADIOACTIVE MATERIALS .................................................................................. 90 16.100 Overall licensing requirement for radioactive material .................................................. 90 16.101 General licenses .............................................................................................................. 90 16.102 Applications for specific licenses ................................................................................... 90 16.103 General requirements for issuing specific licenses ......................................................... 91 16.104 Conditions of specific licenses........................................................................................ 91 16.105 Duration, expiration and termination of specific licenses .............................................. 92 16.106 Renewal or amendment of specific licenses ................................................................... 92 16.107 Amendment, suspension or revocation of licenses ......................................................... 92 16.108 Reserved.......................................................................................................................... 93 16.109 Licensees and contractors of the USNRC and the USDOE within the State.................. 93 16.110 Licensure and inspection of radioactive materials; fees authorized ............................... 94 16.111 Transfer of radioactive material...................................................................................... 94 16.112 Fingerprinting and criminal background check requirements ........................................ 95 HUMAN USES OF RADIOACTIVE MATERIALS ........................................................................... 101 16.120 Specific licenses for the use of radioactive materials on human beings....................... 101 16.121 Reserved........................................................................................................................ 101

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16.122 Reserved........................................................................................................................ 101 16.123 Specific licenses for certain medical uses of radioactive material ............................... 101 16.130 Radon testing and reporting .......................................................................................... 106 16.200 Material incorporated by reference ............................................................................... 106

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Section 16.0 Introductory note. This Part applies to all radiation equipment and radioactive material within the jurisdiction of the New York State Department of Health. Sections of this part set forth under the heading "General Provisions" (Sections 16.1-16.26) contain provisions applicable to radiation equipment operators and persons in possession of radioactive materials, including general radiation protection requirements. Sections of this Part set forth under the heading "Radiation Equipment" (Sections 16.50-16.63) contain the registration provisions for radiation equipment and general and additional radiation protection requirements applicable only to specific radiation equipment. Sections of this Part set forth under the heading "Licensing of Radioactive Materials" (Sections 16.100-16.123) contain the licensing provisions for radioactive materials, i.e., byproduct material, source material, special nuclear material in quantities not sufficient to form a critical mass, naturally occurring radioactive materials, and accelerator-produced radioactive material.1Section 16.130, "Radon testing and reporting", contains provisions applicable to firms performing radon measurements in NY State. Section 16.200, "Material incorporated by reference", provides a list of Federal rules and regulations also related to the regulation of ionizing radiation.

1 All discharges of wastes to the environment are subject to the provisions of the Environmental Conservation Law with particular reference to article 17 (water pollution control), article 19 (air pollution control) and article 27 (collection, treatment and disposal of refuse and other solid waste) thereof, and to all pertinent rules and regulations of the State Department of Environmental Conservation, including its permit requirements.

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GENERAL PROVISIONS

16.1 Applicability and inapplicability of this Part.

(a) Applicability. Except as otherwise provided in subdivision (b) of this section, this Part applies to any person who transfers, receives, possesses or uses any radiation source in this State.2

(b) Inapplicability.

(1) This Part does not apply to any person with respect to any radiation source to the extent that such radiation source is subject to regulation as provided for by law by the State Department of Labor. This exclusion does not apply to persons with respect to radiation sources used at industrial or commercial establishments for the application of radiation to human beings.

(2) This Part does not apply to any common or contract carrier operating within this State to the extent that such carrier is subject to regulation as provided for by law by the United States Department of Transportation or other agencies of the United States or agencies of the State of New York, other than the Department of Health, having jurisdiction.

(3) The licensure requirements contained in Sections 16.100 through 16.110 and Sections 16.120 through 16.123 of this Part shall not apply in a county, part-county or city health district having a population of more than 2,000,000, provided that such health district has established its own substitute licensure requirements with respect to radiation sources located within such health district and transferred, received, possessed or used by persons other than the State and its institutions or other facilities and provided that such substitute licensure requirements are submitted to the State Department of Health prior to their effective date and are acceptable to the State Department of Health as consistent with the corresponding requirements of this Part.

(c) Communications. Except as otherwise provided for in this Part or authorized by the Department, all applications, notifications or other communications filed pursuant to this Part shall be addressed to the New York State Department of Health Bureau of Environmental Radiation Protection, Empire State Plaza, Albany, New York 12237, or by telephone (518) 402-7550. Registrants and licensees that are authorized pursuant to Article 28 of the Public Health Law to operate a hospital may comply with adverse event reporting required by this Part by electronic filing with the Department via the New York Patient Occurrence and Tracking System (NYPORTS).

16.2 Definitions.

(a) As used in these regulations, these terms have the definitions set forth below:

(1) "A1" means the maximum activity of special form radioactive material permitted in a Type A package. "A2" means the maximum activity of radioactive material, other than special form radioactive material, permitted in a Type A package. These values are either listed or may be derived in accordance with the procedure prescribed in Appendix 16-B, Table 1 of this Part.

2 The types of installations to which this Part is generally applicable are described in the definition of "radiation installation" (Section 16.2(a)(98)).

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