N.Y. Comp. Codes R. & Regs. tit. 12 § 38.35

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

Section 38.35 - Special requirements for specific licenses to manufacture or transfer certain items containing naturally occurring or accelerator produced radioactive material

(a)Licenses for the introduction of radioactive material in exempt concentrations into products or materials, and transfer of ownership or possession:

(1) An application for a specific license authorizing the introduction of radioactive material into a product or material owned by or in the possession of the licensee or another person, and the subsequent transfer of ownership or possession of the product or material to persons exempt under Table 1, Exemption 2 of section 38.41 of this Part will be approved if the applicant:

(i) satisfies the general requirements specified in section 38.8 of this Part;

(ii) provides a description of the product or material into which the radioactive material will be introduced, intended use of the radioactive material and the product or material into which it is introduced, method of introduction, initial concentration of the radioactive material in the product or material, control methods to assure that no more than the specified concentration is introduced into the product or material, estimated time interval between introduction and transfer of the product or material, and estimated concentration of the radioisotopes in the product or material at the time of transfer; and

(iii) provides reasonable assurance that the concentrations of radioactive material at the time of transfer will not exceed the concentrations in section 38.41, Table 8 of this Part, that reconcentration of the radioactive material in concentrations exceeding those in Table 8 is not likely, that use of lower concentrations is not feasible, and that the product or material is not likely to be incorporated in any food, beverage, cosmetic, drug or other commodity or product designed for ingestion or inhalation by, or application to, a human being.

(2) Each person licensed under paragraph (1) of this subdivision shall maintain records of transfer of material, and file an annual report with the department which shall identify:

(i) the type and quantity of each product or material into which radioactive material has been introduced during the reporting period;

(ii) the name and address of the person who owned or possessed the product or material, into which radioactive material has been introduced, at the time of introduction;

(iii) the type and quantity of radionuclide introduced into each product or material; and

(iv) the initial concentrations of the radionuclide in the product or material at time of transfer of the radioactive material by the licensee.

(3) The report required by paragraph (2) of this subdivison shall:

(i) indicate whether transfers of radioactive material were made pursuant to paragraph (1) of this subdivision, during the reporting period; and

(ii) cover the year ending June 30th, and be filed by July 31st of the same year.

(b)Licenses for the distribution of naturally occurring and accelerator produced radioactive materials in exempt quantities.^*

(1) An application for a specific license to distribute radioactive materials to persons exempt under Table 1, Exemption 28 of section 38.41 of this Part will be approved if:

(i) the radioactive material is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human being;

(ii) the radioactive material is in the form of processed chemical elements, compounds, or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or similar substances, identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and

(iii) the applicant submits copies of prototype labels and brochures and the department approves such labels and brochures.

(2) Each license issued under paragraph (1) of this subdivision is subject to the following conditions:

(i) No more than 10 exempt quantities shall be sold or transferred in any single transaction. For purposes of this requirement, an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities provided that the sum of such fractions shall not exceed unity.

(ii) Each quantity of radioactive material shall be separately and individually packaged. No more than 10 such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to section 38.41, Table 1, Exemption 28 of this Part. The outer package shall be such that the dose rate at the external surface of the package does not exceed 0.5 millirem per hour.

(iii) The immediate container of each quantity or separately packaged fractional quantity of radioactive material shall bear a durable, legible label which:

(a) identifies the radioisotope and the quantity of radioactivity; and

(b) bears the words "Radioactive Material."

(iv) In addition to the labeling information required by subparagraph (2)(iii) of this subdivision, the label affixed to the immediate container, or an accompanying brochure, shall also:

(a) state that the contents are exempt from State licensing requirements;

(b) bear the words "Radioactive Material - Not for Human Use -Introduction Into Foods, Beverages, Cosmetics, Drugs, or Medicinals, or into Products Manufactured for Commercial Distribution is Prohibited - Exempt Quantities Should Not be Combined;" and

(c) set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage, and disposal of the radioactive material.

(3) Each person licensed under paragraph (1) of this subdivision shall maintain records of transfer of material identifying, by name and address, each person to whom radioactive material was transferred for use under section 38.41, Table 1, Exemption 28 of this Part, or the equivalent regulations of any state, and stating the kinds and quantities of radioactive material transferred. The licensee shall maintain the record of a transfer for a period of one year after the event is included in an annual summary report to the department.

(4) The annual report required by paragraph (3) of this subdivision shall:

(i) indicate whether transfers of radioactive material were made pursuant to paragraph (1) of this subdivision, during the reporting period; and

(ii) cover the year ending June 30th, and be filed by July 31st of the same year.

(c)Licenses for the incorporation of radioactive material into gas and aerosol detectors.

(1) An application for a specific license to manufacture, process, or produce gas and aerosol detectors containing radioactive material, or to initially transfer such products for use pursuant to section 38.41, Table 1, Exemption 27 of this Part or equivalent regulations of any state, will be approved if the maximum quantity of radium 226 in each device does not exceed 0.1 microcurie, and if:

(i) the applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, and conditions of handling, storage, use, and disposal of the gas and aerosol detector to demonstrate that the product will meet the safety criteria set forth in paragraph (2) of this subdivision. The information should include:

(a) a description of the product and its intended use or uses;

(b) the type and quantity of radioactive material in each unit;

(c) the chemical and physical form of the radioactive material in the product and changes in chemical and physical form that may occur during the useful life of the product;

(d) solubility in water and body fluids of the forms of the radioactive material identified in clauses (c) and (l) of this subparagraph;

(e) details of construction and design of the product as related to containment and shielding of the radioactive material and other safety features under normal and severe conditions of handling, storage, use, and disposal of the product;

(f) maximum external radiation levels at 5 and 25 centimeters from any external surface of the product, averaged over an area not to exceed 10 square centimeters, and the method of measurement;

(g) degree of access of human beings to the product during normal handling and use;

(h) total quantity of radioactive material expected to be distributed in the product annually;

(i) the expected useful life of the product;

(j) the proposed methods of labeling or marking the detector and its point-of-sale package to satisfy the requirements of subparagraph (4)(ii) of this subdivision;

(k) procedures for prototype testing of the product to demonstrate the effectiveness of the containment, shielding, and other safety features under both normal and severe conditions of handling, storage, use, and disposal of the product;

(l) results of the prototype testing of the product, including any change in the form of the radioactive material contained in the product, the extent to which the radioactive material may be released to the environment, any increase in external radiation levels, and any other changes in safety features;

(m) the estimated external radiation doses and other data relevant to the safety criteria in paragraph (2) of this subdivision and the basis for such estimates;

(n) a determination that the probabilities with respect to the doses referred to in subparagraph (2)(iii) of this subdivision meet the criteria of that subparagraph;

(o) quality control procedures to be followed in the fabrication of production lots of the product and the quality control standards the product will be required to meet; and

(p) any additional information, including experimental studies and tests, required by the department.

(2) Safety criteria.

(i) An applicant for a license under this subdivision shall demonstrate that the product is designed and will be manufactured so that:

(a) in normal use and disposal of a single exempt unit, and in normal handling and storage of the quantities of exempt units likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, it is unlikely that the external radiation dose in any one year, or the dose commitment resulting from the intake of radioactive material in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the product, will exceed the dose to the appropriate organ as specified in column I of the table in paragraph (3) of this subdivision;

(b) it is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the product from wear and abuse likely to occur in normal handling and use of the product during its useful life; and

(c) in use and disposal of a single exempt unit and in handling and storage of the quantities of exempt units likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, the probability is low that the containment, shielding, or other safety features of the product would fail under such circumstances that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in column II of the table in paragraph (3) of this subdivision; and the probability is negligible that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in column III of that table.^*

(3) Table of organ doses.

*Part of body*	*Column I (rem)*	*Column II (rem)*	*Column III (rem)*
Whole body, head and trunk; active blood-forming organs; gonads; or lens of eye .......	0.005	0.5	15
Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than one square centimeter .......	0.075	7.5	200
Other organs .......	0.015	1.5	50

(4) Each person licensed under this subdivision shall:

(i) Carry out adequate control procedures in the manufacture of the product to assure that each production lot meets the quality control standards approved by the department;

(ii) label or mark each detector and its point-of-sale package so that:

(a) each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing:

(1) the following statement: "Contains Radioactive Material;"

(2) the name of the radionuclide and quantity of activity; and

(3) an identification of the company licensed to transfer the detector for use pursuant to section 38.41, Table 1, Exemption 27 of this Part or equivalent regulations of another state;

(b) the labeling or marking specified in clause (ii)(a) of this paragraph is located where it will be readily visible when the detector is removed from its mounting;

(c) the external surface of the point-of-sale package has a legible, readily visible label or marking containing:

(1) the name of the radionuclide and quantity of activity;

(2) an identification of the person licensed under this subdivision to transfer the detector for use pursuant to section 38.41, Table 1, Exemption 27 of this Part or equivalent regulations of the NRC or another state; and

(3) the following or a substantially similar statement: "This detector contains radioactive material and has been manufactured in compliance with 12 NYCRR Part 38, section 38.35(c). The purchaser is exempt from any regulatory requirements;"

(d) each detector and point-of-sale package is provided with such other information as may be required by the department; and

(iii) maintain records and file a report with the department.

(a) The report must include the following information on products transferred to other persons for use under section 38.41, Table 1, Exemption 27 of this Part or equivalent regulations of the USNRC or another state:

(1) a description or identification of the type of each product;

(2) for each radionuclide in each type of product, the total quantity of the radionuclide; and

(3) the number of units of each type of product transferred during the reporting period.

(b) The licensee shall file the report within 30 days following:

(1) five years after filing the preceding report; or

(2) notifying the department of the licensee's decision to permanently discontinue activities authorized pursuant to the license issued under this subdivision.

(c) The report must cover the period between the filing of the preceding report and the occurrences specified in subclause (b)(l) or (2) of this subparagraph. If no transfers of radioactive material have been made during the reporting period, the report must so indicate.

(d) The licensee shall maintain the record of a transfer for a period of one year after the event is included in a report to the department.

(d)Licensing the manufacture and commercial distribution of devices to persons generally licensed under section 38.41, Table 3, item (b) of this Part.

(1) An application for a specific license to manufacture or commercially distribute devices containing radioactive material to persons generally licensed under section 38.41, Table 3, item (b) of this Part or equivalent regulations of the USNRC or an agreement state, will be approved if:

(i) the applicant satisfies the general requirements of section 38.8 of this Part;

(ii) the applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that:

(a) the device can be safely operated by persons not having training in radiological protection;

(b) under ordinary conditions of handling, storage, and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in any period of one year a dose in excess of 10 percent of the limits specified in section 38.18(a)(1) of this Part;

(c) under accident conditions (such as fire and explosion) associated with handling, storage, and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the following organ doses:

Whole body; head and trunk active blood-forming organs; gonads; or lens of eye	15 rems
Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than one square centimeter	200 rems
Other organs	50 rems

(iii) each device bears a durable, legible, clearly visible label or labels approved by the department, which contain in a clearly identified and separate statement:

(a) instructions and precautions necessary to assure safe installation, operation, and servicing of the device (documents such as operating and service manuals may be identified in the label and used to provide this information);

(b) the requirement, or lack of requirement, for leak testing, or for testing any "on-off" mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity; and

(c) the information called for in one of the following statements, as appropriate, in the same or substantially similar form:

(1) for radioactive material other than NARM:

The receipt, possession, use, and transfer of this device, Model ___ *, Serial No. ___ *, are subject to a general license or the equivalent and the regulations of the USNRC or a state with which the commission has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

Caution-Radioactive Material

______________

(Name of Manufacturer or Distributor)^*

-OR-

(2) for NARM:

The receipt, possession, use, and transfer of this device, Model ___ *, Serial No. ___ *, are subject to a general license or the equivalent, and the regulations of a State. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

Caution-Radioactive Material

______________

(Name of Manufacturer or Distributor)*

(2) In the event the applicant desires that the device be required to be tested at intervals longer than six months, either for proper operation of the "on-off" mechanism and indicator, if any, or for leakage of radioactive material or for both, the applicant shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices and by design features that have a significant bearing on the probability or consequences of radioactive material leakage from the device or failure of the "on-off" mechanism and indicator. In determining the acceptable interval for the test for radioactive material leakage, the department will consider information that includes, but is not limited to:

(i) primary containment (source capsule);

(ii) protection of primary containment;

(iii) method of sealing containment;

(iv) containment construction materials;

(v) form of contained radioactive material;

(vi) maximum temperature withstood during prototype tests;

(vii) maximum pressure withstood during prototype tests;

(viii) maximum quantity of contained radioactive material;

(ix) radiotoxicity of contained radioactive material; and

(x) operating experience with identical devices or similarly designed and constructed devices.

(3) In the event the applicant desires that the general licensee under section 38.41, Table 3, item (b) of this Part, or under equivalent regulations of the USNRC or another state be authorized to collect the sample to be analyzed by a specific licensee for radioactive material leakage, perform maintenance of the device consisting of replacement of labels, rust and corrosion prevention, and for fixed gauges, maintenance of source holder mounting brackets, test the "on-off" mechanism and indicator, the applicant shall include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and bases for such estimates. The submitted information shall demonstrate that performance of such activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a calendar quarter dose in excess of 10 percent of the limits specified in section 38.18(a)(1) of this Part.

(4) Each person licensed under this paragraph to commercially distribute devices to generally licensed persons shall:

(i) furnish a copy of the general license contained in section 38.41, Table 3, item (b) of this Part to each person to whom the licensee directly, or through an intermediate person, commercially distributes radioactive material in a device for use pursuant to the general license;

(ii) furnish a copy of the general license contained in the USNRC's, or a state's regulation equivalent to section 38.41, Table 3, item (b) of this Part, or alternatively, furnish a copy of the general license contained in that section to each person to whom the licensee directly, or through an intermediate person, commercially distributes radioactive material in a device for use pursuant to the general license of the USNRC, this State or another state. If a copy of the general license in section 38.41, Table 3, item (b) of this Part is furnished to such a person, it shall be accompanied by an explanation that the use of the device is regulated by the USNRC or a state under requirements substantially the same as those in section 38.41, Table 3, item (b) of this Part;

(iii) report to the department all commercial distributions of such devices to persons for use under the general license in section 38.41, Table 3, item (b) of this Part. Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the department and the general licensee, the type, model, serial number of device and serial number of source commercially distributed, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall also include identification of each intermediate person by name, address, contact, and relationship to the intended user. If no commercial distributions have been made to persons generally licensed during the reporting period, the report shall so indicate. The report shall cover each calendar quarter and shall be filed within 30 days thereafter;

(iv)

(a) report to the USNRC all commercial distributions of such devices to persons for use under the NRC general license in 10 CFR 31.5;

(b) report to the appropriate state all transfers of devices manufactured and commercially distributed pursuant to this paragraph for use under a general license in that state's regulations equivalent to section 38.41, Table 3, item (b) of this Part;

(c) such reports shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the agency and the general licensee, the type model, serial number of the device and serial number of source commercially distributed, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall also include identification of each intermediate person by name, address, contact, and relationship to the intended user. The report shall be submitted within 30 days after the end of each calendar quarter in which such a device is commercially distributed to the generally licensed person; and

(d) if no commercial distributions have been made to USNRC or state licensees during the reporting period, the fact that no such distributions have been made shall be reported to the USNRC and the states; and

(v) keep records showing the name, address, and the point of contact for each general licensee to whom the licensee directly, or through an intermediate person, commercially distributes radioactive material in devices for use pursuant to the general license provided in section 38.41, Table 3, item (b) of this Part, or equivalent regulations of the USNRC or another state. The records should show the date of each commercial distribution, the isotope and the quantity of radioactivity in each device commercially distributed, the identity of any intermediate person, and compliance with the reporting requirements of this paragraph.

(e)Luminous safety devices for use in aircraft: requirements for license to manufacture, assemble, repair or initially transfer.

(1) An application for a specific license to manufacture, assemble, repair or initially transfer luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under section 38.41, Table 3, item (e) of this Part, will be approved if:

(i) the applicant satisfies the general requirements specified in section 38.8 of this Part;

(ii) the applicant submits sufficient information regarding each device pertinent to evaluation of the potential radiation exposure, including:

(a) chemical and physical form and maximum quantity of tritium or promethium-147 in each device;

(b) details of construction and design;

(c) details of the method of binding or containing the tritium or promethium-147;

(d) procedures for, and results of, prototype testing to demonstrate that the tritium or promethium-147 will not be released to the environment under the most severe conditions likely to be encountered in normal use;

(e) any quality control procedures proposed as alternatives to those prescribed by paragraph (4) of this subdivision; and

(f) any additional information, including experimental studies and tests, required by the department to facilitate a determination of the safety of the device;

(iii) each device will contain no more than 10 curies of tritium or 300 millicuries of promethium-147. The levels of radiation from each device containing promethium-147 will not exceed 0.5 millirad per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber; and

(iv) the department determines that:

(a) the method of incorporation and binding of the tritium or promethium-147 in the device is such that the tritium or promethium-147 will not be released under the most severe conditions which are likely to be encountered in normal use and handling of the device;

(b) the tritium or promethium-147 is incorporated or enclosed so as to preclude direct physical contact by any person with it;

(c) the device is so designed that it cannot easily be disassembled; and

(d) the of device has been subjected to and has satisfactorily passed the prototype tests prescribed by schedule B of part 32 of the Code of Federal Regulations; January 1, 1995 edition¹.

(2) A person licensed under this subdivision to manufacture, assemble, or initially transfer devices containing tritium or promethium-147 for distribution to persons generally licensed under section 38.41, Table 3, item (e) of this Part shall, except as provided in paragraph (3) of this subdivision, affix to each device a label containing the radiation symbol prescribed by section 38.25 of this Part, such other information as may be required by the department including disposal instructions when appropriate, and the following or a substantially similar statement which contains the information called for in the following statement:

The receipt, possession, use, and transfer of this device, Model ___ *, Serial No. ___* containing ___ (identity and quantity of radioactive material) are subject to a general license or the equivalent and the regulations of the USNRC or of a state with which the NRC has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

Caution-Radioactive Material

__________________

(Name of manufacturer, assembler, or initial transferor.)^*

(3) If the department determines that it is not feasible to affix a label to the device containing all the information called for in paragraph (2) of this subdivision, it may waive the requirements of that paragraph and require in lieu thereof that:

(i) a label be affixed to the device identifying:

(a) the manufacturer, assembler, or initial transferor; and

(b) the type of radioactive material;

(ii) a leaflet bearing the following information be enclosed in or accompany the container in which the device is shipped:

(a) the name of the manufacturer, assembler, or initial transferor;

(b) the type and quantity of radioactive material;

(c) the model number;

(d) a statement that the receipt, possession, use, and transfer of the device are subject to a general license or the equivalent and the regulations of the USNRC or of an agreement state; and

(e) such other information as may be required by the department including disposal instructions when appropriate.

(4) Quality assurance.

(i) Each person licensed under this subdivision shall visually inspect each device and shall reject any which has an observable physical defect that could affect containment of the tritium or promethium-147.

(ii) Each person licensed under this subdivision shall take a random sample of the size required by the table for "Lot Tolerance Percent Defective of 5.0 percent" in subpart C of part 32 of the Code of Federal Regulations; January 1, 1995 edition¹, from each inspection lot, and shall subject each unit in the sample to the following tests:

(a) each device shall be immersed in 30 inches of water for 24 hours and shall show no visible evidence of water entry. Absolute pressure of the air above the water shall then be reduced to one inch of mercury. Lowered pressure shall be maintained for one minute or until air bubbles cease to be given off by the water, whichever is the longer. Pressure shall then be increased to normal atmospheric pressure. Any device which leaks as evidenced by bubbles emanating from within the device, or water entering the device, shall be considered as a defective unit;

(b) the immersion test water from the preceding test in clause (a) of this subparagraph shall be measured for tritium or promethium-147 content by an apparatus that has been calibrated to measure tritium or promethium-147, as appropriate. If more than 0.1 percent of the original amount of tritium or promethium-147 in any device is found to have leaked into the immersion test water, the leaking device shall be considered as a defective unit; and

(c) the levels of radiation from each device containing promethium-147 shall be measured. Any device which has a radiation level in excess of 0.5 millirad per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber, shall be considered as a defective unit.

(iii) An application for a license, or for amendment of a license, may include a description of procedures proposed as alternatives to those prescribed by subparagraph (ii) of this paragraph, and proposed criteria for acceptance under those procedures. The department will approve the proposed alternative procedures if the applicant demonstrates that:

(a) they will consider defective any sampled device which has a leakage rate exceeding 0.1 percent of the original quantity of tritium or promethium-147 in any 24-hour period; and

(b) the operating characteristic curve or confidence interval estimate for the alternative procedures provides a "Lot Tolerance Percent Defective of 5.0 percent" at the consumer's risk of 0.10.

(iv) No person licensed under this subdivision shall transfer to persons generally licensed under section 38.41, Table 3, item (e) of this Part:

(a) any luminous safety device which has been tested and found defective under the criteria and procedures specified in this section, unless the defective units have been repaired or reworked and have then met the tests set out in subparagraph (ii) of this paragraph; or

(b) any inspection lot which has been rejected as a result of the procedures in subparagraph (ii) of this paragraph, or alternative procedures in subparagraph (iii) of this paragraph; unless the defective units have been sorted and removed or have been repaired or reworked and have then met the tests set out in subparagraph (ii) of this paragraph.

(5) Material transfer reports. Each person licensed under this subdivision shall file an annual report with the department which shall state the total quantity of tritium or promethium-147 transferred to persons generally licensed under section 38.41, Table 3, item (e) of this Part. The report shall identify each general licensee by name, state the kinds and numbers of luminous devices transferred, and specify the quantity of tritium or promethium-147 in each kind of device. Each report shall cover the year ending June 30th and shall be filed within 30 days thereafter.

(f)Requirements for a license to manufacture or initially transfer calibration or reference sources containing americium-241, plutonium or radium-226.

(1) An application for a specific license to manufacture or initially transfer calibration or reference sources containing americium-241, plutonium or radium-226, for distribution to persons generally licensed under section 38.41, Table 3, item (f) of this Part, will be approved if:

(i) the applicant satisfies the general requirements of section 38.8 of this Part;

(ii) the applicant submits sufficient information regarding each type of calibration or reference source pertinent to evaluation of the potential radiation exposure, including:

(a) chemical and physical form and maximum quantity of radioactive material in the source;

(b) details of construction and design;

(c) details of the method of incorporation and binding of the radioactive material in the source;

(d) procedures for, and results of, prototype testing of sources, which are designed to contain more than 0.005 microcurie of radioactive material, to demonstrate that the radioactive material contained in each source will not be released or be removed from the source under normal conditions of use;

(e) details of quality control procedures to be followed in manufacture of the source;

(f) a description of labeling to be affixed to the source or the storage container for the source; and

(g) any additional information, including experimental studies and tests, required by the dpartment to facilitate a determination of the safety of the source;

(iii) each source will contain no more than five microcuries of radioactive material;

(iv) the department determines, with respect to any type of source containing more than 0.005 microcurie of radioactive material, that:

(a) the method of incorporation and binding of the radioactive material in the source is such that the radioactive material will not be released or be removed from the source under normal conditions of use and handling of the source; and

(b) the source has been subjected to and has satisfactorily passed prototype tests. The following prototype tests shall be conducted, in the order listed, on each of five prototypes of such source:

(1) Initial measurement. The quantity of radioactive material deposited on the source shall be measured by direct counting of the source.

(2) Dry wipe test. The entire radioactive surface of the source shall be wiped with filter paper with the application of moderate finger pressure. Removal of radioactive material from the source shall be determined by measuring the radioactivity on the filter paper or by direct measurement of the radioactivity on the source following the dry wipe.

(3) Wet wipe test. The entire radioactive surface of the source shall be wiped with filter paper, moistened with water, with the application of moderate finger pressure. Removal of radioactive material from the source shall be determined by measuring the radioactivity on the filter paper after it has dried or by direct measurement of the radioactivity on the source following the wet wipe.

(4) Water soak test. The source shall be immersed in water at room temperature for a period of 24 consecutive hours. The source shall then be removed from the water. Removal of radioactive material from the source shall be determined by direct measurement of the radioactivity on the source after it has dried or by measuring the radioactivity in the residue obtained by evaporation of the water in which the source was immersed.

(5) Dry wipe test. On completion of the preceding test in this section, the dry wipe test described in subclause (2) of this clause shall be repeated.

(6) Observations. Removal of more than 0.005 microcurie of radioactivity in any test prescribed by this clause shall be cause for rejection of the source design. Results of prototype tests submitted to the department shall be given in terms of radioactivity in microcuries and percent of removal from the total amount of radioactive material deposited on the source.

(2) Labeling of devices.

(i) Each person licensed under this subdivision shall affix to each source, or storage container for the source, a label which shall contain sufficient information relative to safe use and storage of the source and shall include the following statement, or a substantially similar statement which contains the information called for in the following statement:

The receipt, possession, use and transfer of this source, Model ___, Serial No. ___, are subject to a general license and the regulations of the USNRC or of a state with which the commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

Caution-Radioactive Material-this source contains ____.

Do not touch radioactive portion of this source

____________________

(Name of manufacturer or initial transferor)

(3) Leak testing of each source.

(i) Each person licensed under this subdivision shall perform a dry wipe test upon each source containing more than 0.1 microcurie of radioactive material prior to transferring the source to a general licensee under section 38.41, Table 3, item (f) of this Part. This test shall be performed by wiping the entire radioactive surface of the source with a filter paper with the application of moderate finger pressure. The radioactivity on the paper shall be measured by using radiation detecting instrumentation capable of detecting 0.005 microcurie of the contained radioactive material. If any such test discloses more than 0.005 microcurie of radioactive material, the source shall be deemed to be leaking or losing radioactive material and shall not be transferred to a general licensee.

(g)Manufacture and commercial distribution of radioactive material for certain in vitro clinical or laboratory testing under a general license.

An application for a specific license to manufacture or commercially distribute radioactive material for use under the general license of section 38.41, Table 3, item (h) of this Part will be approved if:

(1) the applicant satisfies the general requirements specified in section 38.8 of this Part;

(2) the radioactive material is to be prepared for distribution in prepackaged units of:

(i) iodine-125 in units not exceeding 10 microcuries each;

(ii) iodine-131 in units not exceeding 10 microcuries each;

(iii) carbon-14 in units not exceeding 10 microcuries each;

(iv) hydrogen-3 (tritium) in units not exceeding 50 microcuries each;

(v) iron-59 in units not exceeding 20 microcuries each;

(vi) cobalt-57 in units not exceeding 10 microcuries each;

(vii) selenium-75 in units not exceeding 10 microcuries each; or

(viii) mock iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each;

(3) each prepackaged unit bears a durable, clearly visible label:

(i) identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 10 microcuries of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 50 microcuries of hydrogen-3 (tritium); 20 microcuries of iron-59; or mock iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241; and

(ii) displaying the radiation caution symbol described in section 38.25(a) of this Part and the words, "Caution, Radioactive Material," and "Not for Internal or External Use in Humans or Animals;" and

(4) one of the following statements, as appropriate, or a substantially similar statement that contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure that accompanies the package:

(i) This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians, clinical laboratories, or hospitals, and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the USNRC or of a state with which the USNRC has entered into an agreement for the exercise of regulatory authority.

__________

Name of Manufacturer

-OR-

(ii) This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians, clinical laboratories, or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of a state.

__________

Name of Manufacturer

-AND-

(5) The label affixed to the unit, or the leaflet or brochure that accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of a mock iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements of section 38.20 of this Part.

(h)Ice detection devices containing strontium-90; requirements for a license to manufacture or initially transfer.

(1) An application for a specific license to manufacture or initially transfer ice detection devices containing strontium-90 for distribution to persons generally licensed under section 38.41, Table 3, item (c) of this Part will be approved if:

(i) the applicant satisfies the general requirements specified in section 38.8 of this Part;

(ii) the applicant submits sufficient information regarding each type of device pertinent to evaluation of the potential radiation exposure, including:

(a) the chemical and physical form and maximum quantity of strontium-90 in the device;

(b) details of construction and design of the source of radiation and its shielding;

(c) the radiation profile of a prototype device;

(d) procedures for and results of prototype testing of devices to demonstrate that the strontium-90 contained in each device will not be released or be removed from the device under the most severe conditions likely to be encountered in normal handling and use;

(e) details of quality control procedures to be followed in manufacture of the device;

(f) a description of labeling to be affixed to the device;

(g) instructions for handling and installation of the device; and

(h) any additional information, including experimental studies and tests, required by the department to facilitate a determination of the safety of the device;

(iii) each device will contain no more than 50 microcuries of strontium-90 in an insoluble form;

(iv) each device will bear durable, legible labeling which includes the radiation caution symbol prescribed by Section 38.25(a) of this Part, a statement that the device contains strontium-90 and the quantity thereof, instructions for disposal and statements that the device may be possessed pursuant to a general license, that the manufacturer or civil authorities should be notified if the device is found, that removal of the labeling is prohibited and that disassembly and repair of the device may be performed only by a person holding a specific license to manufacture or service such devices; and

(v) the department determines that:

(a) the method of incorporation and binding of the strontium-90 in the device is such that the strontium-90 will not be released from the device under the most severe conditions which are likely to be encountered in normal use and handling of the device;

(b) the strontium-90 is incorporated or enclosed so as to preclude direct physical contact by any individual with it and is shielded so that no individual will receive a radiation exposure to a major portion of his body in excess of 0.5 rem in a year under ordinary circumstance of use;

(c) the device is so designed that it cannot be easily disassembled;

(d) the device has been subjected to and has satisfactorily passed the prototype tests prescribed by section 32.103 schedule D of part 32 of the Code of Federal Regulations; January 1, 1995 edition¹; and

(e) quality control procedures have been established to satisfy the requirements of paragraph (2) of this subdivision.

(2) Quality assurance.

(i) Each person licensed under this subdivision shall visually inspect each device and shall reject any which has an observable physical defect that could affect containment of the strontium-90.

(ii) Each person licensed under this subdivision shall test each device for possible loss of strontium-90 or for contamination by wiping with filter paper an area of at least 100 square centimeters on the outside surface of the device, or by wiping the entire surface area if it is less than 100 square centimeters. The detection on the filter paper of more than 2,200 disintegrations per minute of radioactive material per 100 square centimeters of surface wiped shall be cause for rejection of the tested device.

(iii) Each person licensed under this subdivision shall take a random sample of the size required by the table for "Lot Tolerance Percent Defective of 5.0 percent" in subpart C of part 32 of the Code of Federal Regulations; January 1, 1995 edition¹, from each inspection lot, and shall subject each unit in the sample to the following tests:

(a) Each device shall be immersed in 30 inches of water for 24 hours and shall show no visible evidence of physical contact between the water and the strontium-90. Absolute pressure of the air above the water shall then be reduced to one inch of mercury. Lowered pressure shall be maintained for one minute or until air bubbles cease to be given off by the water, whichever is the longer. Pressure shall then be increased to normal atmospheric pressure. Any device which leaks, as evidenced by physical contact between the water and the strontium-90, shall be considered as a defective unit.

(b) The immersion test water from the preceding test in paragraph (c)(1) of this section shall be measured for radioactive material. If the amount of radioactive material in the immersion test water is greater than 0.1 percent of the original amount of strontium-90 in any device, the device shall be considered as a defective unit.

(iv) An application for a license or for amendment of a license may include a description of procedures proposed as alternatives to those prescribed by subparagraph (2)(iii) of this subdivision, and proposed criteria for acceptance under those procedures. The department will approve the proposed alternative procedures if the applicant demonstrates that:

(a) they will consider defective any sampled device which has a leakage rate exceeding 0.1 percent of the original quantity of strontium-90 in any 24-hour period; and

(b) the operating characteristic curve or confidence interval estimate for the alternative procedures provides a "Lot Tolerance Percent Defective of 5.0 percent" at the consumer's risk of 0.10.

(v) No person licensed under this subdivision shall transfer to persons generally licensed under section 38.41, Table 3, item (c) of this Part:

(a) any device which has been tested and found defective under the criteria and procedures specified in this subdivision unless the defective units have been repaired or reworked and then met the tests set out in subparagraph (2)(iii) of this subdivision; or

(b) any inspection lot which has been rejected as a result of the procedures in subpart C of part 32 of the Code of Federal Regulations; January 1, 1995 edition¹, or alternative procedures in subparagraph (iv) of this paragraph, unless the defective units have been sorted and removed, or have been repaired or reworked and have then met the tests set out in subparagraph (2)(iii) of this subdivision.

(i)Manufacture and distribution of sources or devices containing radioactive material for medical use.

(1) An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to part 35 of the Code of Federal Regulations or the equivalent regulations of any state, for use as a calibration or reference source or for medical diagnosis or therapy, will be approved if:

(i) the applicant satisfies the general requirements in section 38.8 of this Part;

(ii) the applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:

(a) the radioactive material contained, its chemical and physical form, and amount;

(b) details of design and construction of the source or device;

(c) procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents;

(d) the radiation profile of a prototype device;

(e) details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests;

(f) procedures and standards for calibrating sources and devices;

(g) legend and methods for labeling sources and devices as to their radioactive content; and

(h) instructions for handling and storing the source or device from the radiation safety standpoint; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device; provided that instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label; and

(iii) the label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity and date of assay, and a statement that the department has approved distribution of the (name of source or device) to persons licensed to use radioactive material identified in section 35.58, 35.400 or 35.500, as appropriate, of part 35 of the Code of Federal Regulations or the equivalent regulations of a state.

(2)

(i) In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than six months, he or she shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source.

(ii) In determining the acceptable interval for test of leakage of radioactive material, the department will consider information that includes, but is not limited to:

(a) primary containment (source capsule);

(b) protection of primary containment;

(c) the method of sealing containment;

(d) containment construction materials;

(e) the form of contained radioactive material;

(f) the maximum temperature withstood during prototype tests;

(g) the maximum pressure withstood during prototype tests;

(h) the maximum quantity of contained radioactive material;

(i) the radiotoxicity of contained radioactive material; and

(j) operating experience with identical sources or devices or similarly designed and constructed sources or devices.

(j)Manufacture, preparation or transfer for commercial distribution of drugs containing radioactive material for medical use under part 35 of the Code of Federal Regulations or the equivalent regulations of any state.

(1) An application for a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs containing radioactive material for use by persons authorized pursuant to part 35 of the Code of Federal Regulations or the equivalent regulations of any state will be approved if:

(i) the applicant satisfies the general requirements specified in section 38.8 of this Part;

(ii) the applicant submits evidence that the applicant is registered or licensed by the New York State Board of Pharmacy as a drug manufacturer or a pharmacy, as appropriate to their practice;

(iii) the applicant submits information on the radionuclide; the chemical and physical form; the maximum activity per vial, syringe, generator, or other container of the radioactive drug; and the shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radioactive drugs by medical use licensees; and

(iv) the applicant satisfies the following labeling requirements:

(a) a label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "Caution, Radioactive Material" or "Danger, Radioactive Material;" the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. For radioactive drugs with a half-life greater than 100 days, the time may be omitted; and

(b) a label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "Caution, Radioactive Material" or "Danger, Radioactive Material" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.

(2) A licensee shall possess and use instrumentation to measure the radioactivity of radioactive drugs. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta-, or photon-emitting radioactive drugs prior to transfer for commercial distribution. In addition, the licensee shall:

(i) perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary;

(ii) check each instrument for constancy and proper operation at the beginning of each day of use; and

(iii) use differing activity concentrations in preparing different radiopharmaceuticals, and ensure that any discrepancy between the calculated volume of a dosage and the volume found to be required by measurement to achieve the prescribed activity, is resolved before the dosage is dispensed. Records of actions taken to resolve any such discrepancy shall be maintained for three years.

(3) A licensee shall possess and use instrumentation for performing surveys and analyses for radioactive contamination, and for making such measurements of radiation levels and radiation dose as may be necessary to demonstrate compliance with all requirements of this Part. In addition, the licensee shall:

(i) provide appropriate instrumentation for each application. This must include but is not limited to: a microrem meter for surveying non-radioactive trash before disposal, and for surveying workers' skin and clothing for contamination; a thyroid uptake system with a reproducible geometry and an adequate lower limit of detection; and analytical instruments for identifying and quantifying radioactive contamination; and

(ii) calibrate all instruments in accordance with the manufacturer's specifications, and calibrate all meters at least every 12 months.

(4)

(i) A licensee shall provide a radiation safety officer who is a health physicist with qualifications listed in subparagraph (iii) of this paragraph.

(ii) A licensee shall only allow persons who are certified by the New York State Board of Pharmacy as nuclear pharmacists to act as pharmacists in a facility licensed pursuant to this subdivision. A licensee may also propose such a certified nuclear pharmacist as radiation safety officer provided that the nuclear pharmacist will be assisted in the administration of the radiation protection program by a health physicist with the qualifications listed in subparagraph (iii) of this paragraph, and who will be present at the licensee's facility for the equivalent of one working day per month at a minimum, and who will provide the following services:

(a) provide classroom instruction to non-professional personnel who will perform work under the license;

(b) review personnel monitoring reports and recommend methods to reduce exposures exceeding ALARA levels;

(c) review survey records and make confirmatory measurements;

(d) review air monitoring and emission levels and ensure compliance with limits;

(e) assist in thyroid bioassays and review absorbed dose calculations;

(f) observe operations and make recommendations for improvements;

(g) assist in response to, and in the evaluation of root causes and impacts of, incidents and accidents in order to minimize their impact and prevent their recurrence; and

(h) generally consult with the RSO and provide health physics support as needed. The services to be provided must be documented in a contractual agreement between the licensee and the health physicist, and the department must be given a minimum of 30 days advance notice of the licensee's intent to retain a different health physicist.

(iii) A health physicist who will act as radiation safety officer, or who will provide the services described in subparagraph (ii) of this paragraph, must have the following qualifications:

(a) experience in performing radiation protection services, or the duties of a radiation safety officer for programs of similar type, size and scope as the licensee's program; and

(b) a Bachelor's degree in health physics or radiological health and four years of the experience as described in clause (a) of this subparagraph; or certification by the American Board of Health Physics (Comprehensive), the American Board of Radiology in Medical Nuclear Physics, the American Board of Science in Nuclear Medicine in Radiation Protection or the American Board of Medical Physics in Medical Health Physics, and two years of the experience as described in clause (a) of this subparagraph.

(5)

(i) A licensee shall only locate a nuclear pharmacy in a building that is zoned for commercial use, and which is not in a heavy public traffic area such as a large shopping center.

(ii) A licensee who proposes to locate within a multi-tenant building must demonstrate that:

(a) there are no areas above or below the proposed facility which are not under the licensee's control, and to which the licensee does not have the authority to restrict access; and

(b) there are no neighboring tenants on the same level with walls contiguous to the proposed radioactive materials use and storage areas. There must be a buffer zone of unrestricted area within the licensee's proposed facility along any walls that are common walls with a neighboring tenant.

Footnotes

* Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the United States Nuclear Regulatory Commission, Washington, D.C. 20555.

* It is the intent of this subparagraph that as the magnitude of the potential dose increases above that permitted under normal conditions, the probability that any individual will receive such a dose must decrease. The probabilities have been expressed in general terms to emphasize the approximate nature of the estimates which are to be made. The following values may be used as guides in estimating compliance with the criteria: Low - not more than one such failure per year for each 10,000 exempt units distributed. Negligible -not more than one such failure per year for each one million exempt units distributed.

* The model, serial number, and name of manufacturer or distributor may be omitted from this label provided they are elsewhere stated in labeling affixed to the device.

1 The documents referenced in this Part are available for review and copying at the Department of Labor, State Campus, Bldg. 12, Rm. 509, Albany, NY or the Department of State, 41 State St., Albany, NY.

* The model, serial number, and name of manufacturer, assembler, or initial transferor may be omitted from this label provided they are elsewhere specified in labeling affixed to the device.

N.Y. Comp. Codes R. & Regs. Tit. 12 § 38.35