reglab/statecodes huggingface dataset:
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-178c - General license to install devices generally licensed in K.A.R. 28-35-178b

Current through Register Vol. 43, No. 28, July 11,
			 2024
Any person who holds a specific license issued by the U.S.
				nuclear regulatory commission or an agreement state authorizing the holder to
				manufacture, install, or service a device described in
				K.A.R.
				28-35-178b is hereby granted a general
				license to install and service such a device in this state, if:
(a) The device has been manufactured,
			 labeled, installed and serviced in accordance with the provisions of the
			 specific licenses issued in regard to manufacturing, labeling, installing and
			 servicing the device; and
(b) Such
			 person assures that all labels required to be affixed to the device are in
			 place.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-178d - Luminous safety devices for use in aircraft

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) A general
			 license is hereby issued to acquire, possess, and use tritium or promethium-147
			 contained in luminous safety devices for use in aircraft if:
(1) the device contains not more than 10
			 curies of tritium or 300 millicuries of promethium-147; and
(2) the device has been manufactured,
			 assembled or imported in accordance with a specific license, issued under the
			 provisions of section 32.53 of the regulations of the United States nuclear
			 regulatory commission or manufactured or assembled in accordance with a
			 specific license issued by an agreement state, which authorizes manufacture or
			 assembly of the device for distribution to persons generally licensed by the
			 agreement state.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-178e - Americium-241 or radium-226 in the form of calibration or reference sources

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) A general
			 license to acquire, possess, use and transfer, in accordance with the
			 provisions of subsections (b) and (c), americium-241 or radium-226 in the form
			 of calibration or reference sources is hereby issued to any person who holds a
			 specific license issued by the nuclear regulatory commission that authorizes
			 the agency to acquire, possess, use, and transfer by-product material, source
			 material, or special nuclear material.
(b) The general license issued in subsection
			 (a) shall apply only to calibration or reference sources that have been
			 manufactured or initially transferred in accordance with the specifications
			 contained in a specific license issued by the secretary, the nuclear regulatory
			 commission, or an agreement state.
(c) The general license issued in subsection
			 (a) shall be subject to the provisions of K.A.R. 28-35-184a, and to all of the
			 provisions of parts 4 and 10 of these regulations. In addition, persons who
			 acquire, possess, use, and transfer one or more calibration or reference
			 sources pursuant to this general license shall meet the following requirements:
(1) Not possess, at any one time, at any one
			 location of storage or use, more than 5 microcuries of either ameri-cium-241 or
			 radium-226 in such sources;
(2) not
			 receive, possess, use, or transfer such a source unless the source, or the
			 storage container, bears a label that includes the following statement or a
			 substantially similar statement that 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 United States Nuclear Regulatory Commission 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 AMERICIUM-241
				(or RADIUM-226). DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
_________________________________
(Name of manufacturer or initial transferor)";
(3) not transfer, abandon, or dispose of such
			 source except by transfer to a person authorized by a license issued by the
			 secretary, the nuclear regulatory commission, or an agreement state to receive
			 the source;
(4) store such source,
			 except when the source is being used, in a closed container designed and
			 constructed to contain either americium-241 or radium-226 that might otherwise
			 escape during storage; and
(5) not
			 use the source for any purpose other than the calibration of radiation
			 detectors or the standardization of other sources.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-178f - General license to own radioactive material

Current through Register Vol. 43, No. 28, July 11,
			 2024
A general license is hereby issued to own radioactive material
				without regard to quantity. However, a general licensee under this regulation
				is not authorized to manufacture, produce, transfer, receive, possess, use,
				import or export radioactive material, except as authorized in a specific
				license.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-178g - General license for strontium-90 in ice detection devices

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) A general
			 license is hereby issued to own, acquire, possess, use and transfer
			 strontium-90 contained in ice detection devices if each device contains not
			 more than 50 microcuries of strontium-90 and if each device is manufactured or
			 initially transferred in accordance with the specifications contained in a
			 license issued to the manufacturer by the secretary, the U.S. nuclear
			 regulatory commission or an agreement state.
(b) Persons who own, acquire, possess, use,
			 or transfer strontium-90 contained in ice detection devices pursuant to the
			 general license issued in subsection (a) of this section:
(1) Shall, if visually observable damage to
			 the device occurs, including a bend or crack or discoloration from overheating,
			 discontinue use of the device until it has been inspected, tested for leakage
			 and repaired by a person holding a specific license issued by the secretary,
			 the U.S. nuclear regulatory commission or an agreement state to manufacture or
			 service the device, or shall dispose of the device pursuant to the provisions
			 of K.A.R. 28-35-223a;
(2) Shall
			 assure that all labels affixed to the device at the time of receipt, and which
			 bear a statement that prohibits removal of the labels, are maintained thereon;
(3) Shall be exempt from the
			 requirements of parts 4 and 10 of these regulations, except that such persons
			 shall comply with the provisions of K.A.R. 28-35-223a, 28-35-228a and
			 28-35-229a.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-178h - General license for use of by-product material for certain in vitro clinical or laboratory testing

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) A general
			 license is hereby issued to any physician, veterinarian in the practice of
			 veterinary medicine, clinical laboratory or hospital to acquire, possess, use
			 and transfer in accordance with the provisions of subsections (b), (c), (d),
			 (e), and (f) of this section, the following radioactive materials in
			 prepackaged units for use in any of the following stated tests:
(1) Iodine-125, in units not exceeding 10
			 microcuries each, for use in in vitro clinical or laboratory tests not
			 involving internal or external administration of radioactive material, or the
			 radiation therefrom, to human beings or animals.
(2) Iodine-131, in units not exceeding 10
			 microcuries each, for use in in vitro clinical or laboratory tests not
			 involving internal or external administration of radioactive material, or the
			 radiation therefrom, to human beings or animals.
(3) Carbon-14, in units not exceeding 10
			 microcuries each, for use in in vitro clinical or laboratory tests not
			 involving internal or external administration of radioactive material, or the
			 radiation therefrom, to human beings or animals.
(4) Hydrogen-3 (tritium), in units not
			 exceeding 50 microcuries each, for use in in vitro clinical or laboratory tests
			 not involving internal or external administration of radioactive material, or
			 the radiation therefrom, to human beings or animals.
(5) Iron-59, in units not exceeding 20
			 microcuries each, for use in in vitro clinical or laboratory tests not
			 involving internal or external administration of radioactive material, or the
			 radiation therefrom, to human beings or animals.
(6) Selenium-75, in units not exceeding 10
			 microcuries each, for use in in vitro clinical or laboratory tests not
			 involving internal or external administration of radioactive material, or the
			 radiation therefrom, to human beings or animals.
(7) Mock Iodine-125 reference or calibration
			 sources, in units not exceeding 0.05 microcuries of Iodine-129 and 0.005
			 microcurie of americium-241 each, for use in in vitro clinical or laboratory
			 tests not involving internal or external administration of radioactive
			 material, or the radiation therefrom, to human beings or animals.
(8) Cobalt-57, in units not exceeding 10
			 microcuries each, for use in in vitro clinical or labratory tests not involving
			 internal or external administration of radioactive material or the radiation
			 therefrom, to human beings or animals.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-178i - General licenses for certain units of radium-226

Current
			 through Register Vol. 43, No. 28, July 11, 2024
(a) Subject to the limitations in subsections
			 (b), (c), and (d), a general license is hereby issued to any person to acquire,
			 possess, use, and transfer radium-226 contained in the following products if
			 manufactured before the effective date of this regulation:
(1) Antiquities originally intended for use
			 by the general public. For the purposes of this paragraph, antiquities" shall
			 mean products originally intended for use by the general public and distributed
			 in the late 19th and early 20th centuries, including radium emanator jars,
			 re-vigators, radium water jars, radon generators, refrigerator cards, radium
			 bath salts, and healing pads;
(2)
			 intact timepieces containing more than 0.037 megabecquerel (1 microcurie),
			 nonintact timepieces, and timepiece hands and dials no longer installed in
			 timepieces;
(3) luminous items
			 installed in air, marine, or land vehicles;
(4) all other luminous products not listed in
			 this subsection, if not more than 100 items are used or stored at the same
			 location at any one time; and
(5)
			 small radium sources containing not more than 0.037 megabecquerel (1
			 microcurie) of radium-226. For the purposes of this paragraph, small radium
			 sources" shall mean discrete survey instrument check sources; sources contained
			 in radiation-measuring instruments; sources used in educational demonstrations,
			 including cloud chambers and spinthariscopes; electron tubes; lightning rods;
			 ionization sources; static eliminators; and small radium sources designated by
			 the commission.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-178j - General license for use of radioactive material for certain in vivo clinical or laboratory testing

Current through Register Vol. 43,
			 No. 28, July 11, 2024
(a) Except as provided in subsections (b) and
			 (c), each person shall be exempt from the license requirements in part 3 and
			 part 6 of these regulations if the person receives, possesses, uses, transfers,
			 owns, or acquires any capsules containing 37 kBq (1 laCi) of carbon-14 urea,
			 allowing for nominal variation that may occur during the manufacturing process
			 for in vivo diagnostic use for humans.
(b) Before using the capsules specified in
			 subsection (a) for research involving human subjects, each person shall apply
			 and shall be considered for approval for a specific license. Each person shall
			 be required to have a specific license before engaging in the research
			 specified in this subsection.
(c)
			 Before manufacturing, preparing, processing, producing, packaging, repackaging,
			 or transferring the capsules specified in subsection (a) for commercial
			 distribution, each person shall apply and shall be considered for approval for
			 a specific license. Each person shall be required to have a specific license
			 before performing any of the actions specified in this subsection.
(d) Nothing in this regulation shall exempt
			 any person from applicable FDA requirements, other federal requirements, and
			 state requirements governing receipt, administration, and use of drugs.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-179a - Application for specific license; renewal or amendment

Current
			 through Register Vol. 43, No. 28, July 11, 2024
(a) Any person may file a written application
			 with the secretary for a specific license to acquire, possess, use, or transfer
			 radioactive material. Each person shall file a written application with the
			 secretary to renew or amend any specific license. Each application for a
			 specific license, or a renewal or an amendment of an existing license, shall be
			 submitted on the appropriate form furnished by the secretary. Each person
			 filing an application shall provide all the information requested on the
			 application form, and any additional relevant information requested by the
			 secretary.
(b) Each application
			 filed with the secretary shall be signed by the applicant or licensee, or by a
			 person authorized to act for or on behalf of the applicant or
			 licensee.
(c) Any application may
			 incorporate, by reference, information provided in applications, reports, or
			 other documents previously filed with the secretary. Each reference to
			 information previously filed with the secretary shall be clear and
			 specific.
(d) Any application for a
			 specific license may include a request for a license authorizing activity at
			 one or more installations or locations.
(e) Except as provided in subsections (f),
			 (g), and (h), each application for a specific license to use radioactive
			 material in the form of a sealed source or in a device that contains the sealed
			 source shall include either of the following:
(1) Identification of the sealed source or
			 device by manufacturer and model number as registered with the department,
			 nuclear regulatory commission (NRC), or an agreement state; or
(2) sufficient information about the design,
			 manufacture, prototype testing, quality control program, labeling, proposed
			 uses, and leak testing to provide reasonable assurance that the radiation
			 safety properties of the sealed source or device are adequate to protect health
			 and minimize danger to life and property. For a device, the application shall
			 also include sufficient information about installation, service and
			 maintenance, operating and safety instructions, and potential hazards, to
			 provide reasonable assurance that the radiation safety properties of the sealed
			 source or device are adequate to protect health and minimize danger to life and
			 property.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-180a - General requirements for the issuance of specific licenses

Current through Register Vol. 43, No. 28, July 11,
			 2024
Each application for a specific license shall be approved only
				if the application meets the requirements of these regulations.
(a) Each applicant shall be required to be
			 qualified by reason of training and experience to use the material in question
			 for the purpose requested, in accordance with these regulations, and in a
			 manner that will protect public health and safety and the
			 environment.
(b) The proposed
			 equipment, facilities, and procedures used by each applicant shall protect
			 public health and safety and the environment.
(c) A specific license shall be approved only
			 if the secretary determines that the license is protective of public health and
			 safety and the environment.
(d)
			 Each applicant shall meet the requirements in these regulations for the
			 particular license sought.
(e)
(1) Each application for a license for
			 commercial waste disposal, source material milling, or any other operation that
			 the secretary determines will affect the environment shall meet the requirement
			 specified in this paragraph. Each application shall include information that
			 permits the secretary to weigh the environmental, economic, technical, and
			 other benefits against the environmental costs and alternatives to ensure the
			 protection of public health and safety and the environment.
(2) The approval of each application
			 specified in paragraph (e)(1) shall be based upon the following:
(A) The information specified in paragraph
			 (e)(1) and other information as necessary; and
(B) the information required by
			 10 C.F.R.
			 51.45, as in effect on April 30,
			 1992.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-180b - Financial assurance for decommissioning

Current through
			 Register Vol. 43, No. 28, July 11, 2024
(a) Each applicant for a specific license
			 authorizing the possession and use of unsealed radioactive material with a
			 half-life greater than 120 days and in quantities exceeding
			 105 times the applicable quantities specified in
			 K.A.R.
			 28-35-201 shall submit a decommissioning
			 funding plan as described in subsection (e) of this regulation. Each applicant
			 shall also submit the decommissioning funding plan if a combination of isotopes
			 is involved and if R divided by 105 is greater than
			 one, where R is defined here as the sum of the ratios of the quantity of each
			 isotope to the applicable value specified in
			 K.A.R.
			 28-35-201.
(b) Each applicant for a specific license
			 authorizing the possession and use of radioactive material with a half-life
			 greater than 120 days and in quantities specified in table I shall submit
			 either of the following:
(1) A
			 decommissioning funding plan as described in subsection (e); or
(2) a certification that financial assurance
			 for decommissioning has been provided in the amount prescribed by table I,
			 using one of the methods described in subsection (f). The certification may
			 state that the appropriate assurance is to be obtained after the application
			 has been approved and the license has been issued, but before the receipt of
			 licensed material. If the applicant defers execution of the financial
			 instrument required under subsection (f) until after the license has been
			 issued, a signed original of the financial instrument shall be submitted to the
			 department before the applicant receives the licensed material. If the
			 applicant does not defer execution of the financial instrument required under
			 subsection (f), the applicant shall submit to the department, as part of the
			 certification, a signed original of the financial instrument.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-181a - Specific licenses for human use of radioactive material in medical institutions

Current through Register Vol. 43, No.
			 28, July 11, 2024
An application for a specific license for human use of
				radioactive material in institutions shall not be approved unless all of the
				following conditions are met:
(a) The
			 applicant has appointed a radiation safety committee as specified in
			 10 CFR
			 35.24(f), which is adopted
			 by reference in K.A.R. 28-35-264.
(b) The applicant possesses adequate
			 facilities for the clinical care of patients.
(c) The physician or physicians designated on
			 the application as the user or users have substantial experience in handling
			 and administering radioactive materials and, if applicable, clinical management
			 of radioactive patients.
(d) If the
			 application is for a license to use unspecified quantities or multiple types of
			 radioactive material, the applicant or applicant's staff has substantial
			 experience in the use of a variety of radioactive materials for a variety of
			 human uses.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-181b - Specific licenses to individual physicians for human use of radioactive material

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) A specific
			 license for the human use of radioactive materials outside of a medical
			 institution shall not be issued to an individual physician unless:
(1) The applicant has access to a hospital
			 and adequate facilities are available for the hospitalization and monitoring of
			 the applicant's radioactive patients when such action is advisable; and
(2) the applicant has extensive
			 experience in the proposed use, handling and administration of radioactive
			 material, and where applicable, clinical management of radioactive patients.
			 The physician shall furnish evidence of this experience with the application
			 for the specific license.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-181c - Specific license for human use of radioactive material in sealed sources

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) A specific
			 license for human use of radioactive materials in sealed sources shall not be
			 issued unless the applicant, or if the application is made by an institution,
			 each individual user of the radioactive material:
(1) Has specialized training in the
			 diagnostic or therapeutic use of the sealed source device or extensive
			 experience in the use of the device; and
(2) is a physician.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-181d - Specific licenses for one or more groups of medical uses

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) Any
			 institution, person, or group of persons meeting the requirements of K.A.R.
			 28-35-181a or 28-35-181b may file a written application with the secretary for
			 a specific license to use radioactive material for any group or groups of
			 medical uses. Each application shall meet the requirements of K.A.R. 28-35-179a
			 and shall designate the intended group or groups of uses for the radioactive
			 material.
(b) Each application for
			 a specific license to use radioactive material for any group or groups of
			 medical uses shall meet all of the following requirements:
(1) The applicant, or the physician or
			 physicians designated in the application as the individual user or users, has
			 adequate clinical experience in performing the medical use or uses for which
			 application is made.
(2) The
			 applicant's proposed radiation detection instrumentation is adequate for
			 conducting the medical procedures specified in the group or groups of uses for
			 which application is made.
(3) The
			 applicant's radiation safety operating procedures are adequate for the proper
			 handling and disposal of radioactive material involved in the group or groups
			 of uses for which application is made.
(4) The applicant, or the physician or
			 physicians designated in the application as the individual user or users, and
			 all other personnel who will be involved in the preparation and use of the
			 radioactive material have adequate training and experience in the handling of
			 radioactive material. The training and experience shall be appropriate for the
			 conduct of the uses included in the group or groups of uses for which
			 application is made.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-181f - Special licenses for the introduction of radioactive material into products in exempt concentrations

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) An application
			 for a specific license to introduce radioactive material into a product or
			 material and to transfer the product or material to any person who is exempt
			 from regulation under K.A.R. 28-35-192b(a) shall not be approved unless the
			 applicant submits with the application for the specific license:
(1) A description of the product or material
			 into which the radioactive material is to be introduced;
(2) an explanation of the intended use of the
			 radioactive material;
(3) the
			 method by which the radioactive material is to be introduced;
(4) the concentration of the radioactive
			 material to be introduced;
(5) the
			 control method or methods to be employed to assure that no more than the
			 specified concentration is introduced;
(6) the estimated time interval between
			 introduction of radioactive material into the product or material and the
			 transfer of the product or material;
(7) the estimated concentration of
			 radioactive material that will be present in the product or material at the
			 time of transfer; and
(8)
			 reasonable assurances that:
(A) the
			 concentrations of radioactive material at the time of transfer will not exceed
			 the limitations prescribed in K.A.R. 28-35-198a, Schedule C;
(B) reconcentration of the radioactive
			 material concentrations exceeding the limitations prescribed in K.A.R.
			 28-35-198a, Schedule C is not likely to occur;
(C) use of lower concentrations of
			 radioactive material is not practical or feasible; and
(D) 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.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-181g - Licensing for industrial radiography operations

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) Each
			 application for a specific license shall be considered for approval for the use
			 of licensed material for industrial radiography only if the application
			 contains the following:
(1) A description of
			 a program for training radiographers and radiographer's assistants that meets
			 the requirements of part 7 in these regulations;
(2) the procedures for verifying and
			 documenting the certification status of radiographers and for ensuring that the
			 certification of individuals acting as radiographers remains valid;
(3) the written operating and emergency
			 procedures as specified in part 7 in this article;
(4) a description of a program for
			 inspections of the job performance of each radiographer and radiographer's
			 assistant at intervals not to exceed six months;
(5) a program for inspection and maintenance
			 of radiographic exposure devices, equipment, and storage containers to ensure
			 proper functioning;
(6) a
			 description of the applicant's overall organizational structure as it applies
			 to the radiation safety responsibilities in industrial radiography, including
			 specified delegation of authority and responsibility;
(7) the qualifications of the individual
			 designated as the radiation safety officer;
(8) if the applicant intends to perform leak
			 testing of sealed sources or exposure devices containing depleted uranium (DU)
			 shielding, a description of the procedures for performing the test. The
			 description shall include the following:
(A)
			 The methods of collecting the samples;
(B) the qualifications of the individual who
			 analyzes the samples;
(C) the
			 instruments to be used; and
(D)
			 the methods of analyzing the samples;
(9) if the applicant intends to perform
			 calibrations of survey instruments and alarming ratemeters, a description of
			 the methods to be used and the experience of each person who will perform the
			 calibrations. All calibrations shall be performed according to the procedures
			 described and at the intervals specified in part 7 in these regulations;
(10) identification and
			 description of the location of each field station and permanent radiographic
			 installation;
(11) identification
			 of each location where all records required by this part and the other parts of
			 these regulations will be maintained; and
(12) if the applicant intends to perform
			 underwater radiography, a description of the following:
(A) Radiation safety procedures and
			 radiographer responsibilities unique to the performance of underwater
			 radiography;
(B) radiographic
			 equipment and radiation safety equipment unique to underwater radiography; and
(C) methods of gas-tight
			 encapsulation of equipment.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-181h - Specific licenses to manufacture and distribute the devices specified in K.A.R. 28-35-178b

Current through Register Vol. 43, No. 28,
			 July 11, 2024
An application for a specific license to manufacture and
				distribute one or more of the devices specified in
				K.A.R.
				28-35-178b shall not be approved unless the
				applicant meets the requirements of subsections (a) and (b) of this regulation
				in addition to meeting all of the additional applicable requirements specified
				in these regulations.
(a) Each
			 applicant shall submit information about 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 the following conditions are met:
(1) The device can be safely operated by
			 individuals not having training in radiological protection;
(2) 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 individual will receive a dose in excess of 10 percent of the
			 limits specified in
			 K.A.R.
			 28-35-212a; and
(3) under accident conditions, including fire
			 and explosion, associated with handling, storage, and use of the device, it is
			 unlikely that any individual will receive an external radiation dose or dose
			 commitment in excess of the following organ doses:
(A) Whole body; head and trunk; active blood-forming
						  organs; gonads; or lens of eye
15 rems
(B) Hands and forearms; feet and ankles; localized areas
						  of skin averaged over areas no larger than 1 square centimeter
200 rems
(C) Other organs
50 rems.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-181i - Special license to manufacture, distribute, assemble, or repair luminous safety devices for use in aircraft

Current through Register Vol. 43,
			 No. 28, July 11, 2024
Each applicant for a specific license to manufacture, assemble,
				or repair luminous safety devices containing tritium or promethium-147, for use
				in aircraft, and to distribute these devices to persons generally licensed
				under
				K.A.R.
				28-35-178d shall meet the requirements of
				10
				C.F.R. 32.53,
				32.54,
				32.55,
				and
				32.56,
				as in effect on December 2, 2015, which are hereby adopted by reference, except
				that wherever the term "commission" appears within the text of the federal
				regulations adopted by reference in this regulation, that term shall be
				replaced with the term "department."
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-181k - Specific licenses to manufacture and distribute ice detection devices

Current through Register Vol. 43, No. 28, July 11,
			 2024
Each applicant for a specific license to manufacture ice
				detection devices and to distribute those devices to persons generally licensed
				under
				K.A.R.
				28-35-178g shall meet the requirements of
				10
				C.F.R. 32.61 and
				32.62,
				as in effect on December 2, 2015, which are hereby adopted by reference, except
				that wherever the term "commission" appears within
				10
				C.F.R. 32.61, that term shall be replaced
				with the term "department."
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-181l - Specific licenses to manufacture and distribute industrial products and devices containing depleted uranium

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) An application
			 to manufacture industrial products and devices containing depleted uranium for
			 mass-volume applications and to distribute those products or devices to persons
			 generally licensed under K.A.R. 28-35-177a(c) shall not be approved unless all
			 of the following conditions, in addition to all of the applicable requirements
			 specified in these regulations, are met:
(1)
			 The applicant submits sufficient information relating to the design,
			 manufacture, prototype testing, quality control procedures, labeling or
			 marking, proposed uses, and potential hazards of the industrial product or
			 device to provide reasonable assurance that the possession, use, or transfer of
			 the depleted uranium in the product or device is not likely to cause any
			 individual to receive a radiation dose in excess of 10 percent of the limits
			 specified in K.A.R. 28-35-212a.
(2) The applicant submits sufficient
			 information regarding the industrial product or device and the presence of
			 depleted uranium for a mass-volume application in the product or device to
			 provide reasonable assurance that unique benefits will accrue to the public
			 because of the usefulness of the product or device.
(3) The secretary finds that the product or
			 device combines a high degree of utility with a low probability of uncontrolled
			 disposal or dispersal of significant quantities of depleted uranium into the
			 environment.
(4) The application
			 states clearly the use or uses for which the product or device is intended.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-181m - Specific licenses to manufacture, prepare, or distribute radiopharmaceuticals containing radioactive material for medical use

Current through
			 Register Vol. 43, No. 28, July 11, 2024
An application for a specific license to manufacture, prepare,
				or distribute radiopharmaceuticals containing radioactive material and used by
				persons as specified in part 6 of these regulations shall not be approved
				unless the applicant meets the requirements of this regulation and all other
				applicable requirements of these regulations.
(a) Each applicant shall meet the
			 requirements in K.A.R. 28-35-180a.
(b) Each applicant shall submit evidence of
			 either of the following:
(1) The
			 radiopharmaceutical containing radioactive material is subject to the federal
			 food, drug and cosmetic act or the public health service act and will be
			 manufactured, labeled, and packaged in accordance with a new drug application
			 (NDA) approved by the U.S. food and drug administration (FDA), a biologic
			 product license issued by the FDA, or a notice of claimed investigational
			 exemption for a new drug" (IND) accepted by the FDA.
(2) The manufacture and distribution of the
			 radiopharmaceutical containing radioactive material is not subject to the
			 federal food, drug, and cosmetic act or the public health service
			 act.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-181n - Specific licenses to manufacture and distribute generators or reagent kits for preparation of radiopharmaceuticals containing radioactive material

Current through Register Vol. 43, No. 28, July 11,
			 2024
Each application for a specific license to manufacture and
				distribute generators or reagent kits containing radioactive material for
				preparation of radiopharmaceuticals by persons licensed as specified in
				K.A.R.
				28-35-181d for the uses listed in group III,
				shall meet the requirements of subsections (a), (b), (c), and (d).
(a) Each applicant shall meet the general
			 requirements specified in K.A.R. 28-35-180a.
(b) Each applicant shall submit documentation
			 of one of the following:
(1) The generator or
			 reagent kit is subject to the federal food, drug and cosmetic act or the public
			 health service act and will be manufactured, labeled, and packaged in
			 accordance with a new drug application (NDA) approved by the food and drug
			 administration (FDA), a biologic product license issued by FDA, or a "notice of
			 claimed investigational exemption for a new drug" (IND) accepted by FDA.
(2) The manufacture and
			 distribution of the generator or reagent kit is not subject to the federal
			 food, drug, and cosmetic act and the public health service act.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-181o - Specific licenses to manufacture and distribute sources and devices for use as a calibration, transmission, or reference source or for certain medical uses

Current through Register Vol. 43, No. 28, July
			 11, 2024
(a) Each
			 application for a specific license to manufacture and distribute sources and
			 devices containing radioactive material to persons licensed as specified in
			 K.A.R.
			 28-35-181d for use as a calibration,
			 transmission, or reference source or for one or more of the uses listed in
			 10 C.F.R.
			 35.400,
			 35.500,
			 35.600,
			 and
			 35.1000,
			 as adopted by reference in
			 K.A.R.
			 28-35-264, shall include the following
			 information regarding each type of source or device:
(1) The radioactive material contained, its
			 chemical and physical form, and amount;
(2) details of design and construction of the
			 source or device;
(3) 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 in accidents;
(4) for
			 devices containing radioactive material, the radiation profile for a prototype
			 device;
(5) details of quality
			 control procedures to ensure that the production sources and devices meet the
			 standards of the design and prototype tests;
(6) procedures and standards for calibrating
			 sources and devices;
(7) legend and
			 methods for labeling sources and devices as to their radioactive
			 content;
(8) radiation safety
			 instructions for handling and storing the source or device. These instructions
			 shall be included on a durable label attached to the source or device. However,
			 instructions that are too lengthy for the label may be summarized on the label
			 and printed in detail on a brochure that is referenced on the label;
(9) the label that is to be affixed to the
			 source or device or to the permanent storage container for the source or
			 device. The label shall contain information on the radio-nuclide, quantity, and
			 date of assay, and a statement that the source or device is licensed by the
			 department for distribution to persons licensed under
			 K.A.R.
			 28-35-181d or under an equivalent license of
			 the nuclear regulatory commission (NrC) or an agreement state. Labeling for
			 sources that do not require long-term storage may be on a leaflet or brochure
			 that is to accompany the source; and
(10) documentation that the source or device
			 is listed on the nuclear regulatory commission's sealed source and device
			 registry.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-181p - Specific license to manufacture or distribute radioactive material for use by persons generally licensed under K.A.R. 28-35-178h

Current through Register Vol. 43, No. 28, July 11,
			 2024
An application for a specific license to manufacture or
				distribute, or to manufacture and distribute radioactive material for use by
				persons generally licensed under
				K.A.R.
				28-35-178h, shall not be approved unless the
				applicant meets the requirements of subsections (a),(b),(c), and (d) of this
				regulation.
(a) The radioactive
			 material shall be prepared for distribution in prepackaged units of:
(1) iodine-125 in units not exceeding 10
			 microcuries each;
(2) iodine-131
			 in units not exceeding 10 microcuries each;
(3) carbon-14 in units not exceeding 10
			 microcuries each;
(4) hydrogen-3
			 (tritium) in units not exceeding 50 microcuries each;
(5) iron-59 in units not exceeding 20
			 microcuries each;
(6) selenium-75
			 in units not exceeding 10 microcuries each;
(7) mock iodine-125 in units not exceeding
			 0.05 microcuries of iodine-129 and 0.005 microcuries of americum-241; or
(8) cobalt-57 in units not
			 exceeding 10 microcuries each.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-181q - Special licenses concerning gas and aerosol detectors containing radioactive material other than by-product, source or special nuclear material

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) An application
			 for a specific license to manufacture, process, produce or transfer gas and
			 aerosol detectors which contain radioactive material other than source,
			 by-product, or special nuclear material, and which are designed to protect life
			 or property from fires and airborne hazards, shall not be approved unless the
			 applicant submits the information required by the United States nuclear
			 regulatory commission under 10 CFR sections 32.26 and
			 32.27, as in effect on March 31,
			 1983, for similar devices containing by-product material.
(b) Each person issued a license under
			 subsection (a) of this regulation shall:
(1)
			 develop and carry out adequate control procedures in the manufacture of the
			 product to assure that each production lot meets quality control standards
			 approved by the department;
(2)
			 agree to label or mark each unit so that the manufacturer of the product and
			 the radioactive material in the product can be identified and provide other
			 information with each unit that may be required by the department, including
			 disposal instruction when appropriate; and
(3) agree to file an annual report with the
			 department, which shall include the following information on products imported
			 for sale or distribution or transferred to other persons for use under K.A.R.
			 28-35-192a or an equivalent regulation of the United States nuclear regulatory
			 commission or an agreement state:
(A) A
			 description or identification of the type of each product imported or
			 transferred;
(B) for each
			 radionuclide in each type of product, the total quantity of the radionuclide
			 imported or transferred; and
(C)
			 the number of units of each type of product imported or transferred during the
			 reporting period. If no imports or transfers of radioactive material have been
			 made during a reporting period, the report shall so indicate.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-181r - Special licenses to manufacture, process, import, distribute, or transfer certain radioactive material to persons exempt from regulation pursuant to K.A.R. 28-35-192a

Current through Register Vol. 43, No. 28,
			 July 11, 2024
(a) An
			 application for a specific license to manufacture, process, produce, import,
			 package, repackage, or transfer quantities of radioactive material other than
			 source, by-product, or special nuclear material for commercial distribution to
			 persons exempt from these regulations pursuant to K.A.R. 28-35-192a or an
			 equivalent regulation of the nuclear regulatory commission or an agreement
			 state shall not be approved unless the applicant submits the information
			 required in 10 C.F.R.
			 32.18 and
			 32.19, dated January 1, 2019,
			 which are hereby adopted by reference.
(b) Each device shall be registered in the
			 sealed source and device registry as defined in
			 10 C.F.R.
			 32.2 and maintained by the NRC.
(c) Each person licensed under subsection (a)
			 shall maintain records identifying, by name and address, each person to whom
			 the licensee transfers radioactive material and stating the kinds and
			 quantities of radioactive material transferred. An annual summary report
			 stating the total quantity of each isotope transferred shall be filed with the
			 department. Each report shall cover the 12-month period beginning on July 1 and
			 ending June 30 and shall be filed on or before July 31 of each year. If no
			 transfers of radioactive material have been made during a reporting period, the
			 report shall indicate this fact.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-181s - Specific licenses for well logging

Current through Register Vol. 43, No. 28, July 11,
			 2024
Each application for a specific license for the use of licensed
				material in well logging shall be considered for approval only if the
				application contains the following:
(a) A description of the training program for
			 logging supervisors and logging assistants that includes the following:
(1) The content of and method for initial
			 training;
(2) on-the-job training;
(3) annual safety reviews provided
			 by the licensee;
(4) the means
			 that the applicant will use to demonstrate the logging supervisor's knowledge
			 and understanding of and ability to comply with these regulations, the license
			 conditions, and the applicant's operating and emergency procedures; and
(5) the means that the applicant
			 will use to demonstrate the logging assistant's knowledge and understanding of
			 and ability to comply with the applicant's operating and emergency procedures;
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-181t - Requirements for license to initially transfer source material for use under the small quantities of source material general license

Current
			 through Register Vol. 43, No. 28, July 11, 2024
(a) Each person submitting an application for
			 a specific license to initially transfer source material for use in accordance
			 with
			 K.A.R.
			 28-35-177a, or equivalent regulations of an
			 agreement state or the nuclear regulatory commission (NRC), shall meet the
			 following requirements:
(1) Meet the general
			 requirements specified in
			 K.A.R.
			 28-35-190a; and
(2) provide information documenting that the
			 NRC approves the methods for quality control, labeling, and providing safety
			 instructions to recipients.