Volume 40 - Issue 46 - November 18, 2021
State of Kansas
Department of Health and Environment
Notice of Hearing on Proposed Administrative Regulations
The Kansas Department of Health and Environment, Division of Public Health, Bureau of Community Health Systems, will conduct a public hearing at 10:00 a.m. Wednesday, January 26, 2022, to receive public comment regarding the adoption of proposed amended regulations K.A.R. 28-35-135a, 28-35-135c, 28-35-135f, 28-35-135i, 28-35-135l, 28-35-135m, 28-35-135n, 28-35-135o, 28-35-135s, 28-35-135u, 28-35-178a, 28-35-178i, 28-35-181d, 28-35-181j, 28-35-181m, 28-35-181r, 28-35-192e, 28-35-192f, 28-35-192h, 28-35-195a, 28-35-196a, 28-35-227c, 28-35-231c, 28-35-264, 28-35-282a, 28-35-291, 28-35-450, 28-35-500, 28-35-504, 28-35-505, and 28-35-700; and the adoption of proposed new regulations K.A.R. 28-35-181u, 28-35-181v, 28-35-500a, and 28-35-504a, all regarding radiation control.
Due to recent public health concerns, only remote public participation is available. To participate in the teleconference hearing, call 1-866-620-7326 and enter conference code 8141969688*. During the teleconference public hearing, all interested individuals will be given a reasonable opportunity to present their comment orally on the proposed regulations. It is requested that each individual giving oral comment provide a written copy of the comment for the record prior to the hearing by email or postal mail to the email or postal mailing address listed in this notice or by fax to the fax number also listed in this notice. In order to give each individual an opportunity to present their comment, it may be necessary for the hearing officer to request that each presenter limit an oral presentation of comment to an appropriate time frame.
The time period between the publication of this notice and the scheduled hearing constitutes a 60-day public comment period for the purpose of receiving written public comment on the proposed regulations. Individuals are encouraged to participate in the public hearing by submitting written comment prior to 5:00 p.m. on the day of the hearing. Submit written comment, including a written copy of oral comment, to Kimberly Steves, Kansas Department of Health and Environment, Bureau of Community Health Systems, Radiation Control Program, Curtis State Office Bldg., 1000 SW Jackson, Suite 330, Topeka, KS 66612-1365, by email to Kim.Steves@ks.gov, or by fax to 785-559-4251.
A summary of the proposed regulations and estimated economic impact follows:
Summary of Regulations:
K.A.R. 28-35-135a. Definitions. Adds the defined terms “Aggregated,” and “Associate radiation safety officer,” and an updated address for “American national standards institute” and “ANSI.”
K.A.R. 28-35-135c. Definitions. Adds the defined terms “Certificate holder,” “Certificate of compliance,” “Certificate of registration,” “Contamination,” and “Criticality safety index.” Updates the term “Consortium.”
K.A.R. 28-35-135f. Definitions. Adds the defined term “fixed contamination.”
K.A.R. 28-35-135i. Definitions. Corrects the definition of “Indian tribe” and “tribe.”
K.A.R. 28-35-135l. Definitions. Adds the defined term “low specific activity material” and “LSA material.”
K.A.R. 28-35-135m. Definitions. Adds the defined term “Master materials license.”
K.A.R. 28-35-135n. Definitions. Removes the defined term “New equipment” and adds the defined term “Non-fixed contamination.”
K.A.R. 28-35-135o. Definitions. Adds the defined term “Ophthalmic physicist.”
K.A.R. 28-35-135s. Definitions. Adopts the most recent federal definition of “Special form radioactive material.”
K.A.R. 28-35-135u. Definitions. Adds the defined term “Uranium.”
K.A.R. 28-35-178a. General license; certain ionization devices. Creates a new category for devices or equipment authorized before federal changes to general licenses occurred on October 23, 2012.
K.A.R. 28-35-178i. General licenses for certain units of radium-226. Clarifies “Small radium sources” and the applicability of parts 4 and 10 of these regulations to general licensees.
K.A.R. 28-35-181d. Specific licenses for one or more groups of medical uses. Adjusts record retention to three years for rubidium and technetium generator testing. Mandates reports for discoveries of breakthrough.
K.A.R. 28-35-181j. Specific licenses to manufacture and distribute calibration sources containing americium-241 or radium-226. Increases the number of prototypes required for testing to five for compliance with federal regulations. Updates terminology for weathering test and dry wipe test.
K.A.R. 28-35-181m. Specific licenses to manufacture, prepare, or distribute radiopharmaceuticals containing radioactive material for medical use. Requires labeling for positron emission tomography (PET) pharmaceuticals to be equivalent to federal regulations. Adds alternate pathway to becoming an authorized nuclear pharmacist as per federal regulations.
K.A.R. 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. Adds a requirement per federal regulations that new sealed sources and devices must be registered in the sealed source and device registry allowing Kansas to enter sealed sources and devices in the national database from Kansas manufacturers.
K.A.R. 28-35-181u. Registration of sealed source information. New regulation that establishes the authority of the state of Kansas to administer a sealed source and device registry for the development of new sealed sources and devices in the state.
K.A.R. 28-35-181v. Inactivation of certificates of registration for sealed sources and devices. New regulation that establishes the authority of the state of Kansas to revoke or inactivate registration of sealed sources and devices.
K.A.R. 28-35-192e. Exemptions; gas and aerosol detectors containing radioactive material. Excludes K.A.R. 28-35-700 security requirements, if total amount of products exceeds security limits, from exemptions.
K.A.R. 28-35-192f. Exemptions; self-luminous products containing tritium, krypton-85 or promethium-147. Reworded exemptions to clarify and to be more consistent with federal regulations.
K.A.R. 28-35-192h. Certain industrial devices. Excludes K.A.R. 28-35-700 security requirements, if total amount of products exceeds security limits, from exemptions.
K.A.R. 28-35-195a. Intrastate transportation of radioactive materials. Adopts subpart H of 10 C.F.R. part 71 and some regulations therein regarding loading and storage of packages, shipping papers, placarding of a transporting vehicle, and incident reporting.
K.A.R. 28-35-196a. Preparation of radioactive material for transport. Requires the licensee to ascertain and record that required tests have been performed.
K.A.R. 28-35-227c. Records of radiation protection programs. Removes some audit information retention duration requirements.
K.A.R. 28-35-231c. Transfer for disposal; manifests. Updates references to federal requirements to latest date of amendment.
K.A.R. 28-35-264. General requirements. Updates the provisions of 10 C.F.R. part 35 to those effective January 14, 2019.
K.A.R. 28-35-282a. Inspection and maintenance of radiation machines, radiographic exposure devices, transport and storage containers, associated equipment, source chargers, and survey instruments. Requires replacement components for radiation-producing machines to meet the design specifications of the manufacturer.
K.A.R. 28-35-291. Performance requirements for radiography equipment. Updates terminology to refer to radiographic exposure devices consistently.
K.A.R. 28-35-450. General requirements. Updates suggested state regulations for therapeutic radiation machines from the Conference of Radiation Control Program Directors, Inc. to the latest revision dated March 2009.
K.A.R. 28-35-500. General license: NRC-approved packages. Specifies methods for registering packages with the Nuclear Regulatory Commission.
K.A.R. 28-35-500a. General license: use of foreign-approved package. New regulation that allows foreign-approved packages to be used in Kansas if the packages are validated by the U.S. Department of Transportation.
K.A.R. 28-35-504. Advance notification of shipment of certain types of licensed or registered material. Includes tribal reservations and tribal authorities in advance notifications of certain radioactive materials shipments. Updates terminology to meet federal requirements as of October 1, 2019.
K.A.R. 28-35-504a. Records. New regulation that expands record retention to three years after shipment of materials for any material not exempt under 10 C.F.R. 71.14. Specifies requirements for what must be recorded, particularly results of determinations required by 10 C.F.R. 71.85.
K.A.R. 28-35-505. Quality assurance requirements. Adopts 10 C.F.R. part 71 subpart H dated January 1, 2019 by reference, modified to follow Kansas regulation requirements.
K.A.R. 28-35-700. General requirements. Updates provisions of 10 C.F.R. part 37 to requirements dated January 1, 2019.
Cost to the agency: The proposed regulations will not result in increased implementation costs to the agency.
Cost to the public and regulated community: There is no expectation of increased costs or decreased revenues for cities, counties, or school districts. Most regulation changes do not include cost-incurring measures. One regulation requires an extended record retention, which is a minimal cost impacting four licensees.
Cost to other governmental agencies or units: There is no estimated cost to other governmental agencies or units.
A detailed economic impact is provided in the economic impact statement that is available from the KDHE contact person designated in this notice of hearing or at the Radiation Control Program website, as listed below.
Complete copies of the proposed regulations and the corresponding economic impact statement may be obtained from the Radiation Control Program website at http://www.kdheks.gov/radiation/radpubnotice.html or by contacting Kimberly Steves at the address above, email Kim.Steves@ks.gov, phone 785-296-1560, or fax 785-559-4251. Questions pertaining to the proposed regulations should be directed to Kimberly Steves at the contact information above.
Any individual with a disability may request accommodation in order to participate in the public hearing and may request the proposed regulations and the economic impact statement in an accessible format. Requests for accommodation to participate in the hearing should be made at least five working days in advance of the hearing by contacting Kimberly Steves.
Lee A. Norman, M.D.
Doc. No. 049571