DHS 157.80 (1) (f) 5. and 6.: The department proposes to require that facilities using newer generation computed tomography(CT) systems ensure that two-way verbal communication exists between the patient and the operator of the device, and that a method be provided to permit continuous observation of the patient during irradiation. Although CT scans can produce a very detailed image of the body from multiple x-ray images or ‘slices,’ radiation exposure to the patient can be very high. These devices are used primarily in large medical facilities. The department anticipates no additional fiscal impact on facilities using these devices since the proposed requirements are consistent with CRCPD suggested state regulations and similar requirements that already exist in s. DHS 157.81. DHS 157.80 (2) (a) 1.: This provision refers to the existing requirement in ch. 462, Stats., that individuals operating x-ray equipment for diagnostic medical purposes have a current radiography license or limited x-ray machine permit issued by the Department of Safety and Professional Services. The department anticipates no additional fiscal impact on facilities using these devices. DHS 157.85 (14) (gn): Electronic brachytherapy is a new technology that uses small x-ray devices to treat cancer within the body. The devices are capable of producing very high levels of radiation. These devices tend to be used primarily in large medical facilities and not small businesses. Based on input from the advisory committee, the department proposes quality control requirements for these devices to ensure safe operation. The department anticipates no additional fiscal impact on facilities using these devices.
Effect on small business
Based on the foregoing analysis, the proposed rules are anticipated to have little to no economic impact on small businesses.
Agency contact person
Paul Schmidt, Chief
Radiation Protection Section
P.O. Box 2659
Madison, WI 53701-2659
Statement on quality of agency data
The department utilized the input of an advisory committee representing entities affected by the proposed rules, a rule template called the “Suggested State Regulations for the Control of Radiation” (SSRCR) developed by the CRCPD, and applicable federal regulations. Please refer to the ‘Summary of Factual Data and Analytical Methodologies’ above for more detail.
Place where comments are to be submitted and deadline for submission
Comments may be submitted to the agency contact person that is listed above until the deadline given in the upcoming notice of public hearing. The deadline for submitting comments and the notice of public hearing will be posted on the Wisconsin Administrative Rules Website at http://adminrules.wisconsin.gov after the hearing is scheduled. RULE TEXT
SECTION 1. DHS 157.01 (16) is created to read:
DHS 157.01 (16) Subchapter XV establishes requirements for the physical protection program for any licensee that possesses a category 1 or category 2 quantity of radioactive material listed in Appendix U.
SECTION 2. DHS 157.03 (6m), (12m) and (Note), (25m), (36m), (56g) and (Note), (56r) and (Note), and (77m) are created to read:
DHS 157.03 (6m) “Access control” means a system for allowing only approved individuals to have unescorted access to the security zone and for ensuring that all other individuals are subject to escorted access.
DHS 157.03 (12m) "Aggregated" means accessible by the breach of a single physical barrier that would allow access to radioactive material in any form, including any devices that contain the radioactive material.
Note: An aggregated total activity equal or exceeding a category 2 to quantity of radioactive material exceeds the thresholds set forth in Appendix U.
DHS 157.03 (25m) "Approved individual" means an individual whom the licensee has determined to be trustworthy and reliable for unescorted access under ss. DHS 157.100 to157.106 and who has completed the training required by s. DHS 157.108 (3). DHS 157.03 (36m) "Background investigation" means the investigation conducted by a licensee or applicant for a license to support the determination of trustworthiness and reliability.
DHS 157.03 (56g) "Category 1 quantity of radioactive material" means a quantity of radioactive material meeting or exceeding the category 1 threshold in Appendix U of this chapter.
Note: This is determined by calculating the ratio of the total activity of each radionuclide to the category 1 threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds 1, the quantity would be considered a category 1 quantity. Category 1 quantities of radioactive material do not include the radioactive material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet.Appendix U is used to determine the category 1 threshold for a category 1 quantity of radioactive material. The category 1 and category 2 thresholds in Appendix U and Appendix T are not interchangeable.
DHS 157.03 (56r) "Category 2 quantity of radioactive material" means a quantity of radioactive material meeting or exceeding the category 2 threshold, but less than the category 1 threshold in Appendix U of this chapter.
Note: This is determined by calculating the ratio of the total activity of each radionuclide to the category 2 threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds 1, the quantity would be considered a category 2 quantity. Category 2 quantities of radioactive material do not include the radioactive material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet.Appendix U is used to determine the category 2 threshold for a category 2 quantity of radioactive material. The category 1 and category 2 thresholds in Appendix U and Appendix T are not interchangeable.
DHS 157.03 (77m) “Contamination” means the presence of a radioactive substance on a surface in quantities in excess of 0.4 Bq/cm2 (1x10-5 microCi/cm2) for beta and gamma emitters and low toxicity alpha emitters, or 0.04 Bq/cm2 (1x10-6 microCi/cm2) for all other alpha emitters.
SECTION 3. DHS 157.03 (84m) and (Note) is repealed and recreated to read:
DHS 157.03 (84m) "Criticality safety index" or "CSI" means the dimensionless number, rounded up to the next tenth, assigned to and placed on the label of a fissile material package to designate the degree of control of accumulation of packages, overpacks, or freight containers containing fissile material during transportation.
Note: Determination of the criticality safety index is described in s. DHS 157.93 (7) and (8). s. DHS 157.93 (7) and (8), and 10 CFR 71.59. The CSI for an overpack, freight container, consignment or conveyance containing fissile material packages is the arithmetic sum of the criticality safety indices of all the fissile material packages contained within the overpack freight container, consignment, or conveyance. SECTION 4. DHS 157.03 (108m), (109m), (124g), (139m), (143g), (150g), (166m), (189m) and (Note), and (193m) are created to read:
DHS 157.03 (108m) "Diversion" means the unauthorized movement of category 1 or category 2 quantity of radioactive material that is subject to subch. XV to a location different from the material’s authorized destination inside or outside of the site at which the material is used or stored.
DHS 157.03 (109m) “Dose length product” or “DLP” means the metric which is related to the total energy imparted in the patient, and is determined by multiplying the CTDIvol value by the scan length, resulting in the units of mGy-cm. DLP is calculated using the following formula:
where:
L = the length of patient scanned.
p = is the pitch.
CTDI100,cent = CTDI100 value determined at the center of a standardized phantom.
CTDI100,periphery = CTDI100 value determined at the periphery of a standardized phantom.
DHS 157.03 (124g) "Escorted access" means the continuous direct visual surveillance by an approved individual over an individual in the security zone who is not approved for unescorted access.
DHS 157.03 (139m) "Fingerprint order" means an order issued by the NRC, a license condition by the department, or a legally binding requirement issued by another agreement state that requires a fingerprints and criminal history records check for individuals who have unescorted access to category 1 and category 2 quantities of radioactive material or safeguards information-modified handling.
DHS 157.03 (143g) “Fixed contamination” means contamination that cannot be removed from a surface during normal conditions of transport.
DHS 157.03 (150g) "Government agency" means any executive department, commission, independent establishment, corporation, wholly or partly owned by the United States of America which is an instrumentality of the United States, or any board, bureau, division, service, office, officer, authority, administration, or other establishment in the executive branch of the Government.
DHS 157.03 (166m) “Indian Tribe” means an Indian or Alaska native tribe, band, nation, pueblo, village, or community that the Secretary of the Interior acknowledges to exist as an Indian tribe pursuant to the Federally Recognized Indian Tribe List Act of 1994, 25 U.S.C. 479a. DHS 157.03 (189m) “License verification system” means the national verification system that enables authorized government authorities and authorized licensees to verify certain information about licensees authorized to possess, use, or ship radioactive materials.
Note: The system may be used to confirm that a license is valid and accurate, a licensee is authorized to acquire quantities and types of radioactive materials, and the licensee’s category 1 or 2 quantities of radioactive material inventories do not exceed the possession limits of the license.
DHS 157.03 (193m) "Local law enforcement agency” or “LLEA" means a public or private organization that has been approved by a federal, state, or local government to carry firearms and make arrests, and is authorized and has the capability to provide an armed response in the jurisdiction where the licensed category 1 or category 2 quantity of radioactive material is used, stored, or transported
SECTION 5. DHS 157.03 (198) is repealed and recreated to read:
