Rule-Making Notices (Hearing Notices)

(200) “Low specific activity - III" or “LSA-III material" means solids, such as consolidated wastes or activated materials, excluding powders, that satisfy the requirements of 10 CFR 71.77, for which all of the following apply:

SECTION 4. DHS 150.03 (221m) is created to read:

DHS 150.03 (221m) “Nationally tracked source" means a sealed source containing a quantity equal to or greater than Category 1 or Category 2 levels of any radioactive material listed in Appendix T. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 1 threshold. Category 2 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 2 threshold but less than the Category 1 threshold.

SECTION 5. DHS 157.03 (222), (374) (a), (c) and (d), (382), (388), (402m), (407), and (413) are amended to read:

(222) “NARM" means any naturally occurring or accelerator-produced radioactive material. It does not include byproduct, source or special nuclear material.

(374) (a) For capacitor energy storage equipment, peak tube potential in kV kilovoltage and quantity of charge in mAsmillamperage-seconds (mAs).

(c) For CT x-ray systemsequipment designed for pulsed operation, peak tube potential in kV, scan time in seconds, and either tube current in mAmillamperes (mA), x-ray pulse width in milliseconds, and the number of x-ray pulses per scan; or the product of tube current, x-ray pulse width, and the number of x-ray pulses per scan expressed as mAs.

(d) For CT x-ray systemsequipment not designed for pulsed operation, peak tube potential in kV, and either tube current in mA and scan time in seconds, or the product of tube current and exposure time in mAs and the scan time when the scan time and exposure time are equivalent.

(382) “Therapeutic radiation machine" means x-ray, gamma ray or electron-producing equipment designed and used for external beam or internal radiation therapy.

(388) “Total effective dose equivalent" or “TEDE" means the sum of the deep effective dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.

(402m) “Unirradiated uranium" means uranium containing not more than 2 X 103 Bq of plutonium per gram of uranium-235, not more than 9 X 106 Bq of fission products per gram of uranium- 235, and not more than 5 X 10 -3 g of uranium-236 per gram of uranium-235.

(407) “Useful beam" means the radiation emanating from which passes through the tube housing port or the radiation head and passing through and the aperture of the beam-limiting device when the exposure controls are in a mode to cause the system to produce radiationswitch or timer is activated.

(413) “Waste" means those materials having a low level of radioactivity containing that are acceptable for disposal in a land disposal facility and are not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in 42 USC 2011low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in DHS 157.03 (50) (b) to (e).

SECTION 6. DHS 157.03 (430m) is created to read:

DHS 157.03 (430m)“X-ray control" means a device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices, which control the technique factors on an x-ray exposure.

SECTION 7. DHS 157.05 (5) title is created to read:

DHS 157.05 (5) PHYSICAL CONTROLS.

SECTION 8. DHS 157.09 (2) (a) 2., (c) 2. intro., 3., and (d) title are amended to read:

DHS 157.09 Exemptions. (2) EXEMPTIONS OF RADIOACTIVE MATERIAL OTHER THAN SOURCE MATERIAL. (a) 2. A manufacturer, processor or producer of a product or material is exempt from the requirements of subch. II if they transfer radioactive material contained in a product or material in concentrations not in excess of those in Appendix A and introduced into the product or material by a licensee holding a specific license issued by the department, the NRC or another agreement state expressly authorizing such introduction. This exemption does not apply to the transfer of radioactive material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.

(c) 2. Timepieces, hands or dials containing promethium-147 or radium-226, when measured through 50 milligrams per square centimeter of absorber, not exceeding the following radiation dose rate:

3. Timepieces containing up to 37 kBq (1.0 microcurie) of radium-226 per timepiece acquired prior to the effective date of August 1, 2002 the effective date of this section ….[legislative reference bureau inserts date].

(d) (title) Self-luminous products containing tritium, krypton-85, or promethium-147 or radium-226.

SECTION 9. DHS 157.09 (2) (d) 4. is repealed.

SECTION 10. DHS 157.09 (2) (f) and (g) 3. are amended to read:

DHS 157.09 (2) (f) Resins containing scandium-46 and designed for sand-consolidation in oil wells. A person is exempt from this subchapter to the extent that the person receives, possesses, uses, transfers, owns or acquires synthetic plastic resins containing scandium-46 which are designed for sand consolidation in oil wells. These resins shall have been manufactured or initially transferred for sale or distribution under a specific license issued by the NRC, or shall have been manufactured under the specifications contained in a specific license issued by the department or any agreement state to the manufacturer of the resins under licensing requirements equivalent to those in 10 CFR 32.16 and 32.17. This exemption does not authorize the manufacture or initial transfer for sale or distribution of any resins containing scandium-46.

(g) 3. Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license according to s. DHS 157.13 (4) (i)10 CFR 32.21.

SECTION 11. DHS 157.11 (2) (b) 3. b., c., g. and h. are amended to read:

DHS 157.11 (2) (b) 3. b. Ensure that the device is tested for leakage of radioactive material and proper operation of the “on-off" mechanism and indicator, if any, at no longer than 6-month intervals or at such other intervals as are specified in the label, except for devices containing only krypton, tritium, not more than 3.7 MBq (100 microcuries) of other beta and gamma-emitting material, or 0.37 MBq (10 microcuries) of alpha-emitting material, and devices held in storage in the original shipping container prior to the initial installation. Devices containing only krypton need not be tested for leakage of radioactive material.

c. Ensure that the tests required by this subd. par. b. and other testing, installation, servicing and removal from installation involving the radioactive material, its shielding or containment, are performed under the instructions provided by the labels, or by a person holding an applicable specific license from the department, the NRC, an agreement state or a licensing state to perform such activities.

g. Except as provided in subd. 3.h. pars. h. and j., transfer or dispose of the device containing radioactive material only by transfer to a specific licensee of the department, the NRC, an agreement state or a licensing state whose specific license authorizes that person to receive the device and within 30 calendar days after transfer of a device to a specific licensee or export of the device shall furnish to the department a written report containing identification of the device by manufacturer's or initial transferer's name and, model and serial number and, the name and , address and license number of the person receiving the device, and the date of the transfer. No report is required if the device is transferred to the specific licensee to obtain a replacement device.

h. Transfer the device to another general licensee only where the device is held in storage in the original shipping container at its intended location of use prior to initial use by a general licensee, or where the device remains in use at a particular location. In the latter case, the transferor shall give the transferee a copy of sub. (2) (b) and any safety documents identified in the label on the device and within 30 calendar days of the transfer. The licensee shall report to the department the manufacturer's name and, model and serial number of device transferred, the name and address of the transferee, and the name, phone number and position of an individual who may constitute a point of contact between the department and the transferee.

SECTION 12. DHS 157.11 (2) (b) 3. j. to m. are created to read:

DHS 157.11 (2) (b) 3. j. Not export the device containing byproduct material except as allowed under 10 CFR Part 110.

k. Respond to written requests from the department to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within the same time period, request in writing a longer time period and provide written justification why it cannot comply.

L. Appoint an individual responsible for having knowledge of the appropriate requirements of this chapter and the authority for taking required actions to comply with these requirements. The general licensee, through this individual, shall ensure the day-to-day compliance with the appropriate requirements of this chapter. This appointment does not relieve the general licensee of any of its responsibility under this chapter.

m. May not hold devices that are not in use for longer than 2 years. If devices with shutters are not being used, the shutter shall be locked in the closed position. The testing required under this subd. par. b. need not be performed during the period of storage only. When devices are put back into service or transferred to another person, and have not been tested within the required time interval, they shall be tested for leakage before use or transfer and the shutter tested before use. Devices kept in standby for future use are excluded from the two-year time limit if the general licensee performs quarterly physical inventories of these devices while they are in standby.

SECTION 13. DHS 157.11 (2) (b) 4. is amended to read:

DHS 157.11 (2) (b) 4. The general license under this paragraph does not authorize the manufacture or import of devices containing radioactive material.

SECTION 14. DHS 157.11 (2) (h) is created to read:

DHS 157.11 (2) (h) General license relating to certain items and self-luminous products containing radium-226. 1. A general license is issued to own, receive, acquire, possess, use or transfer radium-226 contained in the following products:

a. Antiquities originally intended for use by the general public that were manufactured in the 19th and 20 th centuries, such as radium emanator jars, revigators, radium water jars, radon generators, refrigerator cards, radium bath salts and healing pads.

b. Intact timepieces containing greater than 37 kBq (1 microcurie) of radium-226, nonintact timepieces, and timepiece dials and hands no longer installed in timepieces.

c. Self-luminous items installed in air, marine or land vehicles.

d. All other luminous products, provided that no more than 100 items are used or stored at the same location at any one time.

e. Small radium sources, such as discrete survey instrument check sources, sources contained in radiation measuring instruments, sources used in educational demonstrations, electron tubes, lightning rods, ionization sources or static eliminators, containing no more than 37 kBq (1 microcurie) of radium 226.

2. The general license in this paragraph is exempt from the requirements of subchs. III and X with the exception of ss. DHS 157.30 (1), 157.32 (1) and (2). This exemption does not apply to any person specifically licensed under this chapter.

3. A person who owns, receives, acquires, acquires, possesses,uses or transfers radium-226 under the general license in subd. 1. shall do all the following:

a. Report to the department under DHS 157.32 any stolen, lost or missing radioactive material.

b. Not abandon the product containing radium-226. The product, and any radioactive material from the product, shall be disposed of according to the requirements of DHS 157.30 (8), by transfer to a person authorized under a specific license to receive the radium-226, or as approved by the department.

c. Not export products containing radium-226 except under 10 CFR 110.

d. Respond to written requests from the department to provide information relating to the general license within 30 calendar days of the date of the request,or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within the same time period, request in writing a longer time period and provide written justification why it cannot comply.

4. The general license in subd. 1. does not authorize the manufacture, assembly, disassembly, repair, or import of products containing radium-226, except that timepieces may be disassembled and repaired.

SECTION 15. DHS 157.12 (1) is renumbered DHS 157.12 (1) (a) and as renumbered is amended to read:

DHS 157.12 (1) REGISTRATION REQUIREMENT. (a) No person may possess, receive, use, own or transfer a device purchased under a general license that contains at least 370 MBq (10 millicuries) of cesium-137, 3.7 MBq (0.1 millicurie) of strontium-90, 37 MBq (1 millicurie) of cobalt-60, 3.7 MBq (0.1 millicurie) of radium-226 or 37 MBq (1 millicurie) of americium- 241 or any other transuranic unless that person registers annually with the department and pays a fee as prescribed in sub.(6). Each address for a location of use as described in sub. (3) (d) represents a separate general licensee and requires a separate registration.

SECTION 16. DHS 157.12 (1) (b) is created to read:

DHS 157.12 (1) (b) A person in possession of devices that meet the criteria for registration under par. (a) shall notify the department of bankruptcy as specified in s. DHS 157.13 (10) (e) and (f).

SECTION 17. DHS 157.13 (1) (j) is created to read:

DHS 157.13 (1) (j) 1. A request for authorization for the production of PET radionuclides or evidence of an existing license issued by the department, NRC or an agreement state under this chapter or equivalent regulations for a PET radionuclide production facility within its consortium from which it receives PET radionuclides.

2. Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in s. DHS 157.13 (4) (i).

3. Identification of individual(s) authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear pharmacist as specified in s. DHS 157.68.

4. Information identified in s. DHS 157.13 (4) (i) 3. on the PET drugs to be noncommercially transferred to members of a consortium.

SECTION 18. DHS 157.13 (4) (g) 2. b., d. and e., and (i) (title), (intro.) and 2. a. are amended to read:

DHS 157.13 (4) (g) 2. b. Cobalt-57 in units not exceeding 370 MBqkBq (10 microcuries) each.

d. Iodine-125 in units not exceeding 370 MBqkBq (10 microcuries) each.

e. Mock Iodine-125 in units not exceeding 1.85 MBq kBq (0.05 microcurie) of iodine-129 and 185 MBqBq (0.005 microcurie) of americium-241 each.

(i) Manufacture, preparation, or transfer for commercial distribution or noncommercial transfer to medical use licensees in a consortium of radioactive drugs containing radioactive material for medical use under subchapter VI. The department shall approve an application for a specific license to manufacture, prepare, or transfer for commercial distribution or noncommercial transfer to medical use licensees in a consortium drugs containing radioactive material for use by a person authorized under subchapter VI if all the following conditions are satisfied:

2. a. Registered or licensed with the FDA as a drug manufacturerthe owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding or processing of a drug under 21 CFR 207.20 (a).

SECTION 19. DHS 157.13 (4) (i) 2. e. is created to read:

DHS 157.13 (4) (i) 2. e. Registered with a state agency as a positron emission tomography (PET) drug production facility.

SECTION 20. DHS 157.13 (4) (i) 4. a. and b. and 6. a. are amended to read:

DHS 157.13 (4) (i) 4. a. A label is affixed to each transport radiation shield, whether the shield is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution or noncommercial transfer to medical use licensees in a consortium. The label shall 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.

b. A label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution or noncommercial transfer to medical use licensees in a consortium. 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 may be correlated with the information on the transport radiation shield label.

6. a. Possess and use instrumentation to measure the radioactivity of the 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 drugs prior to transfer for commercial distribution or noncommercial transfer to medical use licensees in a consortium.

SECTION 21. DHS 157.13 (4) (i) 4. d. is created to read:

DHS 157.13 (4) (i) 4. d. Measure the concentration of radionuclide contaminant in the first eluate after receipt of a molybdenum-99/technetium-99m or strontium-82/rubidium-82 generator, test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, according to s. DHS 157.63 (3), and retain a record of each measurement under s. DHS 157.71 (14).

SECTION 22. DHS 157.13 (4) (j) (intro.) is amended to read:

DHS 157.13 (4) (j) Manufacture and distribution of sources or devices containing radioactive material for medical use. The department shall approve an application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed under subch. VI for use as a calibration, transmission or reference source or for the uses listed in ss. DHS 157.65 (1), 157.66 (1) and, 157.67 (1) and 157.70 if all of the following conditions are satisfied:

SECTION 23. DHS 157.13 (17) (b) 4. Note and (c) 2. Note and (19) are created to read:

DHS 157.13 (17) (b) 4. Note: Submit report to the Department via telephone at [phone] or via facsimile at [phone].

(c) 2. Note: Submit written reports to the Department at: Department of Health Services, Radiation Protection Section, P.O. Box 2659, Madison WI 53701-2659.

(19) SERIALIZATION OF NATIONALLY TRACKED SOURCES. A licensee who manufactures a nationally tracked source shall assign a unique serial number to each nationally tracked source. Serial numbers shall be composed only of alpha-numeric characters.

SECTION 24. DHS 157.22 (1) (c) 1. is amended to read:

DHS 157.22 Occupational dose limits. (1) (c) 1. When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent shall be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a method approved by the department. The assigned deep-dose equivalent shall be for the part of the body receiving the highest exposure. The assigned shallow- dose equivalent shall be the dose averaged over the contiguous 10 square centimeters of skin receiving the highest exposure. The deep-dose equivalent, lens-dose equivalent and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable.

SECTION 25. DHS 157.25 (2) (a) 6. is repealed.

SECTION 26. DHS 157.29 (6) (e) 1. is amended to read:

DHS 157.29 (6) (e) 1. Removable radioactive surface contamination exceeds the limits of s. DHS 157.94 (1) (h)DHS 157.94 (1) (i).

SECTION 27. DHS 157.30 (1) (a) 4. and (6) (b) are amended to read:

DHS 157.30 (1) (a) 4. Dispose of as authorized under subsubs. (2), (3), (4) or, (5) or (8).

(6) TRANSFER FOR DISPOSAL AND MANIFESTS. (b) Any licensee shipping radioactive waste or byproduct material as defined in s. DHS 157.03 (50) (c) to (e) intended for ultimate disposal at a licensed land disposal facility shall document the information required in Appendix G, Section I and transfer this recorded information to the intended consignee in accordance with the requirements of Appendix G.