SECTION 21.
DHS 157.11 (2) (h) 1. e. is amended to read:DHS 157.11(2) (h) 1. 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 radium-226.
SECTION 22.
DHS 157.11 (2) (h) 3. d. is amended to read:DHS 157.11(2)(h) 3. 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.
SECTION 23.
DHS 157.13 (4) (i) 4. is amended to read:DHS 157.13 (4) (i) 4. The applicant commits to satisfies all of the following labeling requirements:
SECTION 24.
DHS 157.13 (4) (i) 6. d. is amended to read:DHS 157.13 (4) (i) 6. 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). The licensee shall report the results of any test that exceeds the permissible concentration listed in s. DHS 157.63 (3) (a) at the time of generator elution, in accordance with s. DHS 157.72 (4). SECTION 25.
DHS 157.13 (4) (i) 7. is renumbered to DHS 157.13 (4) (i) 8. SECTION 26.
DHS 157.13 (4) (i) 7. is created to read:DHS 157.13 (4) (i) 7. A licensee shall satisfy the labeling requirements in subd. 4.
SECTION 27.
DHS 157.13 (5) is repealed and recreated to read:DHS 157.13 (5) Special requirements for a specific license for medical use of radioactive material.
(a) License application. The department shall approve an application for a specific license for medical use of radioactive material if all of the following conditions are satisfied:
1. The applicant satisfies the general requirements specified in sub. (2).
2. The applicant submits procedures required by s. DHS 157.67, as applicable. 3. In addition to the requirements in this paragraph and par. (b), an application for a license or amendment for medical use of radioactive material as described in s. DHS 157.70 shall also include information regarding any radiation safety aspects of the medical use of the material that is not addressed in ss. DHS 157.59 to 157.62, identification of and commitment to follow the applicable radiation safety program requirements in ss. DHS 157.63 (1) to 157.67 (1) that are appropriate for the specific s. DHS 157.70 medical use, as well as any specific information on each of the following: a. Radiation safety precautions and instructions.
b. Training and experience of proposed users.
c. Methodology for measurement of dosages or doses to be administered to patients or human research subjects.
d. Calibration, maintenance and repair of instruments and equipment necessary for radiation safety.
4. An applicant for a license for mobile services shall assure that release of individuals or human research subjects to whom radioactive drugs or implants containing radioactive material are administered will be released under s. DHS 157.62 (8). 5. The applicant or licensee shall provide any other information requested by the department in its review of the application.
(b) License amendment. An application for a license amendment shall meet all of the following requirements:
1. A licensee shall apply for and must receive a license amendment before the licensee does any of the following:
a. Receives or uses radioactive material for a type of use that is permitted under this subchapter, but that is not authorized on the licensee’s current license issued under this subchapter.
b. Permits anyone to work as an authorized user, authorized nuclear pharmacist, ophthalmic physicist, or authorized medical physicist under the license, except an individual who is certified by a specialty board appropriate to the intended use of radioactive material and recognized by the NRC; or is named as an authorized user, authorized nuclear pharmacist, ophthalmic physicist, or authorized medical physicist on a department, NRC or other agreement state license, or on a permit issued by a licensee who is authorized by a Type A license of broad scope to permit the medical use of radioactive material.
d. Permits anyone to work as an associate radiation safety officer, or before the radiation safety officer assigns duties and tasks to an associate radiation safety officer that differ from those for which this individual is authorized on the license.
e. Receives radioactive material in excess of the amount or in a different form or receives a different radionuclide than is authorized on the license
f. Adds to or changes the areas identified in the application or on the license, except for areas where radioactive material is used only under ss. DHS 157.63 (1) and (2). g. Changes the address of use identified on the application or on the license.
h. Revises procedures required by ss. DHS 157.67 (4) and (10) to (12), as applicable, where such revision reduces radiation safety. i. Receives a sealed source from a different manufacturer or of a different model number than authorized by its license unless the sealed source is used for manual brachytherapy, is listed in the Sealed Source and Device Registry, and is in a quantity and for an isotope authorized by the license.
2. An application for a license amendment shall include procedures required by s. DHS 157.67, as applicable. (c) Notifications. A licensee shall make all of the following notifications:
1. Provide to the department a copy of the board certification, the NRC or agreement state license, or other equivalent permit or license for each individual no later than 30 days after the date that the licensee permits the individual to work as an authorized user, an authorized nuclear pharmacist, an ophthalmic physicist, or an authorized medical physicist under par. (b) 1. b. For individuals permitted to work under par. (b) 1. b., within the same 30 day time frame, the licensee shall also provide, as appropriate, verification of completion of all the following: b. Training in device operation, safety procedures, and clinical use for the type of use for which authorization is sought. This training requirement may be satisfied by satisfactory completion of a training program provided by the vendor for new users or by receiving training supervised by an authorized user or authorized medical physicist, as appropriate, who is authorized for the type of use for which the individual is seeking authorization as an authorized user under s. DHS 157.67 (1). c. Training for the type of use for which authorization is sought that includes hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system. This training requirement may be satisfied by satisfactorily successfully completing either a training program provided by the vendor or by training supervised by an authorized medical physicist authorized for the type of use for which the individual is seeking authorization as an authorized medical physicist.
2. Notify the department in writing no later than 30 days after any of the following occurs:
a. An authorized user, an authorized nuclear pharmacist, a radiation safety officer, an associate radiation safety officer, an authorized medical physicist, or an ophthalmic physicist permanently discontinues performance of duties under the license or has a name change.
b. The licensee’s mailing address changes.
c. The licensee’s name changes but the name change does not constitute a transfer of control of the license.
d. The licensee has added to or changed the areas where radioactive material is used under ss. DHS 157.63 (1) or (2) if the change does not include addition or relocation of either an area where PET radionuclides are produced or a PET radioactive drug delivery line from a PET radionuclide/PET radioactive drug production area. e. The licensee permits an individual qualified to be a radiation safety officer under ss. DHS 157.61 (7) and (11) to function as a temporary radiation safety officer and to perform the functions of a radiation safety officer in accordance with s. DHS 157.61 (1) (c). f. The licensee obtains a sealed source for use in manual brachytherapy from a different manufacturer or with a different model number than authorized by its license for which it did not require a license amendment as provided in par. (b) 1. i. The notification must include the manufacturer and model number of the sealed source, the isotope, and the quantity per sealed source.
(d) Exemptions for Type A broad scope licensees. A licensee possessing a Type A specific license of broad scope for medical use is exempt from all of the following requirements:
1. The provisions of par. (a) 3. regarding the need to file an amendment to the license for medical uses of radioactive material as described in s. DHS 157.70. 2. The provisions of par. (b) 1. b.
3. The provisions of par. (b) 1. f. regarding additions to or changes in the areas of use only at the addresses identified in the application or on the license.
4. The provisions of par. (c) 1.
5. The provisions of par. (c) 2. a. for an authorized user, an authorized nuclear pharmacist, an authorized medical physicist, or an ophthalmic physicist.
SECTION 28.
DHS 157.13 (8) (d) is amended to read:DHS 157.13 (8) (d) The applicant establishes and submits to the department the applicant’s program for annual inspections, at intervals not to exceed 13 months, of the job performance of each well logging supervisor to ensure that the department’s rules, license requirements, and the applicant’s operating and emergency procedures are followed. The applicant’s inspection records shall be retained for 3 years after each annual internal inspection.
SECTION 29.
DHS 157.15 (3) (d) is amended to read:DHS 157.15 (3) (d) A licensee’s financial assurance arrangements may be reviewed annually by the department to recognize any increases or decreases resulting from inflation or deflation, changes in engineering plans, activities performed or any other condition affecting costs for decommissioning to ensure that sufficient funding is available to cover liability that remains until license termination.
SECTION 30.
DHS 157.21(3) is amended to read:DHS 157.21 (3) A licensee or registrant shall, at intervals not to exceed 12 13 months, review the radiation protection program content and implementation.
SECTION 31.
DHS 157.35 is amended to read:DHS 157.35 Exemptions. Industrial uses of hand-held imaging intensification devices are exempt from the requirements of this subchapter if the dose rate 0.45 meters (18 inches) from the source of radiation to any individual does not exceed .02 mSv mGy(2.0 mR) per hour. Industrial x-ray tubes are exempt from the inventory, leak testing and materials labeling requirements of this subchapter. All other requirements apply.
SECTION 32.
DHS 157.44 (6) (a) and (a) 3. are amended to read:DHS 157.44 (6) (a) A licensee or registrant may not permit any individual to act as a radiographer or a radiographer’s assistant unless, at all times during radiographic operations, each individual wears on the trunk of his or her body a combination of direct reading dosimeter, an alarming ratemeter and a personnel dosimeter that is processed and evaluated by an accredited National Voluntary Laboratory Accreditation Program processor. At permanent radiographic installations where other appropriate alarming or warning devices are in routine use or during radiographic operations using radiation machines, the use of an alarming ratemeter is not required. Dosimeters shall comply with all of the following conditions:
DHS 157.44 (6) (a) 3. Personnel dosimeters shall be exchanged at periods not to exceed one month.Film badges shall be replaced at least monthly and all other personnel dosimeters that require replacement must be replaced at least quarterly. All personnel dosimeters must be evaluated at least quarterly or promptly after replacement, whichever is more frequent.
SECTION 33.
DHS 157.44 (6) (a) 4. is repealed.SECTION 34.
DHS 157.44 (6) (d) and (f) are amended to read:DHS 157.44 (6) (d) If an individual’s pocket dosimeter is determined found to be off-scale, or if the electronic personal dosimeter reads greater than 2 millisieverts (200 mrem), and the possibility of radiation exposure cannot be ruled out as the cause, the individual’s film badge, TLD or similar approved device shallpersonnel dosimeter that require processing shall be sent for processing and evaluation within 24 hours. For personnel dosimeters that do not require processing, evaluation of the dosimeter shall be started within 24 hours. In addition, the individual may not resume work associated with the use of sources of radiation until a determination of the individual’s radiation exposure dose has been made. The determination shall be made by the radiation safety officer or the radiation safety officer’s designee. The results of the determination shall be included in the records maintained under s. DHS 157.45 (11). DHS 157.44 (6) (f) Dosimetry reports received from the accredited National Voluntary Laboratory Accreditation Program personnel dosimeter processor shall be retained as specified under s. DHS 157.45 (11). SECTION 35.
DHS 157.45 (11) (c) is amended to read:DHS 157.45 (11) (c) Personnel dosimeter results received from the accredited National Voluntary Laboratory Accreditation Program processor until the department terminates the license or registration
SECTION 36.
DHS 157.51 (1) (a) 2. is amended to read:
DHS 157.51 (1) (a) 2. If a decision is made to abandon the sealed source in the well, the licensee shall meet the requirements of s. DHS 157.56 (3) and any requirements of the department of natural resources under chs. NR 141, 500 to 555 544, and 812. SECTION 37.
DHS 157.52 (4) (a) is amended to read:DHS 157.52 (4) (a) A licensee or registrant shall maintain sufficient calibrated and operable radiation survey instruments at each field station and temporary job site to make physical radiation surveys as required by this subchapter and by s. DHS 157.25 (1). Instrumentation shall be capable of measuring one uSvmicrosieverts (0.1 milliroentgenmillirem) per hour through at least 0.5 mSvmillisieverts (50 milliroentgenmillirem) per hour. SECTION 38.
DHS 157.53 (3) (a) is amended to read:DHS 157.53 (3) (a) A licensee or registrant may not permit an individual to act as a well logging supervisor or to assit logging assistant in the handling of sources of radiation unless the individual wears either a film badge or a thermoluminescent dosimeter or similar approved devicea personnel dosimeter at all times during the handling of licensed radioactive materials. Each film badge or TLD personnel dosimeter shall be assigned to and worn by only one individual. Film badges shall be replaced at least monthly and TLDs all other personnel dosimeters that require replacement shall be replaced at least quarterly. After replacement, each film badge or TLD shall be promptly processed.All personnel dosimeters shall be evaluated at least quarterly or promptly after replacement, whichever is more frequent.
SECTION 39.
DHS 157.61 (1) (b) and (c) are repealed and recreated to read:DHS 157.61 (1) (b) A licensee's management shall appoint a radiation safety officer who agrees in writing to be responsible for implementing the radiation protection program. A licensee, through the radiation safety officer, shall ensure that radiation safety activities are being performed under licensee-approved procedures and regulatory requirements. A licensee's management may appoint, in writing, one or more associate radiation safety officers to support the radiation safety officer. The radiation safety officer, with written agreement of the licensee's management, must assign the specific duties and tasks to each associate radiation safety officer. These duties and tasks are restricted to the types of use for which the associate radiation safety officer is listed on a license. The radiation safety officer may delegate duties and tasks to the associate radiation safety officer but shall not delegate the authority or responsibilities for implementing the radiation protection program.
DHS 157.61 (1) (c) For up to 60 days each year, a licensee may permit an individual qualified to be a radiation safety officer to function as a temporary radiation safety officer and to perform the functions of a radiation safety officer, as provided in par. (f), provided the licensee takes the actions required in pars. (b), (d), (f), and (g) and notifies the department in accordance with s. DHS 157.13 (5) (c) 2. e. A licensee may simultaneously appoint more than one temporary radiation safety officer if needed to ensure that the licensee has a temporary radiation safety officer that satisfies the requirements to be a radiation safety officer for each of the different uses of radioactive material permitted by the license. SECTION 40.
DHS 157.61 (4) (a) 1. is amended to read:DHS 157.61 (4) Written directives. (a) 1. A written directive must be dated and signed by an authorized user prior to administration of I-131 sodium iodide greater than 1.11 Megabequerels Megabecquerels (30 microcuries), any therapeutic dosage of unsealed radioactive material or any therapeutic dose of radiation from radioactive material.
SECTION 41.
DHS 157.61 (4) (b) is repealed and recreated to read:DHS 157.61 (4) (b) The written directive shall contain the patient or human research subject’s name and all of the following information:
