DHS 157.56 NoteNote: Written reports and requests for extensions may be mailed to the department at the following address: Department of Health Services, Radiation Protection Section, PO Box 2659, Madison, WI, 53701-2659. The telephone contact number is: 608-267-4797 during normal business hours and 608-258-0099 after hours.

DHS 157.56(4)(4) Posting. Whenever a sealed source containing radioactive material is abandoned in a well a licensee shall post a permanent plaque, as described in ch. DHS 157 Appendix K, at the surface of the well. The plaque shall be constructed of long-lasting material, such as stainless steel or monel, and contain all the following information engraved on its face:

DHS 157.56 NoteNote: Appropriate warnings may include: (a) “Do not drill below plug-back depth;” (b) “Do not enlarge casing;” or (c) “Do not re-enter the hole,” followed by the words, “before contacting the Department of Health Services, Radiation Protection Section”.

DHS 157.56(5)(5) Loss in potable fresh water aquifer. A licensee shall immediately notify the department by telephone and within 24 hours by confirming letter if the licensee knows or has reason to believe that radioactive material has been lost in or to an underground potable fresh water aquifer. The notice shall designate the well location, describe the magnitude and extent of loss of radioactive material, assess the consequences of such loss and explain efforts planned or being taken to mitigate these consequences.

DHS 157.56 NoteNote: The department may be contacted at: Department of Health Family Services, Radiation Protection Section, P.O. Box 2659, Madison, WI, 53701-2659. Telephone contact is: 608-267-4797 during normal business hours or 608-258-0099 after hours.

DHS 157.56 HistoryHistory: CR 01-108: cr. Register July 2002 No. 559, eff. 8-1-02; CR 06-021: am. (4) (intro.) and (5) Register October 2006 No. 610, eff. 11-1-06; correction in (4) (intro.) made under s. 35.17, Stats., Register January 2018 No. 745.

DHS 157.59(1)(1) Maintenance of records. A record required by this subchapter shall be legible throughout the specified retention period. The record may be the original, a reproduced copy or a microform, provided the copy or microform is authenticated by authorized personnel and the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored electronically with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings and specifications, shall include all pertinent information such as stamps, initials and signatures. A licensee shall maintain adequate safeguards against tampering with and loss of records.

DHS 157.59(2)(2) Provisions for research involving human subjects. A licensee may conduct research involving human subjects using radioactive material provided all of the following requirements are met:

DHS 157.59(2)(a)(a) A licensee shall apply for and receive approval of a specific amendment to its radioactive materials license before conducting the research. A licensee shall obtain informed consent from the human subjects and obtain prior review and approval of the research activities by an “Institutional Review Board” or equivalent under the meaning of these terms as defined and described in the Federal Policy for the Protection of Human Subjects.

DHS 157.59 NoteNote: The definition and responsibilities of an Institutional Review Board are described on 45 CFR Part 46 which may be downloaded from the following website: http://www.access.gpo.gov/nara/cfr/waisidx_00/45cfr46_00.html.

DHS 157.59(2)(b)(b) The research involving human subjects authorized in par. (a) shall be conducted using radioactive material authorized for medical use in the license.

DHS 157.59(2)(c)(c) Nothing in this subsection relieves a licensee from complying with the other requirements in this subchapter or from complying with applicable FDA or other federal requirements governing radioactive drugs or devices.