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. DHS 157.59(3)(a)(a) If the requirements of this subchapter are more restrictive than the existing license condition, a licensee shall comply with this subchapter unless exempted by par. (c). DHS 157.59(3)(b)(b) Any existing license condition that is not affected by a requirement in this subchapter remains in effect until there is a license amendment or license renewal. DHS 157.59(3)(c)(c) If a license condition exempted a licensee from a provision of this subchapter on the effective date of August 1, 2002, the exemption shall continue until the department amends, suspends or revokes the license. DHS 157.59(3)(d)(d) If a license condition cites provisions in this subchapter that are later deleted, the license condition remains in effect until a license amendment or renewal modifies or removes the license condition. DHS 157.59 HistoryHistory: CR 01-108: cr. Register July 2002 No. 559, eff. — see Note at the start of the chapter. DHS 157.61(1)(1) Authority and responsibilities for the radiation protection program. DHS 157.61(1)(a)(a) In addition to the radiation protection program requirements of s. DHS 157.21, a licensee’s management shall approve in writing any of the following: DHS 157.61(1)(a)1.1. A request for license application, renewal or amendment before submittal to the department. DHS 157.61(1)(a)2.2. Authorization prior to using licensed materials for any individual to work as an authorized user, authorized nuclear pharmacist or authorized medical physicist. DHS 157.61(1)(a)3.3. A radiation protection program change that does not require a license amendment and is permitted under sub. (2). DHS 157.61(1)(b)(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)(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. DHS 157.61(1)(d)(d) A licensee shall establish in writing the authority, duties and responsibilities of the radiation safety officer. DHS 157.61(1)(e)(e) A licensee that is authorized for 2 or more different types of uses of radioactive material under ss. DHS 157.64, 157.65 and 157.67 or 2 or more types of units under s. DHS 157.67 shall establish a radiation safety committee to oversee all uses of radioactive material permitted by the license. The committee shall include an authorized user of each type of use permitted by the license, the radiation safety officer, a representative of the nursing service and a representative of management who is neither an authorized user nor a radiation safety officer, and may include other members as the licensee deems appropriate. DHS 157.61(1)(f)(f) A licensee shall provide the radiation safety officer sufficient authority, organizational freedom, time, resources and management prerogative to perform all the following functions: DHS 157.61(2)(a)(a) A licensee may revise its radiation protection program without department approval if the revision meets all the following criteria: DHS 157.61(2)(a)2.2. The revision complies with the requirements of this chapter and the license.