DHS 157.94(5)(e)(e) A licensee shall notify the governor or governor’s designee, Indian tribal official or Indian tribal official’s designee, and the department of any changes to schedule information provided under par. (a). Notification shall be by telephone to a designated responsible individual in the office of the governor or governor’s designee, Indian tribal official or Indian tribal official’s designee, and to the department. A licensee shall retain for 3 years a record of the name of the individual contacted.

DHS 157.94(5)(f)(f) A licensee who cancels a nuclear waste shipment for which advance notification has been sent shall send to the governor of each State or governor’s designee previously notified, Indian tribal official or Indian tribal official’s designee previously notified, and to the department a cancellation notice identifying the advance notification that is being canceled. A copy of the notice shall be retained by the licensee for 3 years.

DHS 157.94(6)(a)(a) A licensee, certificate holder, and applicant for a certificate of compliance are responsible for the quality assurance requirements as they apply to design, fabrication, testing, and modification of packaging. A licensee is responsible for the quality assurance provision which applies to its use of a packaging for the shipment of licensed material subject to this subchapter.

DHS 157.94(6)(b)(b) A licensee, certificate holder, and applicant for a certificate of compliance shall establish, maintain, and execute a quality assurance program satisfying each of the applicable criteria of 10 CFR 71.101 through 71.137 and satisfying any specific provisions that are applicable to the licensee’s activities including procurement of packaging. The licensee, certificate holder, and applicant for a CoC shall execute the applicable criteria in a graded approach to an extent that is commensurate with the quality assurance requirement’s importance to safety.

DHS 157.94(6)(c)(c) Before the use of any package for the shipment of licensed material subject to this subsection, a licensee shall obtain approval of its quality assurance program from the department.

DHS 157.94(6)(d)(d) A licensee, certificate holder, and applicant for a certificate of compliance shall be responsible for establishing and executing the quality assurance program. A licensee, certificate holder, and applicant for a certificate of compliance may delegate to others, such as contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or any part of the quality assurance program, but shall retain responsibility for the program. These activities include performing the functions associated with attaining quality objectives and the quality assurance functions.

DHS 157.94(6)(e)1.1. Assuring that an appropriate quality assurance program is established and effectively executed; and

DHS 157.94(6)(e)2.2. Verifying, by procedures such as checking, auditing, and inspection, that activities affecting the safety-related functions have been performed correctly.

DHS 157.94(6)(f)1.1. Each quality assurance program approval holder shall submit to the department a description of a proposed change to its department-approved quality assurance program that will reduce commitments in the program description as approved by the department. The quality assurance program approval holder shall not implement the change before receiving the department’s approval. The description of a proposed change to the department-approved quality assurance program must identify the change, the reason for the change, and the basis for concluding that the revised program incorporating the change continues to satisfy the applicable requirements of 10 CFR 71 subpart H.

DHS 157.94(6)(f)2.2. Each quality assurance program approval holder may change a previously approved quality assurance program without the prior approval of the department, if the change does not reduce the commitments in the quality assurance program previously approved by the department. Changes to the quality assurance program that do not reduce the commitments shall be submitted to the department every 24 months. In addition to quality assurance program changes involving administrative improvements and clarifications, spelling corrections, and non-substantive changes to punctuation or editorial items, the following changes are not considered reductions in commitment:

DHS 157.94(6)(f)2.a.a. The use of a quality assurance standard approved by the department that is more recent than the quality assurance standard in the certificate holder’s or applicant’s current quality assurance program at the time of the change.

DHS 157.94(6)(f)2.b.b. The use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles, provided that there is no substantive change to either the functions of the position or reporting responsibilities.

DHS 157.94(6)(f)2.c.c. The use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or alternatively, the use of descriptive text, provided that there is no substantive change to the functional relationships, authorities, or responsibilities.

DHS 157.94(6)(f)2.d.d. The elimination of quality assurance program information that duplicates language in quality assurance regulatory guides and quality assurance standards to which the quality assurance program approval holder has committed to on record.

DHS 157.94(6)(f)2.e.e. Organizational revisions that ensure that persons and organizations performing quality assurance functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations.

DHS 157.94(6)(f)3.3. Each quality assurance program approval holder shall maintain records of quality assurance program changes.

DHS 157.94(6)(g)(g) The licensee, certificate holder, and applicant for a certificate of compliance shall maintain sufficient written records to describe the activities affecting quality.

DHS 157.94(6)(g)1.1. The records shall include the following:

DHS 157.94(6)(g)1.b.b. The documented instructions, procedures, or drawings of a type appropriate to the circumstances to prescribe quality assurance activities including appropriate quantitative and qualitative acceptance criteria for determining that activities important to quality have been satisfactorily accomplished.

DHS 157.94(6)(g)1.d.d. the instructions or procedures which establish a records retention program that is consistent with applicable regulations and designates factors such as duration, location, and assigned responsibility.

DHS 157.94(6)(g)2.2. The licensee, certificate holder, and applicant for a certificate of compliance shall retain these records for 3 years beyond the date when the licensee, certificate holder, and applicant for a certificate of compliance last engages in the activity for which the quality assurance program was developed. If any portion of the quality assurance program, written procedures or instructions is superseded, the licensee, certificate holder, and applicant for a certificate of compliance shall retain the superseded material for 3 years after it is superseded.

DHS 157.94(7)(7) Assumptions as to unknown properties of fissile material. When the isotopic abundance, mass, concentration, degree of irradiation, degree of moderation, or other pertinent property of fissile material in any package is not known, the licensee shall package the fissile material as if the unknown properties have credible values that will cause the maximum neutron multiplication.

DHS 157.94(8)(8) Preliminary determinations. Prior to the first use of any packaging for the shipment of radioactive material a licensee shall ascertain that the determination requirements in 10 CFR 71.85 (a) through (c) have been made.

DHS 157.94 HistoryHistory: CR 01-108: cr. Register July 2002 No. 559, eff. 8-1-02; CR 06-021: am. (2) (b) Register October 2006 No. 610, eff. 11-1-06; CR 16-078: r. and recr. (3), am. (5) (a), cr. (5) (am), am. (5) (c) 4., (d) to (f), r. and recr. (6), renum. (8) (intro.) to (8) and am., r. (8) (a) to (d) Register January 2018 No. 745, eff. 2-1-18; correction in (2) (b), (5) (b) 3. a., b., (6) (b), (d), (g) (intro.), 2. made under s. 35.17, Stats., Register January 2018 No. 745; CR 22-015: am. (5) (d), (6) (c), renum. (6) (f) 1. (intro.) to (6) (f) and am., r. (6) (f) 1. a., b., am. (6) (f) 2. (intro.), a. Register June 2023 No. 810, eff. 7-1-23.