Section DHS 157.94 - Operating controls and procedures(1) ROUTINE DETERMINATIONS. Prior to each shipment of licensed material, a licensee shall determine all the following:(a) The package is proper for the contents to be shipped.(b) The package is in unimpaired physical condition except for superficial defects such as marks or dents.(c) Each closure device of the packaging, including any required gasket, is properly installed and secured and free of defects.(d) Any system for containing liquid is adequately sealed and has adequate space or other specified provision for expansion of the liquid.(e) Any pressure relief device is operable and set under written procedures established by the carrier or licensee.(f) The package has been loaded and closed under written procedures established by the carrier or licensee.(g) For fissile material, any moderator or neutron absorber, if required, is present and in proper condition.(h) Any structural part of the package that may be used to lift or tie down a package during transport is rendered inoperable unless it satisfies design requirements specified by the NRC.(i) The level of removable radioactive contamination on the external surfaces of each package offered for shipment is as low as reasonably achievable and does not exceed the levels specified in 49 CFR 173.443.(j) External radiation levels around the package and around the vehicle do not exceed the limits specified in 49 CFR 173.441.(k) Accessible package surface temperatures will not exceed the limits specified in 10 CFR 71.43(g) at any time during transportation.(2) AIR TRANSPORT OF PLUTONIUM. Notwithstanding the provisions of any general licenses and notwithstanding any exemptions stated directly in this section or included indirectly by citation of the U.S. department of transportation regulations, a licensee may not transport or deliver plutonium in any form by air, or deliver to a carrier for air transport, except under any of the following conditions: (a) The plutonium is contained in a medical device designed for individual human application.(b) The plutonium is contained in a material in which the specific activity is less than or equal to the activity concentration values for plutonium specified in ch. DHS 157 Appendix O, Table VII and in which the radioactivity is essentially uniformly distributed.(c) The plutonium is shipped in a single package containing no more than an A 2 quantity of plutonium in any isotope or form and is shipped as provided in s. DHS 157.92 (3).(d) The plutonium is shipped in a package specifically authorized in a certificate of compliance issued by the nuclear regulatory commission for the shipment of plutonium by air, and the licensee requires, through special arrangement with the carrier, compliance with 49 CFR 175.704.(3) SHIPMENT AND PACKAGING RECORDS. (a) A licensee shall maintain for a period of 3 years after shipment, a record of each shipment of licensed material not exempt under s. DHS 157.92 (2), showing all of the following: 1. Identification of the packaging by model number and serial number.2. Verification that the packaging, as shipped, had no significant defect.3. Volume and identification of coolant.4. Type and quantity of licensed material in each package and the total quantity of each shipment.5. For each item of irradiated fissile material, the following:a. Identification by model number and serial number.b. Irradiation and decay history to the extent appropriate to demonstrate that its nuclear and thermal characteristics comply with license conditions.c. Any abnormal or unusual condition relevant to radiation safety.7. For fissile package and for Type B package, any special controls exercised.8. Name and address of the transferee.9. Address to which the shipment was made.10. Results of the determinations required by sub. (1) and by the conditions of the package approval.(b) A licensee, certificate holder, and an applicant for a CoC, shall make available to the department for inspection, upon reasonable notice, of all records required by this subsection. Records are only valid if stamped, initialed, or signed and dated by authorized personnel, or otherwise authenticated.(c) A licensee, certificate holder, and an applicant for a certificate of compliance shall maintain sufficient written records to furnish evidence of the quantity of packaging. The records to be maintained include results of the determinations required by s. DHS 157.94 (8); design, fabrication, and assembly records; results of reviews, inspections, tests, and audits; results of monitoring work performance and materials analyses; and results of maintenance, modification, and repair activities. Inspection, test, and audit records must identify the inspector or data recorder, the type of observation, the results, the acceptability, and the action taken in connection with any deficiencies noted. These records must be retained for 3 years after the life of the packaging to which they apply.(4) REPORTS. A licensee shall provide a written report to the department within 30 days of any of the following: (a) Any instance in which there is significant reduction in the effectiveness of any packaging during use.(b) Details of any defects with safety significance in the packaging after first use, and the means employed to repair the defects and prevent their recurrence.(c) Instances in which the conditions of approval in the certificate of compliance were not observed in making a shipment.(5) ADVANCE NOTIFICATION OF TRANSPORT OF NUCLEAR WASTE. (a) Prior to the transport of any nuclear waste meeting the criteria in par. (b) outside of the confines of the licensee's facility or other place of use or storage, or prior to the delivery of any nuclear waste to a carrier for transport, within or across the boundary of the State, each licensee shall provide advance notification of the transport to the governor of a state, or governor's designee, and to the department. Note: Notification of transport of nuclear waste may be sent to: Division of Emergency Management, 2400 Wright Street, Madison, Wisconsin, 53704. Notification may also be made by telephone at: 608-242-3232; or fax at: 608-242-3247. The telephone number of the 24-hour duty officer is 1-800-943-0003. A list of the names and mailing addresses of the governors' designees receiving advance notification of transportation of nuclear waste was published in the Federal Register on June 30, 1995 (60 FR 34306).
(am) Prior to the transport of any nuclear waste meeting the criteria in par. (b) outside of the confines of the licensee's facility or other place of use or storage, or prior to the delivery of any nuclear waste to a carrier for transport, within or across the boundary of the federally recognized Indian tribe's reservation, each licensee shall provide advance notification of transport to the Indian tribal official of the participating Indian tribes or the Indian tribal official's designee, and to the department. Note: Notification of transport of nuclear waste may be sent to: Division of Emergency Management, 2400 Wright Street, Madison, Wisconsin, 53704. Notification may also be made by: telephone at 608-242-3232; or fax at 608-242-3247. The telephone number of the 24-hour duty officer is 1-800-943-0003. A list of the names and mailing addresses of the governors' designees receiving advance notification of transportation of nuclear waste was published in the Federal Register on June 30, 1995 (60 FR 34306).
(b) Advance notification is required under any of the following conditions: 1. The nuclear waste is required to be in Type B packaging for transportation.2. The nuclear waste is being transported through Wisconsin en route to a disposal facility or to a collection point for transport to a disposal facility.3. The quantity of licensed material in a single package exceeds any of the following criteria: a. Three thousand times the A 1 value of the radionuclides as specified in ch. DHS 157 Appendix O, Table VI for special form radioactive material.b. Three thousand times the A 2 value of the radionuclides as specified in ch. DHS 157 Appendix O, Table VI for normal form radioactive material.c. One thousand terabecquerel (27,000 Ci). (c) Each advance notification required by par. (a) shall contain all the following information: 1. The name, address and telephone number of the shipper, carrier and receiver of the shipment.2. A description of the nuclear waste contained in the shipment as required under 49 CFR 172.202 and 172.203.3. The point of origin of the shipment and the 7-day period during which departure of the shipment is estimated to occur.4. The 7-day period during which arrival of the shipment at state boundaries or Tribal reservation boundaries is estimated to occur.5. The destination of the shipment and the 7-day period during which arrival of the shipment is estimated to occur.6. A point of contact with a telephone number for current shipment information.(d) The notification required by par. (a) shall be made in writing to the office of each appropriate governor or governor's designee, the office of each appropriate tribal official or tribal official's designee, and to the Director, Office of Nuclear Security and Incident Response. A notification delivered by mail shall be postmarked at least 7 days before the beginning of the 7-day period during which departure of the shipment is estimated to occur. A notification delivered by any other means than mail shall reach the office of the governor or governor's designee, the Indian tribal official or Indian tribal official's designee, and the department at least 4 days before the beginning of the 7-day period during which departure of the shipment is estimated to occur. A copy of the notification shall be retained by the licensee for 3 years.(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.(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.(6) QUALITY ASSURANCE REQUIREMENTS. (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.(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.(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.(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.(e) The quality assurance functions include the following: 1. Assuring that an appropriate quality assurance program is established and effectively executed; and2. Verifying, by procedures such as checking, auditing, and inspection, that activities affecting the safety-related functions have been performed correctly.(f) Changes to a quality assurance program shall comply with the following: 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.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: 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.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.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.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.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.3. Each quality assurance program approval holder shall maintain records of quality assurance program changes.(g) The licensee, certificate holder, and applicant for a certificate of compliance shall maintain sufficient written records to describe the activities affecting quality. 1. The records shall include the following: a. Changes to the quality assurance program as required by par. (f).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.c. Closely related specifications such as required qualifications of personnel, procedures, and equipment.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.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.(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.(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.Wis. Admin. Code Department of Health Services DHS 157.94
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.Amended by, 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, eff. 2/1/2018Amended by, 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. 7/1/2023