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)(f) Changes to a quality assurance program shall comply with the following: 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.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.c.c. Closely related specifications such as required qualifications of personnel, procedures, and equipment. 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. DHS 157.95DHS 157.95 Exemptions. A community water system is exempt from the provisions of this subchapter if all of the following apply: DHS 157.95(1)(1) The community water system consists solely of distribution and storage facilities. DHS 157.95(2)(2) The community water system does not include collection and treatment facilities. DHS 157.95(3)(3) The community water system obtains all water from, but is not owned or operated by, a public water system to which the rules of this subchapter apply. DHS 157.95(4)(4) The community water system does not sell water to any person. DHS 157.95(5)(5) The community water system is not a carrier that conveys passengers in interstate commerce. DHS 157.95 HistoryHistory: CR 01-108: cr. Register July 2002 No. 559, eff. 8-1-02. DHS 157.96(1)(a)1.1. The maximum contaminant level for radium-226 and radium-228 in community water systems is 5 pCi/L. DHS 157.96(1)(a)2.2. The maximum contaminant level for gross alpha particle activity in community water systems is15 pCi/L, including radium-226, but excluding radon and uranium. DHS 157.96(1)(b)(b) Beta particle and photon radioactivity from man-made radionuclides in community water systems. DHS 157.96(1)(b)1.1. The average annual concentration of beta particle and photon radioactivity from man-made radionuclides in drinking water may not produce an annual dose equivalent to the total body or any internal organ greater than 0.04 millisievert (4 millirem). DHS 157.96(1)(b)2.2. Except for the radionuclides listed in Table DHS 157.96A, the concentration of man-made radionuclides causing 0.04 millisievert (4 millirem) total body or organ dose equivalents shall be calculated on the basis of a 2-liter per day drinking water intake using the 168 hour data listed in “Maximum Permissible Body Burdens and Maximum Permissible Concentrations of Radionuclides in Air or Water for Occupational Exposure”, National Council on Radiation Protection and Measurements Report No. 22. If 2 or more radionuclides are present, the sum of their annual dose equivalent to the total body or to any organ may not exceed 0.04 millisievert (4 millirem). DHS 157.96 NoteNote: The publication “Maximum Permissible Body Burdens and Maximum Permissible Concentrations of Radionuclides in Air or Water for Occupational Exposure” in the National Council on Radiation Protection and Measurements Report No. 22, is the same document as Handbook 69 published by the National Bureau of Standards and which the Department received permission from the Attorney General and the Legislative Reference on March 22, 1982 to incorporate into ch. HSS 157 by reference. The reference is no longer available through the federal government and the National Bureau of Standards no longer exists. However, the document may be consulted at the Department’s Radiation Protection Section at 1 W. Wilson St. in Madison, WI or the Legislative Reference Bureau and may be ordered from: NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda MD, 20814.
Table DHS 157.96A
Average Annual Concentrations Assumed to
Produce a Total Body or Organ Dose of
0.04 Millisievert (4 Millirem)/Year
DHS 157.96(2)(a)(a) Standard radionuclide. The following methods used to measure radionuclides and specified in “Prescribed Procedures for Measurement of Radioactivity in Drinking Water” EPA-600/4-80- 032 shall be used to determine compliance with sub. (1), except in cases where alternative methods have been approved under sub. (4): DHS 157.96(2)(b)(b) Other radionuclides. When the identification and measurement of radionuclides other than those listed in par. (a) is required, the following references shall be used, except in cases where alternative methods have been approved under sub. (4): DHS 157.96(2)(b)1.1. Procedures for Radiochemical Analysis of Nuclear Reactor Aqueous Solutions, H. DHS 157.96(2)(b)2.2. Section 4.5.4 of the Health and Safety Laboratory Procedure Manual pertaining to testing water, ERDA-HASL 300, 28th Edition. DHS 157.96 NoteNote: 1. The Procedures for Radiochemical Analysis of Nuclear Reactor Aqueous Solutions, H. L. Krieger and S. Gold, EPA-R4-73-014, May 1973, is available upon written request to: Department of Health Services, Radiation Protection Section, PO Box 2659, Madison WI 53701-2659.
DHS 157.96(2)(c)1.1. For the purpose of monitoring radioactivity concentrations in drinking water, the required sensitivity of the radioanalysis is defined in terms of a detection limit. The detection limit shall be that concentration that may be counted with a precision of plus or minus 100% at the 95% confidence level, where 1.96 is the standard deviation of the net counting rate of the sample. DHS 157.96(2)(c)2.2. To determine compliance with sub. (1) (a) 1., the detection limit may not exceed one pCi/L. To determine compliance with sub. (1) (a) 2., the detection limit may not exceed 3 pCi/L. DHS 157.96(2)(c)3.3. To determine compliance with sub. (1) (b), the detection limits may not exceed the concentrations listed in Table DHS 157.96B. Table DHS 157.96B
Detection Limits for Man-made
Beta Particle and Photon Emitters
DHS 157.96(2)(d)(d) Compliance. To judge compliance with the maximum contaminant levels listed in sub. (1), averages of data shall be used and shall be rounded to the same number of significant figures as the maximum contaminant level for the substance in question. DHS 157.96(3)(3) Monitoring frequency in community water systems. DHS 157.96(3)(a)(a) Monitoring requirements for gross alpha particle activity, radium-226 and radium-228. DHS 157.96(3)(a)1.1. Compliance with sub. (1) (a) shall be based on the analysis of an annual composite of 4 consecutive quarterly samples or the average of the analyses of 4 samples obtained at quarterly intervals. DHS 157.96(3)(a)1.a.a. A gross alpha particle activity measurement may be substituted for the required radium-226 and radium-228 analyses provided that the measured gross alpha particle activity does not exceed 5 pCi/L at a confidence level of 95%, where 1.96 is the standard deviation of the net counting rate of the sample. In localities where radium-228 may be present in drinking water, the department may require radium-226 or radium-228 analyses or analyses of both when the gross alpha particle activity exceeds 2 pCi/L. DHS 157.96(3)(a)1.b.b. When the gross alpha particle activity exceeds 5 pCi/L, the same or an equivalent sample shall be analyzed for radium-228. DHS 157.96(3)(a)2.2. A supplier of water shall monitor water supplies at least once every 4 years following the procedure required by subd. 1. At the discretion of the department, when the record taken in conformance with subd. 1. establishes that the average annual concentration is less than half the maximum contaminant levels established by sub. (1) (a), analysis of a single sample may be substituted for the quarterly sampling procedure required by subd. 1. DHS 157.96(3)(a)2.a.a. When ordered by the department, more frequent monitoring shall be conducted in the vicinity of mining or other operations that may contribute alpha particle radioactivity to either surface or groundwater sources of drinking water. DHS 157.96(3)(a)2.b.b. A supplier of water shall monitor in conformance with subd. 1. within one year of the introduction of a new water source for a community water system. More frequent monitoring shall be conducted when ordered by the department if possible contamination or changes in the distribution system or treatment processing occur that may increase the concentration of radioactivity in finished water. DHS 157.96(3)(a)2.c.c. A community water system using 2 or more sources having different concentrations of radioactivity shall monitor source water and water from a free-flowing tap when required by the department. DHS 157.96(3)(a)2.d.d. Monitoring for compliance with sub. (2) (a) need not include radium-228 except when required by the department, provided that the average annual concentration of radium-228 has been assayed at least once using the quarterly sampling procedure required by subd. 1. DHS 157.96(3)(a)2.e.e. A supplier of water shall conduct annual monitoring of any community water system in which the radium-226 concentration exceeds 3 pCi/L, when required by the department. DHS 157.96(3)(a)3.3. If the average annual maximum contaminant level for gross alpha particle activity or total radium as set forth in sub. (1) (a) is exceeded, the supplier of a community water system shall give notice to the department under sub. (7) and notify the public as required by sub. (8). Monitoring at quarterly intervals shall be continued until the annual average concentration no longer exceeds the maximum contaminant level or until a monitoring schedule as a condition to a variance, exemption or enforcement action is no longer in effect. DHS 157.96(3)(b)(b) Monitoring requirements for man-made radioactivity in community water systems. DHS 157.96(3)(b)1.1. Community water systems using surface water sources and serving more than 100,000 persons and any other community water systems as are designated by the department shall be monitored for compliance with sub. (1) (b) by analysis of a composite of 4 consecutive quarterly samples or analysis of 4 quarterly samples. Compliance with sub. (1) (b) may be assumed without further analysis if the average annual concentration of gross beta particle activity is less than 50 pCi/L and if the average annual concentrations of tritium and strontium-90 are less than those listed in Table 157.96A, provided that if both radionuclides are present, the sum of their annual dose equivalents to bone marrow does not exceed 4 millirem. DHS 157.96(3)(b)1.a.a. If the gross beta particle activity exceeds 50 pCi/L, an analysis of the sample shall be performed to identify the major radioactive constituents present. The appropriate organ and total body doses shall be calculated to determine compliance with sub. (1) (b). DHS 157.96(3)(b)1.b.b. A supplier of water shall conduct additional monitoring, as required by the department, to determine the concentration of man-made radioactivity in principal watersheds designated by the department. DHS 157.96(3)(b)1.c.c. At the discretion of the department, a supplier of water utilizing only groundwaters may be required to monitor for man-made radioactivity. DHS 157.96(3)(b)2.2. After the initial analysis required by subd. 1., a supplier of water shall monitor at least every 4 years following the procedure given in subd. 1. DHS 157.96(3)(b)3.3. The supplier of any community water system designated by the department as utilizing water subject to contamination by effluents from nuclear facilities shall initiate quarterly monitoring for gross beta particle and iodine-131 radioactivity and annual monitoring for strontium-90 and tritium. DHS 157.96(3)(b)3.a.a. Quarterly monitoring for gross beta particle activity shall be based on the analysis of monthly samples or the analysis of a composite of 3 monthly samples. If the gross beta particle activity exceeds 50 pCi/L, an analysis of the sample shall be performed to identify the major radioactive constituents present and the appropriate organ and total body doses shall be calculated to determine compliance with sub. (1) (b). DHS 157.96(3)(b)3.b.b. For iodine-131, a composite of 5 consecutive daily samples shall be analyzed once each calendar quarter. As required by the department, more frequent monitoring shall be conducted when iodine-131 is identified in the finished water. DHS 157.96(3)(b)3.c.c. Annual monitoring for strontium-90 and tritium shall be conducted by means of the analysis of a composite of 4 consecutive quarterly samples or analysis of 4 quarterly samples. DHS 157.96(3)(b)3.d.d. Data obtained by the direct monitoring of water supplies in the areas surrounding nuclear facilities may be utilized by the supplier where the department determines such data is applicable to a particular community water system.
