160.05(2)(a)2. 2. The regulatory authority of the regulatory agency over the facility, activity or practice which is the source of the substance.
160.05(2)(a)3. 3. The reasons for believing the substance exists in or has a reasonable probability of entering the groundwater or the reasons for believing the substance should be removed from the list.
160.05(2)(b) (b) Within a reasonable period of time after the receipt of a petition a regulatory agency shall either deny the petition in writing or submit the name of the substance to the department under sub. (1). If the regulatory agency denies the petition, it shall give notice of the denial promptly to the person who filed the petition, including a statement of its reasons for the denial.
160.05(3) (3)Establish categories. Within 60 days following receipt of a name of a substance under sub. (1), the department shall place the substance into one of the following categories:
160.05(3)(a) (a) Category 1, if the substance is detected in groundwater in concentrations in excess of a federal number for that substance.
160.05(3)(b) (b) Category 2, if the substance is detected in groundwater and is of public health or welfare concern but:
160.05(3)(b)1. 1. Is not detected in concentrations in excess of a federal number; or
160.05(3)(b)2. 2. For which there is no federal number.
160.05(3)(c) (c) Category 3, if the substance has a reasonable probability of being detected in groundwater and is of public health or welfare concern.
160.05(4) (4)Ranking within categories. The department shall rank each substance within its category. The department shall give highest rankings to those substances which pose the greatest risks to the health or welfare of persons in the state, taking into consideration, among other things, the following characteristics:
160.05(4)(a) (a) Carcinogenicity.
160.05(4)(b) (b) Teratogenicity.
160.05(4)(c) (c) Mutagenicity.
160.05(4)(d) (d) Interactive effects.
160.05(5) (5)Revision of substance lists. The department shall revise, as necessary, the ranking of substances within categories to include additional substances as they are reported, to reflect a change in the status of a substance which requires that it be placed in a different category or to remove from the list substances which are not shown to involve public health or welfare concerns or which do not have a reasonable probability of entering the groundwater.
160.05(6) (6)Public health concerns.
160.05(6)(a) (a) The department shall designate which of the substances in each category are of public health concern and which are of public welfare concern.
160.05(6)(b) (b) In determining whether a substance is of public health concern, the department shall take into account the degree to which the substance may:
160.05(6)(b)1. 1. Cause or contribute to an increase in mortality;
160.05(6)(b)2. 2. Cause or contribute to an increase in illness or incapacity, whether chronic or acute;
160.05(6)(b)3. 3. Pose a substantial present or potential hazard to human health because of its physical, chemical or infectious characteristics; or
160.05(6)(b)4. 4. Cause or contribute to other adverse human health effects or changes of a chronic or subchronic nature even if not associated with illness or incapacity.
160.05(6)(c) (c) In determining whether a substance is of public health concern, the department may consider other effects not specified under par. (b) if those effects are reasonably related to public health.
160.05(6)(d) (d) In determining whether a substance is of public welfare concern, the department shall take into account whether the substance may:
160.05(6)(d)1. 1. Influence the aesthetic suitability of water for human use;
160.05(6)(d)2. 2. Influence the suitability of water for uses other than human drinking water; or
160.05(6)(d)3. 3. Have a substantial adverse effect on plant life or animal life.
160.05(6)(e) (e) In determining whether a substance is of public welfare concern, the department may consider additional characteristics not specified under par. (d) if those characteristics are reasonably related to public welfare.
160.05 History History: 1983 a. 410.
160.07 160.07 Establishment of enforcement standards; substances of public health concern.
160.07(1)(1)The department of health services and the department shall enter into a memorandum of understanding setting forth the procedures and responsibilities of each agency in establishing enforcement standards under this section. The memorandum shall include those standards to be used by the department in making the designation required under s. 160.05 (6).
160.07(2) (2)Within 10 days after placing the name of a new substance within a category or changing the category of a substance under s. 160.05, the department shall submit the current list of categories and rankings of substances to the department of health services.
160.07(3) (3)The department of health services shall recommend to the department an enforcement standard for each substance submitted to it under sub. (2) which is designated as a public health concern, in the order of rankings within each category under s. 160.05 (4).
160.07(4) (4)The department of health services shall develop recommendations for enforcement standards for substances of public health concern as follows:
160.07(4)(a) (a) If a single federal number exists for a substance, the federal number shall be the enforcement standard.
160.07(4)(b) (b) If more than one federal number exists for a substance, the most recently established federal number representing the most current data shall be the enforcement standard.
160.07(4)(c) (c) If no federal number exists for a substance, but there is a state drinking water standard, the state drinking water standard shall be the enforcement standard.
160.07(4)(d) (d) If neither a federal number nor a state drinking water standard exists for a substance, the department of health services shall develop a recommended enforcement standard using the methodology under s. 160.13.
160.07(4)(e) (e) Notwithstanding pars. (a) and (b), the department of health services may recommend an enforcement standard different than the federal number if there is significant technical information which is scientifically valid and which was not considered when the federal number was established, upon which the department of health services concludes, utilizing the methodology under s. 160.13 and with a reasonable scientific certainty, that such a standard is justified. The department of health services may recommend a change in an enforcement standard previously adopted by utilization of a federal number. In evaluating the evidence for establishing an enforcement standard different than a federal number, the department of health services shall consider the extent to which the evidence was developed in accordance with scientifically valid analytical protocols and may consider whether the evidence was subjected to peer review, resulted from more than one study and is consistent with other credible medical or toxicological evidence.
160.07(5) (5)Within 9 months after transmitting the name of a substance to the department of health services under sub. (2), the department of natural resources shall propose rules establishing the recommendation of the department of health services as the enforcement standard for that substance and publish the notice required under s. 227.16 (2) (e), 227.17 or 227.24 (3).
160.07(6) (6)If a federal number is established or changed for a substance after an enforcement standard is recommended by the department of health services and if any person or regulatory agency submits a request, the department of natural resources shall determine whether the enforcement standard needs revision based on recommendations under sub. (4).
160.07 History History: 1983 a. 410; 1985 a. 182 s. 57; 1995 a. 27 s. 9126 (19); 2007 a. 20 s. 9121 (6) (a); s. 35.17 correction in (3).
160.09 160.09 Establishment of enforcement standards; substances of public welfare concern.
160.09(1)(1)Notwithstanding the authority of the department under ss. 280.11, 281.15 and 281.17 (8) to establish standards for pure drinking water, the department shall establish enforcement standards for substances of public welfare concern as follows:
160.09(1)(a) (a) If a single federal number exists for a substance, the federal number shall be the enforcement standard.
160.09(1)(b) (b) If more than one federal number exists for a substance, the most recently established federal number representing the most current data shall be the enforcement standard.
160.09(1)(c) (c) If no federal number exists for a substance, but there is a state drinking water standard, the state drinking water standard shall be the enforcement standard.
160.09(1)(d) (d) If neither a federal number nor a state drinking water standard exists for a substance, the department shall establish an enforcement standard using all relevant and scientifically valid information available in technical literature concerning the substance and, if necessary, by comparison to similar compounds or classes of compounds.
160.09(1)(e) (e) Notwithstanding pars. (a) and (b), the department may establish an enforcement standard different than the federal number if there is significant technical information which is scientifically valid and which was not considered when the federal number was established, upon which the department concludes, with a reasonable scientific certainty, that such a standard is justified. The department may change an enforcement standard previously adopted by utilization of a federal number. In evaluating the evidence for establishing an enforcement standard different than a federal number, the department shall consider the extent to which the evidence was developed in accordance with scientifically valid analytical protocols and may consider whether the evidence was subjected to peer review, resulted from more than one study and is consistent with other credible medical or toxicological evidence.
160.09(2) (2)The department shall establish an enforcement standard for each substance of public welfare concern in the order of rankings within each category under s. 160.05 (4).
160.09(3) (3)The department shall establish enforcement standards by rule. The department shall prepare proposed rules establishing enforcement standards and shall provide the notice under s. 227.16 (2) (e), 227.17 or 227.24 (3) within 9 months after the name of a substance is received under s. 160.05.
160.09(4) (4)If a federal number is changed or newly established for a given substance after an enforcement standard is established by the department and if a request is submitted to the department by any person or regulatory agency, the department shall determine whether the enforcement standard needs to be revised based on sub. (1).
160.09 History History: 1983 a. 410; 1985 a. 135; 1985 a. 182 s. 57; 1995 a. 227.
160.11 160.11 Public information. In promulgating any enforcement standards as rules under ss. 160.07 and 160.09, the department, with the assistance of the department of health services, shall prepare a document describing the information and methodology used and the conclusions reached in establishing each proposed enforcement standard. The department shall make the document available when the notice is provided under s. 227.16 (2) (e), 227.17 or 227.24 (3). Any person may submit written questions on the document to the department at any time after the notice is provided under s. 227.16 (2) (e), 227.17 or 227.24 (3) and before any public hearing on the proposed rule is held. The department, with the assistance of the department of health services, shall respond at the public hearing to all questions previously submitted in writing.
160.13 160.13 Methodology to establish enforcement standard.
160.13(1)(1)Definitions. In this section:
160.13(1)(a) (a) “Acceptable daily intake" means the dose of a substance which, if ingested daily over an entire human lifetime, appears to be without appreciable risk on the basis of all known facts at the time it is established. Acceptable daily intake is expressed in units of milligrams of the substance per kilogram of body weight.
160.13(1)(b) (b) “Department" means the department of health services.
160.13(1)(c) (c) “No-observable-effect level" means that level of intake of a substance which, when administered to a group of humans or experimental animals, does not produce any of the effects observed or measured at any higher level of intake and produces no significant difference between the test group and an unexposed control group of humans or animals maintained under identical conditions.
160.13(2) (2)Methodology.
160.13(2)(a) (a) The department shall establish a recommended enforcement standard for a substance by first determining the acceptable daily intake for the substance under par. (b) and then basing the recommended enforcement standard on that acceptable daily intake under par. (c). In complying with pars. (b) and (c), the department shall utilize, where available, relevant and scientifically valid information from the office of pesticide programs and the office of drinking water in the federal environmental protection agency.
160.13(2)(b) (b) The department shall determine the acceptable daily intake for the substance as follows:
160.13(2)(b)1. 1. If an acceptable daily intake for the substance is established by the office of pesticide programs or office of drinking water in the federal environmental protection agency, that federal value shall be the acceptable daily intake.
160.13(2)(b)2. 2. Notwithstanding subd. 1., the department may determine an acceptable daily intake value different than the federal value established by the office of pesticide programs or office of drinking water in the federal environmental protection agency, if there is significant technical information which is scientifically valid and which was not considered when the federal value was established, upon which the department concludes, with a reasonable scientific certainty, that such a value is justified. In evaluating the evidence for establishing an acceptable daily intake value different than a federal value, the department shall consider the extent to which the evidence was developed in accordance with scientifically valid analytical protocols and may consider whether the evidence was subjected to peer review, resulted from more than one study and is consistent with other credible medical or toxicological evidence.
160.13(2)(b)3. 3. If no acceptable daily intake for the substance is established by the office of pesticide programs or office of drinking water in the federal environmental protection agency, the department shall determine the acceptable daily intake for the substance by dividing the substance's no-observable-effect level by a suitable uncertainty factor. In establishing a suitable uncertainty factor, the department shall consider all of the following, utilizing, where available, information from the office of pesticide programs and the office of drinking water in the federal environmental protection agency:
160.13(2)(b)3.a. a. The quality and quantity of data relevant to establishing an acceptable daily intake.
160.13(2)(b)3.b. b. The relative importance to full health of the most sensitive target organs or body systems affected by the substance.
160.13(2)(b)3.c. c. The amount of interspecies and intraspecies variations in the effects of the substance.
160.13(2)(b)3.d. d. The dose-response curve and the time-concentration relationships for the substance.
160.13(2)(b)3.e. e. The nature and degree of severity of injury incurred at the intake level at which the effect of exposure to the substance ceases to be reversible.
160.13(2)(b)3.f. f. The potential interactions of the substance within the body with other environmental chemicals or therapeutic drugs.
160.13(2)(b)3.g. g. The known potential cumulative effects of repeated exposure to the substance.
160.13(2)(b)3.h. h. The known chronic or subchronic effects of exposure to similar or related compounds.
160.13(2)(b)3.i. i. The identification of physiologic or pathologic states and functional abnormalities among the potentially exposed population which would constitute a health hazard in the event of exposure to the substance.
160.13(2)(b)3.j. j. The possibility of chronic health effects from repeated, acute short-term exposure to the substance.
160.13(2)(b)4. 4. If no acceptable daily intake or equivalent value for an oncogen is established by the federal environmental protection agency or if an acceptable daily intake is established but oncogenic potential at the established acceptable daily intake presents an unacceptable probability of risk, the department shall provide the department of natural resources with an evaluation of the oncogenic potential of the substance. This evaluation of oncogenic potential shall indicate an acceptable daily intake for the substance which, if ingested daily over an entire human lifetime, appears to present an acceptable probability of risk which is presumed to be a risk level equal to a ratio of one to 1,000,000. A risk level equal to a ratio of one to 1,000,000 is the expectation that no more than one excess death will occur in a population of 1,000,000 over a 70-year period. The department shall base the evaluation of oncogenic potential on a review of the most recent and scientifically valid information available.
160.13(2)(c) (c) The department shall base the recommended enforcement standard for the substance on the intake of one liter of water per day by a person weighing 10 kilograms, where that water is the only source of the substance for the person. The department shall establish the recommended enforcement standard so that the acceptable daily intake of the substance is not exceeded for this type of person under these conditions.
160.13 History History: 1983 a. 410; 1995 a. 27 s. 9126 (19); 2007 a. 20 s. 9121 (6) (a).
160.15 160.15 Establishment of preventive action limits.
160.15(1)(1)The department shall establish by rule a preventive action limit for each substance for which an enforcement standard is established, as follows:
160.15(1)(a) (a) For any substance of public welfare concern, the preventive action limit shall be 50 percent of the concentration established as the enforcement standard.
160.15(1)(b) (b) For any substance of public health concern, the preventive action limit shall be 20 percent of the concentration established as the enforcement standard.
160.15(1)(c) (c) Notwithstanding par. (b), for any substance that has carcinogenic, mutagenic or teratogenic properties or interactive effects, the preventive action limit shall be 10 percent of the concentration established as the enforcement standard.
160.15(2) (2)The department may establish a preventive action limit for a substance which is lower than the level specified under sub. (1) if the department concludes, to a reasonable degree of scientific certainty, based on significant technical information which is scientifically valid, that a more stringent level is necessary to protect public health or welfare from the interactive effects of the substance. In evaluating whether the evidence provides a sufficient basis for a more stringent level, the department shall consider the extent to which the evidence was developed in accordance with generally accepted analytical protocols and may consider whether the evidence was subjected to peer review, resulted from more than one study and is consistent with other credible medical or toxicological evidence.
160.15(3) (3)Notwithstanding sub. (1), the department may establish by rule preventive action limits for indicator parameters used in monitoring waste storage, treatment or disposal facilities regulated by the department such as biochemical or chemical oxygen demand, alkalinity, hardness, conductivity and pH, if enforcement standards are not established under s. 160.07 or 160.09 for the indicator parameters. In establishing preventive action limits for indicator parameters, the department shall consider the background water quality and the potential for the indicator parameters to show that preventive action limits under sub. (1) may be exceeded.
160.15 History History: 1983 a. 410.
160.17 160.17 Collection of information. Concurrently with the identification of substances under s. 160.05 (1), the regulatory agency shall conduct a literature search and shall request, where appropriate, the manufacturer of each substance and other knowledgeable sources to provide relevant data, information on the environmental fate of the substance and recommendations on measures which may be implemented to minimize the concentration of the substance in the groundwater.
160.17 History History: 1983 a. 410.
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2017-18 Wisconsin Statutes updated through 2019 Wis. Act 50 and through all Supreme Court and Controlled Substances Board Orders filed before and in effect on December 6, 2019. Published and certified under s. 35.18. Changes effective after December 6, 2019, are designated by NOTES. (Published 12-6-19)