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)(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)(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.
160.15
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.
160.19
160.19
Regulatory agency; review of existing regulations; design and management criteria. 160.19(1)(1)
When an enforcement standard or a preventive action limit is established by rule for a substance, each regulatory agency shall review its rules and commence promulgation of any rules or amendments of its rules necessary to ensure that the activities, practices and facilities regulated by the regulatory agency will comply with this chapter.
160.19(2)(a)(a) Each regulatory agency shall promulgate rules which define design and management practice criteria for facilities, activities and practices affecting groundwater which are designed, to the extent technically and economically feasible, to minimize the level of substances in groundwater and to maintain compliance by these facilities, activities and practices with preventive action limits, unless compliance with the preventive action limits is not technically and economically feasible.
160.19(2)(b)
(b) If a regulatory agency proposes a rule under par.
(a) which is not designed to maintain compliance with preventive action limits, the proposed rule and the notice required under s.
227.16 (2) (e),
227.17 or
227.24 (3) shall include a statement to that effect, and a summary of the rationale for the proposed rule. If a regulatory agency determines not to amend the substance of an existing rule which contains design or management practice criteria that do not maintain compliance with preventive action limits, it shall nonetheless amend the rule to include a notice that the rule does not maintain preventive action limits. A summary of the rationale for not amending the substance of the rule shall be included in the notice required under s.
227.16 (2) (e),
227.17 or
227.24 (3).
160.19(3)
(3) A regulatory agency may not promulgate rules defining design and management practice criteria which permit an enforcement standard to be attained or exceeded at the point of standards application.
160.19(4)
(4) Notwithstanding previous regulatory agency action to review and amend existing rules or to promulgate new rules:
160.19(4)(a)
(a) If a rule is designed to maintain compliance with a preventive action limit under sub.
(2) (a) and if a preventive action limit is attained or exceeded at a point of standards application, the regulatory agency shall review its rules and, if necessary, revise the rules to maintain or achieve the objectives of subs.
(2) and
(3).
160.19(4)(b)
(b) If an enforcement standard is attained or exceeded at a point of standards application, the regulatory agency shall review its rules and, if necessary, revise the rules to ensure that the enforcement standard is not attained or exceeded at a point of standards application at other locations in the future.
160.19(5)
(5) In conducting any review under sub.
(4), the regulatory agency's analysis shall include an examination of the performance of other comparable activities in the state to determine if the noncompliance at a single site suggests an isolated problem or a problem which is likely to recur.
160.19(6)
(6) The department shall promulgate by rule a scientifically valid procedure for determining if a preventive action limit or enforcement standard is, in fact, attained or exceeded or if a change in concentration of a substance has, in fact, occurred. This procedure shall be used for all regulatory and enforcement purposes under this chapter.
160.19(7)
(7) Notwithstanding subs.
(2) and
(4) (a), modifications to rules and changes in the manner of their administration are not required under this section solely because the background concentration of nitrate or a substance of public welfare concern at individual locations is equal to or greater than the preventive action limit.
160.19(8)
(8) Notwithstanding subs.
(2) to
(4), the department may allow a facility which is regulated under chs.
283 or
289 to
292 to be constructed, after May 11, 1984, in an area where the background concentration of nitrate or a substance of public welfare concern attains or exceeds the preventive action limit or the enforcement standard if the facility is designed to achieve the lowest possible concentration for that substance which is technically and economically feasible and the anticipated increase in the concentration of the substance does not present a threat to public health or welfare.
160.19(9)
(9) Notwithstanding subs.
(2) to
(4), the department may allow a facility which is regulated under chs.
283 or
289 to
292 to be constructed, after May 11, 1984, in an area where the background concentration of a substance of public health concern, other than nitrate, attains or exceeds a preventive action limit for that substance:
160.19(9)(a)
(a) If the facility will not cause the further release of that substance into the environment;
160.19(9)(b)
(b) If the background concentration of the substance does not exceed the enforcement standard for that substance, the facility will not cause the concentration of the substance to exceed the enforcement standard for that substance and the facility is designed to achieve the lowest possible concentration of that substance which is technically and economically feasible; or
160.19(9)(c)
(c) If the background concentration of the substance equals or exceeds the enforcement standard for that substance, the facility is designed to achieve the lowest possible concentration of that substance which is technically and economically feasible, the anticipated increase in the concentration of the substance will not cause an increased threat to public health or welfare and the anticipated incremental increase in the concentration of the substance, by itself, will not exceed the preventive action limit. The department shall take action under s.
160.25 if it determines that the increase in the substance causes an increased threat to public health or welfare or it determines that the incremental increase in the concentration of the substance, by itself, exceeds the preventive action limit.
160.19(10)
(10) If the department allows a facility to be constructed under sub.
(9) (b) or
(c), the department shall specify in the initial approval of or the initial or modified permit for the facility the terms and conditions under which the department may seek remedial action for the specific site under ss.
160.23 and
160.25, relating to the substance.
160.19(11)
(11) Regulatory agencies shall enforce rules promulgated under this section with respect to specific sites in accordance with ss.
160.23 and
160.25.
160.19(12)
(12) The requirements in this section shall not apply to rules governing an activity regulated under ch.
293 or subch.
III of ch. 295, or to a solid waste facility regulated under subch.
III of ch. 289 which is part of an activity regulated under ch.
293 or subch.
III of ch. 295, except that the department may promulgate new rules or amend rules governing this type of activity, practice or facility if the department determines that the amendment or promulgation of rules is necessary to protect public health, safety or welfare.
160.21
160.21
Adoption of rules for regulatory responses for groundwater contamination. 160.21(1)(1)
For each substance for which an enforcement standard or a preventive action limit is adopted by the department, each regulatory agency shall promulgate rules which set forth the range of responses which the regulatory agency may take or which it may require the person controlling a facility, activity or practice which is a source of the substance to take if:
160.21(1)(a)
(a) The preventive action limit is attained or exceeded at the point of standards application; or
160.21(1)(b)
(b) The enforcement standard is attained or exceeded at the point of standards application.
160.21(2)
(2) Each regulatory agency shall determine by rule the point of standards application for each facility, activity or practice which is the source of a substance for which an enforcement standard or a preventive action limit is established, as follows:
160.21(2)(a)
(a) If monitoring is required under existing rules for a facility, activity or practice:
160.21(2)(a)1.
1. The regulatory agency shall establish a point of standards application at any location where groundwater is monitored for the purpose of determining whether the preventive action limit for a substance has been attained or exceeded.
160.21(2)(a)2.
2. The regulatory agency shall establish a point of standards application at the following locations for the purpose of determining compliance with enforcement standards, or determining whether design and management practice criteria established under s.
160.19 (2) (a) successfully maintain compliance with preventive action limits:
160.21(2)(a)2.b.
b. Any point beyond the property boundaries of the premises where the facility, activity or practice is located or undertaken; and
160.21(2)(a)2.c.
c. Any point beyond the design management zone but within the property boundaries of the premises where the facility, activity or practice is located or undertaken.
160.21(2)(b)
(b) If monitoring is not required under existing rules for a facility, activity or practice:
160.21(2)(b)1.
1. The regulatory agency shall establish a point of standards application at the following locations for the purposes of determining whether the preventive action limit or the enforcement standard is attained or exceeded:
160.21(2)(b)1.a.
a. Any point of present groundwater use, except the regulatory agency may exempt points of nonpotable groundwater uses if the regulatory agency determines that the substance will not affect the nonpotable groundwater use; and
160.21(2)(b)1.b.
b. Any point beyond the property boundary of the property where the facility, activity or practice is located or undertaken.
160.21(2)(b)2.
2. The regulatory agency may establish by rule additional points of standards application which the regulatory agency determines are necessary to protect future groundwater uses and the public interest in the waters of the state.
160.21(2)(c)
(c) If facilities are subject to regulation under chs.
283 or
289 to
292, the department shall develop by rule and utilize points of standards application for purposes of facility design, the review of facility performance and enforcement as follows:
160.21(2)(c)1.
1. Rules promulgated by the department under s.
289.05 (1) relating to facility design shall establish design criteria which ensure compliance with s.
160.19 (2) at any point of present groundwater use, at property boundaries and at any point beyond a 3-dimensional design management zone within property boundaries established under general criteria specified by rule and applied to individual facilities.
160.21(2)(c)2.
2. The department shall consider any point at which groundwater is monitored and at which a preventive action limit is exceeded a point of standards application for purposes of facility performance review, including investigations and evaluation of specific sites. If the point is within the design management zone, the department shall evaluate the location of the point, specific characteristics of the site, the nature of the substance involved and the likelihood of substance migration in assessing the need for response activities.
160.21(2)(c)3.
3. The department shall establish the point of standards application for enforcement standards at any point of present groundwater use, at property boundaries and at any point beyond a 3-dimensional design management zone within property boundaries established under general criteria specified by rule and applied to individual facilities.
160.21(2)(d)
(d) The department shall establish criteria for design management zones by rule for the facilities specified under par.
(c). The rule shall take into account different types of facility designs. The design management zone which is applied to a facility utilizing the criteria in the rule may be adjusted based on the following factors:
160.21(2)(d)6.
6. Present and anticipated future uses of land and groundwater;
160.21(2)(d)8.
8. Depth, direction and velocity of groundwater and other hydrogeologic factors; or
160.21(2)(d)9.
9. Likely methods for abatement if an enforcement standard is exceeded.
160.21(2)(e)
(e) The department and each regulatory agency shall enter into a memorandum of understanding setting forth the criteria for acceptable monitoring wells and sample handling for the point of standards application.
