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)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 of 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).
160.09
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).
160.11
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% 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% 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% 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.
