160.13 Methodology to establish enforcement standard.

(1) Definitions. In this section:

(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.

(b) “Department" means the department of health services.

(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.

(2) Methodology.

(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.

(b) The department shall determine the acceptable daily intake for the substance as follows:

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.

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.

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:

a. The quality and quantity of data relevant to establishing an acceptable daily intake.

b. The relative importance to full health of the most sensitive target organs or body systems affected by the substance.

c. The amount of interspecies and intraspecies variations in the effects of the substance.

d. The dose-response curve and the time-concentration relationships for the substance.

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.

f. The potential interactions of the substance within the body with other environmental chemicals or therapeutic drugs.

g. The known potential cumulative effects of repeated exposure to the substance.

h. The known chronic or subchronic effects of exposure to similar or related compounds.

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.

j. The possibility of chronic health effects from repeated, acute short-term exposure to the substance.

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.

(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.

History: 1983 a. 410; 1995 a. 27 s. 9126 (19); 2007 a. 20 s. 9121 (6) (a).