SB894: Bill Text

SB894,6,3 227.182 Peer review. (1) Definition. In this section, “interested party” means a person who will be regulated under a proposed rule, or a person whose client, member, or customer will be regulated under a proposed rule.

SB894,6,6 (2) Application. This section applies only to rules that are based on or that rely on scientific studies, scientific or technical data, scientific methods, or other similar scientific information.

SB894,6,11 (3) Request for peer review. (a) If at any time before submitting a proposed rule to the governor for approval under s. 227.185 an agency receives in writing from an interested party a valid request to conduct an external peer review of the proposed rule, the agency shall initiate an external peer review of the proposed rule under sub. (5).

SB894,6,15 (b) If at any time before submitting a proposed rule to the governor for approval under s. 227.185 an agency receives in writing from the joint committee for review of administrative rules a valid request to conduct an external peer review of a proposed rule, the agency shall initiate an external peer review under sub. (5).

SB894,6,21 (c) If at any time an agency receives in writing from the joint committee for review of administrative rules a valid request to conduct an external peer review of any of the agency's rules that are published in the code, the agency shall initiate an external peer review under sub. (5). The committee may identify one or more specific chapters, sections, or other subunits in the code that are administered by the agency as the rules that are to be the subject of the external peer review.

SB894,7,3 (d) A request for external peer review is valid under this subsection if it objects to specific studies or scientific or technical data, specific scientific methods, or specific findings, conclusions, or assumptions that the agency used in developing the rule and that have not previously been the subject of an external peer review under sub. (5), or if it objects on the basis that the rule does not comply with state or federal law. If more than one valid request for peer review is received under par. (a), the requests shall be consolidated into one external peer review.

SB894,7,8 (4) No agency action during peer review. An agency that receives a valid request for peer review under sub. (3) for a proposed rule shall stop work on the proposed rule and may not continue promulgating the proposed rule notwithstanding any provision authorizing or requiring the agency to promulgate the proposed rule, until a final report has been submitted under sub. (7).

SB894,7,23 (5) Independent external peer review. Within 60 days after receiving a valid request for peer review under sub. (3), the agency shall contract with the National Academy of Sciences, Toxicology Excellence for Risk Assessment, or any similar independent scientific entity, or with a group of independent scientists of comparable stature and qualifications, to conduct an external peer review of the studies or scientific or technical data, the scientific methods, and the findings, conclusions, and assumptions that the agency used in developing the rule and of the state and federal laws relevant to the rule. The contract terms shall ensure that individual peer reviewers have expertise in the subject matter of the rule being reviewed and that the external peer review process is completed within 6 months from the date on which the request for peer review was received under sub. (3), except that the deadline for completion may be extended by an additional 6 months if the initial 6 months is determined to be not feasible. Peer review questions and protocols shall be approved, prior to use in the peer review, by the agency and any parties requesting the peer review.

SB894,7,24 (6) Individual peer reviewers. A peer reviewer may not be any of the following:

SB894,8,3 (a) The party requesting the peer review, an employee of the agency or of the requesting party, or the spouse or family member of an employee of the agency or of the requesting party.

SB894,8,4 (b) An interested party or an employee of an interested party.

SB894,8,6 (c) A person who is conducting research that is funded by the agency or by the requesting party.

SB894,8,8 (d) A person who participated in the development of any study or technical or scientific data being reviewed.

SB894,8,12 (7) Final written report. Following completion of the peer review process, the peer review panel shall prepare and submit a final written report to the agency and to the party that requested the external peer review. The report shall include all of the following:

SB894,8,15 (a) An analysis, supported by the majority of the panel, of the panel's confidence in the studies or scientific or technical data, the scientific methods, and the findings, conclusions, and assumptions that the agency used in developing the rule.

SB894,8,16 (b) One of the following conclusions, supported by the majority of the panel:

SB894,8,17 1. The rule is scientifically defensible.

SB894,8,20 2. The rule is not scientifically defensible, does not comply with state or federal law, or would be scientifically defensible if the agency made certain specified modifications to the rule.

SB894,8,21 (c) The findings of each individual peer reviewer.

SB894,8,24 (8) Agency action after peer review is completed. (a) If the final written report under sub. (7) concludes that a proposed rule is scientifically defensible, the agency may continue to promulgate the proposed rule

SB894,9,7 (b) If the final written report concludes that a proposed rule is not scientifically defensible, does not comply with state or federal law, or would be scientifically defensible if the agency made certain modifications to the proposed rule, the agency shall, before continuing to promulgate the proposed rule, modify the proposed rule, in cooperation and agreement with the party that requested the peer review, as necessary to make the proposed rule comply with state and federal law and be scientifically defensible.

SB894,9,13 (c) If the final written report concludes that a rule that is published in the code is not scientifically defensible, does not comply with state or federal law, or would be scientifically defensible if the agency made certain modifications to the code, the agency shall initiate the rulemaking process to make modifications to the code as necessary to make the rule comply with state and federal law and be scientifically defensible.

SB894,9,20 (9) Costs. If the final written report under sub. (7) concludes that a rule is scientifically defensible, the costs of conducting a peer review under this section shall be paid for by the party that submitted the request for peer review under sub. (3). If the final written report concludes that a rule is not scientifically defensible, does not comply with state or federal law, or would be scientifically defensible if the agency made certain modifications to the proposed rule, the agency shall pay for the costs of conducting the peer review under this section.

SB894,5 Section 5. 227.19 (3) (intro.) of the statutes is amended to read:

SB894,9,25 227.19 (3) Form of report. (intro.) The report required under sub. (2) shall be in writing and shall include the proposed rule in the form specified in s. 227.14 (1); the material specified in s. 227.14 (2), (3), and (4); including any statement, suggested changes, or other material submitted to the agency by the small business regulatory review board; a copy of any economic impact analysis prepared by the agency under s. 227.137 (2); a copy of any revised economic impact analysis prepared by the agency under s. 227.137 (4); a copy of any independent economic impact analysis prepared under s. 227.137 (4m); a copy of any energy impact report received from the public service commission under s. 227.117 (2); a copy of any final written report from a peer review panel under s. 227.182; and a copy of any recommendations of the legislative council staff. The report shall also include all of the following:

SB894,6 Section 6. 227.19 (3) (i) of the statutes is created to read:

SB894,10,11 227.19 (3) (i) If a final written report by a peer review panel regarding the proposed rule is submitted with the report required under sub. (2), an explanation of the changes, if any, that were made in the proposed rule in response to that report.

SB894,7 Section 7. Initial applicability.

SB894,10,15 (1) This act first applies to a rule whose statement of scope is presented for approval under section 227.135 (2) of the statutes on the effective date of this subsection.

SB894,10,16 (End)