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11Section
3. 227.135 (5) of the statutes is amended to read:
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227.135
(5) A statement of scope shall expire on the date that is 30 months after
13the date on which it is published in the register. After a statement of scope expires,
14an agency may not submit a proposed rule based upon that statement of scope to the
15legislature for review under s. 227.19 (2), and any such rule that has not been
16submitted to the legislature for review before that date shall be considered
17withdrawn on that date as provided in s. 227.14 (6) (c) 1. a. For purposes of this
18subsection, a revised statement of scope prepared under sub. (4) shall expire on the
19date that is 30 months after the date on which the revised statement is published in
20the register.
If a valid request for external peer review is made under s. 227.182, the
2130-month periods provided under this subsection shall not include the period of time
22between the agency's receipt of the request for external peer review and the
23submission of the final written report under s. 227.182 (7).
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24Section
4. 227.182 of the statutes is created to read:
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1227.182 Peer review.
(1) Definition. In this section, “interested party”
2means a person who will be regulated under a proposed rule, or a person whose client,
3member, or customer will be regulated under a proposed rule.
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4(2) Application. This section applies only to rules that are based on or that rely
5on scientific studies, scientific or technical data, scientific methods, or other similar
6scientific information.
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7(3) Request for peer review. (a) If at any time before submitting a proposed
8rule to the governor for approval under s. 227.185 an agency receives in writing from
9an interested party a valid request to conduct an external peer review of the proposed
10rule, the agency shall initiate an external peer review of the proposed rule under sub.
11(5).
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(b) If at any time before submitting a proposed rule to the governor for approval
13under s. 227.185 an agency receives in writing from the joint committee for review
14of administrative rules a valid request to conduct an external peer review of a
15proposed rule, the agency shall initiate an external peer review under sub. (5).
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(c) If at any time an agency receives in writing from the joint committee for
17review of administrative rules a valid request to conduct an external peer review of
18any of the agency's rules that are published in the code, the agency shall initiate an
19external peer review under sub. (5). The committee may identify one or more specific
20chapters, sections, or other subunits in the code that are administered by the agency
21as the rules that are to be the subject of the external peer review.
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(d) A request for external peer review is valid under this subsection if it objects
23to specific studies or scientific or technical data, specific scientific methods, or
24specific findings, conclusions, or assumptions that the agency used in developing the
25rule and that have not previously been the subject of an external peer review under
1sub. (5), or if it objects on the basis that the rule does not comply with state or federal
2law. If more than one valid request for peer review is received under par. (a), the
3requests shall be consolidated into one external peer review.
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4(4) No agency action during peer review. An agency that receives a valid
5request for peer review under sub. (3) for a proposed rule shall stop work on the
6proposed rule and may not continue promulgating the proposed rule
7notwithstanding any provision authorizing or requiring the agency to promulgate
8the proposed rule, until a final report has been submitted under sub. (7).
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9(5) Independent external peer review. Within 60 days after receiving a valid
10request for peer review under sub. (3), the agency shall contract with the National
11Academy of Sciences, Toxicology Excellence for Risk Assessment, or any similar
12independent scientific entity, or with a group of independent scientists of comparable
13stature and qualifications, to conduct an external peer review of the studies or
14scientific or technical data, the scientific methods, and the findings, conclusions, and
15assumptions that the agency used in developing the rule and of the state and federal
16laws relevant to the rule. The contract terms shall ensure that individual peer
17reviewers have expertise in the subject matter of the rule being reviewed and that
18the external peer review process is completed within 6 months from the date on
19which the request for peer review was received under sub. (3), except that the
20deadline for completion may be extended by an additional 6 months if the initial 6
21months is determined to be not feasible. Peer review questions and protocols shall
22be approved, prior to use in the peer review, by the agency and any parties requesting
23the peer review.
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24(6) Individual peer reviewers. A peer reviewer may not be any of the following:
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1(a) The party requesting the peer review, an employee of the agency or of the
2requesting party, or the spouse or family member of an employee of the agency or of
3the requesting party.
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(b) An interested party or an employee of an interested party.
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(c) A person who is conducting research that is funded by the agency or by the
6requesting party.
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(d) A person who participated in the development of any study or technical or
8scientific data being reviewed.
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9(7) Final written report. Following completion of the peer review process, the
10peer review panel shall prepare and submit a final written report to the agency and
11to the party that requested the external peer review. The report shall include all of
12the following:
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(a) An analysis, supported by the majority of the panel, of the panel's confidence
14in the studies or scientific or technical data, the scientific methods, and the findings,
15conclusions, and assumptions that the agency used in developing the rule.
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(b) One of the following conclusions, supported by the majority of the panel:
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1. The rule is scientifically defensible.
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2. The rule is not scientifically defensible, does not comply with state or federal
19law, or would be scientifically defensible if the agency made certain specified
20modifications to the rule.
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(c) The findings of each individual peer reviewer.
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22(8) Agency action after peer review is completed. (a) If the final written
23report under sub. (7) concludes that a proposed rule is scientifically defensible, the
24agency may continue to promulgate the proposed rule
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1(b) If the final written report concludes that a proposed rule is not scientifically
2defensible, does not comply with state or federal law, or would be scientifically
3defensible if the agency made certain modifications to the proposed rule, the agency
4shall, before continuing to promulgate the proposed rule, modify the proposed rule,
5in cooperation and agreement with the party that requested the peer review, as
6necessary to make the proposed rule comply with state and federal law and be
7scientifically defensible.
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(c) If the final written report concludes that a rule that is published in the code
9is not scientifically defensible, does not comply with state or federal law, or would be
10scientifically defensible if the agency made certain modifications to the code, the
11agency shall initiate the rulemaking process to make modifications to the code as
12necessary to make the rule comply with state and federal law and be scientifically
13defensible.
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14(9) Costs. If the final written report under sub. (7) concludes that a rule is
15scientifically defensible, the costs of conducting a peer review under this section shall
16be paid for by the party that submitted the request for peer review under sub. (3).
17If the final written report concludes that a rule is not scientifically defensible, does
18not comply with state or federal law, or would be scientifically defensible if the agency
19made certain modifications to the proposed rule, the agency shall pay for the costs
20of conducting the peer review under this section.
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21Section
5. 227.19 (3) (intro.) of the statutes is amended to read:
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227.19
(3) Form of report. (intro.) The report required under sub. (2) shall be
23in writing and shall include the proposed rule in the form specified in s. 227.14 (1);
24the material specified in s. 227.14 (2), (3), and (4); including any statement,
25suggested changes, or other material submitted to the agency by the small business
1regulatory review board; a copy of any economic impact analysis prepared by the
2agency under s. 227.137 (2); a copy of any revised economic impact analysis prepared
3by the agency under s. 227.137 (4); a copy of any independent economic impact
4analysis prepared under s. 227.137 (4m); a copy of any energy impact report received
5from the public service commission under s. 227.117 (2);
a copy of any final written
6report from a peer review panel under s. 227.182; and a copy of any recommendations
7of the legislative council staff. The report shall also include all of the following:
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8Section
6. 227.19 (3) (i) of the statutes is created to read:
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227.19
(3) (i) If a final written report by a peer review panel regarding the
10proposed rule is submitted with the report required under sub. (2), an explanation
11of the changes, if any, that were made in the proposed rule in response to that report.
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12Section
7.
Initial applicability.
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(1) This act first applies to a rule whose statement of scope is presented for
14approval under section 227.135 (2) of the statutes on the effective date of this
15subsection.