LRB-5842/1
MCP:cjs
2021 - 2022 LEGISLATURE
February 15, 2022 - Introduced by Representatives Dallman and Brooks,
cosponsored by Senators Felzkowski and Stroebel. Referred to Committee
on Environment.
AB987,1,4
1An Act to amend 227.135 (5) and 227.19 (3) (intro.); and
to create 160.07 (4m),
2227.135 (1m), 227.182 and 227.19 (3) (i) of the statutes;
relating to: peer review
3of administrative rules, comments to proposed statements of scope, and review
4of proposed groundwater enforcement standards.
Analysis by the Legislative Reference Bureau
Peer review of administrative rules
This bill creates an external peer review process for administrative rules.
Under the bill, an interested party may request an external peer review of a
proposed rule at any time before the proposed rule is submitted to the governor for
review. An interested party is any person who will be regulated under the proposed
rule or any person whose client, member, or customer will be regulated under the
proposed rule. The bill also provides that the Joint Committee for Review of
Administrative Rules may request an external peer review of a proposed rule or of
any agency rule that has been published in the administrative code. Under the bill,
if an agency receives a valid request for peer review of a proposed rule or of a rule that
has been published in the code, the agency must initiate the external peer review
process. A request for peer review may be made only for rules that are based on or
that rely on scientific studies, scientific or technical data, scientific methods, or other
similar scientific information. A request is valid if it objects to specific studies or
scientific or technical data, specific methods, or specific findings, conclusions, or
assumptions that the agency used in developing the rule.
The bill provides that an agency that receives a valid request for peer review
of a proposed rule may not continue promulgating the proposed rule until the peer
review process is complete. Under the bill, the external peer review process must be
completed within six months from the date on which the request for peer review was
submitted, except that the deadline for completion may be extended by an additional
six months if the initial six months is determined to not be feasible. In addition, the
bill requires peer review questions and protocols to be approved prior to use in the
peer review process by the agency and any parties requesting the peer review.
Under the bill, an agency that receives a valid request for peer review of a rule
must 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 methods, or the
findings, conclusions, or assumptions that the agency used in developing the rule.
Under the bill, a peer reviewer must have expertise in the subject matter of the
rule being reviewed. The bill prohibits all of the following people from acting as peer
reviewers: a party requesting the peer review, an employee of the agency or of a
requesting party, or the spouse or family member of an employee of the agency or of
a requesting party; an interested party or an employee of an interested party; a
person who is conducting research that is funded by the agency or by a requesting
party; or a person who participated in the development of any study or technical or
scientific data being reviewed.
Under the bill, once the peer review process is complete, the peer review panel
must prepare a final written report that provides one of two conclusions: 1) the rule
is scientifically defensible; or 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 modifications to the rule. If the peer review panel concludes that a
proposed rule is scientifically defensible, the agency may continue to promulgate the
proposed rule. If the peer review panel 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 must modify the proposed rule as necessary, in cooperation and
agreement with the party that requested the peer review, before continuing to
promulgate the proposed rule. If the peer review panel concludes that a rule that has
been published in the administrative 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 must initiate the rulemaking
process to make necessary modifications to the code.
Under the bill, if the peer review panel concludes that a rule is scientifically
defensible, the costs of the peer review process must be paid by the party that
submitted the request for peer review. If the peer review panel concludes that a rule
is not scientifically defensible, does not comply with state or federal law, or would be
scientifically defensible if certain modifications were made, the agency must pay for
the costs of the peer review process.
Soliciting comments on scope statements
The bill also requires an agency, before submitting a statement of scope of a
proposed rule to the Department of Administration and to the governor, to solicit and
consider comments on the statement of scope from persons who may be regulated
under the proposed rule. For rules that will be based on or rely on scientific studies,
scientific or technical data, scientific methods, or other similar scientific
information, the promulgating agency must incorporate comments into the
statement of scope, if the comments are scientifically valid, are supported by relevant
industries, and recommend changes that will ensure compliance with relevant state
law and will ensure the accuracy, integrity, objectivity, or consistency of data that will
be used to promulgate the rule.
Notice and review of proposed groundwater standards
Under current law, the Department of Health Services develops
recommendations for groundwater enforcement standards for certain substances of
public health concern. The Department of Natural Resources incorporates these
recommendations into its rules relating to groundwater enforcement standards.
This bill requires DHS, before submitting to DNR a recommended enforcement
standard for a substance identified as a public health concern, to provide public
notice of the proposed recommendation and the studies or scientific or technical data,
the methodologies, and the findings, conclusions, and assumptions that DHS used
in developing the recommended enforcement standard.
The bill also provides that if, before DHS submits a recommendation for a
groundwater enforcement standard to DNR, an interested party objects to the
recommendation based on a failure to comply with state groundwater laws or based
on the accuracy, integrity, objectivity, or consistency of the data used to develop the
recommendation, DHS must convene a working group to review the
recommendation. The working group must consist of the interested party objecting
to the recommendation, four members from statewide agriculture associations, one
member from the Department of Agriculture, Trade and Consumer Protection, and
one member from DNR. If there is a consensus by the working group that changes
are needed to ensure compliance with state groundwater laws or to ensure the
accuracy, integrity, objectivity, or consistency of the data used to develop the
recommendation, DHS must modify the recommendation accordingly before
submitting the recommendation to DNR.
For further information see the state fiscal estimate, which will be printed as
an appendix to this bill.
The people of the state of Wisconsin, represented in senate and assembly, do
enact as follows:
AB987,1
1Section
1. 160.07 (4m) of the statutes is created to read:
AB987,4,7
1160.07
(4m) (a) Upon developing a recommendation for an enforcement
2standard under sub. (4) and before submitting the recommendation to the
3department, the department of health services shall provide public notice, including
4by publishing on the department's Internet site, of the proposed recommended
5enforcement standard and the studies or scientific or technical data, the
6methodologies, and the findings, conclusions, and assumptions that the department
7used in developing the recommended enforcement standard.
AB987,4,228
(b) If, before the department of health services submits a recommendation for
9an enforcement standard under sub. (3), an interested party, as defined in s. 227.182
10(1), submits to the department of health services a written objection to the
11recommendation based on a failure to comply with this chapter or based on the
12accuracy, integrity, objectivity, or consistency of the data used to develop the
13recommendation, the department of health services shall convene a working group
14to review the recommendation. The working group shall consist of the interested
15party objecting to the recommendation, 4 members from statewide agriculture
16associations, one member from the department of agriculture, trade and consumer
17protection, and one member from the department of natural resources. If there is a
18consensus by the working group that changes are needed to ensure compliance with
19this chapter or to ensure the accuracy, integrity, objectivity, or consistency of the data
20used to develop the recommendation, the department of health services shall modify
21the recommendation accordingly before submitting the recommendation to the
22department of natural resources.
AB987,2
23Section
2. 227.135 (1m) of the statutes is created to read:
AB987,5,1024
227.135
(1m) Before presenting a statement of the scope of a proposed rule to
25the department of administration and the governor under sub. (2), an agency shall
1solicit comments on the statement of scope from persons who may be regulated under
2the proposed rule. The agency shall consider any comments received in determining
3whether to adopt the statement of scope as originally proposed, modify the proposed
4statement of scope, or take any other action. For any statement of scope of a proposed
5rule that will be based on or rely on scientific studies, scientific or technical data,
6scientific methods, or other similar scientific information, the agency shall
7incorporate into the statement of scope any comments received that are scientifically
8valid, are supported by relevant industries, and recommend changes that will ensure
9compliance with relevant state law and will ensure the accuracy, integrity,
10objectivity, or consistency of the data that will be used to promulgate the rule.
AB987,3
11Section
3. 227.135 (5) of the statutes is amended to read:
AB987,5,2312
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).
AB987,4
24Section
4. 227.182 of the statutes is created to read:
AB987,6,3
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.
AB987,6,6
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.
AB987,6,11
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).
AB987,6,1512
(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).
AB987,6,2116
(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.
AB987,7,322
(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.
AB987,7,8
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).
AB987,7,23
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.
AB987,7,24
24(6) Individual peer reviewers. A peer reviewer may not be any of the following:
AB987,8,3
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.
AB987,8,44
(b) An interested party or an employee of an interested party.
AB987,8,65
(c) A person who is conducting research that is funded by the agency or by the
6requesting party.
AB987,8,87
(d) A person who participated in the development of any study or technical or
8scientific data being reviewed.
AB987,8,12
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:
AB987,8,1513
(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.
AB987,8,1616
(b) One of the following conclusions, supported by the majority of the panel:
AB987,8,1717
1. The rule is scientifically defensible.
AB987,8,2018
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.
AB987,8,2121
(c) The findings of each individual peer reviewer.
AB987,8,24
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
AB987,9,7
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.
AB987,9,138
(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.
AB987,9,20
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.
AB987,5
21Section
5. 227.19 (3) (intro.) of the statutes is amended to read:
AB987,9,2522
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:
AB987,6
8Section
6. 227.19 (3) (i) of the statutes is created to read:
AB987,10,119
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.