[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3210 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 3210
To amend title 5, United States Code, to require disclosure of
conflicts of interest with respect to rulemaking, and for other
purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
November 19, 2025
Ms. Warren (for herself, Mr. Welch, Mr. Van Hollen, Mr. Schiff, Mr.
Sanders, Mr. Blumenthal, Mr. Wyden, Mr. Booker, Mr. Merkley, Ms.
Hirono, Mr. Lujan, Mr. Markey, and Mr. Kim) introduced the following
bill; which was read twice and referred to the Committee on Homeland
Security and Governmental Affairs
_______________________________________________________________________
A BILL
To amend title 5, United States Code, to require disclosure of
conflicts of interest with respect to rulemaking, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Experts Protect Effective Rules,
Transparency, and Stability Act of 2025'' or the ``EXPERTS Act of
2025''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) Congress is dependent on providing discretion to
executive officials and agencies (including independent
agencies) to implement its statutes. Congress provides
appropriate oversight of the use of this discretion.
(2) Regulatory legislation is often phrased in broad terms,
with an intelligible principle, to empower agencies to address
issues, such as those presented by technological, scientific,
or social developments that were not precisely foreseen when
the legislation was enacted, and to draw upon the agency's
specialized knowledge, experience, and responsibility for
implementing the statute.
(3) Such broad authorizing language is often necessary to
empower the administering agency to take effective action when
new or unforeseen issues arise, provided that the rule does not
exceed clear limits in statute nor implement it in an
impermissible manner.
(4) A rule that an agency has adopted to implement a
broadly worded regulatory statute should generally not be held
to be invalid on the basis that Congress has not addressed the
agency's proposed course of action in specific terms.
(5) A rule that an agency has adopted to implement a
regulatory statute should generally not be held to be invalid
on the basis that the agency has not previously adopted a
similar rule or scheme of regulation.
(6) The expectation that a rule will have broad economic,
political, or social significance, should not, standing alone,
negate application of the principle stated in paragraph (1),
(2), or (3).
SEC. 3. SENSE OF CONGRESS.
It is the sense of Congress that--
(1) agency economic analyses of regulatory actions commonly
underestimate the benefits of regulatory actions that protect
public health and safety and overestimate the costs of
regulatory action to industry;
(2) agency regulatory actions often fail to adequately
consider the distributional effects and social equity impact of
regulatory action; and
(3) an agency shall prioritize the statutory direction of
Congress when taking regulatory action.
SEC. 4. DISCLOSURE OF CONFLICTS OF INTEREST.
Section 553 of title 5, United States Code, is amended--
(1) in subsection (c)--
(A) by striking ``After notice required'' and
inserting ``(1) After notice required'';
(B) in the first sentence of paragraph (1), as so
designated, by inserting ``, subject to subsections (f)
and (h),'' after ``the agency shall''; and
(C) by adding at the end the following:
``(2) In the case of any submission under paragraph (1) by an
interested person that includes a scientific, economic, or technical
study or research (or a citation thereto) that the interested person
funded directly or indirectly, or the nonpublic results of any
scientific, economic, or technical study or research that the
interested person funded directly or indirectly, the interested person
shall disclose to the agency the following:
``(A) The amount of any funds that were received by the
person who conducted the study or research.
``(B) The entity that provided the funds referred to in
subparagraph (A).
``(C) Any entity that was allowed to review or revise the
study or research, and the extent of that review or revision.
``(D) Any financial relationship between the person who
conducted the study or research, and any person that would be
affected by the proposed rule.''; and
(2) by adding at the end the following:
``(f) With respect to any submission by an interested person under
subsection (c) or any other submission by an interested person relating
to a proposed rule or final rule that includes a scientific, economic,
or technical study or research by the interested person not published
in a publicly available peer-reviewed publication, or any result of a
scientific, economic, or technical study or research by the interested
person not published in a publicly available peer-reviewed publication,
the interested person, in making that submission, shall disclose to the
agency--
``(1) the source of any funding for the study or research,
as applicable;
``(2) any entity that sponsored the study or research;
``(3) the extent to which the findings of the study or
research were reviewed by a person that may be affected by the
rule making to which the submission relates;
``(4) the identity of any person identified under paragraph
(3); and
``(5) the nature of any financial relationship, including a
consulting agreement, the support of any expert witness, and
the funding of research, between any person that conducted the
study or research and any interested person with respect to the
rule making to which the submission relates.''.
SEC. 5. INCREASING DISCLOSURES RELATING TO STUDIES AND RESEARCH.
Section 553 of title 5, United States Code, as amended by section 4
of this Act, is amended by adding at the end the following:
``(g) With respect to a study or research that is submitted by an
interested person to an agency under subsection (c), the agency shall
ensure that the study or research is available to the public (including
on the internet website of the agency and on the public docket of the
agency for the rule making) unless disclosure is exempted or excluded
under section 552.
``(h)(1) If a study or research submitted by an interested person
to an agency under subsection (c) presents a conflict described in
paragraph (2), the agency shall disclose the conflict to the public on
the internet website of the agency and on the public docket of the
agency, and by publication in the Federal Register, unless disclosure
is exempted or excluded under section 552.
``(2) A conflict described in this subsection means a study or
research for which--
``(A) not less than 10 percent of the funding for the study
or research is from an entity subject to the jurisdiction of
the agency with respect to that rule making; or
``(B) an entity subject to the jurisdiction of the agency
with respect to that rule making that is regulated by the
agency conducts, reviews, or revises the study or research.
``(i) In the case of a violation of the requirement to make a
disclosure under subsection (c)(2) or subsection (f) with respect to a
submission or under subsection (h) with respect to a conflict related
to a submission referred to under subsection (g), the agency may
exclude from consideration or otherwise disregard the submission, and
the agency has no obligation to respond to the submission, except that
the submission may be remade with required disclosures during the
opportunity for participation referred to in subsection (c)(1). Nothing
in this subsection may be construed to affect the level of deference
(in accordance with applicable law) accorded to agency action by a
court reviewing such action.''.
SEC. 6. DISCLOSURE OF INTER-GOVERNMENTAL RULE CHANGE.
With respect to any material provided to the Office with regard to
a regulatory action for purposes of centralized review of regulatory
actions, the agency shall--
(1) not later than the date on which the agency publishes a
general notice of proposed rule making required under section
553(b) of title 5, United States Code, with respect to the
action, place in the rule making docket--
(A) the substance of any change between the text of
any draft regulatory action that the agency provided to
the Office and the text published in the general notice
with respect to the action; and
(B) a statement regarding whether any change
described in subparagraph (A) was made as a result of
communication with--
(i) the Office;
(ii) another agency; or
(iii) any other Federal official; and
(2) not later than the date on which the agency publishes
the regulatory action in the Federal Register, place in the
rule making docket--
(A) the substance of any changes between the text
of the regulatory action that the agency provided to
the Office and the text of the regulatory action that
the agency published in the Federal Register; and
(B) a statement regarding whether any change
described in subparagraph (A) was made as a result of
communication with--
(i) the Office;
(ii) another agency; or
(iii) any other Federal official.
SEC. 7. JUSTIFICATION OF WITHDRAWN RULES.
(a) In General.--If an agency withdraws a regulatory action after
providing the action to the Office under section 6(a)(3) of the
Executive Order 12866 (5 U.S.C. 601 note; relating to regulatory
planning and review) (or, if the agency does not provide the regulatory
action to the Office under that section, after publishing the general
notice of proposed rulemaking with respect to the action under section
553(b) of title 5, United States Code), the agency shall publish in the
Federal Register, on the public docket of the agency, and on the
internet website of the agency a statement regarding the decision by
the agency to withdraw the action.
(b) Contents.--A statement required under subsection (a) with
respect to a decision by an agency to withdraw a regulatory action
shall include, at a minimum--
(1) a detailed explanation of the reasons that the agency
withdrew the action; and
(2) an explanation regarding whether the decision by the
agency to withdraw the action was based, in whole or in part,
on a request by, or input from--
(A) the Office;
(B) another agency; or
(C) any Federal official.
SEC. 8. NEGOTIATED RULEMAKING.
(a) In General.--Subchapter III of chapter 5 of title 5, United
States Code, is amended--
(1) in section 561, in the first sentence, by inserting
``between agencies and Federal, State, local, or Tribal
governments. This subchapter shall apply only to informal
negotiations between Federal, State, local, or Tribal
governments'' after ``informal rulemaking process'';
(2) in section 563--
(A) in subsection (a)--
(i) in paragraph (2), by inserting
``Federal, State, local, or Tribal government''
after ``identifiable''; and
(ii) in paragraph (3), by striking
``persons who'' and inserting ``representatives
of Federal, State, local, and Tribal
governments that''; and
(B) in subsection (b)--
(i) in paragraph (1)--
(I) in subparagraph (A)--
(aa) by striking ``persons
who'' and inserting ``Federal,
State, local, or Tribal
governments that''; and
(bb) by striking ``,
including residents of rural
areas''; and
(II) in subparagraph (B)--
(aa) by striking ``with
such persons'' and inserting
``with representatives of those
governments''; and
(bb) by striking ``to such
persons'' and inserting ``to
those governments''; and
(ii) in paragraph (2), in the second
sentence--
(I) by striking ``persons who'' and
inserting ``representatives of Federal,
State, local, or Tribal governments
that''; and
(II) by striking ``, including
residents of rural areas'';
(3) in section 564--
(A) in the section heading, by striking ``;
applications for membership on committees'';
(B) in subsection (a)--
(i) in paragraph (4), by striking ``the
persons'' and inserting ``the representatives
of Federal, State, local, and Tribal
governments'';
(ii) in paragraph (6), by adding ``and'' at
the end;
(iii) in paragraph (7), by striking ``;
and'' and inserting a period; and
(iv) by striking paragraph (8);
(C) by striking subsection (b);
(D) by redesignating subsection (c) as subsection
(b); and
(E) in subsection (b), as so redesignated--
(i) in the subsection heading, by striking
``and Applications''; and
(ii) by striking ``and applications'';
(4) in section 565(a)--
(A) in paragraph (1), in the first sentence, by
striking ``and applications''; and
(B) in paragraph (2)--
(i) by striking ``and applications''; and
(ii) by striking ``publications,'' and all
that follows through the period at the end and
inserting ``publications.''; and
(5) in section 569(a), in the first sentence--
(A) by striking ``and encourage agency use of'';
and
(B) by inserting ``between Federal, State, local,
and Tribal governments'' after ``negotiated
rulemaking''.
(b) Technical and Conforming Amendments.--
(1) Balanced budget act of 1997.--Section 4554(b)(1) of the
Balanced Budget Act of 1997 (42 U.S.C. 1395u note) is amended
by striking ``, using a negotiated rulemaking process under
subchapter III of chapter 5 of title 5, United States Code''.
(2) Elementary and secondary education act of 1965.--The
Elementary and Secondary Education Act of 1965 (20 U.S.C. 6301
et seq.) is amended--
(A) in section 1601 (20 U.S.C. 6571)--
(i) in subsection (a), by striking
``subsections (b) through (d)'' and inserting
``subsection (b)'';
(ii) by striking subsections (b) and (c);
and
(iii) by redesignating subsections (d) and
(e) as subsections (b) and (c), respectively;
(B) by repealing section 1602 (20 U.S.C. 6572); and
(C) in section 8204(c)(1) (20 U.S.C. 7824(c)(1)),
by striking ``using a negotiated rulemaking process to
develop regulations for implementation no later than
the 2017-2018 academic year, shall define'' and
inserting ``shall, for implementation no later than the
2017-2018 academic year, define''.
(3) Health insurance portability and accountability act of
1996.--Section 216(b) of the Health Insurance Portability and
Accountability Act of 1996 (42 U.S.C. 1320a-7b note) is amended
to read as follows:
``(b) Rulemaking for Risk-Sharing Exception.--
``(1) Establishment.--The Secretary of Health and Human
Services (in this subsection referred to as the `Secretary')
shall establish standards relating to the exception for risk-
sharing arrangements to the anti-kickback penalties described
in section 1128B(b)(3)(F) of the Social Security Act, as added
by subsection (a).
``(2) Factors to consider.--In establishing standards
relating to the exception for risk-sharing arrangements to the
anti-kickback penalties under paragraph (1), the Secretary--
``(A) shall consult with the Attorney General and
representatives of the hospital, physician, other
health practitioner, and health plan communities, and
other interested parties; and
``(B) shall take into account--
``(i) the level of risk appropriate to the
size and type of arrangement;
``(ii) the frequency of assessment and
distribution of incentives;
``(iii) the level of capital contribution;
and
``(iv) the extent to which the risk-sharing
arrangement provides incentives to control the
cost and quality of health care services.''.
(4) Higher education act of