I
105TH CONGRESS
2D SESSION
H. R. 3234
To require peer review of scientific data used in support of Federal
regulations, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
FEBRUARY 12, 1998
Mr. POMBO (for himself, Mr. LEWIS of California, Mr. MCKEON, Mr. SES-
SIONS, Mr. STUMP, Mr. DOOLITTLE, and Mr. COBURN) introduced the
following bill; which was referred to the Committee on Government Re-
form and Oversight, and in addition to the Committee on Science, for a
period to be subsequently determined by the Speaker, in each case for
consideration of such provisions as fall within the jurisdiction of the com-
mittee concerned
A BILL
To require peer review of scientific data used in support
of Federal regulations, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Science Integrity Act’’.
SEC. 2. PEER REVIEW REQUIREMENT.
(a) IN GENERAL.—Not later than January 1, 1999,
the head of each Federal department or agency which
issues or may issue regulations supported by scientific
data shall issue regulations under this section establishing
procedures to ensure that the acquisition, interpretation,
incorporation, and application of all such scientific data
is subject to peer review by at least 2 but not more than
5 individuals from the list created pursuant to subsection
(b).
(b) LIST OF PEER REVIEWERS.—The head of each
Federal department or agency which issues or may issue
regulations supported by scientific data shall create, using
the Federal Register, scientific and commercial journals,
the National Academy of Sciences, and other similar re-
sources, a list of individuals who are qualified and willing
to perform peer review functions for the department or
agency. Such list shall include only individuals who—
(1) by virtue of advanced education, training, or
avocational, academic, commercial, research, or
other experience, are competent to review the appro-
priateness of any scientific methodology supporting
regulations that the department or agency may
issue, the validity of any conclusions drawn from the
supporting data, and the competency of the research
or preparation of the scientific data; and
(2) are not otherwise employed by or under con-
tract with the department or agency.
(c) SELECTION OF PEER REVIEWERS.—The head of
each department or agency shall select individuals from
the list created pursuant to subsection (b) to peer review
each proposed regulation of the department or agency that
is supported by scientific data. No individual shall be se-
lected who—
(1) has actively participated in advocating or
opposing the issuance of the proposed regulation;
(2) has a direct financial interest in the pro-
posed regulation; or
(3) is employed by or related to any person hav-
ing a direct financial interest in the proposed regula-
tion.
(d) PROVISION OF SCIENTIFIC DATA TO PEER RE-
VIEWERS.—Peer reviewers selected under subsection (c)
shall be provided with all scientific data used in support
of the proposed regulation, and any other related data re-
quested by the peer reviewer that is reasonably available
to the department or agency.
(e) EXPENSES.—Peer reviewers selected under sub-
section (c) shall be reimbursed by the department or agen-
cy for expenses directly incurred in performing the peer
review, but shall not otherwise be compensated for per-
forming the peer review.
(f) AVAILABILITY FOR PUBLIC COMMENT.—Upon re-
ceipt of all peer review reports for a proposed regulation,
the head of a department or agency shall publish in the
Federal Register a notice of the availability of those re-
ports, and the scientific data reviewed therein, for public
comment. The department or agency shall make such re-
ports and scientific data readily available upon request
and shall receive public comment thereon for a period of
60 days after the publication of notice in the Federal Reg-
ister.
(g) REVIEW BY OFFICE OF REGULATIONS INTEG-
RITY.—Within 30 days after the completion of a public
comment period described in subsection (f), the head of
a department or agency shall transmit to the Office of
Regulations Integrity established under section 3—
(1) each peer review report;
(2) all scientific data used in support of the
proposed regulation or requested by a peer reviewer;
(3) the response of the head of the department
or agency to points of disagreement, if any, among
the peer reviewers; and
(4) all public comments received.
The proposed regulation may not be issued in final form
until 30 days after the transmittal under this subsection.
Any recommendations of the Office of Regulations Integ-
rity in response to a transmittal under this subsection
shall be provided to the department or agency, the Presi-
dent, and the Congress.
(h) FINAL ISSUANCE.—The publication of a final reg-
ulation peer reviewed under this section shall include a
summary of the related peer review reports and any points
of disagreement among the peer reviewers, and the re-
sponse of the head of the department or agency to the
peer review reports.
(i) EMERGENCY EXCEPTION.—Regulations issued
under subsection (a) shall include provisions that permit
the issuance of regulations supported by scientific data in
emergency circumstances without peer review, on the con-
dition that peer review be completed within 90 days after
such issuance.
SEC. 3. OFFICE OF REGULATIONS INTEGRITY.
(a) ESTABLISHMENT.—There is established an Office
of Regulations Integrity (in this section referred to as the
‘‘Office’’).
(b) DUTIES.—The duties of the Office shall be—
(1) to review regulations issued by each depart-
ment or agency under section 2(a), and if the Office
determines that such regulations do not represent
the expert opinions of a majority of the scientists
who will be carrying out peer reviews under section
2, or that such regulations are inadequate or inap-
propriate in any respect, to notify the department or
agency, the President, and the Congress;
(2) to transmit to the President and the Con-
gress an annual report on the performance of each
department or agency in complying with its regula-
tions issued under section 2(a); and
(3) to review regulations issued by a depart-
ment or agency with supporting scientific data, if
the Office has reason to believe the regulations were
issued, or the scientific data was acquired, inter-
preted, incorporated, or applied, in a manner signifi-
cantly inconsistent with the regulations issued by the
department or agency under section 2(a), and if the
Office finds the issuance, acquisition, interpretation,
incorporation, or application to be inconsistent with
the regulations issued by the department or agency
under section 2(a), to notify the department or
agency, the President, and the Congress.
(c) ACCESS TO INFORMATION.—The Office shall be
provided access by a department or agency to information
required for carrying out a review under subsection (b).
(d) DIRECTOR.—
(1) APPOINTMENT.—The Office shall have a
Director, who shall be appointed by the President,
subject to confirmation by the Senate, for a term of
1 year.
(2) QUALIFICATIONS.—The Director shall be a
person with a scientific background, in good stand-
ing in the scientific community.
(3) BASIC PAY.—The Director shall be paid at
a rate not to exceed the rate of basic pay for level
III of the Executive Schedule, under section 5314 of
title 5, United States Code.
(e) STAFF.—The professional staff of the Office shall
be persons with scientific backgrounds, in good standing
in the scientific community.
(f) ADMINISTRATIVE SUPPORT.—The Office of Man-
agement and Budget shall provide such administrative
support as the Office established under this section re-
quires, but the Director of the Office of Management and
Budget shall have no responsibilities with respect to carry-
ing out the duties of the Office under this section.
SEC. 4. DEFINITION OF PEER REVIEW.
For purposes of this Act, the term ‘‘peer review’’
means identifying technical or scientific deficiencies of a
proposal, assessing whether the methodology and analysis
supporting a proposal conform to the standards of the aca-
demic and scientific community, and determining whether
a proposal is supported by sufficient credible evidence.
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