H. R. 2586—29
for the use of resources available under those laws to address
those risks to human health, safety, and the environment that—
‘‘(A) the covered agency determines to be most serious;
and
‘‘(B) can be addressed in a cost-effective manner, with
the goal of achieving the greatest overall net reduction
in risks with the public and private sector resources
expended.
‘‘(2) DETERMINING THE MOST SERIOUS RISKS.—In identifying
the greatest risks under paragraph (1) of this subsection, each
covered agency shall consider, at a minimum—
‘‘(A) the likelihood, irreversibility, and severity of the
effect; and
‘‘(B) the number and classes of individuals potentially
affected,
and shall explicitly take into account the results of the compara-
tive risk analysis conducted under subsection (d) of this section.
‘‘(3) OMB REVIEW.—The covered agency’s determinations
of the most serious risks for purposes of setting priorities shall
be reviewed and approved by the Director of the Office of
Management and Budget before submission of the covered agen-
cy’s annual budget requests to Congress.
‘‘(4) INCORPORATING RISK-BASED PRIORITIES INTO BUDGET
AND PLANNING.—The head of each covered agency shall incor-
porate the priorities identified under paragraph (1) into the
agency budget, strategic planning, regulatory agenda, enforce-
ment, and research activities. When submitting its budget
request to Congress and when announcing its regulatory agenda
in the Federal Register, each covered agency shall identify
the risks that the covered agency head has determined are
the most serious and can be addressed in a cost-effective man-
ner under paragraph (1), the basis for that determination,
and explicitly identify how the covered agency’s requested
budget and regulatory agenda reflect those priorities.
‘‘(5) EFFECTIVE
DATE.—This subsection shall take effect
12 months after the date of enactment of this Act.
‘‘(d) COMPARATIVE RISK ANALYSIS.—
‘‘(1) REQUIREMENT.—
‘‘(A)(i) No later than 6 months after the effective date
of this Act, the Director of the Office of Management and
Budget shall enter into appropriate arrangements with
a nationally recognized scientific institution or scholarly
organization—
‘‘(I) to conduct a study of the methodologies for
using comparative risk to rank dissimilar human
health, safety, and environmental risks; and
‘‘(II) to conduct a comparative risk analysis.
‘‘(ii) The comparative risk analysis shall compare and
rank, to the extent feasible, human health, safety, and
environmental risks potentially regulated across the spec-
trum of programs administered by all covered agencies.
‘‘(B) The Director shall consult with the Office of
Science and Technology Policy regarding the scope of the
study and the conduct of the comparative risk analysis.
‘‘(C) Nothing in this subsection should be construed
to prevent the Director from entering into a sole-source
H. R. 2586—30
arrangement with a nationally recognized scientific institu-
tion or scholarly organization.
‘‘(2) CRITERIA.—The Director shall ensure that the arrange-
ment under paragraph (1) provides that—
‘‘(A) the scope and specificity of the analysis are suffi-
cient to provide the President and agency heads guidance
in allocating resources across agencies and among programs
in agencies to achieve the greatest degree of risk prevention
and reduction for the public and private resources
expended;
‘‘(B) the analysis is conducted through an open process,
including opportunities for the public to submit views, data,
and analyses and to provide public comment on the results
before making them final;
‘‘(C) the analysis is conducted by a balanced group
of individuals with relevant expertise, including toxi-
cologists, biologists, engineers, and experts in medicine,
industrial hygiene, and environmental effects, and the
selection of members for such study shall be at the sole
discretion of the scientific institution or scholarly organiza-
tion;
‘‘(D) the analysis is conducted, to the extent feasible
and relevant, consistent with the risk assessment and risk
characterization principles in section 633 of this sub-
chapter;
‘‘(E) the methodologies and principal scientific deter-
minations made in the analysis are subjected to independ-
ent peer review consistent with section 633(g), and the
conclusions of the peer review are made publicly available
as part of the final report required under subsection (e);
and
‘‘(F) the results are presented in a manner that distin-
guishes between the scientific conclusions and any policy
or value judgments embodied in the comparisons.
‘‘(3) COMPLETION AND REVIEW.—No later than 3 years after
the effective date of this Act, the comparative risk analysis
required under paragraph (1) shall be completed. The compara-
tive risk analysis shall be reviewed and revised at least every
5 years thereafter for a minimum of 15 years following the
release of the first analysis. The Director shall arrange for
such review and revision by an accredited scientific body in
the same manner as provided under paragraphs (1) and (2).
‘‘(4) STUDY.—The study of methodologies provided under
paragraph (1) shall be conducted as part of the first comparative
risk analysis and shall be completed no later than 180 days
after the completion of that analysis. The goal of the study
shall be to develop and rigorously test methods of comparative
risk analysis. The study shall have sufficient scope and breadth
to test approaches for improving comparative risk analysis
and its use in setting priorities for human health, safety, and
environmental risk prevention and reduction.
‘‘(5) TECHNICAL GUIDANCE.—No later than 180 days after
the effective date of this Act, the Director, in collaboration
with other heads of covered agencies shall enter into a contract
with the National Research Council to provide technical guid-
ance to agencies on approaches to using comparative risk analy-
sis in setting human health, safety, and environmental prior-
H. R. 2586—31
ities to assist agencies in complying with subsection (c) of
this section.
‘‘(e) REPORTS AND RECOMMENDATIONS TO CONGRESS AND THE
PRESIDENT.—No later than 24 months after the effective date of
this Act, each covered agency shall submit a report to Congress
and the President—
‘‘(1) detailing how the agency has complied with subsection
(c) and describing the reason for any departure from the
requirement to establish priorities to achieve the greatest over-
all net reduction in risk;
‘‘(2) recommending—
‘‘(A) modification, repeal, or enactment of laws to
reform, eliminate, or enhance programs or mandates relat-
ing to human health, safety, or the environment; and
‘‘(B) modification or elimination of statutory or
judicially mandated deadlines, that would assist the cov-
ered agency to set priorities in activities to address the
risks to human health, safety, or the environment in a
manner consistent with the requirements of subsection
(c)(1);
‘‘(3) evaluating the categories of policy and value judgment
used in risk assessment, risk characterization, or cost-benefit
analysis; and
‘‘(4) discussing risk assessment research and training
needs, and the agency’s strategy and schedule for meeting
those needs.
‘‘(f) SAVINGS PROVISION AND JUDICIAL REVIEW.—
‘‘(1) IN GENERAL.—Nothing in this section shall be con-
strued to modify any statutory standard or requirement
designed to protect human health, safety, or the environment.
‘‘(2) JUDICIAL REVIEW.—Compliance or noncompliance by
an agency with the provisions of this section shall not be
subject to judicial review.
‘‘(3) AGENCY ANALYSIS.—Any analysis prepared under this
section shall not be subject to judicial consideration separate
or apart from the requirement, rule, program, or law to which
it relates. When an action for judicial review of a covered
agency action is instituted, any analysis for, or relating to,
the action shall constitute part of the whole record of agency
action for the purpose of judicial review of the action and
shall, to the extent relevant, be considered by a court in deter-
mining the legality of the covered agency action.’’.
(b) CLERICAL AMENDMENT.—The table of sections appearing
at the beginning of chapter 6 of title 5, United States Code, is
amended—
(1) by inserting immediately below the chapter heading
the following:
‘‘SUBCHAPTER I—REGULATORY ANALYSIS’’;
and
(2) by adding at the end the following:
‘‘SUBCHAPTER III—RISK ASSESSMENTS
‘‘631. Short title.
‘‘632. Purposes.
‘‘633. Effective date; applicability; savings provisions.
‘‘634. Principles for risk assessment.
‘‘635. Principles for risk characterization and communication.
‘‘636. Recommendations or classifications by a non-United States-based entity.
H. R. 2586—32
‘‘637. Guidelines and report.
‘‘638. Research and training in risk assessment.
‘‘639. Study of comparative risk analysis.
‘‘639a. Definitions.
‘‘639b. Peer review program.
‘‘639c. Petition for review of a major free-standing risk assessment.
‘‘639d. Risk-based priorities.’’.
SEC. 2004. REGULATORY FLEXIBILITY ANALYSIS.
(a) IN GENERAL.—
(1) JUDICIAL REVIEW.—
(A) AMENDMENT.—Section 611 of title 5, United States
Code, is amended to read as follows:
‘‘§ 611. Judicial review
‘‘(a)(1) Not later than one year, notwithstanding any other
provision of law, after the effective date of a final rule with respect
to which an agency—
‘‘(A) certified, pursuant to section 605(b), that such rule
would not have a significant economic impact on a substantial
number of small entities; or
‘‘(B) prepared a final regulatory flexibility analysis pursu-
ant to section 604,
an affected small entity may petition for the judicial review of
such certification or analysis in accordance with the terms of this
subsection. A court having jurisdiction to review such rule for
compliance with the provisions of section 553 or under any other
provision of law shall have jurisdiction to review such certification
or analysis. In the case where an agency delays the issuance of
a final regulatory flexibility analysis pursuant to section 608(b),
a petition for judicial review under this subsection shall be filed
not later than one year, notwithstanding any other provision of
law, after the date the analysis is made available to the public.
‘‘(2) For purposes of this subsection, the term ‘affected small
entity’ means a small entity that is or will be adversely affected
by the final rule.
‘‘(3) Nothing in this subsection shall be construed to affect
the authority of any court to stay the effective date of any rule
or provision thereof under any other provision of law.
‘‘(4)(A) In the case where the agency certified that such rule
would not have a significant economic impact on a substantial
number of small entities, the court may order the agency to prepare
a final regulatory flexibility analysis pursuant to section 604 if
the court determines, on the basis of the rulemaking record, that
the certification was arbitrary, capricious, an abuse of discretion,
or otherwise not in accordance with law.
‘‘(B) In the case where the agency prepared a final regulatory
flexibility analysis, the court may order the agency to take corrective
action consistent with the requirements of section 604 if the court
determines, on the basis of the rulemaking record, that the final
regulatory flexibility analysis was prepared by the agency without
observance of procedure required by section 604.
‘‘(5) If, by the end of the 90-day period beginning on the date
of the order of the court pursuant to paragraph (4) (or such longer
period as the court may provide), the agency fails, as appropriate—
‘‘(A) to prepare the analysis required by section 604; or
‘‘(B) to take corrective action consistent with the require-
ments of section 604,