293
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 para-
graph (1) of this subsection, each covered agency
shall consider, at a minimum—
‘‘(A) the likelihood, irreversibility, and se-
verity of the effect; and
‘‘(B) the number and classes of individuals
potentially affected,
and shall explicitly take into account the results of
the comparative risk analysis conducted under sub-
section (d) of this section.
‘‘(3) OMB REVIEW.—The covered agency’s de-
terminations 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 agency’s
annual budget requests to Congress.
‘‘(4) INCORPORATING
RISK-BASED
PRIORITIES
INTO BUDGET AND PLANNING.—The head of each
covered agency shall incorporate the priorities identi-
fied under paragraph (1) into the agency budget,
strategic planning, regulatory agenda, enforcement,
and research activities. When submitting its budget
294
request to Congress and when announcing its regu-
latory agenda in the Federal Register, each covered
agency shall identify the risks that the covered agen-
cy head has determined are the most serious and
can be addressed in a cost-effective manner under
paragraph (1), the basis for that determination, and
explicitly identify how the covered agency’s requested
budget and regulatory agenda reflect those prior-
ities.
‘‘(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 or-
ganization—
‘‘(I) to conduct a study of the meth-
odologies for using comparative risk to
rank dissimilar human health, safety, and
environmental risks; and
295
‘‘(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 spectrum of
programs administered by all covered agencies.
‘‘(B) The Director shall consult with the
Office of Science and Technology Policy regard-
ing 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 arrangement with a nationally
recognized scientific institution or scholarly or-
ganization.
‘‘(2) CRITERIA.—The Director shall ensure that
the arrangement under paragraph (1) provides
that—
‘‘(A) the scope and specificity of the analy-
sis are sufficient to provide the President and
agency heads guidance in allocating resources
across agencies and among programs in agen-
cies to achieve the greatest degree of risk pre-
296
vention 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 bal-
anced group of individuals with relevant exper-
tise, including toxicologists, biologists, engi-
neers, and experts in medicine, industrial hy-
giene, and environmental effects, and the selec-
tion of members for such study shall be at the
sole discretion of the scientific institution or
scholarly organization;
‘‘(D) the analysis is conducted, to the ex-
tent feasible and relevant, consistent with the
risk assessment and risk characterization prin-
ciples in section 633 of this subchapter;
‘‘(E) the methodologies and principal sci-
entific determinations made in the analysis are
subjected to independent peer review consistent
with section 633(g), and the conclusions of the
peer review are made publicly available as part
297
of the final report required under subsection
(e); and
‘‘(F) the results are presented in a manner
that distinguishes between the scientific conclu-
sions and any policy or value judgments em-
bodied in the comparisons.
‘‘(3) COMPLETION AND REVIEW.—No later than
3 years after the effective date of this Act, the com-
parative risk analysis required under paragraph (1)
shall be completed. The comparative 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 ar-
range 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 pro-
vided 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 com-
pletion of that analysis. The goal of the study shall
be to develop and rigorously test methods of com-
parative risk analysis. The study shall have suffi-
cient scope and breadth to test approaches for im-
proving comparative risk analysis and its use in set-
298
ting priorities for human health, safety, and environ-
mental risk prevention and reduction.
‘‘(5) TECHNICAL
GUIDANCE.—No later than
180 days after the effective date of this Act, the Di-
rector, in collaboration with other heads of covered
agencies shall enter into a contract with the Na-
tional Research Council to provide technical guid-
ance to agencies on approaches to using comparative
risk analysis in setting human health, safety, and
environmental priorities to assist agencies in comply-
ing with subsection (c) of this section.
‘‘(e) REPORTS
AND RECOMMENDATIONS
TO CON-
GRESS 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 pri-
orities to achieve the greatest overall net reduction
in risk;
‘‘(2) recommending—
‘‘(A) modification, repeal, or enactment of
laws to reform, eliminate, or enhance programs
or mandates relating to human health, safety,
or the environment; and
299
‘‘(B) modification or elimination of statu-
tory or judicially mandated deadlines,that would
assist the covered agency to set priorities in ac-
tivities to address the risks to human health,
safety, or the environment in a manner consist-
ent with the requirements of subsection (c)(1);
‘‘(3) evaluating the categories of policy and
value judgment used in risk assessment, risk charac-
terization, or cost-benefit analysis; and
‘‘(4) discussing risk assessment research and
training needs, and the agency’s strategy and sched-
ule for meeting those needs.
‘‘(f) SAVINGS PROVISION AND JUDICIAL REVIEW.—
‘‘(1) IN
GENERAL.—Nothing in this section
shall be construed to modify any statutory standard
or requirement designed to protect human health,
safety, or the environment.
‘‘(2) JUDICIAL
REVIEW.—Compliance or non-
compliance by an agency with the provisions of this
section shall not be subject to judicial review.
‘‘(3) AGENCY
ANALYSIS.—Any analysis pre-
pared under this section shall not be subject to judi-
cial consideration separate or apart from the re-
quirement, rule, program, or law to which it relates.
When an action for judicial review of a covered
300
agency action is instituted, any analysis for, or relat-
ing 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 determining 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.
‘‘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. 3004. REGULATORY FLEXIBILITY ANALYSIS.
(a) IN GENERAL.—
(1) JUDICIAL REVIEW.—
301
(A) AMENDMENT.—Section 611 of title 5,
United States Code, is amended to read as fol-
lows:
‘‘§ 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 im-
pact on a substantial number of small entities; or
‘‘(B) prepared a final regulatory flexibility anal-
ysis pursuant to section 604,
an affected small entity may petition for the judicial re-
view 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 regu-
latory flexibility analysis pursuant to section 608(b), a pe-
tition 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 avail-
able to the public.
302
‘‘(2) For purposes of this subsection, the term ‘af-
fected 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 certifi-
cation 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 re-
quirements 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 ob-
servance 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 para-
303
graph (4) (or such longer period as the court may pro-
vide), the agency fails, as appropriate—
‘‘(A) to prepare the analysis required by section
604; or
‘‘(B) to take corrective action consistent with
the requirements of section 604,
the court may stay the rule or grant such other relief as
it deems appropriate.
‘‘(6) In making any determination or granting any
relief authorized by this subsection, the court shall take
due account of the rule of prejudicial error.
‘‘(b) In an action for the judicial review of a rule,
any regulatory flexibility analysis for such rule (including
an analysis prepared or corrected pursuant to subsection
(a)(4)) shall constitute part of the whole record of agency
action in connection with such review.
‘‘(c) Nothing in this section bars judicial review of
any other impact statement or similar analysis required
by any other law if judicial review of such statement or
analysis is otherwise provided by law.’’.
(B) EFFECTIVE
DATE.—The amendment
made by subsection (a) shall apply only to final
agency rules issued after the date of enactment
of this Act.
304
(2) RULES
COMMENTED
ON
BY
SBA
CHIEF
COUNSEL FOR ADVOCACY.—
(A) IN GENERAL.—Section 612 of title 5,
United States Code, is amended by adding at
the end the following new subsection:
‘‘(d) ACTION BY THE SBA CHIEF COUNSEL FOR AD-
VOCACY.—
‘‘(1) TRANSMITTAL OF PROPOSED RULES AND
INITIAL
REGULATORY
FLEXIBILITY
ANALYSIS
TO
SBA CHIEF COUNSEL FOR ADVOCACY.—On or before
the 30th day preceding the date of publication by an
agency of general notice of proposed rulemaking for
a rule, the agency shall transmit to the Chief Coun-
sel for Advocacy of the Small Business Administra-
tion—
‘‘(A) a copy of the proposed rule; and
‘‘(B)(i) a copy of the initial regulatory
flexibility analysis for the rule if required under
section 603; or
‘‘(ii) a determination by the agency that an
initial regulatory flexibility analysis is not re-
quired for the proposed rule under section 603
and an explanation for the determination.
‘‘(2) STATEMENT OF EFFECT.—On or before
the 15th day following receipt of a proposed rule and
305
initial regulatory flexibility analysis from an agency
under paragraph (1), the Chief Counsel for Advo-
cacy may transmit to the agency a written statement
of the effect of the proposed rule on small entities.
‘‘(3) RESPONSE.—If the Chief Counsel for Ad-
vocacy transmits to an agency a statement of effect
on a proposed rule in accordance with paragraph
(2), the agency shall publish the statement, together
with the response of the agency to the statement, in
the Federal Register at the time of publication of
general notice of proposed rulemaking for the rule.
‘‘(4) SPECIAL RULE.—Any proposed rules is-
sued by an appropriate Federal banking agency (as
that term is defined in section 3(q) of the Federal
Deposit Insurance Act (12 U.S.C. 1813(q)), the Na-
tional Credit Union Administration, or the Office of
Federal Housing Enterprise Oversight, in connection
with the implementation of monetary policy or to en-
sure the safety and soundness of federally insured
depository institutions, any affiliate of such an insti-
tution, credit unions, or government sponsored hous-
ing enterprises or to protect the Federal deposit in-
surance funds shall not be subject to the require-
ments of this subsection.’’.
306
(B) CONFORMING
AMENDMENT.—Section
603(a) of title 5, United States Code, is amend-
ed by inserting ‘‘in accordance with section
612(d)’’ before the period at the end of the last
sentence.
(3) SENSE
OF
CONGRESS
REGARDING
SBA
CHIEF COUNSEL FOR ADVOCACY.—It is the sense of
Congress that the Chief Counsel for Advocacy of the
Small Business Administration should be permitted
to appear as amicus curiae in any action or case
brought in a court of the United States for the pur-
pose of reviewing a rule.
(b) SUBCHAPTER HEADING.—Chapter 6 of title 5,
United States Code, is amended by inserting immediately
before section 601, the following subchapter heading:
‘‘SUBCHAPTER I—REGULATORY ANALYSIS’’.
SEC. 3005. GUIDANCE FOR JUDICIAL INTERPRETATION.
(a) IN GENERAL.—Chapter 7 of title 5, United
States Code, is amended—
(1) by striking section 706; and
(2) by adding at the end the following new sec-
tions:
‘‘§ 706. Scope of review
‘‘(a) To the extent necessary to reach a decision and
when presented, the reviewing court shall decide all rel-
307
evant questions of law, interpret constitutional and statu-
tory provisions, and determine the meaning or applicabil-
ity of the terms of an agency action. The reviewing court
shall—
‘‘(1) compel agency action unlawfully withheld
or unreasonably delayed; and
‘‘(2) hold unlawful and set aside agency action,
findings and conclusions found to be—
‘‘(A) arbitrary, capricious, an abuse of dis-
cretion, or otherwise not in accordance with
law;
‘‘(B) contrary to constitutional right,
power, privilege, or immunity;
‘‘(C) in excess of statutory jurisdiction, au-
thority, or limitations, or short of statutory
right;
‘‘(D) without observance of procedure re-
quired by law;
‘‘(E) unsupported by substantial evidence
in a proceeding subject to sections 556 and 557
or otherwise reviewed on the record of an agen-
cy hearing provided by statute; or
‘‘(F) unwarranted by the facts to the ex-
tent that the facts are subject to trial de novo
by the reviewing court.
308
‘‘(b) In making the determinations set forth in sub-
section (a), the court shall review the whole record or
those parts of it cited by a party, and due account shall
be taken of the rule of prejudicial error.
‘‘§ 707. Consent decrees
‘‘In interpreting any consent decree in effect on or
after the date of enactment of this section that imposes
on an agency an obligation to initiate, continue, or com-
plete rulemaking proceedings, the court shall not enforce
the decree in a way that divests the agency of discretion
clearly granted to the agency by statute to respond to
changing circumstances, make policy or managerial
choices, or protect the rights of third parties.
‘‘§ 708. Affirmative defense
‘‘Notwithstanding any other provision of law, it shall
be an affirmative defense in any enforcement action
brought by an agency that the regulated person or entity
reasonably relied on and is complying with a rule, regula-
tion, adjudication, directive, or order of such agency or
any other agency that is incompatible, contradictory, or
otherwise cannot be reconciled with the agency rule, regu-
lation, adjudication, directive, or order being enforced.
309
‘‘§ 709. Agency interpretations in civil and criminal
actions
‘‘(a) No civil or criminal penalty shall be imposed by
a court, and no civil administrative penalty shall be im-
posed by an agency, for the violation of a rule—
‘‘(1) if the court or agency, as appropriate,
finds that the rule failed to give the defendant fair
warning of the conduct that the rule prohibits or re-
quires; or
‘‘(2) if the court or agency, as appropriate,
finds that the defendant acted reasonably in good
faith based upon the language of the rule as pub-
lished in the Federal Register.
‘‘(b) Nothing in this section shall be construed to pre-
clude an agency:
‘‘(1) from revising a rule or changing its inter-
pretation of a rule in accordance with sections 552
and 553 of this title, and subject to the provisions
of this section, prospectively enforcing the require-
ments of such rule as revised or reinterpreted and
imposing or seeking a civil or criminal penalty for
any subsequent violation of such rule as revised or
reinterpreted;
‘‘(2) from making a new determination of fact,
and based upon such determination, prospectively
applying a particular legal requirement.
310
‘‘(c) This section shall apply to any action filed after
the date of the enactment of the Comprehensive Regu-
latory Reform Act of 1995.’’.
(b) TECHNICAL
AMENDMENT.—The analysis for
chapter 7 of title 5, United States Code, is amended by
striking the item relating to section 706 and inserting the
following new items:
‘‘706. Scope of review.
‘‘707. Consent decrees.
‘‘708. Affirmative defense.
‘‘709. Agency interpretations in civil and criminal actions.’’.
SEC. 3006. CONGRESSIONAL REVIEW.
(a) FINDING.—The Congress finds that effective
steps for improving the efficiency and proper management
of Government operations will be promoted if a morato-
rium on the implementation of certain major final and
proposed rules is imposed in order to provide Congress
an opportunity for review.
(b) IN GENERAL.—Title 5, United States Code, is
amended by inserting immediately after chapter 7 the fol-
lowing new chapter:‘‘
CHAPTER 8—CONGRESSIONAL REVIEW OF
AGENCY RULEMAKING
‘‘Sec.
‘‘801. Congressional review.
‘‘802. Congressional disapproval procedure.
‘‘803. Special rule on statutory, regulatory, and judicial deadlines.
‘‘804. Definitions.
‘‘805. Judicial review.
‘‘806. Applicability; severability.
‘‘807. Exemption for monetary policy.
311
‘‘§ 801. Congressional review
‘‘(a)(1)(A) Before a rule can take effect as a final
rule, the Federal agency promulgating such rule shall sub-
mit to each House of the Congress and to the Comptroller
General a report containing—
‘‘(i) a copy of the rule;
‘‘(ii) a concise general statement relating to the
rule; and
‘‘(iii) the proposed effective date of the rule.
‘‘(B) The Federal agency promulgating the rule shall
make available to each House of Congress and the Comp-
troller General, upon request—
‘‘(i) a complete copy of the cost-benefit analysis
of the rule, if any;
‘‘(ii) the agency’s actions relevant to sections
603, 604, 605, 607, and 609;
‘‘(iii) the agency’s actions relevant to sections
202, 203, 204, and 205 of the Unfunded Mandates
Reform Act of 1995; and
‘‘(iv) any other relevant information or require-
ments under any other Act and any relevant Execu-
tive orders, such as Executive Order No. 12866.
‘‘(C) Upon receipt, each House shall provide copies
to the Chairman and Ranking Member of each committee
with jurisdiction.
312
‘‘(2)(A) The Comptroller General shall provide a re-
port on each major rule to the committees of jurisdiction
to each House of the Congress by the end of 12 calendar
days after the submission or publication date as provided
in section 802(b)(2). The report of the Comptroller Gen-
eral shall include an assessment of the agency’s compli-
ance with procedural steps required by paragraph (1)(B).
‘‘(B) Federal agencies shall cooperate with the Comp-
troller General by providing information relevant to the
Comptroller General’s report under subparagraph (A).
‘‘(3) A major rule relating to a report submitted
under paragraph (1) shall take effect as a final rule, the
latest of—
‘‘(A) the later of the date occurring 60 days
(excluding days either House of Congress is ad-
journed for more than 3 days during a session of
Congress) after the date on which—
‘‘(i) the Congress receives the report sub-
mitted under paragraph (1); or
‘‘(ii) the rule is published in the Federal
Register;
‘‘(B) if the Congress passes a joint resolution of
disapproval described under section 802 relating to
the rule, and the President signs a veto of such reso-
lution, the earlier date—
313
‘‘(i) on which either House of Congress
votes and fails to override the veto of the Presi-
dent; or
‘‘(ii) occurring 30 session days after the
date on which the Congress received the veto
and objections of the President; or
‘‘(C) the date the rule would have otherwise
taken effect, if not for this section (unless a joint
resolution of disapproval under section 802 is en-
acted).
‘‘(4) Except for a major rule, a rule shall take effect
as otherwise provided by law after submission to Congress
under paragraph (1).
‘‘(5) Notwithstanding paragraph (3), the effective
date of a rule shall not be delayed by operation of this
chapter beyond the date on which either House of Con-
gress votes to reject a joint resolution of disapproval under
section 802.
‘‘(b)(1) A rule or proposed rule shall not take effect
(or continue) as a final rule, if the Congress passes a joint
resolution of disapproval described under section 802.
‘‘(2) A rule or proposed rule that does not take effect
(or does not continue) under paragraph (1) may not be
reissued in substantially the same form, and a new rule
that is substantially the same as such a rule or proposed
314
rule may not be issued, unless the reissued or new rule
is specifically authorized by a law enacted after the date
of the joint resolution disapproving the original rule.
‘‘(c)(1) Notwithstanding any other provision of this
section (except subject to paragraph (3)), a rule that
would not take effect by reason of this chapter may take
effect, if the President makes a determination under para-
graph (2) and submits written notice of such determina-
tion to the Congress.
‘‘(2) Paragraph (1) applies to a determination made
by the President by Executive order that the rule should
take effect because such rule is—
‘‘(A) necessary because of an imminent threat
to health or safety or other emergency;
‘‘(B) necessary for the enforcement of criminal
laws;
‘‘(C) necessary for national security; or
‘‘(D) issued pursuant to a statute implementing
an international trade agreement.
‘‘(3) An exercise by the President of the authority
under this subsection shall have no effect on the proce-
dures under section 802 or the effect of a joint resolution
of disapproval under this section.
‘‘(d)(1) In addition to the opportunity for review oth-
erwise provided under this chapter, in the case of any rule
315
that is published in the Federal Register (as a rule that
shall take effect as a final rule) during the period begin-
ning on the date occurring 60 days before the date the
Congress adjourns a session of Congress through the date
on which the same or succeeding Congress first convenes
its next session, section 802 shall apply to such rule in
the succeeding session of Congress.
‘‘(2)(A) In applying section 802 for purposes of such
additional review, a rule described under paragraph (1)
shall be treated as though—
‘‘(i) such rule were published in the Federal
Register (as a rule that shall take effect as a final
rule) on the 15th session day after the succeeding
Congress first convenes; and
‘‘(ii) a report on such rule were submitted to
Congress under subsection (a)(1) on such date.
‘‘(B) Nothing in this paragraph shall be construed
to affect the requirement under subsection (a)(1) that a
report shall be submitted to Congress before a final rule
can take effect.
‘‘(3) A rule described under paragraph (1) shall take
effect as a final rule as otherwise provided by law (includ-
ing other subsections of this section).
‘‘(e)(1) Section 802 shall apply in accordance with
its terms to any major rule that was published in the Fed-