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ment or risk characterization document adopted by a cov-
ered Federal agency on the basis of such a recommenda-
tion or classification shall comply with the provisions of
this title. For the purposes of this section, the term ‘‘non-
United States-based entity’’ means—
(1) any foreign government and its agencies;
(2) the United Nations or any of its subsidiary
organizations;
(3) any other international governmental body
or international standards-making organization; or
(4) any other organization or private entity
without a place of business located in the United
States or its territories.
SEC. 417. GUIDELINES AND REPORT.
(a) GUIDELINES.—Within 15 months after the date
of enactment of this Act, the President shall issue guide-
lines for Federal agencies consistent with the risk assess-
ment and characterization principles set forth in sections
414 and 415 and shall provide a format for summarizing
risk assessment results. In addition, such guidelines shall
include guidance on at least the following subjects: criteria
for scaling animal studies to assess risks to human health;
use of different types of dose-response models; thresholds;
definitions, use, and interpretations of the maximum toler-
ated dose; weighting of evidence with respect to extrapo-
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lating human health risks from sensitive species; evalua-
tion of benign tumors, and evaluation of different human
health endpoints.
(b) REPORT.—Within 3 years after the date of the
enactment of this Act, each covered Federal agency shall
provide a report to the Congress evaluating the categories
of policy and value judgments identified under subpara-
graph (C) of section 414(b)(2).
(c) PUBLIC COMMENT
AND CONSULTATION.—The
guidelines and report under this section, shall be developed
after notice and opportunity for public comment, and after
consultation with representatives of appropriate State,
local, and tribal governments, and such other departments
and agencies, offices, organizations, or persons as may be
advisable.
(d) REVIEW.—The President shall review and, where
appropriate, revise the guidelines published under this sec-
tion at least every 4 years.
SEC. 418. RESEARCH AND TRAINING IN RISK ASSESSMENT.
(a) EVALUATION.—The head of each covered agency
shall regularly and systematically evaluate risk assessment
research and training needs of the agency, including,
where relevant and appropriate, the following:
(1) Research to reduce generic data gaps, to
address modelling needs (including improved model
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sensitivity), and to validate default options, particu-
larly those common to multiple risk assessments.
(2) Research leading to improvement of meth-
ods to quantify and communicate uncertainty and
variability among individuals, species, populations,
and, in the case of ecological risk assessment, eco-
logical communities.
(3) Emerging and future areas of research, in-
cluding research on comparative risk analysis, expo-
sure to multiple chemicals and other stressors,
noncancer endpoints, biological markers of exposure
and effect, mechanisms of action in both mammalian
and nonmammalian species, dynamics and prob-
abilities of physiological and ecosystem exposures,
and prediction of ecosystem-level responses.
(4) Long-term needs to adequately train indi-
viduals in risk assessment and risk assessment appli-
cation. Evaluations under this paragraph shall in-
clude an estimate of the resources needed to provide
necessary training.
(b) STRATEGY AND ACTIONS TO MEET IDENTIFIED
NEEDS.—The head of each covered agency shall develop
a strategy and schedule for carrying out research and
training to meet the needs identified in subsection (a).
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(c) REPORT.—Not later than 6 months after the date
of the enactment of this Act, the head of each covered
agency shall submit to the Congress a report on the eval-
uations conducted under subsection (a) and the strategy
and schedule developed under subsection (b). The head of
each covered agency shall report to the Congress periodi-
cally on the evaluations, strategy, and schedule.
SEC. 419. STUDY OF COMPARATIVE RISK ANALYSIS.
(a) IN GENERAL.—(1) The Director of the Office of
Management and Budget, in consultation with the Office
of Science and Technology Policy, shall conduct, or pro-
vide for the conduct of, a study using comparative risk
analysis to rank health, safety, and environmental risks
and to provide a common basis for evaluating strategies
for reducing or preventing those risks. The goal of the
study shall be to improve methods of comparative risk
analysis.
(2) Not later than 90 days after the date of the enact-
ment of this Act, the Director, in collaboration with the
heads of appropriate Federal agencies, shall enter into a
contract with the National Research Council to provide
technical guidance on approaches to using comparative
risk analysis and other considerations in setting health,
safety, and environmental risk reduction priorities.
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(b) SCOPE OF STUDY.—The study shall have suffi-
cient scope and breadth to evaluate comparative risk anal-
ysis and to test approaches for improving comparative risk
analysis and its use in setting priorities for health, safety,
and environmental risk reduction. The study shall com-
pare and evaluate a range of diverse health, safety, and
environmental risks.
(c) STUDY PARTICIPANTS.—In conducting the study,
the Director shall provide for the participation of a range
of individuals with varying backgrounds and expertise,
both technical and nontechnical, comprising broad rep-
resentation of the public and private sectors.
(d) DURATION.—The study shall begin within 180
days after the date of the enactment of this Act and termi-
nate within 2 years after the date on which it began.
(e) RECOMMENDATIONS FOR IMPROVING COMPARA-
TIVE RISK ANALYSIS AND ITS USE.—Not later than 90
days after the termination of the study, the Director shall
submit to the Congress the report of the National Re-
search Council with recommendations regarding the use
of comparative risk analysis and ways to improve the use
of comparative risk analysis for decision-making in appro-
priate Federal agencies.
SEC. 420. DEFINITIONS.
For purposes of this title:
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(1) RISK ASSESSMENT DOCUMENT.—The term
‘‘risk assessment document’’ means a document con-
taining the explanation of how hazards associated
with a substance, activity, or condition have been
identified, quantified, and assessed. The term also
includes a written statement accepting the findings
of any such document.
(2) RISK CHARACTERIZATION DOCUMENT.—The
term ‘‘risk characterization document’’ means a doc-
ument quantifying or describing the degree of tox-
icity, exposure, or other risk posed by hazards asso-
ciated with a substance, activity, or condition to
which individuals, populations, or resources are ex-
posed. The term also includes a written statement
accepting the findings of any such document.
(3) BEST
ESTIMATE.—The term ‘‘best esti-
mate’’ means a scientifically appropriate estimate
which is based, to the extent feasible, on one of the
following:
(A) Central estimates of risk using the
most plausible assumptions.
(B) An approach which combines multiple
estimates based on different scenarios and
weighs the probability of each scenario.
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(I) The National Oceanic and Atmospheric
Administration.
(J) The United States Army Corps of En-
gineers.
(K) The Mine Safety and Health Adminis-
tration.
(L) The Nuclear Regulatory Commission.
(M) Any other Federal agency considered
a covered Federal agency pursuant to section
413(b)(2)(E).
(6) FEDERAL
AGENCY.—The term ‘‘Federal
agency’’ means an executive department, military de-
partment, or independent establishment as defined
in part I of title 5 of the United States Code, except
that such term also includes the Office of Tech-
nology Assessment.
(7) DOCUMENT.—The term ‘‘document’’ in-
cludes material stored in electronic or digital form.
TITLE II—ANALYSIS OF RISK RE-
DUCTION 
BENEFITS 
AND
COSTS
SEC. 421. ANALYSIS OF RISK REDUCTION BENEFITS AND
COSTS.
(a) IN GENERAL.—The President shall require each
Federal agency to prepare the following for each major
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rule within a program designed to protect human health,
safety, or the environment that is proposed or promul-
gated by the agency after the date of enactment of this
division:
(1) An identification of reasonable alternative
strategies, including strategies that—
(A) require no government action;
(B) will accommodate differences among
geographic regions and among persons with dif-
ferent levels of resources with which to comply;
and
(C) employ performance or other market-
based mechanisms that permit the greatest
flexibility in achieving the identified benefits of
the rule.
The agency shall consider reasonable alternative
strategies proposed during the comment period.
(2) An analysis of the incremental costs and in-
cremental risk reduction or other benefits associated
with each alternative strategy identified or consid-
ered by the agency. Costs and benefits shall be
quantified to the extent feasible and appropriate and
may otherwise be qualitatively described.
(3) A statement that places in context the na-
ture and magnitude of the risks to be addressed and
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the residual risks likely to remain for each alter-
native strategy identified or considered by the agen-
cy. Such statement shall, to the extent feasible, pro-
vide comparisons with estimates of greater, lesser,
and substantially equivalent risks that are familiar
to and routinely encountered by the general public
as well as other risks, and, where appropriate and
meaningful, comparisons of those risks with other
similar risks regulated by the Federal agency result-
ing from comparable activities and exposure path-
ways. Such comparisons should consider relevant
distinctions among risks, such as the voluntary or
involuntary nature of risks and the preventability or
nonpreventability of risks.
(4) For each final rule, an analysis of whether
the identified benefits of the rule are likely to exceed
the identified costs of the rule.
(5) An analysis of the effect of the rule—
(A) on small businesses with fewer than
100 employees;
(B) on net employment; and
(C) to the extent practicable, on the cumu-
lative financial burden of compliance with the
rule and other existing regulations on persons
producing products.
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(b) PUBLICATION.—For each major rule referred to
in subsection (a) each Federal agency shall publish in a
clear and concise manner in the Federal Register along
with the proposed and final regulation, or otherwise make
publicly available, the information required to be prepared
under subsection (a).
SEC. 422. DECISION CRITERIA.
(a) IN GENERAL.—No final rule subject to the provi-
sions of this title shall be promulgated unless the agency
certifies the following:
(1) That the analyses under section 421 are
based on objective and unbiased scientific and eco-
nomic evaluations of all significant and relevant in-
formation and risk assessments provided to the
agency by interested parties relating to the costs,
risks, and risk reduction and other benefits ad-
dressed by the rule.
(2) That the incremental risk reduction or other
benefits of any strategy chosen will be likely to jus-
tify, and be reasonably related to, the incremental
costs incurred by State, local, and tribal govern-
ments, the Federal Government, and other public
and private entities.
(3) That other alternative strategies identified
or considered by the agency were found either (A)
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to be less cost-effective at achieving a substantially
equivalent reduction in risk, or (B) to provide less
flexibility to State, local, or tribal governments or
regulated entities in achieving the otherwise applica-
ble objectives of the regulation, along with a brief
explanation of why alternative strategies that were
identified or considered by the agency were found to
be less cost-effective or less flexible.
(b) EFFECT OF DECISION CRITERIA.—
(1) IN GENERAL.—Notwithstanding any other
provision of Federal law, the decision criteria of sub-
section (a) shall supplement and, to the extent there
is a conflict, supersede the decision criteria for rule-
making otherwise applicable under the statute pur-
suant to which the rule is promulgated.
(2) SUBSTANTIAL EVIDENCE.—Notwithstanding
any other provision of Federal law, no major rule
shall be promulgated by any Federal agency pertain-
ing to the protection of health, safety, or the envi-
ronment unless the requirements of section 421 and
subsection (a) are met and the certifications re-
quired therein are supported by substantial evidence
of the rulemaking record.
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(c) PUBLICATION.—The agency shall publish in the
Federal Register, along with the final regulation, the cer-
tifications required by subsection (a).
(d) NOTICE.—Where the agency finds a conflict be-
tween the decision criteria of this section and the decision
criteria of an otherwise applicable statute, the agency shall
so notify the Congress in writing.
SEC. 423. OFFICE OF MANAGEMENT AND BUDGET GUID-
ANCE.
The Office of Management and Budget shall issue
guidance consistent with this title—
(1) to assist the agencies, the public, and the
regulated community in the implementation of this
title, including any new requirements or procedures
needed to supplement prior agency practice; and
(2) governing the development and preparation
of analyses of risk reduction benefits and costs.
SEC. 424. ENVIRONMENTAL CLEAN-UP.
For purposes of this title, any determination by a
Federal agency to approve or reject any proposed or final
environmental clean-up plan for a facility the costs of
which are likely to exceed $5,000,000 shall be treated as
major rule subject to the provisions of this title (other
than the provisions of section 421(a)(5)). As used in this
section, the term ‘‘environmental clean-up’’ means a cor-
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rective action under the Solid Waste Disposal Act, a reme-
dial action under the Comprehensive Environmental Re-
sponse, Compensation, and Liability Act of 1980, and any
other environmental restoration and waste management
carried out by or on behalf of a Federal agency with re-
spect to any substance other than municipal waste.
TITLE III—PEER REVIEW
SEC. 431. PEER REVIEW PROGRAM.
(a) ESTABLISHMENT.—For regulatory programs de-
signed to protect human health, safety, or the environ-
ment, the head of each Federal agency shall develop a sys-
tematic program for independent and external peer review
required by subsection (b). Such program shall be applica-
ble across the agency and—
(1) shall provide for the creation of peer review
panels consisting of experts and shall be broadly rep-
resentative and balanced and to the extent relevant
and appropriate, may include representatives of
State, local, and tribal governments, small busi-
nesses, other representatives of industry, univer-
sities, agriculture, labor, consumers, conservation or-
ganizations, or other public interest groups and or-
ganizations;
(2) may provide for differing levels of peer re-
view and differing numbers of experts on peer review
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panels, depending on the significance or the com-
plexity of the problems or the need for expeditious-
ness;
(3) shall not exclude peer reviewers with sub-
stantial and relevant expertise merely because they
represent entities that may have a potential interest
in the outcome, provided that interest is fully dis-
closed to the agency and in the case of a regulatory
decision affecting a single entity, no peer reviewer
representing such entity may be included on the
panel;
(4) may provide specific and reasonable dead-
lines for peer review panels to submit reports under
subsection (c); and
(5) shall provide adequate protections for con-
fidential business information and trade secrets, in-
cluding requiring peer reviewers to enter into con-
fidentiality agreements.
(b) REQUIREMENT FOR PEER REVIEW.—In connec-
tion with any rule that is likely to result in an annual
increase in costs of $100,000,000 or more (other than any
rule or other action taken by an agency to authorize or
approve any individual substance or product), each Fed-
eral agency shall provide for peer review in accordance
with this section of any risk assessment or cost analysis
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which forms the basis for such rule or of any analysis
under section 431(a). In addition, the Director of the Of-
fice of Management and Budget may order that peer re-
view be provided for any major risk assessment or cost
assessment that is likely to have a significant impact on
public policy decisions.
(c) CONTENTS.—Each peer review under this section
shall include a report to the Federal agency concerned
with respect to the scientific and economic merit of data
and methods used for the assessments and analyses.
(d) RESPONSE TO PEER REVIEW.—The head of the
Federal agency shall provide a written response to all sig-
nificant peer review comments.
(e) AVAILABILITY TO PUBLIC.—All peer review com-
ments or conclusions and the agency’s responses shall be
made available to the public and shall be made part of
the administrative record.
(f) PREVIOUSLY REVIEWED DATA AND ANALYSIS.—
No peer review shall be required under this section for
any data or method which has been previously subjected
to peer review or for any component of any analysis or
assessment previously subjected to peer review.
(g) NATIONAL PANELS.—The President shall appoint
National Peer Review Panels to annually review the risk
assessment and cost assessment practices of each Federal
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agency for programs designed to protect human health,
safety, or the environment. The Panel shall submit a re-
port to the Congress no less frequently than annually con-
taining the results of such review.
TITLE IV—JUDICIAL REVIEW
SEC. 441. JUDICIAL REVIEW.
Compliance or noncompliance by a Federal agency
with the requirements of this Act shall be reviewable pur-
suant to the statute granting the agency authority to act
or, as applicable, that statute and the Administrative Pro-
cedure Act. The court with jurisdiction to review final
agency action under the statute granting the agency au-
thority to act shall have jurisdiction to review, at the same
time, the agency’s compliance with the requirements of
this Act. When a significant risk assessment document or
risk characterization document subject to title I is part
of the administrative record in a final agency action, in
addition to any other matters that the court may consider
in deciding whether the agency’s action was lawful, the
court shall consider the agency action unlawful if such sig-
nificant risk assessment document or significant risk char-
acterization document does not substantially comply with
the requirements of sections 444 and 445.
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TITLE V—PLAN
SEC. 451. PLAN FOR ASSESSING NEW INFORMATION.
(a) PLAN.—Within 18 months after the date of en-
actment of this Act, each covered Federal agency (as de-
fined in title I) shall publish a plan to review and, where
appropriate revise any significant risk assessment docu-
ment or significant risk characterization document pub-
lished prior to the expiration of such 18-month period if,
based on information available at the time of such review,
the agency head determines that the application of the
principles set forth in sections 414 and 415 would be likely
to significantly alter the results of the prior risk assess-
ment or risk characterization. The plan shall provide pro-
cedures for receiving and considering new information and
risk assessments from the public. The plan may set prior-
ities and procedures for review and, where appropriate, re-
vision of such risk assessment documents and risk charac-
terization documents and of health or environmental ef-
fects values. The plan may also set priorities and proce-
dures for review, and, where appropriate, revision or re-
peal of major rules promulgated prior to the expiration
of such period. Such priorities and procedures shall be
based on the potential to more efficiently focus national
economic resources within Federal regulatory programs
designed to protect human health, safety, or the environ-
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ment on the most important priorities and on such other
factors as such Federal agency considers appropriate.
(b) PUBLIC COMMENT AND CONSULTATION.—The
plan under this section, shall be developed after notice and
opportunity for public comment, and after consultation
with representatives of appropriate State, local, and tribal
governments, and such other departments and agencies,
offices, organizations, or persons as may be advisable.
TITLE VI—PRIORITIES
SEC. 461. PRIORITIES.
(a) IDENTIFICATION OF OPPORTUNITIES.—In order
to assist in the public policy and regulation of risks to
public health, the President shall identify opportunities to
reflect priorities within existing Federal regulatory pro-
grams designed to protect human health in a cost-effective
and cost-reasonable manner. The President shall identify
each of the following:
(1) The likelihood and severity of public health
risks addressed by current Federal programs.
(2) The number of individuals affected.
(3) The incremental costs and risk reduction
benefits associated with regulatory or other strate-
gies.
(4) The cost-effectiveness of regulatory or other
strategies to reduce risks to public health.
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(5) Intergovernmental relationships among Fed-
eral, State, and local governments among programs
designed to protect public health.
(6) Statutory, regulatory, or administrative ob-
stacles to allocating national economic resources
based on the most cost-effective, cost-reasonable pri-
orities considering Federal, State, and local pro-
grams.
(b) STATE, LOCAL, AND TRIBAL PRIORITIES.—In
identifying national priorities, the President shall consider
priorities developed and submitted by State, local, and
tribal governments.
(c) BIENNIAL REPORTS.—The President shall issue
biennial reports to Congress, after notice and opportunity
for public comment, to recommend priorities for modifica-
tions to, elimination of, or strategies for existing Federal
regulatory programs designed to protect public health.
Within 6 months after the issuance of the report, the
President shall notify the Congress in writing of the rec-
ommendations which can be implemented without further
legislative changes and the agency shall consider the prior-
ities set forth in the report and priorities developed and
submitted by State, local, and tribal governments when
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preparing a budget or strategic plan for any such regu-
latory program.
Passed the House of Representatives March 3,
1995.
Attest:
Clerk.