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(C) The terms ‘‘significant risk assessment doc-
ument’’ and ‘‘significant risk characterization docu-
ment’’ shall also include the following:
(i) Any such risk assessment and risk
characterization documents provided by a cov-
ered Federal agency to the public and which are
likely to result in an annual increase in costs of
$25,000,000 or more.
(ii) Environmental restoration and waste
management carried out by or on behalf of the
Department of Defense with respect to any sub-
stance other than municipal waste.
(D) Within 15 months after the date of the en-
actment of this Act, each covered Federal agency ad-
ministering a regulatory program designed to protect
human health, safety, or the environment shall pro-
mulgate a rule establishing those additional cat-
egories, if any, of risk assessment and risk charac-
terization documents prepared by or on behalf of the
covered Federal agency that the agency will consider
significant risk assessment documents or significant
risk characterization documents for purposes of this
title. In establishing such categories, the head of the
agency shall consider each of the following:
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(i) The benefits of consistent compliance
by documents of the covered Federal agency in
the categories.
(ii) The administrative burdens of includ-
ing documents in the categories.
(iii) The need to make expeditious admin-
istrative decisions regarding documents in the
categories.
(iv) The possible use of a risk assessment
or risk characterization in any compilation of
risk hazards or health or environmental effects
prepared by an agency and commonly made
available to, or used by, any Federal, State, or
local government agency.
(v) Such other factors as may be appro-
priate.
(E)(i) Not later than 18 months after the date
of the enactment of this Act, the President, acting
through the Director of the Office of Management
and Budget, shall determine whether any other Fed-
eral agencies should be considered covered Federal
agencies for purposes of this title. Such determina-
tion, with respect to a particular Federal agency,
shall be based on the impact of risk assessment doc-
uments and risk characterization documents on—
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(I) regulatory programs administered by
that agency; and
(II) the communication of risk information
by that agency to the public.
The effective date of such a determination shall be
no later than 6 months after the date of the deter-
mination.
(ii) Not later than 15 months after the Presi-
dent, acting through the Director of the Office of
Management and Budget, determines pursuant to
clause (i) that a Federal agency should be consid-
ered a covered Federal agency for purposes of this
title, the head of that agency shall promulgate a rule
pursuant to subparagraph (D) to establish addi-
tional categories of risk assessment and risk charac-
terization documents described in that subpara-
graph.
(3) EXCEPTIONS.—(A) This title does not apply
to risk assessment or risk characterization docu-
ments containing risk assessments or risk character-
izations performed with respect to the following:
(i) A screening analysis, where appro-
priately labeled as such, including a screening
analysis for purposes of product regulation or
premanufacturing notices.
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(ii) Any health, safety, or environmental
inspections.
(iii) The sale or lease of Federal resources
or regulatory activities that directly result in
the collection of Federal receipts.
(B) No analysis shall be treated as a screening
analysis for purposes of subparagraph (A) if the re-
sults of such analysis are used as the basis for im-
posing restrictions on substances or activities.
(C) The risk assessment principle set forth in
section 104(b)(1) need not apply to any risk assess-
ment or risk characterization document described in
clause (iii) of paragraph (2)(B). The risk character-
ization and communication principle set forth in sec-
tion 105(4) need not apply to any risk assessment
or risk characterization document described in
clause (v) or (vi) of paragraph (2)(B).
(c) SAVINGS PROVISIONS.—The provisions of this
title shall be supplemental to any other provisions of law
relating to risk assessments and risk characterizations, ex-
cept that nothing in this title shall be construed to modify
any statutory standard or statutory requirement designed
to protect health, safety, or the environment. Nothing in
this title shall be interpreted to preclude the consideration
of any data or the calculation of any estimate to more
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fully describe risk or provide examples of scientific uncer-
tainty or variability. Nothing in this title shall be con-
strued to require the disclosure of any trade secret or
other confidential information.
SEC. 104. PRINCIPLES FOR RISK ASSESSMENT.
(a) IN GENERAL.—The head of each covered Federal
agency shall apply the principles set forth in subsection
(b) in order to assure that significant risk assessment doc-
uments and all of their components distinguish scientific
findings from other considerations and are, to the extent
feasible, scientifically objective, unbiased, and inclusive of
all relevant data and rely, to the extent available and prac-
ticable, on scientific findings. Discussions or explanations
required under this section need not be repeated in each
risk assessment document as long as there is a reference
to the relevant discussion or explanation in another agency
document which is available to the public.
(b) PRINCIPLES.—The principles to be applied are as
follows:
(1) When discussing human health risks, a sig-
nificant risk assessment document shall contain a
discussion of both relevant laboratory and relevant
epidemiological data of sufficient quality which finds,
or fails to find, a correlation between health risks
and a potential toxin or activity. Where conflicts
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among such data appear to exist, or where animal
data is used as a basis to assess human health, the
significant risk assessment document shall, to the
extent feasible and appropriate, include discussion of
possible reconciliation of conflicting information, and
as relevant, differences in study designs, compara-
tive physiology, routes of exposure, bioavailability,
pharmacokinetics, and any other relevant factor, in-
cluding the sufficiency of basic data for review. The
discussion of possible reconciliation should indicate
whether there is a biological basis to assume a re-
sulting harm in humans. Animal data shall be re-
viewed with regard to its relevancy to humans.
(2) Where a significant risk assessment docu-
ment involves selection of any significant assump-
tion, inference, or model, the document shall, to the
extent feasible—
(A) present a representative list and expla-
nation of plausible and alternative assumptions,
inferences, or models;
(B) explain the basis for any choices;
(C) identify any policy or value judgments;
(D) fully describe any model used in the
risk assessment and make explicit the assump-
tions incorporated in the model; and
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(E) indicate the extent to which any sig-
nificant model has been validated by, or con-
flicts with, empirical data.
SEC. 105. PRINCIPLES FOR RISK CHARACTERIZATION AND
COMMUNICATION.
Each significant risk characterization document shall
meet each of the following requirements:
(1) ESTIMATES OF RISK.—The risk character-
ization shall describe the populations or natural re-
sources which are the subject of the risk character-
ization. If a numerical estimate of risk is provided,
the agency shall, to the extent feasible, provide—
(A) the best estimate or estimates for the
specific populations or natural resources which
are the subject of the characterization (based
on the information available to the Federal
agency); and
(B) a statement of the reasonable range of
scientific uncertainties.
In addition to such best estimate or estimates, the
risk characterization document may present plau-
sible upper-bound or conservative estimates in con-
junction with plausible lower bounds estimates.
Where appropriate, the risk characterization docu-
ment may present, in lieu of a single best estimate,
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multiple best estimates based on assumptions, infer-
ences, or models which are equally plausible, given
current scientific understanding. To the extent prac-
tical and appropriate, the document shall provide de-
scriptions of the distribution and probability of risk
estimates to reflect differences in exposure varia-
bility or sensitivity in populations and attendant un-
certainties. Sensitive subpopulations or highly ex-
posed subpopulations include, where relevant and
appropriate, children, the elderly, pregnant women,
and disabled persons.
(2) EXPOSURE SCENARIOS.—The risk charac-
terization document shall explain the exposure sce-
narios used in any risk assessment, and, to the ex-
tent feasible, provide a statement of the size of the
corresponding population at risk and the likelihood
of such exposure scenarios.
(3) COMPARISONS.—The document shall con-
tain a statement that places the nature and mag-
nitude of risks to human health, safety, or the envi-
ronment in context. Such statement shall, to the ex-
tent feasible, provide 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 ap-
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propriate and meaningful, comparisons of those risks
with other similar risks regulated by the Federal
agency resulting from comparable activities and ex-
posure pathways. Such comparisons should consider
relevant distinctions among risks, such as the vol-
untary or involuntary nature of risks and the pre-
ventability or nonpreventability of risks.
(4) SUBSTITUTION
RISKS.—Each significant
risk assessment or risk characterization document
shall include a statement of any significant substi-
tution risks to human health, where information on
such risks has been provided to the agency.
(5) SUMMARIES OF OTHER RISK ESTIMATES.—
If—
(A) a commenter provides a covered Fed-
eral agency with a relevant risk assessment doc-
ument or a risk characterization document, and
a summary thereof, during a public comment
provided by the agency for a significant risk as-
sessment document or a significant risk charac-
terization document, or, where no comment pe-
riod is provided but a commenter provides the
covered Federal agency with the relevant risk
assessment document or risk characterization
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document, and a summary thereof, in a timely
fashion, and
(B) the risk assessment document or risk
characterization document is consistent with the
principles and the guidance provided under this
title,
the agency shall, to the extent feasible, present such
summary in connection with the presentation of the
agency’s significant risk assessment document or
significant risk characterization document. Nothing
in this paragraph shall be construed to limit the in-
clusion of any comments or material supplied by any
person to the administrative record of any proceed-
ing.
A document may satisfy the requirements of paragraph
(3), (4) or (5) by reference to information or material oth-
erwise available to the public if the document provides a
brief summary of such information or material.
SEC. 106. RECOMMENDATIONS OR CLASSIFICATIONS BY A
NON-UNITED STATES-BASED ENTITY.
No covered Federal agency shall automatically incor-
porate or adopt any recommendation or classification
made by a non-United States-based entity concerning the
health effects value of a substance without an opportunity
for notice and comment, and any risk assessment docu-
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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. 107. GUIDELINES AND REPORT.
(a) GUIDELINES.—Within 15 months after the date
of enactment of this title, the President shall issue guide-
lines for Federal agencies consistent with the risk assess-
ment and characterization principles set forth in sections
104 and 105 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 enactment of
this title, each covered Federal agency shall provide a re-
port to the Congress evaluating the categories of policy
and value judgments identified under subparagraph (C)
of section 104(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. 108. 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. 109. 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. 110. 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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(C) Any other methodology designed to
provide the most unbiased representation of the
most plausible level of risk, given the current
scientific information available to the Federal
agency concerned.
(4) SUBSTITUTION
RISK.—The term ‘‘substi-
tution risk’’ means a potential risk to human health,
safety, or the environment from a regulatory alter-
native designed to decrease other risks.
(5) COVERED
FEDERAL
AGENCY.—The term
‘‘covered Federal agency’’ means each of the follow-
ing:
(A) The Environmental Protection Agency.
(B) The Occupational Safety and Health
Administration.
(C) The Department of Transportation
(including the National Highway Transpor-
tation Safety Administration).
(D) The Food and Drug Administration.
(E) The Department of Energy.
(F) The Department of the Interior.
(G) The Department of Agriculture.
(H) The Consumer Product Safety Com-
mission.
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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
103(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. 201. 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
Act:
(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. 202. 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 201 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 201 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. 203. OFFICE OF MANAGEMENT AND THE BUDGET
GUIDANCE.
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. 204. 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 201(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. 301. 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