I
104TH CONGRESS
1ST SESSION
H. R. 1022
To provide regulatory reform and to focus national economic resources on
the greatest risks to human health, safety, and the environment through
scientifically objective and unbiased risk assessments and through the
consideration of costs and benefits in major rules, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
FEBRUARY 23, 1995
Mr. WALKER (for himself and Mr. BLILEY) introduced the following bill;
which was referred to the Committee on Science and, in addition, to the
Committees on Commerce and Government Reform and Oversight, 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 provide regulatory reform and to focus national economic
resources on the greatest risks to human health, safety,
and the environment through scientifically objective and
unbiased risk assessments and through the consideration
of costs and benefits in major rules, and for other pur-
poses.
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 ‘‘Risk Assessment and
Cost-Benefit Act of 1995’’.
SEC. 2. FINDINGS.
The Congress finds that:
(1) Environmental, health, and safety regula-
tions have led to dramatic improvements in the envi-
ronment and have significantly reduced human
health risk; however, the Federal regulations that
have led to these improvements have been more cost-
ly and less effective than they could have been; too
often, regulatory priorities have not been based upon
a realistic consideration of risk, risk reduction op-
portunities, and costs.
(2) The public and private resources available
to address health, safety, and environmental con-
cerns are not unlimited; those resources need to be
allocated to address the greatest needs in the most
cost-effective manner and so that the incremental
costs of regulatory alternatives are reasonably relat-
ed to the incremental benefits.
(3) To provide more cost-effective and cost-rea-
sonable protection to human health and the environ-
ment, regulatory priorities should be based upon re-
alistic consideration of risk; the priority setting proc-
ess must include scientifically sound, objective, and
unbiased risk assessments, comparative risk analy-
sis, and risk management choices that are grounded
in cost-benefit principles.
(4) Risk assessment has proven to be a useful
decision making tool; however, improvements are
needed in both the quality of assessments and the
characterization and communication of findings; sci-
entific and other data must be better collected, orga-
nized, and evaluated; most importantly, the critical
information resulting from a risk assessment must
be effectively communicated in an objective and un-
biased manner to decision makers, and from decision
makers to the public.
(5) The public stake holders must be fully in-
volved in the risk-decision making process. They
have the right-to-know about the risks addressed by
regulation, the amount of risk to be reduced, the
quality of the science used to support decisions, and
the cost of implementing and complying with regula-
tions. This knowledge will allow for public scrutiny
and promote quality, integrity, and responsiveness of
agency decisions.
(6) Although risk assessment is one important
method to improve regulatory decision-making, other
approaches to secure prompt relief from the burden
of unnecessary and overly complex regulations will
also be necessary.
SEC. 3. COVERAGE OF ACT.
This Act does not apply to any of the following:
(1) A situation that the head of an affected
Federal agency determines to be an emergency. In
such circumstance, the head of the agency shall com-
ply with the provisions of this Act within as reason-
able a time as is practical.
(2) Activities necessary to maintain military
readiness.
(3) Any individual food, drug, or other product
label, or to any risk characterization appearing on
any such label, if the individual product label is re-
quired by law to be approved by a Federal depart-
ment or agency prior to use.
(4) Approval of State programs or plans by
Federal agencies.
SEC. 4. DEFINITIONS
For purposes of this Act:
(1) COSTS.—The term ‘‘costs’’ includes the di-
rect and indirect costs to the United States Govern-
ment, to State, local, and tribal governments, and to
the private sector, wage earners, consumers, and the
(1) to present the public and executive branch
with the most scientifically objective and unbiased
information concerning the nature and magnitude of
health, safety, and environmental risks in order to
provide for sound regulatory decisions and public
education;
(2) to provide for full consideration and discus-
sion of relevant data and potential methodologies;
(3) to require explanation of significant choices
in the risk assessment process which will allow for
better peer review and public understanding; and
(4) to improve consistency within the executive
branch in preparing risk assessments and risk char-
acterizations.
SEC. 103. EFFECTIVE DATE; APPLICABILITY; SAVINGS PRO-
VISIONS.
(a) EFFECTIVE DATE.—Except as otherwise specifi-
cally provided in this title, the provisions of this title shall
take effect 18 months after the date of enactment of this
title.
(b) APPLICABILITY.—
(1) IN GENERAL.—Except as provided in para-
graph (3), this title applies to all significant risk as-
sessment documents and significant risk character-
ization documents, as defined in paragraph (2).
(2) SIGNIFICANT RISK ASSESSMENT DOCUMENT
OR
SIGNIFICANT
RISK
CHARACTERIZATION
DOCU-
MENT.—(A) As used in this title, the terms ‘‘signifi-
cant risk assessment document’’ and ‘‘significant
risk characterization document’’ include, at a mini-
mum, risk assessment documents or risk character-
ization documents prepared by or on behalf of a cov-
ered Federal agency in the implementation of a reg-
ulatory program designed to protect human health,
safety, or the environment, used as a basis for one
of the items referred to in subparagraph (B), and—
(i) included by the agency in that item; or
(ii) inserted by the agency in the adminis-
trative record for that item.
(B) The items referred to in subparagraph (A)
are the following:
(i) Any proposed or final major rule, in-
cluding any analysis or certification under title
II, promulgated as part of any Federal regu-
latory program designed to protect human
health, safety, or the environment.
(ii) Any proposed or final environmental
clean-up plan for a facility or Federal guidelines
for the issuance of any such plan. As used in
this clause, the term ‘‘environmental clean-up’’
means a corrective action under the Solid
Waste Disposal Act, a removal or remedial ac-
tion under the Comprehensive Environmental
Response, Compensation, and Liability Act of
1980, and any other environmental restoration
and waste management carried out by or on be-
half of a covered Federal agency with respect to
any substance other than municipal waste.
(iii) Any proposed or final permit condition
placing a restriction on facility siting or oper-
ation under Federal laws administered by the
Environmental Protection Agency or the De-
partment of the Interior.
(iv) Any report to Congress.
(v) Any regulatory action to place a sub-
stance on any official list of carcinogens or
toxic or hazardous substances or to place a new
health effects value on such list, including the
Integrated Risk Information System Database
maintained by the Environmental Protection
Agency.
(vi) Any guidance, including protocols of
general applicability, establishing policy regard-
ing risk assessment or risk characterization.
(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:
(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—
(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.
(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
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
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
(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,
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.
(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-
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
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-
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.
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-
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
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).
(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.
(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:
(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.
(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.
(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
Reduction 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
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
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.
(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)
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.
(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.
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
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
which forms the basis for such rule or of any analysis
under section 201(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
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. 401. 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 104 and 105.
Title V—Plan
SEC. 501. 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 104 and 105 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-
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. 601. 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.
(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) 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 when preparing a budget or
strategic plan for any such regulatory program.
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