[Pages S1711-S1719]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

By Mr. ROTH:
S. 291. A bill to reform the regulatory process, to make government
more efficient and effective, and for other purposes; to the Committee
on Governmental Affairs.

regulatory reform legislation

<bullet> Mr. ROTH. Mr. President, I rise to emphasize the critical need
for a smarter, more cost-effective approach to Government regulation.
Today, I introduce legislation intended to generate constructive debate
on this important issue.
As chairman of the Committee on Governmental Affairs, I want to build
consensus on how to regulate smarter among all engaged in the growing
debate on regulatory reform--including the general public, businesses
of all sizes, environmental and public interest groups, academia, State
and local governments, the White House, and my colleagues on both sides
of the aisle. Throughout my career, I have been committed to protecting
the environment, health, and safety. I reaffirm that commitment today.
We should not forget that many regulations provide important
protections and benefits to the public. Let there be no mistake--we
need a clean environment, safe workplaces, and safe medications.
Mr. President, it is clear that the regulatory process is broken. Too
many regulations impose undue costs, and the regulatory process itself
has become too cumbersome, unresponsive, and inefficient. The
cumulative cost of regulation is enormous and is rising at an alarming
rate. The annual cost of Federal regulation was conservatively
estimated at about $560 billion for 1992; it could exceed $660 billion
by the year 2000. About three-fourths of the cost increase is expected
from upcoming risk regulations, such as environmental, health, and
safety standards.
The rising cost of regulation affects us all--businesses large and
small, governments at all levels, and the American worker and consumer.
Regulations drive up prices and stifle wages, innovation, and economic
growth. Although the direct costs of regulation generally are imposed
on businesses and governments, these costs ultimately are passed on to
the American consumer through higher prices, diminished wages,
increased taxes, or reduced government services. The cost of regulation
has been estimated at about $6,000 per year for the average American
household.
The recent elections brought to this Congress historic change, an
with it, and unprecedented opportunity to reform the regulatory
process. However, it is important that we take a balanced approach to
reform. In our zeal to implement substantial changes, we should act
carefully so that we truly perfect needed Government programs--not
cripple or stymie them. Building a smarter regulatory process will
require the expertise and consensus of those on all sides of the
regulatory reform debate. Together, we should strive to achieve
desirable social goals in the most cost-effective manner practical.
My goal is to forge a consensus on effective legislation to make the
regulatory process more efficient and effective. The bill I am
introducing today is a first step in this direction, but it requires
further debate and deliberation. It may be necessary to add further
provisions, delete some, or revise others. I will chair a series of
hearings, beginning on February 8, to provide a forum to discuss the
broad principles of regulatory reform--those reflected in this bill as
well as others we have not yet addressed.
My bill will require Federal agencies to seriously consider whether
the benefits of regulating justify its costs. When regulating risks,
regulators will be required to make realistic estimates of risk based
on the available data, and disclose to the public any assumptions
necessary to measure those risks. The bill also will encourage agencies
to base their priorities on the relative risks posed by various
substances, activities, and products to achieve the greatest overall
reduction in risk at the least cost. More generally, my bill will
require agencies to review existing regulations, to be sensitive to the
cumulative regulatory burden, and to select the most cost-effective,
market-driven method practical. These are but some of the principles to
be discussed at the hearings on regulatory reform.
We can reinvent the regulatory process to ensure that when agencies
choose to regulate, they will do so in a more effective and less costly
manner. We can reduce the burden on governments, businesses, and the
public, and still ensure that important benefits and protections are
provided. We cannot afford to ignore the need to regulate smarter.
I ask unanimous consent that the legislation I introduce today be
printed in the Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 291

Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Regulatory Reform Act of
1995''.

SEC. 2. TABLE OF CONTENTS.

The table of contents for this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of Contents.
[[Page S1712]] TITLE I--REGULATORY ANALYSIS AND REVIEW

Sec. 101. Cost/Benefit Analysis of Agency Proposals; Risk Assessment;
Regulatory Review.
Sec. 102. Use of State or Local Requirements.
Sec. 103. Presidential Authority.

TITLE II--RISK-BASED PRIORITIES

Sec. 201. Short title.
Sec. 202. Purposes.
Sec. 203. Definitions.
Sec. 204. Department and Agency Program Goals.
Sec. 205. Comparative Risk Analysis.
Sec. 206. Reports to Congress and the President.
Sec. 207. Savings Provision and Judicial Review.

TITLE III--REGULATORY ACCOUNTING

Sec. 301. Short title.
Sec. 302. Accounting Statement.
Sec. 303. Associated Report to Congress.
Sec. 304. Guidance from Office of Management and Budget.
Sec. 305. Recommendations from Congressional Budget Office.
Sec. 306. Definitions.

TITLE IV--MARKET INCENTIVES AND ECONOMICALLY EFFICIENT REGULATION

Sec. 401. Short title.
Sec. 402. Program Design Requirements.
Sec. 403. Agency Assessment and OMB Review.
Sec. 404. Definitions.
TITLE I: REGULATORY ANALYSIS AND REVIEW

SEC. 101. COST/BENEFIT ANALYSIS OF AGENCY PROPOSALS; RISK
ASSESSMENT; REGULATORY REVIEW.

(a) In General.--Chapter 6 of title 5, United States Code,
is amended by adding at the end thereof the following:

``Subchapter II--Analysis of Agency Proposals

``Sec. 621. Definitions

``For purposes of this subchapter and subchapter III of
this chapter:
``(1) The term `agency' has the same meaning as in section
551(1) of this title.
``(2) The term `person' has the same meaning as in section
551(2) of this title.
``(3) The term `rule' has the same meaning as in section
551(4) of this title, except that such term does not
include--
``(A) a rule of particular applicability that approves or
prescribes for the future rates, wages, prices, services, or
allowances therefor, corporate or financial structures,
reorganizations, mergers or acquisitions, or accounting
practices or disclosures bearing on any of the foregoing.
``(B) a rule relating to monetary policy proposed or
promulgated by the Board of Governors of the Federal Reserve
System; or
``(C) a rule issued by the Federal Election Commission or a
rule issued by the Federal Communications Commission
pursuant to sections 315 and 312(a)(7) of the Communications
Act of 1934.
``(4) The term `major rule' means--
``(A) a rule or a group of closely related rules that the
agency, the President, or the officer selected under section
624 of this title reasonably determines is likely to have an
annual effect on the economy of $100,000,000 or more in
reasonably quantifiable direct and indirect costs, or has a
significant impact on a subsection of the economy; and
``(B) a rule or a group of closely related rules that is
otherwise designated a major rule by the agency proposing the
rule, or is so designated by the President, or by the officer
selected under section 624 of this title, on the ground that
the rule is likely to result in--
``(i) a substantial increase in costs or prices for wage
earners, consumers, individual industries, nonprofit
organizations, Federal, State, or local government agencies,
or geographic regions; or
``(ii) significant adverse effects on wages, economic
growth, investment, productivity, innovation, the
environment, public health or safety, or the ability of
enterprises whose principal places of business are in the
United States to compete in domestic or export markets.
For purposes of subparagraph (A) of this paragraph, the
term `rule' does not mean--
``(I) a rule that involves the internal revenue laws of the
United States;
``(II) a rule that authorizes the introduction into
commerce or recognizes the marketable status of a product,
pursuant to sections 408, 409(c), and 706 of the Federal
Food, Drug, and Cosmetic Act;
``(III) a rule exempt from notice and public procedure
pursuant to section 553(a) of this title; or
``(IV) a rule relating to the viability, stability, asset
powers, or categories of accounts of, or permissible interest
rate ceilings applicable to, depository institutions the
deposits or accounts of which are insured by the Federal
Deposit Insurance Corporation, or the Share Insurance Fund of
the National Credit Union Administration Board.
``(5) The term `benefit' means the reasonably identifiable
significant benefits and beneficial effects, including social
and economic benefits and effects, that are expected to
result directly or indirectly from implementation of a rule
or an alternative to a rule.
``(6) The term `cost' means the reasonably identifiable
significant costs and adverse effects, including economic and
social costs and effects, that are expected to result
directly or indirectly from implementation of a rule or an
alternative to a rule.

``Sec. 622. Regulatory cost/benefit analysis

``(a) Prior to publishing notice of proposed rule making
for any rule, each agency shall determine whether the rule is
or is not a major rule within the meaning of section
621(4)(A) of this title and, if it is not, whether it should
be designated a major rule under section 621(4)(B) of this
title. For the purpose of any such determination or
designation, a group of closely related rules shall be
considered as one rule. Every notice of proposed rule making
shall include a succinct statement and explanation of the
agency's determination of whether or not the rule is a major
rule within the meaning of section 621 (4)(A) of this title
and, if applicable, of its designation as a major rule under
section 621(4)(B) of this title.
``(b) The President or the officer selected by the
President under section 624 of this title may determine that
a rule is a major rule within the meaning of section
621(4)(A) of this title or may designate a rule as a major
rule under section 621(4)(B) of this title not later than
thirty days after the publication of the notice of proposed
rule making for that rule. Such determination or designation
shall be published in the Federal Register, together with a
succinct statement of the basis for the determination or
designation. The President or the officer selected by the
President under section 624 of this title may designate not
more than seventy-five rules as major rules under section
621(4)(B) of this title in any fiscal year.
``(c)(1) When the agency publishes a notice of proposed
rule making for a major rule, the agency shall issue and
place in the rule making file maintained under section 553(f)
of this title a preliminary regulatory analysis and shall
include in such notice of proposed rule making a summary of
the analysis. When the President or the officer elected by
the President under section 624 of this title has published a
determination or designation that a rule is a major rule
after the publication of the notice of proposed rule making
for that rule, the agency shall promptly issue and place in
the rule making file maintained under section 553(f) of this
title a preliminary regulatory analysis for the rule and
shall publish in the Federal Register a summary of such
analysis. Following the issuance of a preliminary regulatory
analysis under the preceding sentence, the agency shall give
interested persons an opportunity to comment thereon pursuant
to section 553 of this title in the same manner as if the
preliminary regulatory analysis had been issued with the
notice of proposed rule making.
``(2) Each preliminary regulatory analysis shall contain--
``(A) a succinct description of the benefit of the proposed
rule, including any beneficial effects that cannot be
quantified, and an explanation of how the agency anticipates
each benefit will be achieved by the proposed rule, including
a description of the persons, classes of persons, or
particular levels of Government likely to receive such
benefits;
``(B) a succinct description of the costs of the proposed
rule, including any costs that cannot be quantified as well
as the cost-reduction effects of complying with the
requirements of title IV, and an explanation of how the
agency anticipates each such cost will result from the
proposed rule, including a description of the persons,
classes of persons, or particular levels of Government likely
to incur such costs;
``(C) a succinct description of reasonable alternatives for
achieving the identified benefits of the proposed rule,
including alternatives that--
``(i) require no Government action;
``(ii) will accommodate differences between geographic
regions; and
``(iii) employ performance or other market based standards
which permit the greatest flexibility in achieving the
identified benefits of the proposed rule and which comply
with the requirements of title IV;
``(D) in any case in which the proposed rule is based on
scientific evaluations or information, a description of
action undertaken by the agency to verify the quality,
reliability, and relevance of such scientific evaluations or
scientific information in accordance with the requirements of
title IV; and
``(E) where it is not expressly or by necessary implication
inconsistent with the provisions of the enabling statute
pursuant to which the agency is proposing the rule, an
explanation of how the identified benefits of the proposed
rule are likely to justify the identified costs of the
proposed rule, and an explanation of how the proposed rule is
likely to substantially achieve the rule making objectives in
a more cost-effective manner than the alternatives to the
proposed rule, including alternatives identified in
accordance with title IV.
``(d)(1) When the agency publishes a final major rule, the
agency shall also issue and place in the rule making file
maintained under section 553(f) of this title a final
regulatory analysis, and shall include a summary of the
analysis in the statement of basis and purpose required by
section 553(c)(6) of this title. Notwithstanding the
preceding sentence, in any case in which an agency, under
section 553(b)(2) of this title, is not required to comply
with subsections (b) through (f) of section 553 of this title
prior to the adoption of a final rule, any agency is not
required to comply with the preceding sentence prior to the
adoption of the final rule but shall comply with such
sentence when complying with section 553(b)(2)(C) of this
title.
[[Page S1713]] ``(2) Each final regulatory analysis shall
contain--
``(A) a description and comparison of the benefits and
costs of the rule and of the reasonable alternatives to the
rule described in the rule making, including the market-based
mechanisms identified pursuant to title IV; and
``(B) where it is not expressly or by necessary implication
inconsistent with the provisions of the enabling statute
pursuant to which the agency is acting, a reasonable
determination, based upon the rule making file considered as
a whole, that the benefits of the rule justify the costs of
the rule, and that the rule will substantially achieve the
rule making objectives in a more cost-effective manner than
the alternatives described in the rule making, including the
market-based incentives identified pursuant to title IV.
``(e)(1) An agency shall describe the nature and extent of
the nonquantifiable benefits and costs of a proposed and a
final rule pursuant to this section in as precise and
succinct a manner as possible. The description of the
benefits and costs of a proposed and a final rule required
under this section shall include a quantification or
numerical estimate of the quantifiable benefits and costs.
Such quantification or numerical estimate shall be made in
the most appropriate unit of measurement and shall specify
the ranges of predictions and explain the margins of error
involved in the quantification methods and in the estimates
used.
``(2) In evaluating and comparing costs and benefits, the
agency shall not rely on cost or benefit information
submitted by any person that is not accompanied by data,
analysis, or other supporting materials that would enable the
agency and other persons interested in the rule making to
assess the accuracy and reliability of such information. The
agency evaluations of the relationships of the benefits of a
proposed and final rule to its costs required by this section
shall be clearly articulated in accordance with the
provisions of this section. An agency is not required to make
such evaluation primarily on a mathematical or numerical
basis.
``(f) The preparation of the preliminary or final
regulatory analysis required by this section shall only be
performed by an officer or employee of the agency. The
provisions of the preceding sentence do not preclude a person
outside the agency from gathering data or information to be
used by the agency in preparing any such regulatory analysis
or from providing an explanation sufficient to permit the
agency to analyze such data or information. If any such data
or information is gathered or explained by a person outside
the agency, the agency shall specifically identify in the
preliminary or final regulatory analysis the data or
information gathered or explained and the person who gathered
or explained it, and shall describe the arrangement by which
the information was procured by the agency, including the
total amount of funds expended for such procurement.
``(g) The requirements of this section do not alter the
criteria for rule making otherwise applicable under other
statutes.

``Sec. 623. Judicial review

``(a) Compliance or noncompliance by an agency with the
provisions of this subchapter shall not be subject to
judicial review except according to the provisions of this
section.
``(b) Any determination by the President or by the officer
selected under section 624 of this title that a rule is a
major rule within the meaning of section 621(4)(A) of this
title, and any designation by the President or the officer
selected under section 624 of this title that a rule is a
major rule under section 621(4)(B) of this title, or any
failure to make such a designation, shall not be subject to
judicial review in any manner.
``(c) The determination of an agency of whether a rule is
or is not a major rule within the meaning of section
621(4)(A) of this title shall be set aside by a reviewing
court only upon a clear and convincing showing that the
determination is erroneous
in light of the information available to the agency at the
time it made the determination. Any designation by an
agency that a rule is a major rule under section 621(4)(B)
of this title, or any failure to make such a designation,
shall not be subject to judicial review.
``(d) Any regulatory analysis prepared under section 622 of
this title shall not be subject to judicial consideration
separate or apart from review of the rule to which it
relates. When an action for judicial review of a rule is
instituted, any regulatory analysis for such rule shall
constitute part of the whole rule making record of agency
action for the purpose of judicial review of the rule and
shall, to the extent relevant, be considered by a court in
determining the legality of the rule.

``Sec. 624. Executive oversight

``(a) The President shall have the authority to establish
procedures for agency compliance with this title and titles
II, III, and IV of this Act. The President shall have the
authority to monitor, review, and ensure agency
implementation of such procedures. The President shall report
annually to the Congress on agency compliance or
noncompliance with the requirements of this chapter.
``(b) Any procedures established pursuant to the authority
granted under subsection (a) of this section shall be adopted
after the public has been afforded an opportunity to comment
thereon, and shall be consistent with the prompt completion
of rule making proceedings. If such procedures include review
of preliminary or final regulatory analyses to ensure that
they comply with the procedures established pursuant to
subsection (a), the time for any such review of a preliminary
regulatory analysis shall not exceed thirty days following
the receipt of that analysis by the President or by an
officer to whom the authority granted under subsection (a) of
this section has been delegated pursuant to subsection (c) of
this section, and the time for such review of a final
regulatory analysis shall not exceed thirty days following
the receipt of that analysis by the President or such
officer. The times for each such review may be extended for
good cause by the President or such officer for an additional
thirty days. Notice of any such extension, together with a
succinct statement of the reasons therefore, shall be
inserted in the rule making file.
``(c) The President may delegate the authority granted by
this Act to the Vice President or to an officer within the
Executive Office of the President whose appointment has been
subject to the advice and consent of the Senate. Any such
notice with respect to a delegation to the Vice President
shall contain a statement by the Vice President that the Vice
President will make every reasonable effort to respond to
Congressional inquiries concerning the exercise of the
authority delegated under this subsection. Notice of any such
delegation, or any revocation or modification thereof, shall
be published in the Federal Register.
``(d) The authority granted under subsection (a) of this
section and title II shall not apply to rules issued by the
Nuclear Regulatory Commission.
``(e) Any exercise of the authority granted under this
section, or any failure to exercise such authority, by the
President or by an officer to whom such authority has been
delegated under subsection (c) of this section, shall not be
subject to judicial review in any manner under this Act.

Subchapter III--Risk Assessments

``Sec. 631. Findings, purposes, and definitions

``(a) Findings.--
``The Congress finds that:
``(1) Environmental, health, and safety regulations have
lead to dramatic improvements in the environment and have
significantly reduced risks to human health; however, many
regulations have been more costly and less effective than
they could have been; too often, regulatory priorities have
not been based upon a realistic consideration of risk, risk
reduction opportunities, and costs.
``(2) The public and private resources available to address
health, safety, and environmental risks are not unlimited;
those resources should be allocated to address the greatest
needs in the most cost-effective manner and to ensure that
the incremental costs of regulatory options are reasonably
related to the incremental benefits.
``(3) To provide more cost-effective protection to human
health and the environment, regulatory priorities should be
based upon realistic consideration of risk; the priority-
setting process must include scientifically sound, objective,
and unbiased risk assessments and risk management choices
that are grounded in cost/benefit principles.
``(4) Risk assessment has proved to be a useful decision-
making tool; however, improvements are needed in both the
quality of assessments and the characterization and
communication of findings; scientific and other data must be
better collected, organized, and evaluated; most importantly,
the critical information resulting from a risk assessment
must be effectively communicated in an objective and unbiased
manner to decision makers, and from decision makers to the
public.
``(5) The public stakeholders must be fully involved in the
decision-making process for regulating risks. The public has
the right to know about the risks addressed by regulation,
the amount of risk reduced, the quality of the science used
to support decisions, and the cost of implementing and
complying with regulations. This knowledge will allow for
public scrutiny and will promote the quality, integrity, and
responsiveness of agency decisions.
``(b) Purposes.--
``The purposes of this subchapter are--
``(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 to promote sound regulatory decisions and
public education;
``(2) to provide for full consideration and discussion of
relevant data and potential methodologies;
``(3) to require explanation of significant choices in the
risk assessment process that will allow for better public
understanding; and
``(4) to improve consistency within the executive branch in
preparing risk assessments and risk characterizations.
``(c) Definitions.--
``For purposes of this subchapter:
``(1) Best Estimate.--The term `best estimate' means an
estimate that, to the extent feasible and scientifically
appropriate, is based on one of the following:
``(A) Central estimates of risk using the most plausible
assumptions.
``(B) An approach that combines multiple estimates based on
different scenarios and weighs the probability of each
scenario.
[[Page S1714]] ``(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.
``(2) Covered agency.--The term `covered agency' means each
of the following:
``(A) The Environmental Protection Agency.
``(B) The Department of Labor.
``(C) The Food and Drug Administration.
``(D) The Consumer Product Safety Commission.
``(E) The Department of Transportation.
``(F) The Department of Energy.
``(G) The Department of Agriculture.
``(H) The Department of Interior.
``(I) The Nuclear Regulatory Commission.
``(3) Emergency.--The term `emergency' means an imminent
and substantial endangerment to public health, safety, or the
environment.
``(4) Hazard identification.--The term `hazard
identification' means identification of a substance,
activity, or condition as potentially posing a risk to human
health or safety or the environment based on empirical data,
measurements, or testing showing that it has caused
significant adverse effects at some levels of dose or
exposure not necessarily relevant to level of dose or
exposure that are normally expected to occur.
``(5) Risk assessment.--The term `risk assessment' means--
``(A) the process of identifying hazards and quantifying or
describing the degree of toxicity, exposure, or other risk
they pose for exposed individuals, populations, or resources;
and
``(B) the document containing the explanation of how the
assessment process has been applied to an individual
substance, activity, or condition.
``(6) Risk characterization.--The term `risk
characterization'--
``(A) means the element of a risk assessment that involves
presentation of the degree of risk in any regulatory proposal
or decision, report to Congress, or other document that is
made available to the public; and
``(B) includes discussions of uncertainties, conflicting
data, estimates, extrapolations, inferences, and opinions.
``(7) Substitution risk.--The term `substitution risk'
means a potential increased risk to human health, safety, or
the environment from a regulatory option designed to decrease
other risks.

``Sec. 632. Applicability

``(a) In General.--Except as otherwise provided in
subsection (b), this title shall apply to all risk
assessments and risk characterizations prepared by, or on
behalf of, or prepared by others and adopted by any covered
agency in connection with health, safety, and environmental
risks.
``(b) Exceptions.--
``(1) In general.--This title shall not apply to risk
assessments or risk characterizations performed with respect
to--
``(A) a situation that the head of the agency considers to
be an emergency; or
``(B) a screening analysis, including a screening analysis
for the purposes of product registration, product
reregistrations, or premanufacturing notices.
``(2) Treatment of analysis as screening analysis.--An
analysis shall not be treated as a screening analysis for the
purposes of paragraph (1)(B) if the result of the analysis is
used--
``(A) as the basis for imposing a restriction on a
substance or activity; or
``(B) to characterize a positive finding of risks from a
substance, product, or activity in any agency document or
other communication made available to the general public, the
media, or Congress.
``(3) Labels.--This title shall not apply to any food,
drug, or other product label or to any risk characterization
appearing on any such label.

``Sec. 633. Savings provisions

``Nothing in this title shall be construed to--
``(1) modify any statutory standard or requirement designed
to protect human health, safety, or the environment; or
``(2) preclude the consideration of any data or the
calculation of any estimate to more fully describe risk or
provide examples of scientific uncertainty or variability; or
``(3) require the disclosure of any trade secrets or other
confidential information.

``Sec. 634. Requirement to prepare risk assessments

``Except as provided in subsection 632(b), the President
shall require that the head of each covered agency prepare
for each major rule relating to human health, safety, or the
environment that is proposed by the agency after the date of
enactment of this title--
``(1) a risk assessment in accordance with this title; and
``(2) for each such proposed or final rule, an assessment
of incremental risk reduction or other benefits associated
with each significant regulatory alternative considered by
the agency in connection with the rule or proposed rule.

``Sec. 635. Principles for risk assessment

``(a) In General.--The head of each covered agency shall
ensure that risk assessments and all of their components--
``(1) distinguish scientific findings and best estimates of
risk from other considerations;
``(2) are, to the maximum extent practicable, unbiased and
inclusive of all reliable information and employ default
assumptions only if situation-specific information is not
reasonably available;
``(3) rely on scientific findings of risk;
``(4) result in the most plausible and realistic estimates
feasible for the population, or, if only bounds can be
estimated reliably, describe the range encompassed; and
``(5) are tailored so that the degree of specificity and
rigor employed is commensurate with the consequences of the
decision to be made.
``(b) Hazard Identification and Risk Characterization.--A
risk assessment shall clearly separate hazard identification
from risk characterization and make clear the relationship
between the level of risk and the level of exposure to a
hazard.

``Sec. 636. Principles for risk characterization and risk
communication

``In characterizing risk in any risk assessment document,
regulatory proposal or decision each covered agency shall
include in the risk characterization each of the following:
``(1) Estimates of risk.--
``(A) Subject.--A description of the populations or natural
resources that are the subject of the risk characterization.
``(B) Assumptions, Inferences, and Models.--When a risk
assessment involves a choice of any significant assumption,
inference, or model, the covered agency or instrumentality
preparing the risk assessment shall--
``(i) present a representative list and explanation of
plausible and alternative assumptions, inferences, or models;
``(ii) explain the basis for any choices;
``(iii) identify any subjective policy decisions or value
judgments; and
``(iv) indicate the extent to which any significant model
has been validated by, or conflicts with, empirical data.
``(C) Uncertainty.--The major uncertainties in the risk
assessment.
``(D) Exposure scenarios.--Information about exposure
scenarios used, including the likelihood of those scenarios.
``(E) Risk range.--To the extent feasible, a range of risk
estimates, including central estimates, for each exposure
scenario.
``(F) Scientific findings and policy decisions.--To the
extent feasible, each risk characterization should
distinguish between scientific findings and policy decisions.
``(2) Substitution risks.--When a covered agency provides a
risk assessment or risk characterization for a proposed or
final regulatory action, such assessment or characterization
shall include a statement of any significant substitution
risks, when
information on such risks has been provided to the agency.
``(3) Summaries of other risk estimates.--If--
``(A) a covered agency provides a public comment period
with respect to a risk assessment or regulation;
``(B) a commenter provides a risk assessment, and a summary
of results of such risk assessment; and
``(C) such risk assessment is consistent with the
principles and the guidance provided under this subtitle, the
covered agency shall present such summary in connection with
its presentation of the risk assessment or regulation.

``Sec. 637. Guidelines, plan for assessing new information,
and report

``(a) Guidelines.--
``(1) In general.--Within 15 months after the date of
enactment of this title, each covered agency shall issue,
after notice and public comment, guidelines to implement the
risk assessment and risk characterization principles set
forth in sections 635 and 636 and shall provide a format for
summarizing risk assessment results.
``(2) Matters to be addressed.--The guidelines under
paragraph (1) shall--
``(A) include guidance on utilization of specific technical
methodologies and standards for acceptable quality of
specific kinds of data; and
``(B) address important decisional factors for the risk
assessment or risk characterization at issue, such as
criteria for scaling animal studies to assess risk to human
health; use of different types of dose-response models;
thresholds; definitions, use, and interpretations of the
maximum tolerated dose; weighing of evidence with respect to
extrapolating human health risks from sensitive species;
evaluation of benign tumors; and evaluation of differences in
human health endpoints, where relevant.
``(b) Plan.--
``(1) In general.--Within 18 months after the date of
enactment of this title, the head of each covered agency
shall publish a plan to review and revise any risk assessment
published prior to the expiration of such 18-month period if
the covered agency determines that significant new
information or methodologies are available that could
significantly alter the results of the prior risk assessment.
``(2) Contents.--A plan under paragraph (1) shall--
``(A) provide procedures for receiving and considering new
information and risk assessments from the public; and
``(B) set priorities for review and revision of risk
assessments based on such factors as the agency head
considers appropriate.
``(c) Report.--Within 3 years after the enactment of this
title, each covered agency
[[Page S1715]] shall provide a report to the Congress
evaluating the categories of policy and value judgments
identified under subparagraph (B)(iii) of section 636(1).
``(d) Public Comment and Consultation.--The guidelines,
plan and report under this section shall be developed after
notice and opportunity for public comment, and after
consultation with representatives of appropriate State
agencies and local governments, and such other departments
and agencies, organizations, or persons as may be advisable.
``(e) Review.--The President shall review the guidelines
published under this section at least every 4 years.
``(f) Limitation on Judicial Review.--The development,
issuance, and publication of risk assessment and risk
characterization guidelines under this section shall not be
subject to judicial review.

``Sec. 638. Risk management criteria

``For each major rule subject to this title, the head of
the agency or the President shall make a determination that--
``(1) the risk assessment under section 634(1) and the
analysis under section 634(2) are based on a scientific
evaluation of the risk addressed by the major rule and are
supported by the best available scientific data; and
``(2) there is no regulatory alternative that is allowed by
the statute under which the regulation is promulgated that
would achieve an equivalent reduction in risk in a more cost-
effective and flexible manner.

``Sec. 639. Interagency coordination

``To promote the conduct, application, and practice of risk
assessment in a consistent manner and to identify risk
assessment data and research needs common to more than one
Federal agency, the Director of the Office of Science and
Technology Policy shall--
``(1) periodically survey the manner in which each Federal
agency involved in risk assessment is conducting such risk
assessment to determine the scope and adequacy of risk
assessment practices in use by the Federal government;
``(2) provide advice and recommendations to the President
and Congress based on the surveys conducted and
determinations made under paragraph (1);
``(3) establish appropriate interagency mechanisms to
promote coordination among Federal agencies conducting risk
assessment with respect to the conduct, application, and
practice of risk assessment and to promote the use of state-
of-the-art risk assessment practices throughout the Federal
government;
``(4) establish appropriate mechanisms between Federal and
State agencies to communicate state-of-the-art risk
assessment practices; and
``(5) periodically convene meetings with State government
representatives and Federal and other leaders to assess the
effectiveness of Federal-State cooperation in the
development and application of risk assessment.

``Subchapter IV--Regulatory Priorities and Review

``Sec. 641. Review of agency rules

``(a) (1) (A) Not later then nine months after the
effective date of this section, each agency shall prepare and
publish in the Federal Register a proposed schedule for the
review, in accordance with this section, of--
``(i) each rule of the agency which is in effect of such
effective date and which, if adopted on such effective date,
would be a major rule under section 621(4)(A) of this title,
and
``(ii) each rule of the agency in effect on such effective
date (in addition to the rules described in clause (i)) which
the agency has selected for review.
``(B) Each proposed scheduled required by subparagraph (A)
shall include--
``(i) a brief explanation of the reasons the agency
considers each rule on the schedule to be such a major rule
under section 621(a) (4) (A) of this title or of the reasons
why the agency selected the rule for review;
``(ii) a date set by the agency, in accordance with the
provisions of subsection (b)(1) of this section, for the
completion of the review of each such rule; and
`(iii) a statement that the agency requests comments from
the public on the proposed schedule.
``(C) The agency shall set a date to initiate review of
each rule on the schedule in a manner which will ensure the
simultaneous review of related items and which will achieve a
reasonable distribution of reviews over the period of time
covered by the schedule.
``(2) At least ninety days before publishing in the Federal
Register the proposed schedule required under paragraph (1),
each agency shall make the proposed schedule available to the
President, or to the Vice President or other officer to whom
oversight authority has been delegated under section 624(b)
of this title. The President or that officer may select for
review in accordance with this section any additional rule
that the President or such officer determines to be a major
rule under section 621(4) (A) of this title.
``(3) Not later than one year after the effective date of
this section, each agency shall publish in the Federal
Register a final schedule for the review of the rules
referred to in paragraphs (1) and (2) of this subsection.

Each agency shall publish with the final schedule the
response of the agency to comments received concerning the
proposed schedule.
``(b)(1) Except where explicitly provided otherwise by
statute, the agency shall, pursuant to subsections (c)
through (e) of this section, review:
``(A) each rule on the schedule promulgated pursuant to
subsection (a) of this section;
``(B) each major rule under section 621(4) of this title
promulgated, amended, or otherwise renewed by an agency after
the date of the enactment of this section; and
``(C) each rule promulgated after the date of enactment of
this section which the President or the officer designated by
the President pursuant to subsection (a)(2) of this section
determines to be a major rule under section 621(4)(A) of this
title.

Except where an extension has been granted pursuant to
subsection (f) of this section, the review of a rule required
by this section shall be completed within ten years after the
effective date of this section or within ten years after the
date on which the rule is promulgated, amended, or renewed,
whichever is later.
``(2) A rule required to be reviewed under the preceding
subsection on grounds that it is major need not be reviewed
if the agency determines that such rule, if adopted at the
time of the planned review, would not be major under the
definition previously applied to it. When the agency makes
such a determination, it shall publish a notice and
explanation of the determination in the Federal Register.
``(c) An agency shall publish in the Federal Register a
notice of its proposed action under this section with respect
to a rule being reviewed. The notice shall include--
``(1) an identification of the specific statutory authority
under which the rule was promulgated and a statement
specifying the agency's determination of whether the rule
continues to fulfill the intent of Congress in enacting that
authority:
``(2) an assessment of the benefits and costs of the rule
during the period in which it has been in effect;
``(3) an explanation of the proposed agency action with
respect to the rule; and
``(4) a statement that the agency seeks proposals from the
public for modifications or alternatives to the rule which
may accomplish the objectives of the rule in a more effective
or less burdensome manner, including alternatives developed
in accordance with the provisions of title IV of this bill.
``(d) If an agency proposes to repeal or amend a rule under
review pursuant to this section, the agency shall, after
issuing the notice required by subsection (c) of this
section, comply with the provisions of this chapter and
chapter 5 of this title
or other applicable law. The requirements of such provisions
and related requirements of law shall apply to the same
extent and in the same manner as in the case of a proposed
agency action to repeal or amend a rule which is not taken
pursuant to the review required by this section.
``(e) If an agency proposed to renew without amendment a
rule under review pursuant to this section, the agency
shall--
``(1) give interested persons not less than sixty days
after the publication of the notice required by subsection
(c) of this section to comment on the proposed renewal; and
``(2) publish in the Federal Register notice of the renewal
of such rule and an explanation of the continued need for the
rule, and, if the renewed rule is a major rule under section
621(4) of this title, include with such notice an explanation
of the reasonable determination of the agency that the rule
complies with the provisions of section 622(d)(2)(B) of this
title.
``(f)(1) Any agency, which for good cause finds compliance
with this section with respect to a particular rule to be
impracticable during the period provided in subsection (b) of
this section, may request the President, or the officer
designated by the President pursuant to subsection (a)(2) of
this section, to establish a period longer than ten years for
the completion of the review of such rule. The President or
that officer may extend the period for review of a rule to a
total period of not more than fifteen years. Such extension
shall be published in the Federal Register with an
explanation of the reasons therefor.
``(2) An agency may, with the concurrence of the President
or the officer designated by the President pursuant to
subsection (a)(2) of this section, or shall, at the direction
of the President or that officer, alter the timing of review
of rules under any schedule required by this section for the
review of rules if an explanation of such alteration is
published in the Federal Register at the time such alteration
is made.
``(g) In any case in which an agency has not completed the
review of a rule within the period prescribed by subsection
(b) or (f) of this section, the agency shall immediately
publish in the Federal Register a notice proposing to amend,
repeal, or renew the rule under subsection (c) of this
section, and shall complete proceedings pursuant to
subsection (d) or (e) of this section within one hundred and
eighty days of the date on which the review was required to
be completed under subsection (b) or (f) of this section.
``(h)(1) Agency compliance or noncompliance with the
provisions of subsection (a) of this section shall not be
subject to judicial review in any manner.
``(2) Agency compliance or noncompliance with the
provisions of subsection (b), (c), (e), (f) and (g) of this
section shall be subject to
[[Page S1716]] judicial review only pursuant to section
706(a)(1) of this title.
``(i) Nothing in this section shall relieve any agency from
its obligation to respond to a petition to issue, amend, or
repeal a rule, for an interpretation regarding the meaning of
a rule, or for a variance or exemption from the terms of a
rule, submitted pursuant to section 553(e) of this title.

Sec. 642. Regulatory agenda and calendar

``(a) Each agency shall publish in the Federal Register in
April and October of each year an agenda of the rules that
the agency expects to propose, promulgate, renew, or repeal
in the succeeding twelve months. For each such rule, the
agenda shall contain, at a minimum, and in addition to any
other information required by law--
``(1) a general description of the rule, including a
citation to the authority under which the action with respect
to the rule is to be taken, or a specific explanation of the
congressional intent to which the objectives of rule respond;
``(2) a statement of whether or not the rule is or is
expected to be a major rule;
``(3) an approximate schedule of the significant dates on
which the agency will take action relating to the rule,
including the dates for any notice of proposed rulemaking,
hearing, and final action on the rule;
``(4) the name, address, and telephone number of an agency
official responsible for answering questions from the public
concerning the rule;
``(5) a statement specifying whether each rule listed on
the previous agenda has been published as a proposed rule,
has been published as a final rule, has become effective, has
been repealed, or is pending in some other status; and
``(6) a cumulative summary of the status of the rules
listed on the previous agenda in accordance with clause (5)
of this subsection.
``(b) The President or an officer in the Executive Office
of the President whose appointment has been subject to the
advice and consent of the Senate shall publish in the Federal
Register in May and November of each year a Calendar of
Federal Regulations listing each of the major rules
identified in the regulatory agendas published by agencies in
the preceding month. Each rule listed in the calendar shall
be accompanied by a summary of the information relating to
the rule that appeared in the most recent regulatory agenda
in which the rule was identified.
``(c) An agency may propose or promulgate a major rule that
was not listed in the regulatory agenda required by
subsection (a) of this section only if the agency published
with the rule an explanation of the omission of the rule from
such agenda and otherwise complies with this section with
resect to that rule.
``(d) Any compliance or noncompliance by the agency with
the provisions of this section shall not be subject to
judicial review.

``Sec. 643. Establishment of deadlines

``(a)(1) Whenever any agency published a notice of proposed
rule making pursuant to section 553 of this title, the agency
shall include in such notice an announcement of the date by
which it intends to complete final agency action on the rule.
``(2) If any agency announcement under this section
indicates that the proceeding relating to such rule will
require more than one year to complete, the agency shall also
indicate in the announcement the date by which the agency
intends to complete each major portion of that proceeding. In
carrying out the requirements of this subsection, the agency
shall select dates for completing agency action which will
assure that most expeditious consideration of the rule which
is possible, consistent with the interests of fairness and
other agency priorities.
``(3) The requirements of this subsection shall not apply
to any rule on which the agency intends to complete action
within one hundred and twenty days after providing notice of
the proposed action.
``(b) If an agency fails to complete action in a
proceeding, or a major portion of the proceeding, by the date
announced
pursuant to subsection (a) of this section, or, in the case
of a proceeding described in paragraph (3) of such
subsection, if an agency fails to complete action within
one hundred and twenty days after providing notice of such
proposed action, and the expected delay in completing
action will exceed thirty days, the agency shall promptly
announce the new date by which the agency intends to
complete action in such proceeding and new dates by which
the agency intends to complete action on each major
portion of the proceeding.
``(c) Compliance or noncompliance by an agency with the
provisions of this section shall not be subject to judicial
review except in accordance with subsection (d).
``(d) In determining whether to compel agency action
unreasonably delayed pursuant to section 706(a)(1) of this
title, the reviewing court shall consider, in addition to any
other relevant factors, the extent to which the agency has
failed to comply with this section.''.
(b) Technical and Conforming Amendments.--Part I of title
5, United States Code, is amended by striking out the chapter
heading and table of sections for chapter 6 and inserting in
lieu thereof the following:
``Chapter 6--The Analysis of Regulatory Functions

``subchapter I--Regulatory analysis

``Sec.
``601. Definitions.
``602. Regulatory agenda.
``603. Initial regulatory flexibility analysis.
``604. Final regulatory flexibility analysis.
``605. Avoidance of duplicative or unnecessary analyses.
``606. Effect on other law.
``607. Preparation of analyses.
``608. Procedure for waiver or delay of completion.
``609. Procedures for gathering comments
``610. Periodic review of rules.
``611. Judicial review.
``612. Reports and intervention rights.

``subchapter II--analysis of agency proposals

``621. Definitions.
``622. Regulatory cost/benefit analysis.
``623. Judicial review.
``624. Executive oversight.

``subchapter III--risk assessments

``631. Findings, purposes, and definitions.
``632. Applicability.
``633. Savings provisions.
``634. Requirement to prepare risk assessments.
``635. Principles for risk assessment.
``636. Principles for risk characterization and risk communication.
``637. Guidelines, plan for assessing new information, and report.
``638. Risk management criteria.
``639. Interagency coordination.

``subchapter IV--Regulatory priorities and review

``641. Review of agency rules.
``642. Regulatory agenda and calendar.
``643. Establishment of deadlines.''.
SEC. 102. USE OF STATE OR LOCAL REQUIREMENTS.

(a) In General.--Subchapter II of chapter 5 of title 5,
United States Code, is amended by adding at the end thereof
the following new section:

``Sec. 560. Use of duplicative State or local requirements
``(a) Except as otherwise provided by law, the head of each
Federal agency is authorized, in the administration of a
Federal statute with respect to any State or locality, to
adopt as a Federal rule a regulation of that State or local
government or use as a Federal recordkeeping or reporting
requirement or implementation procedure a recordkeeping or
reporting requirement or implementation procedure of that
State or locality if the head of the agency determines--
``(1) that such State or local government regulation,
implementation procedure, recordkeeping requirement, or
reporting requirement duplicates a Federal regulation,
procedure, recordkeeping requirement, or reporting
requirement; and
``(2) that such State or local government regulation,
implementation procedure, recordkeeping requirement, or
reporting requirement is substantively equivalent to or more
stringent than the Federal regulation, procedure,
recordkeeping requirement, or reporting requirement,
``(b) When the head of an agency determines to use a State
or local recordkeeping or reporting requirement, or
implementation procedure, as a Federal recordkeeping or
reporting requirement or implementation procedure in that
State or locality, the head of the agency shall prepare at a
minimum, a written statement of the reasons for any
determination made under subsection (a), and shall make such
statement available to the public.
``(c) This section does not limit the authority or
responsibility of the head of any agency to enforce Federal
law.''
(b) Rule Making.--Section 551 of title 5, United States
Code, is amended by inserting the following between ``rule''
and the semicolon: ``, or the adoption of a rule pursuant to
section 561 of this title''.
(c) Table of Sections.--The table of sections for chapter 5
of such title is amended by inserting after the item relating
to section 559 the following new item:

``Sec. 560. Use of duplicative State or local
requirements.''.

SEC. 103. PRESIDENTIAL AUTHORITY.

Nothing in this Act (i) limits the exercise by the
President of the authority and responsibility that he
otherwise possesses under the Constitution and other laws of
the United States with respect to regulatory policies,
procedures, and programs of departments, agencies, and
offices, or (ii) alters in any manner rulemaking authority
vested by law in an agency to initiate or complete a
rulemaking proceeding, or to issue, modify, or rescind a
rule.
TITLE II--RISK-BASED PRIORITIES

SEC. 201. SHORT TITLE.

This title may be cited as the ``Risk Reduction Priorities
Act of 1995''.

SEC. 202. PURPOSES.

It is the purposes of this title to--
(1) encourage Federal agencies engaged in regulating risks
to human health, safety, and the environment to achieve the
greatest risk reduction at the least cost practical;
(2) promote the coordination of policies and programs to
reduce risks to human health, safety, and the environment;
and
(3) promote open communication among Federal agencies, the
public, the President, and Congress regarding environmental,
health, and safety risks, and the prevention and management
of those risks.

SEC. 203. DEFINITIONS.

For the purposes of this title:
(1) Comparative Risk Analysis.--The term ``comparative risk
analysis'' means a process to systematically estimate,
compare, and
[[Page S1717]] rank the size and severity of risks to provide
a common basis for evaluating strategies for reducing or
preventing those risks.
(2) Covered Agency.--The term ``covered agency'' means each
of the following:
(A) The Environmental Protection Agency.
(B) The Department of Labor.
(C) The Food and Drug Administration.
(D) The Consumer Product Safety Commission.
(E) The Department of Transportation.
(F) The Department of Energy.
(G) The Department of Agriculture.
(H) The Department of Interior.
(I) The Nuclear Regulatory Commission.
(3) Director.--The term ``Director'' means the Director of
the Office of Management and Budget.
(4) Effect.--The term ``effect'' means a deleterious change
in the condition--
(A) of a human or other living thing (including death,
cancer, or other chronic illness, decreased reproductive
capacity, or disfigurement); or
(B) of an inanimate thing important to human welfare
(including destruction, degeneration, the loss of intended
function, and increased costs for maintenance).
(5) Irreversibility.--The term ``irreversibility'' means
the extent to which a return to conditions prior to the
occurrence of an effect are either very slow or will never
occur.
(6) Likelihood.--The term ``likelihood'' means the
estimated probability that an effect will occur.
(7) Magnitude.--The term ``magnitude'' means the number of
individuals or the quantity of ecological resources or other
resources that contribute to human welfare that are affected
by
exposure to a stressor.
(8) Seriousness.--The term ``seriousness'' means the
intensity of effect, the likelihood, the irreversibility, and
the magnitude.

SEC. 204. DEPARTMENT AND AGENCY PROGRAM GOALS.

(a) Setting Priorities.--In exercising authority under
applicable laws protecting human health, safety, or the
environment, the head of each covered agency should strive to
set priorities and to use the resources available under those
laws to address those risks to human health, safety, and the
environment that--
(1) the covered agency determines to be the most serious;
and
(2) can be addressed in a cost-effective manner, with the
goal of achieving the greatest overall net reduction in risks
with the public and private sector resources expended.
(b) Determining the Most Serious Risks.--In identifying the
greatest risks under subsection (a) of this section, each
covered agency shall consider, at a minimum:
(1) the likelihood, irreversibility, and severity of the
effect; and
(2) the number and groups of individuals potentially
affected, and shall explicitly take into account the results
of the comparative risk analysis conducted under section 205
of this Act.
(c) OMB Review.--The covered agency's determinations of the
sources of the most serious risks for purposes of setting
priorities shall be reviewed and approved by the Director of
the Office of Management and Budget prior to submission of
the covered agency's annual budget requests to Congress.
(d) Incorporating Risk-Based Priorities Into Budget and
Planning.--The head of each covered agency shall incorporate
the priorities identified in subsection (a) of this section
into the agency budget, strategic planning, regulatory
agenda, enforcement, and research activities by--
(1) in the covered agency's annual budget request to
Congress--
(A) identifying which risks that the covered agency head
has determined are the most serious and can be addressed in a
cost-effective manner under subsection (a) and the basis for
that determination;
(B) explicitly identifying how the covered agency's
requested funds will be used to reduce those risks, including
the amount of funds requested to address each of those risks;
and
(C) identifying any statutory, regulatory, or
administrative obstacles to allocating agency resources in
accordance with the mandates of subsection (a);
(2) explicitly considering the requirements of subsection
(a) and the results of the comparative risk analysis prepared
under section 205 of this title when
preparing the covered agency's regulatory agenda or other
covered agency strategic plan and explaining how the
agenda or plan reflects those requirements and the
competitive risk analysis when publishing any such agenda
or strategic plan;
(3) developing an annual enforcement strategic plan that
targets the priority risks identified under subsection (a);
and
(4) expressly considering the priority risks determined
under subsection (a) in selecting research activities.
(e) Effective Date.--This section shall take effect 12
months from the date of enactment of his title.

SEC. 205. COMPARATIVE RISK ANALYSIS.

(a) Requirement.--Within 6 months of the enactment of this
title, the Director of the Office of Management and Budget
shall enter into appropriate arrangements with an accredited
scientific body--
(1) to conduct a study of the methodologies for using
comparative risk to rank dissimilar human health, safety, and
environmental risks; and
(2) to conduct a comparative risk analysis. The comparative
risk analysis shall compare and rank, to the extent feasible,
human health, safety, and environmental risks potentially
regulated across the spectrum of programs administered by all
covered agencies.

The Director shall consult with the Office of Science and
Technology Policy regarding the scope of the study and the
conduct of the comparative risk analysis.
(b) Criteria.--In arranging for the comparative risk
analysis referred to in subsection (a), the Director shall
ensure that--
(1) the scope and specificity of the analysis are
sufficient to provide the President and agency heads guidance
in allocating resources agencies and among programs in
agencies to achieve the greatest degree of risk prevention
and reduction for the public and private resources expended;
(2) the analysis is conducted through an open process,
which may include using panels of appropriate independent
experts and public stakeholders;
(3) the methodologies and principal scientific
determinations made in the analysis are subjected to
independent and external peer review and that the conclusions
of the peer review are made publicly available as part of the
final report required by subsection (c);
(4) there is an opportunity for public comment on the
results prior to making them final; and
(5) the results are presented in a manner that
distinguishes between the scientific conclusions and any
policy or value judgments embodied in the comparisons.
(c) Report.--The comparative risk analysis required by
subsection (a) shall be completed and a report submitted to
Congress and the President no later than 3 years following
the enactment of this Act. The comparative risk analysis
shall be reviewed and revised at least every 5 years
thereafter for a minimum of 15 years following the release of
the first Analysis. The Director shall arrange for such
review and revision with an accredited scientific body in the
same manner as provided in subsections (a) and (b) above.
(d) Study.--The study of methodologies provided in
subsection (a) shall be conducted as part of the first
comparative risk analysis. The goal of the study shall be to
develop and rigorously test methods of comparative risk
analysis. The study shall have sufficient scope and breadth
to test approaches for improving comparative risk analysis
and its use in setting priorities for human health, safety,
and environmental risk prevention and reduction. As part of
its analysis, the study shall review and evaluate the
experiences of the states that have conducted comparative
risk analyses.
(3) Report.--Within 180 days after the completion of the
study, the Director shall issue a report of the study to the
Congress, along with results of a scientific peer review of
the study.
(f) Technical guidance.--Not later than 180 days after the
enactment of this Act, the Director, in collaboration with
other heads of covered agencies shall enter into a contract
with the National Research Council to provide technical
guidance to agencies on approaches to using comparative risk
analysis in setting human health, safety, and environmental
priorities to assist agencies in complying with section 204
of this title.

SEC. 206. REPORTS AND RECOMMENDATIONS TO CONGRESS AND THE
PRESIDENT.

(a) In General.--In addition to the statement submitted to
Congress with each covered agency's annual budget request
required under section 204(d)(1) of this title, each covered
agency shall submit a report to Congress and the President 24
months following the enactment of this legislation, and every
24 months therafter--
(1) detailing how the agency has complied with section 204;
(2) describing the reasons for any departure from the
requirement to establish priorities to achieve the greatest
overall net reduction in risk; and
(3) estimating the total public and private costs of
regulatory and voluntary risk reduction activities under
programs administered by the agency that year, a comparison
of that estimate with the previous year, and a projection for
the following year.
(b) Recommendation.--In March of each year, the head of
each covered agency shall submit to Congress specific
recommendations for--
(1) modifying, repealing, or enacting laws to reform,
eliminate, or enhance programs or mandates relating to human
health, safety, and the environment; and
(2) modifying or eliminating statutorily or judicially
mandated deadlines,

that would assist the covered agency to set priorities in its
activities to address the risks to human health, safety, and
the environment that are the most serious and can be
addressed in a cost-effective manner consistent with the
requirements of section 204(a).

SEC. 207. SAVINGS PROVISION AND JUDICIAL REVIEW.

(1) In General.--Nothing in this title shall be construed
to modify any statutory standard or requirement designed to
protect human health, safety, or the environment.
(2) Judicial Review.--Compliance or noncompliance by an
agency with the provisions of this title shall not be subject
to judicial review.
[[Page S1718]] (3) Agency Analysis.--Any analysis prepared
under this title shall not be subject to judicial
consideration separate or apart from the requirement, rule,
program, or law to which it relates. When an action for
judicial review of a covered agency action is instituted, any
analysis for, or relating to, the action shall constitute
part of the whole record of agency action for the purpose of
judicial review of the action and shall, to the extent
relevant, be considered by a court in determining the
legality of the covered agency action.
TITLE III--REGULATORY ACCOUNTING

SEC. 301. SHORT TITLE

This title may be cited as the ``Regulatory Accounting Act
of 1995''.

SEC. 302. ACCOUNTING STATEMENT

(a) In General.--
(1) Responsibility for implementation.--The President shall
be responsible for implementing and administering the
requirements of this title.
(2) Accounting statement.--Every two years, not later than
June of the second year, the President shall prepare and
submit to Congress an accounting statement that estimates the
costs of Federal regulatory programs and corresponding
benefits in accordance with this section.
(b) Years Covered by Accounting Statement.--Each accounting
statement shall cover, at a minimum, the 5 fiscal years
beginning on October 1 of the year in which the report is
submitted and may cover any fiscal year preceding such fiscal
years for purpose of revising previous estimates.
(c) Timing and Procedures.--
(1) Notice and comment.--The President shall provide notice
and opportunity for comment for each accounting statement.
The President may delegate to an agency the requirement to
provide notice and opportunity to comment for the portion of
the accounting statement relating to that agency.
(2) Deadlines for first statement.--The President shall
propose the first accounting statement under this section not
later than 2 years after the date of the enactment of this
Act and shall issue the first accounting statement in final
form not later than 3 years after the date of the enactment
of this Act. Such statement shall cover, at a minimum, each
of the 8 fiscal years beginning after the date of the
enactment of this Act.
(d) Content of Accounting Statement.--
(1) In general.--Each accounting statement shall contain
estimates of costs and benefits with respect to each fiscal
year covered by the statement in accordance with this
subsection. For each such fiscal year for which estimates
were made in a previous accounting statement, the statement
shall revise those estimates and state the reasons for the
revisions.
(2) Statement of costs.--
(A) In general.--An accounting statement shall estimate the
costs of Federal regulatory programs by setting forth, for
each year covered by the statement--
(i) the annual expenditure of national economic resources
for the regulatory program; and
(ii) such other quantitative and qualitative measures of
costs as the President considers appropriate.
(B) National economic resources.--For purposes of the
estimate of costs in the accounting statement, national
economic resources shall include, and shall be listed under,
at least the following categories:
(i) Private sector costs.
(ii) Federal sector administrative costs.
(iii) Federal sector compliance costs.
(iv) State and local government administrative costs.
(v) State and local government compliance costs.
(3) Statement of corresponding benefits.--An accounting
statement shall estimate the benefits of Federal regulatory
programs by setting forth, for each year covered by the
statement, such quantitative and qualitative measures of
benefits as the President considers appropriate. Any
estimates of benefits concerning reduction in human health,
safety, or environmental risks shall present the most
plausible level of risk practical, along with a statement of
the reasonable degree of scientific certainty.

SEC. 303. ASSOCIATED REPORT TO CONGRESS.

(a) In General.--At the same time as the President submits
an accounting statement under section 302, the President,
acting through the Director of the Office of Management and
Budget, shall submit to Congress a report associated with the
accounting statement (hereinafter referred to as an
``associated report''). The associated report shall contain,
in accordance with this section--
(1) analyses of impacts; and
(2) recommendations for reform.
(b) Analyses of Impacts.--The President shall include in
the associated report the following:
(1) Analyses prepared by the President of the cumulative
impact of Federal regulatory programs covered in the
accounting statement on the following:
(A) The ability of State and local governments to provide
essential services, including police, fire protection, and
education.
(B) Small business.
(C) Productivity.
(D) Wages.
(E) Economic growth.
(F) Technological innovation.
(G) Consumer prices for goods and services.
(H) Such other factors considered appropriate by the
President.
(2) A summary of any independent analyses of impacts
prepared by persons commenting during the comment period on
the accounting statement.
(c) Recommendations for Reform.--The President shall
include in the associated report the following:
(1) A summary of recommendations of the President for
reform or elimination of any Federal regulatory program or
program element that does not represent sound use of national
economic resources or otherwise is inefficient.
(2) A summary of any recommendations for such reform or
elimination of Federal regulatory programs or program
elements prepared by persons commenting during the comment
period on the accounting statement.

SEC. 304. GUIDANCE FROM OFFICE OF MANAGEMENT AND BUDGET.

The Director of the Office of Management and Budget shall,
in consultation with the Council of Economic Advisers,
provide guidance to agencies--
(1) to standardize measures of costs and benefits in
accounting statements prepared pursuant to titles I and III,
including:
(A) detailed guidance on estimating the costs and benefits
of major rules;
(B) general guidance on estimating the costs and benefits
of all other rules that do not meet the thresholds for major
rules; and
(2) to standardize the format of the accounting statements.

SEC. 305. RECOMMENDATIONS FROM CONGRESSIONAL BUDGET OFFICE.

After each accounting statement and associated report
submitted to Congress, the Director of the Congressional
Budget Office shall make recommendations to the President--
(1) for improving accounting statements prepared pursuant
to this title, including recommendations on level of detail
and accuracy; and
(2) for improving associated reports prepared pursuant to
this title, including recommendations on the quality of
analysis.

SEC. 306. DEFINITIONS.

For purposes of this title, the following definitions
apply:
(1) The term ``Federal regulatory program'' means a program
carried out pursuant to a related group of Federal statutes
and regulations, as determined by the President.
(2) The term ``regulation'' means an agency statement of
general applicability and future effect designed to
implement, interpret, or prescribe law or policy or
describing the procedure or practice requirements of an
agency. The term does not include--
(A) administrative actions governed by sections 556 and 557
of title 5, United States Code;
(B) regulations issued with respect to a military of
foreign affairs function of the United States; or
(C) regulations related to agency organization, management,
or personnel.
(3) The term ``agency'' means any executive department,
military department, Government corporation, Government
controlled corporation, or other establishment in the
executive branch of the Government (including the Executive
Office of the President), or any independent regulatory
agency, but does not include--
(A) the General Accounting Office;
(B) Federal Election Commission;
(C) the governments of the District of Columbia and of the
territories and possessions of the United States, and their
various subdivisions; or
(D) Government-owned contractor-operated facilities,
including laboratories engaged in national defense research
and production activities.

TITLE IV--MARKET INCENTIVES AND ECONOMICALLY EFFICIENT REGULATION

SEC. 401. SHORT TITLE.

This title may be cited as the ``Market Incentives Act of
1995''.

SEC. 402. PROGRAM DESIGN REQUIREMENTS.

(a) In General.--To the maximum extent practicable,
agencies shall ensure that major rules, especially, but not
limited to, those that limit the emission of environmental
pollutants or otherwise govern the use of natural resources,
operate through the application of market-based mechanisms.
(b) Flexible Alternatives.--Where it is not practicable to
rely on market-based mechanisms in designing regulatory
programs, rules, or requirements, agencies shall ensure that
major rules, to the maximum extent practicable, are
comparable to market-based mechanisms with respect to (i)
assuring the achievement of the regulatory objective, and
(ii) affording flexibility to regulated persons.
(c) Applicability.--Section 402 shall apply, to the extent
feasible, to rules in effect on the date of enactment of this
Act and rules that take effect after the date of enactment of
this Act.
SEC. 403. AGENCY ASSESSMENT AND OMB REVIEW.

(a) In General.--Each agency shall include an assessment of
market-based mechanisms in each proposed major rule. Each
assessment shall demonstrate the extent to which the major
rule complies with the requirements of section 402, or why
section 402 is not applicable or appropriate.
(b) OMB Review.--The Office of Management and Budget shall
review, as part of its
[[Page S1719]] regulatory review and oversight function, the
agency assessments and statements prepared in section 403(a).
OMB shall determine whether such assessments are detailed,
thorough, and otherwise in compliance with section 402.
(c) Effective Date.--Section 403 shall take affect 3 months
after the date of enactment of this Act:

SEC. 404. DEFINITIONS.

For the purposes of this title:
(1) The term ``agency'' means any executive department,
military department, Government corporation, Government
controlled corporation, or other establishment in the
executive branch of the Government (including the Executive
Office of the President), or any independent regulatory
agency, but does not include--
(A) the General Accounting Office;
(B) Federal Election Commission;
(C) the governments of the District of Columbia and of the
territories and possessions of the United States, and their
various subdivisions; or
(D) Government-owned contractor-operated facilities,
including laboratories engaged in national defense research
and production activities.
(2) The term ``major rule'' means--
(A) a rule or a group of closely related rules that the
agency or the President reasonably determines is likely to
have an annual effect on the economy of $100,000,000 or more
in reasonably quantifiable direct and indirect costs, or has
a significant impact on a subsector of the economy; and
(B) a rule or a group of closely related rules that is
otherwise designated a major rule by the agency proposing the
rule, or is so designated by the President, on the ground
that the rule is likely to result in--
(i) a substantial increase in costs or prices for wage
earners, consumers, individual industries, nonprofit
organizations, Federal, State, or local government agencies,
or geographic regions; or
(ii) significant adverse effects on wages, economic growth,
investment, productivity, innovation, the environment, public
health or safety, or the ability of enterprises whose
principal places of business are in the United States to
compete in domestic and export markets.

For purposes of subparagraph (A) of this paragraph, the term
``rule'' does not mean--
(I) a rule that involves the internal revenue laws of the
United States;
(II) a rule that authorizes the introduction into commerce
or recognizes the marketable status of a product, pursuant to
sections 408, 409(c), and 706 of the Federal Food, Drug, and
Cosmetic Act;
(III) a rule exempt from notice and public procedure
pursuant to section 553(a) of title 5, United States Code; or
(IV) a rule relating to the viability, stability, asset
powers, or categories of accounts of, or permissible interest
rate ceilings applicable to, depository institutions the
deposits or accounts of which are insured by the Federal
Deposit Insurance Corporation, or the Share Insurance Fund of
the National Credit Union Administration Board.
(3) The term ``market-based mechanism'' means a regulatory
requirement that:
(a) imposes legal accountability for the achievement of an
explicit regulatory objective on each regulated person;
(b) affords maximum flexibility to each regulated person in
complying with mandatory regulatory objectives, which
flexibility shall include, but not be limited to, the
opportunity to transfer to, or receive from, other persons,
including for cash or other legal consideration, increments
of compliance responsibility established by the program; and
(c) permits regulated persons to respond automatically to
changes in general economic conditions and in economic
circumstances directly pertinent to the regulatory program
without affecting the achievement of the program's explicit
regulatory mandates.
(4) The term ``rule'' has the same meaning as in section
551(4) of title 5, United States Code, except that such term
does not include--
(A) a rule of particular applicability that approves or
prescribes for the future rates, wages, prices, services, or
allowances therefor, corporate or financial structures,
reorganizations, mergers or acquisitions, or accounting
practices or disclosures bearing on any of the foregoing.
(B) a rule relating to monetary policy proposed or
promulgated by the Board of Governors of the Federal Reserve
System; or
(C) a rule issued by the Federal Election Commission or a
rule issued by the Federal Communications Commission pursuant
to sections 315 and 312(a)(7) of the Communications act of
1934.<bullet>
______

By Mr. SHELBY:
S. 292. A bill to provide Federal recognition of the Mowa Band of
Choctaw Indians of Alabama; to the Committee on Indian Affairs.

THE MOWA BAND OF CHOCTAW INDIANS RECOGNITION ACT

<bullet> Mr. SHELBY. Mr. President, today I am reintroducing the Mowa
Band of Choctaw Indians Recognition Act. This particular piece of
legislation has passed the Senate three times in the past two
Congresses. While I would prefer not to have to pursue congressionally
granted recognition for the Mowa Choctaws, this course of action has
been dictated by the institutional resistance of the Bureau of Indian
Affairs to Federal recognition of the Mowa.
The Mowa Choctaws originally applied for Federal recognition in 1983.
A State-recognized tribe with 3,500 members, the Mowa live within the
boundaries of the original Choctaw Nation in Mobile and Washington
Counties of Alabama. Mowa ancestors were signatories of the treaty of
Dancing Rabbit Creek which provided for the nonremoval of Indian
families. Under the treaty, the signatories and their descendants were
entitled to retain their rights to Choctaw citizenship.
The Mowa Choctaws have maintained an intense Indian identity over the
past 160 years and have petitioned Congress for Federal recognition or
to redress treaty grievances several times, beginning as early as 1836.
Because of the failure of the BIA to act upon their petition in a
timely manner, the Senate Committee on Indian Affairs reported the bill
in both the 102d and 103d Congress with the recommendation that the
Mowa be granted full Federal recognition.
Only recently has the BIA acted upon the petition. In December, the
BIA, after 12 years of delay, issued a preliminary finding denying the
Mowa petition. However, the BIA only acted upon the petition when it
became likely that the bill would pass the Congress and be sent to the
President for his signature. I find this conduct at best suspicious,
and most likely reflective of the BIA's longstanding bureaucratic
disposition against the proposal.
Mr. President, I have no intention of dropping this issue, regardless
of the position of the BIA. Indeed, Congress granted Federal
recognition to one-half dozen Indian tribes last year without the
approval of the BIA. Congress writes the laws of this land. Career and
appointed bureaucrats do not. The Mowa case is stronger than scores of
past petitions for recognition that were approved, and I will continue
to work to see that Congress rectifies this bureaucratic injustice and
grants the Mowa Choctaws the Federal recognition that they
deserve.<bullet>

____________________