I
105TH CONGRESS
2D SESSION
H. R. 4863
To ensure the incorporation of risk assessment and cost benefit analysis
in the rulemaking process.
IN THE HOUSE OF REPRESENTATIVES
OCTOBER 20, 1998
Mr. CONDIT (for himself and Mr. JOHN) introduced the following bill; which
was referred to the Committee on the Judiciary, and in addition to the
Committee on Government Reform and Oversight, for a period to be sub-
sequently determined by the Speaker, in each case for consideration of
such provisions as fall within the jurisdiction of the committee concerned
A BILL
To ensure the incorporation of risk assessment and cost
benefit analysis in the rulemaking process.
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 ‘‘Government Regu-
latory Improvement and Performance Act of 1998’’.
SEC. 2. STATEMENT OF REGULATORY PHILOSOPHY AND
PRINCIPLES.
(a) THE REGULATORY PHILOSOPHY.—Federal agen-
cies (in this Act referred to as ‘‘agencies’’) should promul-
gate only such regulations as are required by law, are nec-
essary to interpret the law, or are necessary to protect
and promote or improve the health and safety of the pub-
lic, the environment, or the well-being of the American
people. In deciding whether and how to regulate, agencies
should assess all costs and benefits of available regulatory
alternatives, including the alternative of not regulating.
Costs and benefits shall be understood to include both
quantifiable measures (to the fullest extent that these can
be usefully estimated) and qualitative measures of costs
and benefits that are difficult to quantify, but nevertheless
essential to consider. Further, in choosing among alter-
native regulatory approaches, agencies should select those
approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and
other advantages, distributive impacts, and equity), unless
a statute requires another regulatory approach.
(b) THE PRINCIPLES OF REGULATION.—To ensure
that the agencies’ regulatory programs are consistent with
the philosophy set out in subsection (a), agencies shall ad-
here to the following principles in promulgating any regu-
lation, to the extent permitted by law and where applica-
ble:
(1) Each agency shall identify the problem that
it intends to address by the regulation (including,
where applicable, the failures of private markets or
public institutions that warrant new agency action),
assess the significance of that problem, and if pos-
sible conduct a risk analysis regarding the regula-
tion.
(2) Each agency shall examine whether existing
regulations (or other law) have created, or contrib-
uted to, the problem that a new regulation is in-
tended to correct and whether those regulations (or
other law) should be modified to achieve the in-
tended goal of regulation more effectively.
(3) Each agency shall identify and assess avail-
able alternatives to direct regulation, including pro-
viding economic incentives to encourage the desired
behavior, such as user fees or marketable permits or
providing information upon which choices can be
made by the public.
(4) In setting regulatory priorities, each agency
shall consider, to the extent permitted by law, the
degree and nature of the risks posed by various sub-
stances or activities within its jurisdiction.
(5) When an agency determines that a regula-
tion is necessary, it shall design its regulations in
the most cost-effective manner to achieve the regu-
latory objective. In doing so, each agency shall con-
sider incentives for innovation, consistency, predict-
ability, the costs of enforcement and compliance (to
the government, regulated entities, and the public),
flexibility, distributive impacts, and equity.
(6) Each agency shall assess both the costs and
the benefits of the intended regulation and, recogniz-
ing that some costs and benefits are difficult to
quantify, propose or adopt a regulation only upon a
reasoned determination that the benefits of the in-
tended regulation justify its costs.
(7) Each agency shall base its decisions on the
best reasonably obtainable scientific, technical, eco-
nomic, and other information concerning the need
for, and consequences of, the intended regulation.
(8) Each agency shall identify and assess alter-
native forms of regulation and shall, to the extent
feasible, specify performance objectives, rather than
specifying the behavior or manner of compliance
that regulated entities must adopt.
(9) Wherever feasible, agencies shall seek views
of appropriate State, local, and tribal officials before
imposing regulatory requirements that might signifi-
cantly or uniquely affect those governmental entities.
Each agency shall assess the effects of Federal regu-
lations on State, local, and tribal governments, in-
cluding specifically the availability of resources to
carry out those mandates, and seek to minimize
those burdens that uniquely or significantly affect
such governmental entities, consistent with achieving
regulatory objectives. In addition, as appropriate,
agencies shall seek to harmonize Federal regulatory
actions with related State, local, and tribal regu-
latory and other governmental functions.
(10) Each agency shall avoid regulations that
are inconsistent, incompatible, or duplicative with its
other regulations or those of other Federal agencies.
(11) Each agency shall tailor its regulations to
impose the least burden on society, including individ-
uals, businesses of differing sizes, and other entities
(including small communities and governmental enti-
ties), consistent with obtaining the regulatory objec-
tives, taking into account, among other things, and
to the extent practicable, the costs of cumulative
regulations.
(12) Each agency shall draft its regulations to
be simple and easy to understand, with the goal of
minimizing the potential for uncertainty and litiga-
tion arising from such uncertainty.
SEC. 3. ORGANIZATION.
(a) THE AGENCIES.—Because Federal agencies are
the repositories of significant substantive expertise and ex-
perience, they are responsible for developing regulations
and assuring that the regulations are consistent with ap-
plicable law, the President’s priorities, and the principles
set forth in this Act.
(b) THE OFFICE OF MANAGEMENT AND BUDGET.—
Coordinated review of agency rulemaking is necessary to
ensure that regulations are consistent with applicable law,
the President’s priorities, and the principles set forth in
this Act, and that decisions made by one agency do not
conflict with the policies or actions taken or planned by
another agency. The Office of Management and Budget
(in this Act referred to as ‘‘OMB’’) shall carry out that
review function. Within OMB, the Office of Information
and Regulatory Affairs (in this Act referred as as
‘‘OIRA’’) is the repository of expertise concerning regu-
latory issues, including methodologies and procedures that
affect more than one agency, this Act, and the President’s
regulatory policies. To the extent permitted by law, OMB
shall provide guidance to agencies and assist the Presi-
dent, the Administrator of OIRA, and other regulatory
policy advisers to the President in regulatory planning and
shall be the entity that reviews individual regulations, as
provided by this Act.
(c) THE ADMINISTRATOR OF OIRA.—The Adminis-
trator of OIRA shall coordinate the development and pres-
entation of recommendations concerning, regulatory pol-
icy, planning, and review, as set forth in this Act. In ful-
filling their responsibilities under this Act, the President
and the Administrator of OIRA shall be assisted by the
regulatory policy advisers within the Executive Office of
the President and by such agency officials and personnel
as the President and the Administrator of OIRA may,
from time to time, consult.
SEC. 4. PLANNING MECHANISM.
(a) AGENCIES’ POLICY MEETING.—Early in each
year’s planning cycle, the Administrator of OIRA shall
convene a meeting of the Advisers and the heads of agen-
cies to seek a common understanding of priorities and to
coordinate regulatory efforts to be accomplished in the up-
coming year.
(b) UNIFIED REGULATORY AGENDA.— Each agency
shall prepare an agenda of all regulations under develop-
ment or review, at a time and in a manner specified by
the Administrator of OIRA. The description of each regu-
latory action shall contain, at a minimum, a regulation
identifier number, a brief summary of the action, the legal
authority for the action, any legal deadline for the action,
and the name and telephone number of a knowledgeable
agency official. Agencies may incorporate the information
required under section 602 of title 5, United States Code,
into these agendas.
(c) THE REGULATORY PLAN.—
(1) As part of the Unified Regulatory Agenda,
beginning in 1994, each agency shall prepare a Reg-
ulatory Plan (in this Act referred to as a ‘‘Plan’’)
of the most important significant regulatory actions
that the agency reasonably expects to issue in pro-
posed or final form in that fiscal year or thereafter.
The Plan shall be approved personally by the agency
head and shall contain at a minimum—
(A) a statement of the agency’s regulatory
objectives and priorities and how they relate to
the philosophy and principles set forth in sec-
tions 2(a) and 2(b), respectively;
(B) a summary of each planned significant
regulatory action including, to the extent pos-
sible, alternatives to be considered and prelimi-
nary estimates of the anticipated costs and ben-
efits;
(C) a summary of the legal basis for each
such action, including whether any aspect of the
action is required by statute or court order;
(d) REGULATORY WORKING GROUP.—Within 30
days after the date of the enactment of this Act, the Ad-
ministrator of OIRA shall convene a Regulatory Working
Group (‘‘Working Group’’), which shall consist of rep-
resentatives of the heads of each agency that the Adminis-
trator determines to have significant domestic regulatory
responsibility and the Advisers. The Administrator of
OIRA shall chair the Working Group and shall periodically
advise the President and the Congress on the activities
of the Working Group. The Working Group shall serve
as a forum to assist agencies in identifying and analyzing
important regulatory issues (including, among others (1)
the development of innovative regulatory techniques, (2)
the methods, efficacy, and utility of comparative risk as-
sessment in regulatory decision-making, and (3) the devel-
opment of short forms and other streamlined regulatory
approaches for small businesses and other entities). The
Working Group shall meet at least quarterly and may
meet as a whole or in subgroups of agencies with an inter-
est in particular issues or subject areas. To inform its dis-
cussions, the Working Group may commission analytical
studies and reports by OIRA, the Administrative Con-
ference of the United States, or any other agency.
(e) CONFERENCES.—The Administrator of OIRA and
the heads of agencies shall meet quarterly with representa-
tives of State, local, and tribal governments to identify
both existing and proposed regulations that may uniquely
or significantly affect those governmental entities. The
Administrator of OIRA shall also convene, periodically
conferences with representatives of businesses, nongovern-
mental organizations, and the public to discuss regulatory
issues of common concern.
(f) DEFINITION.—For purposes of this section, the
term ‘‘agency’’ includes independent regulatory agencies,
as defined in section 3502(10) of title 44 United States
Code.
SEC. 5. EXISTING REGULATIONS.
(a) OBJECTIVES.—The objectives of this section are
to reduce the regulatory burden on the American people,
their families, their communities, their State, local, and
tribal governments, and their industries, to determine
whether regulations promulgated by the executive branch
of the Federal Government have become unjustified or un-
necessary as a result of changed circumstances, to confirm
that regulations are both compatible with each other and
not duplicative or inappropriately burdensome in the ag-
gregate, to ensure that all regulations are consistent with
the President’s priorities and the principles set forth in
this Act, within applicable law, and to otherwise improve
the effectiveness of existing regulations.
(b) PROGRAM FOR REVIEW.—Within 90 days after
the date of the enactment of this Act, each agency shall
submit to OIRA a program, consistent with its resources
and regulatory priorities, under which the agency will peri-
odically review its existing significant regulations to deter-
mine whether any such regulations should be modified or
eliminated so as to make the agency’s regulatory program
more effective in achieving the regulatory objectives, less
burdensome, or in greater alignment with the President’s
priorities and the principles set forth in this Act. Any sig-
nificant regulations selected for review shall be included
in the agency’s annual Plan. The agency shall also identify
any legislative mandates that require the agency to pro-
mulgate or continue to impose regulations that the agency
believes are unnecessary or outdated by reason of changed
circumstances.
(c) FUNCTION OF ADMINISTRATOR OF OIRA.—The
Administrator of OIRA shall work with the Regulatory
Working Group and other interested entities to pursue the
objectives of this section. State, local, and tribal govern-
ments are specifically encouraged to assist in the identi-
fication of regulations that impose significant or unique
burdens on those governmental entities, and that result
in the compliance costs that are not funded by the Federal
Government, appear to have outlived their justification, or
are otherwise inconsistent with the public interest.
(d) OTHER REGULATIONS FOR REVIEW.—The Ad-
ministrator of OIRA, in consultation with the Advisers,
may identify for review by the appropriate agency or agen-
cies other existing regulations of an agency or groups of
regulations of more than one agency that affect a particu-
lar group, industry, or sector of the economy, or may iden-
tify legislative mandates that may be appropriate for re-
consideration by the Congress.
SEC. 6. CENTRALIZED REVIEW OF REGULATIONS.
(a) APPLICATION.—The requirements set forth in
this section shall apply to all regulatory actions (including
both new and existing regulations) by agencies other than
those agencies specifically exempted by the Administrator
of OIRA.
(b) AGENCY RESPONSIBILITIES.—
(1) Each agency shall (consistent with its own
rules, regulations, or procedures) provide the public
with meaningful participation in the regulatory proc-
ess. In particular, before issuing a notice of pro-
posed rulemaking, each agency should, where appro-
priate, seek the involvement of those who are in-
tended to benefit from and those expected to be bur-
dened by any regulation (including, specifically,
State, local, and tribal officials). In addition, each
agency should afford the public a meaningful oppor-
tunity to comment on any proposed regulation,
which in most cases should include a comment pe-
riod of not less than 60 days. Each agency also is
directed to explore and, where appropriate, use con-
sensual mechanisms for developing regulations, in-
cluding negotiated rulemaking.
(2) Within 60 days of the date of the enactment
of this Act, each agency head shall designate a Reg-
ulatory Policy Officer who shall report to the agency
head. The Regulatory Policy Officer shall be involved
at each stage of the regulatory process to foster the
development of effective, innovative, and least bur-
densome regulations and to further the principles set
forth in this Act.
(3) In addition to adhering to its own rules and
procedures and to the requirements of chapters 5, 6,
and 7 of title 5, United States Code, the Paperwork
Reduction Act of 1980, and other applicable law,
each agency shall develop its regulatory actions in a
timely fashion and adhere to the following proce-
dures with respect to a regulatory action:
(A) Each agency shall provide OIRA, at
such times and in the manner specified by the
Administrator of OIRA, with a list of its
planned regulatory actions, indicating those
which the agency believes are significant regu-
latory actions within the meaning of this Act.
Absent a material change in the development of
the planned regulatory action, those not des-
ignated as significant will not be subject to re-
view under this section unless, within 10 work-
ing days of receipt of the list, the Administrator
of OIRA notifies the agency that OIRA has de-
termined that a planned regulation is a signifi-
cant regulatory action within the meaning of
this Act. The Administrator of OIRA may
waive review of any planned regulatory action
designated by the agency as significant, in
which case the agency need not further comply
with subparagraph (B) or (C).
(B) For each matter identified as, or de-
termined by the Administrator of OIRA to be,
a significant regulatory action, the issuing
agency shall provide to OIRA—
(i) the text of the draft regulatory ac-
tion, together with a reasonably detailed
description of the need for the regulatory
action and an explanation of how the regu-
latory action will meet that need; and
(ii) an assessment of the potential
costs and benefits of the regulatory action,
including an explanation of the manner in
which the regulatory action is consistent
with a statutory mandate and, to the ex-
tent permitted by law, promotes the philos-
ophy and principles set forth in sections
2(a) and 2(b), respectively, and avoids
undue interference with State, local, and
tribal governments in the exercise of their
governmental functions.
(C) For those actions identified as, or de-
termined by the Administrator of OIRA to be,
a significant regulatory action, the agency shall
conduct an analysis that includes the following:
(i) An assessment, including the un-
derlying analysis, of benefits anticipated
from the regulatory action (including the
promotion of the efficient functioning of
the economy and private markets, the en-
hancement of health and safety, the pro-
tection of the natural environment, and the
elimination or reduction of discrimination
or bias) together with, to the extent fea-
sible, a quantification of those benefits.
(ii) An assessment, including the un-
derlying analysis, of costs anticipated from
the regulatory action (including the direct
cost to the Federal Government and State
and local governments in administering the
regulation and to businesses and others in
complying with the regulation, and any ad-
verse effects on the efficient functioning of
the economy, private markets (including
productivity, employment, and competitive-
ness), health, safety, and the natural envi-
ronment), together with, to the extent fea-
sible, a quantification of those costs.
(iii) An assessment, including the un-
derlying analysis, comparing costs and
benefits of potentially effective and reason-
ably feasible alternatives to the planned
regulation and to the extent feasible a
quantitative comparison of costs and bene-
fits (including improving the current regu-
lation and reasonably viable nonregulatory
actions), and an explanation why the
planned regulatory action is preferable to
the identified potential alternatives.
(D) In emergency situations or when an
agency is obligated by law to act more quickly
than normal review procedures allow, the agen-
cy shall notify OIRA as soon as possible and,
to the extent practicable, comply with subpara-
graphs (B) and (C). For those regulatory ac-
tions that are governed by a statutory or court-
imposed deadline, the agency shall, to the ex-
tent practicable, schedule rulemaking proceed-
ings so as to permit sufficient time for OIRA
to conduct its review, as set forth in subsection
(c)(2) through (4).
(E) After the regulatory action has been
published in the Federal Register or otherwise
issued to the public, the agency shall—
(i) make available to the public the in-
formation set forth in subparagraphs (B)
and (C);
(ii) identify for the public, in a com-
plete, clear, and simple manner, the sub-
stantive changes between the draft submit-
ted to OIRA for review and the action sub-
sequently announced; and
(iii) identify for the public those
changes in the regulatory action that were
made at the suggestion or recommendation
of OIRA.
(F) All information provided to the public
by the agency shall be in plain, understandable
language.
(c) OIRA RESPONSIBILITIES.—The Administrator of
OIRA shall provide meaningful guidance and oversight so
that each agency’s regulatory actions are consistent with
applicable law and the philosophy and principles set forth
in sections 2(a) and 2(b) and do not conflict with the poli-
cies or actions of another agency. OIRA shall, to the ex-
tent permitted by law, adhere to the following guidelines:
(1) OIRA may review only actions identified by
the agency or by OIRA as significant regulatory ac-
tions under subsection (b)(3)(A).
(2) OIRA shall waive review or notify the agen-
cy in writing of the results of its review within the
following time periods:
(A) For any notices of inquiry, advance no-
tices of proposed rulemaking, or other prelimi-
nary regulatory actions prior to a notice of pro-
posed rulemaking, within 10 calendar days after
the date of submission of the draft action to
OIRA.
(B) For all other regulatory actions, within
90 calendar days after the date of submission
of the information set forth in subparagraphs
(B) and (C) of this section, except that if OIRA
has previously reviewed this information and,
since that review, there has been no material
change in the facts and circumstances upon
which the regulatory action is based, OIRA
shall complete its review within 45 days after
the date of submission of such information.
(C) The review process may be extended
(i) once by no more than 30 calendar days upon
the written approval of the Director, and (ii) at
the request of the agency head.
(3) For each regulatory action that the Admin-
istrator of OIRA returns to an agency for further
consideration of some or all of its provisions, the Ad-
ministrator of OIRA shall provide the issuing agency
a written explanation for such return, setting forth
the pertinent provision of this Act on which OIRA
is relying. If the agency head disagrees with some or
all of the bases for the return, the agency head shall
so inform the Administrator of OIRA in writing.
phone conversations between OIRA person-
nel and any such persons).
(iii) OIRA shall publicly disclose rel-
evant information about such communica-
tions, as set forth in subparagraph (B).
(B) OIRA shall maintain a publicly avail-
able log that shall contain, at a minimum, the
following information pertinent to regulatory
actions under review:
(i) The status of all regulatory ac-
tions, including if (and if so, when and by
whom) Vice Presidential and Presidential
consideration was requested.
(ii) A notation of all written commu-
nications forwarded to an issuing agency
under subparagraph (A)(ii).
(iii) The dates and names of individ-
uals involved in all substantive oral com-
munications, including meetings and tele-
phone conversations, between OIRA per-
sonnel and any person not employed by the
executive branch of the Federal Govern-
ment, and the subject matter discussed
during such communications.
(C) After the regulatory action has been
published in the Federal Register or otherwise
issued to the public, or after the agency has an-
nounced its decision not to publish or issue the
regulatory action, OIRA shall make available to
the public all documents exchanged between
OIRA and the agency during the review by
OIRA under this section.
(5) All information provided to the public by
OIRA shall be in plain, understandable language.
SEC. 7. RESOLUTION OF CONFLICTS.
To the extent permitted by law, disagreements or
conflicts between or among agency heads or between OMB
and any agency that cannot be resolved by the Adminis-
trator of OIRA shall be resolved by the President or a
designee of the President.
SEC. 8. PUBLICATION.
Except to the extent required by law, an agency shall
not publish in the Federal Register or otherwise issue to
the public any regulatory action that is subject to review
under section 6 until—
(1) the Administrator of OIRA notifies the
agency that OIRA has waived its review of the ac-
tion or has completed its review without any re-
quests for further consideration, or
(2) the applicable time period in section 6(b)(2)
expires without OIRA having notified the agency
that it is returning the regulatory action for further
consideration under section 6(b)(3),
whichever occurs first. If the terms of the preceding sen-
tence have not been satisfied and an agency wants to pub-
lish or otherwise issue a regulatory action, the head of that
agency may request Presidential consideration through the
Administrator of OIRA, as provided under section 8. Upon
receipt of this request, the Administrator of OIRA shall
notify the Advisers. The guidelines and time period set
forth in section 8 shall apply to the publication of regu-
latory actions for which Presidential consideration has
been sought.
SEC. 9. AGENCY AUTHORITY.
Nothing in this Act shall be construed as displacing
the agencies’ authority or responsibilities, as authorized
by law.
SEC. 10. JUDICIAL REVIEW.
Nothing in this Act shall affect any otherwise avail-
able judicial review of agency action. This Act is intended
only to improve the internal management of the Federal
Government and does not create any right or benefit, sub-
stantive or procedural, enforceable at law or equity by a
party against the United States, its agencies or instrumen-
talities, its officers or employees, or any other person.
SEC. 11. DEFINITIONS.
For purposes of this Act:
(1) The term ‘‘Advisers’’ refers to such regu-
latory policy advisers to the President as the Presi-
dent and the Administrator of OIRA may from time
to time consult, including, among others—
(A) the Director of OMB;
(B) the Chair (or another member) of the
Council of Economic Advisers;
(C) the Assistant to the President for Eco-
nomic Policy;
(D) the Assistant to the President for Do-
mestic Policy;
(E) the Assistant to the President for Na-
tional Security Affairs;
(F) the Assistant to the President for
Science and Technology;
(G) the Assistant to the President for
Intergovernmental Affairs;
(H) the Assistant to the President and
Staff Secretary;
(I) the Assistant to the President and
Chief of Staff to the Administrator of OIRA;
(J) the Assistant to the President and
Counsel to the President; and
(K) the Deputy Assistant to the President
and Director of the White House Office on En-
vironmental Policy.
(2) Except as provided in section 4(f), the term
‘‘agency’’ means any authority of the United States
that is an ‘‘agency’’ under section 3502(1) of title
44, United States Code, other than those considered
to be independent regulatory agencies, as defined in
section 3502(10) of title 44, United States Code.
(3) The term ‘‘Director’’ means the Director of
OMB.
(4) The term ‘‘regulation’’ or ‘‘rule’’ means an
agency statement of general applicability and future
effect, which the agency intends to have the force
and effect of law, that is designed to implement, in-
terpret, or prescribe law or policy or to describe the
procedure or practice requirements of an agency. It
does not, however, include—
(A) regulations or rules issued in accord-
ance with the formal rulemaking provisions of
sections 556 and 557 of title 5, United States
Code;
(B) regulations or rules that pertain to a
military or foreign affairs function of the
United States, other than procurement regula-
tions and regulations involving the import or
export of non-defense articles and services;
(C) regulations or rules that are limited to
agency organization, management, or personnel
matters; or
(D) any other category of regulations ex-
empted by the Administrator of OIRA.
(5) The term ‘‘regulatory action’’ means any
substantive action by an agency (normally published
in the Federal Register) that promulgates or is ex-
pected to lead to the promulgation of a final rule or
regulation, including notices of inquiry, advance no-
tices of proposed rulemaking, and notices of pro-
posed rulemaking.
(6) The term ‘‘significant regulatory action’’
means any regulatory action that is likely to result
in a rule that may—
(A) have an annual effect on the economy
of $100 million or more or adversely affect in
a material way the economy, a sector of the
economy, productivity, competition, jobs, the
environment, public health or safety, or State,
local, or tribal governments or communities;
(B) create a serious inconsistency or other-
wise interfere with an action taken or planned
by another agency;
(C) materially alter the budgetary impact
of entitlements, grants, user fees, or loan pro-
grams or the rights and obligations of recipi-
ents thereof; or
(D) raise novel legal or policy issues aris-
ing out of legal mandates, the President’s prior-
ities, or the principles set forth in this Act.
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